Sheep, multi species, rabbit and fish vaccines - Distribution by luckboy


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									Mr Lea Reynolds Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS

Telephone: 020 7572 2612 Facsimile: 020 7572 2501 e-mail:

17 April, 2008


Dear Mr Reynolds Distribution Category Review – Categories for sheep, multi-species, rabbit & fish vaccines authorised for use in the UK The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional and regulatory body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians on a voluntary basis, which is expected to become statutory under anticipated legislation. The primary objectives of the Society are to lead, regulate, develop and represent the profession of pharmacy. The Society leads and supports the development of the profession within the context of the public benefit. This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it promotes the profession’s policies and views to a range of external stakeholders in a number of different forums. The Society has responsibility for a wide range of functions that combine to assure competence and fitness to practise. These include controlled entry into the profession, education, registration, setting and enforcing professional standards, promoting good practice, providing support for improvement, dealing with poor performance, dealing with misconduct and removal from the register. The Society also produces a Code of Ethics containing standards governing the conduct, the practice of pharmacists and pharmacist’s competencies. Pharmacists under their Code of Ethics are only able to operate within their range of competence. All pharmacists must adhere to the RPSGB Code of Ethics and it is enforced through the RPSGB regulatory machinery. The ultimate sanction would be removing the pharmacist’s name from the Register. The Society’s Pharmacists and Pharmacy Technicians Order 2007 also provides the ability to suspend or restrict practice and where necessary prevent a pharmacist prescribing The Royal Pharmaceutical Society of Great Britain welcomes the recommendations to either change or maintain the distribution categories for Sheep and Multi Species, Poultry, Rabbit and Fish Vaccines authorised for use in the UK. We would also like the VMD to consider the following comments:-

Sheep and Multi Species Vaccines We agree with all the changes proposed in the consultation but would in addition like to see consideration given to a POM-V to POM-VPS switch for the following products: Toxovax Enzovax Mydiavac Scabivax Forte On the issue of diagnosis, most farmers are repeat users of these vaccines and have a risk or problem on the farm. We believe there are about 10% “new users” in any one year and a diagnosis can easily be obtained by either the farmer, the veterinary surgeon or independently. Although these are live vaccines, the veterinarian is not required to administer them personally and pharmacists are able to give advice on operators’ safety. We are of the view that SQPs are competent to do the same. Additionally, the majority of farmers are repeat users and are well aware of the safeguards to be observed. Maintenance of the cool chain from manufacturer to farm is now a matter of industry-wide action. All of these vaccines are now distributed via the wholesale network so all routes to market, vet, pharmacy and merchant are sound in this respect. We can see no valid reason why these vaccines should not now be reclassified to POM-VPS. Rabbit Vaccines We agree with the two vaccines in this group remaining POM-V Poultry Vaccines We agree with the categories proposed here and note the proposal to reclassify chick anaemia and coccidial vaccines to POM-VPS. This is a specialised area currently under the control of a few large poultry processors and the classification. Fish Vaccines Fish breeding is a highly specialised area and the vast majority of vaccines are administered by specialised teams to anaesthetised fish in large numbers. Although, in the main, they are oil based products we have no reason to disagree with the proposed moves from POM-V to POMVPS since advice in safe handling can be given by vets, pharmacists or SQPs. Their use appears to be routine by trained operators and supply is usually made direct from manufacturer to fish farm. For these reasons we think the system of supply is unlikely to change but there is, however, no justification for unnecessary restriction on supply through a POM-V classification. While Norvax Compact PD has efficacy issues remaining we would support the proposal to retain its POM-V classification. We hope these comments will be taken into consideration, and would like to thank the VMD for the opportunity to participate in the consultation. If you have any queries regarding the above, please do not hesitate to contact me. Yours sincerely

Ms Heidi Wright Head of Practice

Mr David Skilton Chairman VPC Veterinary Medicines Directorate Woodham Lane New Haw Addlestone KT15 3LS 18 July 2008

Direct telephone: 020 7572 2409 Facsimile: 020 7572 2501 e-mail:

Dear Mr Skilton In April 2008 I wrote to the VMD in response to the Distribution Category Review – Fourth Consultation. In that response I stated the RPSGB view that valid reasons existed for certain sheep vaccines to be reclassified from POM-V to POM-VPS in addition to those proposed in the consultation document. These additional items were: Toxovax Enzovax Mydiavac Scabivax Forte Recently we were in discussion with AHDA and during this discussion it emerged that the VPC is of the view that such reclassifications should not take place. We are aware that these vaccines are significantly underused in the UK flock at the present time which has implications for animal welfare and is accompanied by an adverse commercial impact on livestock rearers. Improved information and education for farmers is desirable. This is something that can readily be provided by pharmacists and SQPs trained for the purpose. Trained pharmacists and SQPs are currently capable of advising on operator safety and correct use of the products in question and are already handling considerable quantities of other vaccines routinely so the physical route to market is sound. If we are correct in stating that only 10% of “new users” start vaccinating each year most farmers are therefore repeat users at the present time. As we stated in our response in April, for these new users “... a diagnosis can easily be obtained by either the farmer, the veterinary surgeon or independently.”

We would be grateful to know the basis on which the decision to retain the POM-V classification is being made. Yours sincerely

Heidi Wright Head of Practice

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