What is SARSS – Suspected Adverse Reaction Surveillance Scheme?

What is it?

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This is the scheme through which all ‘suspected adverse reactions‘ (side effects etc.) to drugs (and other medicines) should be reported. The Veterinary Medicines Directorate, at New Haw, Weybridge, Surrey,  (web: www.vmd.defra.gov.uk) will supply yellow forms MLA 252A, on which the report can be made. When reports are submitted, the information is analyzed to see if there is any significant trend. Clearly, a good number of reports is 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 ‘suspected 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! This practice is, at best, unprofessional.

It is now also possible for clients to make their own reports. Of course, the veterinary surgeon involved and the drug company will both be informed of the report.

http://www.vmd.defra.gov.uk/adversereactionreporting/

To obtain the forms (or download them) and make the report yourself, there is a link toward the bottom of that web page.

Interestingly, at the time of writing this note (August 2009), if you were to put into Google: VMD SARSS, our web site (this web page) comes up second to that of the VMD – this shows the level of competition we ‘suffer’ worldwide in bringing this scheme to the notice of the public! (When I did this again in February 2012, we were top in Google Search!)

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 (ADR or 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 serious or 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 deemed to have taken place in the event of a failure of a medicine to be effective for its stated indication.

See also: Side EffectsIatrogenic DiseaseEvidence-Based Medicine