Chapter 3

Drug Regulation, Development,

Names, and Information

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 Drug Regulation, Development,
Names, and Information
 Landmark drug legislation
 New drug development
 Drug names
 Over-the-counter drugs
 Sources of drug information

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 Landmark Drug Legislation
 Federal Pure Food and Drug Act, 1906
 Food, Drug, and Cosmetic Act, 1938
 Harris-Kefauver Amendments, 1962
 Controlled Substances Act, 1970
 Permission for accelerated drug approval, 1992

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Landmark Drug Legislation (Cont.)
 Prescription Drug User Fee Act, 1992
 Food and Drug Administration Modernization Act,
1997
 Best Pharmaceuticals for Children Act, 2002
 Pediatric Research Equity Act, 2003
 FDA Amendments Act, 2007
 Family Smoking Prevention and Tobacco Control
Act, 2009
 Comprehensive Addiction and Recovery Act of 2016

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 New Drug Development
 The randomized controlled trial
 Use of controls
 Randomization
 Blinding

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Stages of New Drug Development
 Preclinical testing
 Clinical testing
 Phase I
 Phases II and III
 Phase IV: Postmarketing surveillance

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 Limitations of the
Testing Procedure
 Limited information about the majority of people:
 Women
 Children
 Failure to detect all adverse effects

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 Exercising Discretion
Regarding New Drugs
 Be neither the first to adopt the new nor the last
to abandon the old
 Balance potential benefits against inherent risks
 New drugs generally present greater risks than
old ones

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 Which Name to Use:
Generic or Trade?
 Use of drug names
 Written and oral communication about medicines
 Labeling medication containers

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 Which Name to Use:
Generic or Trade? (Cont.)
 The little problems with generic names
 More complicated than trade names
 The big problems with trade names
 Single drug can have multiple trade names
 U.S. drugs and drugs outside the United States may
have different active ingredients
 Products with the same trade name may have
different active ingredients
• For example, Kaopectate

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 Which Name to Use:
Generic or Trade? (Cont.)
 Generic products versus brand-name products
 Are generic products and brand-name products
therapeutically equivalent?
 Would a difference between brand-name and generic
products justify the use of trade names?

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 Over-the-Counter Drugs
 Americans spend about $20 billion annually on
over-the-counter (OTC) drugs
 OTC drugs account for 60% of all doses
administered
 Forty percent of Americans take at least one
OTC drug every 2 days
 Four times as many illnesses are treated by a
consumer using an OTC drug as by a consumer
visiting a physician

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 Over-the-Counter Drugs (Cont.)
 For most illnesses (60% to 95%), initial therapy
consists of self-care, including self-medication
with an OTC drug

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 Sources of Drug Information
 People
 Clinicians and pharmacists
 Poison control centers
 Pharmaceutical sales representatives

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 Published Information
 Reference books
 Goodman & Gilman’s The Pharmacological Basis of
Therapeutics
 Pharmacotherapy: A Pathophysiologic Approach
 Applied Therapeutics: The Clinical Use of Drugs

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 Published Information (Cont.)
 Newsletters
 The Medical Letter on Drugs and Therapeutics
 Prescriber’s Letter
 Reference books
 Physicians’ Desk Reference
 Drug Facts and Comparisons
 Nursing drug references
 The Internet

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 Question 1
A nurse is administering a drug that is categorized as Schedule
IV. The nurse understands that this means the drug:

A. Has acceptable medical applications with low potential for

abuse.
B. Is a controlled substance with no accepted medical use.
C. Is dangerous to administer to pregnant or breast-feeding
patients.
D. Has the potential for serious and life-threatening adverse
effects.

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 Question 2
The nurse is preparing a list of medications to give
to a patient who is being discharged from the
hospital. The nurse should use which drug name
for each medication?

A. Chemical name
B. Generic name
C. Trade name
D. Classification name

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