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The Pharmaceutical Journal
A robust submission on the Marsh report
The Royal Pharmaceutical Society has released a special projects budget to allow the Veterinary Pharmacists Group to construct a robust submission to the Government following its interim response (PJ, 5/12 January, p6) to the review of the classification, pricing and availability of veterinary medicines carried out by a working group chaired by Sir John Marsh.
What has challenged the VPG in the past is demonstrating the added value of pharmacy involvement in the supply of veterinary medicines. It has been well demonstrated for human medicines, but can we articulate it now to our own satisfaction and lucidly enough to others? The case can then be won for a number of veterinary prescription-only medicines (POMs), especially prophylactics, to be sold under the supervision of a pharmacist without the need for a veterinary prescription.
Should a product be allowed for sale by pharmacists yet not be appropriate for sale by merchants? In fact, we support the Animal Health Distributors Association's case for some POM products to become pharmacy and merchants' list (PML) medicines. This distinction is the essence of the case.
Some recent developments in veterinary medicines
Some recent developments in veterinary medicine have an impact on many pharmacists and not only those specialising in veterinary pharmacy. Among these developments are trends in product development and administration, the reclassification of veterinary medicines, the reporting of suspected adverse reactions from veterinary medicines affecting humans as well as animals and the report of the inquiry into veterinary dispensing (the Marsh report)
In addition, documents distributed for consultation by Government Departments (such as the new Department of the Environment, Food and Rural Affairs) often have wide reaching implications, with potential impact on pharmacy in general. A consultation document issued in November 2001 by the European Commission proposes measures for the control and prevention of zoonoses, with wide ranging implications for all health professionals.
Product trends Many trends in the development of veterinary medicinal products parallel those in human medicine. Disease prevention through the wider application of immunological products is vital to modern farming practice. The Veterinary Data Sheet Compendium gives an indication of the range and importance of such products, especially in the poultry and pig industries. There is always scope for product improvement but it would appear that in some areas the financial return has not been adequate to encourage and promote research into improved products. Adjuvants in particular have often received little attention in both veterinary and human medicine even though they can influence a range of responses and vary in how well they are tolerated in individual animals and humans.
The risk of needlestick injuries when giving injections to moving targets, as occurs when inoculating maybe 2,000 sheep, is just one factor in favour of the development of "pour-on" formulations to treat systemic conditions such as those used to control endoparasites as well as ectoparasites. The potential for topical administration to achieve a systemic effect is attractive, provided the issues of safety and efficacy in use can be reliably ascertained. However, physical characteristics (such as a hairy fleece) and animal behaviour (such as licking the application site) often represent greater challenges than for similar applications designed for human use.
Reclassification Pressures to reclassify veterinary medicines from prescription-only (POM) to pharmacy and merchants' list (PML) the pharmacy (P) category hardly exists in veterinary medicine or from PML to general sale list (GSL) have until recently depended almost entirely on the preference of the marketing authorisation holder, unlike the position with human medicines. The situation is changing, but there are concerns that aspects of dosage, off-licence use (ie, use in a species for which the product is not licensed) and a purchaser's limited knowledge are aggravated when products are made readily available in outlets that lack any professional or trained staff. But what is new? On the rare occasions when a product must be withdrawn from the market speedily and efficiently, there are potentially greater problems when the product is available from any shop or supermarket as a GSL medicine.
The law now requires an audit trail for all POM, P or PML medicines used in food producing animals. Burdensome as the record-keeping requirement may at first appear for the supplier, it greatly facilitates any checks needed as a consequence of issues of possible deficient efficacy or residue levels above defined limits.
Adverse reactions The yellow report form, revised two years ago, for notifying the Veterinary Medicines Directorate about suspected adverse reactions (SARs) from animal medicines, has one side for SARs affecting animals and the other for SARs affecting humans. It is not always recognised that reports are expected and encouraged from pharmacists, as well as from veterinarians, farmers, animal owners and GPs. Forms are included in the Veterinary Data Sheet Compendium and are available from the VMD.
In September 2001, the Veterinary Products Committee appraisal panel for human SARs to veterinary medicines published a report covering 1985 to 2000. A large proportion of the reports relate to cat and dog owners and involve flea collars and small animal spot-on products. Many of these problems could probably have been avoided if instructions for use had been adequately explained and followed.
Reports from pharmacists are included with those from doctors and represent about 5 per cent of reports. The market authorisation holders are the biggest contributors at 55 per cent, farmers 16 per cent, vets 7 per cent, the public 6 per cent and "others" 7 per cent. Pharmacists are in a strategic position to help in reporting for the benefit of patients, customers and pets, and for better recognition of their own professional role in health care.
Information service For those wishing to access the regularly updated information provided by VMD, its excellent quarterly newsletter MAVIS (Medicines Act Veterinary Information Service) is now on line at www.vmd.gov.uk. It regularly includes updates on the SAR surveillance scheme, residue controls and monitoring and an update on the work of the VPC. The website also gives fuller details of the SAR surveillance scheme.
Marsh report The report of the independent review of dispensing by veterinary surgeons of prescription only medicines (the Marsh report) was published in May 2001 and the Government's initial response has just been published. It will require a detailed, careful and considered response from pharmacy within the next two to three months. Watch this space!
Citation: The Pharmaceutical Journal URI: 20006129
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