Chapter 1

Copyright © 2015 Cengage Learning®

Chapter 1Consumer Safety and Drug

Regulations


Introduction• Health care practitioners:

– Inform patients with knowledgeable answers about medications

– Have a serious, responsible attitude about all aspects of drug therapy

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Drug Laws• 1900s in the United States

– Laws were passed with regard to the dispensing of drugs

• Drug standards – Set to assure consumers that they are getting

what they pay for• All preparations with the same drug name must be

of uniform strength, quality, and purity

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Drug Laws (cont’d.)• Drug preparations

– Drug companies must not add other active ingredients or varying amounts of chemicals

• Illegal (illicit) drugs– Lack of enforcement of drug standards poses

consumer danger• No controls on quality can lead to deaths from

overdose

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Drug Laws (cont’d.)• Three major acts

– 1906 Pure Food and Drug Act– 1938 Federal Food, Drug, and Cosmetic Act

and Amendments Of 1951 and 1962– 1970 Controlled Substances Act

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1906 Pure Food and Drug Act• First attempt to establish consumer

protection in drug and food manufacture • Required drugs to meet minimal standards

of strength, purity, and quality• Demanded labeling for preparations

containing dangerous ingredients• Established United States Pharmacopeia

(USP) and National Formulary (NF)

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1938 Federal Food, Drug, and Cosmetic Act

• Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmetics– Example: “Warning” labels must be present

on certain preparations• “May cause drowsiness,” “may cause

nervousness,” “may be habit-forming,” etc.


1970 Controlled Substances Act• Established the Drug Enforcement

Administration (DEA)• Set tighter controls on depressants,

stimulants, psychedelics, narcotics, and anabolic steroids

• Provided guidelines for five schedules of controlled substances – Refer to Table 1-1.

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Additional Drug Legislation • The 1983 Orphan Drug Act

– Gives financial incentives to develop medications for diseases that affect a small number of people

• Omnibus Budget Reconciliation Act (OBRA) of 1990– Mandates that OTC drugs be documented as

part of a medical record– Mandates that pharmacists provide drug use

review and patient counseling

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FDA and DEA• Food and Drug Administration (FDA)

– Oversees drug testing before release– Inspects plants where foods, drugs, medical

devices or cosmetics are made– Reviews new drug applications and petitions

for food additives– Investigates and removes unsafe drugs from

the market– Ensures proper labeling of foods, cosmetics,

and drugs

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FDA and DEA (cont’d.)• Drug Enforcement Administration (DEA)

– Created as the need for better control of addictive drugs became urgent

– Handles all the needs and safety controls for the more dangerous drugs

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FDA and DEA (cont’d.)• Specific areas of control

– FDA• Concerned with general safety standards in the

production of drugs, foods, and cosmetics• Responsible for the approval and removal of

products on the market– DEA

• Concerned with controlled substances only• Enforces laws against drug activities• Monitors need for changing the schedules of

abused drugs

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Health Care Practitioners and the Law

• Guidelines for those who dispense medications– Keep a current drug reference source

available at all times– Keep controlled substances locked securely

• Locked safety box in a locked cupboard– Conceal and secure prescription pads – Properly destroy expired drugs and old

records

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– Keep accurate records of each controlled substance dispensed, received, or destroyed during past two years

– Keep up-to-date with current FDA news, DEA activities, and registration renewals

– Establish a working rapport with a pharmacist– If you work in an office, maintain a

professional rapport with pharmaceutical representatives

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Health Care Practitioners and the Law (cont’d.)

Chapter 1

Documents

drug regulationscopyright

drug testing

drug administration

orphan drug act

drug actfirst attempt

drug use review

drug act1938 federal

cengage learning9fda