PSI Irish Pharmacy Law — Questions and Answers
Question 1: What is the Pharmacy Act 2007 and what did it establish?
- The primary legislation governing pharmacy practice in Ireland, establishing the Pharmaceutical Society of Ireland (PSI) as the pharmacy regulator (Correct answer)
- An act that deregulated pharmacy practice in Ireland
- A law that only applies to hospital pharmacists
- An act governing the manufacture of pharmaceuticals
Correct answer: The primary legislation governing pharmacy practice in Ireland, establishing the Pharmaceutical Society of Ireland (PSI) as the pharmacy regulator
The Pharmacy Act 2007 is the cornerstone of pharmacy regulation in Ireland. It established the PSI as the independent regulator, replacing the old Pharmaceutical Society. The Act covers registration, fitness to practise, inspection, and standards for pharmacy practice.
Question 2: Under Irish law, who can own and operate a pharmacy?
- A registered pharmacist, a partnership where all partners are registered pharmacists, or a company where the superintendent pharmacist is responsible for the professional aspects (Correct answer)
- Only doctors can own pharmacies
- Anyone can own a pharmacy without qualifications
- Only the HSE can operate pharmacies
Correct answer: A registered pharmacist, a partnership where all partners are registered pharmacists, or a company where the superintendent pharmacist is responsible for the professional aspects
The Pharmacy Act 2007 permits pharmacy ownership by registered pharmacists, partnerships of pharmacists, or registered pharmacy businesses. Every pharmacy must have a superintendent pharmacist who takes professional responsibility, and a supervising pharmacist must be present during opening hours.
Question 3: What are Scheduled Substances under the Misuse of Drugs Acts 1977-2016 in Ireland?
- Controlled drugs classified into five schedules based on their therapeutic value and potential for misuse, with different regulations for each schedule (Correct answer)
- All prescription-only medicines
- Only illegal street drugs
- Substances used in food production
Correct answer: Controlled drugs classified into five schedules based on their therapeutic value and potential for misuse, with different regulations for each schedule
The Misuse of Drugs Acts classify controlled substances into five schedules: Schedule 1 (highest restriction, e.g., LSD), Schedule 2 (e.g., morphine, fentanyl), Schedule 3 (e.g., buprenorphine), Schedule 4 (benzodiazepines), and Schedule 5 (preparations with low risk of misuse).
Question 4: What are the requirements for a valid prescription under the Medicinal Products (Prescription and Control of Supply) Regulations 2003?
- It must include the prescriber's name, address, and qualification; the patient's name and address; the drug name, form, strength, dose, quantity; the date; and the prescriber's signature (Correct answer)
- Only the drug name and patient name are required
- Prescriptions can be verbal only
- No specific format is required
Correct answer: It must include the prescriber's name, address, and qualification; the patient's name and address; the drug name, form, strength, dose, quantity; the date; and the prescriber's signature
A valid prescription must contain: prescriber details (name, address, qualification), patient details (name and address), the medicinal product (name, form, strength), directions for use, quantity to be supplied, date, and the prescriber's signature (or electronic equivalent).
Question 5: What is the role of the Pharmaceutical Society of Ireland (PSI)?
- To regulate the pharmacy profession, register pharmacists and pharmacies, set education standards, investigate complaints, and protect public health (Correct answer)
- To represent pharmacists in pay negotiations
- To manufacture and distribute medicines
- To run the national pharmacy chain
Correct answer: To regulate the pharmacy profession, register pharmacists and pharmacies, set education standards, investigate complaints, and protect public health
The PSI is the independent statutory regulator of pharmacy in Ireland. Its functions include maintaining the register of pharmacists and pharmacies, setting standards for education and practice, conducting inspections, investigating fitness to practise concerns, and advising the Minister for Health.
Question 6: What does the Medicinal Products (Control of Advertising) Regulations 2007 restrict?
- The advertising of prescription medicines to the general public, and sets rules for the advertising of all medicinal products including non-prescription medicines (Correct answer)
- Only the advertising of cosmetics
- Only television advertising of medicines
- There are no restrictions on medicine advertising in Ireland
Correct answer: The advertising of prescription medicines to the general public, and sets rules for the advertising of all medicinal products including non-prescription medicines
Irish law prohibits the advertising of prescription-only medicines (POMs) to the general public. Advertising of non-prescription (OTC) medicines is permitted but must comply with strict rules including not being misleading, not suggesting the product is a food, and including mandatory warnings.
PSI Irish Pharmacy Law
What is the Pharmacy Act 2007 and what did it establish?