Chapter 2

2. Chapter 2 Pharmacy Law, Regulations, and Standards for Technicians

3. Chapter 2 Topics • Need for Drug Control • Brief History of Statutory Pharmacy Law • Regulatory Law—Role of National Oversight Agencies • Drug and Professional Standards • State Boards of Pharmacy and Legal Duties of Pharmacy Personnel • Violation of Laws and Regulations

4. Learning Objectives • Distinguish among common law, statutory law, regulatory or administrative law, ethics, and professional standards • Explain the potential for tort actions under the common law related to negligence and other forms of malpractice • List and describe the major effects on pharmacy of the major pieces of statutory federal drug law in the twentieth century

5. Learning Objectives • Discuss the role of the Food and Drug Administration, Drug Enforcement Administration, the United States PharmacopeialConvention, and state boards of pharmacy • Enumerate the duties that may legally be performed by pharmacy technicians in most states

6. Need for Drug Control • Before 1951, U.S. federal law made no distinction between drugs that can and cannot be purchased without a prescription from a physician. • In some countries any drug can still be dispensed or sold without legal restriction.

7. Need for Drug Control Various groups and organizations exercise controls on contemporary pharmacy: • courts • federal, state, and local legislative bodies • federal and state regulatory agencies • United States Pharmacopeia (USP) • professional organizations • individual institutions such as community pharmacies, hospitals, long-term care facilities, and home healthcare organizations

8. Drug Control Professional Organizations Web Links American Pharmacists Association (APhA) American Association of Colleges of Pharmacy (AACP) National Association of Boards of Pharmacy (NABP) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) American Society of Health-System Pharmacists (ASHP) Academy of Managed Care Pharmacy (AMCP)

9. Drug Control • The law offers a minimum level of acceptable standards • Ethics offer guidelines for personal conduct within a profession • State boards of pharmacy and professional organizations have established standards for the provision of healthcare • Additional levels of accreditation beyond minimum level required by law

10. Discussion What are the dangers of inadequate control of drugs and medications?

11. Discussion What are the dangers of inadequate control of drugs and medications? Answer:the possibility of inappropriate use, adverse reactions, and interactions with other drugs

12. Brief History of Statutory Pharmacy Law • In nineteenth century drugs in the United States were unregulated • medicines did not require proof that they were either safe or effective • Traveling medicine shows proclaimed “miracle cures” • no regulations on labeling • no research to support claims

13. Brief History of Statutory Pharmacy Law • Most potions contained a high content of alcohol • Some caused injury or death • To combat abuses in both formulation and labeling, in 1906 the U.S. Congress passed the first of a series of landmark twentieth-century laws to regulate drugs

14. Pure Food and Drug Act of 1906 • Purpose was to prohibit the interstate transportation or sale of adulterated and misbranded food and drugs • Did not require drugs be labeled but required that drug labels not contain false information about the drugs’ strength and purity • Proved unenforceable and new legislation was required

15. Food, Drug, and Cosmetic (FDC) Act of 1938 • The most important piece of legislation in pharmaceutical history • Created the FDA • Required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing

16. Food, Drug, and Cosmetic (FDC) Act of 1938 • Extended and clarified the definitions of adulterated and misbranded drugs • Defined the relevant “official compendia” as the United States Pharmacopeia and the National Formulary

17. Food, Drug, and Cosmetic (FDC) Act of 1938 • Gave FDA the power to conduct inspections of manufacturing plants to ensure compliance • Act applied to interstate transactions, as well as to intrastate transactions • Required only that drugs be safe for human consumption NOT that they be effective or useful for the purpose for which they were sold

18. Durham-Humphrey Amendment of 1951 • States drug containers do not have to include “adequate directions for use” as long as they include “Caution: Federal Law Prohibits Dispensing Without Prescription” • Distinguished between legend (prescription) drugs and over-the-counter (OTC) (nonprescription) drugs • Authorized • verbal prescriptions • prescription refills

19. Kefauver-Harris Amendment of 1962 • Extended the FDC Act of 1938 to require that drugs not only be safe for humans but also be effective • Requires drug manufacturers file an investigational new drug application (INDA) with the FDA before initiating a clinical trial in humans • Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product

20. Comprehensive Drug Abuse Prevention and Control Act of 1970 • Commonly referred to as the Controlled Substances Act (CSA) • Created to combat and control drug abuse and to supersede previous federal drug abuse laws • Classified drugs with potential for abuse as controlled substances • Ranked controlled substances into five categories, or schedules • ranging from those with great potential for abuse (Schedule I) to those with little such potential (Schedule V) • narcotics are most highly regulated

21. Comprehensive Drug Abuse Prevention and Control Act of 1970

22. Comprehensive Drug Abuse Prevention and Control Act of 1970 • Created the Drug Enforcement Administration (DEA), an arm of the Department of Justice • charged with enforcement and prevention related to the abuse of controlled substances like many narcotic pain medications

23. Poison Prevention Packaging Act of 1970 • Passed to prevent accidental childhood poisonings from prescription and nonprescription products • Enforced by the Consumer Product Safety Commission • Requires most over-the-counter (OTC) and legend drugs be packaged in child-resistant containers • cannot be opened by 80% of children under five • can be opened by 90% of adults • Older patients may request a non-child-resistant container; other exceptions are provided for by law

24. Drug Listing Act of 1972 • Gives the FDA the authority to compile a list of currently marketed drugs • Each drug is assigned a unique and permanent product code • known as a National Drug Code (NDC) • ten characters that identify manufacturer or distributor, drug formulation, size and type of packaging • FDA requests, but does not require, the NDC appear on all drug labels

25. Orphan Drug Act of 1983 • An orphan drug is one that is intended for use in a few patients with a rare disease or condition • developing such a drug would be prohibitively expensive, given the small market • The Orphan Drug Act encourages the development of orphan drugs by: • providing tax incentives • granting manufacturers exclusive license • Over 250 orphan drugs have been approved by the FDA

26. Drug Price Competition and Patent-Term Restoration Act of 1984 • Encouraged creation of both generic drugs and new drugs by streamlining the process for generic drug approval and extending patent licenses required for the NDA approval process • A given drug typically has several names: • chemical names • generic name: a common name given to a drug regardless of brand name • one or more brand name(s): name(s) under which the manufacturer markets a drug

27. Drug Price Competition and Patent-Term Restoration Act of 1984 • Generic drugs with the same chemical composition as brand name products • can be substituted in prescriptions • Once the original patent expires, any manufacturer may market a generic drug • usually is less costly than the brand name

28. Prescription Drug Marketing Act of 1987 Prohibits • reimportation of a drug into the United States (United States seniors getting prescription medication from Canada) • sale or trading of drug samples • distribution of samples (provisions for samples added in response to prescription drug samples being illegally diverted and distributed) • to persons other than those licensed to prescribe them • except by mail or by common carrier

29. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) • Requires states to establish standards for drug use review (DUR) by the pharmacist • Requires pharmacist to offer to counsel the patient, offering to discuss with the patient all matters of significance • Uses Medicaid participation to enforce clinical pharmacy practices • although initially required for patients eligible for Medicaid benefits, most state boards of pharmacy have required counseling for all patients

30. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) • Requires manufacturers rebate to state Medicaid programs the difference between the manufacturer’s best price for a drug (typically the wholesale price) and the average billed price

31. Dietary Supplement Health and Education Act (DSHEA) of 1994 • Provided definitions and guidelines on diet supplements • manufacturers are not required to prove safety, efficacy, or standardization to the FDA as they are with prescription and nonprescription drugs • The FDA may only review “false claims” advertisements and monitor safety of diet supplements

32. Dietary Supplement Health and Education Act (DSHEA) of 1994 Safety Note • The FDA does not regulate diet supplements • because diet supplements are sold with nonprescription products, many consumers are unaware of this subtle difference in regulation

33. Health Insurance Portability and Accountability Act (HIPAA) of 1996 • Included “portability” of moving health insurance from one employer to another without denial or restrictions • Affects the confidentiality of patient medical records • has placed safeguards to protect patient confidentiality • requires healthcare facilities to provide information to the patient on how they protect the patient’s health information

34. Health Insurance Portability and Accountability Act (HIPAA) of 1996 In pharmacy, HIPAA requirements include: • restrictions on transmission of prescription data • provision of an area for private counseling • a training program for employees For pharmacy technicians, HIPAA means: • they must not reveal any information on any patient outside the pharmacy • violations would be grounds for immediate termination and legal action Learn more about HIPAA on the Web

35. Food and Drug Administration Modernization Act • Updates the labeling on prescription medications • products labeled “legend” are to be changed to read “ only” • legend is the term that has been used to indicate whether a drug was available by prescription or over-the-counter (OTC) • the new labeling requirements were implemented in 2004 • Authorizes fees to be added to a new drug application (NDA) process to accelerate the review and approval process for new drugs

36. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 • Drug prescription coverage to patients eligible for Medicare benefits • voluntary insurance program • extra premium • Provides reimbursement for services a pharmacist may provide such as: • medication management therapy services (MMTS) • annual in-depth review of the patient’s medication profile

37. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 • Includes the development of health service agencies (HSAs) • a consumer-driven health insurance program • health insurance option for patients under 65 years of age • Under an HAS, the patient or his or her family agree to pay a monthly premium and carry a high deductible • the premium is fully tax deductible • whatever amount is not used during that calendar year carries over to the next year

38. Discussion • How have the various laws changed the way drugs have been used over the years? • Are more laws needed?

39. Discussion • How have the various laws changed the way drugs have been used over the years? • Answer: The laws have addressed a broad scope of issues and provided a basic structure for the safe use of drug products and for the practice of pharmacy.

40. adulterated misbranded FDA new drug application (NDA) United States Pharmacopeia National Formulary controlled substances Drug Enforcement Administration (DEA) child-resistant containers orphan drug generic name brand name Terms to Remember

41. Regulatory Law—Role of National Oversight Agencies • Acts and amendments provide the minimum level of acceptable standards • The FDA and DEA oversee and enforce the standards for drug use that the laws have established

42. Food and Drug Administration (FDA) • Has primary responsibility and authority to enforce the law and create regulations to assist in providing the public with safe drug products • Requires all manufacturers to file applications for investigation studies and approval of new drugs • Provides guidelines for packaging and advertisement • Oversees the recall of dangerous products • Has no legal authority over the practice of pharmacy in each state • Visit the FDA

43. Food and Drug Administration (FDA) • Has regulations for manufacturers to follow while researching new chemical entities and developing those chemicals into drug products • Continues oversight even drugs are approved • Issues guidelines as to how the product may be packaged, labeled, advertised, and marketed to physicians (and now the public) • Manufacturers may not make speculative or false claims • OTC medications also undergo this scrutiny • labels of OTC products must conform to a preferred format

44. Food and Drug Administration (FDA) Safety Note The FDA regulates OTC labeling so it is understandable to a layperson

45. Food and Drug Administration (FDA) • Can force manufacturer to recall a drug product if it is contaminated, of poor quality, or causes serious adverse reactions Recall Classes for Drugs

46. MedWatch • MedWatch is a voluntary program that allows any healthcare professional to report a serious adverse event, product problem, or medication error that is suspected of being associated with the use of an FDA-regulated product • a clearinghouse for information on safety alerts, including drug recalls • Provides information on safety-labeling changes to the product package insert

47. MedWatch • Manufacturers must file a report if an adverse drug reaction is reported • Designed to detect side effects not identified from research studies • Reports can be made: • online • by phone (1-800-FDA-0178) • by mail • Visit MedWatch online

48. Vaccine Adverse Event Reporting System (VAERS) • Vaccine Adverse Event Reporting System (VAERS) is a postmarketing surveillance system operated by the FDA and the Centers for Disease Control (CDC) • collects information on adverse events that occur after an immunization • Reports can be made online, via an 800 number (1-800-822-7967), or submitted by mail on a downloaded form • Visit the VAERS site

49. Drug Enforcement Administration (DEA) • Branch of the U.S. Justice Department responsible for regulating sale and use of drugs with abuse potential • responsible for enforcing laws regarding both legal and illegal addictive substances • directs most of its efforts toward illegal drug trafficking • supervises legal use of narcotics and other controlled substances

50. Drug Enforcement Administration (DEA) • Issues licenses • to medical practitioners to write prescriptions for scheduled drugs • to pharmacies to order scheduled drugs from wholesalers • Inspects medical facilities, including pharmacies • Tracks narcotics from manufacturer to warehouse to pharmacy