Pharmacy Legislation, Ethics and Professional Practice
Core concepts
Candidates must know the Albanian regulatory framework for pharmacy practice and its EU alignment. Key bodies: the Ministry of Health, the National Agency for Medicines and Medical Devices (AKBPM), and the Order of Pharmacists. Understand the classification of medicines (prescription-only vs over-the-counter), the requirements for opening and operating a pharmacy (licensing, premises, qualified pharmacist in charge), the rules for dispensing prescription medicines, record-keeping and pharmacovigilance obligations, and the rules for controlled substances (narcotics and psychotropics) with their stricter documentation. Know the principles of pharmaceutical ethics: confidentiality, informed consent, conflict-of-interest avoidance, professional secrecy, and the prohibition on advertising prescription medicines to the public. Understand the EU-aligned concepts of good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacy practice (GPP).
Traps
Questions test the distinction between prescription-only and OTC status, and the specific legal limits on controlled drugs, which are stricter than ordinary prescription rules. Another trap is assuming that a pharmacist may substitute or dispense without a valid prescription when the law requires one. Advertising rules are frequently tested: prescription medicines may not be advertised to the public.
Rule of thumb
For any legal question, identify the legal category of the medicine first (OTC, prescription-only, controlled), then apply the corresponding dispensing and documentation rules. When in doubt, the safer professional course - refer to the prescriber or the regulator - is usually the correct answer.
Worked example
A patient requests a repeat of a prescription-only antibiotic without a valid prescription. The pharmacist must refuse to dispense, explain the legal requirement, and refer the patient to a prescriber; dispensing without a valid prescription breaches the medicines law and professional standards.