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08 2014 High-Alert Medications- Oral Chemotherapy Agents

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08 2014 Peak Med



Peak Development for ...
Medication Administration

Vol. 15 Issue 8
August 2014
High-Alert Medications:
Oral Chemotherapy Agents
Peak Development Resources
P.O. Box 13267
Richmond, VA 23225

Phone: (804) 233-3707
Fax: (804) 233-3705
Email: [email protected]
After completion the learner should be able to:
1. Identify advantages and risks of oral
chemotherapy agents.
2. Describe factors that increase the risk of
treatment with oral chemotherapy agents.
3. Discuss measures to promote safe use of
oral chemotherapy agents.
4. Correctly calculate drug dosages.
A young woman with brain cancer had a
prescription filled for lomustine, an oral
chemotherapy drug. The prescription was
written for a single 190 mg dose to be taken
once every six weeks. However, the drug label
directed her to take a dose of 190 mg daily,
which she did for several weeks. The young
woman was subsequently admitted to the
hospital with severe bone marrow suppression
and bleeding, and died a month later.
While all medications have the potential to
be toxic or hazardous, especially when used
incorrectly, some medications have the potential
to cause more harm than others. The Institute
for Safe Medication Practices (ISMP) has
created, maintained and updated a list of high-
alert medications since 2008. The ISMP defines
high-alert medications as those that carry an
increased risk of significant patient harm when
errors occur in their use. The list includes drugs
that are used within healthcare settings and in
the home/community setting. Oral chemotherapy
agents, drugs used to treat cancer that are taken
by mouth, are included in this list.
Oral Chemotherapy—Benefits and Risks
The number of oral chemotherapy drugs
and their use have increased significantly in
the last decade, and are expected to increase
even more in the coming years. Selected oral
chemotherapy drugs include:
Advantages to the patient with oral
chemotherapy, compared to intravenous
therapy, include greater convenience, less
travel and treatment time, and avoidance of IV
-related complications, such as extravasation
or infection. Also, some types of cancer are
best treated with daily exposure to medication,
which is more difficult with IV use. In some
cases, the costs associated with oral
chemotherapy may be lower than parenteral
therapy, since less equipment and staff are
required. However, more of the drug costs
may be passed on to the patient in the form of
co-payments, which could be prohibitive for
the patient. Many states have passed
legislation requiring insurers to cover the cost
of oral agents in the same manner as
injectable drugs.
It is important for patients and healthcare
providers to understand that there are significant
risks associated with the use of oral
chemotherapy medications. While many people
believe that oral chemotherapy is “less
dangerous” than IV drugs, this is not the case.
Oral chemotherapy is as effective, and can be
just as toxic, as injectable chemotherapy
medications. This is especially true if the drugs
are used incorrectly. Serious adverse effects of
some oral chemotherapy drugs include bone
marrow suppression that may cause anemia,
leukopenia and thrombocytopenia. This may
result in serious infection or bleeding. Other
serious effects may include pulmonary fibrosis
and liver and kidney toxicity.
Another major risk associated with oral
chemotherapy drugs is non-adherence, when
patients do not take these drugs exactly as
prescribed. If this occurs, their effectiveness
may be significantly reduced. There are many
reasons why patients may not take the drugs as
ordered, including forgetting doses, not
understanding directions, omitting doses due to
uncomfortable adverse effects, and not having
drugs refilled due to financial concerns.
Peak Development for… Medication
and Competency
Assessment Tool for Medication
are components of
a site license for the Peak
Development Resources
Competency Assessment System
for Medication Administration

and may be reproduced for this
individual facility only. Sharing
of these components with any
other freestanding facility within
or outside the licensee’s corporate
entity is expressly prohibited.
The information contained in
Peak Development for… Medication
Administration is intended only as
a guide for the practice of
licensed nursing personnel who
administer medications. Every
effort has been made to verify the
accuracy of the information
herein. Because of rapid changes
in the field of drug therapy, the
reader is advised to consult the
package insert, facility pharmacist
or patient’s physician for relevant
information. This is particularly
important for new or seldom used
drugs. Use of professional
judgment is required in all patient
care situations. It is the reader’s
responsibility to understand and
adhere to policies and procedures
set forth by the employing
institution. The editor and
publisher of this newsletter
disclaim any liability resulting
from use or misuse of
information contained herein.

Copyright © 2014
Capecitabin (Xeloda) Erlotinib (Tarceva)
Methotrexate (Trexall) Lomustine (CEENU)
Imatinib (Gleevec) Cyclophosphamide (Cytoxan)
Tamoxifen (Soltamox) Temozolomide (Temodar)
Sunitinib (Sutent) Mercaptopurine(Purinethol)
Risk for Drug Errors and Patient Harm
There are a number of factors that increase the risk of
patient harm with oral chemotherapy agents:
Therapeutic index: The therapeutic index (TI) is a ratio
measure between a drug’s therapeutic/effective dose and its
toxic dose. For example, if a drug’s effective dose is 20 mg,
and its toxic dose is 4000 mg, the TI is 4000 ÷ 20, or 200. If
the toxic dose of that drug is 500 mg, the TI would be 25. The
lower (more narrow) the TI is, the more likely is the drug to
have toxic effects. Compared to many other drugs, oral
chemotherapy agents have some of the lowest therapeutic
indices and safety margins. This is why they are considered to
be high-alert medications. If dosage errors are made, there is
a higher likelihood of patient harm than with many other drugs.
Compared to standard IV therapy, some oral chemotherapy
protocols allow for more frequent administration at lower
doses, which increases the TI to promote safety.
Dosage regimen: Dosage regimens for oral chemotherapy
drugs can be complex and confusing, increasing the risk for
errors. There may be multiple drugs to take/administer,
multiple dosages, and dosage regimens comprised of several
tablets of differing strengths. These drugs may be ordered on
very atypical schedules, such as one dose daily for five days,
and repeated every 21 days. For example, lomustine is
typically ordered as one dose every six weeks. A dosage of
190 mg is obtained by taking a combination of one 100 mg,
two 40 mg and one 10 mg tablets. Between the schedule and
dosage, there are a number of opportunities for error. Also,
dosage amounts for the same drug can vary widely during the
course of chemotherapy, adding to the risk for error.
Drug names: Just like drugs in other classes, some oral
chemotherapy agents have look alike/sound alike names, for
example, pazopanib and ponatinib. This can cause confusion
and drug errors.
Measures to Promote Safety
Whether oral chemotherapy drugs are administered in a
healthcare setting, or by the patient at home, appropriate
safety measures help to decrease the risk of adverse effects.
Orders for oral chemotherapy agents should not be given or
accepted verbally, except to hold or stop administration.
Orders should be accurately entered into a computerized order
-entry program or using a pre-printed form. Orders should not
include drug abbreviations; drug names should be written in
full. All pertinent lab work, such as CBC with differential,
should be available on the patient chart before chemotherapy
orders are written. When administering oral chemotherapy
drugs, two qualified staff members should accurately identify
the patient, according to facility policy, and also verify the
correct drug, dose, route and frequency/time. Hold the
medication and contact the prescriber if there are any
concerns regarding toxicity or questions about the order.
Unlike parenteral forms of chemotherapy, oral
chemotherapy is most commonly taken without the direct
supervision of the healthcare provider. Therefore, thorough
patient education is essential to promote drug effectiveness
and patient safety. The patient and family should receive clear
verbal explanation, as well as printed directions. Verbal
feedback should be obtained from the patient/family to verify
understanding. Instructions should include the following:
 Take the drug exactly as prescribed. Use a calendar,
medication organizer and/or timer to help remember doses.
 Return for appointments and lab tests as scheduled.
 If a dose is missed, contact your healthcare provider for
direction— do not double up on doses.
 Do not take any other products, such as prescription or over
-the-counter drugs, herbs, or supplements, without
discussing it with your prescribing doctor.
 Do not break, crush or chew tablets or capsules. Anyone
touching the medication should wear gloves.
 Avoid drinking alcohol during therapy unless approved by
your doctor.
 Do not stop taking the medication without talking with your
doctor— call the office/clinic for any concerns.
 Watch for any adverse drug effects, such as nausea/
vomiting, diarrhea, mouth sores, bruising or signs of
infection and report them promptly to the doctor.
 Others should use gloves when contacting the patient’s
urine, stool, emesis, saliva, perspiration or bed sheets. The
toilet should be flushed twice, with the lid closed, after
elimination. These precautions should be continued for 48
hours after drug discontinuation, or longer if directed.
 Avoid environmental contamination by keeping the
medication in its original, closed container. For solid forms,
take out only the tablet(s) needed for immediate use, and
swallow them— do not place them on counters or other
surfaces. Avoid spilling liquid forms, and return any used
oral syringes to the clinic for disposal.
 Do not discard any unused doses or contaminated items in
the trash or toilet— double-bag and return them to the clinic
for disposal.
Through careful verification and administration of oral
chemotherapy agents, as well as thorough patient education,
the nurse can promote safe and effective cancer treatment.
Peak Development for… Medication Administration
High-Alert Medications: Oral Chemotherapy Agents Page 2
Peak Development for ...
Medication Administration

Competency Assessment Tool
Vol. 15 Issue 8
August 2014
High-Alert Medications:
Oral Chemotherapy Agents
Directions: Place the letter of the one best answer in the space provided.
_____1. The Institute for Safe Medication Practices defines high-alert medications as those that:
A. are not commonly used, and are therefore unfamiliar to staff
B. have an increased risk of patient harm if errors are made
C. are not approved by the FDA
D. cause more adverse effects than most other drugs

_____2. Use of oral chemotherapy drugs is expected to decrease in the future, due to concerns
about their effectiveness.
A. True
B. False

_____3. Compared to standard IV chemotherapy, advantages of oral chemotherapy include all of
the following EXCEPT:
A. decreased risk of phlebitis and extravasation
B. more convenient
C. less time required for travel and treatment
D. lower risk of drug toxicity

_____4. Serious adverse effects of oral chemotherapy may include:
A. leukopenia
B. bleeding
C. pulmonary fibrosis
D. all of the above

_____5. A major risk of oral chemotherapy is non-adherence, which may reduce drug effectiveness.
A. True
B. False

Competency Assessment Tool
High-Alert Medications: Oral Chemotherapy Agents Page 2
_____6. A drug with a very low, or narrow, therapeutic index is likely to:
A. cause very few adverse effects
B. be safer for the patient than most other drugs
C. have a high risk of toxicity
D. be ineffective in treating the patient’s disorder

_____7. Which of the following verbal orders is considered acceptable for oral chemotherapy:
A. “Start the second cycle of capecitabin.”
B. “Start tamoxifen 20 mg PO once daily.”
C. “Decrease the lomustine to 150 mg every 6 weeks.”
D. “Stop the methotrexate now.”

_____8. A patient taking an oral chemotherapy drug makes all of the following statements. Which
one most clearly requires follow-up patient education:
A. “I cut my tablets in half to make them easier to swallow.”
B. “I have mild nausea for a day or so after taking my monthly dose.”
C. “I close the toilet lid and flush twice for at least 2 days after my dose.”
D. “I stopped drinking alcohol when I started taking this drug.”

_____9. Drug order: Tamoxifen solution 20 mg PO bid.
Drug label: Tamoxifen oral solution 10 mg per 5 ml
A. 2 ml
B. 5 ml
C. 10 ml
D. 20 ml

_____10. The typical dosage range of oral cyclophosphamide is 1-5 mg/Kg/day. A patient weighing
132 lb is to receive cyclophosphamide 150 mg daily PO. This drug order is within the
typical dosage range.
A. True
B. False

Peak Development for ...
Medication Administration

Group Tracking Log
Month: August 2014
Issue: High-Alert Medications:
Oral Chemotherapy Agents
Employee Name Unit Test Date Score

Cost: $10 per test — nonrefundable
Check Payment method - Provide all information
_______ Check Payable to Peak Development Resources
($40.00 service fee for returned checks)
_______ Credit Card (circle one):
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Billing Address for credit card:
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State: ________ Zip: __________
1. Issue: High-Alert Medications: Oral Chemotherapy Agents
Month: August 2014 Contact Hours Awarded Through: August 2016
2. Facility Information
(provide information about the subscribing facility):
Facility Name: ________________________________
Address: ___________________________________
City: _________________ State: _____ Zip: _______
3. Applicant Information
(provide information about yourself)
Name: ___________________________________
Address: _________________________________
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Previous Peak Development Contact Hours: Yes No
Peak Development Resources

Contact Hour Application for Medication
Additional Information:
Phone: (804) 233-3707
Fax: (804) 233-3705
Email: [email protected]
8. Mail completed application and payment to: Peak Development Resources, LLC
P.O. Box 13267
Richmond, VA 23225
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