Pharmacy Law, Regulations and Standards for Technicians: A Historical Overview, Slides of Competition Law and Policy

Download Pharmacy Law, Regulations and Standards for Technicians: A Historical Overview and more Slides Competition Law and Policy in PDF only on Docsity! Pharmacy Law, Regulations, and Standards for Technicians Docsity.com 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 Docsity.com 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. Docsity.com 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 Docsity.com 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) Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com Comprehensive Drug Abuse Prevention and Control Act of 1970 Schedule Medical Use Examples I For research only Heroin, LSD II Dispensing severely restricted Morphine, oxycodone, meperidine III Prescriptions can be refilled up to 5 times in 6 months Codeine with aspirin, anabolic steroids IV Same as for Schedule III Benzodiazepines, meprobamate V Some sold w/o a prescription; must be 18 Liquid codeine combination preps. Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com Dietary Supplement Health and Education Act (DSHEA) of 1994 • 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 Docsity.com 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 Docsity.com 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 Docsity.com 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 Docsity.com Discussion • How have the various laws changed the way drugs have been used over the years? • Are more laws needed? 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