Exemptions - POMs, Ps

Question 1

What groups are exempt from the rules regarding sale of POMs only with a prescription?

Answer 1

patient group directions (PGDs)
patient specific directions (PSDs)
emergency supply (patient/prescriber)
signer order - optometrist or podiatrist

supply of salbutamol inhalers for schools
supply of adrenaline auto injectors for schools
supply of naxolone by individuals providing recognised drug treatment services

Question 2

What are Patient Specific Directions (PSDs)?

Answer 2

legislation does not define a PSD but is generally accepted to mean
- a written instruction from medical/non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis

are typically used in hospitals
- in-patient charts as directions to administer

Question 3

What is the difference between supply and administration on a PSD?

Answer 3

supply
- requires a written statement with directions to administer

administration
- directions can be given verbally or telephoned

Question 4

How can schools obtain adrenaline autoinjectors and salbutamol inhalers?

Answer 4

can be obtained on a signed order

• to be administrated in an emergency
• must be administered by persons trained
• can only be given to pupils previously prescribed such medication where parental consent has been received

Question 5

What information needs to be included on a signed order for schools?

Answer 5

name of the school
product details 
strength
purpose for which the product is acquired
total quantity required 
signature of the principle/headteacher

Question 6

What is the total quantity of medications that can be obtained by schools on a signed order?

Answer 6

the number that can be obtained by individual schools is not specified in legislation

schools can purchase salbutamol inhalers and/or adrenaline autoinjectors from pharmacies provided it is

• for small quantities
• on an occasional basis
• not for profit

Question 7

What records need to be kept for signed orders?

Answer 7

must keep the signed order for 2 years from the date of supply

must make an entry into the POM register

Question 8

What must be included in the POM register for signed orders?

Answer 8

supply date 
medicine details
- name, quantity, strength, formulation 
receivers details 
- name, address, trade/business/profession 
purpose for which it was sold/supplied

Question 9

Why is naloxone supplied to individuals providing recognised drug treatment services?

Answer 9

naloxone is an opioid/opiate antagonist
- is licensed for the treatment of suspected acute opioid overdose

completely or partially reverse the central nervous system depression, especially respiratory depression, caused by natural or synthetic opioids

Question 10

What is wholesale dealing?

Answer 10

medicinal product sold to the purchaser for the purpose of

• selling
• supplying
• administration to another person

Question 11

What is required of anyone trading medicines to anyone other than a patient?

Answer 11

they are required to:
- hold a wholesale dealers license also known as a wholesaler distribution authorisation (WDA)

• comply with good distribution practice (GDP) standards and pass regular GDP inspections
• have a suitable experienced ‘Responsible Person’ named on the licence to ensure that medicines are procured, stored and distributed appropriately

Question 12

What medicines do wholesaler distribution authorisations (WDAs) apply to?

Answer 12

apply to:

• human medicines = WDA (H)
• veterinary medicines = WDA (V)

Question 13

Which situations are exempt to needing a wholesaler distribution authorisation (WDA)?

Answer 13

registered pharmacies and hospitals supplying small quantities to:

• healthcare professionals for treatment/onward supply to patients
• other community pharmacies
• hospitals to meet a patient’s individual needs

when the transaction takes place on an occasional basis

quantities of medicines supplied is small

supply is not made for a profit basis

supply is not for onward wholesale distribution

Question 14

What is the difference between signed orders and requisitions?

Answer 14

signed orders

• are used in wholesale context for POMs
• different information requirements

requisition
- used by community pharmacies to obtain Schedule 2 and 3 CDs
- require a standardised form
= England (FP10CDF), Wales (WP10CDF), Scotland (GP10A or CDRF)

Question 15

What are the requirements for a requisition?

Answer 15

signature of the recipient 
name of the recipient 
address of the recipient 
profession or occupation of the recipient 
total quantity of the drug
purpose of the requisition

Question 16

What are the rules regarding wholesale dealing?

Answer 16

must be supplied as whole packs

must not label the product in any way

broken bulk and relabelling is not allowed under wholesale dealing and require a license from the MHRA

unlicensed medicines may not be supplied under wholesale dealing