Pharmacy Law, Ethics and Regulatory Affairs
Core concepts
Expect questions on the legal classification of medicines (prescription-only, pharmacy-only, over-the-counter), record-keeping, prescription requirements, controlled substance handling, and dispensing validity. Understand the roles of regulatory authorities in licensing, registration, pharmacovigilance reporting, and advertising control. Ethical principles - autonomy, beneficence, non-maleficence, justice - should be applied to scenarios involving confidentiality, informed consent, conflicts of interest, and refusal to dispense. Know the concepts of substitution, generic prescribing, and professional accountability. Questions often test whether you recognise when to escalate to a manager or regulator.
Traps in questions
- Dispensing on an invalid or incomplete prescription because the patient is known to the pharmacy.
- Breaching confidentiality to a family member without patient consent.
- Assuming a legal right to substitute brands without jurisdiction-specific authority.
- Failing to report an adverse event because it is "already known."
Worked example / rule of thumb
A prescription arrives missing the prescriber's signature. Correct action: do not dispense; verify with the prescriber and document. Rule of thumb: "if in doubt, do not dispense - clarify, document, and escalate." Legal compliance is a floor, not a ceiling; ethical practice may require more than the minimum.