INF2 - B. VETERINARY MEDICINES Flashcards
what is the name of the law which sets out the legal controls on veterinary medicines in UK
Veterinary medicines regulations 2013
- production
- distribution
- possession
- dispensing
- administration
*humans medicines regulations 2012 (sits on medicines act)
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
Veterinary medicines directorate
*medicines and healthcare products regulatory agency
what is a veterinary medicine
any product that gives the impression or claims to treat, prevent or control disease in animals
what are the 4 classes of veterinary medicines
- 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
what type of prescriptions do POM-V and POM-VPS require
- private (nothing to do with NHS)
- written prescription
- only oral if prescriber is supplier
POM-V
- prescribed by vet
- supplied by vet or pharmacist
POM-VPS
- prescribed by vet, pharmacist or SQP
- supplied by vet, pharmacist or SQP
what are the prescription requirements
- 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
how long is prescription valid for
6 months
Sch 2,3,4 CDs - 28 days
repeatable prescription - within 6 months
what additional requirements are their for CD Sch 2 and 3
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
why might a licensed veterinary medicine not always be available
- only one human species we can test in but endless number of species of animals
- not financially viable for company
what is the order of the cascade
- supply licensed veterinary medicine 1.UK.GB 2.NI
(if prescribed generically by drug name, see if there’s a veterinary version first) - supply licensed veterinary medicine for another species or different condition
- supply UK/GB/NI licensed human medicine or veterinary medicine licensed outside UK
- supply extemporaneous or specially manufactured medicine
2,3,4 = (STATE ‘FOR ADMINISTRATION UNDER THE CASCADE ‘ ON PRESCRIPTION)
when do you need to label dispensed medicines
if supplied under the cascade or not in original container but recommended for all
additional requirements to human medicines for labelling
- 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
what can’t you sell/supply in pharmacy
- unlicensed veterinary medicines
- human licensed GSL and P medicines
how do you sell/supply POM-VPS OR NFA-VPS
- 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
what scheme is there for adverse reactions to veterinary medicines
Suspected Adverse Reaction Surveillance Scheme
what information needs to be recorded for received and supplied POM-V and POM-VPS products
- 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
how long should you keep documents/seperate record (paper or electronic)
at least 5 years
when is a annual audit required
if pharmacy supplies POM-V and/or POM-VPS medicines
what is the VMD guidance about wholesale supply
- 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)
