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Refining the rules on medicines

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2005 was a significant year for the Veterinary Medicines Directorate (vmd) and everyone else with an interest in veterinary medicines. It saw the introduction of the Veterinary Medicines Regulations 2005, which had been drafted by the vmd to implement European rules and represented the most significant revision of British veterinary medicines legislation for more than 35 years. In his introduction to the vmd's annual report for 2005/06, which has just been published,* its chief executive, Mr Steve Dean, describes the year as being one of ‘immense change’ — and few among those affected by the new regulations will be inclined to disagree. The process of change, however, does not stop there. An interesting aspect of the new regulations is that they must be revoked and remade each year, to allow for amendments and to keep them up to date. This meant that, even as everyone was getting used to the new legislation, the vmd started consulting on how it might be improved (VR, March 25, 2006, vol 158, p 385). The bva has responded to the vmd's request for comments, and makes some pertinent points in the process.

A key aspect of the new regulations was that they introduced two categories of prescription-only medicines (poms): pom-v, which broadly corresponded to the pom category which existed until the new regulations came into force in October 2005; and the pom-vps category, which included products intended for use in food-producing animals that had previously been on the Pharmacy and Merchants List (pml). pom-v products require a prescription from a veterinary surgeon, and can only be dispensed by veterinary surgeons and registered pharmacists. pom-vps products, on the other hand, can be supplied by veterinary surgeons, pharmacists and ‘suitably qualified persons’ (sqps); they, too, require a prescription, but prescriptions can be provided by pharmacists and sqps as well as veterinary surgeons.

The pom category was split in this way to reconcile a requirement in European law for all products used in food-producing animals to be poms with a desire in Britain to maintain the breadth of distribution outlets for certain animal medicines that existed as a result of the pml category. With the introduction of the pom-vps category, this has largely been achieved. The bva has no wish to limit the choice of supplier. At the same time, however, it believes that a greater veterinary input into what is purchased and how it is used would benefit animal welfare and help to ensure that medicines are used effectively. In its response to the vmd's consultation, it therefore argues that pom-vps products should be supplied in the context of an annual prescription from a veterinary surgeon. The prescription would be provided by the veterinary surgeon for the animals under his or her care, based on a veterinary risk assessment of the likely health challenges to those animals over the next 12 months. It would be permissive in nature, and could be dispensed by any of the suppliers already listed in the regulations. Such an arrangement would be more in tune with the spirit of the European legislation that the regulations aim to implement, and avoid the risk of prescriptions being written without any knowledge of the animals concerned. With the annual prescription being integrated into veterinary farm health plans, there could be additional benefits in helping to move the Animal Health and Welfare Strategy forward.

Suggesting further improvements, the bva argues that the regulations should clarify the distinction between ‘supply’ and ‘prescribing’ and, in the context of the prescribing cascade, specify more clearly what written prescriptions should include. It welcomes clarification relating to the registration of sqps and encourages the vmd to allow listed Veterinary Nurses to become recognised as sqps. On the matter of batch recording, it draws attention to the costs and practical difficulties and, while endorsing batch traceability in the farm sector, argues that the regulations proposed for the companion animal and equine sectors are bureaucratic and unnecessary. At the very least, it believes there will have to be a substantial transitional period of at least five years before the proposed requirements could become practically feasible.

The veterinary medicines regulations may have dominated, but it would be wrong to think that this was the only issue dealt with by the vmd in 2005/06. The annual report provides a useful summary of its activities, whether in licensing products, monitoring suspected adverse reactions or carrying out surveillance for residues in food. Regarding licensing, the report notes that ‘the number of applications for new marketing authorisations was reduced again this year, but variation applications significantly increased.’ Elsewhere, the report lists ‘the economic state of the veterinary pharmaceutical industry and its effect on the volume of licensing work the vmd receives’ as a key challenge for the future. It is vital that new products are developed and can be made available for use in animals. The decline in the number of new marketing authorisations is worrying and should be of concern not just to the vmd but to everyone with an interest in animal health.

    Footnotes

    • * The Veterinary Medicines Directorate's Annual Report and Accounts 2005/2006 is available at www.vmd.gov.uk. The bva's response to the vmd's consultation on the Veterinary Medicines Regulations 2006 is available to members on the Association's website, www.bva.co.uk

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