On 8 April, on the occasion of Veterinary Medicine Safety Day, a series of new tools to support and encourage the reporting of adverse events was released by the FVE and the European Medicines Agency (EMA). The tools include a dedicated website for veterinary professionals, a simple guide How to report adverse events? as well as a more detailed presentation Adverse event reporting in the EU.
According to the FVE, ‘veterinary pharmacovigilance plays a vital role in protecting animal health and welfare, public health, and the environment, ensuring that the benefits of veterinary medicines continue to outweigh their risks.’ It hopes that the resources ‘encourage the reporting of any suspected adverse event in animals after using veterinary medicines, including off-label use or when a treatment or vaccine fails—even if the issue is already mentioned in the product information.’
The FVE recalls that adverse events also include people exposed to veterinary medicines or treated animals, environmental incidents, high residues in food products, and suspected transmission of infectious agents.
Reports can be submitted either to the national competent authority or to the company responsible for the medicine. Anyone can report, and it is not necessary to confirm a direct link between the event and the medicine before doing so.
‘Every report contributes to EU-wide safety monitoring,’ stresses the FVE, adding that the data collected enables authorities ‘to take action when needed, such as updating warnings or, in rare cases, suspending or withdrawing a medicine.’