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IT HAS always been a challenge keeping up with changes in requirements regarding veterinary medicines, and things have not necessarily become any easier following the introduction of the Veterinary Medicines Regulations in 2005. Introduced to take account of changes in European legislation, as well as the recommendations of the Marsh review and the Competition Commission's inquiry into the sale and supply of veterinary medicines, the regulations introduced new medicines distribution categories. They also brought together into a single statutory instrument many separate pieces of legislation on veterinary medicines that had existed in the uk until then, successfully providing a ‘one-stop shop’ for regulation in this area. However, an interesting feature of the regulations is that they have to be revoked and remade each year, so that the legislation can be updated as necessary. Given that the legislation runs to 87 printed pages, and is accompanied by 27 sets of official guidance notes, this can be a somewhat arduous process.
The Veterinary Medicines Regulations 2007 came into force on October 1, following a public consultation in March, marking the end of the second cycle of revision. The Veterinary Medicines Directorate (vmd), which is responsible for the regulations, has helpfully produced a four-page memorandum explaining the changes that have been made since the regulations were last revised in 2006, and has also posted on its website (www.vmd.gov.uk) a version of the 2007 regulations with the amendments shown as tracked changes. Nevertheless, for those who need to comply with the regulations, it can be hard (though no less important) to keep abreast of what is happening.
All of which should make the new bva Good Practice Guide on Veterinary Medicines, copies of which are distributed with bva members' copies of this week's The Veterinary Record, particularly useful. The guide is a successor to the old bva Code of Practice on Medicines, which predated the Veterinary Medicines Regulations and is therefore out of date.
Aimed at veterinary practitioners, the new bva guide consolidates sound, practical advice on the prescription and supply of veterinary medicines into a single, readable document. Starting with an explanation of the current medicines distribution categories, it gives advice on a whole range of requirements concerning the correct handling of medicines, from obtaining the product in the first place, through storage, prescription, dispensing and administration, to ensuring that unused or excess products are disposed of safely. Advice is given on applying the prescribing cascade to both food- and non-food-producing animals, as well as on record-keeping requirements and on drug residues and withdrawal periods.
It is sobering, on reading this concise document, to reflect on just how much care and effort must be devoted to handling and supplying medicines correctly, and the extent of veterinary surgeons' responsibilities in this area. These responsibilities may not always be appreciated by the public, but must be discharged daily, as a matter of routine. In this respect, a section of the guide giving examples of ‘standard operating procedures’ relating to the handling and supply of medicines should prove particularly useful to practices. Additional sections in the guide consider client consent forms and reporting suspected adverse reactions.
The guide takes account of the Veterinary Medicines Regulations and other relevant legislation, and contains much useful information besides. However, it cannot hope, in 36 pages, to cover all aspects of medicines legislation. To keep up with developments, members will also need to refer to other sources of information and these, as well as useful contacts, are listed in the guide.
For those who need to keep up with the changing legislation, there will be little consolation to be gained from the fact that, now that the 2007 regulations have come into force, the annual cycle of revision will soon begin again. As reported on p 575 of this issue, changes introduced in 2007 have included provisions to allow the advertising of pom-v products to veterinary nurses, as well as a requirement, to take effect from April 1, 2009, that veterinary premises supplying and storing veterinary medicines should be registered. The vmd is currently discussing with the rcvs how this provision should be implemented. At present it is a little early to say what changes might be planned for 2008. However, a worrying aspect of the Veterinary Medicines Regulations is that, in legislative terms, changes can be made relatively easily. In most cases, this might not matter too much, as the changes, such as licensing fee updates, will be fairly minor. As experience has shown, however, other changes can be more substantial, and could have significant practical consequences. Once new requirements are included in the legislation, there is an obligation to comply. For this reason too, it remains important to keep track of the evolving legislation and, by being fully engaged in the consultative process, seek to ensure a satisfactory outcome.
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