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.