PSI Irish Pharmacy Law & Ethics 5 — Questions and Answers
Question 1: Which scheme allows pharmacists in Ireland to dispense a generic medicine instead of the branded product prescribed?
- Generic substitution under the Health (Pricing and Supply of Medical Goods) Act 2013 (Correct answer)
- GMS scheme rules only
- Prescriber authorisation each time
- There is no substitution allowed in Ireland
Correct answer: Generic substitution under the Health (Pricing and Supply of Medical Goods) Act 2013
The Health (Pricing and Supply of Medical Goods) Act 2013 allows pharmacists to substitute with a listed generic unless the prescriber has handwritten 'do not substitute' on the prescription.
Question 2: The 'three-way check' in dispensing refers to checking the label against the:
- Prescription, product and patient record — at three points in the dispensing process (Correct answer)
- Three components of the prescription only
- Three pharmacist signatures
- Label checked three times only
Correct answer: Prescription, product and patient record — at three points in the dispensing process
The three-way dispensing check verifies the prescription against the product retrieved, and the label — performed at: (1) product selection, (2) labelling, (3) final accuracy check before dispensing.
Question 3: Which PSI document provides guidance on professional standards for internet and distance pharmacy services?
- PSI Guidance on Internet and Distance Sale of Medicines (Correct answer)
- Pharmacy Act 2007 directly
- EU Falsified Medicines Directive only
- Irish Medicines Board regulations
Correct answer: PSI Guidance on Internet and Distance Sale of Medicines
PSI published dedicated guidance for online pharmacy services, requiring registration, use of the EU common logo, and full compliance with all pharmacy standards despite the remote model of supply.
Question 4: Under the Falsified Medicines Directive (EU 2011/62/EU), pharmacies must use which system to verify medicines?
- The European Medicines Verification System (EMVS) — scanning 2D barcodes at point of dispensing (Correct answer)
- A manual serial number log
- Contacting the manufacturer by telephone
- HPRA database lookup only
Correct answer: The European Medicines Verification System (EMVS) — scanning 2D barcodes at point of dispensing
The Falsified Medicines Directive requires pharmacies to scan the 2D data matrix barcode on medicine packs before dispensing, verifying authenticity and decommissioning the pack via the EMVS/Irish MVO.
Question 5: A patient requests their prescription be returned after it has been dispensed. Under Irish law:
- Pharmacists must retain dispensed prescriptions and cannot return them (Correct answer)
- Prescriptions must be returned on request
- Only GMS prescriptions are retained
- The patient has a GDPR right to have the prescription returned
Correct answer: Pharmacists must retain dispensed prescriptions and cannot return them
Under Irish pharmacy regulations, dispensed prescriptions must be retained by the pharmacy for the required period. They form part of the legal dispensing record and cannot be returned to patients.
Question 6: Which body adjudicates fitness to practise complaints against pharmacists in Ireland at the initial stage?
- PSI Preliminary Proceedings Committee (Correct answer)
- The District Court
- The Medical Council
- The Department of Health
Correct answer: PSI Preliminary Proceedings Committee
Complaints are first assessed by the PSI Preliminary Proceedings Committee, which determines if there is a prima facie case. If so, the matter proceeds to the Fitness to Practise Committee or is resolved via consent.
PSI Irish Pharmacy Law & Ethics 5
Which scheme allows pharmacists in Ireland to dispense a generic medicine instead of the branded product prescribed?