Essentials of Pharmacology for

Health Professions
Eighth Edition

Chapter 1

Consumer Safety and Drug

Regulations

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 Orphan Drugs

• Over the Counter Medication (OTC)

– Health care practitioners:
 Inform patients with knowledgeable answers about
medications
 Have a serious, responsible attitude about all aspects of
drug therapy
 Be aware regarding the legalities of dispensing
medications
 Consider misconceptions and facts

Introduction
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 Drug Laws (1 of 3)

• 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

Introduction
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 Drug Laws (2 of 3)

• 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

Introduction
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 Drug Laws (3 of 3)

• 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 and
Amendments of 1951, 1962 and 1972
• FDA established under the Department of Health and
Human Services (DHHS)
• 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.

Introduction
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 1970 Controlled Substances Act

• Established the Drug Enforcement Administration

(DEA)
• Set tighter controls on a specific group of drug: those
being abused by society. These include depressants,
stimulants, psychedelics, narcotics, and anabolic
steroids
• Provided guidelines for five schedules of controlled
(designated by a capital C) substances ( C I, II, III, IV,
and V)
– Refer to Table 1-1.

Introduction
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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:
 OTC drugs be documented as part of a medical record
 Pharmacists provide drug use review and patient
counseling

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 FDA

• 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 for food additives
– Investigates/removes unsafe drugs from the market
– Ensures labeling of foods, cosmetics, and drugs
– Concerned with general safety standards in the
production of drugs, foods, and cosmetics
– Responsible for the approval and removal of products on
the market

Introduction
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 DEA

• Drug Enforcement Administration (DEA)

– Concerned only with controlled substances
– Enforces laws against drug activities (illegal drug use,
dealing, and manufacturing)
– Monitors need for changing the schedules of abused
drugs
– 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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Health Care Professionals and the Law and
Ethics (1 of 2)
• 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

Introduction
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Health Care Professionals and the Law and
Ethics (2 of 2)
– 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

Introduction
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