Pharmacy Technician Exam Notes

Law and the Technician

• Federal laws establish the foundation for state pharmacy practice laws.
• State boards of pharmacy are responsible for:
  • Licensing prescribers and dispensers.
  • Administering pharmacy practice regulations.
• Professional bodies:
  • Set and maintain standards.
  • Some standards are legally encoded.

Drug Regulation

• The FDC Act (1938):
  • Established the FDA.
  • Defined the legal framework for the FDA's operation.
  • Includes amendments and other federal laws applicable to pharmacy.

Privacy

• HIPAA regulations concern privacy and protected health information (PHI).
• All personnel accessing PHI must undergo HIPAA training.

New Drug Approval

• New drugs must be proven:
  • Safe and effective.
  • Benefits must outweigh risks for market approval.

Marketed Drugs

• After brand drug patents expire, generic versions can be produced.
• Prescription label requirements include:
  • Dispenser name and address.
  • Prescription serial number and date.
  • Prescriber and patient names.
  • Usage directions and cautionary statements.

Public Safety

• Drug recalls are typically voluntary for manufacturers.

Controlled Substances

• The Controlled Substances Act of 1970:
  • Defined five schedules of controlled substances.
  • Imposed strict rules on ordering, distributing, prescribing, and dispensing.

Law and the Courts

• Legal liability: Prosecution is possible for misconduct, including negligence.

Ethics and Compliance

• Ethical perspective: Involves assessing situations using moral standards.
• Institutions use committees (e.g., institutional review boards) for:
  • Ethical guidance.
  • Ensuring compliance.