1. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Chapter 3 Drug Regulation, Development, Names, and Information

2. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Landmark Drug Legislation  Federal Pure Food and Drug Act, 1906  Food, Drug, and Cosmetic Act, 1938  Harris-Kefauver Amendments, 1962 (Thalidomide response)  Controlled Substances Act, 1970  Permission for accelerated drug approval, 1992 2

3. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 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 (after the drug has been approved)  Family Smoking Prevention and Tobacco Control Act, 2009 3

4. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. New Drug Development  The randomized controlled trial  Use of controls  Randomization  Blinding 4

5. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Stages of New Drug Development  Preclinical testing  Clinical testing  Phase I  Phases II and III  Phase IV: Postmarketing surveillance 5

6. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Limitations of the Testing Procedure  Limited information about the majority of people:  Women  Children  Failure to detect all adverse effects 6

7. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 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 7

8. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Drug Names Chemical name Generic name Trade name The three types of drug names: 8

9. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Which Name to Use: Generic or Trade?  Use of drug names  Written and oral communication about medicines  Labeling medication containers 9

10. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 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 United States may have different active ingredients  Products with the same trade name may have different active ingredients For example, Kaopectate 10

11. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 11

12. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Which Name to Use: Generic or Trade?  Generic products vs. 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? 12

13. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 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 13

14. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Over-the-Counter Drugs (Cont.)  For most illnesses (60% to 95%), initial therapy consists of self-care, including self- medication with an OTC drug 14

15. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Sources of Drug Information  People  Clinicians and pharmacists  Poison control centers  Pharmaceutical sales representatives 15

16. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Published Information  Reference books  Goodman & Gilman’s The Pharmacological Basis of Therapeutics  Pharmacotherapy: A Pathophysiologic Approach  Applied Therapeutics: The Clinical Use of Drugs 16

17. Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. 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 17