Exemptions on Retail (7A)

Question 1

What are PSDs?

Answer 1

Patient Specific Directions

• written instruction from a HCP for a medicine to be supplied or admin to a named patient after prescriber has assessed patient

Question 2

What are PGDs?

Answer 2

Patient Group Directions

• written instruction that allows the supply or admin of medicine to a well-defined group of patients requiring treatment for specific condition
• can supply and admin medicines without patient seeing prescriber before

Question 3

What does a signed order to a school require?

Answer 3

• school name
• product details
• name, strength, form
• purpose
• total quantity
• signature of principle

Question 4

What exemption apply to the supply of naloxone?

Answer 4

• individuals employed in drug treatment centres can obtain naloxone from wholesaler and make direct supplies to patient without PSD, PGD or prescription

Question 5

What are the legal requirements for content of a Signed Order, and how long must it be retained for?

Answer 5

• no specific legal requirement, advised to contain same as POMs
• 2 years

Question 6

What are the requirements to wholesale medicines?

Answer 6

• hold a wholesale distribution authorisation (WDA)
• comply with good distribution standards (GDP)
• have suitabel RP to ensure suitable storage and distribution

Question 7

Can a pharmacy supply stock to other pharmacies and if so under what conditions?

Answer 7

yes, can supply stock to pharmacies within the same legal entity (without WDA)

• occasional
• small quantities
• not for profit
• not for onward wholesale distribution

Question 8

What is a Serious Shortage Protocol and what can it permit?

Answer 8

during shortages of certain medicines SSPs can be drafted

• permits different strength, form and quantity
• different POM eg. generic brand