Regulation and Classification of Medicines

Question 1

What are the 3 legal classifications of medicines in the UK?

Answer 1

GSL (General Sales List), P (Pharmacy medicine), POM (Prescription only medicine)

Question 2

General Sales List

Answer 2

• Can be sold/supplied without going through a pharmacist
• Can be sold in any shop
• some even sold in vending machines

Question 3

Pharmacy Medicines

Answer 3

• Have to be sold from a registered pharmacy

- requires supervision of a pharmacist

Question 4

Rules around Supervision of Sale of Pharmacy Medicines

Answer 4

• ensures public safety
• P & POM
• sales must be made by a pharmacist or by a person acting under the supervision of a pharmacist
• responsible pharmacist
• pharmacist must be within clinical area when the sale is taking place

Question 5

SOP requirement for sale of P

Answer 5

assistants must have appropriate qualifications to carry out the task

Question 6

Why are some medicines Prescription Only Medicines?

Answer 6

• if they require medical supervision in their use, as they could cause indirect/direct danger
• if widely/frequently misused
• new active substance
• parenteral use

Question 7

How to access POMs

Answer 7

Only available in response to a prescription from a prescriber. Medical prescribers (doctors) or non-medical prescribers (IP or Nurse)

Question 8

Specific requirements for a POM to be legal

Answer 8

Must be dispensed in a registered pharmacy under direct supervision of a pharmacist. If a POM is supplied, records must be made.

Question 9

Medicines are POM/P/GSL based on what parameters?

Answer 9

• max strength
• purpose
• use
• form
• max dose
• max quantity
• age