Pharmacy Law, Ethics and Regulatory Affairs
Legal framework and controlled drugs
Know the principles of prescription requirements: prescriber details, patient identification, drug, dose, quantity, directions and signature. Understand how controlled/scheduled medicines are classified, the rules for record-keeping, storage and repeat dispensing, and the pharmacist's duty to verify authenticity. Be clear on dispensing errors, substitution rules and generic substitution, and the limits of pharmacist authority.
Ethics
Apply the four principles - autonomy, beneficence, non-maleficence and justice - to scenarios such as refusing to dispense, suspected forgery, or patient confidentiality. Understand informed consent, duty of candour after an error, and conflict of interest management.
Regulatory affairs
Recognise the roles of regulatory authorities in marketing authorisation, pharmacovigilance and adverse drug reaction reporting. Know the difference between pre-marketing approval and post-marketing surveillance, and understand the importance of reporting suspected reactions even when causality is uncertain.
Traps in questions
- Choosing a response that breaches confidentiality to satisfy a relative's curiosity.
- Assuming a pharmacist may substitute a controlled drug without authorisation.
- Treating ADR reporting as optional or requiring proof of causation.
Rule of thumb
When law and ethics conflict in a scenario, follow the legal requirement first, then document and escalate through the appropriate professional channel.