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 BLOCKERITIDINE H2 ANTAGONIST

CILLIN PENICILLINANTI-BIOTICS

FLOXACIN FLUOROQUINOLONE ANTIBIOTICS

CYCLINE TETRACYCLINE ANTIBIOTICS

ROMYCIN MACROLIDE ANTIBIOTICS

LAX LAXATIVEVIR ANTI-VIRAL

     

BRAND GENERIC FUNCTIONVicodin® APAP +

HydrocodonePain Relief(DEA Sch 3)

Prinivil® Lisinopril ACE inhibitorZocor® Simvastatin Statin

Synthroid® Levothyroxine HormoneReplacement

Amoxil® Amoxicillin Antibiotic(Penicillin)

Zithromax® Azithromycin MacrolideAntibiotic

Microzide®Hydro-chlorothiazide(HCTZ)

Thiazide Diuretic

Norvasc® Amlodipine Calcium ChannelBlocker

Xanax® Alprazolam Benzodiazepine(DEA Sch 4)

Glucophage® Metformin AntidiabeticLipitor® Atorvastatin Statin

Prilosec® Omeprazole Proton PumpInhibitor

Augmentin® Amoxicillin +Clavulanate

PenicillinAntibiotic

Tenormin® Atenolol Beta Blocker(B1)

Lasix® Furosemide Diuretic

Lopressor® metoprolol Beta ReceptorBlocker (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 PumpInhibitor

Plavix® ClopidogrelPlateletAggregationInhibitor

Singulair® Montelukast LeukotrieneInhibitor

Sterapred® Prednisone CorticosteroidLexapro® Escitalopram S.S.R.IAdvil® Ibuprofen N.S.A.I.DCelexa® Citalopram Anti-Depressant

(S.S.R.I.)

ProAir® Albuterol B2 ReceptorAgonist(Lungs)

Prozac® Fluoxetine S.S.R.I.Neurontin® Gabapentin Anti-ConvulsantCoumadin® 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

AntibioticCombination

Cipro® Ciprofloxacin QuinoloneAntibiotic

Flonase® Fluticasone Inhaled SteroidDyrenium® 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® alendronateBoneResorptionInhibitor

Allegra® Fexofenadine Antihistamine(H1)

Mevacor® Lovastatin Cholesterol /Statin

Coreg® Carvedilol Beta ReceptorBlocker

Paxil® Paroxetine S.S.R.I.Mobic® Meloxicam N.S.A.I.D.

Valium® Diazepam Benzodiazepine(DEA Sch 4)

Diovan® ValsartanAngiotensin IIReceptor Blocker(A2RB)

Cymbalta® Duloxetine Anti-Depressant

Effexor® Venlafaxine Anti-Depressant

Zantac® Ranitidine HistamineBlocker (H2)

Diflucan® Fluconazole Anti-FungalAleve® Naproxen N.S.A.I.D

Vibramycin® Doxycycline Antibiotic(Tetracycline)

Klor-Con® PotassiumChloride Electrolyte

Elavil® Amitriptyline Anti-Depressant

Prevacid® Lansoprazole Proton PumpInhibitor

Actos® Pioglitazone Anti-Diabetic

Medrol® Methyl-prednisolone

SteroidAnti-Inflammatory

Zyloprim® Allopurinol XanthineOxidase Inhibitor

Tylenol 3® Codeine +APAP

Pain Relief(DEA Sch 3)

Vasotec® Enalapril ACE Inhibitor

Soma® Carisoprodol Muscle Relaxant(DEA Sch 4)

Flomax® Tamsulosin ProstateReceptor Agonist

Vytorin® Ezetimibe +Simvastatin Cholesterol

Seroquel® Quetiapine Anti-psychotic

Levaquin® Levofloxacin Antibiotic(Quinolone)

Tricor® Fenofibrate Cholesterol

Catapres® Clonidine Alpha ReceptorAgonist

Phenergan® Promethazine Anti-Nausea/ Anti-emetic

Yaz®Ethinylestradiol +Drospirenone

Birth Control

Viagra® Sildenafil ErectileDysfunction

Celebrex® Celecoxib N.S.A.I.D.COX-2 inhibitor

Proventil® Albuterol Beta Agonist(B2)(Lungs)

Oxycontin® Oxycodone Pain Relief

(DEA Sch 2)

Lantus® InsulinGlargine Insulin

Nasonex® Mometasone Corticosteroid

Lyrica® PregabalinAnti-convulsant/ Neurologic(DEA Sch 5)

Amaryl® Glimepiride Antidiabetic

Restoril® Temazepam Sleep Aid(DEA Sch 4)

Folvite® Folic Acid Mineral Supp.

Premarin® ConjugatedEstrogen

EstrogenReplacement

Zetia® Ezetimibe ColesterolAldactone® Spironolactone DiureticLanoxin® Digoxin Inotrope

Imdur® IsosorbideMononitrate

NitrateVasodilator

Omnicef® Cefdinir Anti-biotic(Cephalosporin)

Altace® Ramipril ACE InhibitorNasacort® Triamcinolone Inhaled SteroidVentolin® Albuterol BronchodilatorCozaar® Losartan A2RB

Concerta® Methylphenidate ADHD(DEA Sch 2)

DiaBeta® Glyburide Anti-DiabeticValtrex® Valacyclovir Anti-ViralTamiflu® 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.

FDAFood 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

DEADrug 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

BOPBoard 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 CommissionFormerly JCAHOJoint 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 takesThis 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 Administrationand 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 theOfficial 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 anFDA 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

ClassI

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.

ClassII

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.

ClassIII

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 DeviceSafety 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

TheNational 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 segmentof 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.