The Veterinary Medicines Directorate (VMD) has launched a new digital service for reporting adverse events associated with animal medicines that it said will make it easier for veterinary professionals and animal owners to submit reports directly to the regulator.
The service, which goes live today, replaces the VMD’s previous reporting tool and introduces improved guidance to help users submit higher-quality reports from the outset.
Adverse effects, or adverse events as they are more widely described, are observations that are unfavourable and unintended, occurring after giving a medicine to an animal or after an animal or human are exposed to a medicine.
Adverse events might include:
- an unexpected side effect such as vomiting or a skin reaction
- a medicine not working as well as expected
- a risk to a person handling a medicine
- an environment impact, for example, contamination.
The new reporting service
The new adverse event reporting service allows veterinary professionals, Suitably Qualified Persons (SQPs), and animal owners to report directly to the VMD any unexpected or harmful reactions in animals following the use of an animal medicine, as well as cases where a medicine does not appear to work as expected.
Reactions that occur in humans handling animal medicines, or after an animal has been exposed to a human medicine can also be reported. A full list of what can and cannot be reported is available on the reporting page.
You do not need to prove a causal link between a medicine and an adverse event before reporting – this is investigated as part of the VMD’s assessment.
Improvements
The service has been designed with users in mind. It includes additional user-focused guidance to support the completion of high-quality reports to ensure the ‘most complete and useful information possible’ is reported.
The service will also integrate with the VMD’s existing pharmacovigilance processes, supporting more efficient and comprehensive safety oversight of veterinary medicines across the UK. It utilises a more modern, resilient, and maintainable platform, minimising the risk of disruptions to the service.
The service has been tested with a small group of vets and animal owners, and we have already made several improvements based on user feedback. Overall, ‘high levels of satisfaction’ were reported across the pilot group, with users reporting that the platform was simple and easy to use, VMD said.
“We are actively encouraging users to share their experience of the new service, and we will use this feedback to make further improvements. A feedback function is built into the service for this purpose,” VMD said.
VMD’s deputy chief executive officer and director for authorisations, Gavin Hall said: “The launch of our new adverse event reporting service marks a significant step forward in how we gather and use safety data for animal medicines. Better reporting leads to better oversight, and ultimately better outcomes for animal health and welfare.
“We encourage anyone who observes problems with an animal medicine, whether that be a side effect in an animal, accidental exposure or injury to a human, or environmental contamination to report it, and we’ve now made it easier than ever to do so.”
Other ways to report
Reporting directly to the VMD is not the only option. Animal owners and veterinary professionals can also report adverse events directly to the company responsible for the medicine, also known as the Marketing Authorisation Holder (MAH). MAHs have a legal responsibility to pass these reports to the VMD within 30 days.
You only need to report once, either to the VMD or the MAH. Reporting to both may create duplicate reports which affects the efficiency of our data handling or the quality of the data we hold.
The VMD has also published updated guidance on pharmacovigilance for animal health professionals and animal owners, including information on: