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1906 Pure Food and Drug Act

answer

Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products.

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1938 Food, Drug and Cosmetic Act (FDCA)

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This act requires that manufacture prove a new drug is safe for human consumption. Toxicological studies - done on animals. Clinical trials - done on humans. Gave rise to the Food and Drug Administration. Manufacturer must submit New Drug Application (NDA) to FDA.

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1951 Durham-Humphrey Amendment

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This act distinguishes legend drugs (prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs: "Caution: Federal law prohibits dispensing without a prescription". Refills may only be authorized by the subscriber.

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1962 Kefauver-Harris Amendment

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Required drugs be effective for the purpose they were marketed for. Written in response to Thalidomide incident in Europe.

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1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA)

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Purpose is to regulate manufacture and sale of Narcotics. Drug Enforcement Agency (DEA) was formed. Introduced a stair step schedule for narcotics based on their abuse potential. Schedule I drugs have the highest abuse potential and Schedule V drugs have the lowest abuse potential. DEA Form 222 - to buy DEA Form 224 - to sell

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1970 Poison Prevention Packaging Act

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This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as nitroglycerin (Nitrostat SL), birth control pills, inhalers, ointments and creams.

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1972 Drug Listing Act

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Authorized the FDA to compile a list of all legal drugs for sale in the US. Assigned a unique identifier to all drugs called the National Drug Code (NDC) 12 digit code. Leading zero on the ones with only 4 digits in first sequence.

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1983 Orphan Drug Act

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Created to promote the research and development of drugs needed for the treatment of rare diseases. (less than 200,000)

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1987 Prescription Drug Marketing Act

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Enacted to prevent the reimportation of drugs from other countries. This act banned the sale, trade, or purchase of drug samples except by those licensed to prescribe drugs.

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1990 Omnibus Budget Reconciliation Act (OBRA 90)

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This act requires a pharmacist to conduct a Drug Utilization Review (DUR) or offer counsel to patients on all new prescriptions. Pharmacist must provide name and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage, refill information, and what to do if a dose is missed. Administered by State Board of Pharmacies.

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1996 Health Insurance Portability and Accountability Act (HIPAA)

answer

This act created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. Violations punishable by fine up to $250,000.00 per incident

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Class I Recall

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An attempt must be made to notify the patient that the drug he/she may be taking could cause serious harm or death

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Class II Recall

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The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency

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Class III Recall

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Not likely to cause any serious adverse effects and does not go to the customer level

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How are recall notices sent?

answer

Electronically over internet as in e-mail Fax US Postal Service Never by phone

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What are the basic components of a recall notice?

answer

Recall Class Name and description of product Lot number/batch number Instructions

question

When drug manufacturers notify a pharmacy of a drug recall, how are the affected drugs identified?

answer

Lot number and expiration date

question

Food, Drug, and Cosmetic Act requires prescription drugs to contain:

answer

Name, address, phone number of dispensing pharmacy, patient and doctor's name, prescription number and the date filled, drug name, strength, quantity, directions for use, name/initials of dispensing pharmacist or technician, patient address, expiration date, refill information, precautions, the statement "federal law prohibits dispensing without a prescription", package insert on selected drugs.

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OTC labeling must contain:

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Product Name, manufacturer address, net contents, all ingredients (active or inactive), habit-forming drugs contained within, caution/warning labels, directions for use (drug's purpose, dosage, frequency of administration in accordance to meals, symptoms, etc, route of administration)

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Drug Monograph aka Package insert parts

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1. Description of the drug - chemical structure, chemical formula, basic description of the drug, i.e. blue tablet. 2. Clinical pharmacology - detailed info regarding chemical action in body and any drug interactions. 3. Indications and usage - describes what the drug treats or prevents. 4. Dosage - recommended dosage for adults & children by age, sometimes by body weight or body surface area (BSA) 5. How supplied - Forms the drug comes in, strength, bottle size, NDC number for each size, any special considerations for the drug, i.e. how to store it.

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National Drug Code (NDC)

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Each drug produced by a manufacturer is identified with a specific NDC number. The NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size.

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NDC first set (five numbers) indicate what?

answer

Manufacturer

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NDC second set/middle set (four numbers) indicates what?

answer

Specific drug - each drug has its own number

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NDC last two numbers indicate what?

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Package size - (100 tablets may be 01, 500 tablets may be 05)

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Schedule I drugs

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These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential. heroin, LSA, marijuana

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Schedule II drugs

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These drugs have high potential for abuser. These drugs may NOT be refilled. The ordering of these drugs requires a DEA 222 form. Must be kept under lock and key. Cocaine, morphine, Oxycontin, Ritalin

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Schedule III drugs

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These drugs have moderate potential for abuse. These drugs may be refilled 5 times in a six month period. Vicodin, Tylenol #3, anabolic steroids

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Schedule IV drugs

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These drugs have low potential for abuse. These drugs may be refilled 5 times in a 6 month period. Valium, Phenobarbital, Klonopin

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Schedule V drugs

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These drugs have very low potential for abuse. These drugs may be refilled 5 times in a 6 month period. Lomotil, cough syrup containing codeine

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Heroin

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Schedule I

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LSA, LSD

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Schedule I

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Marijuana

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Schedule I

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Cocaine

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Schedule II

question

Morphine

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Schedule II

question

OxyContin - oxycodone

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Schedule II

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Ritalin

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Schedule II

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Tylenol No. 3 - acetaminophen/codeine

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Schedule III

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Vicodin - acetaminophen/hydrocodone

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Schedule III

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Anabolic steroids

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Schedule III

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Valium - diazepam

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Schedule IV

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Luminal - phenobarbitol

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Schedule IV

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Klonopin - clonazepam

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Schedule IV

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Antitussives w/codeine

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Schedule V Robitussin AC

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Antidiarrheals w/opioid

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Schedule V Lomotil

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Controlled substance inventory must be done how often?

answer

Every two years

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Two file Prescription filing system #1:

answer

One file for CII and CIII-CV(marked with a red "C" one inch high at the bottom right corner) and another file for all other prescriptions

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Two file prescription filing system #2:

answer

One file for CDS-CII only. Another file for CDS CIII-CV and all other drugs (CDS-CIII must be marked with a one inch high red "C" on the bottom right corner)

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DEA 41

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Used to document the destruction of controlled substances

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DEA 106

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Used to report lost or stolen controlled substances.

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DEA 222

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Used for purchasing and returning of outdated CII drugs

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DEA 224

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Needed for a pharmacy to dispense controlled substances

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DEA 225

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Needed to manufacture or distribute controlled substances

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DEA 363

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Needed to operate a controlled substance treatment program or compound controlled substances

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A doctor that precribes medications must have this?

answer

DEA Number

question

Valid DEA Number

answer

2 letters followed by 7 numbers. First letter is an A, B or M. Second letter is first letter of last name. Add digits 1,3 and 5. Add digits 2,4 and 6 multiply by 2. Add totals. The last number of the sum of both sets is the last digit of the DEA number.

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Physician's Desk Reference (PDR)

answer

Contains packet insert drug information intended for physicians and is published annually. Contains color pictures with a list of drug manufacturers including addresses and phone numbers

question

Because federal and state record keeping requirements can vary in each state, which law should be followed?

answer

The most stringent law

question

For general laws concerning pharmacy rules and regulations, which law should be followed?

answer

The most stringent law

question

To whom are drug recalls, drug reactions, and outcomes reported?

answer

FDA - through Med Watch or a form in the PDR

question

What do the first five, middle four, and last two digits of an NDC number represent?

answer

Manufacturer, drug, package size

question

A list of drug package inserts could be located in which book?

answer

Physicians Desk Reference

question

What is the maximum amount of refills for CIII-CV prescriptions in a six-,month period?

answer

5 refills

question

Who may initiate the ordering of an investigational drug?

answer

Physician

question

Who may order controlled substance schedule CI drugs?

answer

No one. They're illegal.

question

The expiration date on a bottle of Naproxen is 8/08. When will this drug expire?

answer

The last day of August.

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Which form is used to report lost or stolen drugs?

answer

DEA 106

question

Which form is used when ordering CII drugs?

answer

DEA 222

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Which schedule has no medicinal use?

answer

Schedule I

question

Which drug recall must go to the customer level?

answer

Class I

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