GPhC Pharmacy Law & Ethics 2 — Questions and Answers
Question 1: A Schedule 2 controlled drug prescription must be written in the prescriber's own handwriting unless:
- It is generated by a computer-generated system with a handwritten signature (Correct answer)
- The prescriber is a nurse
- It is for a hospital inpatient
- It is dispensed by a pharmacist
Correct answer: It is generated by a computer-generated system with a handwritten signature
CD prescriptions (Schedule 2 and 3) may be computer-generated but the prescriber's signature must be handwritten. Certain requirements (dose, form, total quantity) must also be present.
Question 2: For how long must a pharmacist retain a Schedule 2 controlled drug register entry?
- 2 years from date of entry (Correct answer)
- 5 years
- 6 months
- 1 year
Correct answer: 2 years from date of entry
Under the Misuse of Drugs Regulations 2001, Schedule 2 CD register entries must be kept for at least 2 years from the date of the last entry.
Question 3: Which Schedule of the Misuse of Drugs Regulations 2001 includes morphine and diamorphine?
- Schedule 2 (Correct answer)
- Schedule 1
- Schedule 3
- Schedule 5
Correct answer: Schedule 2
Schedule 2 includes drugs with accepted medical use but high misuse potential (e.g., morphine, diamorphine, fentanyl, pethidine), subject to full CD controls.
Question 4: The principle of 'autonomy' in pharmacy ethics refers to:
- Respecting a patient's right to make informed decisions about their own healthcare (Correct answer)
- Always following prescriber instructions without question
- Prioritising the greater good over individual needs
- Avoiding harm to patients
Correct answer: Respecting a patient's right to make informed decisions about their own healthcare
Autonomy is one of the four pillars of biomedical ethics (Beauchamp & Childress). It means respecting patients' right to make informed, voluntary decisions about their own treatment.
Question 5: What must a pharmacist do if they have a conscientious objection to dispensing a legal prescription?
- Refer the patient to another provider who can dispense it (Correct answer)
- Refuse without providing any alternative
- Contact the prescriber to cancel the prescription
- Dispense it regardless of personal beliefs
Correct answer: Refer the patient to another provider who can dispense it
GPhC standards require that even if a pharmacist exercises a conscientious objection, they must ensure the patient receives the care they need by referring them to another provider promptly.
Question 6: Which legislation governs the safe and secure handling of controlled drugs in England?
- Health Act 2006 and Controlled Drugs (Supervision of Management and Use) Regulations 2013 (Correct answer)
- Misuse of Drugs Act 1971 only
- Medicines Act 1968
- Human Medicines Regulations 2012
Correct answer: Health Act 2006 and Controlled Drugs (Supervision of Management and Use) Regulations 2013
The Health Act 2006 and CD Supervision Regulations 2013 established the Controlled Drugs Accountable Officer (CDAO) system for oversight and safe management of CDs in England.
GPhC Pharmacy Law & Ethics 2
A Schedule 2 controlled drug prescription must be written in the prescriber's own handwriting unless: