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Chapter_002

Federal Requirements for Pharmacy

Learning Objectives

  • Lesson 2.1: Pharmacy Law

    • Discuss ethics and the American Association of Pharmacy Technicians Code of Ethics.

    • Compare and contrast roles of pharmacists and pharmacy technicians.

    • Discuss federal laws affecting pharmacy.

Ethics in Pharmacy

  • Definition: A study of standards and moral judgment, influenced by society, philosophy, religion, or profession.

  • Source: The American Pharmacists Association has established a code of ethics for pharmacy technicians.

American Association of Pharmacy Technicians Code of Ethics

  • Role of Pharmacy Technicians: Health care professionals assisting pharmacists to ensure patient care.

  • First consideration: Ensure health and safety of patients; serve others with knowledge and skills.

Roles and Responsibilities of Pharmacists

  • Fill prescriptions and verify instructions from physicians.

  • Check for potential drug interactions or patient health conditions.

  • Instruct patients on medication use and potential side effects.

Responsibilities of Community Pharmacy Technicians

  • Assist patients with prescription orders.

  • Enter prescription information and maintain patient profiles.

  • Screen calls for the pharmacist.

Responsibilities of Institutional Pharmacy Technicians

  • Rotate through pharmacy work areas.

  • Transport medications and devices within the institution.

  • Assist pharmacists with entering medication orders.

Expanded Responsibilities of Pharmacy Technicians

  • In some states, technicians may check the work of peers (Tech-Check-Tech program).

  • TCT programs focus on restocking and preparing unit-dose batches but are limited to institutional settings.

Prescribing Authority

  • Professionals with Prescribing Authority:

    • Medical Doctors (MDs)

    • Physician Assistants (PAs)

    • Nurse Practitioners (NPs)

    • Dentists (DDS/DMD)

    • Optometrists (ODs)

    • Osteopaths (DOs)

    • Podiatrists (DPMs)

    • Veterinarians (DVMs)

Federal Laws Affecting Pharmacy

  • Pure Food and Drug Act of 1906:

    • Prohibits the sale of misbranded or adulterated food and drugs.

  • Food, Drug, and Cosmetic Act of 1938:

    • Established the FDA, requiring new drug applications.

  • Manufacturer Drug Labeling:

    • Essential information required includes manufacturer details, drug codes, directions for use, and expiration dates.

Over-the-Counter (OTC) Package Labeling

  • Requirements:

    • Drug name, National Drug Code number, active and inactive ingredients, usage directions, and contact for questions.

More Federal Laws Affecting Pharmacy

  • Durham-Humphrey Act of 1951:

    • Requires prescription labeling; separates drugs into legend and OTC categories.

  • Kefauver-Harris Amendment of 1962:

    • Mandates drug safety and efficacy.

Poison Prevention Packaging Act of 1970

  • Aims to reduce child poisoning by requiring child-resistant packaging for OTC and legend drugs.

Occupational Safety and Health Act of 1970

  • Establishes OSHA to ensure workplace safety, requiring safety guidelines and reporting of injuries.

Safety Data Sheets (SDSs)

  • Sections include:

    • Identification, Hazards Identification, Composition, First Aid, Fire-Fighting, and more.

Hazardous Drug Classification

  • Nonantineoplastic, antineoplastic drugs, and drugs with reproductive risks.

Personnel Training for Hazardous Drugs

  • All pharmacy personnel must be trained prior to handling hazardous drugs, with annual competency training.

Handling Hazardous Drugs

  • Personnel must wear PPE while handling hazardous drugs or contaminated materials.

Disposal of Hazardous Drugs

  • Follow protocols to ensure safe disposal according to EPA and state regulations.

Handling Pharmaceutical Substances

  • Nonhazardous materials can be discarded in regular garbage; sharps must be disposed of in designated containers.

Types of Waste

  • Includes solid waste, hazardous materials, and infectious waste.

Drug Enforcement Administration (DEA)

  • Oversees controlled substance schedules based on abuse potential and accepted medical use.

DEA Schedules

  • Schedule I: No medical use, high abuse potential.

  • Schedule II: Accepted medical use, high abuse potential.

  • Schedule III: Accepted medical use, lower abuse potential.

  • Schedule IV and V: Even lower potential for abuse.

Prescription Requirements for Controlled Substances

  • Must include date, patient and practitioner info, drug details, directions, and prescriber’s signature.

Security of Controlled Substances

  • Schedule II drugs must be stored securely, with careful records maintained for all controlled substances.

Fraudulent Prescriptions

  • Common types of fraudulent prescriptions and prevention techniques include verifying prescriber identities and checking for alterations.

Prescription Drug Monitoring Program (PDMP)

  • State-wide electronic database to monitor prescription drug use and prevent abuse.

Risk Evaluation and Mitigation Strategies (REMS)

  • Programs to manage risk associated with certain high-risk medications.

Recall Classifications

  • Class I: Serious health risks.

  • Class II: Temporary adverse health consequences.

  • Class III: Not likely to cause health consequences.

FDA Responsibilities

  • Evaluates drug safety, approves medical devices, and oversees adverse event reporting.

Joint Commission (TJC)

  • Establishes standards for accrediting healthcare organizations and patient safety.

Additional Pharmacy References

  • Resources include federal and state regulations, USP-NF, and drug evaluation references.