INF2 - B. VETERINARY MEDICINES

Question 1

what is the name of the law which sets out the legal controls on veterinary medicines in UK

Answer 1

Veterinary medicines regulations 2013
- production
- distribution
- possession
- dispensing
- administration

*humans medicines regulations 2012 (sits on medicines act)

Question 2

what is the name of the agency which license veterinary medicines and carry out inspections of those involved in food chain, update and enforce regulations

Answer 2

Veterinary medicines directorate

*medicines and healthcare products regulatory agency

Question 3

what is a veterinary medicine

Answer 3

any product that gives the impression or claims to treat, prevent or control disease in animals

Question 4

what are the 4 classes of veterinary medicines

Answer 4

• POM-V (vet only)
• POM-VPS (vet, pharmacist or suitably qualified person) related to a P medicine, not for shelf selection
• NFA-VPS (non-food animal medicine - vet, pharmacist, SQP) can be out for shelf selection like a GSL but can only be sold by vet, pharmacist, SQP
• AVM-GSL (authorised veterinary medicine) GSL, can be sold from anywhere

Question 5

what type of prescriptions do POM-V and POM-VPS require

Answer 5

• private (nothing to do with NHS)
• written prescription
• only oral if prescriber is supplier

Question 6

POM-V

Answer 6

• prescribed by vet
• supplied by vet or pharmacist

Question 7

POM-VPS

Answer 7

• prescribed by vet, pharmacist or SQP
• supplied by vet, pharmacist or SQP

Question 8

what are the prescription requirements

Answer 8

• prescriber details: name, address, telephone number, qualification, signature
• owner details: name, address
• animal details: identification (number system for herd), species, address if different from owners
• date
• medicine details: name, quantity, dose, administration instructions (can’t use ‘as directed’)
• warnings and withdrawal period of drug from animal’s system (food producing animals)
• ‘prescribed under the cascade’ - if appropriate
• number of repeats - if appropriate

Question 9

how long is prescription valid for

Answer 9

6 months
Sch 2,3,4 CDs - 28 days
repeatable prescription - within 6 months

Question 10

what additional requirements are their for CD Sch 2 and 3

Answer 10

regulations as for human medicines plus:
- standardised forms not required (can use normal vet prescription)
- prescriber declaration ‘prescribed for treatment of an animal or herd under my care’
- prescription forms to be kept for 5 years
- give max 28 days treatment (humans - 30)
- RCVS registration number of prescriber

Question 11

why might a licensed veterinary medicine not always be available

Answer 11

• only one human species we can test in but endless number of species of animals
• not financially viable for company

Question 12

what is the order of the cascade

Answer 12

1. supply licensed veterinary medicine 1.UK.GB 2.NI
   (if prescribed generically by drug name, see if there’s a veterinary version first)
2. supply licensed veterinary medicine for another species or different condition
3. supply UK/GB/NI licensed human medicine or veterinary medicine licensed outside UK
4. supply extemporaneous or specially manufactured medicine

2,3,4 = (STATE ‘FOR ADMINISTRATION UNDER THE CASCADE ‘ ON PRESCRIPTION)

Question 13

when do you need to label dispensed medicines

Answer 13

if supplied under the cascade or not in original container but recommended for all

Question 14

additional requirements to human medicines for labelling

Answer 14

• name of prescriber
• name and address of animal owner
• identification and species of animal
• date of supply
• expiry date of product
• dosage and administration instructions
• ‘for animal treatment only’
• ‘keep out of reach of children’

minimum:
- name and address of dispensing pharmacy
- name and address of animal owner
- date of dispensing

Question 15

what can’t you sell/supply in pharmacy

Answer 15

• unlicensed veterinary medicines
• human licensed GSL and P medicines

Question 16

how do you sell/supply POM-VPS OR NFA-VPS

Answer 16

• advise on safe use
• advise about warnings
• be satisfied that the user is competent
• supply minimum quantity for treatment
• can’t diagnose conditions

*use NOAH compendium resource for information

Question 17

what scheme is there for adverse reactions to veterinary medicines

Answer 17

Suspected Adverse Reaction Surveillance Scheme

Question 18

what information needs to be recorded for received and supplied POM-V and POM-VPS products

Answer 18

• name and quantity of medicine
• date of supply/receipt
• batch number
• name and address of supplier/recipient
• name and address of prescriber if written prescription

Question 19

how long should you keep documents/seperate record (paper or electronic)

Answer 19

at least 5 years

Question 20

when is a annual audit required

Answer 20

if pharmacy supplies POM-V and/or POM-VPS medicines

Question 21

what is the VMD guidance about wholesale supply

Answer 21

• only the manufacturer of a veterinary medicine or a holder of a wholesale dealer’s authorisation may routinely supply authorised retailers with veterinary medicines (ie - vet practice)
• an authorised retailer may supply products they are qualified to supply to another authorised retailer to relieve a temporary supply shortage without a WDA
• wholesale supply of a human medicines for veterinary use under the cascade requires a WDA(H) license from the MHRA (most pharmacies don’t have this)