History of Medicine and Pharmacy Laws

History of Medicine and Pharmacy Accreditation

  • Father of Medicine: Hippocrates

  • Pharmacy Record Keeping and Accreditation:

    • PTCB: Pharmacy Technician Certification Board

    • ASHP: American Society of Health-System Pharmacists (accrediting body)

    • ACPE: Accreditation Council for Pharmacy Education

    • APhA: American Pharmacists Association, established in 1852

    • TPA: Tennessee Pharmacists Association

    • GPhA: Georgia Pharmacists Association

    • Chattanooga Area Pharmacists Society (GAPS)

  • Functions of Different Organizations:

    • ASHP + ACPE

    • PTAC: Pharmacy Technician Accreditation Commission, which accredits pharmacy technician training programs.

    • TPA: Engages in networking, seminars, political advocacy, and advancing/protecting the pharmacy profession.

Laws Pertaining to Pharmacy Practices

  • Laws are designed to prevent quackery and the distribution of counterfeit drugs.

  • Major Laws:

    • Pure Food and Drug Act:

    • Addresses issues of drug purity and contamination, forbidding false claims about drug efficacy.

    • Food, Drug, and Cosmetic Act:

    • Established the FDA, mandates that New Drug Applications (NDA) be submitted.

    • Durham-Humphrey Amendment:

    • Distinguishes prescription (Rx) drugs from over-the-counter (OTC) drugs, stating prescriptions are unsafe without a script.

    • FDA Modernization Act:

    • Streamlines the labeling of drugs to “Rx only” instead of the extensive federal legend.

    • Kefauver-Harris Amendment:

    • Requires proof of safety and efficacy for drugs through clinical trials.

    • Controlled Substances Act:

    • Establishes five schedules of controlled substances based on their potential for abuse and addiction (Schedule I - Schedule V).

    • Orphan Drug Act:

    • Facilitates the development and marketing of medicines for rare diseases.

    • OBRA (Omnibus Budget Reconciliation Act): Mandates patient counseling for all new prescriptions and offers on refills.

    • Combat Methamphetamine Act: Regulates the sale of pseudoephedrine to reduce methamphetamine production.

    • Drug Supply Chain Security Act (DSCSA):

    • Prevents counterfeit drugs from entering the supply chain.

    • HIPAA (Health Insurance Portability and Accountability Act):

    • Provides protections for patient privacy regarding medical information.

Relevant Pharmacy Organizations and Their Purposes

  • IN Pharmacists Association

    • Focuses on establishing and protecting the pharmacy profession.

    • Networking opportunities.

    • Continuing Education (CE) resources.

    • TNBOP: Tennessee Board of Pharmacy

    • NABP: National Association of Boards of Pharmacy

    • CAPS: Chattanooga Area Pharmacists Society

    • PTCB: Overlapping responsibilities concerning pharmacist certification and-quality assurance.