Transcript 1285077881_425968x

Chapter 1
Consumer Safety and Drug
Regulations
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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.
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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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Health Care Practitioners
and the Law (cont’d.)
– 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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