PPM - Veterinary Medicines

1. who regulates veterinary medicines: - the veterinary medicines regulations 2013 - they set out legal controls on production, distribution, possession, dispensing, administration of vet meds 2. who licenses vet meds: - the veterinary medicines directorate (VMD) 3. who is the veterinary products committee: - committee which provides independent scientific advice to the VMD on e.g. applications for marketing authorisations 4. what is a veterinary medicinal product: - any substance or combination of substances presented as having properties for treating or preventing disease in animals or - any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological, immunological or metabolic action, or to making a medical diagnosis 5. who make up RQP under the veterinary medicines regulations: - registered qualified persons (RQP) - vets - pharmacists - suitably qualified persons 6. explain POM-V medicines: Rx only medicine - veterinarian - prescription only meds that can only be prescribed by a vet surgeon and supplied by a vet surgeon or a pharmacist with a written prescription 7. explain POM-VPS medicines: Rx only medicine - veterinarian, pharm, SQP - prescription only medicines that can be prescribed and supplied by a vet surgeon, pharmacist, suitably qualified person - on an oral or written prescription - written prescription only required if the suppler is not the prescriber 8. explain a NFA-VPS medicines: non-food animal - veterinarian, pharm, SQP - medicines for non-food animals that can be supplied by vet surgeon, pharmacist, suitably qualified person - written prescription not required 9. explain AVM-GSL medicines: authorised veterinary medicine - general sales list - an authorised veterinary med that is available on general sale 10. explain SAES medicines: - exempt meds under sch6 of the VMRs - exemptions for small pet animals - an unlicensed vet med that does not require a MA because it meets criteria laid 1/4 out in Sch 6 - exemptions for small pet animals 11. explain unauthorised veterinary medicines: - an unlicensed med that does not have a MA and is not eligible for exemption through the SAES - can only be prescribed by a vet surgeon under the cascade 12. explain the prescription requirements for veterinary meds: - Rx may be written or oral - oral: if the prescriber is also the supplier if not then must be written - written in ink/another indelible format - a standardised Rx form not required 13. explain the Rx requirements for POM-V,POM-VPS and meds supplied under the veterinary cascade: - name, address, number, qualification, signature of prescriber (if CDs prescribed the royal college of veterinary surgeons (RCVS) reg number of prescriber must be included) - name and address of owner - identification and species of the animal and address if it is different from the owner - date - name, quantity, dose, administration instructions of medicine (as directed not acceptable) - any necessary warning and if relevant the withdrawal period - if Rx is repeatable, the number of times it can be repeated 14. how long a vet prescriptions valid for: 6 months 15. what is the veterinary cascade: - an exemption that stated where a licensed vet product is not available, other meds, in a strict order of preference, can be considered. - illegal to supply human meds against vet Rx unless prescribed by a vet AND Rx states 'for administration under the cascade' 16. what is the order of the veterinary cascade: 1. supply a vet med with a GB or UK-wide MA for the species and condition specified where this is not possible 2. supply a vet med with a northern ireland MA for the species and condition indicated where this is not possible 3. consider supplying GB,NI,UK wide vet med licensed for another species or different condition where this is not possible 4. consider a GB,NI,UK licensed human med or a vet med authorised outside UK 2/4 where this is not possible 5. consider supplying an extemporaneous/specially manufactured med 17. explain the sale of unauthorised vet meds: - is unlawful to sell/supply, incl human meds, for an animal unless it takes places under the cascade - applies even if vet surgeon asks owner verbally to buy over the counter human product 18. explain the sale of NFA-VPS and POM-VPS meds: - legal requirement for pharms who supply them to: - advise on how to use product safely - advise on any warnings and contraindications - be satisfied that the recipient intends to use the meds correctly and is competent to do so - prescribe or supply the minimum quantity required 19. explain the requirements for the sale of meds and the physical presence of a pharmacist: - a pharm must be physically present when a POM-V, POM-VPS, NFA-VPS is supplied - exception: transaction has been authorised in advance by the pharmacist and the person handing out the meds is judged to be competent 20. labelling requirements: - name of prescribing vet surgeon - name and address of animal owner - name and address of pharmacy - identification and species of animal -date of supply - expiry date of product - name or description of product - dosage and administration instructions - any necessary warnings - any applicable withdrawal period - the words: for animal treatment only' - the words: 'keep out of reach of children' 21. what are record keeping requirements for vet meds: - requirement to keep records of receipt and supply of POM-V and POM-VPS products showing: - name of med - date of receipt or supply - batch number - quantity - name and address of the supplier or recipient - written Rx: record name and address of prescriber and keep a copy of Rx 3/4 - records can be kept electronically - records and documents must be kept for at least 5 years 22. what is an annual audit: - pharmacies that supply POM-V and POM-VPS meds must undertake an annual audit - incoming and outgoing products must be reconciled with products currently in stock - any discrepancies must be recorded 4/4