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POLICY AND PROCEDURE MANUAL OF THE PHARMACY DEPARTMENT OF UNIVERSITY HOSPITAL AT BROOKLYN TABLE OF CONTENTS
Note: Related Policies & Procedures to JCAHO Standards Are Indexed with MM Standard Reference and National Patient Safety Goals Are Indexed with NPSG Reference Chapter 1. Definition and use of Policy & Procedures Manual Section A. Mission of Pharmacy Chapter 2. Integration of Pharmacy Services into the Hospital Organization Chapter 3. Personnel Issues Section A. Pharmacy Staffing Section B. Departmental Table of Organization Section C. Emergency Evening/Night Staff Shift Coverage Section D. On-Call/Re-Call System 1) Departmental Guidelines for Temporary Disability Calls Section E. Break Periods Section F. Dress and Grooming Codes Section G. Job Description – Director of Pharmacy Section H. Job Description – Associate Director Section I. Job Description – T.H. Pharmacist/Senior Pharmacist Section J. Job Description – T.H. Pharmacy Assistant (Technician) Section K. Job Description T.H. Pharmacy Aide Section L. Job Description – Staff Assistant II (Materials Mgr.) Section M. Job Description – Hospital Attendant Section N. Job Description – Secretary Section O. Orientation and Continuing Education of Pharmacy Section P. Committee Membership of Pharmacy Personnel Chapter 4. Inpatient Dispensing of Medications MM.1.1.10, MM.3.20, MM.4.10, MM.4.30, MM.4.40, MM.7.10 Section A. Main Pharmacy (Cassette Exchange) NPSG 2,3, and 8 Section B. Satellite Pharmacies Section C. Unit Dose Drug Distribution Policy Section D. Appendix to Unit Dose Distribution Policy Section E. Prescription Writing Authority in the UHB; Approved Hospital Abbreviations; Un-approved Abbreviation List Section F. Investigational Drug Dispensing Policy MM.7.40 Section G. Verification and Reviewing of Prescription Orders NPSG 1, 2, & 3 Section H. Prescriptions For Non-FDA Approved Indications or Dosage of Medications Section I. DELETED Section J. Patient Self Medication Policy MM.5.20

Section K. Floor Stock Medication and Distribution Sub-Section I.: Insulin as Floor-stock Section L. Intra-Hospital Distribution of Medication

Section M.

Pass Medications

Chapter 5. Controlled Substances Section A. Definition of Controlled Substances MM.2.20, MM.2.30, MM.

2.40, MM.4.40, MM.7.10
Section B. Inpatient Dispensing of Controlled Substances to Nursing Care Areas 1. Verification of the Administration Record Entries for Controlled Substances Section C. Outpatient Dispensing of Controlled Substances to Clinic Nursing Stations Section D. DELETED Section E. Storage of Controlled Substances Section F. Inventory Control of Controlled Substances Section G. Acquisition Process for Controlled Substances Section H. Verification of DEA Numbers Section I. Expired, Deteriorated, and Non-Reusable Controlled Substances and heir Deposition MM.4.80 Section J. Issuance and Control of NYS Official Prescription Forms Section K. Loss or Theft of Controlled Substances or Official New York State Controlled Substance Prescription Books Section L. Automatic Medication Stop Order Policy MM.7.10 Section M. Controlled Substances Approved Forms for Use at UHB Section N. Administration of Controlled Substances to Visiting Family Members Chapter 6. Repackaging of Pharmaceuticals Either in Unit Dose or Unit of Use Form Chapter 7.Compounding of Pharmaceuticals for Internal or External Use MM.4.20 Chapter 8. Absolute and 95% Alcohol Section A. Definition of Absolute and 95% Alcohol Section B. Ordering of Absolute or 95% Alcohol Section C. Inventory Control and Storage of Absolute or 95% Alcohol Section D. Dispensing of Absolute and 95% Alcohol Section E. Licensing Requirements for the Purchase and Dispensing of Absolute and 95% Alcohol Chapter 9. Adverse Outcomes M.M.6.10, MM.6.20, M.M.8.10 Section A. Medication Errors and Hospital Incident Reporting Involving Medication Section B. Drug – Drug Interactions Section C. (1) Drug – Food Interactions (2) Drug – Food Interactions Monitoring (3) Formulary Drugs Tagged in the Computer Mainframe for DrugFood Interactions Patient Counseling (4) Guide to Food & Drug Interaction Patient Counseling

*Section D. Drug Recalls M.M.4.70 Section E. Adverse Drug Reaction Reporting Section F. Poisoning and Antidotes Section G. Antitoxins and Toxoids Section H. Drug and Device Defects Reporting Chapter 10. Handling of Non-Formulary Medications (including Home Medications and Medications brought in by Practitioners) MM.2.40

Chapter 11. Nursing Station Inspections MM.2.20
Chapter 12. Automatic Medication Stop Order Policy MM.7.10 Chapter 13. Outsourcing of Medications Chapter 14. Procurement of Pharmaceuticals MM.2.10 Section A. Choosing a Vendor Section B. Prime Vendor Program Section C. Borrowing or Loaning of Pharmaceuticals from/to Other Hospitals *Section D. Drug Return Policy M.M.4.80 Section E. Sales Representatives Section F. Inventory and Purchasing Controls Chapter 15. Emergency Drugs and the Pharmacy’s Emergency Responsibilities M.M.2.30 Section A. Pharmacy Responsibility for Crash Carts/Boxes Section B. Controls and Security of Emergency Medications in Crash Carts Section C. Crash Cart Inspections Section D. Drugs Maintained on Crash Carts MM.7.10; NPSG 3 Section E. Crash Cart Distribution at UHB Section F. Pharmacy’s Disaster Cart Section G. Pharmacy Disaster Plan Section H. Emergency Drug Supplies Provided to the Emergency Room Section I. Infant Abduction Policy Section J. Hospital Evacuation/Transfer Procedures Chapter 16. Handling of Multi-dose Vials of Inhalation, Injectable, and Ocular Medication MM.2.20; NPSG 7 Chapter 17. Storage of Pharmaceuticals MM.2.20 Section A. Look-Alike/Sound-Alike Drugs Chapter 18. Antibiotic Control Program MM.8.10; NPSG 7 Section A. Antibiotic Surveillance/Control/Review Policy Hospital-wide Section B. Approved Controlled Antibiotics List Section C. Pharmacy Antibiotic Monitoring Chapter 19. Drug Information and Staff Education Section A. Drug Information to Hospital Services Section B. Drug Information to Discharge and Ambulatory OPD Patients Section C. Patient Medication Profile System MM.1.10; NPSG 8

Section D. Continuing Education of the Pharmacy Staff Section E. Pharmacy Staff Meetings Chapter 20. Prescription Transmission to the Pharmacy Via Fax Machine Chapter 21. Hospital & Patient Confidentiality Section A. The Pharmacy Department’s Patient Confidentiality and Data Security Policy Section B. Patient Bill of Rights and Pharmacy Code of Ethics

Section C.

DELETED

Chapter 22. Inter-Departmental Pharmacy/Nursing Policies Section A. Administrative Table of Organization for the Department of Nursing Services Section B. Drug Weight Conversion Charts on Nursing Care Areas Section C. Medication Orders for Discharge Patients Section D. Medication Storage Areas MM.2.2, 2.3, 2.4 Section E. Medication Orders for Heparin NPSG 2 & 3 Section F. Dispensing Concentrated Sodium Chloride (23.4%) for Sputum Induction MM.7.10; NPSG 3 Chapter 23. Out-Patient Prescription Dispensing MM.1.10 Section A. Medication Dispensing on Prescription Orders Section B. Verification of Practitioner’s Name, License/Registration, and Signature on Ambulatory/Discharge Prescriptions Section C. Weekend and Holiday Dispensing of Ambulatory Care Prescriptions Section D. Prescription Pricing Policy for Ambulatory Care Prescriptions Section E. Cash Transactions Involving Ambulatory Care Prescriptions Section F. Collection Procedures for OPD Pharmacy Services Chapter 24. Safety Policies Section A. General Safety Section B. Fire/Emergency Alarm Codes Section C. Pharmacy Fire Control Units Section D. Pharmacy Key Control Section E. Power Failure Section F. Authorized Signatures and Computer Security Chapter 25. Infection Control MM.4.20; NPSG 7 Chapter 26. Pharmacy and Therapeutics Committee MM.2.10, MM.6.10, MM.6.20, M.M.8.10; NPSG 2, 3, & 9 Section A. Requesting an Addition of a Drug to the Formulary Chapter 27. Administration of Drugs within University Hospital at Brooklyn Section A. Medication Administration Schedule M.M.5.10 Chapter 28. Drug Samples on University Hospital at Brooklyn Property Chapter 29. Sterile Parental Compounding MM.4.20; NPSG 7

Section A. Policy Statement on the Compounding of Sterile Parenteral Admixtures Section B. Staffing Responsibilities and Supervision in the Sterile Parenteral Compounding Laboratories Section C. Aseptic Manipulations (1) Working under the Lamina Air-Flow Hood (2) Syringe Manipulations (3)Reconstitutions and Transfer of a Drug to a Parenteral Solution Section D. Preparing the Sterile Parenteral Admixtures Section E. Discontinued Parenteral Preparations MM.4.80 Section F. Sterility and Quantitative Testing of the Parenteral Solutions Section G. Procedures and Addendums for the Operation of the Automix®, Micromix®, and IV Laboratory Computer Systems Section H. Physician Order Forms for Parenteral Admixtures Section I. Cytotoxic Drug Admixtures Chapter 30. Dispensing of Albumin Solutions Chapter 31. Dosing of Cardiac Medications: Nitrates and Other Anti-Anginals MM.7.10 Chapter 32. Pharmaceuticals Education for Patients and Family Members Chapter 33. TPA Injection for Catheter Clearance Chapter 34. Management of the Pyxis® Medication Chapter 35. High Risk Electrolyte Solutions NPSG 3 Chapter 36. Therapeutic Interchange Policy NPSG 3 Chapter 37. Medication Reconciliation NPSG 8 Chapter 38. Advance ECHO Lab Emergency Medication Box Chapter 39. Patient Medication Orders MM.3.20; NPSG 1 & 2 Chapter 40. Medication Security when Patients are Transferred between Services MM.2.30, MM.4.10, MM.8.10, NPSG #8 Chapter 41. Labeling of Medication/Solution in Perioperative and Procedural Areas NPSG 3D Chapter 42. Look-Alike/Sound-Alike Drugs NPSG 3C Chapter 43. Chemotherapy Ordering and Dispensing MM.3.10.3.20,4.10-4.80, 5.120-5.20 Chapter 44. Ordering and Dispensing of Parenteral Chemotherapy for Non-Oncology Indications (PHA19)

Chapter 45. Medication Orders for Contrast Media for Imaging Procedures (RAD-12) Chapter 46. Titration of Medication Continuous Infusion (PHA-18) Chapter 47. Management of Extravasation Injuries (PHA-20) Chapter 48. Fentanyl Patches Chapter 49. Thalidomide Chapter 50. ID Pharmacy PGY-2 Resident Qualifications and Obligations Chapter 51. IV to Oral Antimicrobial Conversion Program

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 1___ Subject: DEFINITION AND USE OF THE POLICY AND PROCEDURE MANUAL Prepared by: Reviewed by: NICHOLAS GALEOTA WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 3/17/00

Implementation Date: ___8/17/99__ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manua Issued by: Regulatory Affairs

Approved by: CONSTANCE SHAMES, M.D.

I. II.

Purpose: To serve as a guide to all personnel for the proper operation of the Pharmacy service within the Hospital. Definition(s): Each policy and/or procedure covers a specific phase of activity in detail in order that all personnel will accomplish the same function in a manner similar to that of their working associates and thereby obtain the same results. Policy: The manual is not intended to be a static reference. It will be updated on a continuing basis and it is expected that all members of the Pharmacy Staff will contribute ideas and suggestions for the improvement of procedures thereby resulting in revision of the manual contents. Everyone must feel free to constructively criticize any procedure described herein and enter into a free discussion with the Director of Pharmacy Services on any phase of any and all policies in order to improve departmental or organizational performance. Responsibilities (Include all departments/services involved in development/implementation and/or monitoring): N/A Procedures/Guidelines: The policy and procedure manual is also utilized as the basic tool for the orientation of new staff members. All items in this Policy and Procedure Manual relating to the use, distribution, and storage of drugs and the monitoring of the use of medication modalities have been reviewed and approved by the Pharmacy and Therapeutics Committee of the Medical and Dental Staff at SUNY-Downstate Medical Center and the Executive Committee of the Medical Board.

III.

IV.

V.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: NONE References: NONE Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

NICHOLAS GALEOTA MS, RPH

7

Chapter 1. Section A. Mission of the UHB Pharmacy Department The Mission of the Hospital Pharmacy is: a. The basic guiding philosophy for the Pharmacy Staff is to provide the most, accurate complete, safe, neat and expedient Pharmacy service for the patients of the UHB that is expedient Pharmacy Service for the patients of UHB that is possible to render. This is to be accomplished with the utmost regard to the patient’s rights, dignity and privacy. Nothing less than compassion and total commitment to patient care shall be acceptable from the Pharmacy staff. b. To provide the benefits, protection, and pharmacological knowledge of a hospital pharmacist to the patient, the institution, and members of all health professions within the hospital. This includes provision for patient and family education on the safe and effective use of medications. c. To educate future practitioners in hospital pharmacy practice. d. To increase the dissemination of pharmaceutical knowledge providing for drug information education of hospital staff and patient. This mission is accomplished by: 1. Filling, labeling, and dispensing of all drugs, chemicals, and pharmaceutical preparations issued to nursing units, in-patients, and out-patients and dispense in-patient drugs in unit dose form. 2. Provide parenteral dosage forms in ready to use unit dose IV additive/admixture forms. 3. Bulk compounding or pharmaceuticals. 4. The establishment and supervision of control procedures for the distribution and use of all narcotic drugs, controlled substances, alcohol, and other prescribed drugs. 5. Inspection of medications on all nursing units at monthly intervals. 6. Maintaining an approved stock of emergency drugs in each nursing unit including the ambulatory care areas and exchange trays for all code carts. 7. Participating in the teaching of a course in Clinical Pharmacy Practice to undergraduate students of Long Island University and Pharm. D. based curriculum to post-graduates. 8. Encouraging graduate study in the fields of pharmacy, pharmacology, and pharmaceutical chemistry/kinetics as they relate to hospital pharmacy. 9. Assisting members of the hospital staff in studies involving investigational drugs and act as the Pharmacy of Record for the protocol. 10. Providing pharmaceutical dosage forms, including extemporaneous compounding, as prescribed for patient care by the medical and surgical staff. 11. Participation on the Pharmacy and Therapeutics Committee. 12. Cooperation in the Nursing In-Service Education Programs. 13. Participation in the publication of the Pharmacy news letter which is of interest to the Nursing and medical staff.

8

14. Furnishing information concerning medications to physicians, dentist, nurses, and other members of the hospital staff. 15. Keeping abreast of the latest advances in Hospital Pharmacy practice. 16. Provide Clinical Pharmacy services via satellite Pharmacy sites and patient team rounding at the selected areas in the hospital. 17. Purchase and stock all medications. 18. Prepare, under aseptic conditions, parenteral fluids with added medications. 19. Conduct in-service educational programs as needed for the Pharmacy staff. 20. Supply Pharmacy items to other departments as required. 21. Provide Pharmacy service in those specialized areas requiring decentralized distribution via a Satellite Pharmacy program. 22. Provide drug information to all healthcare providers. 23. Counsel patients and their family members on demand about heir drug therapies. 24. Maintain up-to-date medication databases.

25. Utilize computer and automation technology to maintain the highest degree to safety, security and
accuracy when dispensing medications.

9

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 2___ Subject: INTEGRATION OF PHARMACY SERVICES INTO THE HOSPITAL ORGANIZATION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of __1__ Original Issue date: 6/1/2001 Implementation Date: 6/1/2001___________ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

I.

Purpose: To demonstrate the integration of Pharmacy Services within the continuum of care of the hospital. Definition(s): N/A Policy: The chain of accountability within the hospital radiates downward form the President (the Governing Body) through his designated administrative staff to all departments. Some departments and services are directly accountable to the Senior Associate Administrator while others are assigned to designated staff members. Responsibilities: N/A Procedures/Guidelines: The Pharmacy Director is under direct administrative control and direction of the Senior Associate Administrator for Support Services. He/she reports directly to him/her on all major matters and in the resolution of problems that cannot be satisfactorily settled in routine fashion or require a major administrative decision. A descriptive diagram of the Hospital Table of Organization follows this sheet for a ready reference.

II. III.

IV. V.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Downstate Table of Organization References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

10

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. A___ Subject: PHARMACY STAFFING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: 2/16/03 Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To provide adequate staffing to address the pharmaceutical needs of the hospital 24 hours per day 7 days per week. II. III. Definition(s): N/A Policy: It shall be the responsibility if the Departmental Director or his designee to implement and maintain a staffing schedule that will insure coverage by Pharmacists and Pharmacy Technicians that shall be adequate to provide timely service in keeping with work load and traffic flow. The hours of operation for the services provided by the Pharmacy Department are as follows: The Pharmacy Operational Hours are as Follows: Main Pharmacy: Room ALL 1-469   OPD: IPD: 8:30 A.M. – 5:00P.M., Monday through Friday 24 hours per day, 7 days per week, including holidays

Hyperalimentation Lab:  8:30A.M. – 5:00P.M.,Monday through Friday and as needed on WHEN tours Oncology Services: Room A6-401  8:30A.M. – 5:00P.M., Monday through Friday Operating Room Satellite Pharmacy: Room A2-481  6:30A.M. – 3:00P.M., Monday through Friday Parenteral Admixture Lab: Room ALL1-516


7:00 A.M. – 6:00 P.M., Monday through Friday

Investigational Drug Lab: Room ALL1-514A


8:30 A.M. to 5:00 P.M., Monday through Friday, On-Call status during other hours

11

IV. V.

Responsibilities: N/A

Procedures/Guidelines: 1. Daily assignment sheets shall be prepared prior to 8:30 A.M. which allow adequate coverage of all service areas that the Pharmacy Department provides. Chapter 3. Sect. (A) continued 2. Staff Pharmacists shall rotate equally on weekend day shifts and, in case of emergencies, evening and night weekend and weekday shift coverage. 3. Full time technicians shall rotate equally on weekend coverage during Pharmacy operational weekend hours 8:30 A.M. – 12:00 Midnight, and in emergencies through the night shift. 4. Pharmacists shall cover all shifts, Tours I, II, and III Monday through Sunday. 5. Staff Pharmacists and technicians covering weekends shall take time off Monday and Tuesday (for weekend evening coverage compensation) and Wednesday and Thursday (for weekend day coverage compensation) of the week following the assignment. 6. Monday through Friday, the staff shall report to the department at 8:00 A.M., 3:30 P.M., or 11:30 P.M. according to a pre-assigned schedule. 7. Vacation schedules will be adapted to the situation and work-load at the time of request and follow departmental request procedures. 8. Under no circumstances should the Pharmacy be open for service without a pharmacist on duty. 9. The operational hours of the OR satellite pharmacy are 6:30 A.M. through 3:00 P.M., Monday – Friday. Service after these hours reverts to the Control Drug Module or the Main Pharmacy. 10. Official NYS holiday shifts (day, evening, or night) shall be covered by a pharmacist and Pharmacy assistant. All staff pharmacists and Pharmacy assistants shall share in this responsibility except for those pharmacists who in the judgment of the Pharmacy Administration would adversely affect the Pharmacy’s operations if they were to participate in the holiday shift duties subsequent compensatory time off. When personal needs require changes in the schedule for weekend or holiday duty the person desiring a change is responsible for working out alternate coverage at peer level and advising the Director or his designee. Whoever assumes the assignment shall make the change on the weekend/holiday schedule and indicate acceptance and responsibility for the change by placing his/her initials on the schedule and must inform the Associate Director of Pharmacy. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

12

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. B___ Subject: DEPARTMENTAL TABLE OF ORGANIZATION Prepared by: Reviewed by: NICHOLAS GALEOTA WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 3/17/00 12/1/04 Implementation Date: ___________ Administrative Manual Department Manual Patient Care Manual AOD Manual

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

_______________________________________________________________________________________ I. Purpose: To serve as a guide to all personnel for the proper functions of Pharmacy Service areas and reporting lines.. II. III. Definition(s): N/A Policy: The administrative authority and responsibility within the Pharmacy Department begins with the Director and runs down through the appropriate titles within the department. Responsibilities: N/A Procedures/Guidelines: Functions of Pharmacy Service Areas

IV. V.

Materials Management:  Drug and supply purchase requisitions  Receipt of merchandise  Reconciliation of invoices and purchase orders  Returns of un-usable or expired merchandise  Processing drug recalls  Purchase order record keeping  Inspection of merchandise  Borrowing/lending merchandise between hospitals  Annual inventory supervision sand planning  Prime vendor management  Drug usage reports  Formulary additions/deletions to and from information management system  PI activity participation  Inventory management Satellite Pharmacies:  Drug cassettes filling and exchanges  Maintenance of Nursing station supplies  Review patient medical records  Provide drug information  Dispensing record and prescription record keeping  Orientation of new medical house-staff or Nursing staff

13

       

Inventory control of the satellite Rounding with physicians Inter-disciplinary committee participation Nursing station inspections Patient and family education and discharge counseling Telecommunications of orders to Main Pharmacy via FAX PI activity participation Controlled drug dispensing from the OR Satellite

Drug Admixture Services:  Parenteral drug compounding of oncology drugs  Parenteral compounding of hyper-alimentation and cardioplegia solutions  Record keeping of parenteral orders and data management in pc databases  Verification and clinical screening of all admixture orders  Maintenance of patient profiles  Drug information and education to medical house-staff and Nursing staff  Distribution of completed admixtures  Preparation of samples for chemistry and microbiology lab testing  Maintenance of lab result testing of solutions  PI activity participation Main Pharmacy:  OPD prescription dispensing  IPD prescription dispensing  Controlled drug dispensing  Investigational Drug dispensing and record keeping  Prescription record keeping  Nursing station inspections  Extemporaneous drug compounding  Patient and family education and discharge counseling  In-service education to medical house-staff and Nursing staff  Pharmacy student education  Cassette drug filling and exchange  PI activity participation Pharmacy Support Area:  Pre-packaging  Drug label printing  Prescription and floor-stock order record keeping  Inventory management  Unit-dose packaging  Computer charges for medications  Drug order and admixture order delivery  Drug returns and credits processing from Nursing care areas  Separation and discard of deteriorated/expired drugs from inventory Crash cart drug reconciliation and stocking VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Administrative T of O; Departmental T of O Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA, MS, RPH NICHOLAS GALEOTA MS, RPH

VII.

VII. References: none Date Reviewed Revision 12/9/04 10/4/07 Yes Yes Yes Yes

14

ADMINISTRATIVE TABLE OF ORGANIZATION, 12/05:

Robert Jacobs, M.D. CEO

Anny Yeung, RN, MPA AVP Hospital Operations & Perioperative Services

William Gerdes Senior Associate Administrator Pharmacy Therapeutics Committee TH. Staff Assoc. Materials Manager Staff Asst II. Adjunct Clinical Pharmacist Research Clinical Pharmacist Donald Caracciola Associate Director (6) Senior Pharmacists

(11) Pharmacists

(14) Pharmacy Techs

Pharmacy Aide

Hospital Clerk

Pharmacy Attendant

15

Table of Organization Pharmacy Department UHB, (2/05)
Nicholas Galeota Director M. Islam TH. Staff Assoc. Lawrence Melisi Materials Manager Roopali Sharma Adjunct Clinical Pharmacist Motria Mishko Research Clinical Pharmacist Alan Hui Senior Clinical Pharmacist Donald Caracciola Associate Director Ira Dinerman Senior Pharmacist Elizabeth Iroku Senior Pharmacist Helen Pruski Senior Pharmacist Jihan Hanna Senior Pharmacist Raquel Bell Staff Asst II.

Samia Youssef Senior Pharmacist Sung Kew Jung Pharmacist

Henry W. Tseng Pharmacist C. Dufour-Bazelais Pharmacist Rosa Aburto Pharmacist

Miyoung Hahn Pharmacist Digna Roberts Pharmacist Kwame Sarfo Pharmacist

Mahammad Ali Pharmacist Elena Shak Pharmacist Eveline Dorval Pharmacist

Irene Saleh Pharmacist

Reynaldo Rivera Pharmacy Tech Mohammad Edreis Pharmacy Tech Roy Mustard Pharmacy Tech Siu Hoe Oh Pharmacy Tech

Jairho Taboclaon Pharmacy Tech Irina Kuleshova Pharmacy Tech Arlene J. Blyden Pharmacy Tech

Joan Watson Pharmacy Tech Olga Rivera Pharmacy Tech Morvette Spencer Pharmacy Tech

Gloria Safo Pharmacy Tech J. Flemming Pharmacy Tech Edith Bobmanuel Pharmacy Tech

Joyce W. Savage Pharmacy Tech

Leon Gantt Pharmacy Aide

Alva Watson Hospital Clerk

Sandra Cunningham Pharmacy Attendant

16

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. C___ Subject: EMERGENCY EVENING/NIGHT STAFF COVERAGE Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 3/17/00 6/22/01 Implementation Date: ___________ Administrative Manual Department Manual Patient Care Manual AOD Manual

Distribution:

_______________________________________________________________________________________ I. Purpose: To inform all personnel the proper procedure when there is an emergency with staff coverage. II. III. IV. Definition(s): N/A Policy: The Main Pharmacy will remain open 24-hours per day, 7 days per week. Responsibilities: It is the responsibility of Pharmacy Associate Director to seek a pharmacist for this assignment. The Associate Director shall also keep all records of time worked and grant equivalent scheduled time off. Procedures/Guidelines: In the event that the assigned pharmacist is unable to work his or her shift due to an emergency beyond their control, he or she is required to call the Pharmacy office that morning no later than 10 A.M. so that adequate staffing can be arranged. The procedure to obtain emergency coverage will be as follows: 1. A volunteer pharmacist from the day shift shall be sought. 2. In the event that there is no volunteers, then the pharmacist with the least seniority shall be assigned to perform the extra shift, which extends his or her services to 12:00 Midnight or to 8:00 A.M. 3. A record shall be maintained for the emergency duty performed. 4. On the next occasion for emergency coverage the next least senior person shall be assigned the duty in the event of no volunteer. 5. The pharmacist assigned the duty shall be granted equivalent scheduled time off. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none

V.

VII.

17

VIII.

References: none Revision Yes Yes
Yes

Date Reviewed 12/9/04 10/4/07

Required (Circle One) No No
No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

18

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. D ___ Subject: ON-CALL/RECALL SERVICES Prepared by: NICHOLAS GALEOTA Page ____1__ of __1__ Original Issue date: 3/17/00 6/22/01 Implementation Date: ___________

Reviewed by: WILLIAM GERDES

Approved by: CONSTANCE SHAMES, M.D

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

_______________________________________________________________________________________ I. Purpose: To provide a system for supplementing staffing in the event of a staff shortage or emergency. II. III. Definition(s): N/A Policy: The Pharmacy Department shall maintain at least one (1) pharmacist on an On-Call/Recall basis via beeper. A pharmacist shall be On Call at all times to cover staff shortages and emergency situations. TH Pharmacists, TH Senior Pharmacists, and TH Pharmacy Assistants may be re-called at any time if the Pharmacy or hospital operations require the re-call. The on-call pharmacist shall carry a long-range beeper (1-917-760-0496) with the state page at extension 2121. IV. IV. Responsibilities: N/A Procedures/Guidelines: A) When a question or emergency situation arises from the medical staff, nursing staff or administrative staff of UHB, the pharmacist On-Call shall be paged. B) The pharmacist shall respond to the page by calling the telephone number appearing on the beeper. C) The pharmacist shall answer the questions as best as his/her professional knowledge will allow. D) If an emergency situation exists, the On Call pharmacist shall be recalled to UHB, 445 Lenox Road, Brooklyn, Pharmacy Department by either the Director or Associate Director of Pharmacy. E) The Pharmacist shall be allotted a reasonable amount of time to report to the work site (usually within 1 hour). F) When the pharmacist arrives at UHB, he/she must first sign the recall logbook and then proceed to the assigned Pharmacy area and work till the emergency is resolved.

19

G) The pharmacist shall be compensated according to UHB Policy and UUP contractual agreements for On Call/Recall services. H) The pharmacist shall report their On Call/Recall hours on the bi-weekly NTP Report of On Call/Recall services, HSCB form # 0017. I) A monthly report form titled Monthly Overtime Analysis Form (see attached) for Pharmacy Employees shall be compiled every month by the Director of Pharmacy and forwarded to the Senior Associate Administrator responsible for Pharmacy. This form shall provide data for administrative decisions concerning staffing, overtime usage, and budget allocations. This form shall be used for UUP and CSEA employees. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Pharmacy Staff Names and Addresses Sample of On Call/Recall Reporting Forms References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

20

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. E___ Subject: BREAK PERIODS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 3/17/00

6/22/01 Implementation Date: ________ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

_______________________________________________________________________________________ I. Purpose: To advise all personnel the rules of break periods according to their Union Agreements. II. III. A. Definition(s): N/A Policy: Break periods are to be taken according to union agreements by all staff members. Non-Professional (CSEA): Department personnel are entitled to two (2) fifteen minute breaks in the work routine of each routine of each shift worked. This is in addition to the standard thirty minute meal period. The following guidelines shall apply to the scheduling utilization of this commonly-called “coffee break”. 1. Break periods shall not be regularly scheduled because of unpredictable fluctuations in the work load. 2. Personnel desiring such a break can take it after approval by a supervisor. 3. Such breaks can be taken inside or outside of the department. If it is to be spent within the department it must be in the conference room area that is not within a line-of-sight of the main entry to the Pharmacy or the Pharmacy window. 4. Such breaks cannot be added to scheduled meal periods. B. Professional (UUP): According to the UUP agreement, there is no provision for scheduled break time. However, professional employees are entitled to one hour scheduled meal periods, which shall be scheduled by a supervisor. Responsibilities: N/A

IV.

21

V. . VI.

Procedures/Guidelines: All break periods/lunch breaks are scheduled with the Pharmacy supervisor prior to commencing the break.

  

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

22

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. F__ Subject: DRESS AND GROOMING CODES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98 6/22/01 Implementation Date: _______

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To serve as a guide to all personnel to for the proper procedures for dress and grooming codes. II. III. IV. V. Definition(s): N/A Policy: Pharmacy personnel shall observe the following dress and grooming code. (see procedures and guidelines) Responsibilities: N/A Procedures/Guidelines 1. Clothing styles shall be of a nature that will not cause medications to be accidentally dislodged from low shelves during normal movement about the department and that shall preserve modesty when it is necessary to obtain items from the high shelves. 2. Footwear shall be of a nature that will protect the foot in the event of dropped or falling objects striking that part of anatomy. Sandals are not permitted. 3. Hair shall be worn in a fashion that permits restraints being properly worn when working in the clean room or compounding medications. 4. White lab coats shall be worn by all Pharmacy personnel. 5. The approved updated hospital ID tag shall be worn at all times while on hospital property. 6. For the professional staff, the NYS Department of Education’s Board of Pharmacy official white name tag is also to be worn (Reference: Pharmacy Handbook, NYS, Article 130, Section 6808-a, page 33) in place of the hospital I.D. tag, if chosen, while in Pharmacy service areas.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none

VII.

23

VIII.

References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

24

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. G___ Subject: JOB DESCRIPTION: DIRECTOR OF PHARMACY Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: Implementation Date: 3/17/00 6/22/01

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

I. II. III.

______________________________________________________________________________________ Purpose: To serve as a description for the Director of Pharmacy position and duties. Definition(s): N/A Policy: The positions in this job family dispense appropriate doses of drugs to inpatients and outpatients as prescribed by a physician; manufacture sterile and non-sterile prescriptions; deliver drug information and instruction to health care professionals, patients, and their families based on pharmacological expertise and the interpretation of Pharmacy policy. Teaching Hospital Director of Pharmacy: Develops, implements, directs and manages pharmaceutical service programs consistent with the needs of medical staff, patients and the institution. Controls and is accountable for drug products throughout the hospital; develops and implements, with medical staff participation and approval when required, policies and procedures regarding departmental operations and the criteria for evaluation, selection, preparation, procurement, storage, distribution and all other matters relating to drug use in the hospital. Collaborates in the development and implementation of programs of records and documentation management ensuring Pharmacy activities involving review, interpretation and therapeutic monitoring of all drug order, the maintenance of patient medical profiles and participation in patient care. Develops programs to evaluate the effectiveness of drug utilization and departmental function; oversees the preparation of the department’s budget for staff, supplies and equipment. Ensures the maintenance of departmental practice standards and satisfactory operation of staff, nursing, medical staff and students. Ensures compliance with Hospital policies and procedures, local, state, and federal regulations, rules and regulations of the medical staff mandatory JCAHO standards and other regulations and they pertain to Pharmacy operations; develops and maintains effective liaison with all other hospital departments and all appropriate external agencies; maintains the formulary and reference text sand journals; consults with and advises medical staff concerning medication (such as: warnings, incompatibility, contraindications, uses, expenditures, etc.). Participates on various committees (note: e.g., Medical Records Committee, the Nutrition Committee, Infectious Control Committee, and The Pharmacy Therapeutic Committee). Functions independently with collaborative supervision. Responsible for in-service program and instruction to medical staff, residents, students and staff. Provides administrative supervision to Pharmacy staff.

IV.

Responsibilities: N/A

25

V. VI.

Procedures/Guidelines: N/A Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

  

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

26

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. H___ Subject: JOB DESCRIPTION: ASSOCIATE DIRECTOR OF PHARMACY Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 3/17/00 6/22/01 Implementation Date: _______ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

_______________________________________________________________________________________ I. Purpose: To serve as a description for the Associate Director of Pharmacy position and duties. II. IV. Definition(s): N/A Policy: N/A Teaching Hospital Associate Director of Pharmacy: Assists the Director of Pharmacy in the daily operation of the Pharmacy ensuring that all sections of the Pharmacy Department are functioning properly,; endures that all documents related to Pharmacy operations (note: e.g., floor stock sheets and controlled drug sheets, orders and prescriptions) have been computerized, counted and stored as required; ensures that all devices are in working order (note: e.g., pharmaceutical balances, refrigerators, and laminar flow hoods); interprets Pharmacy administrative policies and procedures and makes decisions relative to them; assumes responsibility of Director in his/her absence. Advises the Director of all problems pertaining to the operation of the Pharmacy (note: e.g., specific patient care, drug utilization and materials management); supervises the conduct of departmental studies, and the completion of periodic reports, permit applications and surveys for outside agencies (note: e.g., NYS Department of Health, State Board of Pharmacy); ensures that drug recalls are handled expeditiously, including removal of drug from pharmacy shelves, and all hospital locations; maintains and develops work scheduled for Pharmacy staff. Periodically evaluates performance of subordinates; prepares evaluations of requests to add drugs to the Formulary: disseminates or oversees dissemination of information related drug therapy and departmental policies and procedures; ensures the proper resolution and reporting of patient and professional staff complaints; coordinates investigational drug studies and oversees staff participation; represents the department on appropriate committees. Studies and modifies work flow pattern; evaluates operating procedures within the Pharmacy; assist in preparation of the Pharmacy budgets, the purchase of drugs and supplies and maintenance of inventory control records, approves or obtains approval for requisitions and orders for necessary pharmaceuticals and supplies; develops programs institutes by the Pharmacy, including training sessions. Ensures repackaged medications are in compliance with departmental requirements, that labeling is regulations relating to controlled substances and the maintenance of accurate inventories. Reports to the Director of Pharmacy and may supervise the T.H. Senior Pharmacist, T.H. Pharmacist and T.H. Pharmacist Assistant.

IV. V.

Responsibilities: N/A Procedures/Guidelines: N/A

27

VI.

  

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

28

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. I___ Subject: JOB DESCRIPTION: T.H. PHARMACIST/ TH SENIOR PHARMACIST Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 3/17/00 6/22/01 Implementation Date: ___________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To serve as a description for the TH Senior Pharmacist and TH Pharmacist positions and duties. II. III. Definition(s): N/A Policy: N/A

Teaching Hospital Pharmacist: Compounds and dispenses medications and other pharmaceutical supplies, reviews orders and prescriptions for appropriateness and patient safety. Enters medication orders onto medication profiles and updates medication profiles as required; this includes checking for drug interactions, incompatibilities and optimum drug therapy; participates in narcotic drug and controlled drug distribution program as required; prepares or oversees preparation of parenteral nutrition and other sterile solutions using aseptic preparation of parenteral nutrition and other sterile solutions using aseptic techniques; check medication carts and makes necessary corrections, maintain records of prescriptions or orders filled; provides explanation and directions for proper use of all prescriptions for outpatients. Participates in the department’s in-service education program. Performs monthly nursing unit inspections as assigned in accordance with J.C.A.H.O. Requirements. Participate in Performance Improvement and Drug Utilization Evaluation Programs; provide drug information to professional staff and patients; participate in the On Call/Recall program during hours when the Pharmacy is closed. Supervising Responsibility: Position is supervised by the T.H. Director of Pharmacy, the T.H. Associate Director of Pharmacy, and the TH Senior Pharmacist Supervisor. This title will supervise T.H. Pharmacy Assistant (Technicians), students, and Pharmacy Aides, Pharmacy clerical staff and any Hospital attendants or volunteers assigned to the Pharmacy. IV. V. Responsibilities: N/A Procedures/Guidelines: N/A

29

VI.

  

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

30

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. J__ Subject: JOB DESCRIPTION: PHARMACY ASSISTANT (TECHNICIAN) Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of __1__ Original Issue date: 8/1/98 6/22/01 Implementation Date: ________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To serve as a description for the Pharmacy Assistant (Technician) position and duties. II. III. Definition(s): N/A Policy: The Teaching Hospital Pharmacy Assistant is under the direct supervision of the Director and Associate Director of Pharmacy as well as T.H. Pharmacist/T.H. Senior Pharmacist in their daily duties. Responsibilities: The duties of the Pharmacy Assistant are: a) Receiving written prescriptions b) Typing prescription labels c) Keying prescription data for entry into a computer generated file or retrieving prescription data from the file in accordance to the following: 1. A technician may key prescription data for the approval of the pharmacist, provided that when the pharmacist enters the date into the file along with his or her initials as the dispenser of the prescription 2. A technician may retrieve prescription data from the file for review by the pharmacist, provided that when the prescription is to be refilled, the pharmacist shall enter his or her initials as the dispenser of the refill together with the date on which the prescription was refilled d) e) f) g) Obtaining drugs from stock and returning them to stock Obtaining prescription files and other manual records from storage and locating prescriptions Counting dosage units of drugs Placing dosage units of drugs in appropriate containers affixing the prescription label to the container h) Affixing the prescription label to the container i) Preparing manual records of dispensing for the signature or initials of the pharmacist j) Handling or delivering complete prescriptions to the patient or the patient’s agent k) Filling cassette exchange carts from patient profile records l) Assist in the preparation of parenteral solutions m) Run cart-fill function in the automated dispensing system V. Procedures/Guidelines: N/A

IV.

31

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

32

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. K___ Subject: JOB DESCRIPTION: PHARMACY AIDE Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 3/17/00 6/22/01 Implementation Date: ___________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: Incumbents of positions in this class perform routine manual and clerical activities in receiving, storing, repackaging and issuing pharmaceutical supplies in a pharmacy serving the residents of a State facility. Incumbents also maintain an inventory of pharmaceutical supplies, prepare orders for new supplies and prepare some standard stock solutions according to prescribed formulas. Incumbents also deliver medication supplies throughout the hospital. Positions in this are found in various facilities of the Departments of Mental Hygiene, Correctional Services, and the State University. II. Definition(s): CLASSIFICATION CRITERIA AND DISTINGUISHING CHARACTERISTICS Pharmacy Aides are characterized by the performance of routine and repetitive clerical and manual tasks in the receipt, storage, repackaging and issuance of pharmaceutical supplies, in the preparation standard stock solutions, ointments and other preparations and in the maintenance of uncomplicated records. Although repetitive, the majority of tasks performed by Pharmacy Aides require accuracy, timeliness, strict adherence to guidelines and precise attention to detain to insure safe, effective and efficient operation of the pharmacy. Pharmacy Aides work under the supervision and direct observation of a licensed pharmacist. Other clerical classes responsible for performing a variety of stores and supply activities include Stores Clerk and Mechanical Stores Clerk, incumbents of which perform routine clerical manual work involving the receipt, storage and distribution of a variety of perishable and non-perishable goods, materials and equipment in a stockroom or warehouse. The activities and tasks performed by these two classes are similar, the main distinction being the type of materials and supplies handled. Typically, Stores Clerks are assigned to stores programs handling a wide variety of goods, materials and equipment, household and office equipment and supplies, and printing supplies. Mechanical Stores Clerks receive, store and issue such mechanical stores as tolls, construction materials, and such ground supplies as seed and fertilizer. Position engaged in the practice of pharmacy are classified a Pharmacist or Senior Pharmacist. III. Policy: N/A

IV. Responsibilities: TYPICAL ACTIVITIES, TASKS AND ASSIGNMENTS Unpacks, sorts and counts pharmaceutical supplies for storage or distribution following specific instructions and standard procedures.  Checks incoming shipments for breakages or shortages.

33

Stores supplies in designated areas including some, which require special handling and/or refrigeration.  Restocks storage areas as needed.  Removes outdated drugs.  Replenishes ward stock items.  Records receipt and distribution of supplies on standard forms.  Process orders for alcohol withdrawals. Chapter 3. Sect (K) Continued  Fills various sizes and types of packages or containers by hand or by machine from bulk manufactured or purchased quantities.  Repackages bulk supplies, e.g., soaps, rubbing alcohol and disinfectant into smaller amounts and containers.  Prepackages prescription medications in unit-dose/robotic form for dispensing at a later time.  Prepares various standard preparations according to prescribed procedures.  Assists licensed pharmacist in filling and preparing drug orders.  Operates electronic capsule and tablet counter, which automatically distributes a certain number of capsules or tablets into smaller containers. This includes pneumatic packaging devices for robotics packaging.  Prepares labels under the supervision of a pharmacist by hand or by operating a labeling machine.  Affixes labels by hand or by operating a labeling machine.  Maintains and clean equipment used in the pharmacy.  On occasion, delivers supplies to wards or clinics. Performs a variety of clerical tasks in support of a pharmacy’s operation. Prepares and maintains records for inventory control, such as purchase orders, receipt records, floor stock records, prepackaging records, supplies dispensed and patient Profile.     Notifies the pharmacist of inventory levels for placement of orders. Brings to the attention of the pharmacist unusual requests made by nursing units. May answer routine factual telephone inquiries and/or refer caller to pharmacist. May screen incoming mail to the pharmacy.

May perform a variety of light housekeeping tasks in order to maintain a safe and clean environment in the pharmacy. May assist the pharmacist in conducting ward inspections. V. Procedures/Guidelines: RELATIONSHIPS WITH OTHERS

Pharmacy Aides have frequent written and oral communications with their supervisor, a licensed pharmacist, who provides frequent instructions and directions. Incumbents also have brief written (forms) and oral communications with personnel employed at the facility who pickup deliveries to wards and clinics. On request incumbents submit brief oral and written factual reports to the pharmacist describing the condition of stock, inventory level and the status of orders. NATURE OF SUPERVISION Typically, positions in this class are non-supervisory. The majority of tasks performed by positions in this class are closely supervised by a Pharmacist or Senior Pharmacist. Certain tasks, once learned and performed satisfactorily, however, are usually performed independently. Initially, incumbents receive on-the-job training consisting of step-by-step instructions and in-process review. After initial training, incumbents perform many specifically prescribed tasks under close observation and continuous evaluations to accuracy, neatness and progress.

34

Typically, all activities undertaken by Pharmacy Aides are assigned by pharmacist who give detailed instruction concerning work methods and procedures, demonstrate work techniques, closely supervise work in progress and review completed work. JOB REQUIREMENTS     Working knowledge of the accepted methods and practices used in receiving, storing and issuing pharmaceutical supplies. Working knowledge of inventory procedures. Working knowledge of precautions needed to maintain secure and sanitary conditions. Working knowledge of the generic, chemical and proprietary names of commonly prescribed drugs.

Chapter 3. Sect (K) Continued   Working knowledge of the classification of drugs. Ability to operate various small machines such as a label printing machine, a mixer, and electronic tablet and capsule counter and an automatic unit dose strip-packaging machine. Ability to perceive details, errors or omissions on work orders, checking printed labels. Ability to perform repetitive activities. Ability to understand and carry out both oral and written instructions. Ability to work with metric apothecary systems and abbreviations. Ability to perform basis pharmaceutical calculations. Ability to bend, lift, climb, stoop and kneel. Ability to understand and operate a mainframe computer and/or pc. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none

       VI.

VII. VIII.

Date Reviewed 12/9/04 10/4/07

Revision Yes Yes Yes Yes

Required (Circle One) No No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

35

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. L__ Subject: JOB DESCRIPTION: TEACHING HOSPITAL STAFF ASSISTANT II (MATERIALS MANAGER) Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98 6/22/01 Implementation Date: _______

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To serve as a guide for the Teaching Hospital Staff Assistant II (Materials Manager) position. II. IV. IV. Definition(s): N/A Policy: N/A Responsibilities: Direct and specific areas of responsibility, which encompass the complete spectrum of financial transactions regarding Pharmacy purchases. May prepare monthly and year-end journal entries and assistance to outside CPA firm during the audit and additional assistance to department during audit season as necessary. Full theoretical understanding of general ledger activity and financial reporting. Specific knowledge of financial principles and their application to the health care industry within the N.Y.S. system. Appointee should be proficient in all areas of functional responsibilities. Work involves analytical and problem-solving skills requiring moderate independent judgment; final approval rests with higher authority. Prepares operational reports, which may impact hospital finances. Leadership limited to fulfilling daily work assignments or carrying out projects; regular contact with clerical staff and other finance related areas, occasional but limited outside contacts. This position is responsible for the daily ordering of supplies, the maintenance of all storage areas, accountability of computer inventory records, conduct an annual inventory, supervise drug returns for re-use/credit/destruction, and provide monthly an on-demand usage reports for specific drugs or drug categories. Procedures/Guidelines: N/A Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes

V. VI.

VII.

Attachments: none

36

VIII.

References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/9/04 10/4/07

37

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. M__ Subject: JOB DESCRIPTION: HOSPITAL ATTENDANT Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98 6/22/01 Implementation Date: ___________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To serve as a description for the Hospital Attendant position and duties. II. III. IV. Definition(s): N/A Policy: N/A Responsibilities: When this title is assigned to the Pharmacy the duties shall be:     V. Maintain general orderliness and cleanliness of main pharmacy, labs, storerooms, and satellite pharmacies. Deliver supplies to other hospital departments, nursing care areas, and between the pharmacy service areas. Assist in the break down and storage of supplies. Work with Pharmacy Aides in the packaging areas of the Pharmacy. This position is restricted to non-clinical, on-professional, and non-judgmental task.

Procedures/Guidelines: This position is to be supervised by the Pharmacy Aide, Pharmacy Assistant (technician), T.H. Senior Pharmacist, T.H. Pharmacist, Associate Director of Pharmacy and Director of Pharmacy. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VI.

VII. VIII.

Date Reviewed 12/9/04 10/4/07

38

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. N_ Subject: JOB DESCRIPTION: DEPARTMENT SECRETARY Staff Assistant II Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: Implementation Date: 8/1/98 6/22/01

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

I. II. III. IV.

Purpose: To serve as a description for the Department Secretary position and duties. Definition(s): A full time secretarial person serving in a supportive position to the Department Director and other staff members for secretarial and clerical functions. Policy: N/A Responsibilities: DUTIES 1. Departmental Typing 2. Interdepartmental Charges 3. Maintain Literature Files 4. Compile Pharmacy Statistics 5. Process Patient Charges 6. Audit Patient Charges as Required 7. Maintain Productivity Records 8. Maintain Stock Records 9. Audit Invoices 10. Follow through on Shorts 11. Maintain Purchasing Group Records 12. Perform committee work as needed 13. Completes Performance Improvement Reports 14. Such other duties as may be assigned Procedures/Guidelines: EDUCATION High School graduate or equivalent EXPERIENCE One year in business office environment SKILLS Typing essential, minimum 50 words per minute. Good command of English language, high level spelling ability. Knowledge of computer based programs for word processing and spread sheet creation.

V.

39

CONTACTS Pharmacy personnel, Nursing staff, other hospital employees, sales representatives, Medical Staff members. PHYSICAL DEMANDS Lifting light-weight objects, stooping for filing, on feet approximately 20% of shift VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

40

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. O__ Subject: ORIENTATION AND CONTINUING EDUCATION OF PHARMACY PERSONNEL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98 6/22/01 Implementation Date: __________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To inform all new employees to participate in Orientation and Continuing Education programs. II. Definition(s): N/A

III. Policy: All new Pharmacy employees shall be oriented to the complete operation of the department as the cornerstone of the employee education program. All staff members shall also participate in relevant education programs including in-ser vice and external continuing education programs. IV. Responsibilities: The immediate supervisory shall have the responsibility to complete the orientation process prior to commencement of duties for all new employees. The staff member has the responsibility to adhere to all policies & procedures for both the Pharmacy Department and the Hospital. Pharmacy administration and Hospital Administration shall maintain all the appropriate records of in-service/continuing education.

V.

Procedures/Guidelines: Departmental: The immediate supervisor of the incoming staff member shall conduct an orientation session during the first day of employment to cover the following subjects:  Performance program  Functional and management relationships within the Pharmacy Department and interdepartmentally  Organizational structure within the hospital  Performance evaluation process  Licensing and credentialing of professional staff  Overview of Pharmacy’s Policy & Procedure Manual  Attendance reporting  Requirements for continuing and in-service education  Hours of operation  Location of fire alarms, extinguishers, and exit routes within the department  Location of Disaster Cart, its use, and personnel responsibilities  Patient confidentially and data security

All employees are to receive copies of all written policies and procedures that fall within their job description. Each new employee is to be told to ask questions of his/her immediate supervisor so as to develop competency in the following areas:

41

1) Outpatient Dispensing 2a) Inpatient Dispensing from Main Pharmacy 2b) Inpatient Dispensing from Satellite – Unit Dose Pharmacy 3) Non-sterile manufacture of pharmaceuticals 4) Hyperalimentation & IV Additive Preparation 5) Providing of Drug Information 6) Q/A/DUR/ADR/DUE/CQI Team Participation 7) Controlled Substance Dispensing 8) Investigational Drug Dispensing & Record Keeping 9) Patient and Family Education Requirements 10) Patient Rights and Confidentiality and Data Security 11) Age Specific Competency 12) Clinical Data Evaluation Chapter III Sect. O Continued The employee shall complete an orientation record form after the orientation process is completed. He/she shall sign this document and the document will be placed in the individual’s Departmental personnel file (see attached) VI. The appropriate hospital department shall provide the following orientations to the new staff members:  Fire & Safety  Infection Control  AIDS Confidentiality  Employee Benefits  Right to Know  Sexual Harassment Prevention Training  Patient Confidentiality  Patient Bill of Rights  Hospital Policy & Procedure  Medical and Chemical Waste Management  Data and Information Security Continuing Education:

VII.

Pharmacy administration shall schedule appropriate pharmaceutical in-service education programs for the Pharmacy staff. Records of attendance shall be maintained in the Pharmacy Office. Records of participation in the Pharmacy office unless mandated by law for a licensee to maintain their own records. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Pharmacy Orientation Records References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

42

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 3 SECT. P__ Subject: COMMITTEE MEMBERSHIP OF PHARMACY PERSONNEL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: ___6/22/01____

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: The Pharmacy staff shall be represented and participate in the various Clinical and Administrative Committees within the hospital, the university, and within the Pharmacy Department. The Pharmacy staff shall also participate in the interdisciplinary patient care teams. II. III. IV. Definition(s): N/A Policy: N/A Responsibilities: N/A

V. Procedures/Guidelines: A member of the Pharmacy staff is appointed by the Director of Pharmacy, Hospital Administration, or the Executive Committee to serve as a representative of the Pharmacy on the following Committees within the hospital: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Health Care Review (Institutional Review Board) Infection Control Nutrition Pharmacy & Therapeutics and its sub-committees Ancillary Support, Technical, Q/A, PI Committees CPR Support Services Interdisciplinary Ambulatory Q/A Committee Quality Management Panel Nursing – Pharmacy Committee CQI Teams JCAHO Survey Preparation and Standards Review Task Forces Parenteral Nutrition Team Tumor Board Oncology Grand Rounds Medication Usage Sub-Committee of the P&T Committee Ad Hoc project committees Patient and Family Education

43

Within the Department of Pharmacy 1) Intradepartmental Q/A Committee VI. Reasons for Revision  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/9/04 10/4/07

44

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4__ Subject:: INPATIENT DISPENSING OF MEDICATION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ___1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: ___6/22/01___

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

_____________________________________________________________________________________ I. Purpose: To establish policies and procedures for pharmacists to follow for inpatient dispensing of medication in a safe, efficacious, and legal manner. II. Definition(s): N/A

III. Policy: All medication for in-patients will be dispensed by a licensed pharmacist from the Main Pharmacy, the Pharmacy labs, or satellites in unit dose form, if available and appropriate, upon receipt of a written prescription order from an authorized practitioner. A cassette exchange system shall be utilized daily to provide a 24-hour supply of medication based on current, active physician orders. No verbal orders from authorized prescribers for medication shall be accepted by the Pharmacy staff. IV. V. VI. Responsibilities: N/A Procedures/Guidelines: N/A Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none VIII. Date Reviewed 12/10/04 10/4/07 References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII.

45

Chapter 4 Sect. A
A) #1 Main Pharmacy (Cassette Exchange)

Procedure: (a) An authorized prescriber writes a complete prescription order on the prescription section of the Physician’s Order Form in the patient’s medical records. A complete order contains:  First and last name of the patient  Patient ID number  Date  Drug  Dosage  Route of Administration  Frequency  Duration (maximum is 30 days unless drug falls under automatic stop order policies for shorter durations)  Signature of prescriber and time of the prescribing  Stamped or printed name of the prescriber Note: Diagnosis can be obtained form the patient’s medical record or medication profile. Allergies, height, weight, OTC and herbal medications, pregnancy and lactation data are taken prior to or upon admission and are obtained form the daily computer Allergy & Weight Report as well as the patient’s medical record, medication profile information provided by the EAGLE System. b. A nurse picks up the medication order, signs it and places the time on the order that it is picked up by the nurse. c. The order is then give to the Nursing station clerk to affix a patient label. d. The order is picked up by Pharmacy Technicians during their daily rounds, faxed, delivered by pneumatic tube, or via messenger service to the Pharmacy services. STAT orders may be delivered to the Main Pharmacy via hospital messenger or Nursing personnel. e. The doses of medication are prepared for dispensing after a pharmacist enters the order into the robotics database this creating the patient profile and the technician performs the necessary cart fill function. First doses and STAT doses are dispensed immediately and the continuation therapy is delivered in the cassette exchange. The charge and the backup file is generated daily and these charges are picked up by the EAGLE system for the appropriate charges to patient accounts. f. Upon receipt of the written prescription order, only a pharmacist shall check the order for accuracy, proper dosage, safety, and possible drug, food, or disease interactions.

g. The pharmacist shall make any corrections or initiate any phone inquiry to clarify the order. Any correction to the medication order shall require a new order to be written by the prescriber in the medical record and an order written to discontinue the previous incorrect order. h. The pharmacist shall double check the prescription against the contents of the vial, bottle, robotics package, or injection envelope. i. The pharmacist shall then sign or initial the prescription order as well as stamp the prescription with their identifying stamp. The entry of orders into the robotics database can only be done by pharmacists. The patient profile indicates which pharmacist was responsible for the order. An auxiliary label shall be placed on the immediate drug container by a pharmacist. A WARNING OF SOUND ALIKE – LOOK ALIKE ERROR POTENTIAL SHALL BE PLACED IN THE PATIENT MEDICATION CASSETTE BY THE PHARMACIST IF THE POTENTIAL EXISTS BASED ON DESIGNATED DRUG LIST.

j. Completed prescription orders from the cart-fill function shall be placed in a cassette drawer and delivered during the cassette exchange cycle for the Nursing station. Doses in

46

between cassette exchanges shall be placed on a delivery bag marked with the nursing station number and delivered to the Nursing Station either by Pharmacy personnel or hospital messenger. k. STAT orders will be processed immediately upon receipt from a nurse or hospital messenger and returned directly to these individuals after completion for delivery back to the nursing station. Requirements for in-patient labeling for non-robot packaged medications:              B) Date Patient ID# Nursing Station Patient’s First and Last Name Drug Name (proprietary and/or generic) Strength or Potency of the Drug Dosage Prescribed Route of Administration Frequency Duration Amount Dispensed Precautionary and Auxiliary Labels Dispenser’s Initials Satellite Pharmacies:

All procedures are to be followed as in the Main Pharmacy cassette exchange dispensing of medication and the Policy on Unit Dose/Cassette Dispensing of Drugs. (See Chapter 4, Section C)

47

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4. SECT. C__ Subject: UNIT DOSE DISTRIBUTION SYSTEM Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __6/22/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To direct pharmacists to dispense drugs in unit dose form where available utilizing the unit dose distribution system provided by the robotics dispensing device.. II. Definition(s): N/A

III. Policy: In-patient drugs shall be dispensed in unit dose form, where available and appropriate, using a cassette exchange system. IV. Responsibilities: The support staff shall pick-up the written medication orders to be brought to the Pharmacy./ The Pharmacy technician shall fill the cassette supervised by a pharmacist. The Pharmacy technician shall deliver the cassette to the nursing stations. V. Procedures/Guidelines: A copy of the prescriber’s original order shall initiate the dispensing of individual patient orders for medications. The Pharmacy copies shall be sent via messenger, Pharmacy Aide, technician or Fax machine to the Pharmacy. As patients are admitted, the computer shall send a label for each patient to the nursing station. The patient shall be assigned a drawer on the appropriate cassette. The allergy information section of the profile shall be verified by the pharmacist. The patient’s weight and allergies shall be retrieved from the computer profile system, the printed daily report, or the patient’s medical record. The diagnosis shall be retrieved from the patient medical record (chart) or the medication profile. A pharmacist shall review the Pharmacy copies of all medications orders and discontinuation medication orders hall be checked for correct dose, compatibility, drug, food, disease interactions, and for any prescription or transcription errors. Documentation on the patient medication database profile must follow this format: 1. One line is used for each routine order, containing the name of the drug, dose, strength, frequency, and duration of therapy. All entries on patient medication profile are strictly the responsibility of a licensed pharmacist. 2. A 24-hour supply shall be placed in the patient cassette bin. By 10:00 a.m. daily or at customized times daily, the cassettes shall be delivered to each unit. The empty cassettes are removed from the units and returned to the Pharmacy. These empty cassettes are then filled using the Pharmacy profile sheets. This task is usually done by a pharmacy technician. Unit dose packaged tablets, oral liquid and injections, shall be place din clear plastic bags and labeled both with a bar code and alpha description. All topical, ophthalmic, and otic preparations will be dispensed in the

48

smallest commercially available dosage form. These products when dispensed shall be placed in clear plastic bag. Oral solid dosage forms that are not available in unit dose form shall be labeled appropriately (refer to IPD dispensing medication labeling.) When all cassettes are complete, the registered pharmacist checks each order and initials the medication order, profile, and label where appropriate. Upon checking the cassettes, any extra or excess medication should be taken out of the cart and inquires made by the pharmacist to the nurse to ascertain the reason for the returned doses. Only current drug orders are to be sent in the cassette. Drugs that are returned and that have been ordered on specific schedules should be questioned. A determination of the status of the medication order is to be made by the pharmacist. Communicating with the nurse and prescriber is essential for the completion of this task. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/10/04 10/4/07

49

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4__SECT D Subject: APPENDIX TO UNIT DOSE DISTRIBUTION POLICY Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __6/22/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

I. II.

_____________________________________________________________________________________ Purpose: To inform employees of the Drug Dose Distribution Policy. Definition(s): N/A

III. Policy: The following list of drugs is not available commercially in unit dose packaging. These drug entities shall be dispensed in non-unit packaging by the Pharmacy Department in unit dose form. These drugs are to be packaged, if appropriate, in robotic bar coded packaging. The quantities dispensed will be for no more than a one-day cassette exchange cycle. IV. V. Responsibilities: N/A Procedures/Guidelines: The Drug Entities Are: FLUOXETINE CAP 20MG PINDOLOL TAB 5MG PINDOLOL TAB 10MG METHOTREXAT, TAB 2.5MG BUSULFAN TAB 2MG NH2 CAPROIC ACIDE TAB 500MG AMINOPHYLLINE, TAB 100MG ESTRAMUSTINE CAP 140MG TERFENADINE TAB 60MG D-AMPHETAMINE TAB 5MG SALSALATE TAB 500MG DEXTRO-PROPXPHENE CAP 32MG SALSALATE TAB 750MG ALBUTEROL SA TAB 4MG ALBUTEROL TAB 2MG GUANADREL SULFATE TAB 10MG CYCLOPHOSPHAMIDE TAB 25MG DIETHYLSTILBESTEROL TAB 0.5MG GUANADREL SULFATE TAB 25MG NORETHINDRONE TAB 0.35MG DIETHTILBESTEROL TAB 1MG ETHINYL ESTRADIOL TAB 0.02MG NITROFURANTOIN CAP 25MG ETHINYL ESTRADIOL TAB 0.5MG ETHINYL ESTRADIOL TAB 0.05 MG MESORIDAZINE TAB 50MG MESORIDAZINE TAB FLUOXYMETERONE, TAB 5MG FLUDROCORTISONE TAB 0.1MG PERPHENAZINE TAB 8MG FLUOXYMESTERONE, TAB 10MG MESORIDAZINE TAB 100MG PERPHENAZINE TAB 16MG HYDROCORTISONE, TAB 5MG NITROFURANTOIN CAP 25MG HYDROCORTISONE TAB 20MG HYDROCORTISONE, TAB 10MG FLECAINIDE ACET. TAB 100MG AURANOFIN CAP 3MG NEPHRO-VITE TAB ETRETINATE CAP 10MG LIOTHYRONINE, NA TAB 25MCG MED-P-GESTERONE TAB 2.5MG MED-PROGESTERONE TAB 10MG MELPHALAN TAB 2MG MERCAPTOPURINE TAB 50MG

50

SELEGLINE HCL TAB 5MG METHIMAZOLE, TAB 5MG METHYSERGIDE MALEATE TAB 2MG NITROGLYCERINE TAB 0.3MG CHLORAMBUCIL TAB 2MG NITROGLYCERINE TAB 0.6MG PENICILLAMINE, CAP 250MG PROPYLTHIOUBACIL TAB 50MG QUINACRINE HCL TAB 100MG SOD BICARB, TAB 650MG THYROID, TAB 15MG THYROID, TAB 60MG TRIMETHOBENZAMID, CAP 250MG KANAMYCIN, CAP 500MG PANCRELIPASE CAP DAPSONE TAB 100MG PERPHENAZINE, TAB 4MG PYRIMETHAMINE TAB 25MG PROCARBAZINE CAP 50MG L-DOPA CAP 500MG L-DOPA TAB 100MG RIFAMPIN CAP 300MG OXYMETHOLONE TAB 50MG MYLANTA, TAB FLUCYTOSINE CAP 250MG DIHYDROTACHYSTEROL TAB 0.2MG DANAZOL CAP 200MG STILPHOSTROL TAB 50MG CALCITRIOL, CAP 0.25MG PENICALLAMINE CAP 125MG LONITEN TAB 2.5MG AMINOGLUTETHIMIDE TAB 250MG LOMUSTINE CAP 40MG VI.

METHAZOLAMIDE TAB 50MG METHIMAZOLE, TAB 10MG METYRPONE, TAB 250MG NITROGLYCERINE TAB 0.4MG NORETHINDRONE TAB 5MG STURART NATAL TAB PYRASINAMIDE TAB 500MG SOD BICARB, TAB 325 SULFADIAZINE, TAB 500MG THYROID, TAB 30MG THYROID, TAB 120MG MENADIOL, TAB 5MG ETHACRYCIN ACID TAB 50MG METHYLPHENIDATE, TAB 10MG METHENAMINE HIPPURAT TAB 1.0GM 6-THIOGUANINE TAB 40MG SOD. CHLORIDE TAB 1GM BRONEDECON TAB L-DOPA CAP 250MG THYROID TAB 180MG HYDROXYUREA CAP 500MG AL CARB, CAP MARAX, TAB PRIMIDONE TAB 50MG PHENELZINE TAB 15MG MEGESTROL ACET TAB 40MG DROMOCRIPTINE TAB 2.5MG ZINC SULFATE CAP 220MG MAGNESIUM , GLUCONATE TAB 500MG MINOXIDIL TAB 10MG LOMUSTINE CAP 10MG

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/10/04 10/4/07

51

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. E___ Subject: PRESCRIPTION WRITING AUTHORITY IN UHB Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: __7/3/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To inform pharmacists about which practitioners have prescription authority under their New York State License. Definition(s): N/A Policy: Only those individuals legally authorized to have prescription authority under their New York State licenses as granted by the State Education Department can write for prescription drugs. This license must also include a current registration in the State of New York. Responsibilities: The Risk Management Department, the Medical Board Office, the Graduate Medical Education (House-staff) Office, or the individual medical service administrations and/or Director’s of Service shall arrange to have all signature samples of authorized individuals with license (registration) numbers provided to the Pharmacy. The Pharmacy shall dispense drugs only on the authority of the legally licensed and registered individual. V. Procedures/Guidelines: Only the following individuals can write for prescription drugs* within UHB: a) Physicians licensed and currently registered in New York State. (License number and name must be imprinted/stamped on each OPD prescription and name must be stamped or imprinted on all IPD medication orders). b) Physicians Assistants currently registered in New York State. These individuals, however do not have authority to write for controlled substances or narcotics, without a counter signature by a physician within 24 hours. All in-patient and out-patient prescriptions for controlled substances must be counter-signed at the time of writing (registration number must be written on all prescriptions). c) Certified Nurse Practitioners licensed and currently registered in New York State and who have met additional educational requirements pertaining to issuing prescriptions, and have written practice agreements and protocols established with a collaborating physician. Further, Certified Nurse Practitioners may write for controlled drugs and narcotics provided the individual has a federal DEA number (license number must be written on all prescriptions).

IV.

52

d) House-staff (PGY-1 through PGY-7) currently enrolled in their Graduate Medication Education Program. The five or six digit registry number assigned by the GME office must be marked on all medication orders. e) Medical students only if the order is countersigned by a house-staff supervising physician. f) Opticians within the scope of their practice laws.

*It is UHB policy that all formulary medications require a prescription whether these medications have a Federal legend caution status or are considered over-the-counter (non-legend) medications. This allows accurate and comprehensive monitoring of all drug modalities that may impart any pharmacological effect on the patient.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Approved Abbreviations and Symbols List Un-approved Abbreviation List References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VIII. VIII.

Date Reviewed 12/10/04 10/4/07

53

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. F___ Subject: INVESTIGATIONAL DRUG DISPENSING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: __7/3/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To provide safe handling of FDA designated investigational drugs placing the same directly under the control of the Pharmacy.. Definition(s): Investigational and/or research study drugs are drugs or pharmaceuticals which: B) are in Phase I, II, or III clinical trials or have an IND number or are under investigation, and have not been released by the FDA for general distribution and use. These drugs usually bear the following statement on their labels: “Caution – New Drug – Limited by Federal Law to Investigational use”. C) have FDA approval, but are being investigated for a non-FDA approved indication, use, or a dosage that had not previously been approved by FDA. D) have FDA approval for the intended use, are not on the hospital formulary, and are being supplied to the Principal Investigator or comparison to the new study drug. Policy: Upon presentation of a complete clinical protocol approved by the IRB, the Pharmacy shall store and dispense investigational drugs or drugs used for an investigational study according to the procedure for dispensing these agents. These agents shall be kept separate from the general medication areas and placed under locked storage. Responsibilities: IV. The principal investigator shall provide the Pharmacy with a list of names of authorized physicians along with their signature samples who can prescribe the study drug and a telephone number where they can be reached in the event of an emergency. V. Receipt of Investigational Drugs: It is the responsibility of the principal investigator to direct the supplier of the investigational drug to send the trial material to the investigator. The drug is the property of the investigator; the Pharmacy serves only as the storage and distribution center. Upon notification by the Pharmacy that the predetermined minimum inventory level has been reached, the investigator shall be responsible for notifying the supplier of the trial materials so that a new supply, if required to finish the study, shall be shipped before the current supply is completely expended. VI. Nursing Notification: It is the responsibility of the principal investigator to provide a Nurse’s Data Sheet on the investigational drugs to the Nursing staff charged with administered the drug to the patient, if applicable, and provide in-service education concerning the study drug.

II.

III.

IV.

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Pharmacy Responsibility A) Dispensing investigational medications only upon receipt of a prescription or copy of the physician’s original order signed by an authorized investigator or his designee. B) When Dispensing for In-Patient Use: 1. The dispensing pharmacist shall sign the prescription, enter date of dispensing, quantity dispensed, lot# of the drug and dispense the labeled drug to the principal investigator or his designee. 2. When Dispensing for Out-Patient use: The same procedures should be followed as when dispensing for in-patient use, except the drug is dispensed directly to the patient. C) D) E) F) G) H) I) J) The dispensing pharmacist is responsible for entering all required data on the Drug Accountability Record. The dispensing pharmacist shall confirm that the inventory is accurate and balanced. Periodic Review of usage to determine whether the investigational drug supplies are still active or are no longer needed. Maintain accurate records for the perpetual inventory of an investigational stock, name of patients receiving the drug, data, quantity of each issue, patient’s location, and physician’s name. Store the drug according to the manufacturer’s specifications. Provide suitable containers for storage and dispensing. Notify the principal investigator when the previously determined minimum inventory level is reached. Disposal or returns to the manufacturers of unused or deteriorated drug supply is the responsibility of the principal investigator.

It should be noted that the institutional policy and procedure for the handling of investigational drugs should be reviewed by the pharmacist before undertaking a new investigational drug study. V. Procedures/Guidelines: A) Upon receipt of a prescription for an in-patient or an out-patient for an investigational drug, the following elements of the prescription must be present: 1. Name of the hospital, patient name, and IPD or OPD number 2. Location of the patient 3. Date 4. Name of the drug 5. Dosage or study number for blinded randomization 6. Frequency 7. Duration 8. Quantity to be dispensed 9. Principal investigator’s signature or his designee 10. Printed name of prescriber 11. Investigational Drug Registration number if applicable VII. VIII. IX. VI. A copy of the patient’s informed consent must accompany the medication order for the investigational drug. The drug shall be labeled as follows: See attachment titled: “Requirements For Labeling Investigational Drugs” The properly labeled drug shall be dispensed directly to the principal investigator and/or his designee.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes

55



Institutional/operational changes

VII. VIII.

Attachments: IRB documents References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/10/04 10/4/07

56

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. G___ Subject: VERIFICATION AND REVIEWING OF PRESCRIPTION ORDERS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: 7/3/01

Approved by: CONSTANCE SHAMES, M.D.

Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To give direction to all licensed Pharmacist to review, verify and interpret medication orders as well as resolution of questions or problems. Definition(s): N/A Policy: Review, verification, and interpretation of medication orders as well as the resolution of questions or problems shall be performed by a licensed pharmacist prior to dispensing. Responsibilities: The pharmacist shall review any questions that he/she may have in the course of filling, dispensing, and checking the prescription and document all necessary changes. The physician is expected to discontinue the incorrect prescription order in the medical record and issue a new order. Procedures/Guidelines: A direct copy of the medication order shall be reviewed by the pharmacist. The pharmacist shall verify: 1. Identity of the patient (to include first and last name and second such as MR#, IPD Admission #, DOB) Location of the patient Drug name Drug dosage (expressed in the metric system; see attachment) Drug frequency Drug route Duration Signature of a physician and charting nurse identifier

V.

2. 3. 4. 5. 6. 7. 8.

The pharmacist shall interpret the medication order and resolve all questions or problems prior to dispensing. These problems may take the form of: 9. Inability to identify the patient 10. Improper or incomplete prescription 11. Drug interaction (Drug – Drug, Drug – Food, or Drug – Disease) 12. Over-dosage/sub-therapeutic dose 13. Incorrect dosage form

57

14. Any questions the pharmacist may feel will have a direct impact on the care of the patient, the outcome expected with the drug, or the potential for adverse events by filling the order as written. 15. Restricted drug status requiring expert approval. 16. Sound alike/look alike error potential, potential multiple dose, high-risk drug error potential* 17. Pregnancy and/or lactation incompatibility with the medication 18. Drugs that impact balance and increase risk of falls Upon discovery of any discrepancies or problems that can not be supported by references available in the Pharmacy such as exceeding the maximum average recommended dose, the pharmacist shall contact the nursing station to discuss the nature of the problem with the prescriber. The pharmacist shall not dispense the medication until the problem is resolved. After agreement with the prescriber, the pharmacist shall document on the prescription the necessary changes or verification of the order and proceed to dispense the medication. The label will reflect all changes agreed to by the physician. The physician shall write a new medication order in the medical record and discontinue the incorrect order. Documentation should include the following: 1) 2) 3) 4) 5) Name of the physician Date and time of communication Resolution of the problems Necessary references of scientific literature to validate the physician’s order Pharmacist initials and stamp

The pharmacist shall instruct the physician to discontinue the incorrect order and write a new medication order in the patient’s chart accordingly so that the nurse shall be aware of any changes. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Metric Conversion Chart; List of drugs that impact balance and increase risk of falls References: none

VII. IX.

* IN ORDER TO MINIMIZE/ELIMINATE DISPENSING ERRORS ASSOCIATED WITH SOUND ALIKE/LOOK ALIKE DRUGS, DRUGS AVAILABLE IN MULTIPLE DOSAGE STRENGTHS, OR HIGH-RISK DRUGS (CHEMOTHERAPEUTIC AGENTS, DOPAMINE, DOBUTAMINE, HEPARIN, INSULIN, MAGNESIUM, NARCOTICS AND OPIATES, NEUROMUSCULAR BLOCKERS, POTASSIUM CHLORIDE) DRUG STORAGE BINS ARE MARKED RED FOR SOUND ALIKE/LOOK ALIKE ALERT, GREEN FOR MULTIPLE STRENGTH ALERT, AND ORANGE FOR HIGH RISK ALERT.
Date Reviewed 12/10/04 10/4/07 Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

58

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. H___ Subject: PRESCRIPTIONS FOR NON-FDA APPROVED INDICATIONS OR DOSAGES OF MEDICATIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/10/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To insure that there exists adequate scientific documentation for the non-FDA approved uses and/or doses of medications prescribed. Definition(s): N/A Policy: A prescriber may lawfully prescribe a different dosage of a drug for his/her patient or otherwise vary the conditions for use from what is approved in the FDA approved package labeling. This does not violate the spirit of the FD&C Act or FDA regulations. However, the pharmacist must verify the dosage and usage of the prescribed drug. The policy applies to OPD or IPD medication orders.

IV. Responsibilities: The pharmacist shall document verbal references and maintain all backup documents in a file. The prescriber shall provide documentation on request in support of his/her medical decision. Members of the P&T Committee under the direction of the Chairperson shall review the incidences of drugs used for non-FDA approved uses. V. Procedures/Guidelines: When a pharmacist determines that a drug falls outside of FDA approved indications, dosage, routes of administration, etc., the pharmacist shall contact the prescriber for verification. The pharmacist shall mark on the prescription the following: A) B) C) D) Date Time Physician’s name The reference cited from scientific literature by the physician to support the medication order for a non-FDA approved use or dose.

The medication shall then be dispensed after the verbal verification is taken. The prescriber shall provide to the Pharmacy a copy of the cited reference within seven working days. If the documentation is not received, a follow-up call shall be made by the Pharmacy before referring the matter to the Quality Management, Clinical Q/A Committee of the Service, and/or Risk Management Departments in a written report. A file shall be maintained within these approved usage prescriptions shall be reviewed by the Pharmacy and Therapeutics Committee on a quarterly basis. The P&T Committee shall recommend appropriate action when the incidences are reviewed, if necessary.

59

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/10/04 10/4/07

60

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. J___ Subject: PATIENT SELF MEDICATION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/10/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

_____________________________________________________________________________________ I. II. III. Purpose: To direct pharmacists on the proper procedures to dispense medication to the nursing care areas for self-administration use of medication by the patients. Definition(s): N/A Policy: Upon authorization by the prescribing physician on the face of the prescription, the Pharmacy Department shall dispense medication to the nursing care area for self-administration use by the patient. The container shall be labeled “Self Medication”.

IV. Responsibilities: The physician shall determine the competency of the patient to participate in a selfmedication program. The pharmacist is responsible to prepare a label for the drug container in layman’s language so that the patient may understand the directions for use. The nurse shall supervise and instruct the patient during the course of self-medication. The pharmacist shall only dispense self-medication upon written authorization by the physician on the prescription. The pharmacist shall provide labeling intelligible to the patient. The pharmacist shall provide the medication only to the nurse. V. Procedures/Guidelines: A) A physician shall write on the face of the completed medication order “Self Medication”. B) The physician shall determine the competency of the patient who would administer medication. C) Self-medication shall be supplied by the Pharmacy to the Nursing staff who shall supervise and instruct the patient on the use and administration of the medication. The nurse shall supervise patient’s progress using this mode of treatment. D) The Pharmacy shall limit the amount of medication provided for self-medication to a maximum of a seven-day supply if prescribed for this duration. E) The label provided on the prescription container shall have language that is understandable by the patient e.g., Lasix® 40mg po daily = 1 tablet orally daily; 5ml po three times a day = 1 teaspoon orally 3 times a day. j. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

  

61

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/10/04 10/4/07

62

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. K___ Subject: FLOOR STOCK MEDICATIONS AND DISTRIBUTION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: __7/10/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To inform support staff in the Pharmacy about the procedures relating to floor stock medications and their distribution. Definition(s): N/A Policy: Floor stock medications are those medications not directly chargeable to a patient. Quantities of floor stock medication are kept to a minimum. Only those items on the approved floor stock list may be ordered as floor stock. All other medications are dispensed only upon presentation of a valid prescriber’s medication order for a specific patient. Responsibilities: Nursing personnel are responsible for checking quantities of floor stock items and for requesting replacements. It is the responsibility of Nursing personnel to store all floor stock items properly, e.g., externals separated from internals, refrigerated medication under proper temperature. The Pharmacist is responsible for: III. Preparing items not on the Floor Stock Form for delivery to the Nursing care areas. IV. Checking the work of the Pharmacy Aides for accuracy and completeness V. Inspecting Nursing care areas for the proper storage of medication during the monthly Nursing unit inspection. The Pharmacy Aide shall fill and deliver floor stock supplies pursuant to a completed Floor Stock Form. V. Procedures/Guidelines: NOTE: Those areas with Pyxis machines have floor stock items contained therein, otherwise, A) B) C) D) Upon receipt of a completed Pharmacy Floor Stock Form (see attached), the Pharmacy Aides shall fill the respective order. Floor Stock is filled Monday through Friday except Wednesday. Critical care areas, intensive care areas, operating rooms, and recovery room can request floor stock during any of the Pharmacy’s operational hours. Items that are not listed on the Floor Stock Form and are requested from the critical care areas listed in (C), are to be labeled, packaged, and checked by a pharmacist.

IV.

63

E) F)

A pharmacist shall supervise and check the completeness and accuracy of the filling of the Floor Stock Form by the Pharmacy Aide. A Pharmacy Aide shall deliver the completed order to the Nursing care areas and obtain acknowledgement of receipt by a signature of receipt on the Floor Stock Form by a nurse or an LPN. All floor stock requests are charged to the respective nursing care areas.

G) VI

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments :Floor Stock Order Form References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/10/04 10/4/07

64

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: INSULIN AS FLOOR STOCK Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES No: ___CH. 4 SECT. K Sub-Sect. I___ Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/10/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide for the safe distribution of the high risk drug insulin. Definition(s): N/A Policy: The Pharmacy shall provide insulin vials on a floor stock basis to Nursing care/clinic areas in order to eliminate waste and prevent in-appropriate accumulation of individually labeled vials occurring due to insulin dose variations and titration, discharged patients, transferred patients, etc. Responsibilities: It is the responsibility of the Pharmacy to provide insulin on a floor stock basis to Nursing care/clinic areas. It is the responsibility of the nurse to store insulin under refrigeration and to follow the multi-dose vial procedures when the vial is opened. Procedures/Guidelines (for Nursing care areas without Pyxis machine access): 1) The nurse responsible for preparing the Floor Stock Order Form shall list all types of insulin required for the respective unit and submit it to the Main Pharmacy. 2) The Pharmacy Aide shall prepare the requisition for delivery to the Nursing care/clinic areas. 3) The Pharmacy’s hospital attendant/aide shall deliver the supplies to the unit daily. 4) The nurse shall place the insulin vials in the medication refrigerator on the respective unit. 5) The nurse shall date the vial of insulin with an expiration date when opened (see Chapter XVI, Multi-dose Vials) and chart in the usual fashion. 6) The nurse shall administer insulin pursuant only to written order by a licensed prescriber. 7) The prescription shall be processed through the clerk and forwarded to the Pharmacy for review by a pharmacist. 8) If a problem is identified with the prescription, the pharmacist shall call the prescriber or nurse for clarification or correction. 9) During the monthly Nursing care area inspections a pharmacist shall inspect the medication refrigerators and remove excess insulin stock or stock that has been compromised or has not been dated for expiration upon opening.

IV.

V.

65

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/10/04 10/4/07

66

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. L Subject: INTRA-HOSPITAL DISTRIBUTION OF MEDICATION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/10/01__ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. Purpose: To insure the staff will distribute all medications in an organized, efficient and a safe system. Definition(s): N/A Policy: The Director of Pharmacy shall insure that the distribution of all medications follows an organized, efficient, and safe system so as to address patient needs quickly, support the activities of the nursing and medical staffs, and provide for the maintenance of the manufacturer’s recommendations on the storage of medications as well as the security for general and controlled substance medication. Responsibilities: N/A Procedures/Guidelines: The following flow charts for the path of medication ordering and distribution are to be followed for each respective drug class. (See attached pages for flow chart) Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Flow charts References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

IV. V. VI.

VII. VIII.

Date Reviewed 12/10/04 10/4/07

67

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 4 SECT. M Subject: PASS MEDICATIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to safely dispense medication to patients in the event that they are going home on a pass. Definition(s): N/A Policy: Pursuant to a written ambulatory care prescription, a pharmacist shall label and dispense medication for a duration specified by the prescriber to provide a continuum of medication therapy while the patient is out of the hospital on a pass period, if authorized by the attending physician. Responsibilities: It is the responsibility of the prescriber to write an ambulatory prescription order for pass medications. It is the responsibility of a pharmacist to label the medication in language understandable by the patient and dispense in child-proof containers the pass medication to the nursing station from where the patient will be sent on pass. Procedures/Guidelines: Upon receipt of a written ambulatory care prescription, a pharmacist or pharmacy assistant shall prepare the prescribed medication for dispensing. 2) A pharmacist shall review the prescription to ascertain that all the elements of a valid ambulatory care prescription are present and call the prescribing physician if clarification or correction is necessary. 3) A pharmacist shall label and dispense the medication child proof containers following OPD Medication Dispensing on Prescription Policy, Chapter 23 Section A, Procedures. 4) The medication shall be sent by messenger to the nursing station from where the patient shall be sent on pass. 1) Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none

IV.

V.

VI.

VII. VIII.

68

Date Reviewed 12/10/04 10/4/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

69

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. A Subject: DEFINITION OF CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To inform staff the rules, regulations, and definitions of Controlled Substances. Definition(s): N/A Policy: Controlled Substances are defined as those substances listed and controlled by the following legal authorities: A) Chapter II Administrative Rules and Regulations: 1. Sub chapter K: 2. Controlled Substances: 3. Part: 4. 80 Rules and Regulations Controlled Substances: 5. Public Health Law, SS 3305 (1) (d), 3007 (2), (3) 3308 (2), Act. 3 and its amendments: 6. Under Authority of NYS DOH And/or B) Title 2 of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513 and its amendments under authority of the Federal Drug Enforcement Administration.

IV. V. VI.

Responsibilities: N/A Procedures/Guidelines: N/A Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none

VII.

70

VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/4/07

71

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. B Subject: INPATIENT DISPENSING OF CONTROLLED SUBSTANCES TO NURSING CARE AREAS WITHOUT PYXIS CABINETS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish the rules of Inpatient Dispensing of Controlled Substances to Nursing Care Areas without Pyxis® cabinets. Definition(s): N/A Policy: All Nursing Station orders for controlled substances without Pyxis® cabinets shall be dispensed according to the established procedure contained in Chapter V, Section B, of the Pharmacy’s Policy & Procedure Manual. Responsibilities: A pharmacist shall take the controlled order form the nurse. A pharmacist shall enter the information on all forms and make an entry and deduction from the IPD inventory. A pharmacist or Pharmacy Assistant shall deliver the controlled drug supplies to the nursing station. A RN shall deliver the controlled drug supplies and place them in a double lock cabinet at the Nursing station. Procedures/Guidelines: (1) Monday, Wednesday, and Friday a Pharmacist shall call all Nursing Stations by 8:30A.M. to obtain their controlled drug orders. (2) The orders are transferred to “Controlled Drug Order Sheet” by a pharmacist. (3) Each drug is written up on a “Controlled Drug Administration Record and is signed and dated by the dispensing pharmacist. The following information is entered by the Pharmacist:  Name of Drug  Strength  Requisitioning Station  Drug Number  Dispensing Pharmacist  Date Dispensed  Dosage Form  Quantity Issued  Expiration Date (4) The Pharmacist shall issue an order number in triplicate. One number is placed on the container of the drug, one is placed on the administration record, and the final number is placed on the nursing station receipt.

IV.

V.

72

(5) The number is logged in the IPD Controlled Drug Inventory Log under the corresponding drug record. (6) The Pharmacist shall decrement the IPD inventory accordingly. (7) The drugs, the Administration Records, and the Controlled Drug Order Sheet are placed in a bag marked with the appropriate nursing station and stapled closed for delivery. (8) The orders are then delivered to each nursing station by a Pharmacist or Pharmacy Assistant. (9) At the nursing station, the nurse shall count and verify the controlled drug order. The nurse shall sign and date the receipt, the administration sheet and the controlled drug order sheet and place the drug in a double locked cabinet. (10) The Pharmacist or Pharmacy Assistant shall bring the receipt and Control Drug Order Sheet back to the Pharmacy to be filed. The receipts are filed by nursing station. (11) The Pharmacist or Pharmacy Assistant shall accept any completed Administration Record or drug returns after verifying all the information written on the administration record and confirming the number of doses to be returned, including double signature for wastage. (12) The returned completed Administration Records shall be matched against the original receipt, staples, and filed by the drug name. (13) The Controlled Drug Order Sheets are filed by nursing station after the drugs are charged to the nursing station by a Pharmacy Aide through the computer. (14) Orders called into Pharmacy after 8:30A.M., on Tuesdays, Thursdays, Saturdays, and Sundays, and on Holidays, are processed similarly as above with the exception that the requesting nurse comes to the Pharmacy and after presentation of proper identification shall sign for the controlled substances (15) A daily (Monday through Friday) physical IPD control drug inventory will be conducted by a Pharmacist and entry made in the inventory log. Note: Only RN’s can sign for the drugs. Agency nurses or LPN’s are not permitted to sign for the drugs. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

73

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. V SECT. B SUB. I Subject: VERIFICATION OF THE ADMINISTRATION RECORD ENTRIES FOR CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__

Original Issue date:

8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. IV. Purpose: To insure all pharmacist and pharmacy assistants verify all required information present on the Controlled Drug Administration Record. Definition(s): N/A Policy: A Pharmacist or Pharmacy Assistant shall verify that all required information is present on the Controlled Drug Administration Record. Responsibilities: The pharmacist or pharmacy assistant shall verify all data entries on the control drug administration sheet. A Physician or an R.N. upon the authority of an authorized prescriber’s written medication order is authorized to withdraw drugs for the nursing station sub-stock and enter data on the sub-stock Control Drug Administration Record, and then administer the drug. 5) Procedures/Guidelines: The completed Control Drug Administration Record shall be reviewed by a Pharmacist or Pharmacy Assistant for the following data: A) Date of Administration B) Time of Administration C) Patient’s Full Name D) Professional Staff Administering the Drug E) Name of Prescriber F) Amount of Drug Administered G) Wastage documented, if any. On the occasion of wastage, such as any partial dose to be discarded or breakage: 1. Witnessing signature is required 2. Balance accuracy maintained Verification of orders is done during the monthly nursing station inspection process and upon receipt of a medication order. If data is missing or a discrepancy is apparent either on the Administration Record or in the physical count on the nursing station, the head nurse is contacted to resolve the discrepancy.

V.

6) 7)

74

8) 9)

If the discrepancy can’t be resolved, the Director of Pharmacy and the Director of Nursing is informed and an investigation is conducted. In the event that drugs are to be returned to the Pharmacy, the nurse and pharmacist shall verify the count to be returned. The nurse and pharmacist shall sign and date the Controlled Substance Administration Record to be returned to the Pharmacy. The drugs returned shall be re-inventoried if in unit dose form or destroyed/surrendered to the NYS DOH Bureau of Controlled Substances according to approved procedures or set aside in the Main Controlled Drug wall safe for return to the manufacturer according to legal requirements for such. Controlled drug administration verification from Pyxis® cabinets are handled according to procedures established in Chapter 34.

10) VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

75

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. V SECT. C Subject: OUTPATIENT DISPENSING OF CONTROLLED SUBSTANCES TO CLINIC NURSING STATIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for the dispensing of controlled drugs to clinic Nursing stations. Definition(s): N/A Policy: All outpatient clinic Nursing station orders for controlled substances shall be dispensed according to the established procedures contained in Chapter V., Section C, of the Pharmacy P&P Manual. These orders are limited to one dose or “STAT” orders. Responsibilities: A pharmacist shall take the controlled drug order from the nurse. A pharmacist or Pharmacy assistant checked by a pharmacist shall prepare the controlled drug supplies for pick up. A RN shall sign for the controlled drug supplies and place them in a double locked cabinet at the clinic Nursing Station. Procedures/Guidelines: 1) When requested by a registered nurse, controlled substances shall be dispensed to outpatient clinic Nursing station sub-stock Monday through Friday. 2) The orders are transferred to the “Controlled Drug Order Form” by a pharmacist. 3) Drugs shall be dispensed to outpatient clinic areas from the IPD work safe. 4) Each drug ordered shall be written up on a Controlled Drug Administration Record and is signed and dated by the dispensing pharmacist. The following information shall be entered by the pharmacist:  Name of Drug  Strength  Requisitioning Station  Drug Number  Dispensing Pharmacist  Date Dispensed  Dosage Form  Quantity Issued  Expiration Date

IV.

V.

76

5) The pharmacist shall issue an order number in triplicate placing one number on the drug container, one on the receipt, and one on the Controlled Drug Administration Record. 6) The number is logged in the IPD controlled drug inventory log under the corresponding drug record. 7) The pharmacist shall decrement the inventory accordingly. 8) The drugs, the Administration Record, and the Controlled Drug Order Sheets are placed in a bag marked with the appropriate clinic and stapled closed for pick up. 9) The orders shall be picked up in the Main Pharmacy by the registered nurse who must be present his/her hospital I.D. card as proper identification. 10) The receipt and Controlled Drug Order sheet shall remain in the Pharmacy. 11) Controlled drugs are not to be dispensed to the Lefferts, Throop, Parkside Dialysis, or Midwood satellites. 12) Controlled drugs utilized in the ED are dispensed from the Pyxis cabinet according to the Policy and procedure set forth in Chapter 33. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

77

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. E Subject: STORAGE OF CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To direct the Pharmacy staff on the proper procedures for the storage of controlled substances according to rules, regulations, and legal mandates. II. III. IV. Definition(s): N/A Policy: All controlled substances shall be stored in a locked substantially constructed safe or a double locked cabinet. Responsibilities: It is responsibility of the pharmacists to keep the controlled drug storage safes secured and locked at all times. The combinations for the work safes are disclosed only to the pharmacists. Only designated pharmacist, the Associate Director, and the Director have access to the main walk-in safe. The head nurse of the nursing care area has the responsibility to insure that the controlled drugs are secured and locked in a double locked cabinet on the unit at all times and that shift change verification of stock is completed daily. Procedures/Guidelines: 1) When drugs are received from a manufacturer or supplier, the bulk supply shall be placed by a designated pharmacist into the walk-in Main Wall Safe. 2) Supplies for IPD and OPD nursing units shall be stored in the IPD controlled substance floor safe. 3) Supplies dispensed for IPD and OPD nursing unit use shall be stored in double locked cabinets on these units. 4) All supplies dispensed to the OR satellite Pharmacy shall be stored in the Mosler floor safe in this service area. 5) Controlled Substances requiring refrigeration shall be stored on a locked cabinet within the walkin refrigerator. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none

V.

VII.

78

VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/4/07

79

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. F Subject: INVENTORY CONTROL OF CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To establish inventory controls for controlled substances within the Pharmacy.. Definition(s): N/A Policy: A strict accountability record shall be kept for all controlled drugs in safe storage areas and physical inventories shall be conducted on a pre-assigned schedule. Responsibilities: It is the responsibility of the Director of Pharmacy or his/her designee to maintain accurate accountability of all controlled substances in the Pharmacy. Procedures/Guidelines: OPD Inventory Control [SUSPENDED] (if OPD re-opens) : The only procedure accepted for inventory control of a controlled substance for outpatients is as follows: 1) The pharmacist enters the prescription date, prescription number, patient name and quantity of drug dispensed on the corresponding controlled substance inventory sheet. 2) The pharmacist shall then debit the balance on hand by the quantity dispensed and make the appropriate entry on the balance on hand section of the sheet. 3) The pharmacist shall confirm the balance on hand against the physical inventory and sign his or her name next to the entry, (In the event of discrepancies the pharmacist shall then inform a pharmacy supervisor and an immediate investigation will follow to rectify the problem). I.

A pharmacist shall be assigned daily, Monday through Friday, to conduct the physical inventory on all the controlled substances stored in the OPD safe. The physical inventory shall be conducted between the hours of 2:00p.m. – 4:00p.m. IPD Safe Inventory Control: After the routine daily dispensing and logging in the inventory book (Refer to Chapter V., section B), a pharmacist shall be assigned to conduct the physical inventory. Inventory Control Main Safe: All quantities of drugs stored in the main safe shall be entered in a corresponding inventory log sheet upon receipt from the manufacturer/supplier and maintained in a file kept in the main safe. A biannual inventory shall be conducted on odd years for all controlled substances storage areas in the st Pharmacy, no later than June 1 of that year. III. II.

80

A record shall be maintained in the main safe and a copy filed with the Director of Pharmacy. A physical inventory shall be conducted at the time of either receipt or withdrawal occurs for a particular item form the main controlled substance withdrawal occurs for a particular item from the main controlled substance safe. Satellite Pharmacy Controlled Substance Inventory Control: No controlled substances shall be stored or dispensed from the satellite pharmacies with the exception of the OR Satellite Pharmacy. All controlled substances shall be processed through the Main Pharmacy. Transfer of Controlled Substances Between Safes: Whenever a controlled substance is transferred form one safe to another, the inventory log in the issuing safe shall be debited for the controlled substance being transferred and the inventory log in the receiving safe shall be credited by the quantity received. All entries shall be recorded by a pharmacist and signed by the same. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

81

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. G Subject: ACQUISITION PROCESS FOR CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish procedures for the acquisition of controlled substances according to federal, state, and local legal mandates. Definition(s): N/A Policy: The acquisition process for Class I and II controlled substances shall follow the Federal DEA regulations using DEA Form 222 (Aug. 1990). The acquisition process for Class III, IV, and V controlled substances shall follow standard acquisition procedures for legend drugs. Responsibilities: A pharmacist shall write the order for Class I and III drugs and the materials manager will order Class III, IV, and V drugs upon notification of need. The Director of Pharmacy, Associate Director of Pharmacy, or the TH Senior Pharmacist shall sign the DEA form 222 (Aug. 1990). A pharmacist or the materials manager shall notify Pharmacy Administration as to the need to purchase additional supplies of controlled substances based on inventory reports and controlled drug inventory records. A) Procedures/Guidelines: For Class I and II: 1) 2) A pharmacist with appropriate power of attorney shall complete DEA form 222 (Aug. 1990) in its entirety. The Director of Pharmacy, the Associate Director of Pharmacy and TH Senior Pharmacist hold the power of attorney of the Vice-President for Hospital Affaires/Inpatient Care Services and have the only authorized signatures to sign DEA Form 222 (Aug. 1990). Once signed, the original and the second copy is given to the Materials Manager to initiate a purchase requisition/order and it is sent to the vendor of record. The third copy of DEA Form 222 (Aug. 1990) is maintained in the Main Controlled Substance safe in the acquisition record file. Once the drugs are received and inventoried, the invoice is matched with the third copy of DEA Form 222 (Aug. 1990), date of receipt and quantity received are entered on the DEA Form 222, and kept in the acquisition record file. Any errors or incorrectly completed forms that are voided shall be recorded and maintained in the acquisition record file.

IV.

V.

3) 4) 5) 6) B)

Class III, IV, and V:

82

1)

2) 3) VI.

No special forms are required to acquire these drugs. Most of these drugs are acquired through the current prime vendor wholesaler. Daily invoices are stored in the Main Pharmacy Wall Safe and monthly purchase reports are stored in the Director of Pharmacy’s office. The acquisition procedure is initiated by the Materials Manager upon notification of need by the TH Senior Pharmacist and all record keeping procedures for the purchase process are maintained by him/her. Once the drugs are received and inventoried, the invoice is matched against the purchase requisition and is maintained in the acquisition record file.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

83

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. H Subject: VERIFICATION OF DEA NUMBERS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/25/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To provide a guide for pharmacists to verify the validity of federally issued DEA numbers.. Definition(s): N/A Policy: All controlled substances shall be stored in a locked substantially constructed safe or a double locked cabinet. Responsibilities: The pharmacist is responsible to verify all DEA numbers on prescriptions written for controlled substances. Pharmacy Administration is responsible to contact the Medical Board office or the Federal DEA office when verification of the DEA number cannot be accomplished within the department. Procedures/Guidelines: A) Upon receipt of a controlled substance prescription, the pharmacist can verify the DEA number using the following files: 1) 2) 3) DEA number record of staff Physician’s Attendings, Dentists, or Certified Nurse Practitioners. In-house Graduate Medical Education Institutional numbers for Residents, PGY1-PGY7 e.g. 91025 (91=the year of graduation) or the new six digit numbers Apply the mathematical formula for testing the validity of DEA numbers. Method to determine validity of physicians – DEA number: (e.g. AG 4476429) a) Add Digits 1, 3 and 5 (4+7+4=15) b) Add Digits 2, 4 and 6 (4+6+2=12) then multiply by 2=24 Add a+b totals = 15+24=39 B) If the DEA number cannot be verified using methods 1, 2, or 3 in Chapter 5, Section H, procedure A, the pharmacist shall notify Pharmacy Administration. Pharmacy Administration shall contact the Medical Board office to verify the credentialing of the physician or contact the DEA Washington, D.C.: Registration Branch Drug Enforcement Administration P.O. Box 28083, Central Station Washington, D.CV. 20005 Telephone: 1-202-254-8255 C) The Graduate Medical Education Institution number shall only be honored when:

V.

84

VI.

Accompanied by the institution’s DEA number on NYS official triplicate prescriptions (AH 3303992) as a suffix 2) For prescriptions written by house-staff from the hospital clinic areas and filled only written UHB. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

1)

VII. VIII.

Date Reviewed 12/13/04 10/4/07

85

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. I Subject: EXPIRED, DETERIORATED, AND NON-RESUABLE CONTROLLED SUBSTANCES AND THEIR DISPOSITION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__

Original Issue date:

8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. IV. Purpose: For staff to be aware of how to handle expired, deteriorated, and non-reusable controlled substances and their disposition. Definition(s): N/A Policy: All expired controlled substances shall be removed from active inventory and stored in the Main Wall Safe for appropriate disposition. Responsibilities: It is responsibility of the pharmacist in charge of controlled substance distribution to remove expired, deteriorated, or non-reusable drugs from inventory, keep records of these drugs, and dispose of them properly according to the laws and applicable procedures set forth in this chapter. A) Procedures/Guidelines: Removal From Work Inventory: 1) During the monthly inspection of the Main Pharmacy, a pharmacist shall remove all expired and deteriorated controlled substances from the active inventory and place them in a segregated area of the Main Wall Safe for proper disposition. 2) During the daily controlled drug deliveries and the monthly nursing station or clinic inspections, a pharmacist shall remove all expired, expiring deteriorated and nonreusable controlled drugs from the nursing stations or clinics and place them in a segregated area of the Main Wall Safe for proper disposition. All expired, deteriorated, or non-reusable controlled drugs shall be listed on NYS DOH Bureau of Controlled Substance form DOH 166 (1/90) (Controlled Substance Surrender form) and all information about the drug is completed. If the drug is to be returned to the manufacturer for credit, the drugs shall not be listed on DOH form 166 (1/90)

V.

3)

B)

Surrender and Return of Controlled Substances: 1) If the controlled substance is returnable to the manufacturer for credit, the materials manager shall contact the manufacturer and make arrangements for credit to our account and then return the drugs via certified return receipt requested mail to the manufacturer. A file of returned drugs shall be maintained in the Main Wall Safe or Pharmacy Director’s Office of all drugs returned for credit and these records shall be matched to the certified return receipt when received.

86

2) If the controlled substances are to be surrendered to the NYS DOH Bureau of Controlled Substances, the drugs shall be packed with DOH form 166 (1/90) and mailed via certified return receipt to the: Bureau of Controlled Substances NYS DOH 433 River Street Troy, New York 12180 Copy three (3) (pink) of the DOH form 166 (1/90) is maintained in the wall safe and is matched against copy two (2) (yellow) and the certified return receipt when received. 2) In the event that on-site destruction is desired, the pharmacist shall follow the procedure in Article 33 of the Public Health Law, and Part 80 of the Administration Rules and Regulations for on-site destruction (see attached). (4) Expired and deteriorated drugs can be returned to a manufacturer directly or to a NYS DOH Bureau of Controlled Substances approved drug returns company as long as all city, state, and federal laws are satisfied.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

87

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: ISSUANCE AND CONTROL OF NYS OFFICIAL PRESCRIPTION FORMS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES No: ___CH. 5 SECT. J Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: Establish controlled procedures for the issuance of official NYS Prescription Pads. Definition(s): N/A Policy: Acquisition, distribution and control of NYS Official prescription forms shall be conducted by the Pharmacy Department and use of these prescriptions shall restricted to physicians at UHB. Responsibilities: The Director of Pharmacy shall order supplies of books or blank computer formats and insure security for the supply of books. A pharmacist shall issue the books or formats to a nurse. The nurse shall be responsible for proper storage of the book on the nursing station or clinic. 1) Procedures/Guidelines: The Director of Pharmacy shall initiate an Institutional Order form (DOH Form – 248 [5/89]) for official NYS prescriptions when supplies of these forms are needed or request the pads/formats on-line. When these prescription books are received each box if marked numerically in consecutive order by the pharmacist in charge by controlled substance distribution. These books are entered into a ledger by serial numbers and this ledger is maintained in the OPD safe and the supply of books are maintained in the Main Wall Safe with a limited supply in the OPD safe. When a book is requested by a nursing station or a clinic, a pharmacist shall request a completed book back cardboard from the area and log the return date. The pharmacist shall then issue a new book to the nurse responsible for the area, after presentation of proper ID, recording the date, service area, and signature of the nurse receiving the book. These entries are made opposite the corresponding serial numbers for that book. A resident or employed LIP may also request a book upon presentation of appropriate identification Any returned completed book are marked “VOID” and are stored in a secure area for five (5) years and then they are destroyed. The nurse shall place the ONYSP book in the double locked controlled drug cabinet on the nursing station or clinic. Agency nurses and LPN’s are not authorized to receive prescription books.

V.

2) 3)

4)

5) 6) 7)

88

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

89

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. K Subject: LOSS OR THEFT OF CONTROLLED SUBSTANCES OR OFFICIAL NYS CONTROLLED SUBSTANCE PRESCRIPTION BOOKS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1_

Original Issue date:

8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To inform staff the rules and regulations on loss or theft of Controlled Substances or Official New York State Controlled Substances Prescription Books and the procedures to follow.. Definition(s): N/A Policy: All losses or thefts of Controlled Substances or Official New York State Controlled Substance Prescription Books shall be reported to the Director of Pharmacy or his designee immediately upon discovery of the loss or theft. Responsibilities: It is the responsibility of the Director of Pharmacy to file all required official documentation pertaining to the loss or theft of controlled substances or official NYS prescriptions and notify the appropriate authorities. (1) Procedures/Guidelines: Controlled Substances (Main Pharmacy) : (A) The Director of Pharmacy shall be complete DEA Form 106 (Dec 1985) in its entirety and submit two copies to the local DEA office and retain the original copy in the Pharmacy office. This can also be done on-line. (B) The Director of Pharmacy shall complete the NYS DOH Bureau of Narcotic Enforcement “Report of Loss of Controlled Substances” Form DOH 2094 (3/06) and the original is sent to the NYS DOH, Troy, N.Y., and a copy is retained in the Pharmacy office. (C) The Director of Pharmacy shall notify Public Safety at X 2626 and report the loss of theft of the controlled substances. (D) If necessary, the Director of Pharmacy shall notify the 67 Police Precinct (718-2873211) and report the loss of theft of the controlled substances. The Director of Pharmacy shall conduct an investigation surrounding the reported loss or theft or loss and Human Resources shall notified at extension 3019. (2) Controlled Substance (Nursing Station or Clinic Area) :
th

IV.

V.

90

(A) In the event of a loss of theft of controlled substances on the nursing station or clinic area, the head nurse shall immediately notify his or her Associate Nursing Director and file a hospital Incident Report. (B) The Associate Nursing Director shall immediately notify the Director of Pharmacy who shall then follow the steps as outlined in Chapter 5., Section K., Procedures, #1. (C) The discovering nurse shall file a hospital incident report and attach a copy of the incident report to the Controlled Drug Administration sheet of the drug reported lost or stolen and forward it to the Director of Pharmacy in the Main Pharmacy, Room ALL1-469. (3) Official NYS Prescription Books : (A) In the event of loss or theft of Official NYS Prescriptions or Books, the Director of Pharmacy shall complete NYS DOH Bureau of Narcotic Enforcement form “Notification of Loss/Theft of Official New York State Prescriptions” Form DOH-4387 (3/06). The Director of Pharmacy shall then follow steps C through F as outlines in Chapter V., Section K, Procedures, #1. The discovering nurse shall file a hospital incident report and notify the appropriate Associate Director of Nursing.

(B) (C) VI.

Reasons for Revisions  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

91

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. L Subject: AUTOMATIC MEDICATION STOP ORDER POLICY FOR CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish maximum durations for which controlled substances and other drugs that are considered high-risk may be ordered before re-evaluation of the patient is required. Definition(s): N/A Policy: The maximum inpatient duration for a medication that a prescriber can order is based on the period of medication therapy required to treat the patient (up to 30 days). However, all pre-existing orders are canceled when the patient is transferred between nursing units. New orders must be written by the medical team receiving the patient on the new nursing unit after the evaluation and assessment of the patient’s status. Further, certain orders, due to their potential for adverse side effects and toxicity, e.g., narcotics and controlled substances, are valid for a limited period of time unless otherwise specified in a shorter duration by the prescriber’s orders. IV. Responsibilities: It is responsibility of the prescriber to see that orders are renewed. No nurse shall administer a drug for which the order has expired. It is the responsibility of the nurse to notify the physician prior to the discontinuance of these medications. It is the responsibility of the pharmacist to dispense only the quantities of drugs needed to complete the prescriber’s orders for these drugs within the above time frames. The pharmacist shall inform the nurse that he/she will only dispense a 72 hour supply when an order is written for a longer duration for the above drugs. Procedures/Guidelines: All scheduled Narcotics & Controlled Substances . . . 72 hours Heparin* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 hours Coumadin* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72 hours Oxytocics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72 hours Ketoralac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 days (no renewals) TPN and parenteral solutions. . . . . . . . . . . . . . . . . . . . . .24 hours Low molecular weight heparin*(Lovenox®, Fragmin®).72 hours

V.

* Provided PTT tests are stabilized and therapeutic levels of anticoagulants are achieve, otherwise ONLY a 24 hour duration is to be in effect. Heparin or LMWH (i.e. Lovenox®) administered subcutaneously for DVT prophylaxis may be written for a thirty (30) day supply. Lovenox® 40mg subcutaneously or 30mg subcutaneously every twelve (12) hours are doses for DVT prophylaxis. VI. Reasons for Revision:

92

  

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/4/07

93

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. M Subject: APPROVED FORMS FOR USE AT UHB WITH CONTROLLED SUBSTANCES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To inform the staff of the approved forms to be used for the disposition of any and all contingencies involving controlled substances in UHB. Definition(s): N/A Policy: All controlled substances shall be stored in a locked substantially constructed safe or a double locked cabinet. Responsibilities: N/A. Procedures/Guidelines: The Controlled Substances Forms Approved for Use in the UHB Pharmacy Department are as follows: (16) Class II, III, IV and V Controlled Drugs Order Sheet (17) Narcotic and Controlled Drug Administration Form (18) DEA Form 222 (Aug 1990) (19) Destruction of Controlled Substances: (a) Request of Approval of on Site Destruction of Controlled Substances (b) Controlled Substances Surrender Form (c) Statement of On-Site Destruction of Controlled Substances (20) Inventory sheet (Main Stock Narcotic Record) (21) Copy of NYS Official Triplicate Prescription (22) Prescription Blank for Class III, IV and V (23) Institution Order Form for Official New York State Triplicate Book (24) DEA Form 106 – Report of Theft or Loss of Controlled Substances (25) NYS DOH Bureau of Controlled Substance Form – Report of Loss of Official New York State Triplicate Prescriptions (26) Nursing Station Shift Report Narcotic Check Sheet (27) NYS DOH Bureau of Controlled Substance Form DOH 2094 (6/90) -Report of Loss or Theft of Controlled Substance (13) DEA Form 222a (0/88) – Order Form Requisition to obtain DEA Form 222 Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: see Procedures above.

VI.

VII.

94

VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/4/07

95

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 5 SECT. N Subject: ADMINISTRATION OF CONTROLLED SUBSTANCES TO VISITING FAMILY MEMBER Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To instruct Pharmacy staff about the procedures to follow when dispensing controlled drugs that are to be administered to a visiting family member of a patient. Definition(s): N/A Policy: A single dose of a controlled substance may be administered from an IPD Nursing Station substock of controlled substances to a visiting family member under emotional distress. Responsibilities: A physician is responsible for writing a prescription order for the single dose. A nurse is responsible for withdrawing the drug from the nursing station sub-stock (Pyxis® or otherwise)and attach the written prescription to the administration sheet. The pharmacist is responsible to replace the single dose and file the written prescription. (1) Procedures/Guidelines: The physician in charge of the patient shall reduce to writing a prescription on the OPD prescription blank, an order to the nurse to administer a single dose of a controlled substance (note: All elements of an OPD prescription as stated in Chapter5, Section D, Procedures, #1 of the Pharmacy P&P Manual must be present). The nurse receiving the prescription shall withdraw one (1) dose form the nursing station substock. The nurse shall attach the written prescription to the administration sheet and document on the prescription the date and time of administration and sign the prescription. The nurse shall give the prescription to the pharmacist delivering the controlled substances the next day. The pharmacist shall replace the single dose in the nursing sun-stock and file the prescription in the Main Pharmacy’s Controlled Substance Prescription files for the appropriate controlled substances.

V.

(2) (3) (4) (5)

VI.

Reasons for Revision:

96

  

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/4/07

97

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 6 Subject: REPACKAGING OF PHARMACEUTICALS EITHER IN UNIT DOSE OR UNIT OF USE FORM Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish procedures for the safe re-packaging of pharmaceuticals from manufacturers’ original containers.. Definition(s): N/A Policy: All drugs repackaged from the original manufacturer’s bulk container, shall be repackaged by a pharmacist or by a Pharmacy Aide/Technician under the personal supervision of a pharmacist if the FDA’s approved package insert permits repackaging outside the original manufacturer’s container. Responsibilities: It is the responsibility of a licensed pharmacist to provide the drug for repackaging, check the label for the repackaged drug, and check the final repackaged dosage units for correctness and accuracy before the repackaged drugs are placed in active inventory. It is the responsibility of the pharmacy support staff member to repackage the drugs according to the proper procedure, prepare all of the required documentation for these procedures and maintain all records for a period of five (5) years. A) Procedures/Guidelines: Unit of Use Containers (defined as container that contains a sufficient quantity of medication for one normal course of therapy): 1) For either oral solid, oral liquid or topical dosage forms, a pharmacist shall give the manufacturer’s original bulk container of drug to the pharmacy support staff member. 2) The support staff member shall break open the manufacturer’s original bulk container and count the appropriate number of dosage units to be placed in the container either using a counting machine or pill tray for oral solids. For liquids, a graduated cylinder shall be utilized. 3) The unit of use container shall be closed with a child-proof closure except for compounded creams or ointments manufactured within the Pharmacy. 4) The pharmacy support staff member shall fill out the “Drug Repackaging Work Sheet” record (see appendix A) with all the pertinent information for the drug and sign this record.

IV.

V.

98

5) The pharmacy support staff member shall produce a sample label for the drug repackaged using the Monarch Labeling Machine. The label shall contain the following information: Pharmacy department and name of the hospital, telephone number of the pharmacy, and DEA number of the hospital Generic name of the drug Trade name of the drug Manufacturer of the drug Strength and dosage form of the drug Quantity of drug contained in the container In-house expiration date of the repackaged drug (calculated as 6 months or 50% of the time remaining to the manufacturer’s expiration date, whichever is less, from the date of repackaging). For extemporaneous external preparations, the expiration date of the active ingredient on the manufacturer’s container or 1 year form the date of preparation shall be used. In-house lot number of the repackaged drug (assigned as item of the day repackaged, st nd e.g., 1 item is A, 2 item is B, etc. and date of repackaging [e.g. A 021992] that is, the st 1 items are packed on February 19, of the year) 6) The pharmacy support staff member shall print a sample label and present the label and the filled unit of use container with the drug to the original assigning pharmacist for checking. 7) The pharmacy shall sign the sample label if it is correct for the drug presented to him/her.

8) The pharmacy support staff member shall paste the signed sample label to the Drug Repackaging Work Sheet. 9) The pharmacy support staff member shall then proceed to print a sufficient quantity of labels for the number of containers produced in the repackaging procedure. 10) The pharmacy support staff member shall sign the Drug Repackaging Work Sheet upon completion and present the total quantity of labels, repackaged drugs to a pharmacist for final check 11) If the work is correct and accurate the original assigning pharmacist shall sign the Drug Repackaging Sheet 12) The Pharmacy support staff member shall place the repackaged drugs into the active inventory and place the repackaged drugs into the active inventory and place the completed Drug Repackaging Work Sheet into the Repackaging Drug Log Book. These records shall be maintained for a period of five (5) years. The balance of bulk stock in the original manufacturer’s container is to be placed in the IPD active dispensing stock. 13) The equipment used for repackaging shall be cleaned after each procedure. Exceptions: The following classes of drugs shall NOT be repackaged:  Penicillin and all its derivatives  Cyto-toxic Drug  Immuno-suppressive Drugs

B) Unit Dose Repackaging (Defined as: repackaging drugs in a single unit-container for drugs intended for administration by other than the parenteral route as a single dose, direct form the container.):

99

1) A pharmacist shall give the manufacturer’s original bulk container of drug to the pharmacy support staff member. 2) The support staff member shall break open the manufacturer’s original bulk container and repackaged the dosage form, e.g., tablet, capsule, in unit-dose blister packages utilizing the tablet, capsule, in unit-dose blister packages utilizing the Unit Dose Packaging Machine and the computer control programs for this machine. 3) The pharmacy support staff member shall present one sample of the unit dose drug in a labeled, unit dose blister package for approval to a pharmacist for checking 4) The labeled unit dose package must contain the following information:  Generic name of the drug  Trade name of the drug  Dosage form  Strength  Manufacturer’s name  Manufacturer’s lot number  University Hospital at Brooklyn lot number  Expiration date (Calculated as: six {6} months from the repackaging date; if the six {6} months does not exceed 25% of the remaining times between the date of repackaging and the expiration date on the original manufacturer’s bulk container. In this case the date shall be assigned as 25% of the remaining time from the repackaging date to the manufacturer’s expiration date). A management Report shall be generated by the computer daily and a file maintained.

5)

6) Packaging in robot-ready dosage forms follows all of the procedures in this chapter that apply to unit-dose packaging. Computer printouts are generated daily for pharmacist approval and signature of all drugs packaged in robot-ready packaging. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Drug Repackaging Work Sheet References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/4/07

100

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: COMPOUNDING OF PHARMACEUTICALS FOR INTERNAL OR EXTERNAL USE Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES No: ___CH. 7 Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To inform staff about the procedures to follow when extemporaneously compounded drugs must be prepared by a licensed pharmacist. Definition(s): N/A Policy: All extemporaneously compounded drugs shall be prepared by a licensed pharmacist.

IV. Responsibilities: It is the responsibility of the Materials Manager to inform a Pharmacy manager, of inventory shortages and to make the necessary adjustments to the inventory to decrement or increment the inventory of the drugs used in the compounding and receipt of the finished product. A Pharmacy manager shall assign a pharmacist to prepare the product. The pharmacist is responsible to prepare the product and approve the labeling for the product. It is the responsibility of the Pharmacy aide to prepare a label for the product. It is the responsibility of the Pharmacy support staff to gather the ingredients, package the finished product, and label product with the pharmacist approved label. V. (1) (2) (3) (4) (5) (6) (7) Procedures/Guidelines: The Materials Manager shall inform a Pharmacy manager that a compound drug is in short supply. A Pharmacy manager shall assign a pharmacist to compound the required product. The pharmacist shall go to the “Manufacturer Formulary” cards for the respective product and gather the required ingredients. A T.H. Pharmacy Assistant shall obtain the necessary ingredients for the pharmacist. The Pharmacist shall proceed to extemporaneously compound the drug product using the appropriate equipment, e.g., scales, graduates, ointment slabs, etc. Note: all scales must be balanced by a pharmacist prior to use. The pharmacist or the support staff (T.H. Pharmacy Assistant) shall package the bulk produced product into the appropriate formulary size container e.g. bottles, ointment jars, etc. The T.H. Pharmacy Assistant shall clean and wash all equipment used for the preparation and replace the equipment in the appropriate storage area. The Pharmacist shall make the following entries in the “Manufacturing Record Book”:  Date of Manufacture  Product Manufactured  Assigned Pharmacy Lot Number  Quantity Manufactured  Signature of Compounding Pharmacist

The assigned lot number is derived as follows:

101

A031092 M Indicated an extemporaneously manufactured drug Year 1 item manufactured that day
st

Day Month

A031092M = The first item manufactured on March 10, 1992. (8) The pharmacist shall complete the “Manufacturing Record and Inventory Adjustment Record” (see attached) and record the following information:  Date of Manufacture  Item Manufactured  Formulary Number  Number of Units Manufactured  Signature of Manufacturing Pharmacist  Signature of Assisting T.H. Pharmacy Assistant (if any)  Name of Items Used in Manufacturing  Manufacturer’s Lot#  Manufacturer’s Expiration Date  Formulary Number of Drug Used  Number of Units Used to Prepare the Product  A Sample label Signed by a Pharmacist (The pharmacist shall provide the information necessary to produce labels to a Pharmacy aide shall produce the exact number of labels to label the quantity of product manufactured). (9) The manufacturing Record and Inventory Adjustment Record” shall be retained for five years by the Pharmacy Department. (10) The completed, labeled drug shall be placed in inventory by the T.H. Pharmacy Assistant and the appropriate computer receipt of the drug shall be made, also the appropriate decrement of inventory for the drugs used to prepare the product shall be made using requestor code 0190. (11) Partial units of drugs used for manufacturing shall be returned to inventory. (12) The expiration date for the extemporaneously compounded shall be determined as follows: a. Expiration date on the manufacturer’s container for the active ingredient. b. One year from the date that the drug is compounded or whichever occurs first. (13) For oral preparations, specific recommendations as stated in the manufacturer’s literature concerning the use of their products in extemporaneous compounding shall be followed. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Drug Repackaging Work Sheet; Manufacturing and Inventory Adjustment Record References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/5/07

102

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 8 SECT. A Subject: DEFINITION OF ABSOLUTE AND 95% ALCOHOL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. Purpose: Inform the Pharmacy staff of the federal definition of Absolute & 95% Alcohol. Definition(s): Absolute alcohol is defined as ethanol in a concentration of 100% by volume or 200 proof and requires the Department of the Treasury, Bureau of Alcohol, Tobacco, and Firearms, Industrial Alcohol User Permit to purchase and New York State Liquor Authority Alcohol Permit to use, dispense and purchase. Policy: N/A Responsibilities: N/A. Procedures/Guidelines: N/A Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

III. IV. V. VI.

VII. VIII.

Date Reviewed 12/13/04 10/5/07

103

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 8 SECT. B Subject: ORDERING OF ABSOLUTE OR 95% ALCOHOL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: Establish procedures for the ordering of absolute alcohol. Definition(s): N/A Policy: Absolute or 95% Alcohol shall be ordered in quantities that meet the safe storage requirements of the NFPA, meet the needs of the hospital and university, and is packaged in, volume containers. Responsibilities: It is the responsibility of the Materials Manager to order, receive and store absolute or 95% alcohol according to BFPA, Department of Treasury, and New York State Liquor Authority Regulations. Procedures/Guidelines:  The Pharmacy Materials Manager shall initiate a purchase requisition for absolute or 95% alcohol not to exceed 1000 proof gallons physically on hand at any time. Purchase shall not exceed 6000 proof gallons annually.  The Materials Manager shall order either absolute alcohol packaged in pints or packaged in wine gallons of 95% alcohol. No dispensing drums shall be ordered.  Upon receipt of the alcohol, the Materials Manager shall verify the shipment’s quantity and enter receipts of either pints or gallons in the Alcohol Record Book.  The Materials Manager shall divide the shipment and place a minimum quantity of pints or gallons into the Pharmacy’s alcohol storage area, Room ALL1-468. All other supplies shall be stored in the volatile storage cage in the Receiving Area of the Hospital.  If a discrepancy is discovered in the shipment, the Materials Manager shall immediately notify the manufacturer and the appropriate correction shall be made. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none

V.

VII. VIII.

104

Date Reviewed 12/13/04 10/5/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

105

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 8 SECT. C Subject: INVENTORY CONTROL AND STORAGE OF ABSOLUTE OR 95% ALCOHOL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish procedures for the maintenance of an ongoing inventory of absolute alcohol. Definition(s): N/A Policy: The hospital’s main inventory of absolute or 95% alcohol shall be accurately maintained according to Department of Treasury, Bureau of Alcohol, Tobacco and firearms Regulations and safely stored under NFPA, New York State Fire Inspection and local New York City Fire Department regulations by the Department of Pharmacy. Responsibilities: It is the responsibility of Pharmacy Management to reconcile physical and record of the inventory of absolute and 95% and maintain the storage of the same in a safe and secure manner. It is the responsibility of the Director of Pharmacy to investigate all claims of discrepancies and file all required documentation. I. Procedures/Guidelines: Storage (1) Supplies of absolute or 95% alcohol for dispensing from the Pharmacy shall be stored in the Pharmacy’s alcohol storage area, Room ALL1-468. (2) This storage area shall meet all New York State and New York City Fire Codes and Security Requirements of The Department of Treasury, Bureau of Alcohol, Tobacco and Firearms and remain locked at all times. The fire code features required in this area are:  Type A,B,C Extinguisher  Room Designations Indication: o No Smoking Volatile Storage o Reactivity and Flammability of Contents o Safety Hazard        Fire Rated Door Solid Ramp Type Door Saddle Overhead Sprinklers Spark Proof Light Switches and Electrical outlets Glass Enclosed Light Bulb Fixtures, if pumping from drums Certified Fire Rated Storage Cabinets No Paper or Cardboard in Area

IV.

V.

106

II.

Inventory Control: (1) At the end of each month, a physical inventory of the balance on hand of Absolute and 95% Alcohol shall be taken by the Associate Director of Pharmacy. (2) (3) The physical inventory shall be compared against the Alcohol Record Book. If a discrepancy is discovered, the Director of Pharmacy shall be notified and an investigation shall be initiated to resolve discrepancy. If the discrepancy can’t be resolved, the Director of Pharmacy shall notify the Senior Associate Administrator responsible for the Pharmacy at extension 2401, Public Safety Office at the Hospital, extension 2626, and the Department of Treasury, Bureau of Alcohol, Tobacco, and Firearms Regional Office, 6 World Trade Center, NY, NY. Procedures outlined in Part 213 of Title 26, code of Federal Regulations shall be followed.

(4)

(5) Absolute or 95% Alcohol is received form the manufacturer and recorded in the Alcohol Record Book in Wine Gallons (3784 ml). (6) (7) (8) VI. Monthly inventories shall be recorded in proof gallons. “Report of Tax Free Alcohol Users” [ATF Form 1451 15150] (8-83). This form shall record balance on hand, quantity received, and quantity dispensed all in proof gallons. The “Report of Tax Free Alcohol User” for the year shall be maintained in the Pharmacy Director’s Office for five (5) years.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/5/07

107

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 8 SECT. D Subject: DISPENSING OF ABSOLUTE AND 95% ALCOHOL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish procedures for the dispensing of absolute and 95% alcohol according to federal laws and NYS Fire Safety Codes. Definition(s): N/A Policy: Absolute or 95% Alcohol shall be dispensed by a Pharmacy aide, pharmacy technician or pharmacist only pursuant to a Alcohol Request Form, in duplicate, signed by an authorized individual from the requesting lab or service. Responsibilities: It is the responsibility of the dispensing individual to sign the Alcohol Request Form and record information in the Alcohol Request Book. It is the responsibility of Pharmacy Administration to monitor compliance to appropriate procedure for dispensing absolute or 95% alcohol. Procedures/Guidelines:  Upon presentation of a signed Alcohol Request Form (UH 81-74) (see attached) with all required information present, a Pharmacy aide, Pharmacy assistant, or pharmacist shall dispense the exact quantity of either 95% or absolute alcohol to the requesting service.  The person receiving the alcohol and the dispenser of the alcohol shall sign the requisition form and the Pharmacy shall retain original and give the copy to the receiving person.  The dispenser shall record in the Alcohol Record Book the following information: o o o o o o Date of Dispensing Requesting Department Quantity Dispensed The Decreased Balance on Hand Signature of the Receiving Individual Signature of the dispenser

IV.

V.

 The alcohol shall be dispensed in the sealed, pre-filled gallon or pints to the requestor.  Any wastage or breakage shall be recorded in the Alcohol Record Book, witnessed by a pharmacist and recorded in the monthly entry to the Department of Treasury, “Report of Tax Free and Alcohol User”.

108

 Pharmacy Administration shall verify entries and compliance to procedures handled during the month.  Storage of any alcohol product must be in a fire rated cabinet that is marked accordingly. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Alcohol Request Form (UH 81-74) References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/5/07

109

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 8 SECT. E Subject: LICENSING REQUIREMENTS FOR THE PURCHASE DISPENSING OF ABSOLUTE AND 95% ALCOHOL Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__

Original Issue date:

8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To designate legal documents required to purchase, store, and, dispense absolute and 95% alcohol. Definition(s): N/A Policy: Absolute or 95% Alcohol shall be purchased or dispensed by the hospital pharmacy only under the authority of a valid Department of Treasury Bureau of Alcohol, Tobacco and Firearms Industrial Alcohol User Permit, issued to the hospital and a New York State Liquor Authority permit issued to the hospital. Responsibilities: It is the responsibility of the Pharmacy Administration to keep current all licensing documents for the purchase and dispensing of absolute or 95% alcohol. Procedures/Guidelines:  Department of Treasury Permit# TF-NY-1329 shall be maintained by Pharmacy Administration as long as absolute or 95% alcohol is purchased. 2) New York State Liquor Authority Permit# AP10355 shall be maintained by Pharmacy Administration as long as absolute or 95% alcohol is dispensed or purchased. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes

IV. V.

VI. Attachments: none VIII. References: none Date Reviewed Revision 12/13/04 10/5/07 Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

110

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. A Subject: MEDICATION ERRORS AND HOSPITAL INCIDENTS INVOLVING MEDICATIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/2/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To establish procedures to follow when discovering and investigating medication errors of omission or commission. Definition(s): See Administrative P&P Manual Chapter PHA-10, Medication Error Definition and Classification Policy: All errors of omission or commission involving medications shall be reported immediately to the Director of Pharmacy and not later than 72 hours of the occurrence. Responsibilities: It is the responsibility of the nurse to file an incident report involving in-patients whether Pharmacy is involved or not. It is the responsibility of the Director of Pharmacy to review all incident reports involving medication and take the appropriate corrective and documentation actions. Procedures/Guidelines: I. In-patient Medication Errors Not Involving Pharmacy Dispensing:  Once the error is discovered, the nurse involved with or discovering the error shall report the error to the Assistant Nursing Director of the respective unit and the physician in charge of the patient.  An official UHB Hospital Patient Incident Report (UH-025) shall be filled out by the nurse and record the names to whom the incident was reported and the times of reporting. This report is forwarded to the Inpatient Q/M Department.  The nurse shall then proceed to answer all questions and describe the incident on the form.  The physician responding to the incident or the Assistant Director of Nursing shall describe his/her findings and interventions and sign the incident report.  The Assistant Nursing Director of the respective unit forwards the completed two part Incident Report to the Associate Administrator for Inpatient Q/M at Nursing Quality Management (Box 95).  After review, a copy of the Nursing Q/A copy is sent to the hospital’s Risk Management Department at Box 23.

V.

111

 The Risk Management Department forwards a photocopy of the report to the Director of Pharmacy at Box 36.  The Director of Pharmacy shall review all incident reports with the Medication Error Work Group involving medication and will determine if each incident requires review and recommendations for action by the Medication Usage Sub-Committee of the Pharmacy and Therapeutics Committee to the Committee of the Pharmacy and Therapeutics Committee top the P&T Committee for review and action due to prescribing errors, or systems deficiencies.  These recommendations shall presented at the monthly annual Pharmacy and Therapeutics Committee meetings as part of the Nursing Medication Error Report with a statistical analysis of the errors along with NYPORTS classification of the errors.  If the Committee determines that the incident involves inappropriate prescribing or administration, the Secretary of the Pharmacy and Therapeutics Committee (Director of Pharmacy) shall communicate with the respective service or to the Hospital’s Quality Management office, describe the events surrounding the incident, describe the Pharmacy and Therapeutics Committee’s determinations, and request a plan of corrective action from the respective service. If the Q/M Department determines that this error is a possible sentinel event, the Associate Administrator for Q/M shall convene an interdisciplinary group to investigate the event.  The corrective plan of action shall be reviewed by the Pharmacy and Therapeutics Committee for approval.  Effectiveness of corrective plans of action shall be monitored through the Pharmacy using prescription documentation and any re-occurrences of similar incident reports. II. In-patient Medication Errors Involving Pharmacy Dispensing: 1) All steps are to be followed as described in Chapter 9, Section A, Procedure I. 2) Pharmacy Administration shall retrieve the incorrectly dispensed prescription records form the Pharmacy’s files and identify the dispensing pharmacist. The Assistant Director of Nursing shall return the incorrectly dispensed drug directly to the Director of Pharmacy. 3) The pharmacist involved shall be counseled informally for the first occurrence and formally for any subsequent occurrences. Persistent medication errors shall be dealt with in a disciplinary fashion, e.g., request for disciplinary investigation, notice of discipline, suspension, termination, if necessary, reporting to the State Education Department. 4) The Director of Pharmacy shall present all incidences of Pharmacy involvement in medication errors at Pharmacy Staff meetings. III. Out-patient Medication Errors Involving Pharmacy Dispensing Discovered by the Pharmacy: 1) All steps are to be followed as described in Chapter XI., Section A, Procedures II., 2 through 4. 2) Pharmacy Administration shall contact the respective clinic and inform the physician and nurse in charge to contact the patient at home and tell the patient not to take the drug. 3) Pharmacy shall contact Public Safety, extension 2626, to arrange for a car to bring the correct medication to the patient’s home and recover the incorrect medication. 4) The Director of Pharmacy shall file an Incident Report with Risk Management within 24 hours of the incident. VI. Reasons for Revision: VII. Changes in regulatory or statutory laws or standards VIII. System failures/ changes IX. Institutional/operational changes

112

X. VIII.

Attachments: UHB Patient Incident Report PHA-10

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/5/07

113

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___PHA-10 Subject: MEDICATION ERROR DEFINITION AND SEVERITY CLASSIFICATION Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____3__

Original Issue date:

6/00

Implementation Date: __8/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. Purpose: To categorize medication errors according to NYPORTS classification for analysis and required reporting. II. Definition(s): NYPORTS: New York Patient Occurrence Reporting & Tracking System o All alleged medication errors reported shall be deemed a medication error if it falls within the following definition:

A medication error is any preventable event that may cause or lead to inappropriate medication use and patient harm while the medication is in control of a healthcare professional, patient, or consumer. such events may be related to professional practice, healthcare products, procedures, and systems including prescribing, order communication, product labeling, packaging and nomenclature, compounding, dispensing distribution, administration, education monitoring, and use. o III. QM – Quality Management Department

Policy: By standardizing a universal definition for medication errors and establishing a system for severity classification, an interdisciplinary team can evaluate the root causes of the medication errors and initiate a corrective action so that the error does not re-occur. Responsibilities: All medication errors shall be reported on a patient’s incident report to QM by all hospital staff. Medication errors shall be reviewed by an interdisciplinary group from QM and Nursing. Medication errors and rates are reviewed monthly by the Pharmacy and Therapeutic Committee. Errors categorized in categories G, H, I should be reviewed by an AD HOX reporting to the NYSDOH.

IV.

V.

Procedures/Guidelines: o Once an alleged medication error has been confirmed as a true medication error by the above definition, the medication error shall be classified into one of the following categories: Category A, No Error: Circumstances or events that have the capacity to cause error Category B, Error, No Harm: An error occurred but that reached the patient but did not reach the patient. Category C, Error, No Harm: An error occurred but that reached the patient but did not cause patient harm.

114

Category D, Error, No Harm: An error occurred that resulted in the need for increased patient monitoring but no patient harm. Category E, Error, Harm: An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm Category F, Error, Harm: An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm These categories are reportable to the NYSDOH and may require a sentinel event review: Category G, Error, Harm: Category H, Error, Harm: arrest) An error occurred that resulted in permanent patient harm. An error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac

Category I, Error: An error occurred that resulted in a patient death. VI. Reasons for Revision: XI. Changes in regulatory or statutory laws or standards XII. System failures/ changes XIII. Institutional/operational changes VII. VIII. Attachments: none References: NYSDOH, NYPORTS Classification of Medication Errors Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/13/04 10/5/07

115

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. B Subject: DRUG-DRUG INTERACTIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: In order to prevent injuries or adverse outcomes associate with drug-drug interactions, pharmacist shall follow established procedures to evaluate drug combinations. Definition(s): N/A Policy: All Pharmacists shall check the patient medication profile for potential drug – drug interactions before dispensing a prescription order written by authorized licensed/credentialed prescribers. Responsibilities: It is the responsibility of the pharmacist to all prescriptions for potential drug – drug interactions and communicate with the responsible physician to resolve the problem medication order. Procedures/Guidelines:  Upon receipt of a prescription order, a pharmacist shall check either the computer medication profile or in those satellite areas, the hard copy profile for potential drug – drug interactions prior to dispensing.  If after the pharmacist reviews the profile a determination is made that a potential drug interaction is evident, the pharmacist shall contact the respective nursing station and speak to the physician responsible for the patient.  The pharmacist shall inform the physician about the potential interaction and discuss alternative therapies.  If the physician agrees with the alternative, the pharmacist shall instruct the physician to discontinue the original order and write a new prescription order for the alternative.  If the physician insists on the dispensing of the original order, and in the professional judgment of the pharmacist that it neither poses a life threatening situation nor may produce injury/immediate adverse effects in the patient, the pharmacist shall document the following information on the prescription: Date of Contact with Physician Time of Contact with Physician Name of Physician Reasoning Give by the Physician for Dispensing or Backup Documentation Reference Given by the Physician o Signature of Pharmacist o o o o

116

 If in the pharmacist’s professional judgment dispensing the medication upon the physician’s insistence the patient will be compromised in any manner, the pharmacist shall refer the matter to Pharmacy Administration to resolve the issue with the attending physician. VI. Reasons for Revision: XIV. Changes in regulatory or statutory laws or standards XV. System failures/ changes XVI. Institutional/operational changes Attachments: Top Ten Drug-Drug Interactions References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/5/07

117

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 9 SECT. C Subject: DRUG – FOOD INTERACTIONS Prepared by: Nicholas Galeota, MS, RPh Reviewed by: William Gerdes Alan Hui, Pharm.D. Stefani Skidell, RD Approved by: Constance Shames, MD Page 1 of 1 Original Issue date: 8/1/98 Implementation Date: 8/03/01 Revisions: 12/01/07 Distribution: Administrative Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs _____________________________________________________________________________ I. Purpose: To provide a method to alert healthcare providers of patients that are at risk of potential drug - food interactions, ensure appropriate medication administration, and counsel patients of any dietary modifications. II. III. Definition(s): None Policy: The Pharmacy Department shall inform the hospitals clinical dietary services daily concerning medication orders prescribed for in-patients that have a potential for drug - food interactions. IV. Responsibilities: It is the responsibility of the Pharmacy Department to select drugs with a high profile for food – drug interactions and tag the agents in the computer mainframe for Dietary reporting. It is also the responsibility of the nurse or pharmacist to provide printed drug information for patient discharge interviews and participate, as necessary, in the interview. It is the responsibility of the clinical dietician to review patient charts and make recommendations to the physician or instruct the patient in diet modifications. Procedures/Guidelines: 1. The Pharmacy Department shall tag the following targeted drugs with a high potential for drug – food interactions in the computer mainframe profile (THOMIS) for the drug. a. Monoamine Oxidase Inhibitors ® i. Phenelzine (Nardil ) ® ii. Tranylcypromine (Parnate ) ® b. Warfarin (Coumadin ) c. Fluoroquinolone Anitbiotics ® i. Ciprofloxacin (Cipro ) ® ii. Levofloxacin (Levaquin ) ® iii. Moxifloxacin (Avelox ) d. HMG-CoA Reductase Inhibitors (“Statins”) ® i. Atorvastatin (Lipitor ) ii. Simvastatin (Zocor) ® iii. Rosuvastatin (Crestor ) ® iv. Lovastatin (Mevacor ) ® v. Fluvastatin (Lescol )

IV.

118

vi. Pravastatin (Pravachol ) e. Immunosuppressants ® ® i. Cyclosporine (Neoral , Sandimmune ) ® ii. Tacrolimus (Prograf ) ® iii. Sirolimus (Rapamune ) f. Benzodiazepine ® i. Diazepam (Valium ) ® ii. Midazolam (Versed ) ® g. Phenytoin (Dilantin ) ® h. Metronidazole (Flagyl ) i. Angiotensin Coverting Enzyme (ACE) Inhibitors ® i. Captopril (Capoten ) ® ii. Enalapril (Vasotec ) ® iii. Benazepril (Lotensin ) ® iv. Fosinopril (Monopril ) ® ® v. Lisinopril (Prinivil , Zestril ) ® vi. Moexipril (Univasc ) ® vii. Perindopril (Aceon ) ® viii. Quinapril (Accupril ) ® ix. Ramipril (Altace ) ® x. Trandolapril (Mavik ) 2. Upon arriving the daily robotics database input of medication orders in the Main Pharmacy, an upload of data shall be received by the EAGLE system and a printout of the targeted drug shall be generated in the Clinical Dietary Department with the following information: o o o o Name of Patient Location of Patient Date of the Medication Order Name of Targeted Drug

®

3. The clinical dietician shall then proceed to conduct a chart review of the patient for whom the drug has been ordered and make recommendations as to diet changes, and if necessary, education the patient on the diet restrictions required for a particular drug. 4. If the patient is to be discharged, the nurse in charge of the patient shall use the Micromedex ® CareNotes and provide a printed drug information packet to be given to the patient concerning the drugs that the patient is being surcharged with by the physician. 5. If necessary, the nurse may request that a pharmacist assist the nurse in the patient exit counseling interview concerning the drug orders the patient shall take upon discharge, at extension 2854 or 2856. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Top 10 Drug-Food Interactions References: MicroMedex Revision Yes Yes Yes
®

VII. VIII.

Date Reviewed 8/01 8/04 12/07

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH Alan Hui, PharmD Alan Hui, PharmD

119

Top 10 Drug-Food Interactions
Medication or Drug Class MAO-I (Monoamine Oxidase Inhibitors) Phenelzine (Nardil®) Tranylcypromine (Parnate®) Warfarin (Coumadin®) Offending Foods Tyramine-containing foods such as aged cheeses, fermented meats, fava beans, red wines, pickled fish, figs, and avocados Foods with high vitamin K content such as broccoli, spinach, kale, turnip greens, cauliflower, brussel sprouts Cations containing products: Dietary products containing calcium Iron, magnesium, and zinc supplements Antacids Grapefruit juice Clinical Relevance High Interaction Risk of hypertensive crisis and cardiovascular events Vitamin K produces blood-clotting substances and may reduce the effectiveness of anticoagulants Decrease absorption of these drugs by chelation in the stomach resulting in treatment failure Increased bioavailability of the “statins” resulting in an increased risk of myopathy Increased bioavailability of these medications resulting in toxic serum drug levels Increased bioavailability of these medications resulting in elevated serum drug levels Increased bioavailability of these medications resulting in elevated serum drug levels Decrease absorption of phenytoin resulting in subtherapeutic drug levels A disulfiram-like reaction (flushing, increased respiratory rate, tachycardia) may occur when taken concomitantly Increase serum potassium level Comments and Recommendations Avoid tyramine-containing foods

• •

Moderate

• • • •

Fluoroquinolones Antibiotics Gatifloxacin (Tequin®) Ciprofloxacin (Cipro®) • Levofloxaxin (Levaquin®) Moxifloxacin (Avelox®) • • HMG-CoA Reductase Inhibitors Atorvastatin (Lipitor®) Simvastatin (Zocor®) Lovastatin (Mevacor®) Also know as the “statins” Immunosuppressants Cyclosporine (Neoral®) Tacrolimus (Prograf®) Sirolimus (Rapamune®) Benzodiazepine Diazepam (Valium®) Midazolam (Versed®) Tiazolam (Halcion®) Calcium Channel Blockers Nifedipine (Procardia®) Felodipine (Plendil®) Verapamil (Calan®, Isoptin®) Phenytoin (Dilantin®)

High

Large changes in dietary consumption of foods high in vitamin K should be avoided or accompanied by careful monitoring of the international normalized ratio (INR). Avoid diary products. If taken concomitantly, take one hour before or two hours after ingestion of the cation containing product

Moderate

• • •

Avoid grapefruit juice during therapy. Orange juice may be substituted.

Grapefruit juice

High

• • •

Avoid grapefruit juice during therapy. If taken concomitantly, monitor serum drug levels (if possible) and signs of toxicity. Avoid grapefruit juice during therapy. Monitor mental and respiratory status if taken concomitantly. Avoid grapefruit juice during therapy. Monitor heart rate and blood pressure if taken concomitantly since hypotension can occur. Hold enteral feeds 1-2 hours before and after each phenytoin dose.

Grapefruit juice

High

• • •

Grapefruit juice

Moderate

• • •

Enteral Feeds

Moderate

Metronidazole (Flagyl®)

Alcohol

High

Avoid ethanol ingestion while on metronidazole therapy and for at least three days after the discontinuation of metronidazole treatment. Avoid eating large amounts of foods high in potassium. Monitor serum potassium levels periodically.

• •

ACE-I (Angiotensin Converting Enzyme Inhibitor) Captopril (Capoten®) Enalapril (Vasotec®)

Foods with high potassium content such as bananas, green-leafy vegetables, and oranges

Moderate

120

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. C 1 Subject: DRUG – FOOD INTERACTION MONITORING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____3__ Original Issue date: 8/1/98

Implementation Date: __8/3/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ FOOD – DRUG INTERACTION MONITORING* CLASSES OF DRUGS: 1) Hypo-glycemic drugs 2) Corticosteroids 3) Cardiac Glycosides 4) Beta blocker drugs 5) Anti-coagulants 6) Diuretics 7) Mono-Amine Oxidase Inhibitors 1) Hypoglycemics 1a. 1b. 1c. 1d. Oral Sulfonylureas and Insulin: Formulary Drugs chlorpropamide, tolazamide, and tolbutamide Effects can cause dose-related nausea, vomiting, metallic taste, heartburn, and dyspepsia Advice: no particular Food – Drug precautions Insulin – be aware of sugar and/or carbohydrate contents of food. Oral Hypoglycemics: take with food or after meals to minimize gastric distress; do not take with alcohol or alcoholic beverages

2)

Corticosteriods 2a. 2b. 2c. Mineral Corticoid Formulary Drugs: prednisone, cortisone acetate, prednisolone Effects: Decrease absorption of calcium, phosphorus; increase urinary ascorbic acid, calcium potassium, zinc, nitrogen decrease nitrogen balance; decrease serum zinc increase blood glucose, serum triglycerides, serum cholesterol promotes GI ulceration, delay wound healing increases need for pyridoxine, ascorbic acid, folate, vitamin D Advice: Vitamin supplementation with a multivitamin preparation may be necessary. Take after meals or with food.

2d.

Compiled by the Pharmacy Department at UHB. 3) Lanoxin®

121

3a. 3b. 3c. 3d.

Digoxin Formulary Drugs: digoxin tablets, oral, liquids, or injection Effects: Toxicity symptoms include anorexia, nausea, vomiting, diarrhea, cachexia may competitively inhibit glucose absorption may increase urinary magnesium, calcium Advice: (1) Inform doctor to check for toxicity if patient exhibits anorexia, nausea, vomiting, diarrhea, cachexia, (2) Monitor electrolytes, (3) Don’t take with milk or milk products or foods high in calcium content

4)

Betablockers (Cardiovascular) 4a. 4b. 4c. 4d. Betablockers Formulary Drugs: Inderal ®, Lopressor ® Effects: Can cause nausea, vomiting, constipation, abdominal, cramping, epigastric distress, insignificant decrease in blood glucose. Advice: This class has caused hypoglycemia in humans and can cause potentiation of insulin and oral hypoglycemics. Take before meals; may cause gastric distress

5)

Anticoagulants 5a. 5b. 5c. 5d. Oral Anticoagulants Formulary Drugs: Coumadin ® Effects: Can cause nausea, vomiting, cramps, diarrhea, mouth ulcers Advice – Should not be taken with alcohol, alcoholic beverages, foods rich in vitamin K (green leafy vegetables, fish, fish oils, onions), vitamin C (orange juice, etc), potato chips

6)

Diuretics 6a. 6b. 6c. Thiazides Formulary Drugs: hydrochlorothiazide, acetazolamide, chlorthalidone Effects: (General) – May increase urinary thiamin, pyridoxine, calcium, magnesium, potassium, phosphate may cause hypokalemia, hypomagnesaemia decrease zinc content of liver Specific Effects: Acetazolamide can cause anorexia, increases urinary calcium, potassium

Chlorthalidone: Increases carbohydrate intolerance; increase urinary zinc, potassium

Ethacrynic Acid: Can cause anorexia, abdominal discomfort, dysphagia, nausea, vomiting, diarrhea after several months. May decrease carbohydrate tolerance Increases urinary calcium, magnesium, potassium, can hypokalemia hypomagnesemia Furosemide: Can cause nausea, vomiting diarrhea. Possibly causes peculiar sweet taste, oral and gastric burning sensation Decreases serum calcium hypercalcemia Decreases serum, muscle magnesium Decreases serum, muscle potassium, total exchangeable potassium Decreases carboyhydrate tolerance; may be diabetogenic Spironolocatone: Increases urinary calcium, magnesium Thiazides: Can cause anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, increase urinary excretion of potassium, magnesium, zinc, riboflavin, decreases carbohydrate tolerance Can cause potassium, magnesium depletion Single dose increases calcium excretion, long term use tends to decrease calcium excretion and increase serum calcium Triamterene: Can cause diarrhea, nausea, vomiting, GI upset, dry mouth, antagonizes folate, may decrease serum folate, may increase calcium excretion, does not increase magnesium excretion.

122

6d. Advice: Take in morning if single dose. Can cause dryness in mouth; may cause electrolyte imbalance (hypokalemia, hypotremia); should not be taken with alcohol or alcoholic beverages 7) Mono Amine Oxidase Inhibitors 7a. 7b. 7c. MAO Inhibitors Major interaction: Amine-containing foods This established interaction has major severity and occurs rapidly Formulary Drugs: Phenelzine (Nardil) and Tranylcypromine (Parnate) Effects Marked: elevation of blood pressure, hypertensive crisis or hemorrhagic strokes may occur if amine containing foods are consumed concurrently or after monamine oxidase inhibitor therapy Mechanism: inhibition of monamine oxidase impairs normal metabolism of tyramine and other amines found in certain foods.

7d. Advice: Do not take with alcohol or alcoholic beverages, banana, broad beans, excessive quantities of caffeine, chicken, chocolate, cheese, figs, licorice, liver, meat prepared with meat tenderizers, pickled herring, pineapple, yeast, yogurt, because they may cause hypertensive crisis.

123

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. C. 2 Subject: FORMULARY DRUGS TAGGED IN THE COMPUTER MAINFRAM FOR DRUG-FOOD INTERACTION MONITORING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__

Original Issue date:

8/1/98

Implementation Date: __8/3/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ The following Formulary Drugs are tagged in the computer mainframe so that a printout will be generated in the Dietary department (NOTE: Generic equivalents may exist as the current formulary entry): See attached Top 10 Drug-Food Interactions entries

124

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. C. 3 Subject: GUIDE TO DRUG-FOOD INTERACTIONS PATIENT COUNSELING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/3/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ The medicines you take are a very important part of treating your illness. At times, there are specific changes that you must make in your usual diet to avoid any side effects from medicines. We have taken the most commonly used drugs and provided instructions on how to take the medication and how to eat properly. Every medication does not appear on these lists, therefore ask your pharmacist or physician if you have additional questions.

125

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. D Subject: DRUG RECALLS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __7/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To advise Pharmacy staff how they shall initiate immediate steps to notify all in-patient nursing units and out-patient clinic areas concerning the recall and immediately remove recalled drugs from working stock of all Pharmacy service areas and Nursing Station and Clinic drug storage areas. Definition(s): N/A Policy: Upon official notification from the Food and Drug Administration, the New York State Department of Health, New York City Department of Health, or a drug manufacturer, the Pharmacy Department shall initiate immediate steps to notify all in-patient nursing units and out-patient clinic areas concerning the recall and immediately remove recalled drugs from working stock of all Pharmacy service areas and Nursing Station and Clinic drug storage areas. Responsibilities: It is the responsibility of the Material’s Manager to maintain purchase order history files of all drug products purchased by the Pharmacy. It is the responsibility of the Material’s Manager and the Pharmacy Aides to remove all recalled drugs from the Pharmacy service areas. It is the responsibility of Pharmacy Management to dispatch a staff member to retrieve recalled drugs from the nursing station or clinic areas. It is the responsibility of Pharmacy Management to notify Nursing concerning the drug recall, maintain all appropriate documentation, and supervise the correct disposition of the recalled drugs. Procedures/Guidelines:  When notice is received by the Director of Pharmacy concerning a drug recall, the Material’s Manager shall be directed to search the drug purchase order history file for the recalled drug by lot number.  The Material’s Manager shall match the recalled drug’s lot number and manufacturer to his/her purchase order history file.  If no match is found, the Material’s Manager signs and dates the recall notice and places it in the Drug & Device Recall File.  In the event that a match between the recall notice and the inventory exists, the Material’s Manager shall notify the Associate Director of Pharmacy in writing.  If there is no match between the recall notice and the purchase order history, the Material’s Manager and the Pharmacy Aides shall proceed to remove all of the recalled drugs from all

II. III.

IV.

V.

126

Pharmacy service areas and package the drugs for return to the manufacturer or to the appropriate shipping address provided in the recall notice.  The Associate Director of Pharmacy shall dispatch a Pharmacy staff member to all nursing stations and clinic areas to retrieve all supplies, if any, of the recalled drug and proceed for return as in Chapter IX, section D Procedure #5.  A written memo (see attached) shall be sent to all nursing station and clinic area Assistant Director of Nursing, as a notification of the recall or a computer message will be generated to all Nursing Station and Clinic Areas concerning the recall.  A notice of finds shall also be provided to the Safety Committee of the Hospital through Risk Management (Box 23).  A pharmacist shall prepare replacement supplies for all recalled drugs removed from nursing stations or clinic areas.  The recall notice shall be signed by a Pharmacy Manager and the following information shall be documented on the notice: o o o o o Name of Drug Lot # Manufacturer Quantity of Drug Recovered Date of Shipment to Recalling Agency

 In the event that the recall effects an ambulatory care prescription, Chap. 9, Sect. A, Procedures, Sub-section III, #’s 2 through 4 are to be followed in addition to the above. VI. Reasons for Revision: XVII. Changes in regulatory or statutory laws or standards XVIII. System failures/ changes XIX. Institutional/operational changes Attachments: Drug Recall Notice References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/13/04 10/5/07

127

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. E Subject: ADVERSE DRUG REACTION REPORTING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____3__ Original Issue date: 8/1/98

Implementation Date: __8/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. Purpose: To establish procedures for the reporting and evaluation of adverse drug reactions reported by any healthcare practitioner. Definition(s): An adverse drug reaction is defined as any unwanted/unexpected event occurring in the course of the use of a drug at normal dosages in professional practice which: o increases a patient’s length of stay o results in discontinuance or changing of a drug order o requires treatment with another prescribed drug o results in permanent or temporary disability o requires hospitalization or re-admission o is toxic to the patient, e.g. nausea, diarrhea, severe headache, increase in BUN, etc, o is life threatening or fatal o causes/results in a significant failure of expected pharmacological action Policy: Clinicians and/or healthcare providers shall report any suspected adverse reaction to a drug to the attending physician. The physician shall determine the presence or absence of any adverse drug reaction. All adverse drug reactions shall be reviewed by the Pharmacy and Therapeutics Committee. IV. Responsibilities: It is the responsibility of all healthcare providers to report suspected adverse drug reactions experienced by patients through the ADR hotline. It is the responsibility of the Director of Pharmacy to present all of the suspected ADR’s reported to the Pharmacy and Therapeutics Committee for review and disposition. Procedures/Guidelines: 1) The nurse/clinician shall notify the physician of signs and symptoms indicative of a suspected adverse drug reaction exhibited by the patient. 2) The physician shall treat the patient exhibiting the symptoms of a suspected adverse drug reaction and stabilize the patient. 3) The physician/nurse/clinician shall call the Adverse Drug Reaction Hotline (X 1890) in the Pharmacy. The hotline is available24 hours a day, 7 days a week. The information required is as follows: a) Date and Time of the call b) Patient’s name. medical record number, and location of the patient at the time of the event c) Suspected drug causing the reaction

III.

V.

128

4) The nurse/clinician shall document in the patient’s medical record all of the signs and symptoms that the patient has experienced to the suspected offending drug, the treatment rendered, if any, and the outcome to the patient. 5) The physician shall validate or invalidate the reaction and document his/her findings in the medical record. The suspected adverse drug reaction shall also be documented in the medical record. 6) The Pharmacy staff shall record the information provided from all calls reported to the ADR Hotline on a daily log of the adverse drug reaction hotline calls (see attached). This log shall be given daily to the Associate Administrator for Quality Management for medical record review. 7) ADR’s are also captured by clinical pharmacists at rounds, clinical Pharmacy students on rounds, and through scrutiny of specific drug utilization data from the Pyxis machines. 8) The Director of Pharmacy in collaboration with a physician, shall classify the adverse drug reaction in one of the three (3) severity levels: Level 1. (Mild Reaction): Confirmed reaction without the potential of significant adverse effect(s) on the patient. Level 2. (Moderate Reaction): Confirmed reaction with the potential for significant adverse effect(s) on the patient. Level 3. (Severe Reaction)*: Confirmed reaction with significant adverse effect(s) on the patient. * A severe reaction is defined as unnecessarily prolonged treatment, complications, or re-admission; or patient management which results in anatomical or physiological impairment, disability, or death. 9) If the suspected adverse drug reaction is not confirmed by the attending physician and the symptoms indicate that an adverse drug reaction has occurred, the medical record shall be sent to the Pharmacy and Therapeutics Committee for peer review by a physician member. 10) The Pharmacy and Therapeutics Committee physician shall confirm or reject the presence of an adverse drug reaction. If the reaction is confirmed, the medical record shall be sent to the Pharmacy and Therapeutics Committee for peer review by the Pharmacy and Therapeutics Committee. 11) If the Pharmacy and Therapeutics Committee or its sub-committee review of a confirmed adverse drug reaction by a peer physician member results in an item for action or Committee recommendation for corrective action/clinical service response, a letter requesting a response to the Committee will be forwarded to the clinical service by the Associate Administrator for Quality Management for discussion, corrective action , and documentation in the service’s Clinical Q/A Committee minutes. 12) The response from the clinical service shall be presented to the Pharmacy and Therapeutics Committee by the Associate Administrator for Quality Management for acceptance or a request for further action. 13) If the reaction is of severe nature, the Director of Pharmacy shall report the adverse drug reaction to the FDA’s Med-Watch Program and the drug manufacturer using the Department of Health and Human Service’s FDA form 1693 (7/86) see attached). This reaction may also be designated as a sentinel event. In such case an ad hoc interdisciplinary committee shall review the suspected adverse drug reaction. VI. Reasons for Revision: XX. Changes in regulatory or statutory laws or standards XXI. System failures/ changes XXII. Institutional/operational changes

129

VII. Attachments: Daily log of Adverse Drug Reaction Hotline Calls Form; Suspected Drug Reaction Confirmation Record Form; Med Watch Reporting Form; Vaccine Adverse Event Reporting Form; Pharmacy Staff’s Adverse Drug Reaction Reporting Form VIII. References: none Date Reviewed 12/13/04 10/5/07 Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

130

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. F Subject: POISONING AND ANTIDOTES Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to address poisoning cases, obtain poison information, and maintain antidotes. Definition(s): N/A Policy: The Pharmacy Department shall maintain adequate references to assist the Nursing and Medical Services of UHB in treating cases of poisoning and maintain the telephone number of the regional Poison Control Center. The Pharmacy shall further provide the universal antidote (liquefied activated charcoal) to all in-patient nursing and clinic areas. Responsibilities: It is the responsibility of the pharmacist to provide antidote information and the regional poison control center telephone number to nursing or medical personnel reporting cases of suspected poisoning. It is the responsibility of the Pharmacy Department to maintain adequate supplies of drugs and drug information references to provide antidote information. Procedures/Guidelines: 1) Upon notification from Nursing or a Medical Service of a suspected poisoning incident within the hospital, a pharmacist shall search the references maintained in the Pharmacy to assist the nurse or physician in providing immediate care for the patient [ Note: Nurse should file a patient incident report (UH-025)]. 2) The pharmacist shall call the regional New York City Poison Control Center at 1-212-3454494, if the references do not adequately provide sufficient information to treat the poisoning case. 3) The pharmacist shall direct the nurse or physician to the universal antidote maintained on all nursing stations and Clinic Areas if appropriate (Note: During the monthly nursing station inspections, the pharmacist shall inspect for the presence and integrity of the universal antidote on all nursing care areas and replace, as needed, missing or expired universal antidotes). 4) The Material Manager shall maintain adequate supplies of antidotes for the treatment of poisoning cases e.g. Cyanide Antidote Kit, charcoal suspension, Ca EDTA Injection, disaster supplies for chemical and radiologic poisoning, etc.

IV.

V.

131

5) A pharmacist shall insure that during the monthly nursing station inspection a sticker with the Regional New York City Poison Control Center number is on all phones at the nursing station or clinic areas. VI. Reasons for Revision: XXIII. Changes in regulatory or statutory laws or standards XXIV. System failures/ changes XXV. Institutional/operational changes Attachments: Antidotes and Treatment Modalities Chart References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/14/04 10/5/07

132

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. G Subject: ANTITOXINS AND TOXOIDS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To provide direction to pharmacists on obtaining antitoxins and toxoids on demand. Definition(s): N/A Policy: In the event that an antitoxin or toxoid is non-formulary and is requested by the Medical Staff, Pharmacy Administration shall make appropriate arrangements to obtain the antitoxin or toxoid. Responsibilities: It is the responsibility of the Pharmacy Administration to arrange for the procurement of emergency biologicals (antitoxins or toxoids) in response to a written physician request for emergency patient care. Procedures/Guidelines: I. For interventions provided by New York City DOH: 1) Pharmacy Administration shall contact the New York City DOH, Bureau of Labs at 1-212-447-2533 and make suitable arrangements to provide the drug to UHB. 2) Pharmacy Administration shall contact Public Safety at UHB (extension 2626) to arrange for a car to pick up the drug at: New York City DOH Bureau of Labs st 455 1 Avenue Room 100 – J New York, N.Y. 10013 3) 4) A pharmacy staff member shall accompany the Public Safety Office to the lab and present a written physician request for the drug. When the drug arrives at the hospital, it shall be immediately dispensed to the requesting area by a pharmacist.

V.

II. For inventions Provided by a Drug Manufacturer: 1) The Pharmacy’s Material Manager shall contact the respective drug company and arrange for same day delivery of the drug. 2) Upon receipt of the drug it shall be immediately dispensed to the requesting area by a pharmacist.

133

VI.

Reasons for Revision: XXVI. Changes in regulatory or statutory laws or standards XXVII. System failures/ changes XXVIII. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/14/04 10/5/07

134

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 9 SECT. H Subject: DRUG AND DEVICE DEFECTS REPORTING Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/03/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To instruct staff on how to report drug and/or device defects to the USP. Definition(s): N/A Policy: Upon discovery or a report of a drug defect or device defect within the Pharmacy service areas, Pharmacy Administration shall initiate either a Drug Product Problem Report or Medical Device and Laboratory Product Problem Report and isolate the suspected defective drug or device. Responsibilities: It is the responsibility of Pharmacy Management to report all suspected drug product defects or Pharmacy related suspected device to the US Pharmacopeial Convention, the FDA, and the manufacturer of the product. Procedures/Guidelines: 1) Upon discovery or report of either drug or device defect the Material’s Manager and Pharmacy Administration shall recover all suspected products, lots, or devices throughout the hospital and isolate the recovered items in a locked storage area of the Pharmacy. 2) 3) 4) The Pharmacy Administration shall notify Nursing Administration (Box 95) and Risk Management (Box 23) concerning the defect. Pharmacy Administration shall make telephone contact with the USP Convention at 1-800638-6725 to file an initial verbal report. Pharmacy Administration shall follow up the telephone report by completing either USP Drug Product Problem Report [FDA 2519 F (3/85)], whichever applies, and mail it to (see attached): The US Pharmacopeial Convention 12601 Twinbrook Parkway Rockville, N.S. 20897-5211 5) Pharmacy Administration shall provide samples for testing to the FDA or manufacturers, via certifies mail, as necessary.

IV.

V.

6) The final analysis report from the USP, FDA, or the manufacturer shall be filed in the Drug/Device Recall/Problem file in the Pharmacy and a copy shall be sent to Risk Management at Box 23.

135

VI.

Reasons for Revision: XXIX. Changes in regulatory or statutory laws or standards XXX. System failures/ changes XXXI. Institutional/operational changes XXXII. Attachments: Medical Device and Laboratory Product Problem Reporting Form; USP Drug Product Problem Reporting Program Form VIII. References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/14/04 10/5/07

136

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 10 Subject: Handling of Non-Formulary Medications (including Home Medications and Medications brought in by Practitioners) Prepared by: Nicholas Galeota, MS, RPh Distribution: Reviewed by: William Gerdes Alan Hui, Pharm.D. Administrative Manual Department Manual Patient Care Manual AOD Manual Page ____1__ of ____1__ Original Issue date: Implementation Date: 8/01/98 8/06/01

Approved by: Constance Shames, MD Issued by: Regulatory Affairs _____________________________________________________________________________ I. II. Purpose: To establish a process to manage non-formulary medications in the hospital. Definition(s): Home Medications are defined as drugs brought to the hospital which a patient had taken prior to admission III. Policy: All drugs approved for use in UHB by the Pharmacy and Therapeutics Committee for patient care shall be issued through the Hospital Pharmacy Department and its satellite services. Responsibilities: The patient shall arrange for the disposition of their own medication to a family member upon admission to the hospital. The physician shall request nonformulary use of the medication if deemed necessary. The nurse shall administer the non-formulary order bearing the statement “Patient is required to receive his/her own medications”. Procedures/Guidelines: A. Request for Non-formulary Medications obtained by Pharmacy

IV.

V.

1. In the event a prescriber requires for his/her patient to receive a non-formulary medication that Pharmacy must obtain, the physician shall fill out a Non-Formulary Purchase Request Form (see attached) and submit it to the Pharmacy with a written prescription for the drug. 2. The prescriber must indicate specific therapeutic reason(s) for prescribing the nonformulary medication(s) on the Form. 3. Because it will be necessary to obtain the non-formulary drug from outside the hospital, there may be at least a 24-hour delay in obtaining such drugs. 4. Therefore, an equivalent formulary drug should be considered and used whenever possible.

5. All non-formulary requests are reviewed by the Pharmacy and Therapeutics Committee. B. Handling of Patient’s Home Medications

1. A patient’s home medications shall be sent home with a family member. When the patient is not accompanied by a family member, the medication shall be stored in the locked medication storage area on the nursing unit, labeled with the patient’s name, and returned to the patient at the time of discharge. 2. If the medication disposition does not warrant return to the patient, e.g., patient does not wish to accept the medication back, the medication shall be sent to the Main Pharmacy, Room ALL 1-469, for destruction. 3. Patients admitted to University Hospital must not use their own medication while in the hospital except in the following situations: a. When UHB’s Pharmacy Department does not stock the medication as an approved formulary medication. In this case, if it is the opinion of the attending physician that the medication is a medical necessity, the following procedures are to be followed: i. The physician shall indicate on the “ Prescriber’s Order Form” that the patient is required to receive his/her own medication and a must specify the name, strength, dosage, frequency and duration of each drug to be administered in compliance with “Patient Medication Order” policy. ii. The Nursing station personnel shall bring the medication to the Main Pharmacy to affix a “Non-Formulary” UHB label on the container to confirm the contents by Pharmacy. iii. The medication shall be brought back to the nursing station for administration to the patient by the Nursing staff and stored in the patient medication cassette. iv. The Pharmacy shall not re-label the medication (NYS Education laws for the Practice of Pharmacy). v. b. When the patient must continue taking the medication during a scheduled cycle, e.g., oral contraceptive medication, this also requires that the procedure outline in (a) is followed. C. Handling of Medications brought into the Hospital by Practitioners

1. Medications brought into the hospital by Practitioners for inpatient use is prohibited since UHB’s Pharmacy Department cannot ensure the integrity and stability of such products. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Non-formulary Request Form References: none

VII. VIII.

Date Reviewed 12/26/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH Alan Hui, Pharm.D.

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 11 Subject: NURSING STATION INSPECTIONS Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __7/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To insure that medication is stored properly in Nursing care areas and that expired/deteriorated medications are removed from these areas.. Definition(s): N/A Policy: 1) The Director of Pharmacy shall assign a pharmacist or Pharmacy Assistant (technician) every month to all designated Nursing Stations and clinic areas for the purpose of inspecting medication storage areas. 2) The Pharmacist/technician shall utilize the established criteria for review of medication storage areas and complete the inspection Q/C form (see attached). The pharmacist shall also inspect the expiration date of all crash carts in the Nursing care area. 3) The pharmacist/technician shall inspect medication storage cabinets, drug storage refrigerators, controlled drug cabinets, crash carts, Pyxis® machines, and designated drug storage/drug preparation areas within the nursing stations or clinics. NOTE: Pharmacy Assistants (technicians) shall inspect controlled drug cabinets. 4) The pharmacist/technician shall document compliance or deficiencies of the review process on the inspection form. 5) The pharmacist/technician shall correct all outstanding deficiencies discovered in the inspection process the same day, if within his/her control, as the inspection is conducted. These deficiencies for immediate action are:  Removal of Expired Drugs  Removal of Un-labeled or Deteriorated/Unusable Drugs  Removal of Drugs labeled With A Discharged Patient Name  Removal of Excess Supplies  Removal of Improperly Stored Drugs  Removal of Drug Samples, if any  Replacement of all Drugs Removed, if Required 6) After the review is completed, the pharmacist/technician shall sign and date the inspection form. 7) The inspecting pharmacist/technician shall present his findings to the Assistant Director of Nursing for respective unit. 8) Upon return to the Pharmacy, the pharmacist/technician shall submit all documentation to the Associate Director of Pharmacy.

139

9) The Associate Director of Pharmacy shall review all documentation and, as necessary, make spot checks of the inspection process to determine accuracy and completeness of the inspection process to determine accuracy and completeness of the inspection. He/she shall then sign and date the inspection form. 10) The Associate Director of Pharmacy shall have copies of the inspection form made and distributed to the Associate Administrator for Inpatient Q/M. The original copy remains a part of the Pharmacy’s permanent inspection records. The monthly findings shall be reduced to a statistical report and presented to Nursing Leadership in its monthly Q/A report. 11) All deficiencies that the Pharmacy can assist with shall be resolved with the Associate or Assistant Director of Nursing for the respective unit or Nursing Administration. 12) All of the above data can also be entered into a laptop computer and posted on the appropriate website for leadership viewing. IV. Responsibilities: It is the responsibility of the Director of Pharmacy to assign a pharmacist or Pharmacy Assistant (technician) monthly to inspect all designated storage areas within the hospital. clinics, and its off-site satellites. It is the responsibility of a pharmacist and/or Pharmacy Assistant (technician) to accurately and comprehensively inspect the nursing stations or clinics monthly. Procedures/Guidelines: N/A Reasons for Revision: XXXVI. Changes in regulatory or statutory laws or standards XXXVII. System failures/ changes XXXVIII. Institutional/operational changes Attachments: Medication Usage Quality Control Inspection Report References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

V. VI.

VII. VIII.

Date Reviewed 12/14/04 10/5/07

140

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 12 Subject: Automatic Medication Stop Order Policy Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/06/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To establish automatic stops on high-risk drugs so that a physician will re-evaluate the need to continue the therapy based on lab data and/or patient response as well as risk of inducing a negative outcome. Definition(s): N/A Policy: The maximum inpatient duration for a medication that a physician/authorized prescriber shall order is 30 days. However, all pre-existing orders shall be canceled when the patient is transferred between nursing units. New orders shall be written by the medical team receiving the patient on the new Nursing unit after the evaluation of patient’s condition. Patient’s who are transferred between units that are supervised by medical staff from the same discipline, e.g., NS 81 and CT ICU or the OR, do not require medication orders to be re-written. Further, certain orders, due to their potential for adverse side effects and toxicity, (e.g., narcotics), shall be valid for a limited period of time unless otherwise specified in a shorter duration by the physician’s medication orders. IV. Responsibilities: It is the responsibility of the physician to see that orders are renewed. A nurse shall not administer a drug for which the order has expired. It is the responsibility of the nurse to notify the physician prior to the discontinuance of these medications. It is the responsibility of the pharmacist to dispense only the quantities of drug needed to complete the physician’s orders for these drugs within the above time frames. The pharmacist shall inform the nurse that he/she shall only dispense a 72 hour supply when an order is written for a longer duration for the above drugs.

II. III.

V. Procedures/Guidelines: The maximum duration that a prescription shall remain in effect for the following drugs are All scheduled Narcotics & Controlled Substances….72 hours Heparin Infusions * ………………………………………..72 hours Coumadin ……………………………………………………72 hours Oxytocics ……………………………………………………72 hours Ketorolac …………………………………………………….5 days (no renewals) TPN and parenteral admixtures…………………………24 hours Low molecular weight heparin* (Lovenox®, Fragmin®).. 72 hours * Provided PTT tests are stabilized and therapeutic levels of anticoagulants are achieved, otherwise ONLY a 24 hour duration is to be in effect. Heparin or LMWH (i.e. Lovenox®) administered subcutaneously for

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DVT prophylaxis may be written for a thirty (30) day supply. Lovenox® 40mg Sub-cutaneously or 30 mg subcutaneously every twelve (12) hours are doses for DVT prophylaxis. . VI. Reasons for Revision: XXXIX. Changes in regulatory or statutory laws or standards XL. System failures/ changes XLI. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

142

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: Outsourcing of Medications Prepared by: Donal Caracciola, R.Ph. Reviewed by: Nicholas Galeota, M.S., R.Ph. 12/4/2007 Approved by: Constance Shames, M.D. Distribution: Chapter: 13 Page 1 of 2 Original Issue Date: 01/01/2007 Implementation Date:

Administrative Manual Department Manual Patient Care Manual AOD Manual

William Gerdes Issued by: Pharmacy Department

I.

Purpose: To establish a standard procedure for utilizing the services of an additional compounding facility (outsourced) to Kings Pharmacy for the following medications: A) Oxytocin 10 units/ml 1ml syringes B) Bupivacaine 0.375% 400mls (ON-Q Painbuster)

II. III. IV.

Definition: Outsourcing of the above preparations is defined as the use of an external admixture laboratory for assistance in providing admixed drugs to our patients. Policy: The above products will be accurately, safely, aeseptically compounded and labeled as per JCAHO standards and NYS law by Kings Pharmacy on an as needed basis. Responsibility: It is the responsibility of the licensed off-site Pharmacy, Kings Pharmacy, to ensure for the accuracy and integrity of all of the compounds. Kings Pharmacy 357 Flatbush Avenue Brooklyn, NY 11238 It is the responsibility of Downstate Pharmacy to maintain adequate inventory of these admixtures and to periodically visit the compounding site for inspections.

V.

Procedures / Guidelines:  Downstate Pharmacy will call Kings Pharmacy at 718-230-3535 to order either oxytocin syringes or ON-Q bupivacaine.  The orders called in will be delivered by the next day.  All orders called in on Friday, will be delivered on Monday, however, in an emergency situation orders can be delivered on Saturday. 143

 All orders will be delivered with an invoice sheet.  Upon delivery, the oxytocin will be placed in the appropriate bin, as well as the ON-Q bupivacaine which is kept under refrigeration. VI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures / changes Institutional / operational changes Attachments: NYS Board of Pharmacy Licensure References: None
Date Reviewed 10/5/07 Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH

VII. VIII.

144

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect. A Subject: Choosing a Vendor Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/07/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish sound guidelines for the acquisition of P&T Committee approved formulary drugs so insure safety and efficacy in the patient’s therapy. Definition(s): N/A Policy: After review, recommendation by the Pharmacy & Therapeutics Committee and approval by the Executive Committee for the addition of a drug to the formulary at UHB, the Director of Pharmacy with the assistance of the Pharmacy Material’s Manager shall determine the vendor from whom the drug shall be acquired. Responsibilities: It is the responsibility of the Director of Pharmacy to choose a vendor/manufacturer for drug items approved by the Pharmacy & Therapeutics Committee for addition to the formulary at UHB. It is the responsibility of the Material’s Manager of the Pharmacy to adhere to New York State Purchasing regulations when preparing purchase requisitions. Procedures/Guidelines: (1) The Director of Pharmacy shall verify that all drug product purchase from a vendor meet current USP-NF, USP-DI, and FDA requirements for potency, safety, efficacy and labeling. (2) The Director of Pharmacy shall verify that the vendor/manufacturer complies with Federal Good Manufacturing Practices and meet the New York State Therapeutically Equivalent Prescription Drug Standards if there are more than one product made for a particular drug. 1. The Director of Pharmacy shall select a vendor, after meeting the standards in Chapter 14, Section A, Procedure, numbers 1 & 2, on the following basis:     Quality of products (including safety efficacy) Ability to supply Competitive prices Adequate services, e.g., in-service training, returns policy, timely emergent demand deliveries, etc.

IV.

V.

(4) If a generic drug is to be purchased, the Director of Pharmacy shall select the vendor based on the following criteria:

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 Chemical composition shall be identical to the accepted standard (current USPDI, FDA) for this product and meet Equivalent Drugs  Drug weight per dose shall be identical to the accepted standard (current USPNF, USP-DI, FDA) for this product and meet New York State standards for Therapeutically Equivalent Drugs  Drug weight per dose shall be identical to the accepted standard (current USPNF, USP-DI, FDA)  The manufacturer/vendor shall be an established, FDA approved/licensed pharmaceutical company with sufficient liability protection and one in which the Director of Pharmacy has developed confidence based on past experiences (5) The Director of Pharmacy shall instruct the Material’s Manager to initiate a purchase requisition based on the ability of the manufacturer/vendor to meet the above criteria. This requisition shall be processed adhering to New York State purchasing regulations. (Note: All bids, price quotations, or contract arrangements shall be processed through the Office Procurement services at SUNY-HSCB). (6) If the vendor wishes to utilize any patient, financial, or hospital related data in its course of doing business with UHB, the Director of Pharmacy shall require the vendor to sign and enter into UHB’s Vendor Data Security and Confidentiality Agreement (see attached). Note: If three vendor are required in order to obtain price quotes, the Director of Pharmacy shall provide the names of three vendors that meet the above criteria to the Purchasing Department. VI. Reasons for Revision: XLII. Changes in regulatory or statutory laws or standards XLIII. System failures/ changes XLIV. Institutional/operational changes Attachments: Vendor Data Security and Confidentiality Statement References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

146

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect. B Subject: Prime Vendor Program Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/07/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To establish guidelines for the Pharmacy’s Materials Manager or the use of a NYS contract approved prime vendor for pharmaceutical supplies.. Definition(s): N/A Policy: The Prime Vendor of record shall be utilized to acquire those pharmaceuticals in short supply on a daily basis or in emergent demand. Responsibilities: It is the responsibility of the Material’s Manager to utilize the prime vendor program daily for those drugs in short supply or in emergent demand. Procedures/Guidelines: (1) The Material’s Manager shall utilize only the New York State approved prime vendor who has met the criteria for choosing a vendor as stated in Chapter 14, Section B, Procedures, numbers 1 through 6. (2) The Material’s Manager shall initiate a purchase order through the computer – modem link for the drug item only in short supply or in emergent demand. All other inventory supply requisitions are to be processed through the Office of Procurement Services at SUNY-HSCB. (3) The Material’s Manager shall insure that all purchase orders from the prime vendor are received within 24 hours. (4) Upon receipt of the drugs from the prime vendor, the Material’s Manager shall record in the inventory all supplies received, reconcile the requisition with the receipt, and give the drug supplies to a pharmacist to dispense to answer t he demand for the drug or to a Pharmacy Aide to place the drugs received into the respective stock/storage area.

VI. •

Reasons for Revision: Changes in regulatory or statutory laws or standards

147

• • VII. VIII.

System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/15/04 10/5/07

148

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect. C Subject: Borrowing or Loaning of Pharmaceuticals to Other Hospitals Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/00701__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish guidelines for the borrowing or lending of drug supplies (other than controlled substances) between area hospitals.. Definition(s): N/A Policy: The Pharmacy Department shall maintain adequate supplies of all drugs on UHB’s formulary. The Pharmacy shall only borrow drugs from other local hospitals in the event of a complete outage of a drug causes by an unanticipated use of the drug. The Pharmacy shall provide drugs on loan to other local hospitals in the event of emergent need at these institutions. Responsibilities: It is the responsibility of the Material’s Manager of the Pharmacy to insure prompt return of borrowed drugs and to insure that loaned items are recovered within one week. It is the responsibility of the Director of Pharmacy to determine reasons or to review all documentation that has caused the complete outage of a drug and take correction actions if necessary. Procedures/Guidelines: I. Borrowing From Local Hospitals (1) In the event that a drug must be borrowed from a local hospital, the Material’s Manager shall contact a local area hospital to ascertain the availability of the drug. (2) Upon confirmation of availability, the Material’s Manager shall complete an Emergency Transfer of Drugs Form for the drug needed in duplicate, one for the borrower and one for the lender (see attached). (3) Arrangements shall be made for a Pharmacy courier to obtain the drug from the hospital. (4) When the drug arrives at the Pharmacy Department at UHB, it shall be given to a pharmacist to dispense to the appropriate Nursing unit and credit the inventory with the supply received. (5) The Material’s Manager shall make suitable arrangements to purchase a supply of the drug within twenty hours (24) hours.

IV.

V.

149

(6) When the ordered supply is received, the Material’s Manager shall dispatch a Pharmacy courier to return the drug to the hospital from which it was borrowed. 1. Loaning to Local Hospitals: (1) Upon receipt of a call from a local hospital in need of a drug, the Material’s Manager shall determine if existing supplies shall permit lending of the drug. (2) If the supplies permit, the borrowing hospital shall dispatch courier to pick up the drug at UHB’s Pharmacy and provide the Pharmacy Material’s Manager at UHB’s Pharmacy with a copy of the Emergency Transfer of Drugs Form. (3) The Material’s Manager shall insure that the borrowed drugs are promptly retrieved within one (1) week. (4) VI. The Material’s Manager shall debit the inventory of drugs loaned to another institution.

Reasons for Revision: XLV. Changes in regulatory or statutory laws or standards XLVI. System failures/ changes XLVII. Institutional/operational changes XLVIII. Attachments: Emergency Transfer of Medication or Supplies Form VIII. References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/15/04 10/5/07

150

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect D Subject: Drug Return Policy Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ___21__ Original Issue date: 8/1/98

Implementation Date: __8/07/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish guidelines for Pharmacy staff for the disposition of medications returned from patient care areas to the Pharmacy.. Definition(s): N/A Policy: Drugs which have been sent to in-patient Nursing Units or Clinic Nursing Stations shall be returned to stock only if they are retrieved in unopened unit dose packaging, unopened single use packaging, or robotics bar coded packaging. Responsibilities: It is the responsibility of Pharmacy Aides to sort out an inspect all drug returns to the Pharmacy to determine whether the drug can be used or, if not, disposed of in a appropriate manner (that is returned for credit or exchange). Procedures/Guidelines: (1) All drugs returned to the Pharmacy shall be inspected by the Pharmacy Aides for closure, integrity, and storage requirements. (2) Drugs in unopened unit dose packaging, unopened single dose packaging, or robotics bar coded packaging shall be re-inventoried and placed into stock. (3) Drugs that are not reusable shall be screened for worthiness of return to the manufacturer.

IV.

V.

(4) All unusable drugs shall be discarded in the regulated medical waste container in the Main Pharmacy. These include: (A) Oral liquids (B) Oral solids ( C) Topical ointments, creams, lotions in opened multi-dose packaging (D) Bedside self-medications (E) Out-patient medications returned by a patient (F) Opened multi-dose injections (G) Compounded IV Solutions (Note: Oncology drugs are eliminated via the Cyto-toxic Waste Containers)

151

(5) The regulated chemical waste container shall be sealed when full and Environmental Services shall be called at extension 2997 to remove the container or removed by Pharmacy personnel to the chemical waste store room of the hospital. (6) Drugs that can be returned for credit/exchange from the manufacturer or prime vendor shall be processed as such utilizing an external returns goods processor, e.g. Reverse Management System, Easy Returns, Quick Return Solutions, EXP, Inc., etc. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/15/04 10/5/07

152

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect. E Subject: Sales Representatives Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/07/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To establish procedures for identifying pharmaceutical representatives with a SUNY-DMC limited access ID card and to prevent intrusion into patient care areas. . Definition(s): N/A Policy: Sales representatives shall obtain a SUNY Downstate I.D. Card from the FSA Office before conducting business at UHB’s Pharmacy and are forbidden to enter patient care areas. Responsibilities: N/A Procedures/Guidelines: (1) Sales representative shall be seen on Tuesday and Thursday afternoons by the Pharmacy unless an appointment was previously made. (2) If a sales representative is assigned to this hospital (SUNY-Downstate) on a regular basis, he/she shall obtain an I.D. card from the FSA Office to proceed to any other area other than the Pharmacy. (3) No sales representative shall enter any patient care area unless they have an appointment with a physician in that area. If this is the case, the representative shall wear their I.D. tag and go to that appointment area only. (4) No sales representative shall interrupt any physician on rounds, while giving lectures, conducting ambulatory patient services, or without a appointment. (5) Non-formulary drugs or samples shall not be given out unless a physician requests them for personal private office use. These sample shall not be used within the hospital unless under the direct control and storage by the Pharmacy Department or the control of the requesting physician/service (refer to Chapter 28 for procedures) (6) No sales representative shall enter the dispensing or compounding areas of the Pharmacy, its satellites, or labs.

153

(7) If a sales representative wishes to present an in-service lecture or literature to the Pharmacy staff, they shall coordinate this effort through the Pharmacy Associate Director’s office, extension 3158. (8) If any sales representative is found in an unauthorized area of the Pharmacy or the hospital, at any time, Public Safety shall be notified and the sales representative shall be asked to leave and have their privileges of calling on staff at SUNY-Downstate property revoked. (9) The Pharmacy shall coordinate with sales representatives any and all displays in public areas, e.g., hospital lobby, or their drug products. (10) Any correspondence demonstrations, or in-service lectures for Nursing, shall be arranged with the Nursing Administration/Education office or the Institute of Continuous Learning at SUNYDownstate. VI. Reasons for Revision: XLIX. Changes in regulatory or statutory laws or standards L. System failures/ changes LI. Institutional/operational changes Attachments: ID card request form References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

154

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 14 Sect. F Subject: Inventory and Purchasing Controls Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/06/01__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To establish procedures for testing the integrity of the Pharmacy inventory so that diversion, loss, and waste of drugs can be avoided. II. Definition(s): N/A III. Policy: The Pharmacy inventory, defined as the quantity of medications, goods, or materials on hand that is purchased and brought into the Pharmacy’s storage spaces and controlled until it is dispensed to a patient or a user department, shall be maintained accurately in a perpetual inventory accounting system with predetermined minimums and maximums required for re-ordering and for providing appropriate pharmaceutical patient care. Responsibilities: The Material’s Manager is responsible for initiating a purchase requisition to a recommended vendor for all inventory supplies and required commodities. The Director of Pharmacy is responsible for reviewing all purchase requisitions Support Services is responsible for reviewing and co-signing the purchase requisition before it is sent to Procurement Services is responsible for placing the purchase order with the appropriate vendor that meets the required pharmaceutical standards (refer Chap. 14. Sect. A) and the New York State Manager to receive all supplies delivered from the Receiving Department, sign the Receiving Department’s receipt, open and reconcile the contents of the delivery against the packing invoice, and post receipts in the appropriate computer mainframe inventory account code (321336 for in-patient supplies and 321306 for out-patient supplies) on the same day of receipt. It is the responsibility of the Material’s Manager, the Director of Pharmacy, or the Associate Director of Pharmacy to sign-off on invoices for payment by Accounts Payable to the vendor. Finally, it is the responsibility of the Director of Pharmacy to maintain an accurate accounting of all inventory assets purchased for the Pharmacy Department and insure that an independent official inventory is taken annually of all Pharmacy inventory supplies and commodities stored in all Pharmacy Service areas. Procedures/Guidelines: (1) All medications shall be issued upon written orders in the form of a prescription, floor stock requisition, or grant request. Controlled substance sub-stocks shall be issued to a Nursing care area on a verbal request from an Assistant Director of Nursing or authorized representative for the respective unit. (2) All procedures outlined in Chap. 4 (IPD Dispensing), Chap. 5 (Controlled Substances), and Ch. 23 (OPD Dispensing) shall be followed with the proper subsequent charging through the Rxobot® computer database or computer mainframe (THOMIS OR EAGLE) to the respective patient or user unit.

IV.

V.

155

(3) Daily inventory reports shall be generated by the Computer Center and delivered to the Director of Pharmacy (PHARMINV Report). (4) Monthly drug usage reports shall be generated by the Computer Center and delivered to the Director of Pharmacy (PHARMAVG Report) (5) Daily re-order level reports shall be generated by the Computer Center and delivered to the Director of Pharmacy (PHARMREOR Report). (6) The Director of Pharmacy shall review the PHARMAVG Report monthly and choose a minimum of 3 drug items to be spot checked by the Material’s variances shall be investigated by the Material’s Manager and the appropriate corrections/reconciliation shall be reported to the Director of Pharmacy. (7) A complete physical inventory of all Pharmacy storage and dispensing areas shall be conducted annually in December by an external inventory accounting firm and a written, attested document shall be provided to the Director of Pharmacy. The itemized pricing of the inventory accounting firm and a written, attested document shall be provided to the Director of Pharmacy. The itemized pricing of the inventory shall be done with the current computer value for the particular items. (8) The Director of Pharmacy shall review this document and compare the information to the computer mainframe inventory. Any variances shall be investigated by the Material’s Manager and the appropriate correction/resolution shall be completed by the Material’s Manager and reported to the Director of Pharmacy. (9) The Director of Pharmacy shall annually provide a report with supporting documentation to the Chief Financial Officer or his/her designee of SUNY-Downstate Medical Center after the inventory process is completed. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/15/04 10/5/07

156

UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: __CH. 15 Sect. A Subject: Handling of Crash Carts Page: 1 of 3

NICHOLAS GALEOTA, M.S., R.Ph Prepared by: SETH MANOACH, M.D. LEONARD KLEBANOV, M.S., TERESA CHAN, PHARM.D. Reviewed by: Approved by:

Original Issue Date: 8/1/98 Implementation Date: 1/1/02

Distribution:     Administrative Manual Department Manual Patient Care Manual AOD Manual

WILLIAM GERDES

CONSTANCE SHAMES, M.D.

________________________________________________________________________________________ I. II. III. Purpose: To establish a controlled system for the re-conciliation and distribution of crash carts within the hospital. Definition(s): N/A Policy: Upon completion of a cardiac/respiratory arrest code requiring intervention of a crash cart, the charge nurse from the Nursing station shall immediately call the Pharmacy at 2854 or 2856 and inform Pharmacy personnel that a replacement cart is required. Pharmacy staff shall immediately transport a sealed, completed code cart from the Pharmacy and remove the used cart from the nursing station, collect the appropriate and completed documentation from the nursing supervisor, and replace it with a new cart. This can be accomplished 24-hours a day through all tours. Responsibilities: Nursing ● It is the responsibility of the nurse to notify Pharmacy that a new crash cart is needed and/or an equipment malfunction was noted during a routine inspection or during resuscitation. ● It is the responsibility of nursing supervisor to complete the appropriate documentation and take the Crash Cart completely out of service until a pharmacy personnel replaces it with a new one.

IV.

Pharmacist ● It is the responsibility of the registered pharmacist to check the crash cart trays for appropriateness after restocking by the Pharmacy Aide. Pharmacy Aide ● It is the responsibility of the Pharmacy Aide to bring the used crash cart back to the Pharmacy for re-stocking of the used trays and seal the tray in a tamper evident bag after a pharmacist has checked the tray. The Pharmacy Aide shall replace the sealed and completed drug trays into the crash cart before the cart is locked. ● The Pharmacy Aide should also notify SMIC of any equipment malfunction on the crash carts when informed by the nursing supervisor. SMIC ● Upon being notified of any equipment malfunction on the crash cart, it is the responsibility of SMIC to respond to any service notification. The SMIC engineer will determine whether the equipment must be brought back to the SMIC lab if more extensive repairs are needed. Central Sterile Supply (CSS) ● It is the responsibility of the CSS staff to replenish any supplies/equipments needed in the crash carts and sign off when complete. Once complete, CSS shall transport the crash cart to Pharmacy for restocking of appropriate medications. V. Procedures/Guidelines: (1) All crash carts opened for resuscitation purposes or emergency event regardless of equipment use shall warrant a Code Critique to be generated. (2) If a crash cart is opened for no apparent reason or an equipment malfunction discovered during routine inspections, then an Incident Report alone must be filed. (3) If an equipment failure occurred during the resuscitation process the nursing supervisor shall complete BOTH the Code Critique and an Incident Report. (4) A Pharmacy Technician shall remove all drugs from the used cart and transport the used cart to CSS where used equipment trays shall be replaced. The Pharmacy Aide shall then transport this cart to the Pharmacy for restocking with medications. (5) If the Pharmacy Aide has been notified that any equipment is defective, he/she shall remove the Crash Cart immediately from service, notify SMIC of the problem by submitting a copy of the incident report to SMIC, and document the date, time, and SMIC engineer to whom it was reported to in the Pharmacy Code Cart Log. The SMIC engineer will intervene, sign and document his or her intervention on the Pharmacy Code Cart Log before the crash cart is put back into service. A response/investigation letter will serve as documentation on the SMIC service record that the intervention had taken place and a copy of it shall be submitted to the CPR Committee record. (6) A Pharmacy Aide shall replenish each tray with the correct ACLS approved drugs and quantities as set forth by the CPR Committee for the respective cart and drawer configuration within the Main Pharmacy (Room ALL1-469). The Pharmacy

Aide will sign-off on the re-stocked code cart and lock it with a numbered lock. He/she shall then document on the appropriate crash cart records the lock number used to lock each crash cart along with the expiration dates. The carts shall be stored in the Pharmacy until needed following a subsequent code. (7) A pharmacist shall check the assembled tray before the Pharmacy Aide seals the tray in a tamper evident poly bag and dates the tray with the date of the most recent expiring drug. These trays are stored in the Main Pharmacy (Room ALL1469) until such time that they are used to replenish a crash cart. A numbered lock shall be used when sealing a completed cart and the number recorded in the Pharmacy log. (8) A Pharmacy Aide shall deliver a completed and sealed crash cart on demand and sign the Pharmacy log verifying the seal number. (9) On the Nursing Unit, the Nursing staff shall complete a supply checklist, insuring that the external supplies (defibrillator, oxygen tanks, and suction equipment) on the new cart are fully operational. Nursing shall notify Pharmacy of any malfunction in external supplies or equipments and complete an incident report stating such. Pharmacy shall then contact the relevant departments, e.g., SMIC or Respiratory as needed, to replace or service external equipment and the cart shall be immediately taken out of service. (10)Pharmacy Administration shall forward the code critiques and incident reports to the CPR Committee for review. All drugs provided for the replacement of crash cart supplies shall be charged to the respective nursing station. VI. Reasons for Revision: (1) Changes in regulatory or statutory laws or standards (2) System failures/ changes (3) Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH Nicholas Galeota, M.S., R.Ph. Teresa Chan, Pharm.D.

VII. VIII.

Date Reviewed 12/15/04 4/15/08 5/14/08

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. B Subject: Control and Security of Emergency Medications In the Crash Carts Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __1/1/02__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide a mechanism to insure security of emergency medications contained in the crash carts throughout the hospital. Definition(s): N/A Policy: (1) All crash carts shall be secured at all times with tamper evident numbers, security locks supplies by the Pharmacy. (2) The Pharmacy shall control the distribution of tamper evident crash carts numbered locks through the crash cart exchange system for crash carts. (3) Nurses shall inspect the crash cart seals on every shift. The seal represents not only completeness but also the security to insure that the contents have not been tampered. (4) A crash cart seal is only to be broken in response to a code and monthly during Nursing inspections. If a code cart is opened for any reason, a code critique must be filed and Pharmacy notified. If the cart is opened and a code is not called, an incident report must be filed. If the CPR Committee determines that the cart was used inappropriately, it shall recommend that administrative action be taken. IV. Responsibilities: It is the responsibility of a pharmacist to acquire, distribute, and maintain records for the distribution of tamper evident numbered crash cart locks provided to the Nursing staff. Procedures/Guidelines: (1) A pharmacist at UHB shall supply the Nursing stations with one (1) crash cart tamper evident numbered lock locked to the cart. (2) An additional tamper evident numbered lock is provided to Nursing only during Nursing’s monthly inspection of the cart. (3) A tamper evident numbered lock shall be placed on the crash cart when the cart is secured.

V.

159

VI.

Reasons for Revision: LV. Changes in regulatory or statutory laws or standards LVI. System failures/ changes LVII. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

160

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. C Subject: Crash Cart Inspections Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __1/1/02__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To establish a procedure for checking the expiration dates assigned to crash carts throughout the hospital. Definition(s): N/A Policy: The Pharmacy shall inspect all CPR Committee approved crash carts throughout the hospital for an expiration date during the monthly inspection for each Nursing care area. Responsibilities: It is the responsibility of a pharmacist to inspect the crash cart monthly and insure that an appropriate expiration date is present, insure that only CPR Committee approved drugs are present, and that the sealed trays of drugs have not been opened. Carts expiring within one month of the inspection date shall be removed by a pharmacist or Pharmacy Assistant and replaced with a new cart. Procedures/Guidelines: (1) During the monthly nursing station inspections, a pharmacist shall inspect the crash cart assigned to the nursing station or clinic. (2) The pharmacist shall check the cart is sealed and bears and expiration date that has not been reached as yet. (3) The pharmacist shall check all drugs contained in the crash cart trays for expiration dates before any drugs are placed in the tray by a Pharmacy Aide in the Main Pharmacy. Therefore, a check of each drug contained in the crash cart Is not required when conducting a monthly Nursing station inspection. (4) If the expiration date is approaching before the next Nursing station inspection, the pharmacist shall order a new crash cart for the unit. VI. • • • Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

V.

161

VII. VIII.

Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/15/04 10/5/07

162

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. D Subject: Drugs Maintained on Crash Carts Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/10/02__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To standardized the list of drugs maintained in crash carts that were approved by the CPR Committee. II. III. IV. Definition(s): N/A Policy: A pharmacist shall utilize the list of CPR Committee approved crash cart drugs when checking exchange trays for crash carts in Nursing station or clinic crash cart (see attached list). Responsibilities: The pharmacist is responsible to insure that only the drugs listed on the CPR Committee approved crash cart list are present on the exchange tray for crash carts in the proper quantities and that weight based standardized dosing charts are also attached to all crash carts. Procedures/Guidelines: (1) The pharmacist shall utilize the list of CPR Committee approved crash cart drugs when checking exchange trays for crash carts in Nursing station or clinic crash cart (see attached list). Reasons for Revision: LVIII. Changes in regulatory or statutory laws or standards LIX. System failures/ changes LX. Institutional/operational changes Attachments: Broeslow Neonatal-Pediatric Crash Cart List; Adult and Pediatric Combination Crash Cart List; Adult Crash Cart List; Pediatric Emergency Drug Dosing Chart; Adult Emergency Drug Dosing Chart References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

V.

VI.

VII.

X.

Date Reviewed 12/15/04 10/5/07

163

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. E Subject: Crash Cart Distribution in UHB Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __1/1/02__

Approved by: CONSTANCE SHAME, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: The following attached distribution record is a distribution and assignment list of the Resuscitation Crash Carts approved by the CPR Committee at UHB that shall be inspected by the Pharmacy on a monthly basis (see attachment): II. III. IV. V. VI. Definition(s): N/A Policy: N/A Responsibilities: N/A Procedures/Guidelines: N/A Reasons for Revision: LXI. Changes in regulatory or statutory laws or standards LXII. System failures/ changes LXIII. Institutional/operational changes Attachments: Distribution Record References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

164

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. F Subject: Pharmacy’s Disaster Carts Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/10/02__

Approved by: CONSTANCES SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for the maintenance of Pharmacy Disaster carts used during an internal or external disaster response by Pharmacy personnel to 4-4-4- alarm bells. Definition(s): N/A Policy: The Pharmacy Department shall maintain emergency drug supplies on a cart in the Main Pharmacy (Room ALL1-469) dispensing area for the pose of responding to a disaster signal (4-4-4) within the hospital as the hospital’s disaster response plan. Responsibilities: It is the responsibility of the Pharmacy Director to insure the availability of emergency drugs for response to a disaster signal within the hospital. It is the responsibility of a Pharmacy Assistant to inspect the disaster cart monthly. Procedures/Guidelines: (1) The cart of emergency drugs (see attached list) for disasters shall be maintained in a designated area outside of room ALL1-473 within the Main Pharmacy dispensing area. (2) A Pharmacy Assistant shall inspect this cart monthly for integrity, quantities of drugs, and record the date of inspection on the inspection maintenance record on the cart. The Pharmacy Assistant will remove all drugs expiring within one month of the inspection and replace the drugs before locking the cart. (3) The drug inventory for this cart shall be maintained by a Pharmacy Assistant according to the List of Selected Disaster Drugs (see attached). (4) The Pharmacy Assistant shall maintain on the cart a list of drug companies as sources for drugs, if necessary, during the disaster. (5) The Pharmacy Assistant shall ask a pharmacist to unlock the cart prior to inspection and lock the cart after the inspection is completed. NOTE: Keys to the cart are maintained in the IPD Controlled Drug Safe and access to this safe is restricted to pharmacists only. The carts can also be opened via the keypad code respective to each cart.

IV.

V.

165

VI.

Reasons for Revision: LXIV. Changes in regulatory or statutory laws or standards LXV. System failures/ changes LXVI. Institutional/operational changes Attachments: Disaster Cart Content List References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/15/04 10/5/07

166

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. G Subject: Pharmacy’s Disaster Plan Including Infant Plan Response Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/10/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide for an organized system to mobilize (re-call) Pharmacy staff and initiate Pharmacy’s role in the hospital’s disaster plan. Definition(s): N/A Policy: The Director of Pharmacy shall mobilize the staff and activate disaster response measures in response to an activation of a disaster signal (3 sequences of 4 bells) within the hospital. In the event that the Director of Pharmacy is not available, the Pharmacy staff shall respond to this disaster bell code immediately. Responsibilities: It is the responsibility of the Director of Pharmacy to mobilize all Pharmacy services and personnel in the event of an activation of a disaster signal. It is the responsibility of a pharmacist to respond to the disaster signal by taking the Pharmacy disaster cart to the triage area at the Emergency Room. Procedures/Guidelines: (1) In response to activation of a disaster signal, a pharmacist shall take the Pharmacy disaster cart to the triage area at the Emergency room located on the first floor. (2) The medical triage command post officer shall direct the pharmacist to proceed to a designated area and open the cart and the pharmacist shall prepare for dispensing the drugs to the medical staff. (3) The Director of Pharmacy and the Associate Director during daily working hours, shall review staffing and call in additional staff as needed (see attached cascade plan). (4) The Associate Director shall proceed with the daily assignment sheet to the Personnel Command post in Conference Room 1 & 2 or the Executive Director’s Office to provide information on the distribution of Pharmacy personnel throughout the hospital. (5) The most senior TH Senior Pharmacy shall report to the Pharmacy Director’s Office and assume command for supply lines to the Emergency Room in response to consumption of drug supplies used during the disaster.

IV.

V.

167

(6) As the recalled staff arrives at the hospital, the Director of Pharmacy shall assign personnel in response to the hospital’s pharmaceutical needs for responding to the disaster. (7) During hours when the Director, Associate Director and the most senior TH Senior Pharmacist are not present, Hospital Administration shall notify them at home to report to the hospital’s pharmaceutical needs for responding to the disaster. (8) The dispensing pharmacist in the Emergency Room shall return with the disaster cart upon activation of the all clear signal (4 sequences of 1 bell) (9) A pharmacist shall immediately review the emergency cart and replace all drugs used during the disaster. (10) VI. A pharmacist shall lock the cart.

Reasons for Revision: LXVII. Changes in regulatory or statutory laws or standards LXVIII. System failures/ changes LXIX. Institutional/operational changes Attachments: Notification Cascade for the Department of Pharmacy; Pharmacy Staff Directory; Infant Adduction Plan References: none

VII. VIII.

Date Reviewed 12/15/04 10/5/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

168

NOTIFICATION CASCADE FOR THE DEPARTMENT OF PHARMACY SERVICES IN THE EVENT OF INTERNAL OR EXTERNAL DISASTER Hospital Operator ↓ Nicholas Galeota (Director of Pharmacy Services) HOME # (718) 356-2168 Page: 760-0013 Office: 270-3115 ↓ Donald Caracciola (Associate Director of Pharmacy) HOME # (516) 541-7398 Page: 760-1953 Office: 270-3158 ↓ Mahammad Ali (Supervisor) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Roy Mustard Irina Kuleshova Morvette Spencer Olga Rivera Joan Watson Reynaldo Rivera Mohammad Edreis Joyce Wilson-Savage Jacqueline Fleming Jaihro Tabocloan Noah Silver Ancey Philip Marina Rafilova Anisa Davis Elizabeth Iroku (Supervisor) 1. Ira Dinerman 2. Digna Roberts 3. Rosa Aburto 4. Sung Kew Jung 5. Eveline Dorval 6. Samia Youssef 7. Helen Pruski 8. Jihan Hanna 9. Miyoung Hahn 10. Tseng Hsiang-Wei 11. Claire Defour-Bazelais 12. LilyAnn Jeu 13. Alan Hui 14. Elena Shak 15. Maureen McColl 16. Marc Silbergleit 17. Bichlien Truong 18. Teresa Chan 19. Laurie Ferguson 20. Thanikachalam Arunagiri 21. Ancillary Pharm. D. Staff: a) Roopali Sharma b) Motria Mishko c) Rani Patel Lawrence Melisi (Materials Manager) 1. Leon Gantt 2. Alva Watson 3. Sandra Cunningham 4. Raquel Ferguson

Rev. 8/24/07

169

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 15 Sect. H Subject: Emergency Drug Supplies Provided to the Emergency Room Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/10/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. IV. Purpose: See policy below. Definition(s): N/A Policy: The Pharmacy Department shall supply and maintain the emergency drug supplies within the Emergency Room. Responsibilities: It is the responsibility of the Pharmacy Department’s staff (pharmacists and Pharmacy Assistants) to provide for the emergency drug supplies required by the ER in its daily activities of treating patients. Procedures/Guidelines: (1) A pharmacist shall have a replacement box when the ER’s myocardial infarction box (MI Box) has been used to treat a patient in the ER. (2) The pharmacist shall immediately restock the box with the necessary drugs and seal the box with a tamper evident lock and store two (2) of these boxes within the Main Pharmacy, Room ALL1469, until required by the Emergency Room. (3) A pharmacist shall supply a replacement box when the ER’s Poison Treatment Box has been used to treat a patient in the ER. (4) The pharmacist shall immediately restock the box with the necessary drugs and seal the box with a tamper evident seal and store one (1) of these boxes in the Main Pharmacy, Room ALL1-469, until required by the ER. (5) The Pharmacy Department shall maintain the ER’s crash carts according to Chapter 15, Sections A through D. VI. Reasons for Revision: LXX. Changes in regulatory or statutory laws or standards LXXI. System failures/ changes LXXII. Institutional/operational changes Attachments: none

V.

VII.

170

VIII.

References: none

Date Reviewed 12/30/04 10/5/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

171

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 16 Subject: Handling of Multi-dose Vials of Injectable, Inhalation, And Ocular Medications Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: Implementation Date: __8/10/01__ 8/1/98

Approved by: CONSTANCE SHAMES, M.D.

Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual ______________________________________________________________________________________ I. II. III. Purpose: To establish procedures that insure the proper handling of multi-dose vials to prevent microbiological contamination. Definition(s): A multi-dose vials defined as one that contains a preservative by its manufacturer to prevent contamination so that it can be used more than once Policy: (1) All medication packaged in ampoules is intended for one time use only, handled aseptically, and the un-used portion shall be discarded once opened. (2) All vials intended for multiple use contain preservatives and are labeled by the manufacturer as multi-dose or multiple use vial. All vials without preservatives or not indicated as multiple use by the manufacturer must be handled aseptically and discarded after one time use even if only a fraction of the vial’s volume is withdrawn. (3) If medication vials require the addition of fluid for reconstitution, such as lyophilized powders, the person re-constituting the vial shall place the date and time of reconstitution on the vial’s label. After reconstitution, proper storage and length of storage time after reconstitution shall be according to manufacturer’s recommendations, e.g., penicillin G sodium is stable for 7 days after reconstitution if refrigerated. (4) All multi-dose vials of medication shall be dated with the date of expiration by the nurse responsible for medications on Tour I. The expiration date shall be calculated as twenty-eight (28) days from the date of opening by the nurse or clinician. The vials shall be discarded on that date. Once opened, vials shall be stored in an enclosed clean area. Storage is to be at the manufacturer’s recommended storage temperature for the drug. (5) Multi-dose eye drop containers shall be dated when opened and kept no longer than twentyeight (28) days and used exclusively for one patient when ordered on a prescription basis. (6) Multiple dose containers shall be used one at a time and assessed for integrity before use including visual inspection. When the vial can no longer be used, it shall be discarded and another vial started. It is a poor practice to maintain many partially used multiple dose vials.

172

IV.

Responsibilities: It is the responsibility of a pharmacist during the monthly Nursing station or clinic area inspections to remove undated multiple dose vials of medication as well as determine that appropriateness of storage and integrity of all opened multiple dose vials or containers. The pharmacist and/or staff nurse are responsible to remove all opened vials or containers if the integrity of the drug is questionable. Procedures/Guidelines: N/A Reasons for Revision: LXXIII. Changes in regulatory or statutory laws or standards LXXIV. System failures/ changes LXXV. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA M.S, RPH NICHOLAS GALEOTA, M.S., RPh. NICHOLAS GALEOTA, M.S., R.Ph.

V. VI.

VII. VIII.

Date Reviewed 12/17/04 1/10/06 10/5/07

173

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 17 Subject: Storage of Pharmaceuticals Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/10/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

_______________________________________________________________________________________ I. Purpose: To establish guidelines for the storage of pharmaceuticals to insure the integrity of the drug, prevent theft, and to prevent mis-identification that may cause a medication error. II. III. Definition(s): N/A Policy: The Pharmacy Department shall maintain adequate space, facilities, and equipment for the storage of drug supplies that are supervised by the Director of Pharmacy or his designee and according to the manufacturer’s, current USP-NF, USP DI, or FDA approved storage conditions. Responsibilities: It is the responsibility of the Director of Pharmacy to provide for the proper storage of all pharmaceuticals purchased and stored within the Pharmacy so that the potency, stability, and integrity of the drugs is maintained in order to prevent adverse patient outcomes caused by deteriorated or sub-potent drugs. Procedures/Guidelines: (1) Upon receipt of drugs from a manufacturer/vendor, the Material’s Manager shall place all drugs into the appropriate storage areas under the manufacturer’s/FDA approved requirements for temperature, light, moisture, ventilation, sanitation, segregation, if any, and security. Those drugs placed in the Main Store Room will be arranged generically. (2) A pharmacist or Pharmacy Assistant shall inspect all Pharmacy storage and dispensing areas monthly using the “Main and Satellite Pharmacy Inspection Findings” record (see attached). (3) The inspecting pharmacist or the Pharmacy Assistant shall remove all drugs expiring within one (1) month of the inspection date (Note: the pharmacist shall check the daily log of drugs received created by the Material’s Manager when inspecting the ‘ (4) The Material’s Manager shall place all supplies of absolute or 95% alcohol and any other bulk supply of flammable/combustible drugs within the Pharmacy’s designated volatile storage area (Room ALL 1-468) and into the fire rated yellow cabinets. (5) Upon receipt of controlled substances, the Material’s Manager shall give the drug supplies to the TH Senior pharmacist or one of the Pharmacy administrator’s in charge of controlled substances to store in the Main Controlled Substance Safe.

IV.

V.

174

(6) The Material’s Manager shall place all bulk supplies of drugs packed in cartons on pallets sealed to the floor or on shelving 18” inches off the floor to allow for cleaning under the shelving. (7) The Pharmacy Aides shall store all drug supplies within the appropriate storage areas 18” inches down from any ceiling or sprinkler system. (8) The Pharmacy Aides shall rotate stock in the storage areas to insure that drug supplies are used according to the appropriate manufacturer’s expiration dates. (9) A pharmacist shall store all investigational drugs in the locked investigational storage cabinet or in the locked investigational refrigerator. (10) Pharmacy Administration shall call Facilities, Management, and Development (x1212) to report problems with the Pharmacy’s physical plant, e.g., lighting, plumbing, refrigeration, etc. and arrange prompt correction of any deficiencies that would inhibit or create an unsafe condition for the dispensing, storage, or compounding of medications. (11) In order to prevent look-alike errors, Pharmacy storage bins for drugs where appropriate shall be marked with a red sticker for look-alike drugs and a green sticker for drugs that are available in multiple strengths. Pharmacy technicians shall record temperatures in a log of the Main Pharmacy, all refrigerators, and all freezers storing medication on a daily basis. It the temperature is out of range in these storage areas, the temperature shall be rechecked in one (1) hour. If the temperature has returned to normal, the technician shall enter the corrected temperature in the log and circle the corrected temperature. If the temperature does return to normal range, a technician or pharmacist shall report it to the Control Room at X 2810 and make arrangements to remove the drugs for proper temperature storage.

(12)

VI.

Reasons for Revision: LXXVI. Changes in regulatory or statutory laws or standards LXXVII. System failures/ changes LXXVIII. Institutional/operational changes Attachments: Medication Usage Quality Control Inspection Record References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/17/04 10/5/07

175

SUNY DOWNSTATE MEDICAL CENTER

UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Chapter 17 Subject: LOOK-ALIKE/SOUND-ALIKE DRUGS Prepared by: LilyAnn Jeu, Pharm.D., BCPS Reviewed by: Approved by: Nicholas Galeota, M.S., R.Ph. Constances Shames, MD Page Original Issue date: Supersedes: 1 SECTION A

of

3

10/06 10/06 Administrative Manual Department Manual Patient Care Manual AOD Manual Regulatory Affairs

Approval date: Distribution:

Issued by: I. Purpose:

To define the organization’s process for identifying and compiling the look-alike/sound-alike drug list. To define preventive measures implemented by the institution to prevent look-alike/sound-alike medication errors. II. Definition(s): Look-alike/sound-alike drug names are names that are similar in appearance or pronunciation, or have the potential to be confused with other medication names due to these similarities. Confusion between such agents may lead to potentially harmful medication errors. III. Policy: The Department of Pharmacy will identify and annually review the list of look-alike/sound-alike drugs used in the organization. The Department will implement measures to prevent errors involving interchange of these drugs. The organization’s list will consist of a minimum of 10 sets of look-alike/sound-alike drug names based on The Joint Commission’s recommendations. IV. Responsibilities: Pharmacist: The Department of Pharmacy will update the organization’s list of look-alike/soundalike drugs and disseminate the updated list to Prescribers and Nursing personnel through the Pharmacy & Therapeutics Committee. Preventive strategies to reduce medication errors with such

176

drugs will be disseminated via the same venue. Pharmacists shall follow preventive strategies to reduce these medication errors. Prescribers: Medication orders shall be complete with drug names clearly and correctly spelled. When applicable, the indication for use of look-alike/sound-alike medications shall be included on the medication order. Nursing: Nurses shall obtain and transcribe only complete, clear medication orders to reduce the risk of medication errors with look-alike/sound-alike drugs. Nurses shall practice and/or participate in preventive strategies to reduce such types of medication errors. V. Procedures/Guidelines: 1. On an annual basis, the Department of Pharmacy will review the Joint Commission recommendations for updating the organization’s list of look-alike/sound-alike drugs. 2. The following preventive strategies will be employed to reduce potential and actual medication errors with look-alike/sound-alike drug names in medication storage and/or patient care areas: a. Physical separation of agents with similar names. b. Use of different drug delivery devices to distinguish drugs with similar names (e.g., NovoLog FlexPen vs Novolin R vials). c. Use of brand and generic names on unit-dose packaging, in medication storage areas, and/or medication orders whenever possible. d. Inclusion of prompts for nurses to specify indication for use when medication is retrieved from the automated dispensing cabinet (Pyxis). e. Inclusion of dosing limits for medications with similar names but different dosage ranges. f. Placement of “Look-Alike, Sound-Alike” auxiliary alerts on medication storage bins. g. Use of tall man lettering for medication names in storage areas (e.g., shelf labels and bins, automated dispensing cabinets) and in electronic ordering systems. h. Abbreviations of drug names are not acceptable. i. Remove drugs with potentially problematic names from formulary, whenever possible. 3. Guidelines outlined in the policy for Verbal and Telephone Orders shall be followed to prevent medication errors when look-alike/sound-alike drugs are named. 4. The updated list of look-alike/sound-alike drugs shall be made available in nursing stations, within the Department of Pharmacy, and in medication storage areas. 5. If at any time a nurse or pharmacist is unclear about the drug name, the health-care professional shall contact the prescriber to clarify the medication order. XI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes x Institutional/operational changes Attachments: Top 10 Sound-Alike & Look-Alike Drugs References: JCAHO 2007 National Patient Safety Goal 3C Look-alike/sound-alike drug tables (2006-2007) available at web site www.jcaho.org

VII.

VIII.

177

Date Reviewed 12/07

Revision Required (Check One) Yes X Yes No No

Responsible Staff Name and Title P&T Committee

178

Department of Pharmacy Services

Potential Problematic Drug Names in Red
BRAND (and generic) NAMES

Potential Errors and Consequences



INSULIN PRODUCTS NOVOLIN (human insulin products) NOVOLOG (human insulin apart) NOVOLIN 70/30 (70% isophane insulin [NPH] and 30% insulin regular) Similar names, strengths and concentration ratios have contributed to medication errors. Mix-ups may result in hypoglycemia or poor diabetes control. CATAPRESS (clonidine) KLONOPIN (clonazepam) The generic name of clonidine can easily be confused as the trade or generic name of clonazepam. Mix-ups may result in hypotension, loss of seizure control, or other serious adverse events.



ULTRAM (tramadol) DESYREL (trazodone) KETOROLAC (toradol) Drugs with similar generic names. Mix-ups may result in a decline in pain control, change in psychiatric symptoms, or other serious adverse events.





VISTARIL, ATARAX (hydroxyzine) APRESOLINE (hydralazine) HYDRODIURIL (hydrochlorothiazide) Drugs with similar names and dosage strengths. Mix-ups may result in sedation, hypotension, or other serious adverse drug events.





AMBISOME (amphotericin B liposomal) ABELCET (amphotericin B lipid complex) AMPHOCIN, FUNGIZONE (amphotericin B desoxycholate, conventional amphotericin B) Doses of lipid-based products are usually higher than conventional products. Doses also vary from product to product. Confusion between products may result in respiratory arrest, renal failure and sometimes fatal adverse events. GLUCOPHAGE (metformin) FLAGYL (metronidazole) Drugs with similar names and dosage strengths may be confused with poorly handwritten orders. Mix-ups may result in hypoglycemia or untreated infection.

COUMADIN (warfarin) AVANDIA (rosiglitazone) CARDURA (doxazosin) Poorly handwritten orders for Avandia (used for type II diabetes) or Cardura (used for blood pressure or urinary symptoms) have been misread for Coumadin (an anticoagulant), or vice versa.





DILAUDID (hydromorphone) injection ASTRAMORPH, DURAMORPH, INFUMORPH (morphine) injection Hydromorphone is 4-8 times more potent than morphine. Fatal errors have occurred due to the false belief that hydromorphone is the generic equivalent of morphine.





VELBAN (vinblastine) ONCOVIN (vincristine) Fatal errors have occurred, often due to name similarity, when patients were given vincristine at a vinblastine dose.

CELEBREX (celecoxib) CEREBYX (fosphenytoin) CELEXA (citalopram) Drugs with similar brand names may be confused with poorly handwritten orders. Mix-ups may result in decline in mental status, lack of pain or seizure control, or other serious adverse events.

Strategies to Prevent Look-Alike/Sound-Alike Errors

Examples

        

Avoid abbreviations of drug names. Physically separate agents in storage areas and automated dispensing cabinets (Pyxis®). Use novel dosage delivery devices to distinguish products with similar names. Print generic and brand names on unit-dose packaging, when possible. Use TALL MAN lettering to emphasize the spelling of drug names in Pyxis® and medication storage areas. Include prompts for nurses to specify indication for use when medication is removed from Pyxis. Include dosing limits for medications with similar indications. Place “Look Alike, Sound Alike” auxiliary alerts on medication storage bins. Remove drugs with potentially problematic names from formulary, whenever possible.

     

All drugs Insulin products NovoLog FlexPen®

traMADOL, trAZODONE Hydroxyzine, hydralazine Tramadol, toradol

Department of Pharmacy, Revised 2007

179

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 18 Sect. A Subject: Antibiotic Surveillance/Control/Review Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/13/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish policies and procedures that would prevent nosocomial infections and reduce the incidences of antibiotic resistance. Definition(s): N/A Policy: In order to assure appropriate and quality utilization of antimicrobial agents, a concurrent Antibiotic/Review/Surveillance Program has been implemented by the University Hospital Pharmacy & Therapeutics Committee and approved for implementation by the Executive Committee. The objectives of the program are: (1) To prevent the development of resistant microorganisms, thus prolonging the useful like of potent new anti-microbial agents. (2) To improve patient care by providing for a consult (usually by telephone) with an Infectious Disease Division physician at the time that initial treatment decisions are made on patients who are suspected of having serious infections. (3) To prevent unnecessary expenditures for anti-microbial agents. On a periodic basis, implementation mechanisms of control of certain antibiotics shall be designated by the Pharmacy & Therapeutics Committee as “for use only after consultation with Infectious Disease Division”. A list of presently designated antibiotics is appended. The Committee shall review the list of designated drugs periodically. Most new antibiotics added to the formulary shall be so designated. Drugs may also be dropped from the designated list when so warranted. IV. Responsibilities: It is the responsibility of the house-staff physician in charge of the patient to page the IDD Fellow to obtain approval to use the controlled antibiotic. It is the responsibility of the IDD Fellow to call the Pharmacy to authorize release of the antibiotic. Procedures/Guidelines: (1) When a patient is considered to be in need of a designated antibiotic, the house-staff physician responsible for the patient’s care shall page the Infectious Disease Division Fellow on-call for University Hospital. A brief discussion of the patient shall ensue. The Infectious Disease Divisions physician may offer suggestions as to additional diagnostic procedures or alternative anti-microbial agents (or both). An attending physician in the Infectious Disease Division shall always be available if

V.

180

additional consultation is required. The Infectious Disease Division physician may ask to see the patient if he/she feels that firsthand evaluation is needed. There shall be no consultation fee unless the physician responsible for the patient’s specifically requested a formal consultation. (2) The Infectious Disease Division physician shall call the Pharmacy indicating that the designated antibiotic should be released. Dosage and duration of treatment shall be specified if so indicated. The name of the Infectious Disease Division physician shall be recorded. (a) If the house-staff physician does not page the IDD Fellow and the prescription comes to the Pharmacy, then the prescriber shall be called (name taken) and time recorded. The prescriber is told that the prescription is for a controlled antibiotic; he/she shall be informed to contact the IDD fellow responsible for the respective time period to obtain approval for the use of the antibiotic. (3) Designated antibiotics which have been released but which are not administered to the patient, for whom they are approved, shall be returned by Nursing to the Pharmacy. VI. Reasons for Revision: LXXIX. Changes in regulatory or statutory laws or standards LXXX. System failures/ changes LXXXI. Institutional/operational changes Attachments: Adult Restricted Antibiotic Order Form References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/17/04 10/5/07

181

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 18 Sect. B Subject: Approved Controlled Antibiotic List at UHB Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Supersedes Date: __10/17/01__ Approval Date: 10/05

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Pharmacy and Therapeutics Committee ______________________________________________________________________________________ PARENTERAL AGENTS Generic Name Acyclovir Amphotericin Caspofungin Flucanozole Ganciclovir Cefipime Linezolid Meropenum Gatifloxacin Pentamidine Azetreonam Valgancyclovir Vancomycin Voriconozole Cidofovir All non-formulary Type Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Trade Name Zovirax® Fungizone® Cancidas® Diflucan® Cytovene® Maxipine® Zyvox® Merrum® Tequin® Pentam® Neutrexin Valcyte® Vancocin® V-fend® Vistide® ORAL AGENTS Generic Name All anti-retroviral agents Atovaquone Flucytosine Rifabutin All non-formulary Type Suspension Capsule Capsule Oral dosage forms Trade Name Mepron® Ancobon® Mycobutin®

APPROVAL IS TO BE OBTAINED BY THE PRESCRIBING PHYSICIAN FROM THE INFECTIOUS DISEASE DIVISION PRIOR TO PRESCRIBING THE ABOVE ANTIBIOTICS INCLUDING ANY REQUEST FOR A NONFORMULARY ANTIBIOTIC, revised 12/04. Date Reviewed 12/20/04 10/5/07 Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

182

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 18 Sect. C Subject: Pharmacy Antibiotic Monitoring Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide advice to the Infectious Disease Division faculty on the use, patterns, and volume of antibiotic usage within the hospital. Definition(s): N/A Policy: The Pharmacy Department shall review monthly the usage of all antibiotics used for in-patient care for the purpose of therapeutic drug utilization review and cost containment analyses. Responsibilities: It is the responsibility of the Director of Pharmacy or the Associate Director of Pharmacy to monitor all antibiotic usage patterns for in-patient care and resolve all usage questions with the Infectious Disease Division, the originating service, or the Pharmacy & Therapeutics Committee for the purpose of improving patient care and monitoring prescribing trends of the medical staff. Procedures/Guidelines: (1) The Computer Center shall provide on the first of each month a printed report (PHARANTI) of all antibiotic usage for in-patient care from the previous month. This report shall indicate usage for individual Nursing care units and a cumulative house-wide tally. (2) The Director of Pharmacy or Associate Director Pharmacy shall review the report for usage patterns. (3) Controlled antibiotics shall be separated from non-controlled antibiotics and price calculations for dollar value shall be calculated. (4) Any excessive or unusual usage patterns shall be identified.

IV.

V.

(5) These patterns shall be brought to the attention of the Infectious Disease Division Department for clarification at extension 1330. If the discrepancy cannot be resolved, the service in question shall be contacted for clarification. (6) The Director of Pharmacy shall create a DUE study for review by physician experts for drugs that have unresolved questions concerning usage and prescribing excesses.

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(7) Upon completed review by the physician, the DUE shall be forwarded to the hospital Q/M Case Management Department for Manual shall be followed). The results shall be presented at a P&T meeting for corrective action, if any. (8) A computer file and graph depiction of usage patterns can be created in the Pharmacy Director’s Office for the year with monthly entries posted during the first week of each month. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

184

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 19 Sect. A Subject: Drug Information to Hospital Services Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To give direction to pharmacists for providing drug information to healthcare professionals. Definition(s): N/A Policy: A Pharmacist shall provide drug information to any hospital service requesting assistance by using current books, journals, magazines, or periodicals and, if necessary, through computer search through the Health Science Education Library, Med-Line ®, Micro-Medex® Drug-Dex, Dolphin® MSDS, Micro-Medex® Patient Leaflets, or Micro-Medex® Altern-Dex. The Director of Pharmacy shall co-chair the standing Nursing/Pharmacy Committee for the purpose of disseminating drug information, policies on the use and handling of drugs, e.g., parenteral, orals, etc., as well as resolving Nursing and patient issues associated with Pharmacy operations. IV. Responsibilities: It is the responsibility of a pharmacist to answer any and all requests for drug information posed by the Hospital Services at UHB using current literature. It is the responsibility of the Director of Pharmacy to share this information with all services and committees. Procedures/Guidelines: (1) Upon receipt of a request for drug information, a pharmacist shall search through the titles of books and other publications in the Pharmacy Library for the appropriate information to expeditiously answer the question. (see attached listing) (2) The Pharmacist shall document the request and the information provided on the Drug Information Request Form or the Drug Information Form for Unofficial Medication Use (see attached). These requests will be filed in the corresponding file

V.

maintained in the Pharmacy Director’s office or in the Non-FDA Approved use File, respectively.

185

(3) The Director of Pharmacy shall present these drug information questions and answers at the monthly Pharmacy Staff meeting and Pharmacy/Nursing Committee, or in the Pharmacy newsletter publication, which is circulated hospital-wide. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: Drug Information Form; Library of Pharmacy Text References References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

186

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 19 Sect. B Subject: Drug Information to Discharge and Ambulatory OPD Patients Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide for pharmacist counseling expertise to discharge and/or ambulatory care patients. Definition(s): N/A Policy: Upon request by a nurse conducting a discharge interview or by an OPD Ambulatory patient, a pharmacist shall provide drug information in language understandable by the patient and distribute any drug information literature applicable. Responsibilities: It is the responsibility of a pharmacist to provide drug information in understandable language to all patients requesting assistance and to provide pharmaceutical expertise and to any of the medical services at UHB. Procedures/Guidelines: (1) A pharmacist shall assist a nurse conducting a discharge interview with a patient by either participating in the interview, by providing written drug information, or printing patient information leaflets from the Micro-Medex® database to the nurse to use during the interview. (2) A pharmacist shall provide information to ambulatory OPD patients at the OPD Pharmacy window so that any question concerning the drug, its use, its dose, its toxicity, if any, warnings, adverse effects, and possible drug – drug, or drug – food interactions, or warnings are clearly understood by the patient. (3) Drug information printed from the Opus® Ambulatory Pharmacy Management System shall be given to the patient to assist in reinforcing the education of the patient concerning the medication that the patient is taking when an ambulatory prescription is dispensed. (4) Any follow-up telephone calls for further assistance from a nurse or a patient shall be answered professionally, courteously, and intelligibly. (5) Cross reference shall also be made to Chapter 23 Titles Pharmaceutical Education for Patients and Family Members. VI. Reasons for Revision:

IV.

V.

187

• • • VII. VIII.

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

188

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 19 Sect. C Subject: Patient Medication Profile System Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to maintain a patient’s drug profile for use and evaluation by pharmacists and other healthcare professionals. Definition(s): N/A Policy: In order to capture, use, and communicate patient medication information throughout the hospital community responsible for evaluating the effects of medication modalities in the care of the patient, making patient care decisions, and improving organizational performance concerning the use of medications, the Pharmacy shall maintain a patient medication profile system through the Robot Automated Dispensing System. This system shall be supported by both the patient’s medical record information and the documents of Pharmacy. Responsibilities: It is the responsibility of the Admitting office to assign a computer number to the patient, enter this number in to the computer mainframe which creates the patient’s medication profile, and, in conjunction with the Nursing station clerical staff to enter the admitting patient demographics into the patient’s medication profile. It is the responsibility of the pharmacist staff to enter medication orders and maintain the completeness and accuracy of the medication profile. Procedures/Guidelines: (1) Upon admission to the hospital, a patient medication profile shall be created in the computer mainframe through entries made by the Admitting Office and the Nursing station clerical staff (The EAGLE System). The initial profile shall contain the following patient demographics (this information is interfaced with the Robot Automated Dispensing System): • • Patient name, age, sex, location, medical record number, and computer number The patient’s weight (in pounds and kilograms), height (in inches and centimeters), all known allergies, OTC and herbal medications taken prior to admission, pregnancy and lactation states for female patients The patient’s admitting diagnosis

IV.

V.



(2) As physicians prescribe medications for the patient in the patient’s medical record, the medication orders written shall be computerized by the pharmacist staff within the Main

189

Pharmacy. These computerized orders are added to the patient’s medication profile in chronological order and comprise the body of a multi-page profile. NOTE: The physician’s orders computerized include new, renewal, discontinuation, and floor sock medication orders used in the patient care while in the hospital. (3) Improperly/incorrectly written prescriptions shall be corrected by a pharmacist contacting the prescriber at the Nursing station, a discontinuation order written for the incorrect order, and a new corrected order written by the prescriber. (4) Clinicians hall have access to the information contained in this profile in all patient care areas in hard copy form provided by the Pharmacy during the daily medication drug cassette exchange and as needed. (5) For the OR area serviced by a satellite Pharmacy, the Pharmacy shall maintain a written patient profile system of drugs administered pre-operatively and intra-operatively. These documents are available for review by the clinical staff of the hospital in this location. (6) Lab test requests and lab test results shall be obtained by entering the appropriate menu choice on the computer screen at the Nursing stations. This is accessible to all clinicians in Nursing care areas and in the Main Pharmacy also through the patient’s computer number. (7) The patient medication profile system shall also be available for ambulatory OPD patients. This profile can be accessed by clinicians utilizing the patient’s outpatient computer number immediately followed by the letter “p” and pressing ENTER in the THOMIS system. (8) The outpatient Pharmacy department shall also maintain a free standing computerized patient profile system (OPUS®) which is available for review by the clinical staff. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none

Date Reviewed 12/20/04 10/5/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

190

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 19 Sect. D Subject: Continuing Education of the Pharmacy Staff Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide for the continuing education and competency of professional and paraprofessional staff within the Pharmacy. Definition(s): N/A Policy: Pharmacy Administration shall provide for continuing in-service education to the entire Pharmacy staff on current additions to the hospital formulary, changes in therapeutic usages/doses of pharmaceuticals, pertinent drug information specific to professional practice, e.g., pharmakinetics, pharmacology, age-specific dosing and competency, etc, and new medication modalities. Pharmacy Administration shall encourage all staff to attend external continuing education programs, participate in literature continuing education opportunities and maintain documentation of attendance or credit accumulation. Responsibilities: It is the responsibility of Pharmacy Administration to provide for the in-service continuing education of the Pharmacy staff on an on-going basis so that the pharmaceutical expertise of the staff external to the UHB Pharmacy. Procedures/Guidelines: (1) On an as needed basis, the Associate Director of Pharmacy shall schedule an inservice education session for all of the Pharmacy staff. The presentations shall be conducted by pharmaceutical company representatives on recent additions of drugs to the formulary or changes in existing drugs or dosage forms on the formulary. (2) A post-test shall be given to the staff to ascertain competency and learning potential for the session. (3) A record of attendance shall be taken and maintained in the Pharmacy Associate Director’s office. (4) Pharmacy Administration shall attached all continuing education programs to the files for staff members attending those sessions or educational programs participated in or attended by the staff external to the UHB Pharmacy. VI. Reasons for Revision:

IV.

V.

191

• • • VII. VIII.

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

192

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 19 Sect. E Subject: Pharmacy Staff Meetings Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/14/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To provide for forum to communicate with the Pharmacy staff by Pharmacy Administration concerning administrative, clinical, and operational issues. Definition(s): N/A Policy: Pharmacy Administration shall conduct monthly or as needed Pharmacy Staff meetings for the entire Pharmacy staff. Responsibilities: It is the responsibility of the Director of Pharmacy to schedule and conduct monthly staff meetings for the purpose of efficient communication to the entire staff of subject matter effects Pharmacy operations, systems improvement, legal matters relating to hospital Pharmacy practice, and patient care and safety. It is the responsibility of the Director of Pharmacy to publish official minutes of all staff meetings for the entire staff. Procedures/Guidelines: (1) On a monthly basis, a general staff meeting shall be scheduled and conducted in the Main Pharmacy Room (ALL 1-469) (2) Attendance by all staff members is mandatory and shall be taken.

V.

(3) Minutes shall be compiled or recorded, including handout, and distributed before the next staff meeting. An official copy of the minutes shall be maintained in the Pharmacy Director’s office. (4) Agenda material shall include: (a) Policies & Procedures (b) Operational problems and information (c) Changes in legalities concerning hospital Pharmacy practice or hospital operations (d) P&T Updates (e) Q/A – PI projects, committee formations, follow-ups, and updates (f) Medication Errors and Adverse Drug Reaction incidents (g) Changes in hospital information systems (h) Update on investigational drug protocols (i) Controlled substance problems

193

(j) (k) (l) (m) (n) (o) (p) (q)

Personnel and Labor Relations subjects Infection Control Education and instruction Drug Re-Calls Good & Welfare of the staff Regulatory agency information, e.g., JCAHO, NYS DOH Information technology upgrades and training High-risk drug advisories and “black box warnings”

(5) Any staff unable to attend shall be briefed on the subject matter of the meeting, e.g., sick leave, vacation, operational coverage assignment. (6) VI. • • • VII. VIII. All staff members shall receive a copy of the minutes.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

194

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 20 Subject: Prescription Transmission to the Pharmacy Via Fax Machine Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/16/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Establish procedures for the faxing of medication orders to the Pharmacy. Definition(s): N/A Policy: In-patient prescription orders can be transmitted to the Pharmacy department via a facsimile telephone transmission device (FAX machine). The faxed prescription shall be the authority by which a pharmacist shall verify the prescriber’s orders, and thereafter dispense the prescribed medication to the Nursing station for administration by a nurse to the patient. Responsibilities: The physician is responsible to initiate the order process. The nurse is responsible to place the order into the transmittal cycle to the Pharmacy. The Nursing station clerk is responsible to fax the order to the Pharmacy. The pharmacist is responsible to check all prescription orders faxed or otherwise, and then release the completed medication order for delivery to the Nursing station. Procedures/Guidelines: (1) After a nurse picks up a new medication order and signs the medication order, the prescription order shall be given to the Nursing station clerk. (2) The clerk shall then FAX the order to the Pharmacy at x2855.

IV.

V.

(3) The pharmacist shall review the order for accuracy and completeness. (Note: follow Chapter 4, Section G) (4) Upon confirmation, the pharmacist shall enter the medication order in to the patient’s profile database and release the first dose of medication for delivery to the Nursing station. All subsequent doses shall be delivered in the daily cassette exchange. (5) The original medication order shall be delivered to the Pharmacy at a later time, matched checked against the Faxed copy by a pharmacist, and filed with the Faxed copy by a pharmacist, and filed with the Faxed copy.

195

(6) If the Faxed copy is vague, obscured, or otherwise questionable to read, the pharmacist shall contact the Nursing station to clarify the order before dispensing. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/5/07

196

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 21 Sect. A Subject: The Pharmacy Department’s Patient Confidentiality and Data Security Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/16/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To insure that patient confidentiality is maintained at all times during the provision of pharmaceutical care. Definition(s): N/A Policy: All Pharmacy employees shall maintain hospital and patient confidentiality relating to all of their daily activities as it relates to the pharmaceutical and medical care of the patient. Responsibilities: It is the responsibility of Pharmacy Administration to provide for the in-service continuing education of the Pharmacy staff on an on-going basis so that the pharmaceutical expertise of the staff external to the UHB Pharmacy. Procedures/Guidelines: Each employee shall: (A) Uphold the patient’s right to privacy in the disclosure of personally identifiable medical social information as stated in the Patient’s Bill of Rights. (B) Disclose to no one but proper authorities any evidence of conduct or practice revealed in medical reports or observed conduct that has indicated possible violation of established rules and regulations of the hospital or a professional’s practice. (C ) Preserve the confidential nature of professional determinations made by official committees of the Medical Staff or health and health-service organizations. (D) Preserve patient confidentiality by securing all computer data, programs, files, and graphs after use. (E) At the time of commencing employment personnel responsible for handling confidential patient information shall be required to sign the following statement: “I understand and agree that in the performance of my duties as an employee of University Hospital/SUNY HSCB, I must hold medical information in confidence. Further I understand that intentional or involuntary violation of the Hospital’s or Patient’s confidentiality may result in punitive action. I hereby attest my acceptance of this responsibility by my signature.”

V.

197

(F) At the time of the annual employee evaluation and re-appointment, each Pharmacy employee shall sign the Staff Confidentiality of Protected Health Information document. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: Staff Confidentiality of Protected Health Information document References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

198

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. A Subject: Administrative Table of Organization for the Department of Nursing Services Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. IV. V. VI. Purpose: The following table of organization represents the reporting lines for the Department of Nursing Services: Definition(s): N/A Policy: N/A Responsibilities: N/A Procedures/Guidelines: N/A Reasons for Revision: LXXXII. Changes in regulatory or statutory laws or standards LXXXIII. System failures/ changes LXXXIV. Institutional/operational changes Attachments: Table of Organization Patient Care/Nursing Administration References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

199

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. B Subject: Drug Weight Conversion Chart on Nursing Care Areas Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To provide a tool for the safe conversion of metric weights of drugs to apothecary weights and vice versa. Definition(s): N/A Policy: During the monthly Nursing care area inspection, a pharmacist shall check for the presence of a drug weight conversion chart (apothecary-metric conversion) and replace any missing any charts. Responsibilities: It is the responsibility of the prescribing physician to write medication orders using the metric system unless the manufacturer’s labeling expresses the concentration or strength of the drug in the apothecary system. It is the responsibility of a pharmacist to insure the presence of a conversion chart when questions arise concerning metric-apothecary conversions. Procedures/Guidelines: (1) A pharmacist shall inspect each Nursing care area monthly.

V.

(2) A pharmacist shall check for the presence of a drug weight conversion chart posted on the unit. (3) If the chart is missing, a pharmacist shall affix a drug weight conversion chart to an area in the medication preparation room in the Nursing station area. (4) Any nurse responsible for administering medication shall refer to this chart if a question concerning metric/apothecary weight conversion occurs or telephone the Pharmacy at extension 2854 or 2856 to obtain a pharmacist’s assistance. VI. Reasons for Revision: LXXXV. Changes in regulatory or statutory laws or standards LXXXVI. System failures/ changes LXXXVII. Institutional/operational changes Attachments: Drug Weight Conversion Chart References: none

VII. VIII.

200

Date Reviewed 12/20/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

201

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. C Subject: Medication Orders for Discharge Patients Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To prevent adverse medication events associated with inpatient medication if given to a patient upon discharge. Definition(s): N/A Policy: Any medication labeled for an in-patient from a Nursing station shall not be given by a nurse or other medical professional to a patient upon discharge. Responsibilities: It is the responsibility of an authorized practitioner responsible for the patient to write ambulatory prescriptions for the patient upon discharge. It is the responsibility of the nurse responsible for the patient to return all unused in-patient labeled medication to the Pharmacy upon discharge of the patient. Procedures/Guidelines: (1) Upon discharge of an in-patient, the attending physician or a house-staff physician shall write the necessary prescriptions for the patient on an out-patient prescription blank including all of the mandated legal information (see attached). (2) The patient can have the prescription filled at their neighborhood Pharmacy if it is written by a practitioner with prescriptive authority in the State. (3) If the prescription is to be filled at the UHB outpatient Pharmacy due to financial burdens on the patient, a pharmacist shall dispense the medication according to legal requirements, properly label for ambulatory patients, and in a child proof container where applicable. (4) The nurse responsible for the patient shall return all unused inpatient labeled medication to the Pharmacy. Reasons for Revision: LXXXVIII. Changes in regulatory or statutory laws or standards LXXXIX. System failures/ changes XC. Institutional/operational changes Attachments: OPD Prescription Blank References: none

V.

VI.

VII. VIII.

202

Date Reviewed 12/20/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

203

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. D Subject: Medication Storage Areas Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To insure that medications are stored safely to insure their integrity when stored in patient care areas. Definition(s): N/A Policy: Medication received by Nursing Care area nurses shall only be stored according to the manufacturers and/or Pharmacy labeled storage requirements for the drug in the officially designated Nursing station locked medication storage areas and/or medication carts. Responsibilities: It is the responsibility of the Assistant Director of Nursing for the respective unit to insure that all drugs are properly stored upon receipt from the Pharmacy. It is the responsibility of the monthly inspecting pharmacist to insure that all drugs are stored under the appropriate storage conditions. Procedures/Guidelines: (A) A nurse shall store medication supplies only in the official nursing station medication storage areas and/or medication carts under locked conditions, which include: • • • • (B) Medication Preparation Areas (including crash carts) Controlled Substance Cabinets Cassette Exchange Carts Medication Refrigerators A nurse shall segregate internal medication storage from external medical storage.

IV.

V.

(C ) The nurse and the monthly inspecting pharmacist shall insure that drugs are stored under the proper storage temperatures according to USP-NF or USP DI Official storage temperatures that is: (see attached). (D) The monthly inspecting pharmacist shall inspect for proper operation of the medication refrigerators and insure that a thermometer is present. (E) If a medication is suspected of being improperly stored, the nurse or pharmacist shall remove the suspected drug from the Nursing unit and the replacement medication is to be placed under the proper storage conditions.

204

VI.

Reasons for Revision: XCI. Changes in regulatory or statutory laws or standards XCII. System failures/ changes XCIII. Institutional/operational changes Attachments: Storage Temperature Sheets References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

205

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. E Subject: Medication Orders for Heparin Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To establish procedures for the safe prescribing of the high-risk drug heparin. Definition(s): N/A Policy: Heparin medication orders shall be written in terms expressing strength and dosage in U.S.P units. Responsibilities: It is the responsibility of the prescribing practitioner to write all orders for heparin in terms of units or units/ml. It is the responsibility of the nurse to refer to all heparin orders not written in terms of units or units/ml back to the physician for correction. Procedures/Guidelines: (1) A prescribing practitioner shall indicate on the prescription the strength of the appropriate dosage form of heparin in terms of units/ml. (2) The dosage and administration rate of an infusion for heparin shall be written by the prescriber in terms of units/ml or units/hour, respectively. (3) A Nurse receiving medication orders for heparin in terms other than units shall refer the order back to the prescriber for corrections. 4. A pharmacist shall only fill heparin orders expressed in terms of units or units/m 5. No medication order shall be filled if the symbol “U” is used to express “UNITS”. term “UNITS” must be spelled out. The

V.

VI.

Reasons for Revision: XCIV. Changes in regulatory or statutory laws or standards XCV. System failures/ changes XCVI. Institutional/operational changes Attachments: none References: none

VII. VIII.

206

Date Reviewed 12/20/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

207

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 22 Sect. F Subject: Dispensing Concentrated Sodium Chloride (23.4%) for Sputum Induction Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To control the distribution of the high-risk concentrated 23.4% sodium chloride solution when it required for sputum induction by the Respiratory Therapy Department. Definition(s): N/A Policy: Upon receipt of a faxed copy of a respiratory therapy order written by an authorized prescriber, a pharmacist shall dispense concentrated sodium chloride (23.4%) to a Nurse for use by a respiratory therapist for sputum induction. Responsibilities: It is the responsibility of an authorized prescriber order to order concentrated sodium chloride (23.4%) for sputum induction. It is Nurse’s responsibility to pick up the Prescription for Respiratory Care and send the order to the Pharmacy. It is the responsibility of the pharmacist to dispense and properly label this medication for safe use in sputum induction. Procedures/Guidelines: (1) Upon receipt of a copy of the Prescription Form for Respiratory care (UH 198-A) (see attached) signed by an authorized prescriber indication the type of therapy, a pharmacist shall obtain a vial of concentrated sodium chloride (23.4%) from the Pharmacy stock room. (2) Using a syringe, the pharmacist shall withdraw the contents of the vial and place this solution into an amber prescription bottle, number the bottles according to the prescribed treatment regimen, and indicate the volume of solution contained therein according to the Prescription for Respiratory Care. (3) The pharmacist shall label this bottle according to correct format for in-patient labels and add an auxiliary label stating “For Sputum Induction Use Only”. (4) This medication shall be dispensed to a Nurse for his/her patient’s therapy.

IV.

V.

(5) The Nurse shall give this medication to a respiratory therapist for use in the sputum induction procedure. (6) The respiratory therapist shall discard any unused portion of this medication after the completing of each treatment.

208

VI.

Reasons for Revision: XCVII. Changes in regulatory or statutory laws or standards XCVIII. System failures/ changes XCIX. Institutional/operational changes Attachments: Respiratory Therapy Sheet References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

209

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. A Subject: Medication Dispensing on Prescription Orders For Ambulatory Care Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: The Pharmacy Department does not maintain an ambulatory care Pharmacy Division, however, in the event Hospital Administration through the Social Work Department authorizes the dispensing of medication to a discharge/ambulatory care patient, the following procedures apply. Definition(s): N/A Policy: A licensed pharmacist shall dispense ambulatory care medication (clinic or discharge) properly labeled to patients pursuant to a written prescription issued by a licensed/registered medical/dental practitioner or by a post-graduate medical house-staff resident under the supervision of a licensed supervising or attending physician. Responsibilities: It is the responsibility of a pharmacist to dispense medication and properly label all medications pursuant to a written prescription for ambulatory care or discharge patients before the patient receives the medication. It is the responsibility of a pharmacist to provide drug information and counseling to the patient prior to releasing the medication to an ambulatory care or discharge patient. Procedures/Guidelines: (1) Upon receipt of a prescription written by a licensed/registered practitioner or a post graduate medical resident for use within the hospital, pharmacist or Pharmacy assistant shall gather the medication to satisfy the practitioner’s order. (2) A pharmacist shall verify the identity, license/registry number, and signature of the prescribing practitioner. (3) The prescription shall be stamped with the appropriate prescription number, that is:

II. III.

IV.

V.

(A) The pharmacist shall review the prescription for completeness and propriety (Refer Chapter 4, Section G, Procedures). (5) A pharmacist or Pharmacy assistant shall create a label to be affixed to the immediate container of the medication. (6) A pharmacist shall insure that the label bears the following information: (A) Name, address, telephone number of the hospital Pharmacy

210

(B) (C ) (D) (E) (F) (G) (H)

Date and identifying prescription number of the prescription Full name and address of the patient Drug name, strength, and quantity of the drug Directions to the patient in language understandable Name of prescribing physician Name or initials of dispensing pharmacist Any pertinent accessory or advisory/cautionary labels or DEA cautionary labeling

(7) A pharmacist shall insure that the drug container is a child-proof container, unless the drug is exempt, e.g. nitroglycerin, before it is dispensed to the patient. If the patient desires a non-child-proof container, the patient must sign and date the back of each prescription accompanied by a statement indicating their desire and knowledge that the container is not child-proof. (8) A pharmacist or Pharmacy assistant shall verify the identity of the patient by requesting either a clinic identification card or other appropriate identification, e.g., health insurance card, driver’s license, before the medication is dispensed to the patient. (9) A pharmacist shall provide to the patient or family member information and patient counseling concerning the use of the prescribed medication. (Refer also to Chapter 14, Section B and Chapter 32). (10) All business transactions shall be completed according to Chapter 23, Sections D, E, F, whichever applies, before the medication is dispensed. (11) All business transactions shall be completed according to Chapter 33, Sections D, E, F, whichever applies, before the medication is dispensed. (12) The completed prescription form is to be filed in the appropriate prescription file according to legal requirements by a pharmacist or pharmacy assistant. VI. Reasons for Revision: C. Changes in regulatory or statutory laws or standards CI. System failures/ changes CII. Institutional/operational changes Attachments: Sample Label References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

211

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. B Subject: Verification of Practitioner’s Name, License / Registration, and Signature on Ambulatory Care/Discharge Prescriptions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__

Original Issue date:

8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To direct pharmacists to verify the identity of an authorized prescriber.. Definition(s): N/A Policy: A pharmacist preparing OPD Pharmacy prescriptions for dispensing to ambulatory care or discharge patients shall verify the prescribing practitioner’s name, license/registration number, and signature before dispensing the prescription medications. Responsibilities: It is the responsibility of a pharmacist to verify all practitioner information contained on ambulatory care/discharge prescriptions presented for filling at the OPD Pharmacy prior to dispensing to the patient. Procedures/Guidelines: (1) Upon receipt of a written prescription at the OPD Pharmacy Service Area for an ambulatory care/discharge patient, a pharmacist shall ascertain that the following information is contained in the prescribing practitioner’s field on the prescription: (A) (B) (C) Practitioner’s signature Stamp/imprint of the practitioner’s name License/registration number of the practitioner’

IV.

V.

(2) In any information in Procedure #1 is missing or unreadable, the patient shall be referred back to the prescribing practitioner for clarification or correction. (3) In the information is present and complete, a pharmacist or Pharmacy assistant shall verify the authenticity of the information against the medical/dental/resident/PA CNP practitioner files in the OPD Pharmacy dispensing area. (4) If the information is correct, the pharmacist shall proceed to fill and dispense the prescription medication. (5) If the information cannot be verified, the pharmacist or Pharmacy assistant shall notify the Associate Director of Pharmacy, extension 3158, who shall contact the originating service for clarification. Reasons for Revision:

VI.

212

CIII. CIV. CV. VII. VIII.

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

213

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. C Subject: Weekend and Holiday Dispensing of Ambulatory Care Prescriptions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for filling an ambulatory/discharge prescription after authorization is received from Hospital Administration and/or Social Work Department. Definition(s): N/A Policy: The pharmacist on-duty for weekend and holiday tours in the Main Pharmacy shall fill and dispense prescriptions for discharge or clinic ambulatory care patients in financial burden presenting written prescriptions signed by the administrator on-duty for medications not readily obtainable in local pharmacies, e.g., heparin, chemotherapy medication, etc., in response to an emergency, or in circumstances when an ambulatory patient cannot have their prescriptions filled in a community Pharmacy. The OPD Pharmacy services shall otherwise be closed on weekends and holidays. Responsibilities: It is the responsibility of a pharmacist to dispense and label medication pursuant to a written prescription by a licensed/registered practitioner and signed by the administrator-on-duty for medications not readily obtainable in local pharmacies, e.g., heparin, chemotherapy medication, etc., in response to an emergency, or in circumstances when an ambulatory patient cannot have their prescriptions filled in a community Pharmacy. The OPD Pharmacy service shall otherwise be closed on weekends and holidays. Procedures/Guidelines: (1) Upon presentation of written discharge prescriptions or clinic ambulatory care prescriptions from a licensed/registered practitioner for medications not readily obtainable in local pharmacies, the pharmacist shall proceed to fill and dispense the prescription according to Chapter 23, Section A, Procedures 1 through 11, inclusive. (2) All business policies and procedures shall be followed as described in Chapter 23, Sections D, E, and F, whichever applies. VI. Reasons for Revision: CVI. Changes in regulatory or statutory laws or standards CVII. System failures/ changes CVIII. Institutional/operational changes Attachments: none

IV.

V.

VII.

214

VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

215

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. D Subject: Prescription Pricing Policy for Ambulatory Care Prescriptions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish financial guidelines for pharmacists to follow when Hospital Administration and/or the Social Work Department authorizes dispensing of ambulatory care medications. Definition(s): N/A Policy: Upon presentation, a pharmacist or Pharmacy assistant shall price the ambulatory care prescription according to the hospital approved mark-up schedule programmed into the OPD (OPUS FORTE) Pharmacy management system. Responsibilities: It is the responsibility of a pharmacist or Pharmacy assistant to price all prescriptions according to the hospital approved policy and collect all charges for the subsequent dispensing of the medication. Procedures/Guidelines: (1) Employees, students, and private patients who wish to pay by cash or check for out-patient prescription services, shall be charged for out-patient prescription services according to the following formula: AVERAGE WHOLESALE PRICE + A MARKUP = PRICE CHARGED (2) The markup schedule to be followed is: (a) If the average wholesale price falls between &0.01 and $10.00, inclusive, a markup of $3.00 shall be added (b) If the average wholesale price is greater than $10.00, a 30% markup shall be added.

IV.

V.

(3) Licensed/registered practitioners purchasing drugs for their private practice, shall pay only the average wholesale price of the drug without a mark-up. The drugs included for physician practice are vaccinations, injectable oncologicals, injectable anti-inflammatory steroid agents, and any infection that a physician requires and is justified for his/her practice. (4) Third-party payor prescriptions shall be priced according to the regulations of the payor and the appropriate co-pay shall be collected. The following third party payor plans are accepted for prescription services:

216

(a) (b) (c ) (d) (e) (f) (g) (h) (i) (j) VI. • • • VII. VIII.

Medicaid PAID Prescriptions National Prescription Administrators GHI EPIC ADAP PCS RECAP DPS VALUE Rx Caremark

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

217

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. E Subject: Cash Transactions Involving Ambulatory Care Prescriptions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: To establish procedures for the deposit of funds received in the Pharmacy from OPD transactions, manufacturer rebates, or medication returns. It should be noted that the Pharmacy does not provide general ambulatory care Pharmacy services. Definition(s): N/A Policy: Collection of payments for OPD prescription services at the OPD Pharmacy Department shall follow an organized and verifiable system to accept case, checks, and money orders, and subsequent deposits of receipts at the Hospital Business Office. Responsibilities: It is the responsibility of a pharmacist to collect, enter sales in the register, and issue receipts to patients for prescription services in the OPD Pharmacy. It is the responsibility of the Director of Pharmacy to prove out the register, reconcile receipts against the receipt book, and make deposits of all receipts at the Hospital Business Office. The Director of Pharmacy is responsible for investigation all discrepancies and taking corrective measures to resolve any discrepancies. Procedures/Guidelines: (A) RECEIPTS: (1) All case received for prescription services at the OPD Pharmacy Department shall be entered into the cash register by the pharmacist assigned the register responsibility in the OPD Pharmacy. (2) A pre-numbered written receipt and a register receipt shall be given to the patient. (3) The second copy of the written receipt shall go to the Business Office daily and the third copy shall remain in the Pharmacy in the receipt book. 2. All checks received for payment shall be stamped FOR DEPOSIT ONLY, JP Morgan Chase Bank/SUNY-DMC. 3. All third party checks received in the mail shall be recorded by the Director of Pharmacy in the annual check receipt log and stamped as in Procedure #4 for deposit with the Business Office.

II. III.

IV.

V.

218

(B) PROVING OF THE REGISTER: (1) At the end of the day, the Director of Pharmacy shall reconcile the receipt book with the register tape. (2) The total receipts for the day shall be recorded and verified by Director of Pharmacy. (3) The receipts shall be placed in the safe until it is deposited at the Hospital Business Office. (C) DEPOSITS: (1) The Director of Pharmacy shall prepare deposit for the Business Office breaking down the deposit total into cash, patient checks, and third party insurance checks. The Director of Pharmacy deposits all receipts from the day daily. The Assistant Patient Account’s Manager or other authorized Hospital Business Office employee shall count and verify the deposit. The Hospital Business Office shall issue a receipt for the Pharmacy receipts to the Director of Pharmacy.

(2) (3) (4)

(D) ERRORS AND VOIDS: (1) (2) Any error or void in ringing the sale in to the register, shall be presented to a manager with the register receipt and written receipt. A manager shall sign the void transaction and write a VOID RECEIPT and attach this to the original transaction receipts. This is placed into the register and the correct transaction shall be entered by the pharmacist. Any discrepancies between the register tape, the actual deposit, and the written receipts shall be reported to the Business Office by the Director of Pharmacy. The Director of Pharmacy shall proceed to investigate the discrepancy, tale corrective actions, and report to the Business Office any corrections or action taken. A file of discrepancies shall be maintained in the Director’s Office.

(3) (4)

VI. • • •

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes VI. VII. Attachments: Sample Receipts, Deposit stamp References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

219

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 23 Sect. F Subject: Collection Procedures for OPD Pharmacy Services Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/17/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for providing medication to the indigent/un-insured patient and to insure proper collection procedures for dispensing activities.. Definition(s): N/A Policy: The Out-Patient Pharmacy Department shall provide medication initially without charge to those patients who have been approved by the respective financial screener and hospital administrator provided that the patient has initiated appropriate insurance/assistance applications to cover the medication charges incurred. Responsibilities: It is the responsibility of a pharmacist to direct those patients who do not have the means to pay for prescription services to the appropriate financial screener and/or the Social Work Department for review.

IV.

V.

Procedures/Guidelines: (1) All procedures described in Chapter 23, Section D & E, are to be followed, EXCEPT, in those situations where the patient does not have the ability to pay for pharmaceutical services or does not have appropriate insurance coverage. (2) In the case of inability to pay, the pharmacist shall follow the Hospital’s Procedure for Collection for Out-patient Pharmacy Services using the attached form. VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: Outpatient Pharmacy Prescription Financial Questionnaire References: none

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Date Reviewed 12/20/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

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SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 24 Sect. A Subject: General Safety Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____4__ Original Issue date: 8/1/98

Implementation Date: __8/21/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish general safety and safety response procedures in the physical environment within the Pharmacy. Definition(s): N/A Policy: Pharmacy Administration shall educate the entire Pharmacy staff to be aware of safety measures required in their practice and to maintain safety standards in all Pharmacy environments. NOTE: Refer to specific Policies * Procedures for extensive procedures for each section. IV. Responsibilities: It is the responsibility of the Director of Pharmacy and Pharmacy Management to insure that a safe environment is maintained for the professional activities of the staff. It is the responsibility of the Pharmacy Management to educate the staff on an on-going basis safety policies and practices both within the Pharmacy and in response and provide assistance. Procedures/Guidelines: (A) Access to Pharmacy Areas:

V.

1. Only authorized Pharmacy personnel are permitted in all Pharmacy areas (Main Pharmacy, Room ALL1-469, Satellite Pharmacies and Laboratories) 2. I.D. cards shall be worn at all times

3. Sterile compounding areas are restricted to pharmacists unless supervisory arrangements are made for support staff. (B) Pharmacy Environment: 1. 2. 3. 4. Dispensing and Compounding areas shall be cleaned daily Refuse shall not to be thrown on the floor Smoking shall not be permitted in an y area of the Pharmacy No food shall be brought into the compounding, dispensing, or storage areas

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5. 6. 7. Services

Food or drinks shall not be stored in drug storage refrigerators White Lab coats shall be worn at all times when on duty Trash is collected, floors swept daily and waxed once a week by Environmental

8. A first aid kit shall be maintained in the event of injury or accident (in the Main Pharmacy, RM ALL1-469). C) is unreadable 2. 3. There shall be a minimal number of drug containers on work area shelving External preparations shall be kept separate from internal preparations. Drug Storage Areas and Shelves: 1. Drug containers shall be kept in an orderly manner on shelving and removed if labeling

4. Alcohol and other flammable substances are to be stored in the alcohol storage room or in designated fire rated yellow cabinets (AB-468) 5. 6. The walk-in refrigerator shall be kept orderly and free of boxes on the floor Expiration dates shall be checked monthly from the log of expiration dates

7. Expired drugs shall be stored for return outside the Main Pharmacy dispensing area in the designated location 8. 9. 10. discarded 11. Cyto-toxic drugs shall be stored on shelving marked accordingly in the main stockroom (ALL 1-427) or dispensing area and segregated from the general drug inventory 12. (D) Flammable liquids shall not be kept in refrigerators All refrigerators shall contain a thermometer and these are checked for accuracy daily. Glassware shall be cleaned immediately after use All containers shall be clearly marked with contents otherwise the container shall be

Sterile Preparation Areas (TPN Lab and IV Addictive Preparation 1. 2. 3. 4. 5. Only trained personnel shall work in these areas No food or smoking shall be permitted in these areas Laminar airflow hoods shall be turned on one (1) hour prior to use Logs of lot numbers and manufacturers of drugs products used shall be kept All personnel working under the hoods shall wash with a bactericidal agent, e.g., All completed IV bags shall be clearly labeled with name of patient, location, content,

Hibiclens 6. expiration date, etc.

7. Intravenous tubing and intravenous bags shall be discarded in the regulated medical waste (red bag) containers 8. Messengers shall sign for the completed solutions

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9. IV solution delivery

Nurses shall sign a receipt form to be returned to the Pharmacy when they accept an

10. Delivery boxes shall be marked with the Nursing station number and a red label marked REFRIGERATE is placed on the outside of the box 11. 12. Pharmacists shall initial completed labels before adhering the label to the IV bag A first aid kit shall be maintained in the event of injury or accident

13. Parenteral preparation hoods shall be inspected and certified semi-annually and the inspection certificate affixed to the hood (E) Emergency Preparedness and Fire Plans:

1. Staff shall be appraised of locations of fire exits, fire extinguishers, alarm signal code directions, fire alarms, and proper use of fire doors. 2. Fire Wardens and Fire Captains shall insure that all staff is safely evacuated

3. Staff shall attend fire safety lectures given by hospital administration through Environmental Safety 4. inches 5. IF a disaster is called (bell signal of 4-4-4), the Pharmacy shall respond by bringing the disaster cart to the Emergency Room and be prepared to give assistance with triage and patient care (refer Chapter 15, Section G, Procedures 1-10) 6. checked monthly 7. The Pharmacy disaster cart shall be maintained, accuracy and expiration dates shall be All bulk supplies of flammable substances shall be stored in hazardous materials room All boxes and packaging shall be kept away from sprinklers a minimum of eighteen (18)

8. Upon sounding of the fire alarm system, the OPD Pharmacy window shall be closed as well as all fire doors and not re-opened until the all clear signal is sounded (1-1-1) 9. • The fire alarm boxes located within the closest proximity to the Pharmacy are: Stairway 6 (6-6-1-1), Stairway 8 (6-1-1-1), and Stairway 5 (6-5-1-1)

10. In the event that a fire alarm does not activate a verbal alarm of “Code Red” shall be called out and all fire procedures shall be followed (F) Repackaging Areas: 1. 2. 3. 4. All drugs repackaging shall be assigned by a pharmacist Equipment for repackaging shall be cleaned before use New labels shall be used when re-packing All paperwork with drug information shall be presented with the re-packaged item

5. A pharmacist shall check the re-packaged drug, the label made for the container, and check randomly a sample of repackaging procedure (G) Electrical Equipment:

1. All electrical equipment shall be certified safe by SMI, tagged, and inspected annually. UL certification shall also be required

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2. displayed 3. supervisor 4. 5.

All IV hoods shall be certified at least once every six (6) months and the certificate All personnel shall report an y defective equipment and frayed wires immediately to a Only grounded hospital grade equipment and outlets shall be used Only vital equipment shall be plugged into emergency outlets

6. No extension cords shall be used (Exception: power surge cords on computer equipment in offices) (H) Hazardous Materials and Wastes:

1. All expired drugs which cannot be returned for credit shall be discarded in the regulated medical chemical waste container (white and yellow bag) 2. 3. containers 4. Used needles and syringes used in compounding shall be placed in sharps containers or in sealed Winfield containers for syringes 5. Material Safety Data sheets shall be available to the staff in the Director’s office, in the IPD compounding/investigational drug area, and on-line as the Dolphin MSDS program. (I) Miscellaneous: In the even of a cardiac arrest, the hospital’s overhead page system shall sound a Code All cytotoxic drugs shall be placed in Winfield containers when discarded All IV tubings and bags shall be discarded in regulated medical waster (red bag)

1. 99 or Code Blue

2. In the event of an infant or child abduction, the hospital’s overhead page system shall sound Code Pink (See Infant Abduction Policy and Procedure, Chapter 15, Section I). VI. Reasons for Revision: CIX. Changes in regulatory or statutory laws or standards CX. System failures/ changes CXI. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

225

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 24 Sect. D Subject: Pharmacy Key Control Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/21/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To control the distribution of keys to Pharmacy Service areas. Definition(s): N/A Policy: The Director of Pharmacy shall only issue a key for the Pharmacy service areas to pharmacists. Responsibilities: It is the responsibility of the Director of Pharmacy to provide for key security to all Pharmacy service areas. Procedures/Guidelines: (1) The Director of Pharmacy provides keys to the pharmacist that have been cut and coded by UHB’s FM&D’s locksmith shop and are not keyed to the hospital master or sub-master keys. (2) The pharmacist receiving the key shall sign and date a receipt for the key.

(3) The Director of Pharmacy shall provide an entry key to the Public Safety Security Office (A1339) to be used in an emergency. (4) Combinations to controlled substance work safes are only given to the pharmacists.

(5) Combinations to the Main Stock Controlled Substance safe is given only to Pharmacy Administration and the TH Senior pharmacists responsible for controlled substances. (6) When a pharmacist leaves UHB service, the issue key shall be returned and the pharmacist shall sign and date that the key was returned VI. • • • VII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none

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VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/20/04 10/8/07

227

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 24 Sect. E Subject: Power Failure Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/21/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to follow in the event of a power failure and/or non-activation of emergency power so that medication integrity will not be compromised . Definition(s): N/A Policy: In the event of a power failure, a pharmacist shall be dispatched to all drug areas within the hospital to determine the effects of the power failure on the storage provisions for drugs stored under refrigeration and provide for interim alternate storage provisions during failure. Responsibilities: It is the responsibility of a pharmacist to inspect all nursing care/clinic areas to insure proper storage requirements of drugs under refrigeration. It is the responsibility of the Director of Pharmacy to provide for the operational needs of all Pharmacy services during a power failure emergency. Procedures/Guidelines: (A) Nursing Care/Clinic Areas: 1. A pharmacist shall proceed to the Emergency Power Failure Box and break the seal.

IV.

V.

2. A pharmacist shall remove a flashlight and the list of Nursing care/clinic areas where medication is stored. 3. A pharmacist shall proceed to the Nursing care/clinic areas where drugs are stored and ascertain the viability of the refrigerator storage for drugs. 4. If the refrigerator is operational (on emergency power) the pharmacist shall notify the Assistant Director of Nursing for that unit that the refrigerator storage is viable. 5. If the refrigerator is not operational, the pharmacist shall inform the Assistant Director of Nursing for the unit of this fact, and proceed to collect the refrigerated drugs, and store these drugs in the Main Walk-In Refrigerator in the Main Pharmacy (ALL1-469) until the emergency is over.

228

6. Box. (B)

After the power is restored, a pharmacist shall secure the Emergency Power Failure

Intra-departmental:

1. Emergency overhead lights in the IPD Dispensing areas, the Pharmacy Director’s office and the Drug Receiving area will go one once the power has failed. 2. power. 3. All IV Lamina Airflow Hoods and Vertical Flow Class B Bio Safety Hoods are on emergency power. 4. All Pharmacy personnel shall remain in or return to their assigned areas for deployment as needed to assist during the power failure. 5. Pharmacists shall write all prescription labels as required. All refrigerators and freezers in the Main Pharmacy and Satellite are on emergency

6. The Director of Pharmacy shall create a command post for the emergency in his/her office and if required, re-call staff members to address the needs of the hospital during the emergency. 7. The emergency light power packs shall immediately be energized at the entrance to the Main Dispensing area, the OPD Dispensing area, and the Floor Stock Room areas. VI. Reasons for Revision: CXII. Changes in regulatory or statutory laws or standards CXIII. System failures/ changes CXIV. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/20/04 10/8/07

229

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 24 SECT. F___ Subject: Authorized Signatures and Computer Security Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 3/17/00 8/21/01 Implementation Date: ___________

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

____________________________________________________________________________________ II. II. III. Purpose: See policy below. Definition(s): N/A Policy: A) Only the following signatures shall be authorized to execute or approve the specified transactions: Policy and Procedure Approval: Nicholas Galeota Donald Caracciola Overtime Authorization and Payment: Nicholas Galeota Donald Caracciola On Call/Recall Authorization and Payment: Nicholas Galeota Donald Caracciola Personnel Transactions excluding promotions, salary upgrades, appointment renewal, or renewal: Nicholas Galeota Donald Caracciola non-

Personnel Transactions including promotions, salary upgrades, appointment renewal or non-renewal or non-renewal: Nicholas Galeota Donald Caracciola Purchase Requisitions: Nicholas Galeota Donald Caracciola Receiving Department Receipts: Nicholas Galeota Donald Caracciola

230

Larry Melisi Authorization for Invoice Payment: Nicholas Galeota Donald Caracciola Class I and II Controlled Substance DEA Order Form 222: Nicholas Galeota Donald Caracciola Pharmacy and Therapeutic Committee Minutes and Agendas: Nicholas Galeota Donald Caracciola Telephone Access Level Changes: Nicholas Galeota Donald Caracciola Prescriptions and Dispensing Records: All pharmacists (see Pharmacist Signature File) B) Computer Security: The following computer screens are only accessible to the authorized individuals indicated using their personal ID numbers or codes and authorization access granted by the Director of Pharmacy: All Pharmacy Screens: Nicholas Galeota Donald Caracciola All Pharmacy Screens excluding AZ, A3, A5, BI, OO, 53, BQ None All other Pharmacy Screens included in THOMIS and Eagle, the Rxobot database (level access to be assigned by the Director of Pharmacy), the free standing TPN, Oncology, and drug information pc’s: Pharmacy Staff IV. Responsibilities: It is the responsibility of the Director of Pharmacy to authorize use of an official signature for Pharmacy transactions. It is the responsibility of the Director of Pharmacy to provide authority level user ID’s into the Pharmacy computer system with an associated level of security. V. VI. Procedures/Guidelines: N/A Reasons for Revision: CXV. Changes in regulatory or statutory laws or standards CXVI. System failures/ changes CXVII. Institutional/operational changes Attachments: none References: none

VII. VIII.

231

Date Reviewed 12/28/04 10/8/07

Revision Yes Yes Yes Yes

Required (Circle One) No No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

232

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 25 Subject: Infection Control Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____4__ Original Issue date: 8/1/98

Implementation Date: __8/22/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To prevent contamination of pharmaceuticals at the point of dispensing.. Definition(s): N/A Policy: The Pharmacy Department functions as the starting point for the dispensing of medication in the hospital and therefore plays a part in infection control in the hospital. To that end, all pharmacists and Pharmacy staff will maintain all Pharmacy service areas in a manner consistent with infection control as directed by legal authorities, advisory councils, and the hospital’s Infection Control Policy and Procedure Manual under the authority of the Infection Control and Epidemiology service and the Medical Staff’s Infection Control Committee. Responsibilities: It is the responsibility of the Director of Pharmacy to provide for key security to all Pharmacy service areas. Procedures/Guidelines: (A) General housekeeping guidelines for maintaining cleanliness in all Pharmacy service areas: 1. The housekeeping department shall wipe down shelves each with disinfectant detergent. 2. 3. 4. 5. 6. (B) The lavatory shall be cleaned each day. The Pharmacy shall be swept each day. Garbage collection and disposal shall be carried out daily. The entire Pharmacy shall be mopped with a cleansing solution and waxed at once a week. Regular visits from the exterminators shall be carried out. least

IV. V.

Pharmacy Guidelines for Pharmacy staff: 1. 2. Universal precautions shall be practices whenever the situation warrants. All medication personnel shall wash their hands before handling medication.

233

3. solutions. 4. 5. 6. 7.

Whenever possible, unit dose medication shall be provided, especially for injectable All equipment and glassware shall be cleaned before and after use. All refrigerators shall be kept clean and under proper refrigeration temperatures. Garbage pails shall be kept clean Pharmacy counters shall be wiped down each day.

8. Expired drugs shall be removed from shelves and sent back to the manufacturer for credit and segregated from the general inventory. 9. packaging. Oral medications returned form Nursing stations shall be discarded if not in unit dose

10. Sterile distilled water for reconstituting oral suspensions shall be obtained from single use containers. 11. All reconstituted oral antibiotic liquids shall contain an expiration date.

12. Any questions on infection control shall be answered by referring to the hospital’s Infection Control Manual or by calling the Infection Control and Epidemiology Department at extension 1940. (C) Sterile Compounding of Pharmaceuticals:

All hyper-alimentation fluids and cardioplegia solutions shall be prepared under a laminar flow hood utilizing the following procedures: 1. The laminar flow workbench shall be located in an area which is clean, orderly, and free from strong air currents. The filter shall be tested for integrity and wind velocity at least semi-annually and whenever the hood is moved. A “DoP” smoke detector system shall be used to test for filter integrity. 2. At the beginning of each workday, the beginning of each shift, and when spillage occurs, the workbench surface shall be wiped thoroughly with a clean, lintless sponge dampened with a suitable disinfectant such as 70% ethyl alcohol, isopropyl alcohol, or Chlorox® solution. 3. The blower shall be turned on each morning and operated continuously until the day’s orders are filled. 4. Traffic in the area of the workbench shall be minimized and controlled.

5. Supplies entering the buffer area shall be isolated until they can be decontaminated by removing the outer packaging. Outer cartons and packaging materials shall not be brought near the workbench. 6. work area. All supply items shall be examined for defects prior to being introduced into the aseptic

7. work area.

All supply items shall be examined for defects prior to being introduced into the aseptic

8. Personnel may enter the buffer area with street clothes or daily uniforms but shall not approach the workbench. Before approaching the workbench, personnel shall thoroughly scrub hands and arms and Hibliclens® or equivalent. A face mask shall be worn if the operator has facial hair or an upper respiratory condition that promotes sneezing and coughing.

234

9. After proper introduction of supply items into the aseptic workbench, they shall be arranged in a manner such that operations can take full advantage of the direction of laminar airflow. Supply items within the workbench shall be limited to minimize clutter of the work area and provide adequate space for critical operations. A clean path of HEPA filtered air shall be provided directly from the filter to the critical work site. Therefore no objects shall be placed behind the critical work site in a horizontal flow workbench such as outs. Also, all work shall be performed at least six (6) inches within the hood to avoid drawing in contamination from the outside, and arms shall not be moved in and out of the work area any more than shall be absolutely necessary. 10. All supply items shall be arranged so that the work flow will provide maximum efficiency and order. 11. It shall be noted that the hands are antiseptically clean but sterile. Therefore, all procedures are performed in a manner to minimize the risk of contact contaminated. For example, the outside barrel of a syringe may be touched with the hands since it does not come in contact with the solution, but the plunger or needed shall not be touched. 12. All rubber stoppers of vials and bottles and the neck of ampoules shall be cleaned with 70% alcohol and a non-linting sponge, prior to the introduction of the needle for removal or addition of drugs. 13. Spraying of solutions on the workbench screen and filter shall be avoided. This may cause cracking of the filter material or otherwise generate holes. 14. Medication orders shall be worked on one (1) at a time.\

15. After every admixture, the contents of the container shall be thoroughly mixed and then shall be inspected for the presence of particulate matter of evidence of an incompatibility, e.g., precipitation. 16. additive. If possible to minimize coring, use needles 22 gauge or smaller for making transfer of

17. Filtration of solutions to remove particulate matter is frequently necessary, particularly where admixtures have been prepared. A small volume of solution may be filtered by attaching an appropriate membrane filter to the end of a syringe, using the plunger force the liquid through the filter. Note: To avoid rupture of the membrane, force shall be applied in one direction only through the filter, unless the membrane is adequately supported on both sides. 18. The porosity of the appropriate membrane filter shall be determined by the objective of the filtration. To remove particulate matter, a 1 micron porosity filter should be satisfactory. To sterilize a solution, a 0.2 micron filter shall be required. 19. The complete preparation shall be provided with an appropriate tamper proof cap or closure to assure the user that the integrity of the container has been maintained until the time of use. 20. Parenteral nutrition solutions shall be refrigerated at 4 Celsius and used within a 72hour period following preparation. No infusion bag shall hang for more than 24 hours.

VI. • • •

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

VII. Attachments: Blood and Other Potentially Infectious Materials Exposure Control Plan; OSHA Occupational Exposure to Blood borne Pathogens; IC Manual excerpt The Pharmacy Department and Its Role in Infection Control

235

VIII.

References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

236

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 26___ Subject: The Pharmacy and Therapeutics Committee Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/22/01___

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

____________________________________________________________________________________ III. Purpose: The Primary purposes of the Pharmacy and Therapeutics Committee are: 1. Advisory: The Committee recommends the adoption of, or assists in the formulation of, policies regarding evaluation, selection, and therapeutic use of drugs in the hospital. 2. Educational: The Committee recommends the adoption of, or assists in the formulation of, programs designed to meet the needs of the professional staff (physician, nurse, pharmacists, and other healthcare-care practitioners) for complete current knowledge on matters related to drugs and drug use). 3. Quality of Care Assessment: The Committee reviews adverse drug reaction reports and incidents involving medication to determine if reaction reports and incidents involving medication to determine if corrective actions or recommendations are necessary to a particular medical service or other professional staff so as to improve patient care. II. III. Definition(s): N/A Policy: The Director of the Pharmacy shall sit as the Secretary of the Pharmacy & Therapeutics Committee and, as such, shall prepare agendas, compile minutes, provide reviews of adverse drug reactions or incident reports involving medication, present policies & procedures involving the use of medications within the hospital review, addition, or revision, present proposals for drug utilizations evaluations, reviews, investigational drug protocols, and present any information that affects the distribution, storage, handling, administration, or clinical use of medication within the hospital. Philosophy: The multiplicity of drugs available and the complexities surrounding their safe and effective use make it necessary for hospitals to have an organized, sound program for maximizing rational drugs use. The Pharmacy and Therapeutics Committee, is the organizational keystone and standardization committee of this program. In making its decision on formulary additions the Committee shall consider not only safety and efficacy of the drugs but also the drug’s potential to cause adverse events, its addiction potential, and its involvement or potential involvement in sentinel events The Pharmacy and Therapeutic Committee is an advisory committee of the Medical Staff and serves as the organizational line of communication between the Medical Staff and Pharmacy Department. This committee is composed of physicians, pharmacists, and other healthcare professionals as well as representatives from Hospital Administration, Risk Management and Hospital Quality Management and

237

Nursing, selected with the guidance of the Medical Staff. It is a policy-recommending body to the Medical Staff and the administration of the hospital on matters related to the therapeutic use of drugs. IV. Responsibilities: It is the responsibility of the Director of Pharmacy to coordinate the activities of the Pharmacy and Therapeutics Committee through agendas, minutes, and official communications representing the actions to be taken as follow-ups of recommended or directed determinations by the Director of Pharmacy to provide minutes that include recommendations of the Pharmacy and Therapeutics Committee to the Medical Board office for inclusion as items for action, if necessary, at the Executive Committee of the Medical Board meeting held monthly. Procedures/Guidelines: (A) Organization and Operation:

V.

The following shall apply: (1) The Pharmacy and Therapeutics committee shall be composed of at least three physicians, a pharmacist, a nurse, and an administrator. Committee members are appointed by the governing unit or elected official of the Executive Committee of the Medical Staff. Members to the P&T Committee sub-committees shall be appointed by the Chairperson of the P&T Committee (see attached). (2) A chairperson from among the physician representatives shall be appointed. The Pharmacy Director of UHB shall be designated as secretary. The Committee shall meet regularly at a minimum, ten times per year, and more often when necessary. The Committee shall invite to its meetings persons within or outside the hospital who can contribute specialize or unique knowledge. An agenda and supplementary materials (including minutes of the previous meeting) shall be prepared by the secretary and submitted to the Committee members in sufficient time before the meeting for them to review the material properly. Minutes of the Committee meetings shall be prepared by the secretary and maintained in the permanent records of the hospital and the Pharmacy Department. Recommendations of the Committee shall presented to Medical Staff or its appropriate committee for adoption or recommendation. Liaison with other hospital committees concerned with drug use, e.g., Infection Control, IRB, shall be maintained.

(3)

(4)

(5)

(6)

(7)

(8)

(B)

Function and Scope:

The basic organization of the hospital and Medication Staff determine the functions and scope of the Pharmacy and Therapeutics Committee. The following is a list of committee functions: (1) The Pharmacy and Therapeutics Committee shall serve in an advisory capacity to the medical staff and hospital administration in all matters pertaining to the use of drugs (including investigational drugs). (2) The Pharmacy and Therapeutics Committee shall develop a formulary of drugs accepted for use in the hospital and provide for its constant revision. The selection of items to be included in the formulary is based on objective evaluation of their relative therapeutic merits, safety, and cost. The Committee shall minimize duplication of the same basic drug type, drug entity, or drug product.

238

(3) The Pharmacy and Therapeutics Committee shall establish programs and procedures that help insure cost-effective drug therapy. (4) The Pharmacy and Therapeutic Committee shall establish or plan suitable educational programs for the hospital’s professional staff on matters related to drug use. (5) The Pharmacy and Therapeutics Committee shall participate in quality assessment and improvement activities related to distribution, administration, and use of medications. (6) The Pharmacy and Therapeutics Committee shall review adverse drug reactions and incidents involving medications in the hospital. The Pharmacy and Therapeutics Committee shall initiate or direct (or both) drug use review and drug utilization evaluation programs and studies and review the results of such activities. The Pharmacy and Therapeutics Committee shall advise the Pharmacy in the implementation of effective drug distribution and control procedures. The Pharmacy and Therapeutics Committee shall make recommendations concerning drugs shall be stocked in hospital patient-care areas.

(7) (8)

(9)

VI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes VII. VIII. Attachments: Flow Chart of P&T Drug Approval and Evaluation Process References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/28/04 10/8/07

239

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 26 Sect. A Subject: Requesting an Addition of a Drug to the Formulary Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/22/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for healthcare practitioners to follow when proposing drugs for addition to the formulary. Definition(s): N/A Policy: Only drugs recommended for addition to the formulary by the Pharmacy and Therapeutics Committee and approved by the Executive Committee of the Medical Board for addition to the formulary shall be used in University Hospital at Brooklyn for patient care, with the exception of investigational drugs used in a n investigational protocol approved by the IRB accompanies by a patient informed consent. Responsibilities: It is the responsibility of the requesting physician to complete a formulary addition kit and attend the scheduled Pharmacy and Therapeutics Committee meeting addressing the request for presentation. It is the responsibility of the Director of Pharmacy to notify the requesting physician of the Pharmacy and Therapeutics Committee and Executive Committee’s determinations and provide for the acquirement of the drug for Pharmacy stock, if approved. Procedures/Guidelines: (1) When a physician wished to sponsor a drug for addition to UHB formulary, he/she shall first obtain a copy of a formulary addition kit (see attached) from the Pharmacy Director’s office, Room ALL 1-469, extension 3115. (2) The physician is required to complete the Request for Addition to the Formulary Form and have it signed by the Department Chairperson. (3) The physician is required to write drug utilization guidelines for the requested drug and address those questions contained in the DUG portion of the formulary addition kit. (4) The physician is required to append to the kit and article from a mainstream medical journal concerning the use, advantage, or comparisons to other agents of the requested drug. (5) The completed kit is submitted to the Director of Pharmacy, Room ALL 1-469, Box 36.

IV.

V.

240

(6) The Director of Pharmacy shall schedule a review of the request at the next available Pharmacy and Therapeutics Committee meeting, provided all of the required documentation is complete. (7) The Director of Pharmacy shall call the requesting physician to invite him/her to the scheduled meeting addressing the new request. At the meeting the physician shall present his/her case for addition of the drug, defend their position against questioning from Pharmacy and Therapeutics Committee members, and answer any questions addressed to the request. (8) After presentation, the requesting physician shall leave and a vote and/or discussion shall ensue concerning the request. (Note: a vote will not be taken unless a quorum of physicians is present.) (9) The Director of Pharmacy shall notify the requesting physician of the committee’s determination in writing. (10) Non-formulary requests for drugs shall be acquired following the procedures in Chapter 10, Procedure C. (11) If approved for addition by the Executive Committee meeting of the Medical Board.

(12) If approved for addition by the Executive Committee of the Medical Board, the Director of Pharmacy shall make arrangements to obtain the drug for stock in the Pharmacy. VI. Reasons for Revision: CXVIII. Changes in regulatory or statutory laws or standards CXIX. System failures/ changes CXX. Institutional/operational changes Attachments: Request for Addition to the Formulary Form, Drug Utilization Guidelines Format References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

241

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 27 Subject: Administration of Drugs in University Hospital Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/28/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To define classes of healthcare practitioners who may administer drugs within the hospital. Definition(s): N/A Policy: Only medically qualified and legally licensed/registered individuals shall administer drugs pursuant to a valid written order from a practitioner within the hospital according to hospital policies and procedures, interdisciplinary protocols and manufacturers/FDA guidelines. Further, only medication labeled by the hospital Pharmacy shall be administered. The medications administered shall be charted only by the licensed individual who prepares the medication for administration this insuring patient safety and fostering quality patient care. Responsibilities: Department of Nursing has authority over the Nursing staff, i.e., RN’s and LPN’s, to insure that all licensed Nursing personnel who administer medications have met all legal, training, and competency requirements. The Executive Committee and Medical Board through the Rules and Regulations of the Medical and Dental Staff have responsibility for physician activities relating to patient care. The patient is the responsibility of the attending physician or his designee. Procedures/Guidelines: 1. (A) NURSING: Registered Nurses:

IV.

V.

(1) Registered nursed may add the following types of parenteral medications to infusions as ordered: antibiotics, electrolytes, vitamins, etc. (2) designated areas Registered nurses may add oxytocin to infusions for ante-partum Obstetrics in

(3) Registered nurses may add narcotics or barbiturates to infusions to control chronic uncontrollable pain as ordered by an M.D. (4) medications. (5) RN's with credentialing or an I.V. team member may start an infusion. All RN’s shall be responsible for administering parenteral and non-parenteral

242

(B)

Licensed Practical Nurse:

(1) LPN’s may administer heparin via heparin lock and “IV” piggyback medications only after required training has been completed. 2. MEDICAL STAFF:

(1) Physicians with clinical privileges, including authorized house staff, may administer all medications, parenteral and non-parenteral dosage forms. (2) (3) (4) (5) 3. Physicians may titrate I.V. solutions of oxytocics, narcotics, and barbiturates. Physicians may administer investigational drugs. Physicians may administer IV push drugs and intrathecal injections. Physicians may start I.V. infusions.

PATIENT POPULATIONS ONLY SUBSEQUENT TP PHYSICIAN’S ORDER: (1) Follow Chapter 4, Section J, “Policy on Self Medication by Patients”.

(2) Only patients deemed competent shall self administer drugs on units such as NS 82 where an active self medication program exists, under present rules, under strict procedures, and using the proper infusion device, e.g., PCA pump. (3) A patient may self-administer I.V. medications at rates prescribed by the physician programmed into the infusion pump by the registered nurse. VI. Reasons for Revision: CXXI. Changes in regulatory or statutory laws or standards CXXII. System failures/ changes CXXIII. Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

243

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 27 Sect. A Subject: Medication Administration Schedule Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/28/01__ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: See policy below. Definition(s): N/A Policy: Medication shall be administered on scheduled times for routine medications or on a schedule prescribed by an authorized practitioner. Responsibilities: It is the responsibility of a pharmacist to dispense medication only if defined dosing schedules (frequency) and durations are indicated by the prescriber. It is the responsibility of the nurse to administer medication to patients based on the prescriber directions and according to the Department of Nursing’s approved schedule. Procedures/Guidelines:

V.

(1) Upon written prescription order, the scheduled times for administration medications of drugs shall follow these intervals: b.i.d h.s. Daily q.h. q.i.d Twice a day Bedtime Every day Every hour Four times a day 10 A.M. – 2P.M. – 6P.M. – 10P.M. 10 A.M. 10 A.M. – 12 Noon – 2P.M. 4 P.M. – 6P.M. – 8:P.M. 10 P.M. – 12 A.M. – 2A.M. 4 A.M. – 6A.M. – 8A.M. q4h q6h Every four hours Every six hours 10 A.M. – 2P.M. – 6P.M. 10 P.M. – 2A.M. – 6A.M. 6P.M. – 12 Noon 10 A.M. – 6P.M. 10P.M. 10A.M.

Every other day Every other day q2h Every two hours

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6P.M. – 12 A.M. q8h q12h t.i.d. a.c. p.c. Every eight hours Every twelve hours Three times a day 6 A.M. – 2 P.M. – 10P.M. 10 A.M. – 10 P.M. 10 A.M. – 2P.M. – 6P.M.

Half hour before meal Depends on meal schedule Half hour after meal Depends on meal schedule

Subject to change by specific order of the physician. IT SHOULD BE NOTED THAT ANY ORDER CONTAINING AN ABBREVIATION FROM THE HOSPITAL’S LIST OF UNACCEPTABLE ABBREVIATIONS SHOULD NOT BE PICKED UP BY NURSING PERSONNEL (See attached). VI. Reasons for Revision: CXXIV. Changes in regulatory or statutory laws or standards CXXV. System failures/ changes CXXVI. Institutional/operational changes Attachments: Unacceptable Abbreviation and Symbol List References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

245

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 28 Subject: Drug Samples on University Hospital at Brooklyn Property Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __12/5/07 Supersedes : 8/28/01_ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

Approved by: CONSTANCE SHAMES, M.D.

_____________________________________________________________________________ _________ I. II. III. Purpose: To control the integrity of any medication utilized in patient care in the IPD or OPD care areas. Definition(s): N/A Policy: The use and distribution by drug company representatives as well as the dispensing and administration by the professional staff at UHB of drug samples and complimentary packages of medication is not permitted on UHB property for patient use. The use of paper vouchers is allowed. Responsibilities: The pharmacist shall dispense only Executive Committee approved drugs or IRB approved investigational drugs for in-patient or out-patient use. Sales representatives shall not distribute drug samples within the hospital. Physicians shall not dispense or administer drug samples to patients within the hospital’s patient care areas. Procedures/Guidelines:

IV.

V.

(1) All drugs to be used within UHB shall be sponsored by a physician for inclusion to the formulary at a Pharmacy and Therapeutics Committee meetings. Applications for formulary addition can be obtained from the Director of Pharmacy in Room ALL1-469. Once the application is complete with all attachments, the Director of Pharmacy shall place the request on a P&T agenda. The P&T Committee shall hear the sponsor’s presentation and review supporting documentation. If the Committee determines that the drug warrants addition to the formulary (Due to its benefit to UHB patients, its effectiveness and superiority to other agents on formulary, its safety recommended for addition to the formulary to the Executive Committee and, if approved, shall be purchased

and stocked by the Pharmacy. The Pharmacy shall dispense only those drugs recommended by the P&T Committee and approved by the Executive Committee or investigational drugs approved by the IRB for use within UHB.

VI. • • • VII. VIII.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: Letter to Pharmaceutical Manufacturing Industry References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 12/5/07

TO: FROM: RE: DATE:

All Our Colleagues Representing the Pharmaceutical Manufacturing Industry Nicholas Galeota, M.S., R.Ph. Director of Pharmacy Drug Samples within University Hospital of Brooklyn December 5, 2007 This memo is being given to you to seek your help and assistance to insure the safety of our patients. We recognize your tireless efforts to keep our healthcare community well informed about new drugs and research for the same. We also recognize that without your pharmaceutical products, the work of our medical staff would not be as successful as it has been.

Because of safety and regulatory concerns, Downstate has banned the distribution of pharmaceutical samples. We seek your support and assistance in this regard, and request that you do not distribute pharmaceutical samples on our property. Your cooperation will be greatly appreciated
We also respectfully suggest that you utilize a voucher system to provide access to initial supplies of your product line. In this way there is no question about the integrity of the drug and the patient can take this voucher to their community Pharmacy to process the drug without charge. If your company does not provide this type of service, I would urge you to discuss it with your leadership as a strong effort on your part to support all hospitals’ mission of medication safety. Your compliance with this request is sincerely appreciated.

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. A Subject: Policy Statement on the Compounding of Sterile Parenteral Admixtures Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/28/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: See policy below. Definition(s): N/A Policy: The Pharmacy Department at UHB compounds and dispenses parenteral admixtures by licensed pharmacists in response to physician orders under aseptic techniques and conditions to prevent exposure of the patient population to hospital-acquired infections from contaminated solutions to sub-therapeutic or toxic therapies from physical incompatibilities or combinations, and to outdated or improperly stored products. The labeling of parenteral admixtures prepared by the Pharmacy Department shall meet all JCAHO, NYS DOH, NYS Education Department and ASHP Practice Standards so as to clearly inform the healthcare professional administering the preparation as to the correct demographics and prescribed requirements for the patient to insure safety and quality patient care. The professional staff of the Pharmacy Department provides the following sterile parenteral preparations.
         

Irrigation solutions with additive, e.g., cardioplegia Central and peripheral parenteral nutrition solutions Chemotherapy solutions utilizing cyto-toxic drug admixtures Potassium Chloride infusions in mini-bags or LVP’s Peritoneal dialysis solution mixtures PCA narcotic infusions Epidural infusions Anti-fungal infusions, e.g., liposomal amphotericin B TPA injection for catheter clearance Through the Pharmacy’s Parenteral Admixture Lab (Rm ALL1-516) any and all parenteral drugs shall be admixed, compounded, labeled, and dispensed by a pharmacist IV. Responsibilities: It is the responsibility of a pharmacist to mix parenteral drugs for use by Nursing when treating patients.



V. VI.

Procedures/Guidelines: N/A Reasons for Revision:

248

• • • VII. VIII.

Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

249

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. B Subject: Staffing Responsibilities and Supervision in The Parenteral Compounding Laboratories Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/28/01__ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide for adequate, competent staffing and supervision within the Pharmacy’s sterile compounding labs. Definition(s): N/A Policy: The sterile parenteral nutrition compounding labs are supervised by TH Senior Pharmacists who report to the Associate Director of Pharmacy. The lab is staffed by full-time pharmacists and pharmacy assistants, Monday thru Fridays, inclusive, from 8:30A.M. to 5:00P.M. The Parenteral Admixture Lab is operational from 7:00 A.M. to 6 :00 P.M. Mondays through Fridays. The sterile compounding areas are located within the Main Pharmacy, at Rm All1-516, Rm ALL1-514A, Rm A6-401, and Rm A2-481. Responsibilities: The responsibilities of the supervisory staff are: • • • • • • • • • • Education and professional certification of staff Maintenance of all records and statistics Supervision of all staff activities relating to technique, infection control, labeling, storage, distribution, housekeeping, and removal of waste after each procedure Maintenance of adequate supplies of drugs, compounding equipment, and infection control materials Maintenance of lamina flow hood certification every 6 months Maintenance of computer compounding equipment, programs, an auxiliary compounding equipment, e.g., Auto-Mix®, Micro-Mix® Supervision and instruction of undergraduate students Supervising the sterility testing of solutions by the Microbiology lab and quantitative testing of neonate preparations by the Chemistry Lab Maintain quality assessment measures and procedures for all practices in the lab Report directly to the Director of Pharmacy concerning problems, opportunities to improve, or patient incidents involving the laboratory, including quantitative errors and microbiological contamination problems.

IV.

The responsibility of the pharmacist is to compound and label the solution accurately according to the specific stages for each respective component procedure involved in the compounding procedure. The responsibilities of the Pharmacy assistants are: • Stock the lab with all necessary drugs, solutions, and equipment daily

250

• • • • • V. VI. • • • VII. VIII.

Turn hoods on one (1) hour prior to commencement of the compounding procedure and replace unused drugs on storage shelves Assist the pharmacist in non-compounding procedure Remove all regulated medical waste at the end of the day’s activities for housekeeping disposal Deliver preparations to the respective nursing unite, as needed Assist in maintaining all files for each procedure

Procedures/Guidelines: N/A Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

251

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. C 1 Subject: Working under the Lamina Air-Flow Hood Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/29/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. V. Purpose: To provide guidance for Pharmacy staff in the utility of sterile lamina flow compounding hoods so as to maintain a sterile field for compounding and sterile techniques when compounding. Definition(s): N/A Policy: All procedures to prepare intravenous parenteral nutrition solutions shall be conducted under a lamina vertical air-flow hood using aseptic techniques. Responsibilities: N/A Procedures/Guidelines:

(1) All staff members shall scrub up to the elbows with Hibliclens® or equivalent germicidal cleaner and utilize a hand/nail scrub brush. (2) All staff members working under the lamina air-flow hood shall wear cover-up gowns over their street clothes and cover their hair with a cap. Gloves shall be worn when handling ampoules or when the compounder feels that an extra measure of asepsis is necessary. NOTE: the protective garments shall not be worn outside the lab and shall be discarded in the appropriate receptacle. Rings and jewelry shall not be worn while working under the hood. (3) All interior surfaces of the lamina air-flow shall be cleaned before each procedure with 70% isopropyl alcohol and a final wash shall be done at the end of the day. Wipe downs shall be conducted in the event of a spill or breakage. (4) work. The staff shall turn on the lamina air-flow hood one (1) hour prior to the commencement of the day’s

(5) The staff shall wear masks in the event of respiratory problems, such as allergies, which might cause particle contamination from a sneeze or cough. (6) The staff shall wash down all bottles, vials, ampoules, and bags with 70% isopropyl alcohol prior to manipulation.

252

(7) All work done under the lamina air-flow hood shall be performed six (6) inches in front of the rear HEPA filter. (8) Large bottles or IV bags shall not be placed next to the Hepa filter so that sufficient air flow and exchange can be maintained. (9) Removal of hands outside the lamina air flow hood, the staff shall be a minimal, if at all, so as to avoid any compromise to the sterile field. (10) When working under the lamina air-flow hood, the staff shall utilize a smooth technique so that no disruption of air-flow shall be created. (11) The staff shall not be permitted to eat or drink within any sterile parenteral admixture lab.

VI. • • • VII. VIII.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

253

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. C 2 Subject: Syringe Manipulations Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Approved by: CONSTANCE SHAMES, M.D. Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/29/01__ Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide guidance for Pharmacy staff when utilizing syringes to introduce medications into parenteral drug delivery containers. Definition(s): N/A Policy: Syringes shall be utilized only by the pharmacist staff to introduce medication into base parenteral solutions in an aseptic fashion, with regard to patient safety, and disposed of according to accepted practices for regulated medical waste. Responsibilities: It is the responsibility of the compounding pharmacist to utilize syringes in a safe, aseptic manner to insure the safety of the patient and to dispose of the used syringes in a fashion to insure the safety of housekeeping staff and in accordance with all Federal, State, City, OSHA, EPA, and CDC regulations and/or recommendations on medical waste disposal. Procedures/Guidelines:

IV.

V.

(1) Inspect the outer packaging of the syringe to ascertain that the package ha snot been broken resulting in a breach of sterility (2) Choose the appropriate size-volume syringe to complete the medication transfer correctly.

(3) Remove the syringe from the outer packaging, place in the lamina air-flow hood, but leave the hub cover on until it is necessary to place a needle on the syringe. (4) be accessed. Choose a needle with the appropriate bore so as to minimize coring if a vial medication must

(5) Remove the outer wrapping of the needle and attach the needle to the hub of the syringe leaving the needle sheath over the needle until the syringe shall be used. (6) Swab the neck of the vial, ampoule, or IV bag/bottle with 70% isopropyl alcohol before inserting the needle and syringe. (7) Remove the needle sheath on the needle and pull the plunger back without touching the inside of the plunger to the desired volume mark of the solution to be withdrawn. (8) Insert the needle into a vial at a 45 degree angle and slowly push the needle through rubber stopper. When withdrawing solution is injected into the base solution.

254

(10) Withdraw a volume slightly greater than desired, invert the syringe and cover the needle with a sterile gauge pad. Slowly depress the plunger to expel any air or excess solution. (11) The withdrawn solution shall be immediately introduced into the base solution and then the base solution shall be shaken to insure homogeneity and the presence of evidence of physical incompatibilities (12) If the withdrawn solution cannot be added immediately label the syringe and leave it in the lamina air-flow hood. (13) When the syringe is no longer needed, dispose of the needle and syringe in its entirety in the appropriate regulated medical waste container (hard plastic molded covered sharps container). VI. • • • VII. VIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

255

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. C 3 Subject: Reconstitution and Transfer of a Drug to a Parenteral Solution Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/30/01__

Approved by: CONSTANCE SHAMES, M.D

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To provide guidance for the sterile transfer of medications into parenteral solutions. Definition(s): N/A Policy: All drugs in sterile, powder/crystal non-preservative form requiring reconstitution with a sterile diluent shall be diluted aseptically and immediately added to the base parenteral solution. Responsibilities: It is the responsibility of the compounding pharmacist to reconstitute drugs required for the parenteral admixture according to the manufacturer’s recommendations and introduce the drug in an aseptic manner into the base solution. Procedures/Guidelines:

V.

(1) Follow all steps for syringe manipulation as stated in Chapter 29., Sect. C, Sub-section 2, Procedures 1 through 13, inclusive. (2) Inject the diluent into the medication vial/ampoule.

(3) Hold the vial/ampoule in an upright position between the palms of the hands and rotate the vial/ampoule until all of the powder/crystals has been dissolved. (4) Wipe the top of the vial with an alcohol swab before attempting

(5) Inject the same volume of air as the volume of drug that is desired to be withdrawn. This step is not necessary when withdrawing reconstituting drug from an ampoule. (6) Do not touch the inside of the plunger as it is pushed out of the vial as the drug fills the syringe.

(7) Remove the syringe from the vial and cover the needle with a sterile gauze while expelling air or excess drug from the syringe. (8) Immediately introduce the drug into the base solution and mix the solution so as to insure homogeneity and to observe for physical incompatibilities VI. • Reasons for Revision: Changes in regulatory or statutory laws or standards

256

• • VII. VIII.

System failures/ changes Institutional/operational changes Attachments: None References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

257

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. D Subject: Preparation of the Sterile Parenteral Admixture Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____3__ Original Issue date: 8/1/98

Implementation Date: __8/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish sterile technique procedures used by pharmacists when compounding parenteral admixtures. Definition(s): N/A Policy: All sterile parenteral admixtures shall be compounded only by licensed pharmacists trained and annually in-serviced in the appropriate techniques required to safely prepare the prescribed admixture. Responsibilities: It is the responsibility of a pharmacist to compound the parenteral solution. It is the responsibility of the Pharmacy assistant to assist the pharmacist in all non-compounding activities. It is the responsibility of a messenger or Pharmacy staff member to deliver the product to the Nursing Station. It is the responsibility of a registered Nurse to receive the parenteral products. Procedures/Guidelines:

IV.

V.

(1) Mondays through Fridays, inclusive, a pharmacist shall collect all parenteral drug orders from the Pediatric and Neonatal Nursing stations in the morning before 10:00A.M. Adult orders will be sent directly to the TPN lab after the Parenteral Nutrition Service physician evaluates the patient’s needs. Cyto-toxic drug admixture orders and general parenteral drug admixtures are sent directly to these labs or faxed to this lab. (2) The pharmacist shall review the prescribed order before leaving the Nursing station or review received orders before compounding procedures are started so that any ambiguities or errors can be corrected by the prescribing physician. (3) The pharmacist shall bring the NCR copy of the order to the TPN laboratory for processing.

(4) The pharmacist shall first compare the order against the patient’s allergy profile, secondly, check dosage propriety and physical compatibility of the prescribed ingredients, and thirdly, check that the route of administration is appropriate for the concentrations prescribed by the physician. (5) The pharmacist shall make all dosage calculations based on the parenteral bag volume size or syringe volume size prescribed by the physician. (6) The Pharmacy assistant shall gather all ingredients requested by the pharmacists for the respective preparation and prepare a log sheet for the procedure (see attached).

258

(7) The demographic data on the patient is then entered in to the computer based patient profile system in the lab by a pharmacist or by a Pharmacy assistant checked by the pharmacist. (8) The volumes of drugs required to satisfy the physician’s order are programmed into the Auto-Mix ® machine or the Micro-Mix® machine only by a pharmacist when preparing parenteral nutrition admixtures. (9) The Pharmacy assistant shall create the IV procedure log sheet recording the product used, the manufacturer of the product, and the lot number of the product used, the manufacturer of the product, the volume of the drug used in the procedure, and the lot number of the product used. The expiration dates of the products used in the preparation shall be maintained by the Material’s Manager. (10) After the admixture is completed by the pharmacist, the Pharmacy assistant shall initiate a print order to the computer to generate a label for the respective preparation in the TPN lab. (11) • • • • • • • • • The label for all parenteral admixtures shall contain the following information: (see attached sample) Patient’s name and location Bag or bottle prescription number Name and amount of drugs added Flow rate of administration Name and volume of basic parenteral solutions Date and time of the additions Name, initials, or identifying code of the pharmacist who prepared the mixture Supplemental instructions Expiration date of the compounded solution NOTE: The expiration data of all solutions shall not exceed 72 hours unless stability data is available to substantiate a longer expiration. Products stable for less than 72 hours will be marked according to the product information or manufacturer’s recommendations.

(12) The final label shall be checked by a pharmacist before affixing to the bag or bottle (if bottle or bag is prepared, invert the label). Auxiliary labels shall be affixed at this time. (13) The finished parenteral nutrition products shall be placed paper bag or box and cyto-toxic drug admixture shall be placed in an appropriately labeled bag and then into a delivery container clearly labeled with the Nursing station destination and a red label to refrigerate for parenteral nutrition admixtures. (14) A nurse’s receipt shall be made indicating the Nursing Station, the patients’ names, date, and the number of products for each patient. For cyto-toxic drug admixtures, a delivery log is created for the Nurse to sign upon delivery of preparation. (15) The Pharmacy assistant shall prepare a pickup entry in the messenger pick-up book for parenteral nutrition admixtures indicating date, Nursing Station, and number of bottles or bags to be picked up. (16) The Pharmacy assistant shall call the floor messenger for a pickup. Cyto-toxic drug admixtures shall only be delivered by Pharmacy personnel. (17) The messenger shall sign the pickup book before receiving the products of parenteral nutrition admixtures. (18) The messenger or Pharmacy staff member shall deliver the products to the appropriate Nursing Station and only a registered nurse shall sign for the delivery and place the products immediately into the refrigerator, if required. (19) The messenger shall return the Nurse’s receipt to the TPN laboratory and the Pharmacy staff member shall return the delivery log to the Oncology Admixture Lab. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

• • • •

259

VII. VIII.

Attachments: Hyperalimentation Log Sheet; Sample Labels References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

260

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 29 SECT. E___ Subject: Discontinued Parenteral Preparations Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__ Original Issue date: 8/1/98

Implementation Date: __8/3/01___

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

____________________________________________________________________________________ IV. II. III. Purpose: To establish procedures for the safe disposal of discontinued/expired parenteral solutions. Definition(s): N/A Policy: All parenteral preparations prepared by the Pharmacy that are discontinued by a physician’s order shall be removed from the Nursing Station and returned to the Main Pharmacy for proper destruction or disposition. Responsibilities: It is the responsibility of a pharmacist or Pharmacy assistant/aide to remove and destroy all un-used or discontinued IV solutions. It is the responsibility of a registered Nurse to inform the admixture labs of discontinuation orders from a physician or changes in orders that may influence the number of preparations to be made by the Pharmacy, e.g., change in flow rates. Procedures/Guidelines: (1) During the daily rounds to pick-up new orders or discontinued drugs, the pharmacist or Pharmacy assistant /aide shall check the IV solution refrigerator or the drug return bin on the Nursing station for un-used or discontinued preparations and remove them for return to the Main Pharmacy. (2) During the course of the day if a nurse calls the admixture labs to inform the lab that a order has been discontinued by a physician, a Pharmacy assistant/aide shall be dispatched to the Nursing Station to retrieve all unused preparations. (3) The returned products shall be destroyed according to regulated medication waste procedures or cyto-toxic waste procedures. (4) (5) The patient’s account shall be credited for all un-used products. The patient’s computer profile shall be updated accordingly.

IV.

V.

261

(6)

During the monthly Nursing station inspections, the inspecting pharmacist shall double check the parenteral solutions overlooked.

VI. • • • VII. VIII.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/28/04 10/8/07

262

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 29 Sect. F Subject: Sterility and Quantitative Testing of Parenteral Solutions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____3__ Original Issue date: 8/1/98

Implementation Date: __8/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to verify the qualitative and quantitative testing of parenteral admixtures. Definition(s): N/A Policy: The Associate Director of Pharmacy shall implement, collect data, evaluate results, and take corrective actions if necessary in procedures, personnel training, or equipment maintenance/upgrading based on regularly schedule sterility and quantitative testing on compounded parenteral solutions. Responsibilities: It is the responsibility of the Director of Pharmacy to maintain and evaluate results of the microbiological sterility and quantitative testing program for parenteral solutions compounded by pharmacists and take appropriate corrective actions as required. It is the responsibility of the compounding pharmacist to maintain sterile technique and care in the preparation of these solutions so as to insure the safety and care in the preparation of these solutions so as to insure the safety of all parenteral solutions compounded for patients at UHB. Procedures/Guidelines: Sterility Testing: (1) Random sterility testing on compounded solutions shall be conducted on a weekly basis. (2) The sample shall be obtained by puncturing the entry port of the solution with a needle attached to a Vacutainer ® collection tube. A minimum of a 5ml sample is required. (3) The Vacutainer® collection tube label shall contain the following information: The name of the compounding pharmacist The date of the sample was taken The name of the patient for which the solution was prescribed The prescription number of the solution from which the sample was obtained The information contained on the Vacutainer® collection tube label shall be recorded in the TPN Sterility Sample Log Book. (a) (b) (c) (d)

IV.

V.

(4)

263

(5)

The sample shall be sent to the hospital’s Clinical Laboratory for microbiology sterility testing.

(6) The Director of Pharmacy receives the lab result slip and after review gives the lab slip to a pharmacist who records the results in the TPN Sterility Sample Log Book. (7) The pharmacist files the lab result slip in a chronological file for 1 year.

(8) If the results indicate the presence of micro-organisms, the Director of Pharmacy shall conduct an investigation to determine the Director of Pharmacy shall conduct an investigation to determine the source of the contamination, immediately recover all un-used solutions from the Nursing stations, inform the physician responsible for the patient, and inform the Hospital Epidemiologist of the steps taken to find the source of the contamination and the results of his/her investigation. (9) The Director of Pharmacy shall instruct a pharmacist to immediately prepare a new solution and dispatch a Pharmacy assistant to the Nursing station to replace the patient’s solution. (10) If the source of the contamination is attributed to pharmacist technique, the Associate Director shall remove the pharmacist from the lab rotation schedule and provide an in-service to re-affirm the proper procedures for infection control and sterile technique. (11) Pharmacists identified as sources of microbiological contamination, shall have their techniques and solutions re-evaluated on a weekly basis for a period of 1 month after the inservicing has been completed. (12) The Director of Pharmacy shall conduct appropriate Quality Assessment studies on all procedures in the lab on a annual basis. Quantitative Testing: (1) Quantitative testing of all preparations mixed for the pediatric and neonatal Nursing units shall be tested for Na+, K”, and glucose. (2) The compounding pharmacist shall take a sample of the TPN preparation.

(3) The sample shall be sent to the Clinical Labs along with a completed Hyperalimentation Solution Quality Control Form at 3:00p.m. (see attached form). (4) The Clinical labs shall perform the necessary tests to insure that a safe and accurate quantity of these agents is present in the preparation. This form will be signed by the lab technician and his/her supervisor indicating that a safe an accurate level of these agents is present. If the solution doesn’t test safe and accurate, this shall be indicated on the form. (5) The form shall be sent back to the TPN lab where, if ascertained as safe and accurate, a pharmacist shall sign the form to indicate that he has reviewed the results and take form to indicate that he has reviewed the results and take responsibility for releasing the preparation to the Nursing unit. (6) NOTE WELL: If the sample solution tests unsafe or inaccurate, the TPN pharmacist shall re-mix the solution and submit samples for testing as outlined in steps 1 through 5, inclusive, of the Quantitative Testing section of this procedure. No preparation shall be released until it has passed these testing procedures. (7) Records of these test trials shall be maintained in the Pharmacy’s TPN lab for a period of one (1) year. VI. • • • Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes

264

VII. VIII.

Attachments: Hyperalimentation Solution Quality Control Form; Acceptable Ranges of Analytes References: None Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

Date Reviewed 12/21/04 10/8/07

265

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 29 Sect. G Subject: Procedures and Addendums for the Operation Of the Auto-mix®, Micro-mix®, and Laboratory Computer Systems Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____1__

Original Issue date:

8/1/98

Implementation Date: __8/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: Regulatory Affairs ______________________________________________________________________________________ I. II. III. Purpose: Provide for technical instructions for Pharmacy staff for the operation of automated compounding equipment within the TPN Lab. Definition(s): N/A Policy: All pharmacists with responsibilities for compounding parenteral admixture solutions shall be trained by the Associate Director of Pharmacy in the use of automated technology used to mix, compound, and preserve data in the parenteral admixture compounding laboratories. Responsibilities: It is the responsibility of the Associate Director of Pharmacy to train and maintain a safe and effective level of education in the use of automated technology for all pharmacists responsible for compounding parenteral admixture solutions. Procedures/Guidelines: See the appended procedural instructions. Reasons for Revision: CXXVII. Changes in regulatory or statutory laws or standards CXXVIII. System failures/ changes CXXIX. Institutional/operational changes Attachments: Automix 3+3 addendums 1 &2; TPN Laboratory Computer Procedures References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

IV.

V. VI.

VII. VIII.

Date Reviewed 12/21/04 10/8/07

266

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 29 Sect. H Subject: Physician Order Forms for Parenteral Admixture Solutions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/30/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: Identify approved forms that prescribers may use to order TPN solutions. Definition(s): N/A Policy: Physicians requesting parenteral nutrition or cyto-toxic drug admixture solutions for patients shall order the appropriate solutions using the service approved physician order form for Pediatrics and Neonatology or the P&T Committee/Medical Records Committee form for adult parenteral nutrition preparations or cyto-toxic drug admixtures. Responsibilities: It is the responsibility of the prescribing physician to use only the approved order forms to request these solutions and provide the required information to direct the pharmacist in compounding and labeling and the Nurse in administration of the solution. It is the responsibility of the Nurse to sing (pick-up) the order form in the patient’s chart. It is the responsibility of the pharmacist to maintain all records according to legal requirements. Procedures/Guidelines: (1) The attached form shall be used by the appropriate service of the origin and completed in their entirety. (2) The Nurse responsible for the patient shall sign for the order before releasing it for compounding to the parenteral admixture lab. (3) VI. All completed orders shall be maintained by the Pharmacy for a period of 5 years.

IV.

V.

Reasons for Revision: CXXX. Changes in regulatory or statutory laws or standards CXXXI. System failures/ changes CXXXII. Institutional/operational changes Attachments: Neonate, Pediatric, Adult TPN Order Forms References: none

VII. VIII.

267

Date Reviewed 12/21/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

268

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 29 Sect. I Subject: Cyto-toxic Drug Admixtures Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES __8/30/01__ Page ____1__ of ____6__ Original Issue date: Implementation Date: 8/1/98

Approved by: CONSTANCE SHAMES, M.D. Administrative Manual Manual

Distribution: Department Patient Care

Manual AOD Manual _____________________________________________________________________________ _________ I. II. III. Purpose: To establish safe procedures for the admixing/handling of the high-risk cyotoxic (chemotherapy) drugs including safe waste management. Definition(s): N/A Policy: Any medication labeled for an in-patient from a Nursing station shall not be given by a nurse or other medical professional to a patient upon discharge. (1) The accuracy and appropriateness of the drug and dose. (2) The sterility of the parenteral agents. (3) The safety of personnel preparing the chemotherapy. (4) The proper disposal of chemotherapy waste with increasing awareness of environmental health hazards. IV. Responsibilities: It is the responsibility of an authorized practitioner responsible for the patient to write ambulatory prescriptions for the patient upon discharge. It is the responsibility of the nurse responsible for the patient to return all unused inpatient labeled medication to the Pharmacy upon discharge of the patient.

V. Procedures/Guidelines: The procedural steps to comply with the policy are broken down into specific subjects as follows: (1) All professional staff shall receive training before working with antineoplastic agents and pass a certification exam.

(2) Access to the compounding lab and hood shall be limited to authorized and trained personnel. (3) Personnel shall be rotate through the area on an as needed basis to minimize exposure. (4) Personnel working with these agents shall be observed on a regular basis by supervisory personnel to insure compliance with accepted safety standards. (5) Staff working with cytotoxic agents shall be identified to University Hospital’s Heath Service.

(6) Staff working directly with mixing chemotherapeutic drugs shall have an annual CBC, differential, and SMA-18 performed in addition to the annual Health Service screening Physical examination and other lab test shall be done if the Physical examination and other lab tests shall be done if the Health Service physician feels these are indicated. (7) According to OSHA guidelines, staff shall be fully informed of the potential reproductive hazard, and, id they so request, staff members who are pregnant, breast-feeding, attempting to conceive, have a history of cancer or other condition that may be aggravated by or limit the staff members ability to safely mix cyto-toxic drugs shall be transferred to comparable duties that do not involve handling cyto-toxic drugs. NOTE: On the basis of available evidence, it seems reasonable to assume that if appropriate procedures are followed, and proper equipment and protection are provided, reproductive hazards shall be reduced. (8) Acute exposure must be documented in an official Employee Accident Investigation Report and referred immediately to the Employee Health Service for treatment. ENVIRONMENTAL PROTECTION: (1) The preparation of all cyto-toxic agents shall be done in a vertical air flow Class II, Type B externally vented biological safety cabinet within the negative pressure, self contained IV Admixture Lab (Room ALL1-516). (2) The biological safety cabinet shall be certified by an independent scientific medical instrumentation agency twice (2) annually or whenever the cabinets are moved. (3) The blower on the cabinet shall remain on at all times.

(4) The viewing screen of the cabinet shall be engaged at the recommended opening during any preparation. (5) Aseptic technique as stated in Chapter 29, Section C, Sub-sections 1 through 3, inclusive, shall be employed. (6) No other admixtures are to be prepared in the safety cabinet designated for chemo admixture.

OPERATOR PROTECTION: (1) Disposable latex gloves shall be worn for procedures involving antineoplastic agents. (2) Double gloving is recommended, with the outside glove being changed at least every hour. a) When using “Chemo Safety” gloves it is not necessary to double glove. (3) In the event of a spill or if the gloves become wet due to leakage of medication, both pairs of gloves shall be discarded and placed in the chemotherapy waste container. (4) Disposable protective barrier garments shall be worn during the compounding procedure. These gowns shall have a closed front, long sleeves and closed (elastic or knit) cuffs. (5) Goggles and face masks shall be provided for operator protection.

(6) All contaminated or used garments and gloves shall be discarded in the hazardous waste containers and must not be worn outside of the cytotoxic preparation area of the admixture lab. (7) If the double glove method is used, the outer gloves shall be changed hourly. Should the gloves or gowns become wet from chemotherapeutic agents, they shall be changed immediately. (8) A plastic backed absorbent drape (barrier field) shall be placed on the work surface of the biological safety cabinet. This barrier field shall be changed whenever spillage occurs and at the end of each production sequence. The barrier shall be discarded in the hazardous waste container. (9) The pharmacist shall preplan the work area so that everything needed for the complete procedure should be placed in the cabinet before starting the procedure so that nothing passes in or out through the air barrier until the procedure is completed. (10) The materials needed for the procedure shall be arranged in a logical manner, such that clean and contaminated materials are segregated, preferably on opposite sides of the compounding pharmacist. (11) When all of the materials needed for the procedure are in place within the cabinet, the access door shall be shut. This restricted opening is necessary for proper operation of the biological safety cabinet. (12) The unit shall operate for at least 3 minutes after closing the access door before proceeding to mix the drugs to allow purging of the air space. (13) All procedures shall be performed on the solid work surface of the cabinet and not on the screened surface.

(14) Only syringes and IV sets with luer-lock fittings shall be used in preparing and dispensing chemotherapeutic admixtures. (15) The pharmacist shall work as far as possible into the cabinet but not less than six (6) inches behind the viewing screen. (16) (17) A no point in time shall the airflow be blocked in any fashion. Aseptic technique shall be used at all times.

(18) Using an alcohol swab, all bag ports, vial covers, and ampoule necks shall be wiped down. (19) A chemo-pin or a Cytogard ® shall be used with vials.

(20) A sterile alcohol soaked sponge shall be carefully wrapped around the needle and vial top during withdrawal from the vial. (21) When reconstitution of a vial is necessary, gently swirl the vial to dissolve the medication. (22) When using a syringe, always pull back the plunger before pushing it forward when entering a vial. This will reduce aerosolization of vial contents. (23) When ejecting air bubbles from a syringe, use an alcohol soaked sponge to cover the needle tip. (24) External surfaces of syringes shall be rinsed or wiped clean of any drug contamination.

(25) The filled needle less syringes shall be capped using syringe caps and labeled. (26) Before opening an ampoule, be sure that the top of the ampoule if free of any liquid. (27) Place a sterile alcohol soaked sponge around the neck of the ampoule before opening. This shall contain aerosol produced and to prevent fingers from being lacerated by broken glass. (28) Use a filter straw or filter needle attached to a syringe to draw up contents of an ampoule. (29) The ampoule shall be discarded as cyto-toxic hazardous waste.

(30) Chemotherapeutic agents shall be dispensed in the following dosage forms: pre-filled syringe, IV piggyback minibag for infusion, or large volume parenteral for infusion. (31) After preparation, the ports shall be wiped down with an alcohol swab and the sides/tops of vials used in preparation are also to be wiped down.

(32)

Syringes and tubing’s shall be primed under the hood.

(33) All final labeled products shall be placed in a polyethylene, zip locked bag and sealed. This shall be placed in a second, outer bag marked “CHEMOTHERAPY DRUG, TOXIC, DISPOSE OF AS BIOHAZARD.” (34) All doses shall be delivered to the Nursing care areas in a plastic cooler container by Pharmacy Technicians (35) A spill kit shall accompany the delivery at all times.

(36) All chemotherapeutic preparations in bags are to be primed with naked solution using Baxter # 2C55015 tubing or equivalent. LABELING OF CHEMOTHERAPEUTIC DRUGS: Each label for IVPB and syringes shall contain the following information: • Name of patient • Location of patient • Date • Drug Name • Dose (x mg in y ml) • Date and time of the additions • Name of base solution and total volume (based on Mfg. 5% overfill) • Date, time, and route of administration • Compounding pharmacists initials or identification • Expiration date • Prescribing physician Labels on outer bags: • Caution sticker and any other accessory labels. • Nursing unit and name of patient. Handling of Oncovin ® (vincristine): • NOT FOR INTRATHECAL USE • DO NOT REMOVE COVER UNTIL TIME OF INJECTION

PROFILING AND RECORDING: (1) Upon receipt of a chemo order to be mixed, the pharmacist responsible shall be notified. (2) The pharmacist shall then prepare a patient profile.

(3) When patients receive medication for more than 1 day, this profile shall serve as a daily work sheet and each profile shall be reviewed each morning by the pharmacist for doses due each day. (4) A separate log for each day’s preparations shall be maintained.

(5) When the preparations are delivered to the Nursing Station, a registered nurse shall sign for the medication and indicate the time received and the form or log shall be returned to the Pharmacy.

(6) The completed orders shall be charged to the patient account by a pharmacy technician on a daily basis. (7) All calculations of dosage shall be double calculated on the back of the prescription and verified by another pharmacist. (8) DISPOSAL: (1) Contaminated needles and syringes shall be disposed of intact to prevent aerosol generation from clipping needles. Special containers shall be supplies for this waste. (2) Contaminated gloves, paper, gowns, etc., shall be disposed in the waste container marked “Hazardous Waste”. (3) Anti-neoplastic drug waste shall be transported according to the institutional procedures for contaminated waste. (4) Needles shall NEVER be recapped. A sample label shall be affixed to the back of the prescription.

CLEANING OF HOOD WORK SURFACE: Utilizing the Surface Safe® product (comprised of two pads labeled #1, containing a 2% hypochlorite solution, #2, containing a thiosulfate solution, the following procedure is followed: 1) Use pad #1 to wipe down all surfaces of the hood, allowing the solution to remain on the surfaces for thirty (30) seconds 2) Use pad #2 (after waiting 30 seconds) to wipe down all surfaces of the hood, allowing the solution to remain on the surfaces for thirty (30) seconds 3) Use the solution labeled H20 orange to wipe down all surfaces of the hood allowing the solution to remain on the surface for three (3) minutes 4) Use the alcohol spray bottle on all surfaces of the hood and wipe with gauze SPILL CONTROL: (1) In the event of a spill of a chemotherapeutic agent, the user department shall contact the Housekeeping Service at ext. 2997. (2) All participants shall use the items contained in the chemo spill kit to contain and clean the spill. (3) The area of the spill shall be mopped with Clorox® and rinsed with water 3 times. (4) All materials used shall be discarded in the hazardous waste containers.

(5) Personnel shall wash hands with Betadine® scrub for at least three (3) minutes. (6) MEDICAL STAFF: (1) Only those physicians specifically authorized to prescribed chemotherapeutic agents shall write for these medications. The lab shall be cleaned each night before closing.

(2) Physicians shall include body surface area on all orders to facilitate ease of re-calculations for double-checking. (3) Physicians shall indicate the order the patient’s age, diagnosis, height, weight in kilograms, locations, and sex. (4) Orders for chemotherapeutic agents shall be received in the additive lab at least one (1) hour before administration time and no later than 4:00P.M. on the scheduled day for administration. (5) Medication to be administered before 9:00 a.m. requires receipt of the orders in the Main Pharmacy by 9:00 P.M. on the day preceding the scheduled administration day. (6) Orders written for chemotherapeutic agents that are not received in the additive lab by 4:00P.M. on the day scheduled for administration WILL NOT be compounded by Pharmacy personnel. (7) Agents whose stability is less than three (3) hours, e.g., mechlorethamine (15 minutes) and investigational agents whose stability is unknown, shall not be compounded by Pharmacy personnel. (8) On Saturdays and Sundays, if the product is stable and the patient is on a continuation order, the product shall be mixed on Fridays and delivered to the Nursing stations. If the drug is not stable, the physician may mix the drug and can use the biological safety hood in the additive lab. It is preferred that a pharmacist mix the drugs, however. SPECIAL PRECAUTIONS: (1) Eating, drinking, chewing gum or storage of food in, around or near the hood is prohibited. Each of these are sources of ingestion of the chemotherapeutic agent. (2) Spills inside the hood shall be cleaned immediately with Clorox ® and rinsed with copious amounts of water. NEUPOGEN® ORDERS: (1) Fridays. (2) Neupogen® shall be sent to the Nursing units on the following basis: Blood work (Complete Blood Counts) is done on Mondays and

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 30 Subject: Dispensing of Albumin Solutions Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/31/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures to be followed by pharmacists for the safe storage and dispensing of the blood derivative albumin. Definition(s): N/A Policy: All albumin products shall be dispensed from the Pharmacy service areas by a pharmacist on the written prescription order of a physician or other legally licensed professional with prescriptive authority.

IV. Responsibilities: It is the responsibility of a physician or other legally authorized professional to write a medication order for albumin products. It is the responsibility of a pharmacist to dispense the medication upon presentation of a complete prescription order and record all of the necessary information about the product as required by NYS DOH laws. (A) A physician or those individuals legally authorized to have prescription authority under the NYS laws granted by the NYS Education Department shall write a complete prescription order for albumin products in the physician’s medication order section of the patient’s medical record. (B) The Nurse assigned to the patient shall pick up the order and give the order to the Nursing station clerk for subsequent delivery of the order via messenger or Pharmacy Technician to the Main Pharmacy. (C ) Upon receipt of the prescription, all procedures for dispensing medication according to Chapter 4, Section A, Procedures e –1 (D) The Pharmacy shall record the following information required by the NYS DOH on the Albumin Monitoring Log: 1) 2) 3) 4) 5) Date dispensed Patient name Location of patient Signature of dispenser Strength and volume of albumin dispensed

276

6) 7) 8) (E)

Manufacturer Quantity dispensed Lot number of the product For those requests for albumin from Cardio-Thoracic Surgery: 1) 2) All albumin products shall be dispensed from the OR Satellite Pharmacy directly to the physician or a member of the Perfusion Team. The physician or a member of the perfusion team shall sign for these products on an administration record given to him/her by the pharmacist.

3) The administration record and any unused albumin shall be returned to the OR Satellite Pharmacy after the surgical procedure is completed by a member of the perfusion team. VI. Reasons for Revision: CXXXIII. Changes in regulatory or statutory laws or standards CXXXIV. System failures/ changes CXXXV. Institutional/operational changes Attachments: none References: none

VII. VIII.

Date Reviewed 12/21/04 10/8/07

Revision Yes Yes Yes

Required (Circle One) No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

277

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 31 Subject: Dosing of Cardiac Medications: Nitrate and Other Anti-Anginals Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/31/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To establish procedures for utilizing anti-anginal drugs to insure a nitrate free period and at the same time insuring that the patient is covered during this period.. Definition(s): N/A Policy: In order to obtain the maximum therapeutic response and at the same time cover the patient through 24 hour periods during his/her stay in the hospital, the prescribing physician shall prescribed nitrates and other anti-anginal medications according to a rigid dosing schedule based on the pharmacokinetic properties of the drug. Responsibilities: It is the responsibility of the prescribing physician to prescribe nitrates and other anti-anginal medication according to specific dosing schedules for efficacy and safety. It is the responsibility of the registered Nurse not to pick up incorrectly written orders for these classes of drugs. It is the responsibility of a pharmacist not to fill incorrectly written orders for these classes of drugs and contact the physician for correction if an order is received in the Pharmacy. Procedures/Guidelines: (1) A prescribing physician shall write prescriptions for nitrates and other anti-anginals according to the following schedules for the respective pharmacologic class: I. Nitrates: A) Oral: In order to minimize the risks of increased susceptibility to ischemic episodes and at the same time allow for a nitrate free interval to prevent tolerance, it is recommended that oral nitrates shall be prescribed at with a nitrate free interval of 10 to 12 hours, e.g. 8:00A.M., 2:00P.M., and 9:00P.M. and the frequency of “TID” not be used. The frequency of q8 hours is acceptable. B) Topical Patches: with the same considerations in mind as stated in Procedure #1-I, section A, nitrate patches shall be prescribed by the physician to be applied at 8:00A.M. and removed at 10:00P.M. through a 24 hour period during the patient’s stay in the hospital.

IV.

V.

a) If extenuating circumstances exist that require the patch medication to remain on the patient for 24 hours, the physician shall state on the comments sections of the medication order and document these reasons in the progress notes of the patient’s medical record.

278

b) The nurse applying the patch to the patient shall write the date and time of application on the patch before applying the patch. II. Oral Anti-Anginals: A) The prescribing physician shall prescribe oral anti-anginal medication, e.g., Procardia ®, Cardizem®, on an equal dosing interval schedule, such as q6 or q8 hours. B) If another schedule is prescribed, the physician shall indicate on the prescription the times, e.g., 8:00A.M., 2:00P.M., etc., in frequency section of the medication order and document in the comments section and in the progress notes the reason for this schedule. (2) The prescribing physician shall not use BID, TID, or QID to indicate a dosing frequency on the medication order nor shall a Nurse pick up an order written in this fashion for nitrates and other anti-anginal drugs. (3) If a medication order is received by the Pharmacy that is written in a manner other than as stated in this Procedure, Sections 1a. or 2a. and b., the pharmacist shall not dispense the medication until the physician is contacted, the correct dosing scheduled is determined, and a new medication order is written. (4) A pharmacist shall label all medication orders for nitrates and other anti-anginal medication according to these procedures. VI. Reasons for Revision: CXXXVI. Changes in regulatory or statutory laws or standards CXXXVII. System failures/ changes CXXXVIII. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

279

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 32 Subject: Pharmaceutical Education for Patients and Family Members Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 8/1/98

Implementation Date: __8/31/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. Purpose: To provide direction to pharmacists when providing medication counseling to patients or family members. Definition(s): N/A Policy: The Pharmacy Department at UHB shall participate in the facilitation of the patient’s understanding of his/her health care status by providing education to the patient and/or family members concerning the safe and effective use of medication interventions prescribed by a qualified practitioner. Responsibilities: It is the responsibility of the Pharmacy Department to provide approved printed patient leaflets to the Nursing staff to be used at discharge counseling of patients. It is the responsibility of a pharmacist to counsel all patient receiving outpatient prescription services at the OPD Pharmacy. Procedures/Guidelines: (1) The Pharmacy Department provides to all Nursing stations a series of approved printed patient drug information leaflets from the Micromedex® Patient Leaflet database reference source. The information in these references provide the following information: • • • • • • • The pharmacological class of the drug The trade and generic name of the drug The dosage forms and strengths of the drug An explanation of pharmacological effects An explanation of directions on how to take the drug with cautionary statements An explanation of how to recognize and how to respond to the side effects and adverse reactions while taking the drug Directions on how to avoid drug-food interactions

IV.

V.

(2) The references shall be distributed by the Nursing staff to patients and/or family members during the discharge planning interview conducted for the patient.

280

NOTE: Language translations are available through the hospital contracted translator telephone line or through a hospital translator. (3) A Nursing staff member can contact the Main Pharmacy, ext. 2854 or ext. 2856, to obtain the assistance of a pharmacist when counseling a discharge patient. (4) When a discharge patient o ran ambulatory care patient presents prescriptions at the OPD Pharmacy Department, the patient shall be counseled by a pharmacist concerning his/her prescription medication. (5) The patient will sign in the documents of Pharmacy that the counseling was conducted. The patient has the right to refuse counseling and also indicates this by his/her signature. (6) Upon receiving the completed prescription order, the patient also receives from the pharmacist’s a computer printout concerning each medication received. This printout contains written information and support for the patient concerning the proper use of the medication, directions for use, indications of side effects and their management, drug-food interactions, and how to optimize the therapeutic effect of the drug. VI. Reasons for Revision: CXXXIX. Changes in regulatory or statutory laws or standards CXL. System failures/ changes CXLI. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

281

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 33 Subject: TPA Injection for Catheter Clearance Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 12/14/99

Implementation Date: __8/16/01__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. II. III. IV. Purpose: To establish procedures for pharmacists to follow when compounding TPA for catheter clearance when industrial shortages occur. Definition(s): N/A Policy: Due to the ongoing nation availability problems with urokinase injection, the Pharmacy Department shall extemporaneously prepare, store, and dispense TPA injection for catheter clearance. Responsibilities: It is the responsibility of an authorized prescriber to write the medication order for TPA catheter Clearance on the physician’s order form. It is the responsibility of a pharmacist to prepare the alteplase syringe in the appropriate dosage concentration and to store the syringe in a frozen state until dispensed. The pharmacist’s procedure shall yield 100 doses of this preparation. It is the responsibility of the Nurse to thaw the syringe prior to installation into the catheter. Procedures/Guidelines: PHYSICIAN: (1) The prescribing physician who determines that catheter Clearance, a pharmacist shall dispense a pre-filled frozen syringe labeled as follows: Alteplase 0.5mg/1ml 0.5mg alteplase = 30,000 units urokinase activity Preparation Date: Good for 1 month from Preparation Date in Freezer (2) a) b) c) d) e) Preparation of this syringe shall be done by a pharmacist in the following manner: The pharmacist water. The pharmacist The pharmacist The pharmacist The pharmacist this container. shall reconstitute a 50mg alteplase (TPA) vial with 50ml of sterile shall let this solution set until the foaming has subsided. shall take a 25oml sterile evacuated bottle and shall remove the contents of the TPA vial from Step shall then add an additional 50ml of sterile water for injection to

V.

282

f) g) h) NURSE:

This final volume shall be 100ml and the dilution shall yield a final concentration of 0.5mg/1ml of alteplase. The pharmacist shall withdraw 1ml (0.5mg) of this solution into a 3ml syringe and seal the syringe with a sterile cap. The pharmacist shall label the syringe as stated above and place the pre-filled syringes into the freezer for storage.

(1) The Nurse shall thaw the syringe by leaving the syringe at room temperature. The thawed syringe is stable for eight (8) hours. (2) The syringe contents may be diluted with normal saline to a sufficient quantity to fill the lumen of the catheter in which it shall be used. VI. Reasons for Revision: CXLII. Changes in regulatory or statutory laws or standards CXLIII. System failures/ changes CXLIV. Institutional/operational changes Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

283

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: CH. 34 Subject: Management of the Pyxis® Medication Dispensing Cabinets NICHOLAS GALEOTA HELEN PRUSKI WILLIAM GERDES ____________________________ Distribution: Administrative Manual Page ____1__ of ____1__ Original Issue date: 9/19/00

Prepared by:

Reviewed by:

Approval Date: Supersedes:

10/10/06 1/2/02

Approved by:

CONSTANCE SHAMES, M.D.
_____________________________ _____________________________

Department Manual
Patient Care Manual AOD Manual

Issued by: P&T Committee ______________________________________________________________________________________ I.

Purpose:
To describe staff responsibilities and to provide guidelines relating to the operation of the Automated Medication Dispensing Machine.

II. Definition(s): Pharmacy and Nursing Services may use the Automated Dispensing Machine System (henceforth known as Station) as an administration and charging system for the following types of medications: 1) All Controlled Substances

2. Stat PAR level medications (medications required for first dose emergency administration)
3. First doses and missing doses 4. All floor stocks in the PYXIS

The existing manual of controlled substance cabinet will be operational for storage and usage of controlled substances that are not included in PYXIS.
III.

Policy:
The Department’s of Pharmacy and Nursing shall work co-operatively to maintain, operate, and manage the ® Pyxis medication dispensing cabinets

IV.

Responsibilities:
Pharmacist, pharmacy technicians, nursing, and physicians will have the responsibilities described below in the procedure and guidelines.

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i. Procedures/Guidelines:
AUTHORIZED ACCESS: 1. The Pharmacy department leadership establishes privileges for all non-temporary access (lasting > 1 day) codes. These ID’s will be entered and maintained by the appropriate Pharmacy System Manager. It is recommended that all passwords should be from 3 to 6 alphanumeric characters. The password may contain both letters and numbers and should not be the same as the user ID. Any user with access to the Station may change his/her password if needed. 2. All user ID’s will be issued with an initial temporary password. The user must immediately access the Station and follow the prompts to change the temporary password to a confidential, permanent password. Once the user has established his/her password, the user will be prompted at the station only to register his/her Biometric ID (finger print). The user will register his/her Biometric ID by scanning one finger four times. In the event that the Biometric ID system is down, the users will revert to using their passwords. 3. All requested additions, deletions or changes to permanent access ID’s must be (submitted in writing) and implemented by the Pharmacy System Manager, or his/her designee. If a nurse is discharged from UHB, a Unit Head Nurse, or their designee must notify (in writing) the Pharmacy system Manager within 24 hours of discharge so that their access privileges can be removed from the system. Periodic reports may also be printed out by Pharmacy System Manager, or his/her designee as a second check to remove past employees. 4. Short term Agency nurses, will be issued a temporary access ID and password by the Unit Head Nurse or his/her designee. This temporary ID and password shall expire 14 hours after issuing. The nurse shall follow the same procedure for registering his/her Biometric ID. Long term Agency nurses, will have permanent Station privileges: a. Station Login/Witness Function b. Access to Non-Controlled Substances c. Station System Report Access 5. All a. b. c. d. e. 6. Staff Nurses, Nurse Managers, and Charge Nurses have the following Station privileges: Station Login/Witness Function Access to Non-Controlled Substances Access to Controlled Substances Station System Report Access and Station Temporary User Privileges (This privilege is reserved to the nurse manager his/her designee)

Selected Physicians (Anesthesiologists) privileges: a. Station login/Witness Function b. Access to Non-Controlled Substances c. Access to Selected Controlled Substances d. Station System Report Access

MEDICATION REMOVAL FROM PYXIS 1. Medication is removed at the station by selecting the Remove Medications option on the main menu and following the instructions on the screen. 2. The nurse must verify the inventory count when removing selected medication from the Station. 3. Upon completion of each transaction, a transaction slip can be generated and printed at the Station. This slip is not a legal document. The nurse may use it for charting purposes or to verify a patient’s ID when giving the medication. This transaction slip can be discarded. 4. The MedStation is intended for STAT doses, first doses, missing doses, controlled substances, as-needed (PRN) doses and some floor stock medications. All orders shall be faxed to pharmacy for review. Before removal of medication from the MedStation, a pharmacist reviews all prescriptions or medication orders unless a) a licensed independent practitioner controls the ordering, preparation, and administration of the medication or

285

b) there is an urgent situation in which the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status (e.g., new onset of nausea). 5. For STAT orders, the nurse shall fax the medication order to the pharmacy for review. The nurse will then call the pharmacy for a verbal verification of the order. If the order is verified as correct and complete, the nurse will inform the pharmacist of the number of doses that will be taken from Pyxis (to prevent dispensing a duplicate doses). The pharmacist shall then process the order, note the number of doses the nurse plans to take, and provide subsequent doses of medication, if necessary. 6. For FIRST dose orders, the nurse shall fax the medication orders to pharmacy for review and processing. If the dose is urgently needed, the nurse shall follow the procedure for a STAT order. 7. Orders for PRN doses of medications shall also be faxed to the pharmacy for review. The nurse may then retrieve medications from Pyxis. If necessary, PRN medications shall be dispensed from the pharmacy. 8. Missing doses may be removed from Pyxis after review of medication orders by a pharmacist. However, the Pyxis cabinet should not be used for routine retrieval of missing doses of medication. 9. If a dose is missing after more than one nursing shift from the time the order was acknowledged by a nurse, the order should be faxed to the pharmacy. The nurse shall then call the pharmacist to review and process the order or to identify unresolved problems with the order (e.g., medication error, non-formulary medication, order not received in the pharmacy). 10. Orders for controlled substances shall be faxed to the pharmacy for review and profiling. The nurse may then retrieve controlled substances from the Pyxis. For controlled substances not stored in Pyxis, see procedure outlined under, “Obtaining Medications That Are Not in Pyxis.” OBTAINING MEDICATIONS THAT ARE NOT IN PYXIS 1. If a medication order is written for a controlled substance that is not available in PYXIS (after 4pm, weekend or holidays): a. Assistant Director of Nursing/designee places the order with the Pharmacy that indicates the unit, his/her name and title and name and title of RN picking up the order b. Drugs are picked up by RN with identification badge after presenting the physician order and completing the required Pharmacy records. c. The drugs and narcotic sheets are returned to the unit and secured according to policy: • Narcotics and controlled drugs are kept in a double locked cabinet at all times • The keys to the cabinet are never to be taken off the unit /are kept in the possession of a UHB licensed Registered Nurse (who has completed orientation at all time) • The Assistant Director of Nursing /designee on each shift assigns a Registered Nurse and a relief Registered Nurse responsibility for the narcotic keys • Controlled drugs are counted at the beginning of each tour by the off-going and on-coming assigned RN’s (12-hour shift-7a.m. and 7:30p.m., 8 hour shift-7:30am, 3:30pm., and 11:45 pm Mixed shifts-7:30am. and 7:30p.m.) • All nurses needing controlled drugs must confer with the RN assigned to carry keys. Removal and documentation is done in the presence of the assigned RN. • Wastage must be witnessed and countersigned by assigned RN • All controlled drug discrepancies are reported to the Assistant Director of Nursing and investigated immediately d. Completed narcotic sheets should be returned back to pharmacy immediately 2. If a medication order is written for a non-controlled substance that is not available in PYXIS, pharmacy will process the order and provide medication 3. Any additional medication (controlled or non-controlled) recommended for inclusion to the PYXIS machine by a Nursing supervisor or the Medical Director of the ED shall be referred (in writing) to the Pharmacy System Manager or his/her designee for implementation. ADMINISTRATION OF MEDICATIONS OBTAINED FROM PYXIS

286

1. Nurse will check orders and compare to Physician Order Sheet and Medication Records prior to administration 2. Administer Pharmacy approved medications after checking the following: a. Patient’s allergy history (MAR/PYXIS) b. Purpose/therapeutic action c. Dosage d. Side/adverse effects e. Method and frequency f. Storage e. Resource information (Micromedex, Lexi-Comp)

ENTERING PATIENT INFORMATION
1. The patient’s name should appear on the Station census list. This information is obtained via an interface with the UHB admission, discharge and transfer patient care system. 2. If the patient is in the unit but not listed on ADT, complete the following steps to add a new patient: a. Select Add Patient (This patient stays in the system 6 hours) b. Enter the patient’s last name, select Enter to go to the next field c. Enter the patient’s first name, select Enter to go to the next field d. Enter patient’s admission number 3. The patient ID field will automatically be assigned once the ADT has been received. After adding a new patient to the station, the nurse can access the patient’s account by selecting Remove Meds.

RETURNING MEDICATIONS
1. A narcotic medication removed from the station in its original package and not administered to the patient will be returned to the Station Return Bin. This allows the patient to be credited for the medication. To return the medication to the return bin, select the Procedures option on the Main Menu and select the Return option. Follow the instructions on the screen return the medication. Two nurses will be required to witness and to document the return of a controlled substance 2. An unscheduled medication removed from the Station in its original package and not administered to the patient will be returned to Station Return Bin. This allows the patient to be credited for the medication. To return the medication, select the Procedures option on the Main Menu and select the Return option. Follow the instructions on the screen to return the medication. 3. If the medication package is not intact and an un-used controlled substance for example in tubex form follow the procedure below (WASTING MEDICATIONS) for wasting medications. 4. Items too large to fit in the Pyxis internal Return Bin will be placed in the external bins picked up by pharmacy personnel. If the return is a narcotic, it should be credited by the patient’s name in the Pyxis and returned to existing manual controlled substance cabinet. Two nurses will be required to witness and document return of controlled substances. WASTING MEDICATIONS 1. Medication wastes are defined as all or part of a medication that is not in its original sealed package and not administered to a patient as well as un-used controlled substances. 2. If all or part of a controlled substance originally taken from the Station has been wasted, it will be documented at the Station by using the Waste option under Procedures. Two nurses will be required to witness and document waste of controlled substances. 3. Any part of wasted controlled substance can be documented at the time of removal from Pyxis, or after the administration within 32 hours of transaction when patient entered via hospital admission or 6 hours if entered manually NARCOTIC INVENTORY

287

1. Controlled drugs are counted at the beginning of tour II by the off-going and on-coming assigned RN’s Mondays, Wednesdays, and Fridays. 2. All controlled substance access will require mandatory blind count 3. If discrepancy is discovered, follow UHB policy on discrepancies

DISCREPANCIES
1. When the user’s entered count of medication at the Station differs from the displayed count for that medication, a discrepancy exists. All narcotic (meds classified as II through V) discrepancies are logged and can be printed out at the Station. All stock medication discrepancies are logged, but are then automatically resolved and sent to the Console. Unresolved narcotic discrepancy information remains on the Station for seven days. 2. Any narcotic discrepancy discovered should be reported immediately to the nurse in charge. 3. To ensure controlled substance discrepancies are resolved not later than at the end of each shift, the charge nurse must print a discrepancy report. The charge nurse should notify all staff involved of any unresolved discrepancies. The procedure for printing a discrepancy report is: a. Select Report Menu from the Screen. b. Select Discrepancies to print the report 4. A narcotic discrepancy should be resolved at the time of discovery or at the change of shift. A narcotic discrepancy is resolved between the user changing the count and the user with previous access. The charge nurse must print a discrepancy report at the end of each shift 5. Once resolution is established, the involved users will use the Resolve Discrepancy function from the Procedures menu to attach an electronic explanation for the discrepancy. The procedure for resolving discrepancies on the PYXIS is as follows: a. Select Procedures b. Select Resolve Discrepancy c. Advance page to the discrepancy of the perspective nurses involved d. Select the appropriate response from predefined list of resolutions if none of the reasons are appropriate, select other and type in the reason for the discrepancy, a witness is necessary to document resolution of the discrepancy, the witness will be prompted to enter user ID 6. If the discrepancy cannot be resolved, The Unit Head Nurse must be informed. The Charge Nurse should notify all staff involved of any unresolved discrepancies. A University Hospital Brooklyn Patient Incident Report (UH-025) will be filled out. The referral carbon copy shall be forwarded to Pharmacy. 7. Pharmacy will review the Discrepancy Report for valid explanations and any discrepancies that may need further investigation. Pharmacy will follow-up with the Unit Head Nurse.

DOCUMENTATION
1. Electronic signature authorization has been approved by the State of New York. At the end of each shift it is recommended that each nurse print an “Activity Report” and review it for verification of all activity during his/her shift, to ensure accurate documentation. 2. To print the controlled substance Activity Report the nurse should: a. Enter his/her ID and the Biometric ID in PYXIS b. Choose Reports Menu c. Choose My Activities d. Press Next button until All Classes is highlighted e. Choose print report 3. Discrepancies should be resolved as soon as they are discovered. In the event an unresolved discrepancy is discovered during production of an activity report, the nurse should notify the Charge Nurse and resolve the discrepancy.

288

STOCK REPLENISHMENT 1. The Pharmacy will be responsible for maintaining adequate inventory of all medications in the Station. 2. Inventory levels will be checked periodically. Pharmacy staff will refill the medications that are recorded as low inventory. 3. Pharmacy personnel will empty the return bin. 4. The Pharmacy personnel will replenish the controlled substance stock. A nurse and pharmacy personnel will do inventory on refilled controlled medications. 5. Pharmacist will verify Narcotic quantity removed from main pharmacy safe vs. what is refilled into Pyxis on Nursing Stations. STOCK AND INVENTORY LEVEL CHANGE 1. Any change to the stock or inventory levels will be requested in writing by the unit head nurse and discussed with the Pharmacy System Manager. EMPTYING THE RETURN BIN 1. Pharmacy personnel are responsible for emptying the return bin. PROBLEM-SOLVING 1. If a problem arises that requires manual opening of MedStation in the back, an access key will be in the possession of the Pharmacy System Manager or his or her designee. If the problem cannot be resolved by referring to the Station Reference Guide the nurse may call the PYXIS 800 service number found on the Station for additional assistance. POWER OUTAGE/EMERGENCY PROCEDURES 1. The station is plugged into the emergency power system and should remain operational 2. If it becomes necessary to manually open the Station for medication access, the Pharmacist System Manager or his/her designee will be notified. The Pharmacist System Manager or his/her designee will have access to the keys. If it is necessary to have a Pyxis service representative available to repair the Station, a pharmacist or Pharmacy personnel will remain with the repair person at the Station at all times. 3. PYXIS will be called in the event of a software or hardware problem and will plan and coordinate the resolution to the problem. Pharmacy will make this call if the Pharmacy is unable to resolve the issue at the Console. Nursing may also call if it appears to be hardware issue or a localized problem, but they should notify the Pharmacist System Manager or his/her designee of the call. 4. In the event a controlled substance cannot be added to the PYXIS it should be placed in the controlled substance cabinet on the unit and inventoried by manual system. The Pharmacist System Manager or his/her designee will “Load” the new medication to the station as soon as the power outage/emergency is resolved.

289

REPORTS 1. The Unit Head Nurse may request special reports from the Pharmacy manager. Examples of these reports are: a. Medication Removal-generates a report on the activities that have occurred for a specified medication beyond 32 hours b. Activities by Nurse- generates a report on the activities that a specific nurse has done beyond 32 hours c. Activities by Witness-- generates a report on the activities of a specific witness has done beyond 32 hours d. Discrepancies –generates report on any discrepancies that have occurred. Discrepancies can be printed on the unit for 1 month period 2. The Station will store information for 32 hours. The Console will store information for 31 days. All data is archived to a disk 3. Pharmacy will generate and distribute to Nursing Units “User modification Report- an effective security assurance tool, ensures that all temporary users added were appropriate. 4. Pharmacy generates monthly report on: a. Control Substance wastage variance b. Medication error summary report c. Monitoring Medication Safety in Dispensing with prompts to alert to potential problems d. Outdate inventory report to verify that all controlled drugs that were outdated were logged (witness signature necessary) in a binder MAINTENACE OF REMOTE REFRIGERATION MONITORS 1. Refrigerator temperature is monitored by Smart Remote Managers (SRM) and has a LED readout outside the refrigerator on the Nursing units that interfaces with the PYXIS console. The temperatures are set in Fahrenheit measurement and each device is tested for accuracy on monthly basis using infrared thermometer. 2. The temperature is maintained @ 36 F -46 F 3. If temperature falls outside the range, “Temperature out of range” icon appears on the MedStation, Nursing will notify FM&D for repair and Main Pharmacy for relocation of medication for the period of repairs. 4. The Main Pharmacy will get a remote notification “Temperature Warning” for out of range readings and will notify Nursing units affected. 5. Main Pharmacy will get an automatic printout of the daily status of all refrigerators including interventions implemented to correct malfunction 6. Nursing document in the temperature log sheet every shift I. Reasons for Revision: CXLV. Changes in regulatory or statutory laws or standards CXLVI. System failures/ changes CXLVII. Institutional/operational changes III. IV. Attachments: none References: none
0 0

290

Date Reviewed

Revision Yes Yes Yes Yes

9/06 10/8/07

Required (Circle One) No No No No

Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH HELEN PRUSKI, RPH LilyAnn Jeu, PharmD, BCPS Helen Pruski, RPh Nicholas Galeota, MS, RPh NICHOLAS GALEOTA MS, RPH

291

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: ___CH. 35 Subject: High-Risk Electrolyte Injections Prepared by: NICHOLAS GALEOTA Reviewed by: WILLIAM GERDES Page ____1__ of ____2__ Original Issue date: 9/11/01

Implementation Date: __NEW__

Approved by: CONSTANCE SHAMES, M.D.

Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

______________________________________________________________________________________ I. Purpose: Direct administration of undiluted parenteral potassium chloride can cause severe hyperkalemia and possibly death. The JCAHO considers the use of concentrated KCL as a potential sentinel event and suggest that “Health care organizations NOT make concentrated KCL available outside the pharmacy unless appropriate specific safeguards are in place.” This position has been extended to all parenteral electrolyte preparations. Definition(s): N/A Policy: Concentrated KCL vials and other high-risk electrolytes will no longer be dispensed and all vials of Concentrated KCL will be removed from all patient care areas. All orders for potassium chloride solutions or other high risk electrolyte solutions will be dispensed as pre-mixed IV solutions by the Department of Pharmacy services. Pre-mixed KCL IV solutions (large volumes and K-riders) will not be stocked on the floor, and will only be dispensed when a prescription is written for a patient. Exceptions are the critical care units where pre-mixed KCL IV solutions (large volumes) will be available as a floor-stock. Responsibilities: It is the responsibility of a pharmacist to provide a ready-to-use diluted dosage form to a Nurse of any and all high risk electrolytes Procedures/Guidelines: (A) All orders for parenteral potassium/or other electrolyte must include the following: 1. 2. 3. 4. 5. (B) Amount of drug per L in mEq’s Name of Base Solution Volume of Base Solution Infusion rate in mEq/hr Number of doses desired

II. III.

IV. V.

No standing orders for Intermittent Infusion of KCL will be accepted.

(C ) An EKG rhythm strip should be taken pre and post administration of an intermittent infusion of KCL. EKG telemetry monitoring is required

292

(D) If multiple intermittent infusions of KCL are required, the physician should indicate this by writing “X ____ doses’ (E) Volume controllers should be used on all patients receiving K solutions or other electrolytes.

(F) The recommended maximum rate of administration of Potassium Chloride Solutions in Adults on continuous EKG monitoring is: • 10mEq/hr in patients with a serum K>3 • 20mEq/hr in patients with a serum K<3 • 40 mEq/hr in patients only with life-threatening arrhythmias, or respiratory failure. (G) Infusions of potassium chloride should be discontinued when the serum level of potassium is 3.5 or greater. (H) The infusion of multiple simultaneous KCl solutions are not permitted (e.g, IV KCL being infused at the same time as TPN). (I) Orders for intermittent infusion of KCL (IV Piggy Back) are most expeditiously dispensed when ordered for one of the following commercially available solutions: KCL 10mEq in 100ml Sterile water for infusion KCL 20mEq in 100ml Sterile water for infusion KCL 40mEq in 100ml Sterile water for infusion (J) Orders for large volume parenteral (LVP’s) potassium chloride solutions or other electrolyte will be dispensed by the Department of Pharmacy services – using whatever possible commercially available Pre-mixed solutions. The recommended maximum concentration of potassium chloride in a large volume solution in 40mEq/L. (K) (L) No additional additives will be made to any Pre-Mixed solutions.

Pediatric Patients. The Pharmacy staff will prepare all potassium or other electrolyte solutions for patients in these areas. VI. Reasons for Revision: CXLVIII. Changes in regulatory or statutory laws or standards CXLIX. System failures/ changes CL. Institutional/operational changes CLI. Attachments: none References: none Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title NICHOLAS GALEOTA MS, RPH NICHOLAS GALEOTA MS, RPH

VII. VIII.

Date Reviewed 12/21/04 10/8/07

293

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: Therapeutic Interchange Policy Prepared by: Alan Hui, Pharm.D. No: Chapter 36 Section: _______ Original Issue Date: 7/12/05 Implementation Date: 9/1/05 Supersedes date: 3/06 Distribution:  Administrative Manual  Departmental Manual  Patient Care Manual  AOD Manual Issued by: Pharmacy and Therapeutics Committee I. Purpose: To provide safety, improve cost-effectiveness, facilitate medication delivery, and streamline the medication formulary at SUNY Downstate Medical Center. II. Definitions: Therapeutic interchange is the automatic substitution of therapeutically equivalent drugs as determined by the Pharmacy and Therapeutics (P&T) Committee. Agents must demonstrate therapeutically equivalent efficacy to be approved for substitution. Agents are only substituted during the patient’s inpatient hospital stay. III. Policy: The Pharmacy and Therapeutics Committee will determine the agent(s) of certain class of drugs to be on the medication formulary at SUNY Downstate Medical Center. In appropriate situations, therapeutic interchange will occur for non-formulary medications and will be substituted with the formulary agent of its class at therapeutically equivalent doses based on the procedures below. Drug classes that will participate in the therapeutic interchange policy are as follows: a. Insulin Products b. Proton Pump Inhibitors c. HMG CoA Reductase Inhibitors (Statins) d. Angiotensin Converting Enzyme (ACE) Inhibitors e. Ophthalmic Products IV. Responsibility: It is the responsibility of the pharmacist to interchange non-formulary medications for therapeutically equivalent dose of the formulary agent, fill out the therapeutic substitution sticker correctly, properly label and dispense the therapeutically equivalent agent. It is the responsibility of the nurse to acknowledge the therapeutic interchange, place the completed therapeutic interchange sticker on the medical chart, and administer the substituted formulary medication. Physicians will be notified upon daily review of patients’ medical chart.

Reviewed by: Nicholas Galeota, MS, Rph Approved by: Constance Shames, MD William Gerdes

V.

Procedure/Guidelines:

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1. When a nurse obtains a complete and legible order for a non-formulary medication that is in the therapeutic interchange program, the nurse shall accept the medication order and send it to the pharmacy for prescription processing. The nurse will also transcribe the medication order to the Medication Administration Record (MAR). 2. Upon receiving an order for a non-formulary medication to be substituted, the pharmacist will review the patient profile and ensure no contraindications to the medication substituted exist. The pharmacist will use the therapeutic dosage conversion chart for each P&T approved drug class to initiate the therapeutic interchange policy. 3. The pharmacist will fill out and sign a Therapeutic Interchange/Clarification Alert sticker indicating that the prescribed non-formulary medication has been substituted for the formulary agent at the therapeutic equivalent dose determined by the P&T Committee. 4. The pharmacist must document in the pharmacy computer system that a therapeutic interchange has occurred indicating the originally prescribed agent, dose, route, and duration and the newly substituted agent, dose, route, and duration. 5. The Therapeutic Interchange/Clarification Alert sticker will be sent along with the first dose of the formulary agent to the corresponding nurse who will place it in the Progress Notes section of the patient chart. This sticker will serve as a notification to the medical team of the therapeutic interchange. 6. When the therapeutic interchange sticker is sent from pharmacy with the first dose of the newly substituted agent, the nurse shall update the MAR to reflect that the order for the non-formulary item has been substituted with an order for the newly substituted item and sign the alert to acknowledge that the MAR has been updated. The newly substituted drug order will be added to the end of the list of medication orders. 7. At the time of administration of the first dose of the newly substituted medication, the nurse will attempt to inform the patient of the therapeutic interchange and identify the medication by name and dose. In the event that the patient reports lack of efficacy with, intolerability to, or a previously undocumented allergy to the newly substituted medication, the nurse will notify the prescriber of this information. If necessary, the prescriber may discontinue the order for the newly substituted medication and pursue the non-formulary process with a clear and complete request indicating the reason that the non-formulary medication is being requested instead of the formulary agent. 8. A request from a prescriber for a particular product for a specific patient will be honored. The prescriber may write “Do Not Substitute” on the order to prevent the initiation of the substitution process. A nonformulary request form should also be completed prior to dispensing the non-formulary medication. The P&T Committee will track these requests. 9. When a prescriber writes a complete and legible order for a combination medication that is not available on the formulary as a combination product, but the components of the products are available, pharmacy shall dispense the components of the combination product or drugs that can be substituted for one or more components based on the approved therapeutic interchange policy. 10. Dosage form interchange will be indicated on the Therapeutic Interchange/Clarification Alert by the pharmacist completing the sticker. 11. The Order Duration Clarification alert shall be used when the duration of a written order for a restricted medication (e.g., restricted antimicrobial) conflicts with the approved duration relayed to pharmacy personnel. In the event of conflicting duration of treatment on the order, the pharmacist shall complete the Therapeutic Interchange/Clarification Alert sticker with the approved duration provided by the authorizing service (e.g., Infectious Disease Fellow) and send the alert to the nurse with the first dose of the medication. 12. The nurse will follow the same procedure as outlined above for updating the MAR and alerting the patient as to the nature of the interchange for both the dosage form interchange and order duration clarification. The MAR will be updated accordingly to reflect the names of the substituted components or the new duration on the medication order, respectively.

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Appendix A. Therapeutic Interchange for Insulin Products
INSULIN TY PE Rapid Acting LIS PRO* ASPART* Short Acting REGULAR Intermediate Acting NPH LENTE Long Acting ULTRA-LENTE Mixed Insulins NPH 70% and Regular Insulin 30% Humulin U (No Subsitution)
®

Lilly™ Brand

NOVO Nordisk™ Brand

Onset

Peak

Duration

Route

Time (AC)

Humalog >>>> >>>>Novolog
®

®

10-15 min 10-15 min
®

½ - 1.5 hour 1-3 hours

3-4 hours 3-5 hours

IV or Sub-Q Sub-Q IV or Sub-Q Sub-Q Sub-Q

5-15 min 5-10 min

Humulin R >>>>Novolin R

®

½-1 hour 4-12 hours 7-15 hours 10-24 hours

2-4 hours 4-12 hours 7-15 hours 10-24 hours

8-12 hours

30-60 min

Humulin N >>>>Novolin N
®

®

®

24 hours 24 hours

30-60 min 30-60 min

Humulin L (No Subsitution)

36 hours

Sub-Q

30-60 min

Humulin >>>>>Novolin ® ® 70/30 70/30

½-1 hour

2-12 hours

16-24 hours

Sub-Q

30-60 min

Formulary Oral Agent Lansoprazole (Prevacid®) Dose to be substituted 15 mg 30 mg 45 mg 60 mg 75 mg 90 mg

Non-Formulary Oral Agents Pantoprazole (Protonix®) Dose prescribed 40 mg Esomeprazole (Nexium®) Dose prescribed 20 mg Omeprazole (Prilosec®) Dose prescribed 10 mg 20 mg 30 mg 80 mg 40 mg 40 mg 50 mg 120 mg 60 mg 60 mg 60 mg 40 mg 20 mg Rabeprazole (Aciphex®) Dose prescribed

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Appendix B. Therapeutic Interchange for Proton Pump Inhibitors Intravenous PPI Therapeutic Conversion
Formulary IV Agent Lansoprazole (Prevacid) Dose to be substituted 30 mg GI Bleed*: 60 mg IV bolus, then continuous infusion at 6 mg/hr** Non-Formulary IV Agent Pantoprazole (Protonix) Dose prescribed 40 mg GI Bleed*: 80 mg IV bolus, then continuous infusion at 8 mg/hr

*Continuous infusion of PPI for active GI bleeding is not a FDA indication. **Mixed 60 mg of lansoprazole IV in 100 mL of normal saline or D5W and infuse over 1 hour for the initial bolus. A second admixture of 60 mg of lansoprazole IV in 100 mL should be prepared and infused at 6 mg/hr (10 mL/hr).

Formulary Agent Atorvastatin (Lipitor®) Dose to be substituted ------10 mg 20 mg 40 mg 80 mg Simvastatin (Zocor®) Dose prescribed 5 mg 10 mg 20 mg 40 mg 80 mg Fluvastatin (Lescol®) Dose prescribed 20 mg 40 mg 80 mg

Non-Formulary Agents Lovastatin (Mevacor®) Dose prescribed 10 mg 20 mg 40 mg 80 mg Pravastain (Pravachol®) Dose prescribed 10 mg 20 mg 40 mg 5 mg 10 mg 20 mg 40 mg

Rosuvastatin
(Crestor®) Dose prescribed

Append ix C. Therape utic Intercha nge of HMG CoA Reducta se Inhibito rs

Note: There are no therapeutically equivalent doses of atorvastatin for simvastatin 5 mg and 10 mg, fluvastatin 20 mg and 40 mg, lovastatin 10 mg and 20 mg, and

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Appendix D. Therapeutic Interchange of ACE Inihibitors Formulary Oral Agent Enalapril (Vasotec®) Benazepril Fosinopril (Lotensin®) (Monopril®) Lisinopril (Prinivil®, Zestril®) Non-Formulary Oral Agents Moexipril (Univasc®) Perindopril (Aceon®) Quinapril (Accupril®) Ramipril (Altace®) Trandolapril (Mavik®)

Dosage Conversion 5 mg/day 10 mg/day (2 divided doses) 20 mg/day (2 divided doses) 40 mg/day (2 divided doses) 5 mg/day 10 mg/day 20 mg/day 40 mg/day 5 mg/day 10 mg/day 20 mg/day 40 mg/day 5 mg/day 10 mg/day 20 mg/day 40 mg/day 3.75 mg/day 7.5 mg/day 15 mg/day 30 mg/day 2 mg/day 4 mg/day 8 mg/day 16 mg/day 5 mg/day 10 mg/day 20 mg/day 40 mg/day 1.25 mg/day 2.5 mg/day 5 mg/day 10-20 mg/day 1 mg/day 2 mg/day 4 mg/day 8 mg/day

Captopril (Capoten®) will remain as a formulary agent since it is the sole ACE-Inhibitor classified as a short-acting agent. Therefore, no agents will be automatically substituted for captopril.

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Appendix E. Therapeutic Interchange of Ophthalmic Medications Non-formulary Medication Nefpafenac 0.1% (Nevanac®) or Diclofenac 0.1% (Voltaren®) Loteprednol 0.5% (Lotemax®) or Loteprednol 0.2% (Alrex®) Brimonidine 0.15% (AlphaganP®) Levobunolol 0.25% or 0.5% Bimatoprost 0.03% (Lumigan®) or Latanoprost 0.005% (Xalatan®) Ofloxacin 0.3% (Ocuflox®) or Ciprofloxacin 0.3% (Ciloxan®) or Gatifloxacin 0.3% (Zymar®) Non-formulary Medication Dose 1 drop in affected eye TID 1 drop in affected eye QID 1 drop in affected eye QID 1 drop in affected eye TID 1 drop in affected eye BID 1 drop in affected eye HS variable Formulary Alternative Ketorlac 0.5% (Acular®) [If unavailable, may give ketorlac LS 0.4% (Acular LS®)] Fluorometholone suspension 0.1% Brimonidine 0.2% (Alphagan®) Timolol 0.25% or 0.5%, respectively Travatan 0.04% (Travoprost®) Moxifloxacin 0.5% (Vigamox®) Dorzolamide (Trusopt®) 2% AND Timolol 0.5% (2 separate orders) Formulary Medication Dose 1 drop in affected eye QID 1 drop in affected eye QID 1 drop in affected eye TID 1 drop in affected eye BID 1 drop in affected eye HS 1 drop in affected eye TID

Dorzolamide 2% at 1 drop in Dorzolamide 2%/Timolol 0.5% affected eye BID and timolol 1 drop in affected eye BID (Cosopt®) 0.5% at 1 drop in affected eye BID Note: If a different dosing schedule is desired for formulary medications, the prescriber must write an order for the formulary medication with that dosing schedule.

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IV.    VIII. VIII.

Reason for Revisions: Changes in regulatory or statutory laws or standards System failures/changes Institutional/operational changes Attachements: References: None Revision Required (Circle One) Yes No Yes No Yes No Yes Yes Yes No No No Responsible Staff Name and Title Alan Hui, Pharm.D. Nicholas Galeota, MS, RPh LilyAnn Jeu, Pharm.D., BCPS Nicholas Galeota, MS, RPh LilyAnn Jeu, Pharm.D., BCPS Alan Hui, Pharm.D. Nicholas Galeota, MS, RPh

Date Reviewed 9/1/05 9/1/05 3/1/06 6/13/06 10/8/07

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SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: CH 37 Subject MEDICATION RECONCILIATION Page __1___ of __3__ Original Issue Date: 1/1/06

Prepared by: LilyAnn Jeu, Pharm.D. Maureen Green, RN, Ed.M Muhammad Islam, MS, MCH Reviewed by: Nicholas Galeota, M.S., R.Ph.____ Diane Woods, RN_____________ Constance Shames, M.D. _____

Supersedes: Effective Date:

2/06 5/06

JCAHO Standards: Distribution:  Administrative Manual Approved by: Margaret Jackson, RN, MA______ David Conley, MBA_____________ Michael Lucchesi, M.D._________ Issued by: Debra D. Carey, MS___________ I. PURPOSE To establish the policy and procedure for obtaining, documenting and reconciling patients’ medication orders accurately and completely upon hospital admission and with each change in setting, provider, or level of care across the continuum of care and when new medication orders are written. POLICY For all patients admitted to UHB, a list of medications the patient was taking at home at the time of admission shall be collected within 24 hours of admission and documented on the hospital-wide “Medication Reconciliation Form.” This list will be used for reconciliation of admission medication orders. Upon transfer between services or levels of care, medication orders written following the transfer shall be reconciled against medication orders active at the time of transfer. Upon discharge from the hospital, the discharging physician must provide a list of medications the patient will continue to take as a reference for the patient and next medical provider. Upon patient entry to an ambulatory setting of the institution, medication reconciliation will be conducted. At subsequent visits, medications will be reviewed and an updated “Medication Regulatory Affairs  Department Manual  Patient Care Manual  AOD Manual

II.

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Flow Sheet” will be maintained in clinics and made available to patients. An updated list will be provided to the patient only if there is a change. When a patient is unable to actively or fully participate in the medication reconciliation process, authorized person(s) will be involved in the reconciliation process (e.g. family member, significant other, surrogate decision maker). III. DEFINITION(S) “Reconciling medications” is a systematic process that develops an accurate, up-to-date medication list for patients at admission, and then compares that list against the physician’s admission orders. Discrepancies are brought to the attention of the physician and, if appropriate, changes are made to the orders. Any resulting changes in orders are documented. The process is designed to promote communication and information transfer at patient handoffs, a well-known opportunity for error. “Medications” shall refer to drugs including, but not limited to, oral prescription and over-the counter medications, parenteral medications, vitamins, nutriceuticals, herbal remedies, and intravenous solutions (with and without additives). IV. Responsibilities The active admission medication list for medications the patient was taking at the time of admission may be compiled by a nurse, physician or other licensed prescriber, or pharmacist. The prescriber reconciles the medication orders collected upon admission, transfer and discharge.

V.

Objectives Reduce errors of omission, duplications in therapy and potential adverse drug reactions. 1) Provide accurate and complete medication list across continuum of care. 2) Improve communication between providers regarding medication history and course of treatment at different stages of hospitalization. 3) Involve the patient (and/or patient caregivers) in the process of documenting and reconciling medication orders. PROCEDURE/GUIDELINES HOSPITALIZED PATIENTS Admission: In the Emergency Department (ED), the first clinician to interview the patient should initiate the medication reconciliation process by obtaining a list of active home medications taken prior to admission. The name, dose, route, and frequency of each medication listed shall be recorded in the electronic charting system, “T-system”, in the ED. If the patient is unable to recall his/her medications, other sources of information shall be consulted (e.g., caregiver recall, patient’s pharmacy, patient’s primary care provider). For patients who are treated and discharged directly from the ED (“treat and release patients”), an ED clinician shall document discharge medications in the medication reconciliation section of the T-system. A printed hard copy of the discharge medications will be generated and given to the patients at discharge from the ED. For patients that are admitted from the ED, the “Home Medication Reconciliation List” shall be completed and signed by the admitting service. The admitting service will be granted access to view the home medication list in the T-system and a hard copy of the electronic patient chart, which includes home medication list, will be printed to remain permanently in the physical medical chart.

VI.

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All medications shall be listed on one form for the same patient. If additional pages are needed, indicate at the bottom of the page. If a second nurse, prescriber or other health-care provider identifies additional medications during his or her review of medications, the Home Medication Reconciliation List shall be updated, as appropriate. Additional medications shall be recorded on the same list. Clinicians involved in interviewing the patient and obtaining the medication list must sign and print his/her name at the bottom of the Home Medication Reconciliation List. After admission, the ordering prescriber must review the home medication list and choose to continue or discontinue each medication. All medication orders must be reconciled within 24 hours of admission. Nursing staff shall fax/send a copy of the reconciled (completed and signed) Home Medication Reconciliation List to the Department of Pharmacy Services with the admitting medication orders for the patient. If the Home Medication Reconciliation List is not received, admitting orders cannot be processed and medications cannot be dispensed. The pharmacist shall page the attending on record to request a completed and signed copy of the Home Medication Reconciliation List. The Home Medication Reconciliation List shall be placed in the Physicians Orders section of the chart. Clerical staff shall be instructed that this form must remain in the patient’s medical record throughout the hospitalization (i.e., not removed in the event the chart must be thinned out). The nurse shall write on the Nursing Data Base “See Medication Reconciliation Form.” Transfer: Medication reconciliation is required with any change in level or care or change in service. As per the policy “Patient Medication Orders,” medication orders from the previous service or level of care are discontinued upon transfer and new medication orders shall be written by the prescriber of the receiving service. To comply with the medication reconciliation requirement, the prescriber shall review the admission home medication list and list of active medication orders for medications the patient was taking at the time of transfer (which is available in the Medication Administration Record [MAR]). The MAR should be consulted for the time and date of administration of the last dose of each medication. Discharge: Upon patient discharge, the discharging prescriber shall review admission home medication list and list of active medication orders for medications the patient was taking at the time of discharge and agree upon medications to continue after discharge, as part of the medication reconciliation process. The prescriber shall then list the medications the patient should continue after discharge in the designated area on the Home Medication Reconciliation List. The original list should be attached to the rest of the Discharge Summary and kept in the medical record. One copy of the Home Medication Reconciliation List shall be attached to the patient’s copy of the Discharge Summary. The patient shall be encouraged to bring the list to the next appointment with the patient’s provider of follow-up care. If the next provider of care is known, a copy of the Home Medication Reconciliation List shall also be provided to the next provider of care. AMBULATORY CARE PATIENTS Initial Visit: Upon initial presentation to an ambulatory setting in which medication reconciliation must take place, a Medication Reconciliation Form will be completed for each

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patient and filed in the clinic chart. The Medication Reconciliation Form will replace the medication section on the “Adult Ambulatory Care Summary” (Form UH-286-98), where applicable. The patient should be interviewed and involved in obtaining the list of medications for medications the patient had been taking prior to entry in the clinic or office-based setting. As part of the clinic or office records, starting with the first patient visit, a Medication Flow Sheet will be completed for each patient. The Medication Flow Sheet shall serve as a record of the medications that the patient is taking. An original copy of the Medication Flow Sheet remains in the clinic file, while a copy of the Medication Flow Sheet should be provided to the patient at the end of the initial visit. For providers who are not part of the clinic but who are currently participating in the care of the patient, a copy of the Medication Flow Sheet should be provided when the provider is known. The patient should be encouraged to keep a copy of this list in his/her wallet or to at least bring the list to each clinic appointment. Follow-up Visits: The Medication Flow Sheet shall be reviewed at each subsequent visit and updated accordingly. A copy of the updated list, reflecting changes in the medication regimen, shall be provided to the patient at the end of the visit. The original copy of the Medication Flow Sheet will be continually updated and filed in the clinic chart. A copy of the Medication Reconciliation Form and the Medication Flow Sheet shall be provided to the next provider with any change in service, setting, or provider. Outpatient Procedure Visits: In outpatient encounters in which systemically administered medications may be administered or prescribed, a Medication Reconciliation Form must be completed upon the patient’s presentation. A Medication Flow Sheet should be completed at the end of the encounter if there was initiation, modification, or discontinuation of medications. If medications were initiated and/or administered during this outpatient encounter and should not be continued, the initiation and discontinuation dates should be clearly recorded on the Medication Flow Sheet and the patient should be counseled about such changes. The patient should be provided an updated copy of the Medication Flow Sheet. This reconciliation process shall apply if intravenous contrast agents may be administered, conscious sedation may be used, or if other medications may be administered during the encounter. In brief outpatient encounters in which there appears to be minimal medication use, a Medication Reconciliation Form must be completed upon the patient’s presentation, even though few medications may be administered in these encounters. In these situations, the Medication Reconciliation Form can facilitate the review of medications and review of history of allergies and past sensitivities. Prescribers shall use the medication reconciliation process to screen for potential drug interactions or contraindications between medications to be administered in the brief encounter and medications taken on a regular basis. In these encounters with minimal medication use, a Medication Flow Sheet is not required if ALL of the following conditions apply: a. “Minimal medication use” is in the context of a brief outpatient encounter.

304

b. Medications administered in the encounter act locally with negligible systemic effects (e.g., minimally absorbed topical agents, topical fluoride dental treatment, nonabsorbable enteric (oral or rectal) contrast agents c. Medications are administered under the direct control of a licensed independent practitioner d. No other medications are used during the encounter e. No new medications are prescribed for or provided to the patient for use after discharge f. There are no changes to the patient’s “current medications” g. Any provider of care to whom the patient is being referred already has the patient’s current medication information. STAFF EDUCATION UHB will provide orientation and ongoing education on procedures for reconciling medications to all health care providers. VII. VIII. Attachments: Medication Reconciliation Form Medication Flow Sheet References: JCAHO 2007 National Patient Safety Goal 8 FAQs for the 2007 National Patient Safety Goals (updated 1/07). Accessed on 5/11/07 from the following web site: www.jointcommission.org Revision Yes Yes Yes Yes Yes Yes Yes Required (Circle One) Responsible Staff Name and Title Nicholas Galeota, M.S., R.Ph. Diane Woods, R.N. Constance Shames, M.D. LilyAnn Jeu, Pharm.D. Adeola O. Dabiri, MBA, MPA LilyAnn Jeu, PharmD Pharmacy & Therapeutics Committee Alan Hui, PharmD Pharmacy & Therapeutics Committee

Date Reviewed 12/27/05 12/27/05 3/14/06 5/9/06 5/24/06 6/12/07 11/7/07

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Patient Name: MRN:

HOME MEDICATION RECONCILIATION LIST
FORM MUST BE FAXED TO PHARMACY WITH ADMITTING ORDERS. Check the following, if applicable:  No home medications.  Medication list not available at time of admission.  Only partial list available at time of admission. Documented by: ___________________________ Date: ___________ PATIENT PHARMACY AND PHONE NUMBER:

ADMISSION HOME MEDICATION LIST
Admitting prescriber must indicate whether home medications should be continued or discontinued within 24 hours of admission. If additional space is needed, please use second copy of Home Medication List.

Continue on Admission? Y (yes) or N (no)

Resume at Discharge? Y (yes) or N (no)

Drug Name
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Dose, Route, Frequency

Indication

Last Dose Date Time

Recorded Date Initials Y Y Y Y Y Y Y Y Y Y Y Y N N N N N N N N N N N N Y Y Y Y Y Y Y Y Y Y Y Y N N N N N N N N N N N N

Recorded by: __________________________________________________________ RN / LPN / MD / PA / NP /RPh / _____ Medications reviewed on admission by: ______________________________________ MD / PA / NP / _____ Additions/Corrections by: _________________________________________________ RN / LPN / MD / PA / NP / RPh / _____

Date: ___________ Date: ___________ Date: ___________

DISCHARGE HOME MEDICATION LIST (To be completed upon patient discharge.)
Discharge prescriber reviews Admission Home Medication List and current orders in MAR prior to writing prescriptions at discharge. Indicate above whether admission home medications will be continued and list all medications patient should take upon discharge below.

Instructions for the Patient:

Drug Name

 Take the medications listed below after you leave the hospital.  Bring a copy of this list with you to your next doctor’s appointment. /Dose / Route / Frequency / Duration if necessary. (Use Patient Language).

Medications reviewed on discharge by: ______________________________________ MD / PA / NP / _____

Date: ___________

306

Signature of Translator (if applicable): _______________________________________ MD / RN / PA / NP / _____

Language: __________



Check here if multiple forms needed. Please indicate: Page ____ of ____.
Chart Copy: White Patient Copy: Yellow Provider Copy: Pink

PLACE LIST IN PHYSICIAN’S ORDERS SECTION OF CHART. ATTACH TO DISCHARGE SUMMARY UPON DISCHARGE.

307

Patient Name: MRN:

HOME MEDICATION RECONCILIATION LIST
FORM MUST BE FAXED TO PHARMACY WITH ADMITTING ORDERS. Check the following, if applicable:  No home medications.  Medication list not available at time of admission.  Only partial list available at time of admission. Documented by: ___________________________ Date: ___________ PATIENT PHARMACY AND PHONE NUMBER:

ADMISSION HOME MEDICATION LIST
Admitting prescriber must indicate whether home medications should be continued or discontinued within 24 hours of admission. If additional space is needed, please use second copy of Home Medication List.

Continue on Admission? Y (yes) or N (no)

Resume at Discharge? Y (yes) or N (no)

Drug Name
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Dose, Route, Frequency

Indication

Last Dose Date Time

Recorded Date Initials Y Y N N N N N N N N N N N N Y Y Y Y Y Y Y Y Y Y Y Y N N N N N N N N N N N N

Dear Patient, STOP these medications. After hospital discharge, take medications listed below.

Y Y Y Y Y Y Y Y Y Y

Recorded by: __________________________________________________________ RN / LPN / MD / PA / NP /RPh / _____ Medications reviewed on admission by: ______________________________________ MD / PA / NP / _____ Additions/Corrections by: _________________________________________________ RN / LPN / MD / PA / NP / RPh / _____

Date: ___________ Date: ___________ Date: ___________

DISCHARGE HOME MEDICATION LIST (To be completed upon patient discharge.)
Discharge prescriber reviews Admission Home Medication List and current orders in MAR prior to writing prescriptions at discharge. Indicate above whether admission home medications will be continued and list all medications patient should take upon discharge below.

Instructions for the Patient:

Drug Name

 Take the medications listed below after you leave the hospital.  Bring a copy of this list with you to your next doctor’s appointment. /Dose / Route / Frequency / Duration if necessary. (Use Patient Language).

Medications reviewed on admission by: ______________________________________ MD / PA / NP / _____

Date: ___________

308

Signature of Translator (if applicable): _______________________________________ MD / RN / PA / NP / _____

Language: __________



Check here if multiple forms needed. Please indicate: Page ____ of ____.
Chart Copy: White Patient Copy: Yellow Provider Copy: Pink

PLACE LIST IN PHYSICIAN’S ORDERS SECTION OF CHART. ATTACH TO DISCHARGE SUMMARY UPON DISCHARGE.

309

Patient Name: MRN:

HOME MEDICATION RECONCILIATION LIST
FORM MUST BE FAXED TO PHARMACY WITH ADMITTING ORDERS. Check the following, if applicable:  No home medications.  Medication list not available at time of admission.  Only partial list available at time of admission. Documented by: ___________________________ Date: ___________ PATIENT PHARMACY AND PHONE NUMBER:

ADMISSION HOME MEDICATION LIST
Admitting prescriber must indicate whether home medications should be continued or discontinued within 24 hours of admission. If additional space is needed, please use second copy of Home Medication List.

Continue on Admission? Y (yes) or N (no)

Resume at Discharge? Y (yes) or N (no)

Drug Name
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Dose, Route, Frequency

Indication

Last Dose Date Time

Recorded Date Initials Y Y N N N N N N N N N N N N Y Y Y Y Y Y Y Y Y Y Y Y N N N N N N N N N N N N

Dear Patient, STOP these medications. After hospital discharge, take medications listed below.

Y Y Y Y Y Y Y Y Y Y

Recorded by: __________________________________________________________ RN / LPN / MD / PA / NP /RPh / _____ Medications reviewed on admission by: ______________________________________ MD / PA / NP / _____ Additions/Corrections by: _________________________________________________ RN / LPN / MD / PA / NP / RPh / _____

Date: ___________ Date: ___________ Date: ___________

DISCHARGE HOME MEDICATION LIST (To be completed upon patient discharge.)
Discharge prescriber reviews Admission Home Medication List and current orders in MAR prior to writing prescriptions at discharge. Indicate above whether admission home medications will be continued and list all medications patient should take upon discharge below.

Instructions for the Patient:

Drug Name

 Take the medications listed below after you leave the hospital.  Bring a copy of this list with you to your next doctor’s appointment. /Dose / Route / Frequency / Duration if necessary. (Use Patient Language).

Medications reviewed on admission by: ______________________________________ MD / PA / NP / _____

Date: ___________

310

Signature of Translator (if applicable): _______________________________________ MD / RN / PA / NP / _____

Language: __________



Check here if multiple forms needed. Please indicate: Page ____ of ____.
Chart Copy: White Patient Copy: Yellow Provider Copy: Pink

PLACE LIST IN PHYSICIAN’S ORDERS SECTION OF CHART. ATTACH TO DISCHARGE SUMMARY UPON DISCHARGE.

Medication Reconciliation in Ambulatory Care Areas
MEDICATION RECONCILIATION is the process of identifying the most accurate medication list and resolving disparities in medication orders as the patient moves across the continuum of care. Purpose: To improve patient safety with medications by screening for omissions, duplications, and potential interactions at each stage of a patient’s care.

311

Initial Visit RN records patient’s current medications on Ambulatory Care Medication List and signs page.


MD may add medications to list, if necessary, and reviews medication list as part of medication reconciliation.


RN sees patient at end of visit for brief exit interview. RN reviews medications listed in progress note and transcribes list onto Patient Medication List.


Distribution of Patient Medication List White copy: Scanning Yellow copy: Patient Pink copy: Medical chart


Patient is encouraged to bring list to all appointments. Follow-up Visits Scanned copy of most recent Patient Medication List is available in centralized database.


RN interviews patient to find out about medication changes since the last appointment. Ask patient to see list of current medications.


MD reviews medication changes and current list of medications as part of medication reconciliation.


RN sees patient at end of visit for brief exit interview. RN reviews medications listed in progress note and updates Patient Medication List, as needed. Copy of last scanned list may be provided to patient if no medications have been changed.


Patient is reminded to bring list to all appointments.

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Patient Name: MRN: FIN: Date of Birth:

Patient Medication List (Date Started: ________)
Dear Patient: Please bring this list to all clinic visits. Update this list with changes in medications.
Date Started Medication Name Dose How Often How Taken
Initials

Date Stopped

Special Instructions

Initials

Vitamins and Supplem ents

Over-theCounter

Prescription Medications

313

Scan Copy: White

Patient Copy: Yellow

Chart Copy: Pink

314

Patient Name: MRN: FIN: Date of Birth:

Patient Medication List (Date Started: ________)
Dear Patient: Please bring this list to all clinic visits. Update this list with changes in medications.
Date Started Medication Name Dose How Often How Taken
Initials

Date Stopped

Special Instructions

Initials

Vitamins and Supplement s

Over-theCounter

Prescription Medications

315

Scan Copy: White

Patient Copy: Yellow

Chart Copy: Pink

316

Patient Name: MRN: FIN: Date of Birth:

Patient Medication List (Date Started: ________)
Dear Patient: Please bring this list to all clinic visits. Update this list with changes in medications.
Date Started Medication Name Dose How Often How Taken
Initials

Date Stopped

Special Instructions

Initials

Vitamins and Supplement s

Over-theCounter

Prescription Medications

317

Scan Copy: White

Patient Copy: Yellow

Chart Copy: Pink

318

How Can You Help Prevent Medication Errors?
List all medications you take inside this card. Include prescription medications ordered by any one of your doctors, any over -the-counter medications, and vitamins and supplements you may take. Include the dose (or amount of medication) you usually take and how often you take it, even if you take some medications only once in a while. Carry this list with you and share it with all your doctors. This will help all your medical providers stay up -to-date about your medications. Be sure to bring this list with you to all your doctor visits and appointments for medical tests. If any medications are changed, the list should be updated.

getting Information the right treatments and Patient medications by the right health care professionals. Don’t Name assume anything. ______________________________
Allergies and Drug Reactions _______________________________ _______________________________ Emergency Contacts Name: _________________________ Relationship: ____________________ Phone Number: __________________ Name: _________________________ Relationship: ____________________ Phone Number: __________________ Patient ’s Community Pharmacy Name: _________________________ Phone Number: __________________ Name: _________________________ Phone Number: __________________

state-of-the-art quality and safety standards, such as that provided the Joint Patient ’s by Doctors Commission. Primary Care Provider

Participate in all decisions Phone Number: ________________
about your treatment. You are the center of the health care Specialty Doctors team.
Name: _______________________ Phone Number: ________________ Type of Specialist: ______________ Name: _______________________ Phone Number: ________________ Type of Specialist: ______________ Name: _______________________ Phone Number: ________________ Type of Specialist: ______________ Name: _______________________ Phone Number: ________________ Type of Specialist: ______________

Name: _______________________

This medication card is based on the Joint Commission’s Speak UpTM patient safety program. Launched in March 2002, Speak UpTM urges patients to take a role in preventing health care errors by becoming active, involved and informed participants on the health care ream. Speak UpTM encourages the public to:

Educate yourself about your
diagnosis, the medical tests you are undergoing, and your treatment plan.

University Hospital of Brooklyn 450 Clarkson Avenue Brooklyn, NY 11203 718-270-1000

Ask a trusted family member or
friend to be your advocate.

Know what medications you
take and why you take them. Medication errors are the most common health care mistakes.

Speak up if you have questions
or concerns, and if you don’t understand, as again. It’s your body and you have a right to know.

Use a hospital, clinic, surgery
center, or other type of health care organization that has undergone a rigorous on-site evaluation against established

Patient Medication List

Pay attention to the care you are
receiving. Make sure you are

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For more patient safety health care tips, visit the Joint Commission on Accreditation of Healthcare Organizations web site at http://www.jointcommission.org/Patien tSafety/ SpeakUp.

320

Patient Name: MRN: FIN: Date of Birth:

Ambulatory Care Medication List
TO BE FILLED OUT BY NURSE OR PROVIDER Check the following, if applicable:  No home medications.  Medication list not available at initial clinic visit.  Only partial list available at initial clinic visit. Documented by: ____________________ Date: _______ LIST ALL MEDICATIONS PATIENT TAKES AT HOME.
  Include the dose, number of doses each day, and when the last dose was taken. Include prescription and over-the-counter medications, vitamins and supplements or herbal products. PATIENT PHARMACY AND PHONE NUMBER:

HOME MEDICATION LIST
Medication Name Dose How do you take this? How often do you take this each day? When did you last take this? Date Time Initials of Recorder

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 321

25.
List recorded by (Indicate name and title): ________________________________________ Date: _________ Providers should review this list of home medications, in accordance with medication reconciliation. PILOT

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SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: ADVANCED ECHO EMERGENCY MEDICATION BOX Prepared by: ALAN HUI Original Issue Date: NEW Reviewed by: WILLIAM GERDES NICHOLAS GALEOTA Implementation Date: _11/1/04__ Approved by: CONSTANCE SHAMES, M.D. Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual No: __Chapter 38__ Section: _______ Page __1___ of __3___

I.

Purpose: During procedures in the Advanced ECHO lab, emergency situations may arise when administration of certain medications is necessary to alleviate the current condition of the patient. These emergency situations include respiratory distress secondary to bronchospasm or chronic heart failure (CHF) exacerbation, hypoglycemia, frequent premature ventricular contractions (PVC) > 5 per minute, complex ventricular ectopy, supraventricular tachycardia (SVT), or allergic reactions. Specific medications will be made available to the medical staff present in the advanced ECHO lab for the treatment of these emergency situations. Definition(s): NA Policy: Medications such as albuterol (Proventil ), Dextrose 50% in Water, furosemide (Lasix ), ® ® metoprolol (Lopressor ) and methylprednisolone (Solu-Medrol ) will be made available to the medical staff in the Advanced ECHO lab that will be used to treat patients in distress. These medications will be kept in a secured box that is prepared and dispensed by pharmacy. The physician will assess and prescribe the necessary medication for the patient and the nurse will administer as prescribed. Responsibility: It is the responsibility of the pharmacist to provide the appropriate dosage and formulation of each medication for the Emergency Medication Box for the Advanced ECHO lab. It is the responsibility of the nurse to administer the medication based on orders or prescriptions provided by the physician and to inspect the Emergency Medication Box on a monthly basis. It is the responsibility of the physician to prescribe the appropriate medication during the specified emergency situations and to monitor the patient’s condition. Procedure: The following medications and quantity will be dispensed by pharmacy in a sealed red box labeled “Emergency Medications for Advanced ECHO Lab”: Drug Quantity ® Albuterol (Proventil ) 0.083% 3 mL Inhalation Solution Dextrose 50% in Water (D50W) 50 mL vial ® Furosemide (Lasix ) 40 mg/4 mL vial for injection ® Metoprolol (Lopressor ) 5 mg/5 mL ampoule for injection ® Methylprednisolone (Solu-Medrol ) 125 mg vial for injection 1. 5 2 2 3 1
® ®

II. III.

IV.

V.

A pharmacist or a technician will prepare the Advanced ECHO Lab Emergency Medication Box that contains the medications and quantities stated above. There will be two such boxes,

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labeled #1 and #2, where one will be dispensed to the Advanced ECHO lab and the other will remain in the main pharmacy until subsequent exchange for a new emergency medication box. 2. A pharmacist must verify the proper medication, dosage, formulation, expiration, and quantity and document the verification in a log book. A plastic seal will be placed on the box to ensure integrity and should not be broken until the time of use. A label indicating the earliest expiration date of any medication within the box will be placed on the outside of the box for future inspection. A nurse from the Advanced ECHO lab will sign out and pick up the Emergency Medication Box from pharmacy when needed. Only one box will be dispensed each time. The Emergency Medication Box should be placed in a secured area of the Advanced ECHO lab until it is needed. Medications in the box will be used in the following manner: Respiratory Distress secondary to bronchospasm: ® Administer 3 mL of albuterol (Proventil ) 0.083% inhalation solution via a hand-held nebulizer X 1 dose. Repeat one dose after 15 minutes if necessary. Hypoglycemia (Symptomatic and/or blood glucose < 80 mg/dL): Administer 50 mL of D50W via IV push and repeat finger stick in 15 minutes. Respiratory Distress secondary CHF exacerbation: ® Administer furosemide (Lasix ) 40-80 mg IV push X 1 dose. Frequent PVC (> 5 per minute), complex ventricular ectopy, or SVT: Administer metoprolol 5 mg IV push. May repeat metoprolol 5 mg IV push q 5 minutes X 2 doses if necessary. Allergic Reactions: ® Administer methyprednisolone (Solu-Medrol ) 100 mg IV push X 1 dose 7. After assessment of the patient, the physician will write a prescription or order (for inpatients and out-patients) indicating the appropriate medication, dose, route, frequency, and duration. The orders and prescriptions must also include the full name of the patient, medical record number, patient number, date of use, and signature of physician and nurse. The nurse or physician will break the plastic seal of the Emergency Medication Box and remove the medications to be administered. After the treatment is completed, the orders or prescriptions for the medications used will be place back in the Emergency Medication Box. The nurse will transport the opened Emergency Medication Box to the pharmacy to obtain a new Emergency Medication Box for the Advanced ECHO lab. Upon receiving the opened Emergency Medication Box, a pharmacist or technician will charge for the medications used based on the orders or prescriptions received. A pharmacist or technician will replaced any missing medications from the opened Emergency Medication Box. However, a pharmacist must follow procedure #2 and #3 and provide the final verification prior to the plastic seal being placed on the box. A nurse on a monthly basis will inspect the Emergency Medication Box in the Advanced ECHO lab for expiration (expiration label). If an Emergency Medication Box is expired, a nurse from the Advanced ECHO lab will exchange for a new Emergency Medication Box from pharmacy. Reason for Revisions: Changes in regulatory or statutory laws or standards 

3. 4. 5. 6.

8. 9.

10. 11.

12. 13. V.

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  VII. VIII.

System failures/changes Institutional/operational changes Attachments: None References: None

Date Reviewed 12/21/04 12/21/04 10/8/07

Revision Required (Circle One) Yes No Yes No Yes No Yes No

Responsible Staff Name and Title Alan Hui, Pharm.D. Nicholas Galeota, MS, RPH NICHOLAS GALEOTA MS, RPH

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SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: Subject: Prepared by: Reviewed by:

CH. 39

PATIENT MEDICATION ORDERS Alan Hui, Pharm.D. Nicholas Galeota, M.S., R.Ph. Cheryl Okundaye, RN Diana Woods, RN Constance Shames, MD William Gerdes Margaret Jackson, RN
Issued by: Pharmacy and Therapeutics Committee Original Issue date: Supersedes:

8/86 12/04 5/06
Administrative Manual Department Manual Patient Care Manual AOD Manual

Approved by:

Approval date: Distribution:

I.

Purpose:
To define the process by which a legally authorized prescriber may order medications and how medication orders are handled by nursing personnel and pharmacists from the SUNY Downstate Medical Center.

II.

Definition(s):
A medication is defined as a drug or chemical entity approved for use in humans by the FDA for the treatment or diagnosis of disease or which otherwise affects the psychological function of the patient. This includes OTC (Over - The - Counter) medication.

III.

Policy:
All medication orders for patients shall be prescribed by the individuals legally authorized∗ and shall be written on a “Prescriber’s Order Form” and filed in the patient’s chart. All medication orders shall include all necessary information and be signed by the prescribing individual. Nursing personnel will obtain only complete and clear medication orders and transcribe orders accurately to the Medication Administration Record (MAR). The pharmacist will verify medication orders and dispense the medications when it is appropriate. "Prescriber's Order Form" will replace the previously named "Physician's Order Form" in policies. The function of the order form will remain the same.

IV.

Responsibilities (Include all departments/services involved in development/implementation and/or monitoring):
Prescriber: It is the responsibility of the prescribing healthcare practitioner to ensure that all medication orders are complete according to the procedures noted below. Nursing:



Licensed and currently registered physicians and dentists Registered Physicians Assistant Certified Nurse Practitioners licensed and currently registered House staff physicians (PGY 1 through PGY 7)

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It is the responsibility of Nursing Personnel to obtain and transcribe only complete and clear medication orders. Otherwise, Nursing Personnel shall clarify the medication order with the prescriber before forwarding the medication order to the Pharmacy Department. Pharmacist: It is the responsibility of the pharmacist to dispense medication on the authority of a complete, clear, and clinically sound and safe medication order written by an authorized prescriber. If the medication order does not meet these criteria, then the pharmacist shall contact the prescriber, discuss the issues involving the medication order, and ask the prescriber to correct the medication order, if necessary.

V.

Procedures/Guidelines:
1. All medication orders shall be written on the right-hand section of the “Prescriber’s Order Form” in the section marked “Medication and Intravenous Admixture Orders.” If either side of the order form is completed, the nurse shall cross out the remaining white space on the opposite side of the page. New orders for either side of the page will need to be written on a new order form. 2. Patient information must be completed on each order form, including patient first and last name, patient medical record number (MRN) or in-patient account number, and allergy information. 3. Each medication order shall be written legibly and contain all required information including: • Date and time the order was written • Drug i. Full name of the drug, brand or generic. Abbreviations of drug names are not acceptable. (e.g., PCN is unacceptable) • Dose i. Dosage strength is written in metric units (without the use of unacceptable or unapproved abbreviations) ii. The prescribed dose does NOT contain trailing zeros after a decimal (e.g., 1.0 milligram is unacceptable) iii. The prescribed dose MUST contain leading zeros before a decimal (e.g., digoxin 0.25 mg) iv. The dosage prescribed for chemotherapy drugs is rounded to the nearest whole dosage (e.g., 5.1 mg should be rounded to 5 mg) • Route of administration • Frequency • Duration of therapy i. The maximum duration of therapy that is prescribed will be 30 days for most medication orders. Refer to the Automatic Medication Stop Order Policy for exceptions. 4. For Pediatric/Neonatal medication orders, all doses are calculated by body weight or body surface area (BSA) and the weight-based or BSA-based dosing shall be written on the medication order. The patient’s body weight must be included on the medication order form. 5. The prescriber shall sign immediately below medication orders each time orders are written and then stamp name with his/her rubber stamp or print his/her name after his/her signature. If multiple orders are written at the same time, the prescriber may sign one time at the end of the list of medication orders (a.k.a., order set) written at that time. 6. Any medication order containing unacceptable abbreviations as per SUNY Downstate Medical Center policy is invalid and will NOT be accepted by nursing and/or pharmacy. 7. Upon encountering new orders, the nurse shall sign below the prescriber’s signature for the order or order set. The nurse should indicate the date and time that the medication order or order set was acknowledged and faxed to the pharmacy (a.k.a., the action time) next to his/her signature. In addition, the nurse will indicate the number of valid, complete orders obtained for the order set next to his/her signature. 8. If duration of therapy is not indicated on the medication order, the order will be valid for one dose only. The nurse may give one dose only after the order has been reviewed by a pharmacist. 9. The nurse shall transcribe all the information on the medication order to the MAR.

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10. Upon identifying an order that is incomplete, incorrect, unclear, unacceptable (e.g., contains unacceptable abbreviations) or written for a non-formulary drug, the nurse shall specify the problem on the Prescriber Order Form below his/her signature. Nurses should clearly identify the problem order by drug name and problem. For example, the nurse may designate, "Problem order: Drug A order incomplete, unclear, unacceptable, or non-formulary." If the medication order is not legible, the nurse shall circle the medication name and make a similar notation on the order form (e.g., "Problem order: Drug name not clear.") The nurse shall contact the prescriber for clarification or correction of the order and document the name of the prescriber he/she spoke with, the date and time of the communication on the order form, and his/her signature at the end of the communication. 11. Prescribers must discontinue and/or rewrite all medication orders that have been identified as unclear, incomplete, incorrect, or unacceptable. For non-formulary medications, prescribers may complete a non-formulary request form and follow the non-formulary request procedure. 12. Medication orders will be sent to the pharmacy, Room ALL1-469, via fax or pneumatic tube system (if available to the unit). In the event the fax machine is not able to transmit orders, a copy of the medication order can be sent to pharmacy via messenger. 13. The pharmacist checks the medication order for completeness and appropriateness and enters the order into the patient’s database profile using the pharmacy computer system. If the order is incomplete, incorrect, unclear, unacceptable, or written for a non-formulary medication, the pharmacist must contact the prescriber for clarification, a new order, a non-formulary request form. Formulary alternatives may be recommended to replace non-formulary medications. The pharmacist will document communication with the prescriber for problem orders, as per procedures. If the duration of therapy is not indicated on any medication order, the order will be valid for one dose only. The pharmacist will contact the prescriber for a follow-up order, if appropriate. 14. All medication orders must be checked by the pharmacist and initialed before the corresponding medications are dispensed. 15. Medications will be sent to nursing stations by messenger, Pyxis Helpmate , pneumatic tube system or via cassette exchange system by Pharmacy Technicians. 16. Before administration, the nurse checks that the information on the MAR and medication container label coincide. 17. If a patient is transferred from one unit to another within the hospital, the medication orders from the previous unit are automatically discontinued and new medication orders must be written to continue any drug therapy. Any order stating, “Resume orders,” is not acceptable. 18. STAT Medication Orders:
®

Time of day must be noted on all STAT medication orders. When the prescriber writes for a STAT order, that prescriber is to personally speak with the nurse covering that patient to expedite the order being carried out. The nurse shall fax the order to the Pharmacy for processing. All STAT medication orders should be transcribed onto the section for STAT orders on the MAR.
19. PRN Medication Orders: PRN medication orders must include the indication for administration along with all information required for a standing medication order. If the PRN medication order is for a clinical symptom, the nurse may act on behalf of the patient in determining the frequency of administration. These orders are transcribed onto the PRN medication section of the MAR. 20. RANGE Medication Orders: Medication orders with a dosage or frequency range, such as “Morphine sulfate 2 to 4 mg every 4 to 6 hours as needed for pain,” are NOT permitted and should not be transcribed or entered into the pharmacy computer system. All medication orders must include a specific dose and a specific frequency. 21. HOLD Medication Orders:

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These orders are intended to provide a mechanism to temporarily suspend the administration of a medication for a defined period of time. HOLD orders must be specific and include each drug name and the specific schedule of doses to be held. If the order states “HOLD” without a specific time period, then the prescriber should discontinue the medication order. The order must be re-written to be re-started. The orders shall be transcribed to the MAR with specific time frames and documentation of specific doses that were ordered to be held. 22. ON CALL Medication Orders: Each dose of On Call medication is considered a “one time only” and is transcribed onto the MAR. If more than one dose of an “on call” medication is required, the doses must be written separately. The date of administration and reason for administration must be part of the order (e.g., On Call to OR on 12/23/04). 23. Any incomplete or incorrect medication order is to be documented as a medication error, when written by the medical staff or others who have prescriptive authority within SUNY Downstate Medical Center.

XII.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/ changes Institutional/operational changes Attachments:
Prescriber’s Order Form

VII. VIII.

References:
Policy and Procedure on Medication Order Completeness Revision Required (Check One) Yes No Yes No Yes No Yes No Responsible Staff Name and Title Nicholas Galeota, Director of Pharmacy Nicholas Galeota, Director of Pharmacy Alan Hui, Pharm.D. Nicholas Galeota, Director of Pharmacy Nicholas Galeota, Director of Pharmacy

Date Reviewed 8/01 8/03 12/04 10/8/07

329

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
Subject: Medication Security When Patients are Transferred Between Services No: Chapter 40 Section: _______ Page 1 of 2 Prepared by: Nicholas Galeota, M.S., R.Ph. Director of Pharmacy NEW Original Issue Date: _______________ Reviewed by: Diane Woods, R.N. Deputy Director, Nursing Services 5/9/06 Implementation Date: ______________ Approved by: Pharmacy and Therapeutics Committee Distribution:  Administrative Manual Constance Shames, M.D.  Departmental Manual Chairperson  Patient Care Manual ________________________________  AOD Manual Issued by: Pharmacy and Therapeutics Committee

I.
II. III.

Purpose: To insure security of medications when a patient undergoes inter unit transfer or evacuation from the facility. Definition(s): NA Policy: All current medication orders are discontinued when a patient is transferred between services. Medications are not to be moved between units. New medication orders must be re-written by the receiving medical team upon arrival of the patient in the new unit. The receiving medical team is not required to obtain re-approval for previously approved restricted antibiotics and/or previously approved non-formulary drugs. All prior approvals remain in effect if the receiving medical team re-orders these classes of medications. Responsibility: Responsibility is broken up amongst the Nursing staff, medical staff, and the Pharmacy staff: Nursing staff: The nurse on the originating unit shall remove all medications from the medication cart and place the medications into the returns bin for the Pharmacy. The nurse should administer any medications to the patient due within one (1) hour of the patient transfer. The nurse should notify the Pharmacy about the patient’s new location. Medical Staff: It is the responsibility of the receiving medical team to evaluate the patient upon arrival in the new unit and re-write the medication orders based on an evaluation of the patient, evaluation of previous medication orders, and any new medication orders required. Pharmacy Staff: It is the responsibility of the pharmacist to review the new orders against the existing patient profile to ascertain if any maintenance medications have been omitted and require re-ordering. The pharmacist shall notify the physician if this situation occurs.

IV.

V.

Procedure: 14. Within one (1) hour after transfer of a patient from a unit, all medication for the patient must be returned to the Pharmacy 15. New medication orders at the patient destination unit are to be written as soon as possible by the receiving service team upon arrival of the patient at the new unit. 16. The new medication orders are then processed according Pharmacy’s policy and procedures. 17. If a dose of medication is required immediately, a nurse may access a first dose, a “STAT” dose, or an emergency dose from the Pyxis® cabinet. 18. Any medication due within one (1) hour of the transfer may be administered by the nurse before the transfer. 19. In the event of a disaster, requiring the complete or partial evacuation of the facility, a review of the current medications for the patients being evacuated would be performed, and for those medications that will be readily available at the receiving institution the patient’s profile would be sent with the patient. If any of the current medications the patient is receiving are not available at the receiving institution, the Pharmacy

330

Department would prepare a two (2) day supply that would be sent with the patient, including all pertinent drug and ordering information. Controlled substances not available would also be sent with the patient in a two (2) day supply, and a controlled substance administration record would be completed and sent with the patient. The receiving facility would be required to sign off as receiving the controlled substances intact and the exact quantity dispensed by the appropriate licensed professional and the original must be returned immediately to Downstate for our records. VI. Reason for Revisions:  Changes in regulatory or statutory laws or standards  System failures/changes  Institutional/operational changes Attachments: None VIII.

VII.

References: JCAHO Standards MM.2.30, MM.4.10, MM.8.10 NPSG #8 Date Reviewed Revision Required (Circle One) Responsible Staff Name and Title Yes No Nicholas Galeota, M.S., R.Ph. Yes No Diane Woods, R.N. Yes No Constance Shames, M.D. 10/8/07 Yes No NICHOLAS GALEOTA MS, RPH

331

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN
POLICY AND PROCEDURE
No: PTSAF-13 Chapter 41 Subject: LABELING OF MEDICATION /SOLUTION IN PERIOPERATIVE AND PROCEDURAL AREAS Patient Safety Committee Page __1___ of __4__

Original Issue Date: Prepared by: Reviewed by:

01/06

Supersedes:
Lilyann Jeu, Pharm. D._______ Maria Mendez______________ Prissana Alston, MA, RN______ Jaycinth Blackman, RN, CPHQ P&T Committee_____________ Nicholas Galeota, R.PH _____ Margaret Jackson, MA, RN____ David Conley, MBA__________ Michael Lucchesi, M.D._______ Debra D. Carey, MS_________ Issued by: Effective Date:

New
01/06

JCAHO Standards:MM.2.20,MM.4.20,NPS 3,MM.5.10,IM.6.10 Distribution     Administrative Manual Department Manual Patient Care Manual AOD Manual

Approved by:

Regulatory Affairs

I.

PURPOSE To provide safe utilization of medication and solutions on or off the sterile field in all procedural areas.

II.

POLICY

SUNY Downstate Medical Center/University Hospital of Brooklyn is committed to provide safe medication practices by ensuring the safe administration of medication and solution on or off the sterile field and other procedural areas.

Medications and solutions on or off the sterile field will be labeled even if there is only one medication being used.

Labeling occurs immediately when any medication or solution is transferred from the original packaging to another container, and when medications or solutions are prepared but are not administered immediately, the medication container must be labeled.

332

At a minimum all medications prepared in the hospital are labeled with the following: • • • • • Drug name, strength, amount (if not apparent from the container) Expiration date and time, not more than 24 hours, from the date and time of preparation Expiration time when expiration occurs in less than 24 hours The date prepared and the diluents of all compounded IV admixtures and parenteral nutrition solutions. Initial of the professional preparing the medication/solution.

When preparing individualized medications for multiple specific patients, or when the person preparing the individual medications is not the person administering the Medication, the label also includes the following: • • • Patient name Patient Location Direction for use and any applicable cautionary statements either on the label or attached as an accessory label(for example, “requires refrigeration,” “for IM use only)

III.

DEFINITIONS Perioperative area – includes operating rooms and ambulatory surgery units.

Procedural settings – include Cardiac Catheterization and Endoscopy, suites, Radiology Department, Respiratory and all other areas where surgical or other invasive procedures may be performed, including the clinical units.

Medication– includes any prescription medication, radioactive medication, IV solutions (plain or with additives), blood derivatives, albumin, diagnostic and contrast agents, respiratory therapy treatment

Solutions - include saline, water, chemicals and reagents such as glutaraldehyde and chlorhexidine, alcohol, betadine, & hydrogen peroxide. Immediate: Without interruption between withdrawal of medication/solution from original container and administration to patient. IV. RESPONSIBILITIES

Perioperative service, Radiology, Endoscopy, Cardiac Catheterization, Respiratory and all other procedural areas, including the clinical units.

V.

PROCEDURE/GUIDELINES • Verify medication order(s) according to hospital policy.



In case of emergency, confirm all verbal orders by repeating the order and document the order in the patient’s chart as soon as feasible.

333



Verbally and visually verify all medications delivered to the sterile or non sterile field, including name of medication, strength, dosage, route of administration and expiration date.



In the preoperative setting, circulating nurse and scrub person should concurrently verify the medication/solution. If there is no scrub person, the circulating nurse will verify the medication visually and verbally with the licensed professional performing the procedure.



In the procedural setting, the person assisting such as the Physician, PA, will verify the medication visually and verbally stating name of medication/solution dose, patients name and location, with the licensed professional performing the procedure. In the event that there is no other person assisting, the health care provider should follow the verification process as outline in the (policy PTSAF-03) Patient Identification for Clinical Care and Treatment.



Prior to labeling the medication or solution, visually inspect product for changes in color, consistency or presence of precipitation that may suggest that the product is not safe for use.



Label all medications or solution, medication or solution containers (e.g., syringes, medicine cups, basins) with patient’s name, medication name and strength and dosage. Complete the label with all required information.



In accordance with the multi-dose policy, accurately labeled Original container from which the solution or medication was withdrawn be accurately labeled with expiration date not more than 14 days from the date of opening.



All original containers from medications or solutions remain available for reference in the perioperative area until the conclusion of the procedure.



Discard any solution or medication found without any identification label. All labeled containers on the sterile field must be discarded at the conclusion of the procedure.



At shift change or break relief, all medications/solutions on or off the sterile field and their labels will be noted and verified concurrently by entering and exiting personnel.



All original containers including syringes used during any procedure must remain in the perioperative and procedural area until completion of the procedure.

VI.

SCOPE This policy applies to all Downstate Medical Center physicians, nurses, and other healthcare providers involved with patient care.

VII.

RELATED UHB POLICIES

334

Policy (PHA-16) Handling of Multi-dose Vials of Inject able /Inhalation, and Ocular Medications Policy (PTSAF-3) Patient Identification for Clinical Care and Treatment

VIII.

ATTACHMENTS None

VIII.

REFERENCES

JCAHO National patient Safety Goal 3D

Date Reviewed 10/8/07

Revision Required (Circle One) Yes Yes Yes No No No

Responsible Staff Name and Title

NICHOLAS GALEOTA MS, RPH

335

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: Subject: LOOK-ALIKE/SOUND-ALIKE DRUGS Prepared by: LilyAnn Jeu, Pharm.D., BCPS Reviewed by: Nicholas Galeota, M.S., R.Ph. Page Original Issue date: Supersedes: 1 CHAPTER 42

of

3

10/06 NEW 10/10/06 Administrative Manual Department Manual Patient Care Manual AOD Manual P&T Committee

Approval date: Approved by: Constances Shames, MD Distribution:

Issued by:

III.

Purpose: To define the organization’s process for identifying and compiling the look-alike/sound-alike drug list. To define preventive measures implemented by the institution to prevent look-alike/sound-alike medication errors.

IV.

Definition(s): Look-alike/sound-alike drug names are names that are similar in appearance or pronunciation, or have the potential to be confused with other medication names due to these similarities. Confusion between such agents may lead to potentially harmful medication errors.

IV.

Policy: The Department of Pharmacy will identify and annually review the list of look-alike/sound-alike drugs used in the organization. The Department will implement measures to prevent errors involving interchange of these drugs. The organization’s list will consist of a minimum of 10 sets of look-alike/sound-alike drug names based on the Joint Commission’s recommendations.

IV.

Responsibilities: Pharmacist: The Department of Pharmacy will update the organization’s list of look-alike/soundalike drugs and disseminate the updated list to Prescribers and Nursing personnel through the

336

Pharmacy & Therapeutics Committee. Preventive strategies to reduce medication errors with such drugs will be disseminated via the same venue. Pharmacists shall follow preventive strategies to reduce these medication errors. Prescribers: Medication orders shall be complete with drug names clearly and correctly spelled. When applicable, the indication for use of look-alike/sound-alike medications shall be included on the medication order. Nursing: Nurses shall obtain and transcribe only complete, clear medication orders to reduce the risk of medication errors with look-alike/sound-alike drugs. Nurses shall practice and/or participate in preventive strategies to reduce such types of medication errors. V. Procedures/Guidelines: 1. On an annual basis, the Department of Pharmacy will review the Joint Commission recommendations for updating the organization’s list of look-alike/sound-alike drugs. 2. The following preventive strategies will be employed to reduce potential and actual medication errors with look-alike/sound-alike drug names in medication storage and/or patient care areas: a. Physical separation of agents with similar names. b. Use of different drug delivery devices to distinguish drugs with similar names (e.g., NovoLog FlexPen vs Novolin R vials). c. Use of brand and generic names on unit-dose packaging, in medication storage areas, and/or medication orders whenever possible. d. Inclusion of prompts for nurses to specify indication for use when medication is retrieved from the automated dispensing cabinet (Pyxis). e. Inclusion of dosing limits for medications with similar names but different dosage ranges. f. Placement of “Look-Alike, Sound-Alike” auxiliary alerts on medication storage bins. g. Changing the appearance of names on shelf labels and bins, including the automated dispensing cabinets (e.g., “tall man” letters). h. Avoiding the use of abbreviations for drug names. i. Remove drugs with potentially problematic names from formulary, whenever possible. 3. Guidelines outlined in the policy for Verbal and Telephone Orders shall be followed to prevent medication errors when look-alike/sound-alike drugs are named. 4. The updated list of look-alike/sound-alike drugs shall be made available in nursing stations, within the Department of Pharmacy, and in medication storage areas. 5. If at any time a nurse or pharmacist is unclear about the drug name, the health-care professional shall contact the prescriber to clarify the medication order. XIII. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes Institutional/operational changes Attachments: Top 10 Sound-Alike & Look-Alike Drugs References: JCAHO 2006 National Patient Safety Goal 3C Look-alike/sound-alike drug tables (2006-2007) available at web site www.jcaho.org

VII.

VIII.

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Date Reviewed 10/8/07

Revision Required (Check One) Yes Yes No No

Responsible Staff Name and Title
NICHOLAS GALEOTA MS, RPH

338

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE

No: __CH. 43________ Subject

CHEMOTHERAPY ORDERING AND DISPENSING Gerald Soff, MD__________ William Solomon, MD______ Yi-Chun Lee, MD_________ Sreedhar Rao, MD________ Megan Sargent, RN______ Marlene Ferguson, RN_____

Page __1__ of __6__

Prepared by: LilyAnn Jeu, PharmD, BCPS

Original Issue Date:

6/07

Reviewed by: Nicholas Galeota, M.S., R.Ph.____ Dianne Woods, RN_____________ Patient Safety Work Group_______

Supersedes: Effective Date:

_NEW_ 9/07

Approved by: Michael Lucchesi, M.D._________ Margaret Jackson, RN, MA______

JCAHO Standards: MM.3.10,3.20,4.10-4.80,5.10 Distribution:  Administrative Manual  Department Manual  Patient Care Manual  AOD Manual Issued by:

Torrance Akinsanya_________
Debra D. Carey, MS____________

I.

PURPOSE

To delineate the inter-disciplinary process for ordering and dispensing of chemotherapy and associated medications for patients receiving treatment in the Ambulatory Chemotherapy Unit. To describe medication management practices targeted to reduce medication errors with chemotherapy agents as a class of high-risk medications. To increase patient satisfaction by improving the work flow and reducing waiting time for medications in the Ambulatory Chemotherapy Unit.
II. POLICY

Physicians of oncology services at University Hospital of Brooklyn who are authorized by their respective departments shall prescribe chemotherapy, in accordance with requirements for medications orders (e.g., policies “Patient Medication Orders,” “Unacceptable Abbreviations,” and “Look-Alike/Sound-Alike Drugs.”) Nurses shall execute those orders in accordance, when appropriate. The pharmacy department shall process these orders that are complete and correct and free of unacceptable abbreviations. In 339

addition, responsibilities and procedures specific to staff providing care in the Ambulatory Chemotherapy Unit are outlined below.
III. DEFINITION(S)

Chemotherapy agents (or antineoplastics) are those used to treat oncology disorders. Non-chemotherapy agents may be administered in combination with chemotherapy agents to enhance their therapeutic effects or to reduce adverse effects associated with their use in chemotherapy regimens. Premedicants are non-chemotherapy agents administered prior to the administration of chemotherapy to prevent known side effects of chemotherapy regimens (e.g., antiemetics, antihistamines, corticosteroids, etc).
IV. Responsibilities

Physicians authorized to prescribe chemotherapy at University Hospital of Brooklyn shall write orders on the “Physician’s Chemotherapy Orders” form based on the evaluation of individual patients’ clinical status. Evaluation of height, weight, body surface area, appropriate laboratory evaluation, and chemotherapy cycle number shall be indicated on the form. For patients receiving medications with a cumulative lifetime dosing limit, physicians should maintain records of total doses received to date for individual patients. Nurses authorized to administer chemotherapy shall screen orders for completeness, fax/send orders to the chemotherapy pharmacy satellite for compounding, administer medications, and monitor patients for side effects. In addition, to promote a more efficient rate of patient turn-around time, the nursing staff of the Ambulatory Chemotherapy Unit will attempt to schedule patients requiring visits of anticipated shorter duration (e.g., patients receiving intravenous bolus of medication or regimens with relatively shorter infusion times) for earlier appointments during the working hours of the Ambulatory Chemotherapy Unit. Nursing staff shall also provide guidance to the pharmacy staff on the priority in which patients’ medications shall be prepared, in order to improve communication, work flow and patient satisfaction. Pharmacists shall verify doses and calculations used to derive those doses (e.g., body surface area, cumulative lifetime dose for pertinent medications) for chemotherapy agents, non-chemotherapy agents in chemotherapy regimens, and premedicants prior to compounding. Premedicants shall be prepared by batching in standardized intravenous concentrations, when possible. The pharmacy department shall maintain a par level of these batched medications according to stability data. Chemotherapy orders shall be processed based on individual orders.
V. PROCEDURE/GUIDELINES

340

Ambulatory Chemotherapy Unit Medication Ordering and Dispensing

(May 2007)

PROPOSAL

Patient arrives in unit in AM (Step 2)

Patient is informed of cancellation and given follow -up instructions . (Step 7)

Patient

RN administers medications to patient and monitors for adverse effects . (Step 12 and 15)

Nursing staff schedule patient for appt . (Step 1)

RN draws blood from patient and sends to lab (Step 3)

Blood work not satisfactory . MD informs nurses chemotherapy canceled for patient . (Step 6a)

RN acknowledges medication orders and faxes / sends them to chemotherapy (and/ or investigational ) pharmacist . (Step 8)

RN staff of unit pick up premedicants for administration prior to chemo (Step 11)

RN staff pick up chemotherapy products from chemo satellite . (Step 14a)

Investigational pharmacist delivers meds to unit, when applicable . (Step 14b)

Laboratory

Nurse

Lab processing of blood work (Step 4)

Physician

If blood work is satisfactory , MD writes orders for premedicants and chemotherapy . (Step 6b)

MD reviews blood work (Step 5)

Pharmacist

Pharmacy department batches and maintains supply of premedicants . (Preparation for step 9)

Chemo pharmacist and second pharmacist verify orders. Chemo pharmacist processes orders . (Step 9)

Chemo pharmacist alerts RN when premedicants ready for pick up . (Step 10)

When preparations ready , chemo and / or investigational pharmacist alerts RN staff of the unit . (Step 13)

1. Nursing staff schedule patient for ambulatory chemotherapy session. Staff shall attempt to schedule patients with anticipated visits of shorter duration for earlier appointments in the day, as to promote more efficient use of space in the Ambulatory Chemotherapy Unit. 2. Scheduled patient arrival. 3. Nurse performs blood draw and sends to lab. 4. Lab processing of blood work. 5. Physician evaluates blood work. 6a. If blood work is not satisfactory for the patient to receive chemotherapy that day, physician cancels chemotherapy for that day. 6b. If blood work is satisfactory for patient to receive chemotherapy, physician writes orders for premedicants (if needed) and chemotherapy orders on “Physician’s Chemotherapy Orders” form. Physician completes the height, weight, body surface area calculation, chemotherapy cycle number, allergy information, medication order information, and indication blood work was evaluated and deemed appropriate. For pediatric orders, weight-based dosing is required. Whenever possible, the physician is encouraged to select pre-printed premedicants listed on the order form. If a patient is part of an investigational protocol that requires a product to be compounded by the investigational pharmacist, the physician must indicate the protocol number on the order and indicate that the investigational pharmacist should be contacted to compound the product. 341

If a patient is receiving carboplatin, serum creatinine and target area-under-the curve must be indicated on the order form. If a patient is receiving a chemotherapy agent that has a cumulative lifetime dose limit (e.g., doxorubicin), it is recommended that the physician should evaluate the total dose to date prior to writing the order. 7. If chemotherapy is cancelled by the physician, the nurse shall inform the patient of the cancellation and provide subsequent instructions for follow-up care. 8. If medications have been ordered, the nurse acknowledges orders and faxes/sends order form to Chemotherapy Pharmacy Satellite. Nurse verifies patient information is complete (e.g., height, weight, blood work evaluation) and medication orders are complete before acknowledging order. The nurse communicates the order in which products should be compounded to the pharmacist as follows: In the top, right-hand corner of the order form for each patient, a nurse will number orders in order of priority of compounding (i.e., “#1” indicates the first order the pharmacist should compound for that day). The nurse shall then send/fax orders to chemotherapy pharmacy satellite. Orders for different services (e.g., Pediatric Oncology, Medical Oncology, Obstetrics/Gynecology Oncology) shall be sent to the pharmacy when available. There is no need to wait for all orders from all services to be available before sending these orders to the Chemotherapy Pharmacy. However, all orders shall be labeled with a priority number for compounding. If the physician has indicated that a product must be compounded by the investigational pharmacist, the nurse shall contact this pharmacist and send the order to the appropriate lab. 9. Upon receipt of chemotherapy orders, chemotherapy pharmacist faxes/sends orders to main pharmacy for verification of calculations by a second pharmacist. The chemotherapy pharmacist verifies the medication order for completeness, as well as body surface area calculation, evaluation of appropriateness of blood work, and total cumulative dose for pertinent medications (when applicable). If a chemotherapy order is found to be incorrect, incomplete, unclear, or contains an unauthorized abbreviation, the pharmacist shall contact the physician to discuss the problem and request that the order be re-written, if necessary. 10. If chemotherapy orders have been written for a patient, the chemotherapy pharmacist processes orders and prepares premedicants for dispensing. Batched premedicants shall be labeled appropriately prior to dispensing. The chemotherapy pharmacist shall iinform nursing staff when premedicants are ready to be picked up. The premedicants should be ready and available for dispensing prior to preparation of the chemotherapy. 11. Nursing staff will pick up the premedicants. Staff will sign the log to document which products have been received by the Ambulatory Chemotherapy Unit. 12. Nurses administer premedicants to patients in a timely fashion. 342

13. When the chemotherapy preparations have been prepared, the chemotherapy pharmacist or investigational pharmacist will alert the nursing staff of the unit. 14a: Nursing staff will pick up the chemotherapy agents from the chemotherapy satellite. Staff will sign the log to document which products have been received by the Ambulatory Chemotherapy Unit. 14b: The investigational pharmacist will deliver products to the unit, when applicable. 15: Chemotherapy agents are administered. Patients are monitored by nursing staff.
VI. VII. Attachments: Physician’s Chemotherapy Orders References: Policy and procedure on “Patient Medication Orders.” Policy and procedure on “Unacceptable Abbreviations.” Policy and procedure on “Medication Orders and Completeness Standard.” Policy and procedure on “Look-Alike/Sound-Alike Drug Names.” Institute of Safe Medication Practices’s List of High Alert Medications. Available on website www.ismp.org/Tools/highalertmedications.pdf. Accessed May 22, 2007.

Schauberger CW, Larson P. Implementing Patient Safety Practices in Samll Ambulatory Care Settings. Joint Commission Journal on Quality and Patient Safety. 2006;32(8):419425. Robinson DL, Heigham M, Clark J. Using Failure Mode and Effects Analysis for Safe Adminsitration of Chemotherapy to Hospitalized Children with Cancer. 2006;32(3):161-166.
Date Reviewed 10/8/07 Revision Yes Yes Yes Required (Circle One) No No No Responsible Staff Name and Title
NICHOLAS GALEOTA MS, RPH

343

Patient Name:

PHYSICIAN’S CHEMOTHERAPY ORDERS
DIAGNOSIS
HEIGHT ________ inches ________ cm WEIGHT _________ pounds _________ kg SURFACE AREA (m )
2

MRN: NS or Clinic:

Financial Number: DOB: Sex:  Male  Female

Appropriate Blood Work Evaluated

Patient Age:

 YES

 NO

Attending Physician’s Name:

ALLERGIES

CYCLE ________ OF _________

NON-CHEMOTHERAPY (Include IV fluids without additives)
Check box to order. Drug Name Dose Route IV Fluid and Volume No. of Doses How Often? (e.g., Once/Daily/q __ h/Before chemo/etc). Indicate special directions. If doses for different days, indicate days of cycle.

Dexamethasone Diphenhydramine Ondansetron Ondansetron Famotidine

10 mg 25 mg 16 mg 32 mg 20 mg

IVPB IVPB IVPB IVPB IVPB

50 mL D5W 50 mL D5W 50 mL D5W 50 mL D5W 50 mL NS

CHEMOTHERAPY (Include drugs to be added to chemotherapy preparations)
If investigational drug, MD writes protocol number. Circle if investigational pharmacist should prepare.*

Drug Name

Dosing Schedule 2 (e.g., mg/m , mg/kg, units/kg, etc.)

Dose (e.g., mg, grams, units, etc.)

IV Fluid and Volume

Route (e.g., IVPB/IV push, PO, continuous infusion) and Rate/Duration of Infusion

No. of Doses

How Often?

If doses for different days, indicate days of cycle.

DOXOrubicin ® (Adriamycin ) Cyclophosphamide ® (Cytoxan ) 5-Fluorouracil Methotrexate vinCRISTine ® (Oncovin ) CISplatin ® (Platinol ) vinBLASTine ® (Velban ) CARBOplatin ® (Paraplatin )
For carboplatin orders, also indicate: Serum creatinine: _________ mg/dL AND AUC target: ___________.

Paclitaxel ® (Taxol ) Mannitol (mixed with cisplatin) Magnesium (mixed with cisplatin)

* Call Investigational Clinical Research Pharmacist to order dose (×4340).
MD SIGNATURE PRINT NAME DATE TIME PAGER NO. RN SIGNATURE PRINT NAME DATE TIME RPh #1 NAME/SIGNATURE DATE RPh #2 NAME/SIGNATURE TIME

344

PILOT replacement SD 033-D (5/07)

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: Subject: ORDERING AND DISPENSING OF PARENTERAL CHEMOTHERAPY FOR NON-ONCOLOGY INDICATIONS LilyAnn Jeu, PharmD, BCPS Nicholas Galeota, M.S., R.Ph. Donald Caracciola, RPh Dianne Woods, RN MEC Original Issue date: Supersedes: Approval date: Distribution: 1/07 CHAPTER 44

Prepared by: Reviewed by:

New

Approved by:

Administrative Manual Department Manual Patient Care Manual AOD Manual Regulatory Affairs

Issued by: I.

Purpose: To reduce the potential for medication errors with antineoplastic agents. To improve the safe preparation of parenteral chemotherapy for non-oncology indications. To enhance patient safety with parenteral chemotherapy when used for non-oncology indications by requiring a standardized ordering process. Definition(s): Antineoplastic agents (or chemotherapy) are those agents used to treat oncology disorders. This policy discusses agents prepared for parenteral administration. Parenteral administration refers to administration by injection of medications (e.g., intravenous, intramuscular, subcutaneous, etc). Policy: All parenteral chemotherapy shall be ordered using the Physician’s Chemotherapy Order Form by prescribers authorized to prescribe chemotherapy at UHB. When dosing regimens for chemotherapy for non-oncology indications are not FDA approved or are not readily available for pharmacist verification, prescribers who order chemotherapy for non-oncology indications shall provide evidence-based protocols (or references) to the pharmacy department for verification of medication orders. Pharmacists shall make the request for these protocols when there is a concern regarding the dosing regimen ordered. Chemotherapy orders for non-oncology indications written before 4 PM Monday through Friday shall be sent to the Chemotherapy Pharmacy Satellite for processing and verification and preparation of medication. Orders written after 4 PM or on weekends or holidays shall be sent to the Main Pharmacy. All parenteral chemotherapy shall be prepared in the Pharmacy Department and dispensed in ready-toadminister form. No vials of chemotherapy shall be sent to patient care areas.

II.

III.

IV.

Responsibilities: Physicians, nurses, pharmacists

345

V.

Procedures/Guidelines: 1. Physicians authorized to prescribe chemotherapy shall write orders for parenteral chemotherapy on the Physician’s Chemotherapy Order Form. All required elements of the order form must be completed, including patient height and weight, body surface area calculation, chemotherapy cycle number, allergy information, medication order information, and indication blood work was evaluated and deemed appropriate. Medication orders shall indicate weight- or body-surface-area-based dosing, where appropriate. 2. Nurses shall acknowledge chemotherapy orders and fax/send the order form to Chemotherapy Pharmacy Satellite. Nurses shall verify the patient information is complete (e.g., height, weight, blood work evaluation) and medication orders are complete before acknowledging orders. 3. Upon receipt of chemotherapy orders, chemotherapy pharmacist faxes/sends orders to main pharmacy for verification of calculations by a second pharmacist. The chemotherapy pharmacist verifies the medication order for completeness, as well as body surface area calculation, evaluation of appropriateness of blood work, and total cumulative dose for pertinent medications (when applicable as defined in the policy “Chemotherapy Ordering and Dispensing”). 4. If a chemotherapy order is found to be incorrect, incomplete, unclear, or contains an unauthorized abbreviation, the pharmacist shall contact the physician to discuss the problem and request that the order be rewritten, if necessary. 5. The pharmacist shall verify the dose of chemotherapy ordered using available references (e.g., ® ® MicroMedex , Up To Date , the text Hematology-Oncology Therapy edited by Boyiadzis et al, or protocols provided by the specialists who are prescribing the chemotherapy for non-oncology indications. Pharmacists shall contact prescribers for resources to verify doses when there is a concern regarding the dosing regimen. (See attachment.) 6. Upon verification of doses of chemotherapy, the pharmacist shall prepare all doses for parenteral administration according to procedures in the policy “Cytotoxic Drug Admixtures.” This includes drawing up syringes for intramuscular or intravenous push injection. 7. Upon completion of preparation of the medication, pharmacy personnel shall deliver the dose of chemotherapy to the nursing unit.

XIV.

Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes Institutional/operational changes Attachments: Physician’s Chemotherapy Orders Uses of Antineoplastics for Non-oncology Indications References: UHB Policy on “Patient Medication Orders” (PHA-02) Pharmacy Policy on “Cytotoxic Drug Admixtures” Pharmacy Department Policy on “Chemotherapy Ordering and Dispensing.” (Chapter 43) Boyiadzis MM, Lebowitz PF, Frame JN, Fojo T, eds. Hematology-Oncology Therapy. New York, NY: McGraw Hill, 2007

VII.

VIII.

Date Reviewed 1/10/08

Revision Required (Check One) Yes No Yes No

Responsible Staff Name and Title Nicholas Galeota, Director of Pharmacy

346

Uses of Antineoplastics for Non-oncology Indications Updated Dec 2007. Doses accessed from www.uptodate.com and www.micromedex.com on 12/19/07.
Specialty Dermatology Gastroenterology Generic Name Methotrexate Methotrexate Brand Name Indication Psoriasis: Oral: 2.5-5 mg/dose every 12 hours for 3 doses given weekly or Oral, I.M.: 10-25 mg/dose given once weekly Active Crohn's disease (unlabeled use): Induction of remission: I.M., SubQ: 15-25 mg once weekly; remission maintenance: 15 mg once weekly Sickle cell anemia (investigational use): I.V., SubQ: 0.15-0.3 mg/kg/day over 2 minutes 5 days/week for 2 weeks (5 days on, 2 days off, 5 days on; 10 doses total) every 6 weeks Multiple sclerosis, Secondary progressive, progressive relapsing, or worsening relapsing-remitting; to reduce neurologic disability and/or frequency of clinical relapses: 12 mg/m(2) IV every 3 months; should not be administered to patients who have received a cumulative dose of 140 mg/m(2) or greater Ectopic pregnancy (unlabeled use): I.M.: 50 mg/m2 single-dose Age-related macular degeneration. Intravitreal: 1.25 mg (0.05 mL) monthly until improvement/resolution, usually ~1-3 injections (Avery, 2006) or 2.5 mg (0.1 mL) every 4 weeks for 3 doses Glaucoma surgery (unlabeled use): 0.2-0.5 mg (0.2-0.5 mg/mL solution). Glaucoma surgery (unlabeled route): Apply to pledget and place in contact with surgical wound for 2-5 minutes (doses and techniques may vary) Glaucoma: 5 mg subconjunctival injections in various dosing protocols has been used Pleural sclerosing: Intrapleural: 60 units as a single instillation (some recommend limiting the dose in the elderly to 40 units/m2; usual maximum: 60 units). Dose may be repeated at intervals of several days if fluid continues to accumulate (mix in 50-100 mL of NS); Lupus nephritis: Adult usual dose is 1 g/m(2)/month IV. Peds 500 to 750 mg/m(2)/month IV, titrate to 1 g/m(2)/month JRA/vasculitis: I.V.: 10 mg/kg every 2 weeks SLE: I.V.: 500-750 mg/m2 every month; maximum dose: 1 g/m2 Juvenile rheumatoid arthritis (peds): Oral, I.M.:10 mg/m2 once weekly, then 5-15 mg/m2/week as a single dose or as 3 divided doses given 12 hours apart Rheumatoid arthritis (Moderate to Severe), In combination with methotrexate, in patients who had an inadequate response to one or more tumor-necrosis-factor antagonist therapies: 1000 mg IV followed by a second 1000 mg IV dose 2 weeks later; MAX: a total of 2 doses; used in combination with methotrexate Anti-rejection kidney

Hematology

Decitabine

Dacogen

Neurology Ob/Gyn

Mitoxantrone Methotrexate

Novantrone

Ophthalmology

Bevacizumab

Avastin

Ophthalmology

Mitomycin

Mutamycin

Ophthalmology

Fluorouracil

Adrucil

Pulmonary Renal/ Rheumatology Rheumatology Rheumatology Rheumatology

Bleomycin sulfate Cyclophosphamide Cyclophosphamide Cyclophosphamide Methotrexate

Blenoxane Cytoxan Cytoxan Cytoxan

Rheumatology Transplant

Rituximab Cyclophosphamide

Rituxan Cytoxan

347

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No. Chapter 45 Subject: MEDICATION ORDERS FOR CONTRAST MEDIA FOR IMAGING PROCEDURES Page 1 of 4

Prepared by: James Shanahan__________ Lily Ann Jeu, PharmD_______ Reviewed by: Hyman Shwarzberg, M.D.____ Roger Holt, M.D.___________ Dianne Woods, RN________ Salvatore Sclafani, M.D._____ P&T Committee Medical Executive Committee Approved by: Nicholas Galeota, MS, RPh__ Anny Yeung, RN, MPA_____ Margaret Jackson, MA, RN__ David Conley, MBA________ Stanley Fisher, M.D._______ Michael Lucchesi, M.D._____ Debra D. Carey, MS_______

Original Issue Date Supersedes: Effective Date:

12/07 NEW 12/07

The JC Standards:

MM.4.10

Issued by: Regulatory Affairs

I.

PURPOSE To expedite ordering and performance of procedures requiring radiocontrast and to facilitate the pharmacy review of medication orders for contrast media

II.

POLICY The Physician ordering an imaging procedure that requires contrast shall order the contrast in RIS at the same time as the procedure. The RIS shall prompt the ordering physician with the safety information necessary to make a risk-benefit analysis of the order. The Ordering Physician may, as needed, consult with the radiologist and the radiologist will be considered the supervisor of the imaging study.

348

Orders for contrast media in RIS shall be based on radiologist-approved protocols. These orders shall contain the required elements for medication orders (medication name, dose, route, frequency, duration) as per the Patient Medication Orders policy. For contrast media not ordered via the approved protocols, a radiologist and/or pharmacist shall review the order prior to administration, as applicable. Before the administration of contrast media, a pharmacist reviews the medication orders, except when the medication is urgently needed and a delay in medication administration may harm the patient or licensed independent practitioner supervises the patient during and after administration of IV contrast. In the event of an adverse reaction to a patient during the administration of contrast, the radiologist and the physician ordering the imaging study shall be notified. The ED physician provides supervision of the patient for timely intervention in the event of a patient emergency. The hospital code team shall be called to respond to patients with severe reactions to contrast media. III. DEFINITION(s) Studies requiring Contrast: • MRI and CT Studies with contrast (Some are done without contrast). • Gastrointestinal Imaging Procedures • Genitourinary Imaging Procedures • Interventional Radiology Approved contrast media protocols (including agent, dose, route of administration) as indicated on attached lists. RIS: Radiology Information System Protocolling of cases: Radiologist decision as to the methodology to be used for imaging, including the use of contrast. IV. RESPONSIBILITIES Ordering Physician: Orders procedure, orders contrasts associated with the procedure, reviews contraindication and safety information associated with the contrast order, makes a risk/benefit judgment regarding the use of contrast. Radiologist: Protocols the case in RIS in a timely manner. In the case of off-hours coverage where the radiologist is not present at UHB, protocolling shall be done verbally. Technologist: Records the protocol in RIS for verbal orders and performs the imaging procedure in accordance with the protocol. Nurse: Administers the contrast material as ordered by the Licensed Independent Practitioner ordering the procedure and contrast. The Nurse is authorized to instruct the patient on holding the regular doses of metformin as it relates to the use of contrast. Pharmacist: Verifies and reviews order for contrast media for completeness. Pharmacist screens patient medication profile for allergies, contraindications, and drug interactions according to the policy, “Verification and Review of Prescription Orders.” For patients 349

actively receiving metformin according to the medication profile and who have been prescribed intravenous contrast media, the pharmacist shall contact the patient’s primary care team to discontinue metformin for 48 hours after administration of IV contrast (as recommended by the manufacturer). V. PROCEDURES/GUIDELINES 1. CT, MRI, or GI/GU Exams are ordered and Contrast selected by ordering MD in RIS from the NS or Clinic or Outpatient arrives with MDs written request for CT. MRI, Nuclear, or GI/GU Exams. All hand written requests are scanned in to be reviewed by Radiologist 2. All requests are scheduled in RIS. 3. Radiologist opens Approve/Protocol Queue. By selecting a Patient, the Reason for Exams, Contrast Selection & Order Comments popup. A. If Approve is selected a screen opens for a. Selection of protocol from list b. Selection of Contrast for Outpatients c. Review of Contrast ordered by Nursing Stations and Clinics d. Proceed to next patient for approval e. If emergency, flag as STAT. Exam is then flagged by RIS to let the staff know that it was approved & Protocolled & is ready to be performed. Protocols & Contrast selections can be viewed from today’s schedule & Tech Worklist and can be printed. Printed request will display protocol, contrast, dosage and the approving MD. B. If Reject is selected a screen opens with possible rejection reasons including: a. Inadequate History b. Inappropriate exam ordered c. MRI Suggested d. CT Suggested e. Sono suggested f. Pt. has Allergies g. Not medically necessary h. MRI contraindicated i. A Free Text Entry
4. If Radiologist is not in the CT vicinity, technologist pages the Radiology

Resident/Radiologist. The radiology resident opens the queue remotely and reviews the requested contrast study. A radiologist is available by telephone for consultation, if needed. The technologist reads the request to the radiology resident and takes a telephone order from the radiology resident to approve or reject the exam. If the exam has been approved, the technologist enters protocol information in RIS, does a read-back to verify the order and then finalizes the order. 5. Upon approval of an imaging study that requires contrast media, the order for contrast media shall be sent to the pharmacy department. 6. Nurse administers contrast as per protocol. 7. For patients receiving IV contrast media, the physician and/or nurse instructs the patient to hold his/her metformin or metformin-containing medication the day of the study and until 48 hours after the study. They should have their labs evaluated by their physician before restarting the held medication. 350

XV.

ATTACHMENTS CT/MRI Contrast Media Orders Diagnostic Radiology Contrast Media Orders Adult Code Team Activation Criteria

VII.

REFERENCES “Interim Action for Standard MM 4.10, Element of Performance 1, for Critical Access Hospitals and Hospitals. Modifications for the Emergency Department and Radiology Practitioners.” Joint Commission Perspectives. January 2007: 9. UHB Policy on “Patient Medication Orders” (PHA-02) UHB Policy on Rapid Response Code Team Activation Pharmacy Department Policy on “Verification and Review of Prescription Orders” (Ch 4, Section G) Pharmacy Department Policy on “Look-alike, Sound-alike Drugs” (Ch 42)

Date Reviewed

Revisi on

Required (Circle One) No No No No

Responsible Staff Name and Title

351

RIS Work flow for Protocal of Contrast cases
ED Cat Scans are done as ordered . N o approval or scheduling necessary . O rders go directly to Tech w orklist . ED w ill Select protocol & contrast from a drop dow n list w hen ordering exam CT . M RI, or G I /G U Exams are ordered & Contrast selected by ordering M D . in RIS from the N S or Clinic .

O utpatient arrives w ith M D s w ritten request for CT. M RI, N uclear , Sonography or G I /G U Exams . A ll hand w ritten requests are scanned in to be review ed by Radiologist .

A ll requests are scheduled in RIS

Radiologist on duty at U H B ?

Yes

Radiologist opens A pprove /Protocol Q ueue . By selecting a Patient the Reason for Exams , Contrast Selection & O rder Comments popup .

No

Radiologist Selects A pprove or R eject & validates by selecting his /her name from drop dow n list If A pprove is selected a screen opens for 1 . Selection of protocol from list 2 . Selection of Contrast for O ut patients 3 . Review of Contrast ordered by N S , CL 4 . Precede to next patient for approval 5 . If emergency , flag as STA T . Exam is then flagged by RIS to let the staff know that it w as approved & Protocoled & is ready to be performed . Protocols & Contrast selections can be view ed from today’s schedule & Tech Worklist and can be printed . Printed request w ill display protocol , contrast , dosage and the approving M D . M edication order prints in pharmacy .

Exam is protocoled by phone & Contrast review ed by our Radiologist or Resident

If R eject is selected a screen opens w ith possible rejection reasons including : 1. Inadequate H x 2. Inappropiated exam ordered 3. M RI Suggested 4. CT Suggested 5. Sono suggested 6. Pt . has A llergies 7. N ot medically necessary 8. M RI contraindicated 9. A Free Text Entry

Technician enters Protocol and selects radiologists name in RIS .

Clerical Staff w ill arrive Pt in RIS w hen Pt comes to modality

Pharmacy review s all Contrast orders .

Floor is notified by RIS w ith reason for Rejection

The exams goes to Tech Worklist w here protocol & contrast selection can be view ed by technologist .

Tech closes exam in RIS . Technical charge is dropped & exams goes to TA LK for dictation .

Draft 12/07 Diagnostic Radiology Contrast Media Order Form
Radiologist checks box to order contrast media. Doses may be repeated up to maximum prn radiologist request.

Patient Name: _________________________________ Medical Record #: _____________ Allergies:  NKDA



______
Exam
Angiocardiography, Angiography, or Arteriography Visipaque (Iodixanol, 320 mg iodine/mL)  Adult Dose: 10 mL intra-arterial x 1 dose. May repeat dose up to maximum 5ml/kg patient weight intra-arterial. Patient weight: __________. Maximum dose: __________ mL.  Patient requires increased dosage of contrast due to_______________________________  Pediatric Dose: 2 mL/kg intra-arterial x 1 dose. Patient weight: __________. Dose = ______ mL. May repeat dose up to maximum 4 mL/kg intra-arterial prn radiologist request. Maximum dose: _________ mL. Omnipaque (Iohexol, 300 mg iodine/mL) Adult Dose: 50 mL IV x 1 dose. May repeat dose up to 3-5 mL/kg patient weight IV prn radiologist request. Patient weight: __________. Maximum dose: __________ mL.  Patient requires increased dosage of contrast due to _______________________________________  Pediatric Dose: 2 mL/kg IV x 1 dose. Patient weight: __________. Dose = __________ mL. ®  Sol-O-Pake (Barium sulfate for suspension, 99% w/w) Preparation: Add 500 mL water to 454 grams powder contrast in enema bag and shake vigorously 30 seconds. Wait 5 minutes, then add water to make 2000 mL final volume (23% w/v, 19% w/w). Dose: 2000 mL PR x 1 dose via enema bag. Shake well before administration. ®  Liquid Polibar Plus (Barium sulfate suspension, 105% w/v, 58% w/w) Dose: 700 mL (undiluted) PR x 1 dose via enema kit. ®  1) E-Z-HD (Barium sulfate for suspension, 98% w/w) Preparation: Add 65 mL water to 340 grams powder contrast in bottle and mix. Shake vigorously 30 seconds. Wait 5 minutes, then reshake thoroughly to make 135 mL suspension (85% w/w, 250% w/v). Dose: 135 mL PO x 1 dose. Shake well before administration. ®  2) Varibar Pudding (Barium sulfate esophageal paste, 40% w/v, 30% w/w) Dose: 2 tablespoonsful PO x 1 dose. May repeat dose up to maximum 3 tablespoonsful PO as per MD. ®  1) Entero-H (Barium sulfate suspension, 80% w/v, 49% w/w). Dose: 500 mL (undiluted) PO x 1 dose. ®  2) Hydroxypropyl Methylcellulose (after Entero-H administration) Preparation: Mix 500 mL methylcellulose solution with 1500 mL water in feeding bag. ® Dose: 500 mL PO x 1 dose after Entero-H dose ®  Entero-H (Barium sulfate suspension, 80% w/v, 49% w/w) ® Preparation: Dilute 1 part Entero-H in 3 parts water. Dose: 1000 mL PO x 1 dose. ®  Visipaque (Iodixanol, 320 mg iodine/mL) Dose: 10 mL intra-arterial x 1 dose. May repeat up to maximum 150 mL intra-arterial. ®  Gastrografin (Diatrizoate meglumine 660 mg/Diatrizoate sodium 100 mg per mL). Dose: 20 mL PO/NG/G tube x 1. Repeat as necessary as per MD up to maximum 60 Ml ®  E-Z-HD (Barium sulfate for suspension, 98% w/w) Preparation: Add 65 mL water to 340 grams powder contrast in bottle and mix. Shake vigorously 30 seconds. Wait 5 minutes, then reshake thoroughly to make 135 mL suspension (85% w/w, 250% w/v). Dose: 135 mL PO x 1 dose. Shake well before administration. ®  Liquid E-Z-Paque (Barium sulfate suspension, 60% w/v, 41% w/w) Dose: 150 mL PO x 1 dose. Shake well before administration.
®

Check Box to Order Contrast Medium

Angiocardiography, Angiography or Arteriography



Barium Enema, Single Contrast Barium Enema with Air, Double-Contrast Barium Swallow

Enteroclysis with Methylcellulose, DoubleContrast Enteroclysis, SingleContrast ERCPs, T-tubes G-tube Placement GI Series, Double Contrast

GI Series, Single-Contrast GI Tract Visualization

 Gastrografin (Diatriazoate meglumine 660 mg/Diatriazoate sodium 100 mg per mL)
Preparation: Dilution of 1:1 recommended for patients < 10 years old. Dilution of 1:3 recommended for patients < 10 kg body weight. May dilute in water, carbonated beverage, or milk.  Age < 5 years. Dose: 30 mL PO x 1 dose  Age 5-10 years. Dose: 60 mL PO x 1 dose ®  Sinografin (Diatrizoate meglumine 527 mg/Iodipamide meglumine 268 mg per mL) Dose: 10 mL injection for hysterosalpingography x 1 dose. May repeat dose up to maximum 20 mL. ®  Omnipaque (Iohexol, 300 mg iodine/mL). Dose: 50 mL IV x 1 dose.

Hysterosalpingography Intravenous Urography Pelvic Studies Retrograde Cystourethrography

Small Bowel Series

 Rectal READI-CAT via CAT-PAK. Dose: 400 mL suspension PR x 1 dose ® Hypaque-Cysto 240 (Diatrizoate meglumine, 141 mg iodine/mL; 30% w/v) ® Preparation: Dilute 200 mL Hypaque-Cysto to 500 mL with sterile water for injection.  Age < 3 years. Dose: 20 mL injection into bladder x 1 dose. May repeat dose up to maximum 50 mL.  Age 3 - 8 years. Dose: 150 mL injection into bladder x 1 dose. May repeat dose up to maximum 180 mL.  Age > 8 years. Dose: 200 mL injection into bladder x 1 dose. May repeat dose up to maximum 300 mL. ®  Entero Vu 24% (Barium sulfate suspension, 24% w/v, 20% w/w) Dose: 600 mL PO x 1 dose, within 15 minutes of radiography. Shake well.

For patients receiving IV contrast and taking metformin or metformin-containing medications, patient was instructed to discontinue these agents for 48 hours after receiving IV contrast. Check one:  Yes  No  Not Applicable

Radiologist Name and Signature: ____________________________________________________ Date: _____________ Time: __________ Nurse Signature: __________________________________________________________________ Date: _____________ Time: __________

Return Fax

#:___________

Pharmacist Initials: ________________ Date: ________ Time: ________

353

PILOT 12/07 CT/MRI Contrast Media Order Form Radiologist checks box to order contrast. Doses may be repeated up to maximum prn radiologist request. Patient Name: ____________________________________ Medical Record #: __________ Allergies:  NKDA ________
Exam
Abdomen Studies

Check Box to Order Contrast Medium Computed Tomography
 Oral READI-CAT (Barium sulfate suspension, 1.3% w/v, 1.2% w/w) Dose: 300 mL suspension PO x 1 dose 60 minutes before scan and 150 mL PO x 1 dose prior to scan. May repeat dose up to maximum 2000 mL PO prn radiologist request.  Rectal Gastrografin (Diatriazoate meglumine 660 mg/Diatriazoate sodium 100 mg per mL) Preparation: Dilute 30 mL to 1 liter with tap water. Dose: 400 mL solution PR x 1 dose. May repeat up to 1 liter prn radiologist request. Omnipaque (Iohexol, 300 mg iodine/mL) Adult Dose: 50 mL IV x 1 dose. May repeat dose up to 200 mL IV prn radiologist request. Pediatric Dose: 2 mL/kg IV x 1 dose. Patient weight: __________. Dose = __________ mL. ® Visipaque (Iodixanol, 320 mg iodine/mL)  Adult Dose: 10 mL intra-arterial x 1 dose. May repeat dose up to maximum 150 mL intra-arterial.  Pediatric Dose: 2 mL/kg intra-arterial x 1 dose. Patient weight: __________. Dose = ______ mL. May repeat dose up to maximum 4 mL/kg intra-arterial prn radiologist request. Maximum dose: _________ mL. Omnipaque 300 (Iohexol, 300 mg iodine/mL)  Adult Dose: 50 mL IV x 1 dose. May repeat dose up to maximum 200 mL IV prn radiologist request.  Pediatric Dose: 2 mL/kg IV x 1 dose. Patient weight: _________. Dose: ________ mL. Visipaque (Iodixanol, 320 mg iodine/mL)  Adult Dose: 100 mL x 1 dose. May repeat up to maximum 150 mL IV prn radiologist request.  Pediatric Dose: 2 mL/kg IV x 1 dose. Patient weight: _________. Dose: ________ mL. May repeat dose up to maximum 4 mL/kg IV prn radiologist request. Maximum dose: _____ mL.  VoLumen (Barium sulfate suspension, 0.1% w/v, 0.1% w/w) Dose: 900 mL PO x 1 dose within 45-60 minutes prior to scan. Recommended rate 150 mL every 5 mins. May repeat dose up to maximum 1800 mL PO prn radiologist request. ® Visipaque (Iodixanol, 320 mg iodine/mL)  Adult Dose: 10 mL intra-venous x 1 dose. May repeat dose up to maximum 5ml/kg patient weight intra-arterial. Patient weight: __________ Maximum dose: __________ mL.  Patient requires increased dosage of contrast due to _______________________________________  Pediatric Dose: 2 mL/kg intra-arterial x 1 dose. Patient weight: __________. Dose = ______ mL. May repeat dose up to maximum 4 mL/kg intra-arterial prn radiologist request. Maximum dose: _________ mL.  Gastrografin (Diatriazoate meglumine 660 mg/Diatriazoate sodium 100 mg per mL) Preparation: Dilute 30 mL to 1 liter with tap water. Dose: 240 mL of diluted solution PO x 1 dose 15-30 minutes prior to imaging. May repeat dose up to maximum 2000 mL PO prn radiologist request. Magnetic Resonance Imaging  Omniscan (Gadolinium or Gadodiamide, 287 mg/mL) Dose: 0.1 mL/kg IV x 1 dose. Patient weight: __________ Dose = __________ mL. May repeat dose up to 0.4 mL/kg IV prn radiologist request. Max dose: ______ mL.  GastroMark (Ferumoxsil oral suspension, 175 micrograms iron/mL) Dose: 600 mL PO x 1 dose at rate of 300 mL over 15 minutes. May repeat up to 900 mL PO.

Abdomen/Pelvic Studies

Angiocardiography, Angiography or Arteriography Angiocardiography, Angiography or Arteriography Contrast-Enhanced CT

 

Contrast-Enhanced CT

GI Tract

Lower/Upper Extremity or Central Venography

Tomography (CT of Torso)

Contrast-Enhanced MRI

GI Tract

For patients receiving IV contrast and taking metformin or metformin-containing medications, patients should be instructed to discontinue these agents for 48 hours after receiving IV contrast. Check one:  Yes  No  Not Applicable
Radiologist Name and Signature: ____________________________________________________ Date: _____________ Time: __________ Nurse Signature: __________________________________________________________________ Date: _____________ Time: __________

Return Fax

#:___________

Pharmacist Initials: ________________ Date: ________ Time: ________

354

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No. Chapter 46 Subject: FOR TITRATION OF MEDICATION CONTINUOUS INFUSION Prepared by: Theresa Chan, Pharm.D. Reviewed by: Dianne Woods, RN__________ Cheryl Okundaye, RN________ Alan Hui, Pharm.D., BCPS Approved by: Nicholas Galeota, MS, RPh___ Anny Yeung, RN, MPA_____
Related Policies

Page

1

of

3

Original Issue Date Supersedes:

1/08 NEW

Effective Date: The JC Standards:

1/08

MM.3.20

Margaret Jackson, MA, RN__ David Conley, MBA________ Stanley Fisher, M.D._______ Michael Lucchesi, M.D._____ Debra D. Carey, MS_______

PHA-2 Patient Medication Order

Issued by: Regulatory Affairs

I.

PURPOSE • To delineate responsibility and provide clinical guidelines/indicators in monitoring patient’s response to medications requiring continuous infusion, which includes the first dose of a new medication. To establish clinical parameters to monitor and/or titrate such medications administered to patients.



II.

POLICY

It is the policy of University Hospital of Brooklyn to ensure that safe and therapeutic medication practices are utilized. This includes but is not limited to appropriate medication procedures/ guidelines for prescribing, preparation, administration, titration, and monitoring. III. DEFINITION 355

Titration of continuous infusion medications refers to adjusting the rate of the infusion to meet parameters set by the clinical practitioner. Typical medications requiring titration includes vasoactive agents, analgesics, sedatives, paralytics, anticoagulants, antiarrhythmics, antihypertensives, and hypoglycemics. IV. CHARACTERISTICS OF MEDICATION ORDERS FOR CONTINUOUIS INFUSION

Orders for drugs administered via continuous IV infusion must specify the following: • The name of the drug • The amount of the drug in a specific volume of diluent • The diluent used for dilution • Standard concentration as listed on the SUNY Downstate Critical Care drip chart or by manufacturer guidelines shall be used for all continuous infusion medications. • The administration route and initial rate of infusion expressed as dose per unit time (e.g. mg/hr, unit/hr) or dose per kilogram weight per unit time (e.g. mcg/kg/min or mg/kg/hr). • Orders containing ONLY volume per time (e.g. mL/hr or mL/min) are unacceptable due to potential medication errors • The duration of therapy (must comply with the Automatic Medication Stop Order Policy) • Monitoring parameter(s) according to subjective (e.g. sedation or pain) and/or objective (e.g. hemodynamic or laboratory) goals or statement to notify prescriber when such parameters are out of range or unable to reach must be specified on the medication order V. RESPONSIBILITIES Prescriber: • It is the responsibility of the prescribing healthcare practitioner to ensure that the complete medication orders complies with the Patient Medication Order policy (PHA2) and must write medication orders for continuous infusion containing the above characteristics. Any orders lacking the above information shall be referred back to the prescriber for correction or completion. Nursing: • It is the responsibility of the registered nurse to check all medication orders for completeness prior to acknowledging and transcribing orders. The Registered Nurse caring for a patient is responsible for the monitoring, titration, and documentation of response to medications. This is particularly important when a patient is to receive the first dose of a new medication. Pharmacist: • It is the responsibility of the registered pharmacist to verify any medication order for appropriateness and safety. The registered pharmacist shall dispense the medication after appropriateness and safety of the medication order has been confirmed. The Pharmacist will also be a source of drug information. VI. PROCEDURES/GUIDELINES 1. All critical care areas (ED, MICU, CTICU, CCU, OR, PACU and Stepdown) may use continuous intravenous medications. Any medications requiring continuous infusion must have critical care monitoring. 356

2. All non-critical care areas with cardiac monitoring may infuse continuous intravenous medications with appropriate equipment and personnel. 3. ALL medications requiring titration and continuous monitoring shall be infused using the smart infusion pumps in ALL areas. 4. Upon administering the first dose of a new medication to a patient, the nurse is responsible for observing the patient‘s response to the medication for therapeutic and adverse effects. Monitoring parameters are defined either within the order itself or by protocol. 5. The frequency of monitoring for the effect of medications will be determined by the clinical discretion of the prescriber and nurse, the clinical condition of the patient, and clinical standards of the medications. Established protocols may also dictate frequency of monitoring. 6. In addition, the nurse shall elicit subjective and objective information including, patient vital signs and other appropriate parameters as necessary. This information shall be documented in the patient flow sheet or nursing progress note. VII. REFERENCES JCAHO Medication standard SUNY Downstate Standard Critical Care IV Drip Chart Micromedex Handbook of Injectable Drugs 14th edition by Lawrence Trissel Lippincott’s Critical Care Drug Guide Revision Required (Circle One) YES YES YES NO NO NO

Date Reviewed

Responsible Staff Name and Title

357

SUNY Downstate Medical Center - Department of Pharmacy PLEADE NOTE: SUNY Downstate Medication Policy does NOT accept range orders. Dosing ranges are provided for references ONLY. STANDARD CRITICAL CARE IV DRIP DILUENT MEDICATIONS STANDARD DILUTIONS PREPARATION DOSAGE RANGES S
ALTEPLASE (tPA) for pulmonary embolism AMIODARONE (CORDARONE®) ARGATROBAN CISATRACURIUM (NIMBEX®) DILTIAZEM (CARDIZEM®) DOBUTAMINE (DOBUTREX )
®

100 mg/100 mL (1 mg/mL) 450 mg/250 mL (peripheral line) (1-6mg/mL, central line for high concentration) 250 mg/250 mL 100 mg/100 mL 125 mg/125mL 500-1000 mg/250 mL 500 mg/250 mL (premix) 400-800 mg/250 mL 400 mg/ 250 mL D5W (premix) 2-4 mg/250 mL 2 g/100mL (premix) 1250 mcg/250 mL (premix) 250 mg/50-250 mL (1-5mg/mL) 25,000 Units/250 mL (premix) 100 Units/100 mL 100-300 mg/100 mL (1.25-3.75mg/mL) 1-2g/250mL 40 mg/40 mL or 60mg/60 mL (1mg/mL) 100 mg/50 mL (2mg/mL) (premix)

Sterile Water D5W NS D5W or NS D5W or NS D5W or NS D5W or NS D5W or NS NS NS D5W or NS D5W NS D5W or NS D5W or NS D5W preferred NS D5W D5W or NS D5W or NS NS D5W or NS D5W or NS D5W preferred D5W preferred D5W or NS D5W or NS D5W or NS

100 mg in 100 mL Loading: 150 mg/100 mL (bag) Maintenance: 450 mg/250 mL (USE GLASS BOTTLE) 250 mg (2.5 mL) in 250 mL 100 mg (50 mL) in 50 mL 125 mg (25 mL) in 100 mL 500 mg (40 mL) in 210 mL 400 mg (10 mL) in 240 mL 2-4 mg (2-4 mL) in 250 mL Not Applicable Not Applicable 250 mg (25 mL) in 225 mL Not Applicable 100 units (1 mL) in 100 mL 1:1 = 100 mg (20 mL) in 80 mL 2:1 = 200 mg (40 mL) in 60 mL 1000 mg (50 mL) in 200 mL 40 mg (10 mL) in 30 mL 60 mg (20 mL) in 40 mL Not Applicable Not Applicable 50 mg (5 mL) in 45 mL 1.5 mg (5 mL) in 245 mL 80 mg/100 Ml 25 mg (10 mL) in 240 mL 125 mg (50 mL) in 200 mL Not Applicable 50 mg (2 mL) in 250 mL 4 mg ( 4mL) in 250 mL 8 mg (8 mL) in 242 mL 500 mcg in 100 mL 20 mg (2 mL) in 250 mL 1 gm (10 mL) in 240 mL

100 mg over 2 hours Loading= 150mg IV bolus over 10min Maintenance= 1mg/min X 6hrs then 0.5mg/min X 18hrs (max 2.2g/day) 0.5–2 mcg/kg/min (Titrate to target PTT) Initial: 0.08-0.1 mg/kg (IBW) IV bolus. (Higher initial doses-up to 0.3 mg/kg-may be used for rapid onset Maintenance: 0.01-0.015 mg/kg q25 to 45min prn 1-3 mcg/kg/min (titrate to Train Of Four) 5-15mg/hr 2-20mcg/kg/min (titrate) 5-10 mcg/kg/min (beta-1) ≥10mcg/kg/min (α) Shock: 1-10mcg/min (titrate) Loading= 500mcg/kg over 1min, Maintenance= 50-200mcg/kg/min (titrate) 25-500mcg/hr (titrate) 5-10mg/hr (titrate) Heparin weight-based nomogram(Titrate to target PTT) Titrate 0.25-3 mg/min (titrate) 1-4mg/min 0.5-10 mg/hr (titrate slowly) 2-10mg/hr (titrate) 0.375 → 0.5 → 0.75mcg/kg/min (reduce dose in renal insufficiency) 1-10mg/hr (titrate) Bolus= 2mcg/kg over 60 second; infusion= 0.01mcg/kg/min 80 mg IV bolus then infuse at 8 mg/hr Initial: 5 mg/hr, increase by 2.5 mg/hr to maximum dose of 15 mg/hr 5-200mcg/min (titrate) 0.5-10mcg/kg/min (titrate) 1-30mcg/min (titrate) 25-50mcg/hr 40-200 mcg/min (titrate) 1-4mg/min

DOPAMINE EPINEPHRINE ESMOLOL (BREVIBLOC )
®

FENTANYL FUROSEMIDE (LASIX®) HEPARIN INSULIN LABETALOL LIDOCAINE LORAZEPAM (ATIVAN®) MIDAZOLAM (VERSED )
®

MILRINONE (PRIMACOR )
®

20 mg/100 mL (premix) 50mg/50mL or 100mg/100mL (1mg/mL) 1.5 mg/250 mL 80 mg/100 mL 25 mg/250 mL (peripheral) 125 mg/250 mL (central) 100 mg/250 mL (premix bottle) 50-100 mg/250 mL 4-16 mg/250 mL 500 mcg/100 mL 20-40 mg/250 mL 1-2 g/250 mL

MORPHINE NESIRITIDE (NATRECOR®) (NEXIUM®) ESOMEPRAZOLE NICARDIPINE (CARDENE )
®

NITROGLYCERIN (TRIDIL ) NITROPRUSSIDE (NIPRIDE®)
®

NOREPINEPHRINE (LEVOPHED®) OCTREOTIDE (SANDOSTATIN ) PHENYLEPHRINE (NEO-SYNEPHRINE®) PROCAINAMIDE (PRONESTYL®)
®

PROPOFOL (DIPRIVAN®) VASOPRESSIN (PITRESSIN®) VECURONIUM (NORCURON®)

500 mg/50 mL (premix bottle) 60 Units/100 mL 10-20 mg/100 mL

Lipid emulsion D5W or NS D5W or NS

Not Applicable 60 Units (3 mL) in 100 mL 10 mg (10 mL) in 90 mL

5-50mcg/kg/min (titrate) Vasodilatory shock= 0.04 Units/min (do NOT titrate) 0.5-1.7 mcg/kg/min (titrate to Train Of Four)

(7/04,12/04,3/06, 10/07, 11/07)

Initial Treatment Protocol for Extravasation Injuries with Antineoplastic Drugs
Local Care
For all injuries: 1. Stop infusion. 2. Aspirate residual drug through access device. 3. Elevate extremity. 4. Avoid applying pressure to extravasation site. 5. See recommendations for agent-specific treatments. Agent-specific treatments 1. Apply cold or hot protocol, as listed below.

 

Cold Protocol: Apply cold to area for 15-60 minutes at least 4 times per day for 24-48 hours.

Warm Protocol: Apply warm pack to area for 15-20 minutes at least 4 times per day for 24-48 hours. 2. Follow additional local care instructions listed.

Agent-Specific Treatments
Medication Name ® Actinomycin D (Cosmegen ) ® Carboplatin (Paraplatin ) Carmustine (BiCNU) ® Cisplatin (Platinol ) Additional Local Care Cold protocol No specific recommendations No specific recommendations No specific recommendations Antidote Preparation and Administration None routinely recommended None routinely recommended None routinely recommended Sodium thiosulfate In a syringe, mix 1.6 mL of 25% sodium thiosulfate with 8.4 mL sterile water. Inject 2 mL sodium thiosulfate subcutaneously for each 100 mg cisplatin extravasated into tissue surrounding site with multiple injections. None routinely recommended None routinely recommended Dimethyl sulfoxide 99% Apply 1-2 mL of 99% dimethyl sulfoxide with gauze to affected site every 6 hours. None routinely recommended None routinely recommended None routinely recommended Dimethyl sulfoxide 99% Apply 1-2 mL of 99% dimethyl sulfoxide with gauze to affected site every 6 hours. Hyaluronidase (150 units/mL) [REFRIGERATOR] Inject 1 mL of hyaluronidase (150 units) subcutaneously into site with multiple injections for each 1 mL extravasated. None routinely recommended None routinely recommended Dimethyl sulfoxide 99% Apply 1-2 mL of 99% dimethyl sulfoxide with gauze to affected site every 6 hours. Dimethyl sulfoxide 99% Apply 1-2 mL of 99% dimethyl sulfoxide with gauze to affected site every 6 hours. None routinely recommended Sodium thiosulfate In a syringe, mix 1.6 mL of 25% sodium thiosulfate with 8.4 mL sterile water. Inject 2 mL sodium thiosulfate subcutaneously for each 1 mg mechlorethamine extravasated into tissue surrounding site with multiple injections. Dimethyl sulfoxide 99% Apply 1-2 mL of 99% dimethyl sulfoxide with gauze to affected site every 6 hours. None routinely recommended Sodium thiosulfate

Dacarbazine (DTIC-Dome ) Dactinomycin (actinomycin-D, ® Cosmegen ) Daunorubicin (Cerubidine ) ® Doxorubicin (Adriamycin ) Daunorubicin citrate liposome ® injection (DaunoXome ) ® Docetaxel (Taxotere ) Doxorubicin hydrochloride ® liposome injection (Doxil ) Epirubicin hydrochloride ® (Ellence ) Etoposide (VePesid )
® ®

®

Protect exposed tissues from light. Cold protocol Cold protocol Cold protocol Cold protocol Cold protocol Cold protocol Warm protocol

Fluorouracil (Adrucil ) Gemcitabine hydrochloride ® (Gemzar ) Idarubicin hydrochloride (Idamycin) Ifosfomide (Ifex ) Irinotecan hydrochloride ® (Camptosar ) Mechlorethamine hydrochloride (nitrogen ® mustard. Mustargen )
®

®

No specific recommendations No specific recommendations Cold protocol Cold protocol Cold protocol Remove IV access device.

Mitomycin (Mutamycin ) Mitoxantrone hydrochloride ® (Novantrone ) Nitrogen mustard

®

Protect area from sunlight. Cold protocol Cold protocol Remove IV access device.

Agent-Specific Treatments
Medication Name ® (Mustargen ) Additional Local Care Antidote Preparation and Administration In a syringe, mix 1.6 mL of 25% sodium thiosulfate with 8.4 mL sterile water. Inject 5 mL sodium thiosulfate subcutaneously into tissue surrounding site with multiple injections. None routinely recommended Hyaluronidase (150 units/mL) [REFRIGERATOR] Inject 1 mL of hyaluronidase (150 units) subcutaneously into site with multiple injections for each 1 mL extravasated. None routinely recommended Hyaluronidase (150 units/mL) [REFRIGERATOR] Inject 1 mL of hyaluronidase (150 units) subcutaneously into site with multiple injections for each 1 mL extravasated. None routinely recommended Hyaluronidase (150 units/mL) [REFRIGERATOR] Inject 1 mL of hyaluronidase (150 units) subcutaneously into site with multiple injections for each 1 mL extravasated.

Oxaliplatin (Eloxatin ) ® Paclitaxel (Taxol )

®

No specific recommendations Cold protocol

Pemetrexed (Alimta ) ® Teniposide (Vumon )

®

No specific recommendations Warm protocol

Topotecan hydrochloride ® (Hycamtin ) ® Vinblastine (Velban ) ® Vincristine (Oncovin ) ® Vinorelbine (Navelbine )

Cold protocol Warm protocol

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: Subject: Prepared by: MANAGEMENT OF EXTRAVASATION INJURIES LilyAnn Jeu, PharmD, BCPS Maureen McColl, PharmD Megan Sargeant, RN Nicholas Galeota, M.S., R.Ph. Cheryl Okundaye, RN Dianne Woods, RN MEC Original Issue date: 1/08 Supersedes: Approval date: Distribution: New CHAPTER 47

Reviewed by:

Approved by:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by:

P&T Committee

I.

Purpose: To standardize the list of drugs to be provided in extravasation kits for treatment of extravasation injuries with antineoplastic agents. To standardize the accessibility of antidotes for extravasation injuries from non-antineoplastic agents. To provide guidelines for preparation and administration of pharmacologic treatments for extravasation injuries. Definition(s): Extravasation is the inadvertent leakage or escape of a drug or solution from a vein or unintentional injection surrounding healthy tissues. Antineoplastic agents (or chemotherapy) are those used to treat oncology disorders. This policy relates to such agents that may become extravasated through intravenous administration. Antidotes for antineoplastic extravasation injuries are the following: Hyaluronidase Dimethyl sulfoxide solution Sodium thiosulfate Approved protocols for treatment of antineoplastic extravasation injuries are attached and shall be included in chemotherapy extravasation kits (“Initial Treatment Protocol for Extravasation Injuries with Antineoplastic Drugs”). Antidotes for non-antineoplastic extravasation injuries are the following: Hyaluronidase Phentolamine Topical nitroglycerin ointment

II.

III.

Policy: Extravasation kits shall be stocked with antidotes (see attached list) that will be used for treatment of extravasation injuries due to antineoplastic agents. Extravasation kits shall be stored in the Ambulatory Chemotherapy Unit (in NS 62), Pediatric Ambulatory Oncology (Suite N), and Nursing Station 72. Refrigerated items shall be stored in refrigerators in the vicinity.

have not been tampered. Pharmacy personnel shall be called to remove the opened box and provide a replacement box. Each kit shall be labeled with the expiration date of the earliest expiring medication. Any box that will expire within one month shall be replaced by pharmacy personnel. Nurses shall inspect the expiration date at a minimum of the first Monday of every month. Pharmacy personnel shall also review expiration dates on a monthly basis. Protocols for treatment of chemotherapy extravasation injuries shall be approved jointly by Oncology, Pharmacy, and Nursing Departments. For chemotherapy extravasation injuries, nurses shall prepare and administer recommended initial treatments for chemotherapy extravasation injuries as per protocol included in the kit. For non-chemotherapy extravasation injuries, medication orders shall be written by a licensed independent practitioner to initiate pharmacologic treatment. Antidotes for non-chemotherapy extravasation injuries may be stored in automated dispensing units in nursing stations, as requested per unit. Otherwise, these medications shall be obtained from the main pharmacy. IV. Responsibilities: Pharmacists, pharmacy technicians Pharmacy personnel are responsible for the completeness and integrity of medications used for treatment of extravasation injuries. Pharmacy personnel are also responsible for maintaining records for the distribution of tamper-evident locks for chemotherapy extravasation kits provided to nursing staff. Registered nurses Registered nurses shall assess intravenous access sites for extravasation injury. In the event of an antineoplastic extravasation injury that requires treatment, the nurse shall initiate treatment per protocol, even prior to the arrival of a physician at the bedside. For non-antineoplastic extravasation injuries, nurses may obtain antidotes located in automated dispensing machines pursuant to a medication order for treatment. Providers (e.g., physicians, physician’s assistants, certified nurse practitioners, etc) Providers shall evaluate patients with suspected extravasation injuries. For injuries from antineoplastic agents, providers may prescribe additional therapies not included in the initial treatment protocol via medication orders as per the policy “Patient Medication Orders.” Medication orders shall be required for antidotes for non-antineoplastic extravasation injuries. V. Procedures/Guidelines: Registered Nurses 1. Monitor patients for signs and symptoms of extravasation injury. 2. If extravasation is recognized, stop infusion to the infiltrated site. If applicable, do not remove angiocatheter until after treatment. 3. Identify the fluids or medications that infiltrated to determine appropriate treatment strategy. 4. Notify prescriber to assess potential injury and to prescribe appropriate therapy. 5. For chemotherapy extravasation injuries, nurses may initiate treatment as listed in the “Initial Treatment Protocol for Extravasation Injuries with Antineoplastic Drugs” even prior to the arrival of the physician at the patient bedside, as needed. 6. Document extravasation event and treatment in the patient’s medical record. 7. Call extension 1890 to report adverse drug reaction to UHB Pharmacy Department. 8. Nursing staff shall check extravasation kits with each shift change to ensure the kit has not been opened and contents have not been tampered. The integrity of the lock is checked every shift and recorded. 9. Nursing staff shall check the expiration date for the kit at a minimum on the first Monday of each month. The expiration date is checked and recorded. Pharmacy shall be called for a replacement kit if the kit contents will expire within one month. 10. Manager of unit/nursing station will maintain signature log for checks on lock and expiration date for one year. (See “Extravasation Kit Checklist”.) 11. Extravasation kit will be kept in a secured area when not being used.

Pharmacy Department 1. Pharmacy personnel shall stock medications and supplies for chemotherapy extravasation kits according to the attached list. Guidelines for the preparation and administration of antidotes for chemotherapy extravasation kits shall also be included in the kit contents. ® 2. Each month, pharmacy personnel shall review expiration dates of the kits and antidotes placed in Pyxis . If a kit will expire within one month, pharmacy personnel shall remove the kit (and any refrigerated items that belong to the kit) and provide a replacement to the nursing unit or suite. 3. Medication orders for treatment of extravasation injuries shall be processed as per the policy, “Verification and Reviewing of Prescription Orders. 4. The Pharmacy Department shall investigate adverse drug reactions according to the policy, “Adverse Drug Reaction Reporting.” Providers 1. Treatment with medications for extravasation from non-antineoplastics shall require a medication order. Orders shall be written on the Prescriber’s Order Form, as per policy on “Patient Medication Orders.” 2. Guidelines for treatment with other antidotes are listed below for non-antineoplastic extravasation injuries: Extravasated Drug(s) Aminophylline Calcium salts Dextrose > 10% Mannitol > 5% Parenteral nutrition Phenytoin Contrast media Sodium bicarbonate 8.4% Sodium chloride > 0.9% Tetracycline Tromethamine (and other hyperosmolar and acidic or alkaline nonchemotherapeutic agents) Adrenergic/vasoactive agents: Dobutamine Dopamine Epinephrine Norepinephrine Phenylephrine Vasopressin Antidote Hyaluronidase (150 units/mL) Administer within 1 hour of IV extravasation to minimize tissue necrosis. Dose and Preparation of Antidote* Infants and children: Dilute to 15 units/mL by adding 0.1 mL of hyaluronidase 150 units/mL to 0.9 mL of 0.9% sodium chloride. Inject 0.2 mL aliquots subcutaneously or intradermally at the leading edges of the extravasation site. Change needle after each injection. Adults: May use undiluted hyaluronidse 150 units/mL or may dilute as above. Inject 150 units (1 mL undiluted) in 0.2-mL aliquots subcutaneously or intradermally along leading edges of the extravasation site. Dilute to phentolamine 0.5 mg/mL solution according to steps below: 1. Reconstitute powder with 1 mL 0.9% sodium chloride for concentration 5 mg/mL. 2. Add 0.1 mL of 5mg/mL phentolamine solution to 0.9 mL of 0.9% sodium chloride to make final concentration 0.5 mg/mL. 3. Inject 0.5 mg (1 mL) of phentolamine subcutaneously into site of infiltration in a circular fashion. Change needle after each injection. Neonates: Recommended dose 0.1 mg/kg. Maximum 2.5 mg total. Infants and children: Recommended dose 0.1-0.2 mg/kg. Maximum 5 mg total. Adults: Recommended dose 0.1-0.2 mg/kg. Maximum 10 mg total. If dose is effective, normal skin color should return to the blanched area within 1 hour. NOT for neonatal use.

Phentolamine (5 mg/vial) Vial holds 2 mL of fluid. Administer within 12 hours of IV extravasation.

Topical nitroglycerin 2% ointment

Apply thin layer to extravasated area (not to exceed total dose of one inch). * RN Note: Clean area with povidone-iodine prior to subcutaneous or intradermal administration of antidote. XVI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes Institutional/operational changes

VII.

Attachments: Chemotherapy Extravasation Kit Contents Initial Treatment Protocol for Extravasation Injuries with Antineoplastic Drugs Extravasation Kit Checklist References: UHB Policy on “Patient Medication Orders” (PHA-02) Pharmacy Department Policy on “Adverse Drug Reaction Reporting” (Chapter 9, Section E)
Polovich M, White JM, Kelleher LO, eds. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. Second Edition. Pittsburgh, PA: Oncology Nursing Society, 2005:78-88. Kohler DR. Antineoplastic Drugs: Preventing and Managing Extravasation. In: Boyiadzis MM, Lebowitz PF, Frame JN, Fojo T, eds. Hematology-Oncology Therapy. New York, NY: McGraw Hill, 2007:582-588. Reeves D. Management of Anthracycline Extravasation Injuries. Ann Pharmacol. 2007;41:1238-1242. Wichham R, Engelking C, Sauerland C, Corbi D. Vesicant Extravasation Part II: Evidence-Based Management and Continuing Controversies. Oncology Nursing Forum. 2006;33(6):1143-1150. Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook International. 13 Ed., 2006-2007. Hudson, OH: Lexi-Comp, Inc., 2006: 1542-1543. Zenk KE, Sills JH, Koeppel RM. Neonatal Medications and Nutrition A Comprehensive Guide. 3 Edition, NICU Ink, Santa Rosa CA 2003.
rd th

VIII.

Date Reviewed

Revision Required (Check One) Yes No Yes No

Responsible Staff Name and Title

Chemotherapy Extravasation Kit Contents
Check lock on kit with change of each nursing shift. Check expiration date on kit at least on the first Monday of every month. Call Pharmacy Department (x2854) if kit will expire within one month. Item Dimethyl sulfoxide 99% solution (100 mL) Sodium thiosulfate 25% (250mg/mL in 50 mL vial) Hyaluronidase (150 units/mL) Sterile water for injection (10 mL) 12-mL syringes 3-mL syringes 20-gauge needle 25-gauge needle Alcohol swabs 4 x 4 Sterile gauze sponges List “Initial Treatment Protocol for Extravasation Injuries with Antineoplastic Drugs” White tamper-evident seal Quantity 1 bottle 1 vial 2 vials 1 vial 2 syringes 2 syringes 3 needles 10 needles 6 swabs 6 sponges 1 copy 1 seal Special Instructions Must dilute prior to use. Must be refrigerated.

Secure kit after it has been opened and call pharmacy for replacement kit. Also, call x1890 to report an adverse drug reaction.

STATE UNIVERSITY OF NEW YORK DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN

EXTRAVASATION KIT CHECKLIST
Kit Location/Nursing Station: __________________ Lock Number: ________________ Kit Expiration Date: _______________

MONTH: ___________________________
Nurse checks integrity of kit and lock with change of each nursing shift and signs record below to indicate kit and lock are intact. Day tour (Tour II) nurse also checks expiration date on kit at least on the first Monday of every month. Call Pharmacy Department (x2854) for a replacement if kit will expire within one month.

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SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: Subject: Prepared by: FENTANYL PATCH LilyAnn Jeu, PharmD, BCPS Ed Porosnicu, MD Noelle Best, NP Carline Sainvil, RN Nicholas Galeota, M.S., R.Ph. Dianne Woods, RN Marilyn Resurreccion, MD Bonnie Arak-Druven, RN Michael Lucchesi, MD Margaret Jackson, MA, RN Issued by: I. Original Issue date: 5/08 Supersedes: New Approval date: Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual Regulatory Affairs CHAPTER 48

Reviewed by:

Approved by:

Purpose: To promote patient safety with the use of fentanyl patches for pain management. To delineate the process for safe application and disposal of fentanyl patches. Definition(s): Fentanyl patch (a.k.a. fentanyl transdermal system) is a high-concentration formulation of the Schedule II opiate pain medication fentanyl that is applied to the skin for treatment of persistent, moderate-to-severe pain for opioid-tolerant patients who require around-the-clock pain management for more than a few days. Opioid-tolerant patients should be receiving opioids for pain management on an around-the-clock schedule at the time fentanyl transdermal system is prescribed. Patients may be considered opioid tolerant if they have been receiving at least 60 mg of morphine per day or an equianalgesic dose of another opioid for at least one week or longer.

II.

III.

Policy: Fentanyl patches shall not be ordered for opioid-naïve patients. Fentanyl patches should not be used to treat sudden, occasional, or mild pain. Patches shall be applied and removed in accordance with guidelines to promote safe use of the patch. Patches shall be safely disposed after use to prevent unintended release of fentanyl remaining in the transdermal system. Responsibilities: Prescribers, Nurses, Pharmacists Procedures/Guidelines:

IV.

V.

1

Prescribing 1. Prescribers shall review the patients’ medication histories and clinical indications prior to ordering fentanyl patches for pain management. Fentanyl patches shall be ordered only for opioid-tolerant patients. 2. Fentanyl patches may be ordered for a maximum duration of 72 hours per inpatient medication order, as per the “Automatic Stop Order Policy.” 3. Due to potentially life-threatening hypotension, fentanyl transdermal system is contraindicated in the following situations: a. Patients who are opiate-naïve b. Patients with acute pain who require opioid analgesia for a short period of time c. Management of post-operative pain, including use after out-patient or day surgeries d. Management of mild pain e. Management of intermittent pain f. Situations of significant respiratory depression, especially in unmonitored settings with a lack of resuscitative equipment g. Patients with acute or severe bronchial asthma 4. Fentanyl transdermal system is also contraindicated in patients with known or suspected paralytic ileus or hypersensitivity to fentanyl or components of the transdermal system. 5. Fentanyl transdermal system is not recommended for patients younger than 2 years old. 6. Concomitant use of fentanyl and potent cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, nefazodone) may increase plasma concentrations of fentanyl and increase or prolong the potential for adverse effects. Dosage adjustment and/or additional monitoring of patients is recommended. 7. Fentanyl transdermal system is not recommended for use in patients who have received a monoamine oxidase (MAO) inhibitor within 14 days due to severe and unpredictable potentiation of fentanyl effects. 8. Changes in fentanyl patch dose should not be made until at least 24 hours after change in dose, unless the patient is experiencing side effects that warrant a dosage reduction. 9. Breakthrough pain medication should be ordered for patients receiving the fentanyl patch for pain management. Administration/Application 1. Clean intended site of application with plain, clear water, if necessary, and allow skin to dry completely. Do not use soaps, oils, lotions, alcohol, or any other agents to cleanse skin before application as these may irritate the skin or alter absorption of fentanyl from the transdermal system. 2. Hair at the application site may be clipped (not shaved) prior to patch application.

2

3. Apply patch to intact, non-irritated and non-irradiated skin on a fat pad on chest, back, flank, or upper arm immediately after removal from the sealed package. Press patch firmly in place with the palm of the hand for 30 seconds, making sure contact is complete. 4. Do not cut or alter the patch in any way, as damage to the patch may result in rapid release of fentanyl and may lead to the absorption of a potentially fatal dose. 5. Document on the patch the date and time of application of the patch and initials of the nurse who applied the patch. 6. Nurse documents on the Pain Assessment/Intervention Record the location of the fentanyl patch (e.g., left upper back) with the medication order. 7. Each patch may be worn continuously for up to 72 hours. Change patch according to prescriber’s orders. After removal of a used patch, apply new patch to a different skin site. 8. If the fentanyl patch that was applied to a patient is discovered missing before the time for removal, the nurse shall notify the primary team and complete an incident report. 9. If the dose of a fentanyl transdermal system is changed (i.e., increase or decrease in dosage), remove all patches the patient is currently wearing and dispose of the patch(es) according to procedures outlined below. Then, apply one or more unused fentanyl transdermal patches to deliver the entire new dose prescribed. 10. If the fentanyl patch order is discontinued (or dose is changed), the nurse shall remove the used patch from the patient and document wastage as described below. Monitoring and Precautions 1. Patient shall be monitored for efficacy of pain management according to the “Pain Management” Policy. 2. Patients shall be monitored for side effects of fentanyl including, but not limited to, the following: a. Respiratory distress or slow, shallow breathing a. Bradycardia b. Severe drowsiness, confusion or change in mental status c. Dizziness d. Risk for falls e. Difficulty walking or talking f. Constipation and urinary retention 3. Heat may increase the absorption of fentanyl from the transdermal system. a. Patch application sites should not be directly exposed to external heat sources, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated water beds. b. Prescriber should be notified in the event of patients presenting with or developing fever while wearing the fentanyl transdermal system.

3

Removal and Disposal 1. Upon removal of a fentanyl patch system, wastage should be documented on the Pain Assessment/Intervention Record. The nurse removing the patch should make and entry, :Patch removed” or “Patch wasted” and document the date and time of removal. Two nurse signatures are required to document the wastage of fentanyl patch. 2. After removal of a fentanyl patch from a patient, the used fentanyl transdermal patch shall be folded so that the adhesive side of the patch adheres to itself AND the patch shall be flushed down the toilet. Patient Discharge 1. If a patient shall be discharged with a fentanyl patch, the nurse documents in the Discharge Summary that the patient is being discharged from the hospital with a patch and directions for when the patch shall be replaced, if applicable. 2. Patients who will continue to use the fentanyl transdermal system after discharge shall receive patient education on safe use and disposal of the patch prior to discharge. Patients shall be advised to dispose of used and unused patches by folding the patches so that the adhesive side adheres to itself and the patches are flushed down the toilet. Unused patches that are no longer needed should be removed from pouches, folded, and flushed, as well. VI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes Institutional/operational changes Attachments: None. References: ® Duragesic [package insert]. Titusville, NJ: Janssen Pharmaceutica Products, LP; 2007. Office of National Drug Control Policy. Proper Disposal of Prescription Drugs. Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf. Accessed January 21, 2008. FDA Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System (Patch). Available at http://www.fda.gov/cder/drug/advisory/fentanyl_2007.htm. Accessed January 4, 2008. UHB Policy and Procedure on “Pain Management.” UHB Policy and Procedure on “Automatic Stop Order Policy.” Date Reviewed 4/8/08 Revision Required (Check One) Yes No Yes No Responsible Staff Name and Title Nicholas Galeota, Director of Pharmacy

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VIII.

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SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: Subject: THALIDOMIDE (THALOMID®) LilyAnn Jeu, Pharm.D., BCPS Gerald Soff, MD William Solomon, MD Nicholas Galeota, M.S., RPh Donald Caracciola, RPh Dianne Woods, RN Pharmacy and Therapeutics Committee Medical Executive Committee Page Original Issue date: Supersedes: New CHAPTER 49 1 n/a of 9

Prepared by: Reviewed by:

Approved by:

Approval date: Distribution:

Administrative Manual Department Manual Patient Care Manual AOD Manual

Issued by: I. II.

Regulatory Affairs

PURPOSE To delineate procedures for prescribing, dispensing, and storage of thalidomide for inpatient orders. POLICY Thalidomide may only be prescribed by prescribers registered with the S.T.E.P.S.® program. Thalidomide may only be dispensed to patients registered with the S.T.E.P.S.® program. Thalidomide medication orders shall be restricted to Hematology/Oncology physicians at UHB who are registered with the S.T.E.P.S. ® program. All requirements of the S.T.E.P.S. ® program must be completed for patients to receive thalidomide from the UHB Pharmacy Department. Thalidomide shall be dispensed in the form of 28-capsule blister packs. Upon patient discharge from the hospital, any remaining thalidomide dispensed for any inpatient shall be given to the patient to continue after discharge.

III.

DEFINITION(s) Thalidomide is an immunomodulary agent with FDA indications for usage in patients with newly diagnosed multiple myeloma and cutaneous manifestations of moderate-to-severe erythema

1

nodosum leprosum. Thalidomide is a teratogen known to cause severe, life-threatening human birth defects and, thus, should not be used by women who are pregnant or who could become pregnant while taking the drug. Thalidomide is only available through the System for Thalidomide Education and Prescribing (S.T.E.P.S. ®), a restrictive distribution system by Celgene Corporation to minimize the chance of fetal exposure to thalidomide. The Customer Care Center number for Celgene Corporation is (888) 423-5436. This number should be called for prescribers to register with the manufacturer and prior to prescribing and dispensing. IV. RESPONSIBILITES Prescribers, Pharmacists, Nurses PROCEDURES/GUIDELINES Prescribing 1. Both the patient and prescriber must be registered with the S.T.E.P.S. ® program (888-4235436). 2. The primary team for the patient shall contact the Hematology/Oncology consult team to order thalidomide via the S.T.E.P.S. ® program. The Hematology/Oncology Attending Physician or Fellow shall call Celgene Corporation to obtain an authorization number to prescribe thalidomide. 3. The registered prescriber shall write the medication order for thalidomide. The order must include the authorization number provided by the S.T.E.P.S.® program. 4. The medication order for thalidomide should not exceed 28 days in duration. 5. If a patient would like to use his/her own medication, the Hematology/Oncology prescriber shall be consulted and the complete medication order shall be written and include a notation that the “Patient may take own medication.” The patient’s supply of thalidomide should then be brought to the pharmacy for verification and labeling, as per the policy, “Patient Medication Brought Into UHB.” Additional procedures listed below for thalidomide shall also be followed. Dispensing 1. The medication order for thalidomide can only be accepted if it was written within the last 7 days. Telephone prescriptions are NOT permitted. 2. Prior to dispensing thalidomide, the pharmacist must call the S.T.E.P.S. ® program to activate the authorization number on the prescription and to obtain a confirmation number to dispense. 3. To obtain the confirmation number the pharmacist must also submit the following information to the S.T.E.P.S. ® program: a. Pharmacy DEA Number (AH 3303992) b. Number of milligrams and number of capsules to be dispensed for each dosage strength 4. Prior to dispensing, the pharmacist shall transcribe BOTH the authorization number and the confirmation number to the label marked, “Required information needed before dispensing thalidomide,” and affix this label to the medication order. The order shall then be filed in the Thalidomide binder for monitoring usage. 5. The pharmacist shall dispense one “Thalidomide Kit” for each valid medication order that receives a confirmation number. Each kit contains the following:

V.

2

a. Pharmacy label for the recording of the authorization and confirmation numbers for the medication order (to be completed prior to dispensing of thalidomide and then filed with the prescription). This label is NOT to be given to the patient. b. One 28-capsule blister pack of thalidomide. c. Copy of Drug Administration Record to be completed by nurses administering the drug. d. Copy of the Patient Resource Pack from the S.T.E.P.S. ® program to be given to the patient. 6. The Thalidomide Kit shall be given to a nurse directly. The nurse shall sign for receipt of the blister pack on the Drug Administration Sheet. 7. The pharmacist shall dispense ONE INTACT BLISTER PACK for the medication order as part of the Thalidomide Kit. Each blister pack contains 28 capsules of one strength. Thalidomide should be dispensed in the original package, since the packaging contains patient warnings for its use. 8. Blister pack should be labeled with instructions for use of thalidomide. The patient shall be given the blister pack to continue the medication after discharge from the hospital. 9. The pharmacist shall not dispense more than 28-days supply of thalidomide to any one patient at one time. 10. The inpatient pharmacy supervisor shall be notified that thalidomide has been dispensed and requires tracking. 11. When the patient is discharged or the Drug Administration Record has been completed, pharmacy personnel shall obtain the Record and attach it to the medication order filed in the thalidomide binder. 12. If a patient brings his/her own supply of thalidomide, a Thalidomide Kit containing the Drug Administration Record shall still be signed out to the nursing staff and nursing staff shall document doses of thalidomide administered on the Record until all capsules have been consumed and a new supply of thalidomide needs to be authorized by the S.T.E.P.S. ® program. The patient’s supply of thalidomide shall be brought to the pharmacy for verification and labeling. 13. If the patient is transferred between services during the same hospital admission, the nurse of the receiving unit shall bring the remaining capsules in the blister pack, the Drug Administration Record, and the new medication order for thalidomide to the pharmacy for verification of doses administered. A new Drug Administration Record shall be issued from the pharmacy with an update on the number of capsules remaining in the blister pack. 14. If a thalidomide blister pack is discovered missing, an incident report shall be filed by nursing staff. The incident report must be brought to the pharmacy before additional doses may be dispensed. A new confirmation number may also be required to be issued by the Celgene Corporation prior to dispensing. Storage 1. Thalidomide capsules shall remain in blister packs until ingestion. 2. Nurses shall secure the remaining doses in the thalidomide blister pack for any individual patient in the controlled substance cabinet of the patient care unit. The Drug Administration Record shall be kept with the blister pack. 3. Remaining capsules of the blister pack should be given to the patient upon discharge from the hospital. Handling and Administration

3

1. Health-care providers should wear gloves when handling thalidomide capsules. 2. Health-care providers should wash hands with soap and water after handling of thalidomide or bodily fluids from patients who are taking thalidomide. 3. Nurses shall document doses administered on the Drug Administration Record in the Thalidomide Kit and the Medication Administration Record. 4. When the Drug Administration Record is complete, the nurse shall return the completed record to the pharmacy in order to obtain a new Record for documenting additional doses to be administered. 5. If a patient is transferred between different services during the same hospital admission, the blister pack with remaining doses of thalidomide and the current Drug Administration Record shall be brought to the pharmacy by a nurse of the receiving service. A new medication order shall be required for the patient to continue thalidomide on the new service. Patient Education 1. Patients shall be warned that exposure of a fetus to thalidomide will almost certainly result in death or severe, life-threatening birth defects in the fetus. 2. Thalidomide is not intended for women who are pregnant, women who are breast-feeding, or women who are able to get pregnant and not using two forms of contraception. 3. All patients (male and female) registering with the S.T.E.P.S.® program shall receive mandatory contraception counseling and pregnancy testing, as applicable, upon enrollment. 4. A Patient Resource Pack shall be given to the patient with each blister pack of thalidomide dispensed. 5. Patients shall be counseled not to share thalidomide, not to engage in blood or sperm donation while taking the medication and for four weeks after stopping the medication, and to use appropriate contraception while taking thalidomide and for four weeks after discontinuation. VI. Reasons for Revision: Changes in regulatory or statutory laws or standards System failures/changes x Institutional/operational changes Attachments: Step-By-Step Guide to Dispensing Thalidomide Thalidomide Administration Summary for Nurses References: System for Thalidomide Education and Prescribing Safety (S.T.E.P.S. ®) Program at (888)423-5436 or www.THALOMID.com.

VII.

VII.

Policy and Procedure for Patient Medication Brought Into UHB (PTSAF-5) Date Revision Required (Check One) Responsible Staff Name and Title Reviewed Yes No Yes No

4

STEP-BY-STEP GUIDE TO DISPENSING THALIDOMIDE
Registration with Celgene Coroporation’s S.T.E.P.S.® Program  S.T.E.P.S.® stands for System for thalidomide Education and Prescribing Safety. It can be accessed through the Celgene Customer Care Center at 1-888-423-5436.  All patients and prescribers must be registered with the S.T.E.P.S.® Program  Medication orders for thalidomide at UHB are restricted to Hematology/Oncology physicians. Procedure for Dispensing Thalidomide 1. The prescribing physician calls the Celgene Customer Care Center for an authorization number. The authorization number is written on the prescription. 2. The pharmacist may ONLY accept a medication order written within 7 days. 3. The pharmacist calls the Celgene Customer Care Center to activate the authorization number. The pharmacist should be prepared to provide the following: a. Hospital pharmacy DEA number (AH 3303992) b. Strength of thalidomide capsules to be dispensed c. Number of capsules of thalidomide to be dispensed (28 capsules per blister pack) 4. Celgene provides the pharmacist with a confirmation number to dispense. 5. Pharmacist profiles the medication order in Rx Connect. 6. Pharmacist obtains the Thalidomide Kit from its high-alert bin to give to nurse. 7. From the kit, pharmacist records both the authorization number and confirmation on pharmacy label marked, “Required information needed before dispensing thalidomide.” Pharmacist affixes this label to the hard copy of the medication order and files the order in the thalidomide binder. 8. Pharmacist completes the required information on the Drug Administration Record and the patient label on the blister pack of thalidomide in the Thalidomide Kit. Pharmacist dispenses no more than 28 days of thalidomide for the confirmation number. 9. Pharmacist requests the nurse for this patient to retrieve and sign for the thalidomide blister pack. The nurse will be given the Thalidomide Kit, containing the INTACT 28-capsule blister pack, the Patient Resource Pack, and the Drug Administration Record. 10. Pharmacist attaches the receipt from the Drug Administration Record to the original hard copy of the thalidomide medication order in the thalidomide binder. Alert the inpatient supervisor that thalidomide has been dispensed and requires tracking. 11. If a thalidomide blister pack is discovered missing, an incident report shall be filed by nursing staff. The incident report must be brought to the pharmacy before additional doses may be dispensed. A new confirmation number may also be required to be issued by the Celgene Corporation prior to dispensing. Patients Using Their Own Medications 1. The thalidomide order shall be written by the Hematology/Oncology physician with a notation that “Patient may use own medication.” 2. The nurse shall acknowledge the order and bring the thalidomide to the pharmacy. 3. The pharmacist shall verify the identity and dose of thalidomide in the blister pack and label it according to hospital policy. 4. The pharmacist shall profile the thalidomide as patient taking own medication. 5. The pharmacist shall issue a Drug Administration Record to the nurse to record doses of thalidomide administered while the patient is admitted to UHB.

Updated February 25, 2008 (L. Jeu, PharmD)

Page 5 of 9

STEP-BY-STEP GUIDE TO DISPENSING THALIDOMIDE (Continued) Documentation on the Drug Administration Record 1. Nurses shall document all doses of thalidomide administered on the Drug Administration Record. 2. If the Drug Administration Record is completed prior to the completion of therapy, the nurse shall bring the completed Record to pharmacy in order to obtain a subsequent Administration Record. 3. The pharmacist shall verify that the number of doses administered (as per the Administration Record and blister pack) appears complete and correct. 4. The pharmacist shall issue a replacement Drug Administration Record with an updated number of capsules remaining in the blister pack. 5. The pharmacist should attach the original Drug Administration Record to the hard copy of the thalidomide order in the thalidomide binder. Change in Thalidomide Dose or Discontinuation 1. If the thalidomide dose changes, the Hematology/Oncology physician will need to call Celgene for a new authorization number. 2. The pharmacist shall call Celgene to activate the authorization number and to obtain a new confirmation number ONLY WHEN additional capsules must be dispensed. [However, the patient may not have more than 28 days of medication at one time.] 3. The nurse shall bring the blister pack and the Drug Administration Record to pharmacy with the new medication order for evaluation and updating of instructions. 4. If the thalidomide order is discontinued, the nurse shall return the blister pack and the Drug Administration Record to the pharmacy. 5. The pharmacist should attach the original Drug Administration Record to the hard copy of the thalidomide order in the thalidomide binder. Patient Transfer Between Units 1. For any change in service, a new medication order for thalidomide is required from the Hematology/Oncology physician. 2. For any change in service or change in unit location of the patient, the nurse of the receiving unit shall bring the blister pack, the Drug Administration Record, and the current thalidomide order to pharmacy for verification of doses administered. 3. The pharmacist shall verify that the number of doses administered (as per the Administration Record and blister pack) appears complete and correct. 4. The pharmacist shall issue a replacement Drug Administration Record with an updated number of capsules remaining in the blister pack. 5. The pharmacist should attach the original Drug Administration Record to the hard copy of the thalidomide order in the thalidomide binder. Patient Discharge 1. Upon patient discharge, the blister pack should be given to the patient to continue at home. 2. The Drug Administration Record should be brought to the pharmacy or may be left in the controlled substance cabinet in the patient care unit until pharmacy retrieval. 3. Pharmacist should attach the Drug Administration Record to the hard copy of the thalidomide order in the thalidomide binder.

Updated February 25, 2008 (L. Jeu, PharmD)

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THALIDOMIDE ADMINSTRATION SUMMARY FOR NURSES

Medication Orders for Thalidomide  Medication orders for thalidomide at UHB are restricted to Hematology/Oncology physicians who are registered in the S.T.E.P.S.® (System for thalidomide Education and Prescribing Safety) Program. It can be accessed through the Celgene Customer Care Center at 1-888-423-5436.  Physicians must obtain an authorization number to prescribe thalidomide. All medication orders for thalidomide MUST contain an authorization number.  The pharmacist MUST activate the authorization number and obtain a confirmation number in order to dispense thalidomide. Obtaining Thalidomide from the Pharmacy Department  At UHB, the pharmacist dispenses thalidomide in a Thalidomide Kit directly to a nurse.  Each kit contains the following: 12. One INTACT 28-capsule blister pack 13. One Patient Resource Pack 14. One Drug Administration Record (the same as the one used for controlled substances)  The nurse must sign for receipt of the Thalidomide Kit and treat thalidomide with the same scrutiny as used for controlled substances.  If a thalidomide blister pack is discovered missing, an incident report shall be filed by nursing staff. The incident report must be brought to the pharmacy before additional doses may be dispensed. A new confirmation number may also be required to be issued by the Celgene Corporation prior to dispensing. Patients Using Their Own Medications  If the patient prefers to use his/her own supply of thalidomide, the order shall be written by the Hematology/Oncology physician with a notation that “Patient may use own medication.”  The nurse shall acknowledge the order and bring the patient’s thalidomide to the pharmacy for verification, counting, and labeling according to hospital policy.  The pharmacist shall issue a Drug Administration Record to the nurse for documentation of doses administered at UHB. Documentation of Administration  All doses of thalidomide shall be documented on the Drug Administration Record and the Medication Administration Record.  Upon completion of a Drug Administration Record, the nurse shall bring the completed Record and the blister pack to the pharmacy for verification of doses administered. The pharmacist shall then issue a replacement Drug Administration Record, if needed. Storage of Thalidomide  Thalidomide capsules shall be stored with the Drug Administration Record in the controlled substance cabinet of the patient care unit. This includes the patient’s own medications.  Thalidomide capsules shall remain in the blister pack until ingestion.  Upon patient discharge, the remainder of the blister pack should be given to the patient.
Updated February 25, 2008 (L. Jeu, PharmD) Page 7 of 9

THALIDOMIDE ADMINSTRATION SUMMARY FOR NURSES (Continued)
Handling and Administration of Thalidomide  Health-care providers should wear gloves when handling thalidomide capsules.  Health-care providers should wash hands with soap and water after handling thalidomide capsules or bodily fluids from patients taking thalidomide.  Thalidomide is most commonly given once daily at bedtime.  Thalidomide should be given with a glass of water at least one hour after a meal. Patient Education  The Patient Resource Pack in the Thalidomide Kit shall be given to the patient with each blister pack of thalidomide dispensed.

   

Thalidomide is not intended for women who are pregnant, women who are breast-feeding, or women who are able to get pregnant and not using two forms of contraception. Patients shall be warned that exposure of a fetus to thalidomide will almost certainly result in death or severe, life-threatening birth defects in the fetus. All patients (male and female) registering with the S.T.E.P.S.® program shall receive mandatory contraception counseling and pregnancy testing, as applicable, upon enrollment. Patients shall be counseled not to share thalidomide, not to engage in blood or sperm donation while taking the medication and for four weeks after stopping the medication, and to use appropriate contraception while taking thalidomide and for four weeks after discontinuation.

Change in Thalidomide Dose or Discontinuation  If the thalidomide dose changes, the Hematology/Oncology physician will need to call Celgene for a new authorization number.  The nurse shall bring the blister pack and the Drug Administration Record to pharmacy with the new medication order. The pharmacist will verify the doses administered and then issue a new Drug Administration Record. The blister pack instructions shall also be updated.  If the thalidomide order is discontinued, the nurse shall return the blister pack and the Drug Administration Record to the pharmacy. Patient Transfer Between Units  For any change in service, a new medication order for thalidomide is required from the Hematology/Oncology physician.  For any change in service or change in unit location of the patient, the nurse of the receiving unit shall bring the remaining capsules in the blister pack, the Drug Administration Record, and the current thalidomide order to pharmacy for verification.  The pharmacist shall verify that the number of doses administered (as per the Administration Record and blister pack) appears complete and correct.  The pharmacist shall issue a replacement Drug Administration Record with an updated number of capsules remaining in the blister pack. Patient Discharge  Upon patient discharge, the blister pack should be given to the patient.  The Drug Administration Record should be brought to the pharmacy or may be left in the controlled substance cabinet in the patient care unit until pharmacy retrieval.

Updated February 25, 2008 (L. Jeu, PharmD)

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Updated February 25, 2008 (L. Jeu, PharmD)

Page 9 of 9

SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: Subject: ID Pharmacy PGY-2 Resident Qualifications and Obligations Prepared by: Roopali Sharma, PharmD Reviewed by:Nicholas Galeota, Ms, RPh, Alan Hui, PharmD Approved by: The Pharmacy and Therapeutics Committee Medical Executive Committee Distribution: Administrative Manual Department Manual Patient Care Manual AOD Manual Regulatory Affairs Chapter 50 Page 1 of 06/1/08 5

Original Issue date:

Supersedes: ________________ Approval date: NEW

Issued by:

I.

Purpose: This policy has been developed for the Post Graduate Year Two (PGY -2) resident in Infectious Diseases of the SUNY Downstate Medical Center to provide information on policies, procedures, application process, qualifications for the program and obligations of the resident. These policies and guidelines may directly affect a resident completing our program. It is recommended to read this policy and keep a copy of it for future reference. Questions regarding the policy may be addressed with the Residency Program Director (RPD) or the Director of Pharmacy Services. Revision of policies and procedures may happen at any time and it is the obligation of the RPD to inform the changes to the resident. The purpose of this PGY-2 Residency is to provide an opportunity to accelerate their growth beyond PGY-1 residency so they can become specialist in an area of pharmacy and can provide patient care in infectious diseases. Further development of leadership skills that can be applied in any position and in any practice setting is fostered during this residency. A PGY-2 Infectious Disease Pharmacy Practice resident will acquire knowledge to refine their problem-solving strategies, strengthen their professional values, work-ethics, attitudes, and advance the growth of their clinical judgment. The residency year provides an educational environment to develop competencies necessary to provide pharmaceutical care to patients with infectious diseases by providing patient care, teaching, and clinical research in the area of infectious diseases pharmacotherapy. A graduate of the program will be a competent and confident clinician in the management of Infectious Disease Pharmacotherapy. Additionally, the resident will be an educator while working with patients and other health care professionals in both inpatient and HIV clinic. Upon successful completion of this PGY-2 residency, the graduate will be prepared to be a prospective faculty candidate at the college of pharmacy and/or enter a clinical practice in Infectious Diseases.

II.

Definition(s): Residency Candidate: A resident candidate is a pharmacist who has completed a PGY-1 residency from an American Society of Health-Systems Pharmacists (ASHP) accredited program who is applying for the post-

graduate year 2 residency program in Infectious Diseases at SUNY Downstate Medical Center. A residency candidate must be enrolled in the ASHP Resident Matching Program to be considered for the position. Residency Committee: The residency committee is made up of the following individuals Nicholas W. Galeota.,M.S.,RPh, Roopali Sharma, PharmD, Alan Hui, PharmD, LilyAnn Jeu, PharmD, Maureen McColl, PharmD, Teresa Chan, Pharm.D Resident: A resident is a resident candidate who is successfully matched to SUNY Downstate Medical Center by the ASHP match process, and accepts an offer for employment. If no candidate is matched with the program, then the program will attempt to interview candidates on a first-available basis until an offer has been made and accepted. III. Qualifications: Applicants for the position of resident post-graduation year two (PGY2) should possess a PharmD degree by an American Council of Pharmaceutical Education accredited college of Pharmacy and should have completed (or be currently enrolled in) a PGY-1 Pharmacy Practice Residency. The applicant must also demonstrate a commitment to excellent verbal and written communication skills, professionalism and leadership, and to the provision of pharmaceutical care. Applicants should be licensed, or otherwise eligible for pharmacy licensure, in New York State. The resident candidate will apply for the program by submitting a curriculum vitae, completing an application, writing a letter of intent and submitting an official college transcript. The candidate must also solicit three (3) letters of recommendation to be submitted on their behalf by the recommender, one letter should be from the director of the program. Only candidates who submit all of the required materials by the application deadline will be considered for an onsite interview. IV. Policy: PGY-2 Infectious Disease resident are subject to and must comply with all SUNY Downstate Medical Center Human Resources and Pharmacy Department Policies and Procedures. Policies relating to conduct, attendance etc. are all reviewed at the institutional orientation sessions during the first two days of employment. In addition, the PGY-2 resident must comply with the Program Overview and Requirements as they relate to completing the goals set out by ASHP for completion of the residency. V. VI. Responsibilities (Include all departments/services involved in development/implementation and/or monitoring): Pharmacy Procedures/Guidelines: INTERVIEW PROCESS: • Candidates who submit all of the required materials, as outlined in the QUALIFICATIONS section, by the deadline (January 20th), will be considered for an onsite interview. • SUNY Downstate Medical Center will conduct a maximum of 10 onsite interviews for each available residency position • If it is necessary to limit those candidates who are invited onsite, the application materials will be reviewed by the Residency Program Director (RPD), Director of Pharmacy, and at least one Clinical Specialist (see: Resident Interview Form) for: o Academic credentials o Letters of recommendations o CV (relevant work experience) o Letter of intent • Candidates with the highest scores in these areas will be invited for an onsite interview

o o o o o o • • • • •

Onsite interviews will be conducted to determine, in addition to verification of relevant work experience, academic credentials, letter of intent (see: Resident Interview Evaluation Form): Professionalism Communication skills Clinical skills Service orientation Understanding of PGY-2 residency in infectious diseases

The candidate will interview with the RPD, Director of Pharmacy, all the clinical specialists, two infectious disease physicians and the current resident. After the last interview, the preceptors, director, clinical specialists, resident and RPD will meet to determine the rank-order for the ASHP match process. When there are conflicting assessments, the interviewers will negotiate an agreement. Between the results of the negotiation and the overall Resident Interview Form assessment, the rank order will be obtained and submitted. The ASHP match process is the final authority which determines placement of the resident candidate with the institution.

POSITION ACCEPTANCE AND STARTING THE JOB:
• • • A resident candidate who successfully matches with the institution must agree to the terms and conditions of employment, as outlined in the offer letter. The resident candidate must make every attempt to obtain New York Pharmacy licensure as soon as possible. The resident candidate is expected to contact Human Resources and provide all requested materials (i.e., proof of identity), complete a physical examination, and obtain an identification badge prior to the start date. The start date will be on or about August 1 of the same year as the ASHP match. Pharmacy Practice Residents are subject to and must comply with all SUNY Downstate Medical Center Human Resources Policies and Procedures. Policies relating to conduct, attendance etc. are all reviewed at the institutional orientation sessions during the first two days of employment. In addition to those policies the following also applies to the PGY-2 Resident: DISMISSAL: The Residency Program Director may direct that a resident be dismissed during the term of his/her residency for unsatisfactory performance or conduct. Examples include, but are not limited to the following: • Continued unsatisfactory performance and/or progress in the program • Performance which presents a compromise to acceptable standards of patient care, or jeopardizes patient’s welfare. • Illegal and/or unethical conduct • Excessive tardiness and or absenteeism • Unprofessional behavior • Inability to perform the obligations pursuant to the resident contract DISMISSAL ACTION PROCESS: will be utilized if the resident fails to meet his/her obligations. (see above Dismissal) • Resident will be given two verbal warning by the preceptor. If the behavior does not change then the Residency Program Director will be notified to conduct an investigation, including meeting with the preceptor and the resident to identify information that relates to the problem. • If the resident continues to engage in behavior which are deemed harmful to the residency program and fails to meet the obligations of the residency, the resident shall be given a warning in writing and will have suggestions on the corrective action. This will be documented in the resident’s file. • If the preceptor determines that the resident may not be able to complete the obligations of the rotation/residency, a plan to adequately complete the requirements shall be presented by the preceptor and reviewed by the Residency Program Director and the Residency

• • •



• •



Committee. No action will be taken against the resident until the Residency Committee has reviewed the report and recommendations concerning any action. If the Residency Committee feels that the action recommended by the preceptor / Residency Program Director is appropriate, the action will be implemented and the resident will be in a probationary period. During the probationary period if significant improvement is not documented. Action may include termination. The Director of Human Resources at SUNY Downstate Medical Center will be notified in advance of placing a resident on probation. Dismissal of a resident requires consultation with the Director of Human Resources. If dismissal is recommended the resident is given two weeks advance notice in writing by the Residency Program director.

TIME OFF FOR EXTENDED LEAVE (DISABILITY/PROFESSIONAL/FAMILY/SICK): Attempts will be made to accommodate in the event that the resident must take an extended leave for certain life emergencies or life events. The resident must first use accrued sick time and vacation time, unless the resident qualifies for Family Medical Leave Act (FMLA). If the leave extends beyond the accrued time the resident will continue to be paid. However, the resident must sign a contract to make up all missed time which does not qualify for accrued time, without pay until the requirements and time (1-year) of the residency are satisfactorily completed. Failure to comply with above will be a reason for dismissal from the residency program. VI. Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Interview evaluation, Evaluation form to screen for on-site interviews, signed offer, application packet. References: Revision Yes Yes Yes Yes Required (Circle One) No No No No Responsible Staff Name and Title Nicholas Galeota, Director of Pharmacy Roopali Sharma, PharmD Alan Hui, PharmD

VII. VIII.

Date Reviewed 06/01/08 06/01/08 06/15/08

SUNY DOWNSTATE MEDICAL CENTER
UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
No: Chapter 51 Subject: Intravenous to Oral Antimicrobial Conversion Program Prepared by: Roopali Sharma, PharmD Page 1 of 1 10/14/08

Original Issue date: Supersedes: Approval date:

Reviewed by: Infectious Disease Division Pharmacy and Therapeutics Committee Medical Executive Committee Approved by:

NEW Administrative Manual Department Manual Patient Care Manual AOD Manual Regulatory Affairs

Distribution:

Issued by:

I.

Purpose: The purpose of this program is to provide a process and establish guidelines for the conversion of intravenous to oral/enteral (IV to PO) anti-infectives when medically appropriate. The advantages of this program are: • To provide an oral/enteral dosage form with comparable bioavailability to the intravenous form, this could reduce hospital length of stay. • To avoid the added risks associated with continued intravenous therapy (e.g. IV infiltration, line infection). • To lower overall medication and associated costs to the patient and the hospital. Background Information: A number of commonly used antimicrobial agents have near 100% bioavailability*. The intravenous forms of these agents are useful in situations where the patient may have compromised gastrointestinal function. In cases where the patient is in need of continued antimicrobial therapy but is clinically stable with a functioning GI tract, oral therapy is a viable and preferred option. Oral administration of medications has the advantages of greater safety, decreased staff workload and decreased medication ancillary costs. A number of institutions have implemented “Intravenous to Oral” conversion programs and have documented the pharmacoeconomic benefit of an automatic, pharmacist-initiated automatic oral conversion program. Medications suitable for such “Intravenous to Oral” programs are those which are either well (>90%) absorbed in patients with functioning GI tracts or those which have been shown to produce equivalent therapeutic effects at appropriate doses with either route of administration. *The exception to this is azithromycin. The oral bioavailability of azithromycin is about 40%. Nevertheless, aside from treatment for community-acquired pneumonia in an ICU patient, oral azithromycin is still recommended for patients able to take oral medications. Azithromycin has a long half-life (11-68 hours) and concentrates intracellulary. In general, tissue concentrations are much higher (10 to 100 times) than corresponding serum concentrations.

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Cost Difference and Potential Savings at a Large teaching Hospital PO Linezolid (600 mg) Voriconazole (200 mg) Azithromycin (500 mg) Levofloxacin (500 mg) Fluconazole (200 mg) $37.87 $21.27 $3.58 $5.60 $0.08 IV $52.00 $73.00 $12.00 $11.73 $8.68 2006 IV Cost $ 472,783 $ 444,646 Potential % conversion 40% 30% Potential Cost Savings 40,114 88,400

Cost Difference of IV vs. PO Antimicrobials at SUNY Downstate Medical Center PO/unit IV/unit

Linezolid (600 mg) Voriconazole (200 mg) Azithromycin (500 mg) Moxifloxacin (400 mg) Fluconazole (200 mg)

$60.00 $32.00 $6.60 $2.55 $0.02

$78.00 $ 99.00 $7.00 $11.75 $8.00

II.

Policy: In accordance with the Infectious Disease Division and P&T guidelines, the Department of Pharmacy services shall facilitate an intravenous to oral conversion program to adult patients at SUNY Downstate Medical Center with the goal of providing high-quality, cost-effective care. This service will be provided Monday to Friday. Patients receiving certain IV antimicrobials (see Appendix A) will be identified on a daily basis. The Post Graduate Year- 2 (PGY-2) infectious disease resident and/or clinical pharmacist may automatically convert patients taking “approved intravenous-oral equivalent medications” (see Appendix A) from intravenous to oral/per tube administration when the PGY-2 infectious disease resident and clinical pharmacist patient evaluation demonstrates the patient meets the established criteria for conversion. Definition(s): (Optional) Responsibilities (Include all departments/services involved in development/implementation and/or monitoring): Pharmacy Procedures/Guidelines: 1. All patients taking any of the “approved intravenous –oral equivalent medications” will be identified on a daily basis by the PGY-2 infectious disease resident and/or clinical pharmacist Monday to Friday. 2. When a patient is prescribed one of the “approved intravenous-oral equivalent medications” the medical record and medication administration record will be reviewed by the PGY-2 infectious disease resident and/or clinical pharmacist. If necessary, the PGY-2 infectious disease resident and/or clinical pharmacist will consult with the ID fellow/attending or patient’s physician to obtain necessary information. If the inclusion criteria for route change are met without exclusion criteria being present, the PGY-2 infectious disease resident and/or clinical pharmacist will place an “Intravenous-Oral Equivalent Auto-substitution Order Sheet” (see Appendix B) and a

III. IV. V.

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3. 4.

5.

6. 7. 8. 9.

10.

progress note in the chart documenting the route change “per P&T IV to PO conversion protocol”. Once the CONVERSION OCCURRS, the PGY-2 Infectious Disease Resident and/or Clinical Pharmacist will continue to monitor the patient’s progress to assure the change was clinically adequate and to identify and prevent any unexpected or untoward patient response. If the primary physician refuses to accept the conversion, the IV to PO protocol may be overridden by WRITING A NEW IV ORDER AS “Do not Auto Substitute” and no further changes will occur for the patient during that admission. Reasons for declining the conversion should be stated on the progress note. Patients who did not initially fall under the inclusion criteria will be followed-up by the PGY-2 infectious disease resident and/or clinical pharmacist and monitored for IV to PO conversion per protocol. Once the clinical presentation improves and patients fall under the inclusion criteria, the IV to PO protocol will apply. Stop Date – the new order stop date should be the same as that of the original order. Applicable Antimicrobials – Linezolid, Azithromycin, Moxifloxacin, Ciprofloxacin, Fluconazole, Voriconazole, Metronidazole Criteria for Switch: (IV therapy for > 24 hours and must meet at least one of the Inclusion Criteria and none of the Exclusion Criteria) INCLUSION CRITERIA for automatic pharmacy conversion from intravenous to oral/per tube administration of approved medications are: a. Patient is receiving and tolerating oral/enteral medications and/or oral/enteral diet. b. Patient is hemodynamically stable. c. Absorption of oral/per tube medication is expected to be reliable (see exclusion criteria) d. Patient is receiving an approved intravenous-oral equivalent medication. e. Afebrile for at least 24 hours (temp < 100.4ºF) and WBC decreasing toward normal range (if leukocytosis initially present) f. If an organism is identified, it must be sensitive to current choice of antibiotic g. Additional specific criteria for documented indications should be met prior to switching therapy in patients: 1. Bacteremia: afebrile x 24 hours, blood cultures negative x 48 hours, and received IV therapy for at least 3 days. 2. Septic arthritis/osteomylelitis: Afebrile x 24 hours, received IV therapy for at least 5 days, negative repeat cultures (if recultured), and with adequate drainage where appropriate. 3. Draining abscess: Afebrile x 24 hours 4. Candidemia/Invasive Candidiasis; afebrile x 24 hours, blood cultures negative x 72 hours, and received IV therapy for at least 3 days. 5. Invasive Asergillosis/other invasive fungal infections: Received IV therapy for at least 7 days. EXLUSION CRITERIA for automatic pharmacy conversion from intravenous to oral/per tube administration of approved medications are: a. Patient is NPO (including medications) b. Vomiting and diarrhea present in the last 24 hours c. Presence of continuous NG suction, short bowel syndrome, ileus, proximal resection of the small bowel, active GI bleed, patient is on paralytics d. Dysphagia associated with recent seizure episodes; risk of aspiration e. Patients who are comatose or have decrease in consciousness f. Patients with bacteremia due to ( Staphylococcus aureus or Pseudomonas aeruginosa); endocarditis, myocarditis, mediastinitis, meningitis, intracranial abscesses; febrile neutropenia (ANC < 500), Legionella or Pseudomonas pneumonia, inadequately drained abscesses and empyema, severe soft tissue infections (strep Group A) g. Sepsis (evidence of infection and two or more of the following criteria: temperature > 38ºC (100.4ºF) or < 36ºC (96.8ºF), heart rate > 90 beats/min, respiratory rate > 20 breaths/min or PaCO2 of < 32 mmHg, and WBC count > 12, 000/mm3 or < 3 4,000/mm or > 10% immature neutrophils) h. Mucositis, esophagitis, stomatitis

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11. The PGY-2 infectious disease resident and/or clinical pharmacist should also assess for drug allergies, appropriate time of administration, drug interactions (drug-drug, drug-food) and potential for adverse effects. In any notable issue is detected during the pharmacist’s assessment, the PGY-2 infectious disease resident and/or clinical pharmacist should write a note in the progress notes section of the patient chart. 12. In situations where the clinical assessment is ambiguous, the PGY-2 infectious disease resident and/or clinical pharmacist will discuss individual cases with the prescribing physician/ID fellow prior to proceeding to the switch. 13. The Acceptance/disregard of IV to PO recommendations will be tracked and reported back to the P&T committee along with estimated cost implications. This data will also be reported to the ID division. 14. Each IV to PO conversion will be documented as a clinical intervention.

VI.

Reasons for Revision:  Changes in regulatory or statutory laws or standards  System failures/ changes  Institutional/operational changes Attachments: Appendix A, Appendix B References: 1. Ramirez J. Early discharge strategies: role of transitional therapy programs. In: Owens R, Ambrose PG, Nightingale CH, eds. Antibiotic Optimization: Concepts and Strategies in Clinical Practice. Boca Raton, FL: Taylor & Francis Group;2005:431-451. 2. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007;44:S27-72. 3. Sevinc et. Al . Early switch from intravenous to oral antibiotics: guidelines and implementation in a large teaching hospital. Journal of antimicrobial Chemotherapy 1999; 43:601. 4. Wong-Beringer et. Al. Implementing a program for switching from IV to oral antimicrobial therapy. AJHSP 2001;58:1146. 5. Kuti et. Al Pharmacoeconomics of a pharmacist –managed program for automatically converting levofloxacin route from IV to oral. AJHP 2002;59:2209. 6.Ramirez et.al. Early switch from IV to Oral antibiotics in hospitalized patients with bacteremic community acquired Streptococcus pneumoniae Pneumonia. Archives of Internal Medicine 2001;161:848. 7.Ankee at. Al Early switch from Intravenous to Oral Antibiotics in Hospitalized Patients with Infections: A 6 month prospective study. Pharmacotherapy 1997; 30; 569 8. Lelekis et. al sequential antibiotic therapy for cost containment in the hospital setting; why not? Journal of Hospital Infection 2001;48:249.

VII. VIII.

Date Reviewed

Revision

Required (Circle One)

Responsible Staff Name and Title

Yes Yes Yes Yes

No No No No

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APPENDIX A : Proposed Intravenous - Adult Oral Equivalent Antimicrobials IV DRUG
Azithromycin 500 mg IVPB Q 24hr Azithromycin 250 mg IVPB Q24hr Ciprofloxacin 400 mg IVPB Q12hr Ciprofloxacin 200 mg IVPB Q12hr Moxifloxacin 400 mg IVPB Q 24hr Linezolid 600 mg IVPB Q 12hr Metronidazole 250 mg IVPB Q 8h Metronidazole 500 mg IVPB Q 8h Fluconazole 400 mg IVPB Q 24hr Higher doses can be converted 1:1 Fluconazole 200 mg IVPB Q 24hr Fluconazole 100 mg IVPB Q 24hr Voriconazole 4 mg/kg* IVPB Q 12hr

ORAL Equivalent
Azithromycin 500 mg PO Q24hr Azithromycin 250 mg PO Q 24hr Cirpofloxacin 500 mg PO Q 12hr Ciprofloxacin 250 mg PO Q 12 hr Moxifloxacin 400 mg PO Q 24hr Linezolid 600 mg PO Q 12hr Metronidazole 250 mg PO Q 8hr Metronidazole 500 mg PO Q 8hr Fluconazole 400 mg PO Q 24hr Fluconazole 200 mg PO Q 24hr Fluconazole 100 mg PO Q 24 hr Voriconazole 200 mg PO BID, dose may be increased to 300 mg BID if not responding

Rationale
Recommended dosing Recommended dosing Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels Equivalent serum levels

* Based on 70 Kg patient (4 mg/kg x 70 = 280 mg)

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APPENDIX B - Intravenous-Oral Equivalent Auto-substitution Order Sheet

PHARMACY THERAPEUTIC SUBSTITUTION ORDER SHEET Instructions:
1. 2. 3. Imprint patient’s plate before placing in chart Sign bottom of form. Kardex order as substitution.

ALLERGIES:

WEIGHT

lb.

kg. HEIGHT:

CrCL:

Intravenous to Oral Conversion Therapeutic Substitution
BY DIRECTION OF THE SUNY DOWNSTATE MEDICAL CENTER P&T COMMITTEE, THE ROUTES OF THESE AGENTS ARE DESIGNATED THERAPEUTIC EQUIVALENTS FOR AUTOMATIC SUBSTITUTION.

Physician – Please discontinue:

______________________________ __________ mg IV ____________
(drug) (dose) (frequency)

Nursing – Please document substitution in the MAR as follows:

______________________________ __________ mg po ____________
(drug) (dose) (frequency)

Clinical Pharmacist Signature: __________________________________ Date:_________Time:_______ Print Name: _______________________________Beeper #: RN Signature:_________________________________________Date:_________Tim e:_______ Print Name:________________________________

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