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The authors say that whilst it has long been suspected that adverse drug reactions are under-reported, this study is the first to show the scale of the problem, using real data from veterinary clinical records.
For the study, researchers looked for electronic heath records within the Small Animal Veterinary Surveillance Network (SAVSNET) which contained “adverse drug reactions” and “side effects” in the free-text clinical narratives.
The results were then analysed to determine the suspected product, the seriousness and expectedness of the event, and whether the event had been reported to the Veterinary Medicines Directorate or Marketing Authorisation Holders.
Of the 827 cases of suspected adverse drug reactions identified out of a total of 10,565 records reviewed, approximately 90% were not reported.
74% were related to dogs and 70% were listed as “expected” (i.e. already listed in the product information).
The clinical severity of the reaction didn’t appear to impact whether it was reported.
Dr Heather Davies, lead author of the study, said: “As adverse drug reaction reporting rate is directly linked to the regulators ability to mitigate safety issues, this paper is a call to arms encouraging all veterinary professionals to report suspected adverse drug reactions and regulators to make reporting quicker and easier.
"It also the highlights the promise that big real-world data sets hold in enhancing drug safety monitoring processes.”
https://onlinelibrary.wiley.com/doi/full/10.1111/jsap.13721