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A RECENT article in the veterinary press (Veterinary Times, June 6, 2011) discussed the release of customer information leaflets providing handling, storage and administration details for off-licence medicines. The article touched briefly on a significant issue for British practitioners, namely non-compliance with cascade labelling laws.
The article referred to Veterinary Medicines Directorate and RCVS reports last year, which highlighted high levels of non-compliance with the cascade labelling rules of the Veterinary Medicine Regulations (VMRs). At the BSAVA congress earlier this year, the VetFormulary Project discussed the issue of cascade labelling with over 400 delegates. The result of our straw poll implied a non-compliance rate of over 99 per cent within the small animal profession.
The two main explanations for non-compliance are, first, a lack of awareness of the labelling provisions, and, secondly, the difficulty for a practitioner (or even a group practice) to collate the prescribed information for the label.
In relation to awareness, the cascade labelling law is somewhat buried in a schedule to the VMRs, and many practitioners confuse the RCVS requirement for written client consent with the labelling rules. Regarding the second explanation, there is no doubt that there is an enormous amount of work required to research and collate the evidence on, for instance, special precautions in the target species, for each cascade medicine. Because the medicine is being supplied off-label, the manufacturer's package insert necessarily does not provide this information. The rules also require warnings in relation to the user, that is, the client, including handling, storage and disposal instructions.
Although the cascade labelling obligations are onerous, they serve incontrovertible public policy objectives of public safety and animal welfare. Indeed, having researched the laws in a number of other countries in Europe and North America, we believe that the UK's veterinary off-label dispensing requirements lead the world in setting standards of public information and safety.
Nevertheless, our profession needs further guidance on, and standardisation of, the labelling requirements in order to genuinely realise that world's best practice. Based on our own discussions with the regulators, we are hopeful that both guidance and standardisation will be forthcoming later this year.
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