An adverse event is any observation in animals or humans, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any extralabel use) of a product, including events related to a suspected lack of expected effectiveness. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis. The AVMA encourages continued development and strengthening of adverse event reporting systems.
Veterinary pharmacovigilance is the detection and investigation of the effects of the use of veterinary products, mainly aimed at safety and effectiveness in animals and safety in people exposed to the products. The FDA Center for Veterinary Medicine, USDA Center for Veterinary Biologics, and the EPA maintain pharmacovigilance programs. The manufacturers of legally marketed veterinary products are required to report all adverse events of which they are aware to the regulatory authority. AVMA encourages veterinarians to report adverse events.
Pharmacovigilance programs should collect reports of all product-associated adverse events, including any perceived failures in safety and/or efficacy. Reporting systems should be user friendly and readily available to facilitate adverse event reporting by veterinary practitioners. Reports should follow a standardized, systematic template. Any compilation or interpretation of reports should be provided in a form that is useful to firms and clinically relevant for veterinarians.