PSI Irish Pharmacy Law & Ethics 1 — Questions and Answers
Question 1: Which legislation established the Pharmaceutical Society of Ireland (PSI) as the regulator of pharmacists and pharmacies?
- Pharmacy Act 2007 (Correct answer)
- Misuse of Drugs Act 1977
- Medical Practitioners Act 2007
- Health Act 2004
Correct answer: Pharmacy Act 2007
The Pharmacy Act 2007 established the PSI, replacing the Pharmaceutical Society of Ireland Act 1875. It set out PSI's functions: registration, fitness to practise, pharmacy inspection and education standards.
Question 2: Under the Pharmacy Act 2007, who is legally responsible for ensuring a pharmacy complies with all legal requirements?
- The superintendent pharmacist (Correct answer)
- The pharmacy owner only
- The dispensing technician
- The Health Products Regulatory Authority
Correct answer: The superintendent pharmacist
The superintendent pharmacist bears legal responsibility for the management of the pharmacy and compliance with all relevant laws, including the Pharmacy Act 2007 and Misuse of Drugs Regulations.
Question 3: The Health Products Regulatory Authority (HPRA) in Ireland is responsible for:
- Authorisation and licensing of medicinal products (Correct answer)
- Registration of pharmacists
- Setting pharmacy education standards
- Prescribing guidelines
Correct answer: Authorisation and licensing of medicinal products
The HPRA authorises medicines for the Irish market, oversees clinical trials, regulates medical devices and controls narcotics licensing. It is the competent authority under EU pharmaceutical law.
Question 4: A controlled drug prescription under Irish law must be valid for how long after the date of issue?
- 28 days (Correct answer)
- 6 months
- 3 months
- 12 months
Correct answer: 28 days
Under the Misuse of Drugs Regulations, a CD prescription is valid for 28 days from the date written. Pharmacists must not dispense after this period.
Question 5: Which schedule of the Misuse of Drugs Regulations 1988 (as amended) covers morphine?
- Schedule 2 (Correct answer)
- Schedule 1
- Schedule 3
- Schedule 5
Correct answer: Schedule 2
Morphine is a Schedule 2 controlled drug. Schedule 2 CDs have the highest level of control for medicinal use — requiring full CD prescription requirements, CD register entries and safe custody.
Question 6: Under PSI guidance, the minimum period for retaining prescription records in a pharmacy in Ireland is:
- 6 years (Correct answer)
- 2 years
- 1 year
- 10 years
Correct answer: 6 years
PSI requires pharmacy prescription records (including GMS/DPS claims) to be retained for a minimum of 6 years. This aligns with general healthcare record retention policy in Ireland.
PSI Irish Pharmacy Law & Ethics 1
Which legislation established the Pharmaceutical Society of Ireland (PSI) as the regulator of pharmacists and pharmacies?