90667477 Generic Drug Suffix Chart

Generic Drug Suffix Chart
Suffix Drug Class
STATIN
CHOLESTEROL
(HMG CoA Reductase Inhibitor)
RAZOLE
PROTON PUMP
INHIBITOR
ARTAN
A2RB
(Angiotensin 2 receptor blocker)
PAM
BENZODIAZEPINES
(BENZOS)
OLOL BETA BLOCKER
PRIL
ACE INHIBITOR
(Angiotensin Converting Enzyme)
AZOSIN ALPHA BLOCKER
ITIDINE H2 ANTAGONIST
CILLIN
PENICILLIN
ANTI-BIOTICS
FLOXACIN
FLUOROQUINOLONE
ANTIBIOTICS
CYCLINE
TETRACYCLINE
ANTIBIOTICS
ROMYCIN
MACROLIDE
ANTIBIOTICS
LAX LAXATIVE
VIR ANTI-VIRAL








BRAND GENERIC FUNCTION
Vicodin®
APAP +
Hydrocodone
Pain Relief
(DEA Sch 3)
Prinivil® Lisinopril ACE inhibitor
Zocor® Simvastatin Statin
Synthroid®
Levothyroxine
Hormone
Replacement
Amoxil® Amoxicillin
Antibiotic
(Penicillin)
Zithromax® Azithromycin
Macrolide
Antibiotic
Microzide®
Hydro-
chlorothiazide
(HCTZ)
Thiazide Diuretic
Norvasc® Amlodipine
Calcium Channel
Blocker
Xanax® Alprazolam
Benzodiazepine
(DEA Sch 4)
Glucophage® Metformin Antidiabetic
Lipitor® Atorvastatin Statin
Prilosec® Omeprazole
Proton Pump
Inhibitor
Augmentin®
Amoxicillin +
Clavulanate
Penicillin
Antibiotic
Tenormin® Atenolol
Beta Blocker
(B1)
Lasix® Furosemide Diuretic
Lopressor® metoprolol
Beta Receptor
Blocker (B1)
Zoloft® Sertraline S.S.R.I.
Ambien® Zolpidem
Sleep Aid
(DEA Sch 4)
Percocet®
Oxycodone
+ APAP
Pain Relief
(DEA Sch 2)
Nexium®
Esomeprazole
Proton Pump
Inhibitor
Plavix® Clopidogrel
Platelet
Aggregation
Inhibitor
Singulair® Montelukast
Leukotriene
Inhibitor
Sterapred® Prednisone Corticosteroid
Lexapro® Escitalopram S.S.R.I
Advil® Ibuprofen N.S.A.I.D
Celexa® Citalopram
Anti-Depressant
(S.S.R.I.)
ProAir® Albuterol
B2 Receptor
Agonist(Lungs)
Prozac® Fluoxetine S.S.R.I.
Neurontin® Gabapentin Anti-Convulsant
Coumadin® Warfarin Blood Thinner
Ultram® Tramadol
Pain Relief
(Non-Narcotic)
Klonopin® Clonazepam
Benzodiazepine
(DEA Sch 4)
Ativan® Lorazepam
Benzodiazepine
(DEA Sch 4)
Keflex® Cephalexin
Antibiotic
(Cephalosporin)
Flexeril®
Cyclo-
benzaprine
Muscle Relaxant
Septra®
Sulfamethoxazole
+ Trimethoprim
Antibiotic
Combination
Cipro® Ciprofloxacin
Quinolone
Antibiotic
Flonase® Fluticasone Inhaled Steroid
Dyrenium® Triamterene Diuretic
Pravachol® Pravastatin
Cholesterol
/ Statin
Crestor® Rosuvastatin Statin
Advair®
Fluticasone +
Salmeterol
Bronchodilator +
Steroid
Desyrel® Trazodone Anti-Depressant
Darvocet®
Propoxyphene
+ APAP
Pain Relief
(DEA Sch 4)
Fosamax® alendronate
Bone
Resorption
Inhibitor
Allegra® Fexofenadine
Antihistamine
(H1)
Mevacor® Lovastatin
Cholesterol /
Statin
Coreg® Carvedilol
Beta Receptor
Blocker
Paxil® Paroxetine S.S.R.I.
Mobic® Meloxicam N.S.A.I.D.
Valium® Diazepam
Benzodiazepine
(DEA Sch 4)
Diovan® Valsartan
Angiotensin II
Receptor Blocker
(A2RB)
Cymbalta® Duloxetine Anti-Depressant
Effexor® Venlafaxine Anti-Depressant
Zantac® Ranitidine
Histamine
Blocker (H2)
Diflucan® Fluconazole Anti-Fungal
Aleve® Naproxen N.S.A.I.D
Vibramycin® Doxycycline
Antibiotic
(Tetracycline)
Klor-Con®
Potassium
Chloride
Electrolyte
Elavil® Amitriptyline Anti-Depressant
Prevacid® Lansoprazole
Proton Pump
Inhibitor
Actos® Pioglitazone Anti-Diabetic
Medrol®
Methyl-
prednisolone
Steroid
Anti-
Inflammatory
Zyloprim® Allopurinol
Xanthine
Oxidase Inhibitor
Tylenol 3®
Codeine +
APAP
Pain Relief
(DEA Sch 3)
Vasotec® Enalapril ACE Inhibitor
Soma® Carisoprodol
Muscle Relaxant
(DEA Sch 4)
Flomax® Tamsulosin
Prostate
Receptor Agonist
Vytorin®
Ezetimibe +
Simvastatin
Cholesterol
Seroquel® Quetiapine Anti-psychotic
Levaquin® Levofloxacin
Antibiotic
(Quinolone)
Tricor® Fenofibrate Cholesterol
Catapres® Clonidine
Alpha Receptor
Agonist
Phenergan® Promethazine Anti-Nausea
/ Anti-emetic
Yaz®
Ethinyl
estradiol +
Drospirenone
Birth Control
Viagra® Sildenafil
Erectile
Dysfunction
Celebrex® Celecoxib
N.S.A.I.D.
COX-2 inhibitor
Proventil® Albuterol
Beta Agonist
(B2)(Lungs)
Oxycontin® Oxycodone
Pain Relief
(DEA Sch 2)
Lantus®
Insulin
Glargine
Insulin
Nasonex® Mometasone Corticosteroid
Lyrica® Pregabalin
Anti-convulsant
/ Neurologic
(DEA Sch 5)
Amaryl® Glimepiride Antidiabetic
Restoril® Temazepam
Sleep Aid
(DEA Sch 4)
Folvite® Folic Acid Mineral Supp.
Premarin®
Conjugated
Estrogen
Estrogen
Replacement
Zetia® Ezetimibe Colesterol
Aldactone® Spironolactone Diuretic
Lanoxin® Digoxin Inotrope
Imdur®
Isosorbide
Mononitrate
Nitrate
Vasodilator
Omnicef® Cefdinir
Anti-biotic
(Cephalosporin)
Altace® Ramipril ACE Inhibitor
Nasacort® Triamcinolone Inhaled Steroid
Ventolin® Albuterol Bronchodilator
Cozaar® Losartan A2RB
Concerta®
Methylphenidate
ADHD
(DEA Sch 2)
DiaBeta® Glyburide Anti-Diabetic
Valtrex® Valacyclovir Anti-Viral
Tamiflu® Oseltamivir Anti-Viral (Flu)
Pen-VK® Penicillin vk Antibiotic


Pharmacy Regulators and Agencies

DEA Schedule Definitions for controlled substances

How DEA Numbers work

Guidelines for Filling Prescription Orders

FDA Recall Definitions

FDA - New Drug Application (NDA) basics explained

Federal Acts and Amendments in the US

National Drug Code (NDC) Numbers





Pharmacy is regulated by several agencies. As a Pharmacy
Technician It's mandatory to generally know which does what to
prepare for the PTCB or ExCPT exams.

These agencies do more than what is listed below. We're just
covering the areas that involve Pharmacy.




FDA
Food and Drug Administration

- Approve new drugs to be sold in the US
- Process New Drug Applications (NDA)
- Regulate package inserts
- Regulate advertising of drugs
- Issue recalls
- Federal agency


DEA
Drug Enforcement Agency

- Federal Agency (U.S. Dept. of Justice)
- Enforce the CSA (controlled substances act)
- Track controlled substances manufactured and sold
- Investigates all violations involving controlled substances
- Set the DEA Sch. Definitions
- Issue DEA Numbers


BOP
Board of Pharmacy (each state)

- Regulate licensing of Pharmacists
- Regulate licensing of Pharmacy Technicians
- Set state laws / requirements
- Outline the operating guidelines in the pharmacy
- Investigate violations of the operating guidelines
- Determine state regulated controlled substances*
- State agency
* States may control drugs not controlled by DEA.



The Joint Commission
Formerly JCAHO
Joint Commission on Accreditation of Healthcare Organizations

- Watches over Healthcare Organizations
- Third Party Auditors / Regulators for insurance Providers
**They changed their name in 2009


How to remember who does what?
When trying to determine which agency regulates what, first ask if the question
involves a controlled substance. If it does then DEA will likely be the answer. If
the question involved a drug that is not controlled, FDA will likely be the answer.
If the question sounds state specific or involves licensing, then the BOP is likely
the answer.

Below is a basic outline of the process required by the Food and Drug Administration in
order for a manufacturer to bring a new drug to the market.

The process is very lengthy and involves many details, however this is the basic framework.
It is recommended to know about the NDA process to prepare for the ExCPT and PTCB
exams.

New Drug Initial Development
-Pre-Clinical
· Pre-Clinical (animal) testing.

-Investigational New Drug Review (IND)
· Review of of Pre-clinical Trial results.
· Determination of safety to use on humans.
· Authorization to ship across state lines.

New Drug Clinical Trials
-Phase I
· Involves a small number of healthy volunteers (25-100).
· Safely tolerated dosages determined.
· Identification of major side-effects
· Emphasis on safety and maximum tolerated dosages.

-Phase II
· Involves many more volunteers (100-300).
· Emphasis on the drugs effect against what it's designed to treat.
· Effects compared with similar patients receiving different treatments.

-Phase III
· Involves a few more volunteers (300-3000).
· Emphasis on the drugs overall effect.
· Effects compared with patients unknowingly taking placebos
· Study of different populations and different dosages.
· Testing the drug in combination with other drugs.
· Final Phase before presenting to FDA for approval.



New Drug Post Approval Trials
-Phase IV
· Ongoing/Post approval trials.
· Health-care professionals to report any adverse findings.
· This phase lasts eternally, as long as the drug is on the market.






Time the process takes
This process can usually take 12-15 years. The time elapsed from a drugs discovery in a
lab until it becomes available to market to the general public can be even longer. Keep in
mind that a Patent only lasts 20 years from the time the application for patent was
filed. After the patent runs out, competitors may seek approval to produce Generic drug
equivalents. Also, It is estimated that less than half of new drugs approved for clinical trials
ever make it to Phase III and less than 20% make it to market with FDA approval.

U.S. Drug Enforcement Administration
and Pharmacy
The DEA is a branch of the U.S. Department of Justice. Their mission is to enforce the
Controlled Substances Act. In pharmacy, they monitor a closed system of distribution for
controlled substances. What that means is that all individuals and companies handling
controlled substances are required to keep accurate inventories and records of every
transaction involving those controlled substances.

In preparation for the PTCB or ICPT exam, it's recommended to become familiar with
Controlled Substance Schedule Definitions:


D.E.A. Schedule definitions:


Schedule I - No accepted medical use. Extremely high potential for abuse. High potential
for psychological and physical dependency. A few examples are: Marijuana, Heroin and
MDMA (Extasy).


Schedule II - Does have medical use. High potential for abuse. Relative potential for
psychological and physical dependency. A few examples are: Oxycodone, Codeine and
Ritalin.


Schedule III - Does have medical use. Moderate abuse potential exists, but less than Sch
II. Examples are: Vicodin and Tylenol w/Codeine.


Schedule IV - Abuse potential exists, but less than Sch III. Examples are: Ambien,
Darvocet and Lorazepam.


Schedule V - Lowest abuse potential of the DEA Sch. Abuse potential exists, but less than
Sch IV. Example: Cough medicine w/codeine or anti-diarrheals.

D.E.A. Form 222 - must be used whenever Sch I or II drugs are bought, sold or
transferred between pharmacies or qualified distributors. The forms are only available
through the DEA and errors are not acceptable on the form. In the case of an error, the
form must be voided and kept on file and a new form used. For Sch III - V, a form 222 is
not necessary.

Refills on scheduled drugs are explained on the Prescription Order Abbreviations page. Two
very important things to remember are: 1) there are no refills allowed on Sch II drugs and
2)Sch II drug prescriptions cannot be "called in" or transmitted electronically unless it is an
absolute emergency and certain criteria is met.

Drug Enforcement Agency Numbers

With advanced technology now available for
DEA number verification,
most of you will be letting a computer verify DEA numbers over a fast internet
connection that will verify the number and the identity of the prescribing entity.
However, it's important to know the basics about how the numbers work.

The
Drug Enforcement Agency assigns authorized practitioners and hospitals a unique
number in order to keep track of the distribution of controlled drugs. The
instructions below explain how a DEA number verification is done. DEA numbers
can be verified by using the last number, which is known as the Check Digit.

Let's look at an example:


DEA Number - B J 6 1 2 5 3 4 1


6 + 2 + 3

=
11

↑

↑

↑

↓
B J 6 1 2 5 3 4 1

+

↓

↓

↓

↓

1 + 5 + 4 = 10 x 2 =
20
↓

= 31
>
1. Add together the 1st, 3rd and 5th digits.
2. Add together the 2nd, 4th and 6th digits. Double it.
3. Add the two totals together.
4. The second digit in that total is the check digit.




In retail pharmacy, forgeries are occasionally presented in an attempt to obtain narcotics.
Using the check digit is one method to detect the legitimacy of the order.

The numbers are preceded by two letters. The first letter represents the type of practice or
institution the DEA number is issued to. The second letter represents the first letter of the
practitioners last name. As such, that is another way to check the legitimacy of the DEA
number. If the number starts with BJ and the script is from a Dr. Shaw, that's a red flag.

Have you read about DEA Controlled Drug Schedules.



Interpreting Prescription Orders (Rx)
Sig Codes | Expiration Dates | Refills | Generic Drugs | D.E.A.

The prescription information on this site follows Federal guidelines and may not reflect
tighter laws in individual states. The Federal requirements for pharmacy technicians are
what the PTCB and ExCPT exams will ask about.


Sig Codes - Rx Abbreviations



The lingo "sig" refers to a string of
Prescription Abbreviations
found on a drug order.

When the sig is properly decoded, it becomes the directions for the preparation and use of
the medication.

This is important because it tells pharmacy technicians how to dispense it. The sig is also
printed on the container the prescription is dispensed in, but, translated into regular words
for the patient to read.


Besides decoding a prescription's sig, there are several other concerns. There are refill
limits, DEA laws, PPPA requirements, patient requests and many other considerations.
Pharmacy technicians must know with certainty how to decode prescription orders.

Click on these links for:

Sig Code List / Abbreviations

Dosage Forms / Routes of Administration

Roman Numerals in Pharmacy





Prescription order expiration dates

A prescription order must be dated, and it has an appropriate expiration date based on the
type of drug ordered. If it's not filled in time, the script expires.
DEA Sch II No Expiration
DEA Sch III thru V 6 Months
Legend Drugs 12 Months






Refills

If refills are allowed by the prescriber, it will be noted on the prescription. However, there
are boundaries and limitations. These are the guidelines:
DEA Schedule II NO REFILLS ALLOWED
DEA Schedule III thru V up to 5, but only 5 times*
Legend Drugs up to 12 Months worth

*If a patient has a Sch 3-5 prescription with 5 refills of 100, but can only afford 50 at a time, they will only get 250 total.
(not 500) Period. Each time a refill is redeemed, that refill is then voided. So, if you are authorized a refill of
100, but only get 50, you then forfeit the other 50.





Generic Substitutions

Generic drug substitutions may not be used unless the prescriber has authorized it.
Generic substitutions may only be used if the prescriber has requested or authorized
them.



DEA Controlled Drug Prescriptions

→ Must contain at least :

 Date of prescription issue

 Patient's name and address

 Practitioner's name, address, and phone number

 Drug name

 Drug strength

 Dosage form and instructions

 Exact quantity prescribed

 Complete directions for use

 Number of refills authorized

 Have a valid DEA Number


Schedule II drug prescriptions also:

→ Must be manually signed by the practitioner. No exceptions.

→ May not be Faxed or Called in, except for a valid emergency.

→ May not have any refills.





Pediatric Dosage Calculations

Pediatric Dosage Calculation methods should be memorized to prepare for the pharmacy
technician exam. However, in the field most prescribers will use a ratio to body weight
formula for more accuracy. Pharmacy technicians will be better equipped to package the
correct dosage with this more straight-forward method.










According to the
Official FDA website
"Recalls are actions taken by a firm to remove a product from the market.
They may be conducted on a firm's own initiative, by FDA request, or by FDA
order under statutory authority."

The urgency and severity of an
FDA Recall is what determines the "class" of the recall. Very similar to the
DEA Sch., the FDA recall class schedule uses "1" as the most dangerous.
However, unlike the DEA's schedule, the FDA Class schedule only goes to
"3". The severity of the recall is less as the number increases.



FDA Recall Class Definitions

Class
I
Would be used in a case where there is a probability that, the use of or exposure to
a violative product will cause serious adverse health consequences or death.

Class
II
Would be used in a case where use of a violative product may cause temporary
health problems and the probability of serious adverse health consequences is
remote.

Class
III
May be used in a situation in which use of a violative product is NOT likely to
cause adverse health consequences, but has violated some FDA regulation.

< />

Other Actions
FDA Market
Withdrawal
Is appropriate when a product has a minor violation that would not be
subject to FDA legal action. The manufacturer must remove the product
from distribution markets or correct the violation. An example from the
FDA Official website says, "A product removed from the market due to
tampering, without evidence of manufacturing or distribution problems,
would be a market withdrawal."
FDA Medical
Device
Safety Alert
Used only for medical apparatus equipment. This is when a medical
device may present an unreasonable risk of substantial harm. In some
cases, these situations also are considered recalls.

Pharmacy laws is made at local, state and federal levels.

For the purpose of studying for the PTCB or ExCPT exams it is necessary to know the
federal acts and pharmacy law. Outlined below is brief summary of the major acts and
amendments.

These laws and acts give authority to the Pharmacy Regulating Agencies to protect
consumers and prosecute criminals. They also give guidance to the court system in deciding
on legal matters and Pharmacy law.

The acts and amendments are listed in chronological order to loosely tell the story of how
the current laws we use today were developed.



This is not a comprehensive list, but, major acts that are recommended for pharmacy
technicians to be familiar with.



Federal Food and Drug Act of 1906
• Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of
adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and
Alcohol which were available at most stores as miracle cure-alls be labeled with correct
information about their ingredients as well as suggested dosages.



Narcotic Tax Act of 1914
• Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax
Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be
registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the
public from rising addiction.



Federal Food, Drug and Cosmetic Act of 1938
• Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.



The Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.



The Kefauver-Harris Amendment of 1962
• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate information
about side effects



The Bureau of Narcotics and Dangerous Drugs (BNDD)
• Predecessor agency of the DEA.
• In 1973 the BNDD merged into the DEA.
• DEA (Drug Enforcement Administration)



Drug Abuse Prevention / Control Act of 1970
• Also known as the Controlled Substances Act (CSA)
• Completely replaced the Harrison Act.
• Required the use of DEA Numbers
• Required comprehensive record keeping and transaction tracking.
• Enforced by the DEA under the US Dept. of Justice



Poison Prevention Packaging Act of 1970
• Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions



Combat Methamphetamine Epidemic Act (2005)
• Enacted to regulate the OTC sales of pseudoephedrine.
• Identity and address of each purchaser to be kept for two years.
• Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
How NDC numbers work


The
National Drug Code (NDC)
is a system used to identify legend drugs. Part of the Drug Listing Act of 1972
requires manufacturers of drug products to assign a unique number to each product
based on the individual drug type, strength, packaging size and where is was
manufactured. For the purpose of studying for the PTCB or ExCPT exams, it is
recommended to know what each segment of numbers identifies.


Every NDC number has 3 segments.


The First segment of an NDA number
string identifies the drug's
Manufacturer. This number is unique to the maker or re-packager
of the product.



The Second segment of an NDA number string identifies the
Product. This number is unique to the formulation and strength of
the product.




The Third segment
of an NDA number string identifies the Packaging. This number is
unique to the size and quantity of the product.




When studying for the PTCB or ExCPT exam, you should learn which segment
identifies what aspect of the product. If you are enrolled in a pharmacy technician
program, the syllabus may expand on National Drug Code (NDC) numbers in
more detail.