Veterinary Meds Legislation

1. intro >medicines act 1968 covered it first >veterinary medidinces regulations in 2005 took over and made the veterinary medicines directorate responsible 2. What is the The Veterinary Medicines Regulations 2013 regulation for vetenary medications? 3. What is a vet•(a)any substance or combination of substances presenterinary medicinal ed as having properties for treating or preventing disease product? in animals; or •(b)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 functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. 4. What does VMD stand for? Veterinary Medicines Directorate 5. What is the >Issues liscences veterinary medi- >controlls manufacture and distribution of vet medicines cines directorate >makes up the inspection and investigation team do? 6. Who is respon- Northern ireland department of health sible for the enforcement of the regulations? 7. Who carries out VMD inspection of veterinary practices? 8. Registered qualifies persons: Vets- veterniary surgeons registeref wiht the royal colledge of veterinary surgeons, 1/6 Who can only pharmacists- registered with the pharmaceutical Society supply veterinary of Ni and SQP's- Suitably Qualifies Persons registered medicines? with AMTRA 9. SQP is a Registered qualifies person 10. What are the types of veterinary medicinal products? 1.POM-V - Prescription Only Medicine - Veterinarian 2.POM-VPS - Prescription Only Medicine - Veterinarian, Pharmacist, Suitably Qualified Person 3.NFA-VPS - Non Food Animal - Veterinarian, Pharmacist, Suitably Qualified Person 4.AVM-GSL - Authorised Veterinary Medicine - General Sales List 11. POM-V >only veterniary surgeon or pharmacist can prescribe >needs written prescription from a veterinary surgeon >may be uner the misuse of Drugs Legislation eg Ketamine, Fentanyl and tramadol 12. POM-VPS Only given by vet surgeon, pharmacist of SQP needs prescrition 13. NFA-VPS Non-Food Animal - Veterinarian, Pharmacist, Suitably Qualified Person from a pharmacy, registered merchant or registered veterinary practice 14. AVM-GSL Authorised Veterinary Medicine - General Sales List Sold from any retial premesis 15. Veterinary prescriptions Oral or written 16. When must a pre- if the supply is not made by the person who prescribed it scription be written? copy is kept for 5 years 17. •The name, address and telephone number of the prescriber 2/6 Whar does a writ- •The prescriber's qualifications ten prescription •The name and address of the owner or keeper of the need? animal(s) •The species and identification of the animal and the number of animals •The premises at which the animals are kept (if different from the owner or keeper) •The date of the prescription •The signature or authentification of the prescriber •The name and amount of the product prescribed •The dosage and administration instructions •Any necessary warnings •The withdrawal period if relevant •Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary cascade (e.g. 'prescribed under the cascade' or other wording to the same effect). 18. How long is a 6months written prescription valid for? 19. how long is a 28days written prescription for a Controlled drug valid for? 20. what is the veteri- Allows non- liscensed veterinary medicines. (or human nary cascade? medicines) to be administered to animals. exemption within the vet meds regulaitons If you don't have a drug to use for that condition in that species: you can move to a drug for the same species but different condition; then same condition but different species; then human medication 3/6 phamacists ant supply human meds to animals unless prescribed by a veterinary surgeon under the cascade 21. Where can VMP's Registered pharmacy, place registered with the RCVS or be supplied if the medicine is a POM-VPS or NFA-VPS the place must from? be registered as an Agricultural merchent 22. •A pharmacist supplying a VMP (other than a AVM-GSL product) must be present when the product is handed over unless the pharmacist: •Authorises each transaction individually before the product is supplied; and •Is satisfied that the person handing it over is competent to do so and is going to use it fir its actual purpose advises on warnings and safe usage isnt prescribing more than the minimum amount required for immediate treatment 23. What needs to be >info for safe usage on labels of vet >vet may change label to reflect prescription but no info on medicines? outer packaging or immediate contaner can be touched 24. Record keeping. need to keep record and a reciept of suppy of POM-V and POM-VPS must show: date, identity of product.batch number, quantity, name and address of the supplier or recipient and the name and address o f the person who wrote the the prescription. kept for ATLEAST 5 years 25. transactions def- •all incoming and outgoing movements of POM-VPS medinition icines including those sold, returned, damaged or date-expired stock, or otherwise disposed of. 26. Where are docu- private prescription book ments kept? kept electronically 27. What is the adverse reac- like the yellow card scheme in humans 4/6 tions scheme for veternary medicines? 28. How many times do pharmacists need to carry out an audit? >atleast once a year >must be available for inspection >Incoming and outgoing VMP's have the be checked against any products already in stock. 29. Where is reverse VMD using SARSS- Suspected Adverse Reaction Surveilreactions report- lance Scheme ed to? 30. What does an Authorised Veterinary Medicinal Product have on its packaging? >Marketing authorisation number eg EU/2/06/025/001 EU means authorised by the european commision 31. When can inspectors inspect? anytime >Distribution category eg •POM-V, POM-VPS, NFA-VPS or AVM-GSL 32. What do inspec- -Inspect tors do? -Search -Take samples -Seize documents and computers -Seize any VMP or anything purporting to be a VMP -Carry out inquires, examinations and tests -Inspect documents and records -Have access to and inspect any computer 33. What are the dif- >Dont keep records ferent types of of- >Possess or supply an authorised VMP fences? >Supply an out of date VMP >•Substitute a different product for a VMP that has been prescribed by another RQP >•Supply a POM-VPS or NFA-VPS from anywhere other than registered premises 5/6 >•Supply a human medicine for veterinary use - except if prescribed under cascade by a veterinary surgeon 6/6