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IT IS less than two years since, after an extensive overhaul of the existing legislation, new veterinary medicines regulations came into force in the uk, introducing new distribution categories in an attempt to reconcile eu requirements that all products used in food-producing animals should be prescription-only medicines with the recommendations of the Marsh and Competition Commission inquiries, which sought, where possible, to make products more readily accessible to the end user.
An important aspect of the new regulations was that they introduced two categories of prescription-only medicines (poms) where only one had existed previously: pom-v, which broadly corresponds to the old pom category; and pom-vps, which includes products intended for use in food-producing animals that were previously on the Pharmacy and Merchants List (pml) and could formerly be obtained from authorised suppliers without a prescription. pom-v products require a prescription from a veterinary surgeon, and can be dispensed only by veterinary surgeons and registered pharmacists. pom-vps products, on the other hand, can be supplied by veterinary surgeons, pharmacists and registered suitably qualified persons (sqps). These, too, require a prescription, but prescriptions can be provided by pharmacists and registered sqps as well as by veterinary surgeons.
The medicines regulations were drafted in a way that means they have to be revoked and remade each year, to allow for amendments and to keep them up to date. This has led to an annual round of consultation on proposed changes, and consultation on the draft 2007 regulations, which are due to come into force in October, is currently under way. Among this year's proposals is that all premises used by veterinary surgeons to supply veterinary medicines should be registered (VR, March 17, 2007, vol 160, pp 350-351). Intriguingly, however, and quite separately from the annual consultation round, the Veterinary Medicines Directorate (vmd) is consulting ‘informally’ on the possibility of a third category of pom, which would sit between the pom-v and pom-vps categories (see p 638 of this issue).
The new category has been proposed by a working group of the Veterinary Products Committee to fill ‘a gap’ in the current classification regime. This, it is suggested, arises where a veterinary surgeon makes a clinical assessment (or diagnosis), determines which disease is present and, as a result, prescribes a medicine intended for ongoing treatment or control of an endemic or persistent disease in farm animals. The working party apparently sees a problem here in that, ‘Where a medicine could be used regularly over a given period of time, as originally directed by the veterinary surgeon but without further need for veterinary intervention, then none of the current categories seems suitable for use of such a product in practice. If the product is classified cautiously, it appears to be overly restrictive in product use; however, if it is allocated a pom-vps category, there would be no obligation for a veterinary surgeon to input and the product may be used inappropriately.’
It suggested that introducing a third category of pom would rectify this. Under the proposed solution, medicines in the new category would require initial prescription by a veterinary surgeon. They could then be supplied by another veterinary surgeon, pharmacist or sqp for a period specified in the initial prescription.
The vmd suggests that the new category could be linked to farm health plans, and called pom-v(hp) or pom-hp. It notes that defra is currently working with farming and other stakeholder groups under the Animal Health and Welfare Strategy to increase the use of health plans but ‘it has not yet been decided who should draw them up’. The suggestion seems to be that, if a veterinary surgeon was drawing up the health plan, the medicines section would need to be signed and dated, specifying how long the medicine could be used before the matter was reconsidered. If someone else was drawing up the health plan, a countersignature from a veterinary surgeon would be required.
It seems odd that the vmd should be contemplating introducing a third category of pom when so much effort was devoted to devising the existing categories, which have barely had time to bed down. It also seems odd that it should be considering linking the new category to health plans at this stage, when it was reluctant to link prescribing to health plans when the current regulations were being drafted; if it had been amenable to this idea at the time, the need for a provision allowing pharmacists and sqps to write prescriptions for products in the pom-vps category could have been avoided.
In terms of animal health and welfare, there is a need for a greater veterinary input into animal health plans and into which medicines are purchased and how they are used, to help ensure that products are used appropriately and effectively. In this respect, it is difficult to see what more might be achieved by having a third category of pom: indeed, if products are moved ‘down’ from pom-v into the proposed new category, veterinary input could be reduced and animal health and welfare could suffer as a result. Conversely, if concerns exist about some products in the pom-vps category, they might be better classified as pom-v. Clarification is needed on what is driving this proposal. Unless there are genuine benefits for animal health, public health and animal welfare, the status quo should be maintained.