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.