PSI Irish Pharmacy Law & Ethics

Question 1

Which legislation established the Pharmaceutical Society of Ireland (PSI) as the regulator of pharmacists and pharmacies?

Accepted Answer

Pharmacy Act 2007

Answer

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?

Accepted Answer

The superintendent pharmacist

Answer

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:

Accepted Answer

Authorisation and licensing of medicinal products

Answer

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?

Accepted Answer

28 days

Answer

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?

Accepted Answer

Schedule 2

Answer

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.

PSI Pharmacy Practice Test

PSI Pharmacy Practice Test

PSI Irish Pharmacy Law & Ethics