1. Copyright (c) The McGraw-Hill Companies, Inc. Permission required for reproduction or display. 9-1 Chapter 9 Principles of Pharmacology

2. 9-2 Objectives

3. Pharmacology –The study of drugs or medications and their effect on living systems 9-3

4. Pharmacology Pharmacodynamics –The study of the effects of drugs and their mechanisms of action at target sites in the body 9-4

5. Drug Legislation in the United States 9-5

6. Drug Legislation Protects the public from contaminated or mislabeled drugs 1848 – Drug Importation Act –Required U.S. Customs Service inspectors to stop entry of contaminated drugs from overseas 9-6

7. Drug Legislation 1902 – Biologics Control Act –Passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans 9-7

8. Drug Legislation 1906 – Pure Food and Drug Act Prohibited interstate commerce in misbranded and impure foods, drinks, and drugs 9-8

9. Drug Legislation 1912 Shirley Amendment Prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser 9-9

10. Drug Legislation 1914 – Harrison Narcotic Act –Established the word “narcotic” –Required prescriptions for products exceeding the allowable limit of narcotics –Required increased recordkeeping for physicians and pharmacists who dispense narcotics 9-10

11. Drug Legislation 1937 Elixir of Sulfanilamide kills 107 persons, many of whom were children 9-11

12. Drug Legislation 1938 – Federal Food, Drug, and Cosmetic Act of 1938 –Required that new drugs be shown to be safe before marketing –Established the FDA’s responsibility for supervising and regulating drug safety –Authorized factory inspections –Required that drugs contain a label listing all of the ingredients and directions for use 9-12

13. Drug Legislation 1951 – Durham-Humphrey Amendment Required that prescription drugs (also called legend drugs) must carry the following label: “Caution: Federal law prohibits dispensing without a prescription.” 9-13

14. Drug Legislation 1962 – Kefauver-Harris Drug Amendments –Passed to ensure drug effectiveness and greater drug safety –Drug manufacturers required to prove to FDA the effectiveness of their products before marketing them 9-14

15. Drug Legislation 1970 – Controlled Substances Act –Established five schedules (classifications) of drugs based on their accepted medical use in the United States, abuse potential, and potential for addiction 9-15

16. Drug Legislation 1983 – Orphan Drug Act –Enabled FDA to promote research and marketing of drugs needed for treating rare diseases 9-16

17. Drug Legislation 1988 – Food and Drug Administration Act –Officially established FDA as an agency of the Department of Health and Human Services 9-17

18. Drug Legislation 1990 – Anabolic Steroid Act –Identified anabolic steroids as a class of drugs and specified over two dozen items as controlled substances 9-18

19. Federal Regulatory Agencies and Services 9-19

20. Federal Regulatory Agencies Drug Enforcement Agency (DEA) –Division of the Justice Department –Became the sole legal drug enforcement agency in July 1973 Food and Drug Administration (FDA) –Enforces Federal Food, Drug, and Cosmetic Act 9-20

21. Drug Sources Plants Minerals or mineral products Animals and humans Synthetic, semi-synthetic drugs 9-21

22. Drug Names Chemical name Generic name Trade name 9-22 Generic NameTrade NameChemical Name albuterol Proventil, Ventolinalpha1[(tert-Butylamino)methyl]-4- hydroxy-m-xylene-alpha, alpha´-diol sulfate ibuprofen Motrin, Advil, Midol (±)-2-(p-isobutylphenyl) propionic acid sildenafil citrate Viagra, Revatio1-[[3-(6,7-dihydro-1-methyl-7-oxo-3- propyl-1H-pyrazolo[4,3-d]pyrimidin- 5- yl)-4-ethoxyphenyl]sulfonyl]-4- methylpiperazine citrate

23. Sources of Drug Information United States Pharmacopeia (USP) American Hospital Formulary Service (AHFS) Physician’s Desk Reference (PDR) Patient package inserts 9-23

24. Drug Forms 9-24

25. Drug Effects Local effects Systemic effects 9-25

26. Drug Forms Gas –Breathed in and absorbed through the respiratory tract –Example Oxygen 9-26

27. Drug Forms Liquid –Contain medication that is ground into a powder and mixed with a substance, such as water –Examples Elixir Emulsion Gel Lotion Suspension 9-27

28. Drug Forms Solid –A drug that is in solid form is usually swallowed –Requires a responsive patient who is cooperative and has an intact gag reflex 9-28

29. Drug Profile 9-29

30. Drug Profile Generic and trade names of the drug Mechanism of action Indications Dose Route of administration Contraindications Adverse effects Special considerations 9-30

31. Questions? 9-31