Pharmacy Law Review

1906 Pure Food and Drug Act

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

Prohibits the mislabeling and misbranding of products.

1938 Food, Drug and Cosmetic Act (FDCA)

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.

1951 Durham-Humphrey Amendment

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.

1962 Kefauver-Harris Amendment

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

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

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

1970 Poison Prevention Packaging Act

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.

1972 Drug Listing Act

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.

1983 Orphan Drug Act

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

1987 Prescription Drug Marketing Act

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.

1990 Omnibus Budget Reconciliation Act (OBRA 90)

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.

1996 Health Insurance Portability and Accountability Act (HIPAA)

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

Class I Recall

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

Class II Recall

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

Class III Recall

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

How are recall notices sent?

Electronically over internet as in e-mail

Fax

US Postal Service

Never by phone

What are the basic components of a recall notice?

Recall Class

Name and description of product

Lot number/batch number

Instructions

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

Lot number and expiration date

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

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.

OTC labeling must contain:

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)

Drug Monograph aka Package insert parts

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.

National Drug Code (NDC)

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.

NDC first set (five numbers) indicate what?

Manufacturer

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

Specific drug - each drug has its own number

NDC last two numbers indicate what?

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

Schedule I drugs

These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential.

heroin, LSA, marijuana

Schedule II drugs

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

Schedule III drugs

These drugs have moderate potential for abuse.

These drugs may be refilled 5 times in a six month period.

Vicodin, Tylenol #3, anabolic steroids

Schedule IV drugs

These drugs have low potential for abuse.

These drugs may be refilled 5 times in a 6 month period.

Valium, Phenobarbital, Klonopin

Schedule V drugs

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

Heroin

Schedule I

LSA, LSD

Schedule I

Marijuana

Schedule I

Cocaine

Schedule II

Morphine

Schedule II

OxyContin - oxycodone

Schedule II

Ritalin

Schedule II

Tylenol No. 3 - acetaminophen/codeine

Schedule III

Vicodin - acetaminophen/hydrocodone

Schedule III

Anabolic steroids

Schedule III

Valium - diazepam

Schedule IV

Luminal - phenobarbitol

Schedule IV

Klonopin - clonazepam

Schedule IV

Antitussives w/codeine

Schedule V Robitussin AC

Antidiarrheals w/opioid

Schedule V Lomotil

Controlled substance inventory must be done how often?

Every two years

Two file Prescription filing system #1:

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

Two file prescription filing system #2:

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)

DEA 41

Used to document the destruction of controlled substances

DEA 106

Used to report lost or stolen controlled substances.

DEA 222

Used for purchasing and returning of outdated CII drugs

DEA 224

Needed for a pharmacy to dispense controlled substances

DEA 225

Needed to manufacture or distribute controlled substances

DEA 363

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

A doctor that precribes medications must have this?

DEA Number

Valid DEA Number

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.

Physician's Desk Reference (PDR)

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

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

The most stringent law

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

The most stringent law

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

FDA - through Med Watch or a form in the PDR

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

Manufacturer, drug, package size

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

Physicians Desk Reference

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

5 refills

Who may initiate the ordering of an investigational drug?

Physician

Who may order controlled substance schedule CI drugs?

No one. They're illegal.

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

The last day of August.

Which form is used to report lost or stolen drugs?

DEA 106

Which form is used when ordering CII drugs?

DEA 222

Which schedule has no medicinal use?

Schedule I

Which drug recall must go to the customer level?

Class I