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Chapter 3

Chapter 3. Drug Regulation, Development, Names, and Information. Drug Regulation, Development, Names, and Information. Landmark drug legislation New drug development Drug names Over-the-counter drugs Sources of drug information. Landmark Drug Legislation.

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Chapter 3

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  1. Chapter 3 Drug Regulation, Development, Names, and Information

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

  3. 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 of accelerated drug approval, 1992

  4. Landmark Drug Legislation • 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

  5. New Drug Development • The randomized controlled trial • Control use • Randomization • Blinding

  6. Stages of New Drug Development • Preclinical testing • Clinical testing • Phase I • Phase II and III • Phase IV: postmarketing surveillance

  7. Limitations of the Testing Procedure • Limited information for women and children • Women • Children • Failure to detect all adverse effects

  8. 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.

  9. Drug Names

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

  11. Which Name to Use:Generic or Trade? • 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 U.S. may have different active ingredients. • Products with the same trade name may have different active ingredients. • Monistat and Kaopectate

  12. Which Name to Use:Generic or Trade? • 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?

  13. Over-the-Counter Drugs • Americans spend about $20 billion annually on OTC drugs. • OTC drugs account for 60% of all doses administered. • 40% 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.

  14. Over-the-Counter Drugs • With most illnesses (60%–95%), initial therapy consists of self-care, including self-medication with an OTC drug. • The average home medicine cabinet contains 24 OTC preparations.

  15. Sources of Drug Information • People • Clinicians and pharmacists • Poison control centers • Pharmaceutical sales representatives

  16. Published Information • Text-like books • Goodman & Gilman’s The Pharmacological Basis of Therapeutics • Pharmacotherapy: A Pathophysiologic Approach • Applied Therapeutics: The Clinical Use of Drugs

  17. Published Information • 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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