2H. The Use of Veterinary Medicinal Products

1. This guidance is based on current EU and UK law and published guidelines & Codes of Practice (see below)

2. The responsible use of veterinary medicines for therapeutic and prophylactic purposes is one of the major skills of a veterinary surgeon and crucial to animal welfare and to the maintenance of public health.

3. Under the Veterinary Medicines Regulations, veterinary surgeons may prescribe POM-V veterinary medicinal products only following a clinical assessment of animals under their care.

4. Failure by the profession to observe these requirements could result in the removal of the exemption for the supply of medicines by veterinary surgeons.

Under his care

5. The Veterinary Medicines Regulations do not define the phrase 'under his care' and the RCVS has interpreted it as meaning that:

a. the veterinary surgeon must have been given the responsibility for the health of the animal or herd by the owner or the owner's agent

b. that responsibility must be real and not nominal

c. the animal or herd must have been seen immediately before prescription or,

d. recently enough or often enough for the veterinary surgeon to have personal knowledge of the condition of the animal or current health status of the herd or flock to make a diagnosis and prescribe.

e. the veterinary surgeon must maintain clinical records of that herd/flock/individualWhat amounts to 'recent enough' must be a matter for the professional judgement of the veterinary surgeon in the individual case.

Clinical assessment

6. The Veterinary Medicines Regulations do not define "clinical assessment", and the RCVS has interpreted this as meaning an assessment of relevant clinical information, which may include an examination of the animal under the veterinary surgeon's care.

POM-VPS veterinary medicinal products

7. Veterinary surgeons may prescribe POM-VPS veterinary medicinal products in circumstances where there has been no prior clinical assessment of the animals and the animals are not under his or her care. In these circumstances veterinary surgeons should prescribe responsibly and with due regard to the health and welfare of the animals.

Diagnosis

8. Diagnosis for the purpose of prescription should be based on professional judgement following clinical examination and/or post mortem findings supported if necessary by laboratory or other diagnostic tests.

Choice of medicinal products

9. A veterinary surgeon must be satisfied that the animal would benefit from medication, particularly in the case of antibiotics or hormones.

10. The selected product must be authorised for use in the UK in the target species for the condition being treated and used at the manufacturer's recommended dosage.

11. If there is no suitable authorised veterinary medicinal product in the United Kingdom for a condition in a particular species, in order to avoid unacceptable suffering veterinary surgeons may exercise their clinical judgement according to the 'Cascade', whereby they select in the following order

a. a veterinary medicinal product authorised in the United Kingdom for use with another animal species, or for another condition in the same species (off-label use); or

b. if, and only if, there is no such product that is suitable, either:

i. a medicinal product authorised in the United Kingdom for human use; or

ii. a veterinary medicinal product not authorised in the United Kingdom but authorised in another European Member State for use with any animal species (in the case of a food-producing animal, it must be a food-producing species); or

c. if, and only if, there is no such product that is suitable, a veterinary medicinal product prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

12. A decision to use a medicine which is not authorised for the condition in the species being treated where one is available should not be taken lightly or without justification. In such cases clients should be made aware of the intended use of unauthorised medicines and given a clear indication of potential side effects. Their consent should be obtained in writing. In the case of exotic species most of the medicines used are unlikely to be authorised for use in the UK and owners should be made aware of and consent to this from the outset.

Associated responsibilities with the prescription and supply of medicines

13. A veterinary surgeon who prescribes a POM-V or POM-VPS veterinary medicinal product, or supplies a NFA-VPS veterinary medicinal product, must:

a. before he does so, be satisfied that the person who will use the product is competent to use it safely and intends to use it for a use for which it is authorised;

b. when he does so, advise on the safe administration of the veterinary medicinal product;

c. when he does so, advise as necessary on any warnings or contra-indications on the label or package leaflet; and

d. not prescribe (or in the case of a NFA-VPS product, supply) more than the minimum quantity required for the treatment.

14. The Veterinary Medicines Regulations do not define 'minimum amount' and the RCVS considers this must be a matter for the professional judgement of the veterinary surgeon in the individual case.

15. Veterinary medicinal products must be supplied in appropriate containers and with appropriate labelling.

16. Veterinary surgeons may make retail supplies of POM-V veterinary medicinal products on the prescription of another veterinary surgeon (i.e. for animals that are not under the care of the supplying veterinary surgeon).

Registration of practice premises

17. From 1 April 2009, practice premises from which veterinary surgeons supply veterinary medicinal products must be registered with the RCVS as ‘veterinary practice premises’, in accordance with the Veterinary Medicines Regulations; this Regulation (Regulation 8 of Schedule 3) does not apply to Authorised Veterinary Medicines – General Sales List (AVM-GSL).

18. Premises likely to be considered as ‘veterinary practice premises’ are those:

a. from which the veterinary surgeons of a practice provide veterinary services; and/or,

b. advertised or promoted as premises of a veterinary practice; and/or,

c. open to members of the public to bring animals for veterinary treatment and care; and/or,

d. not open to the public, but which are the base from which a veterinary surgeon practises or provides veterinary services to more than one client; and/or,

e. to which medicines are delivered wholesale, on the authority of one or more veterinary surgeons in practice.

19. Main and branch practice premises from which medicines are supplied are veterinary practice premises that must be registered with the RCVS.

Records

20. Veterinary surgeons should keep a record of premises and other places where they store or keep medicinal products, for example, homes where medicinal products may be kept for on-call purposes and practice vehicles; the record should be held at the practice’s main ‘veterinary practice premises’ in accessible form.

21. Veterinary surgeons should keep a full record of all incoming and outgoing medicinal products and at least once a year carry out a detailed audit reconciling these with stock, recording any discrepancies. For further information please see the Veterinary Medicines Directorate's Clarification Note on record keeping.

Ketamine

22. Ketamine may be the subject of misuse and, therefore, should be stored in the controlled drugs cabinet and its use recorded in an informal register.

Food-producing animals

23. The act of dispensing, including quantity and batch numbers should be recorded in the animal's/farm's clinical records.

24. Farm clients should be advised specifically about withdrawal periods and on the recording of medicine use in their Medicines Record Book.

Suspected adverse reactions to veterinary medicines

25. The Suspected Adverse Reaction Surveillance Scheme (SARSS) for veterinary medicines is operated by the VMD (telephone number for SARSS 01932/338427, fax 336618). All suspected adverse reactions should be reported using the yellow form (MLA 252A Rev. 8/01). Supplies should be held in the practice and may be obtained by return of post using the tel/fax number. Serious reactions (death or prolonged severe clinical signs) are mentioned specifically in the European Directives and companies marketing products are required to report them to the SARSS. Further information is available from the VMD.