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SARSS |
Alternative Veterinary Medicine Centre |
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SARSS - The Suspect Adverse Reaction Surveillance SchemeWhat is it?This is the scheme through which all 'suspect adverse reactions' to drugs (and other medicines) should be reported. The Veterinary Medicines Directorate, at New Haw, Weybridge, Surrey KT15 3LS (tel: 01932 336911; fax: 01932 336618; e-mail: postmaster@vmd.defra.gsi.gov.uk ; web: www.vmd.gov.uk ) will supply yellow forms MLA 252A, on which the report can be made. When reports are submitted, the information is analysed to see if there is any significant trend. Clearly, a good number of reports are necessary to create a valid collection of data. This scheme is the mainstay of UK medicines safety and efficacy surveillance. Does it work? Computers await all this information but, sadly, a negligible proportion of 'suspect adverse reactions' is ever reported. There are several reasons for this. One is good old British apathy. Another is that the reaction may be written off to some other cause. Another is that reactions are often reported to the pharmaceutical industry, who do not pass on the information to the VMD. There are even cases in which a vet will ignore the possibility that certain problems may have arisen from the use of a drug, thus resulting in censorship at source! It is now also possible for clients to obtain the forms (or download them) and make the reports themselves: http://www.defra.gov.uk/corporate/regulat/forms/vetmed/mla252a.pdf What constitutes a suspect adverse reaction? For a problem to be eligible for reporting, there only has to be a suspicion that it may have been an adverse drug reaction (adverse drug event - ADE). It does not need to be proven to be an adverse reaction. A coincidence of timing, soon after drug administration is enough to warrant that suspicion. It is the job of appropriate computer software and professionals to sift the information sent, to see if it is of importance in relation to drug safety. It is not the job of the vet or client in the field, to 'filter' information of this kind. I have even heard expert witnesses, in court, stating that they do not fill out the forms, "because the reactions are already known"! As a result of this unjustifiable attitude, the extent of a potential problem remains hidden. If information is not sent, potentially dangerous effects of drugs may not come to light or enlightenment may be dangerously delayed. For the good of animals, everyone should do his or her bit for animal safety and welfare, by reporting anything suspicious. A SARSS event is also a failure of a medicine to be effective for its stated indication. http://www.vmd.gov.uk/Publications/SARSS/sarss.pdf http://www.vmd.gov.uk/General/Adverse/animal2.pdf http://www.defra.gov.uk/corporate/regulat/forms/vetmed/mla252a.pdf
See also: Side Effects - Iatrogenic Disease - Evidence-Based Medicine Copyright © AVMC March 2007 SARSS - ADE - Adverse Drug Event - drug surveillance - side effect - side effects - side-effects - side-effect - drug side-effect - drug side effect - VMD - Veterinary Medicines Directorate - suspect adverse reaction - MLA252A - New Haw - Weybridge |
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