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Chapter Summary: Pharmacy Law, Ethics, and Regulatory Agencies

Objectives

  • Review the history of federal drug laws.

  • Understand HIPAA implications.

  • Explore ACA and DQSA impacts on healthcare.

  • Define FDA and DEA functions and reporting procedures.

  • Discuss drug recall classifications.

Key Legislation

Major Acts

  • Pure Food and Drug Act of 1906: Established FDA to ensure safety and effectiveness of drugs.

  • Federal Food, Drug, and Cosmetic Act of 1938: Required proof of safety for drugs before market release.

  • Durham-Humphrey Amendment (1951): Defined prescription vs OTC drugs.

  • Kefauver-Harris Amendments (1962): Ensured drug efficacy and safety.

  • Controlled Substances Act (1970): Classified drugs into schedules based on abuse potential.

  • Health Insurance Portability and Accountability Act (1996): Protects patient health information.

Regulatory Agencies

  • FDA: Enforces laws regarding drug safety and labeling.

  • DEA: Regulates controlled substances and combat drug abuse.

Drug Handling and Controlled Substances

  • Drug Recalls: Classified as Class 1 (serious harm), Class 2 (temporary health issue), Class 3 (minor defect).

  • Controlled Substances Scheduling: Drugs are categorized by potential for abuse (C-I being the highest).

    • C-I: No accepted medical use (e.g., heroin).

    • C-II: High potential for abuse (e.g., opioids).

    • C-III to C-V: Lower potential; more regulation on refills.

  • Inventory Requirements: Controlled substances must be tracked and recorded meticulously.

Drug Monographs

  • Provide comprehensive information on medications, including:

    • Indications and dosage

    • Contraindications

    • Adverse reactions

    • Warnings and use in specific populations

Ethical Considerations

  • Technicians must understand the law to perform duties without infringing on regulations.

  • The distinction between morals and ethics is crucial in pharmacy practice.

Special Programs

  • iPledge Program: Regulation for isotretinoin to prevent fetal exposure.

  • Risk Management Programs: Ensure medications with potential risks are used safely.

Pharmacy Practice Guidelines

  • Know who can prescribe (varies by state).

  • Importance of confidentiality and patient information protected by HIPAA.

  • Internet pharmacies must comply with regulations; only licensed entities can dispense prescribed medications.