1. Pharmacy Law and Ethics Meet the Instructors Overview of schedule Blackboard – please use it! Exams and Grading Attendance Respect for everybody’s opinions

2. Instructors Me (Joe Schnabel) Dell Alexander – R.Ph., J.D. Board of Pharmacy – members and staff Karen Peterson – R.Ph., J.D. DEA Agents(?)

3. Course Overview Federal Laws (Joe Schnabel) –FDA and DEA Civil/Criminal Law (Dell Alexander) State Law (Joe Schnabel) Ethics (Joe Schnabel)

4. Major Federal Drug Laws Food Drug and Cosmetic Act Federal Alcohol Tax Poison Prevention Packaging Act OBRA 90 Controlled Substances Act

5. Sources of Federal Law Constitution U.S. Congress (House of Representatives and Senate) Federal Agencies (FDA, DEA, CMS, FTC…) Courts (Common Law)

6. Where to Find Federal Laws Federal Register –Published daily –On the internet Code of Federal Regulations (CFR) –A compilation of Federal Law –Updated more slowly than Federal Register

7. Federal vs. State Law State can regulate where Federal doesn’t If there is a Federal regulation, State can only make more restrictive State can not permit activities that are illegal under Federal Law Conflicts? Feds win! Usually… –See Oregon: Medical Marijuana, Death With Dignity Acts –“State’s rights” issues (See: Civil War)

8. Regulatory Agencies Oregon Board of Pharmacy Drug Enforcement Administration (DEA) Food and Drug Administration (FDA) Oregon Public Health Services Centers for Medicare and Medicaid Services (CMS) Federal Trade Commission (FTC) Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

9. Pharmacy Laws Statutes (ORS) - from the Oregon Leglslature Administrative Rules (OAR) - from the Board of Pharmacy Federal Laws (CFR) –From US Congress –From FDA and DEA

10. Legal Illegal Ethical Unethical 12 34 Four Categories of Professional Activity You will want to spend most of your time in this box. You will have to make difficult decisions that are in this box. Do what is best for the patient! You might get away with things in this box, but you should avoid them! Stay away! People in this box can and do lose their licenses.

11. 11 years old 14 years old

12. History of Food and Drug Law 1906 Pure Food and Drug Act 1938 Food, Drug, and Cosmetic Act 1951 Durham-Humphrey Amendment 1958 Food Additives Amendment 1960 Color Additives Amendment 1962 Kefauver-Harris Amendment 1976 Medical Device Amendments

13. History of Food and Drug Law 1983 Orphan Drug Act 1984 Drug Price Competition/Patent Term Restoration Act 1987 Prescription Drug Marketing Act 1990 Nutrition Labeling and Education Act 1992 Prescription Drug User Fee Act 1994 Dietary Supplement Health and Education Act 1997 Food and Drug Modernization Act

17. 1906 Pure Food and Drug Act Inspired by widespread sales of ineffective and/or unsafe “remedies” No provision to test drugs prior to sale Action taken only after harmful effects occurred 1906 law was preceded by 103 bills dating to 1848 Opposition to 1906 law was overcome by Upton Sinclair’s Novel “The Jungle”, which exposed substandard (and disgusting!) meat packing conditions (see Blackboard for excerpt)

18. 1906 Pure Food and Drug Act 1.Protect public from adulterated and misbranded food and drugs 2.States took limited action to solve problem of interstate commerce 3.Secure a uniform law throughout the U.S.  The Food and Drug Administration, 1862

19. 1906 Pure Food and Drug Act Needed Strengthening and six amendments were added over the years Amendments were inadequate to monitor growing technology Did not require premarket testing for safety 1938 Elixir of Sulfanilamide Case prepared with diethylene glycol, a poison

20. 1938 Food Drug and Cosmetic Act Is current law of the land, as amended. Gave the Federal Gvt power to establish product safety, but did not mention efficacy Regulates Drug quality No new drug can be marketed until proven safe under conditions described on the label required all drugs to be labeled with “adequate directions for use”

21. 1951 Durham-Humphrey Amendment Many drugs on market were not safe for use, except under medical supervision These drugs could not meet “adequate directions for use” requirement Drugs labeled by manuf. with “Caution: Federal law prohibits dispensing without a prescription” are exempt from labeling requirement directing “adequate directions for use” Labels on Rx drugs do not contain directions on how to use the product

22. 1951 Durham-Humphrey Amendment Established the category of “prescription” or “legend” drugs Established the OTC (non- prescription) category of drugs

23. Kefauver-Harris Amendment 1962 Required proof of efficacy and strengthened safety requirements Thalidomide tragedy occurred at this time Manufacturers had to evaluate pre-1962 drugs for efficacy Led to DESI - Drug Efficacy Study implementation National Academy of Sciences reviewed 50,000 + Rx/OTC Products Established Good Manufacturing Practices (GMP) Strengthened clinical trial safeguards/adverse reaction reporting

24. Thalidomide

25. Medical Device Amendment 1976 Gave FDA much more oversight of medical devices –Similar safety and efficacy issues –Classification of devices according to function –premarket approval required –establishment of performance standards –“Good Manufacturing Practices” (GMP) required –record keeping and reporting of problems

26. Orphan Drug Act 1983 Orphan drug - drugs that have little or no commercial value (rare diseases) Drug development costs exceed any possible return on investment Provides pharmaceutical manufacturers tax and licensing incentives to develop them

27. Drug Price Competition and Patent- Term Restoration Act 1984 Also called Waxman-Hatch Amendment Streamlined generic drug approval process to make them more readily available Brand-name manufacturers have become increasingly creative at delaying generics Bush limits automatic 30-month patent extensions to one in 2002

28. Prescription Drug Marketing Act of 1987 Established sales restrictions and recordkeeping requirements for prescription drug samples Prohibits hospitals and other non-profit organizations from reselling Rx items to other businesses Requires state licensing of drug wholesalers

29. “Drug” means: (A)articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) of this title or sections 403(r)(1)(B) and 403(r)(5)(D) of this title, is made in accordance with the requirements of section 403(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

30. Definition of “Drug” in English It is listed in the United States Pharmacopoeia/ National Formulary (USP/NF), or the official Homoeopathic Pharmacopoeia of the United States, or any supplement to them. It is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. It is intended to affect the structure or any function of the body. It is a component of any article specified above.

31. Drug Definition Established by FDCA Articles recognized as official by USP, Homeopathic Pharmacopoeia, NF To treat disease

32. Counterfeit Drug A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness… Without legal authorization Recent increase in counterfeiting of high cost drugs

33. Device instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory Intended to diagnose or treat diseases Similar wording to “drug” definition

34. Foods vs. Drugs Natural products--Health Foods i.e.., St. John’s Wort to treat depression Sometimes called “Nutraceuticals” if neither food or drug Often lacking evidence of efficacy

35. “Nutritional Supplement” Regulation Nutrition Labeling and Education Act of 1990 Dietary Supplement & Health Education Act of 1994Dietary Supplement & Health Education Act of 1994 –both prohibit disease prevention claims of dietary supplements –regulates allowable claims nutrient deficiency, how it affects the body, mech of action etc.

36. Labels and Labeling Label: Display of written material on the product’s container and on the outside container or wrapper, if any. Labeling: All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising)

37. Official Compendia United States Pharmacopoeia/ National Formulary (USP/NF) Homeopathic Pharmacopoeia of the United States

38. Enforcement FDA can enforce FDCA via civil or criminal charges FDA works with other agencies i.e...., State Boards of Pharmacy, DEA, Customs Service…

39. Product Recalls FDA can remove adulterated or misbranded products from the market via a recall Usually a manufacturer informs the FDA of a problem and initiates a voluntary recall

40. Product Recalls Recalls are divided into three classes I, II, III –Class I reasonable probability that the use of or exposure to the product will cause serious adverse consequences or death. –Class II may cause temporary or medically reversible adverse consequences or the probability of serious adverse health consequences is remote. –Class III not likely to cause adverse health consequences

41. Product Recalls 1994 –Two Class I Recalls –120 Class II Recalls –145 Class III Recalls

42. Source: FDA

43. Adulterated Drugs If it consists in whole or in part of any filthy, putrid or decomposed substance If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health If the strength differs, or quality or purity fall below label standards

44. Adulterated Drugs Most provisions apply to manufacturers A pharmacy is considered a manufacturer if it repackages or compounds for resale

45. Current Good Manufacturing Practice (GMP) A drug is adulterated unless it is manufactured in accordance with GMP GMP establishes minimum requirements for facilities, manufacturing controls, processing, packaging. Pharmacies are not subject to GMP unless they are manufacturing Rx products for resale to other pharmacies, physicians or retail outlets

46. Product Tampering Congress passed the Federal Anti- Tampering Act 1982 Gave authority to FBI, USDA and FDA to investigate tampering Due to Tylenol capsule tampering

47. Misbranded Drugs (Definition) If the label is false or misleading Label must contain name/place of business Accurate statement of contents If required information is not displayed as required Label must warn of habit forming drugs

48. Counterfeit Drugs Misbranding occurs if one drug is an imitation of another drug Neupogen®, Epogen® in 2002 Viagra® More likely with high cost drugs See Dangerous Doses, by Katherine Eban

50. Batch Certification 1941 Amendment to FDCA mandated insulin batch certification for efficacy and safety 1945 Amendment to FDCA mandated antibiotic batch certification for efficacy and safety D/Cd in 1982