Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Chapter 3 Drug Regulation, Development, Names, and Information

2Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Drug Regulation, Development, Names, and Information   Landmark drug legislation   New drug development   Drug names   Over-the-counter drugs   Sources of drug information

3Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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

4Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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

5Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. New Drug Development  The randomized controlled trial  Control use  Randomization  Blinding

6Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Stages of New Drug Development  Preclinical testing  Clinical testing  Phase I  Phase II and III  Phase IV: postmarketing surveillance

7Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Limitations of the Testing Procedure  Limited information for women and children  Women  Children  Failure to detect all adverse effects

8Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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.

9Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Drug Names Chemical name Generic name Trade name The three types of drug names:

10Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Which Name to Use: Generic or Trade?  Use of drug names  Written and oral communication about medicines  Labeling medication containers

11Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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 Monistat and Kaopectate

12Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc.

13Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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?

14Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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.

15Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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.

16Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Sources of Drug Information  People  Clinicians and pharmacists  Poison control centers  Pharmaceutical sales representatives

17Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. Published Information  Text-like books  Goodman & Gilman’s The Pharmacological Basis of Therapeutics  Pharmacotherapy: A Pathophysiologic Approach  Applied Therapeutics: The Clinical Use of Drugs

18Copyright © 2013, 2010 by Saunders, an imprint of Elsevier Inc. 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