PSI Irish Pharmacy Law & Ethics 4 — Questions and Answers
Question 1: A pharmacist dispensing a Schedule 2 controlled drug must record the supply in:
- The Controlled Drugs Register (Correct answer)
- The dispensing computer only
- The prescription file only
- No register is required for Schedule 2
Correct answer: The Controlled Drugs Register
Under the Misuse of Drugs Regulations, every supply and receipt of Schedule 2 CDs must be entered in the Controlled Drugs Register — a bound, indelible-ink register kept for 7 years.
Question 2: Which Irish regulatory body must pharmacies notify when a medicine defect or recall is issued?
- Health Products Regulatory Authority (HPRA) (Correct answer)
- PSI only
- HSE only
- Department of Health directly
Correct answer: Health Products Regulatory Authority (HPRA)
The HPRA manages medicine recalls and safety alerts in Ireland. Pharmacies must remove recalled products from dispensary stock and return them per HPRA instructions.
Question 3: Which PSI standard requires that a pharmacist must personally supervise the dispensing process?
- PSI Standard for the Operation of Pharmacy Services (Correct answer)
- The Misuse of Drugs Act only
- GMS contract only
- European Medicines Agency guideline
Correct answer: PSI Standard for the Operation of Pharmacy Services
PSI's Standards for the Operation of Pharmacy Services require pharmacist supervision of all dispensing. Dispensing staff may perform technical tasks but a pharmacist must check and clinically verify.
Question 4: A dispensing error is discovered after a patient has left the pharmacy. The pharmacist's first action should be:
- Contact the patient immediately to advise them and prevent harm (Correct answer)
- File the incident report first before contacting the patient
- Only notify the superintendent pharmacist
- Wait to see if the patient contacts the pharmacy
Correct answer: Contact the patient immediately to advise them and prevent harm
Patient safety takes priority. The pharmacist must contact the patient immediately to prevent harm, then complete incident documentation, inform the superintendent, and take corrective action.
Question 5: The 'yellow card' equivalent for adverse drug reaction reporting in Ireland is submitted to:
- The HPRA (Correct answer)
- The PSI
- The patient's GP
- The manufacturer directly
Correct answer: The HPRA
ADRs in Ireland are reported to the HPRA (Health Products Regulatory Authority) via the online reporting system. Healthcare professionals and patients can both report. The HPRA feeds data to EudraVigilance.
Question 6: Under Irish legislation, who can legally own a pharmacy (retail pharmacy business)?
- A registered pharmacist or pharmacy body corporate meeting PSI requirements (Correct answer)
- Any registered company
- The HSE only
- Only Irish citizens
Correct answer: A registered pharmacist or pharmacy body corporate meeting PSI requirements
The Pharmacy Act 2007 requires pharmacy owners to be registered pharmacists or a body corporate meeting specified ownership criteria. This is known as registering as a 'retail pharmacy business' with the PSI.
PSI Irish Pharmacy Law & Ethics 4
A pharmacist dispensing a Schedule 2 controlled drug must record the supply in: