The Veterinary Medicines Directorate (VMD) has launched a new digital service for reporting adverse events associated with animal medicines, making it easier for veterinary professionals and animal owners to submit reports directly to the regulator.
The service replaces the VMD’s previous reporting tool and introduces improved guidance to help users submit higher-quality reports from the outset.
What is an adverse event?
Adverse effects, or adverse events as they are more widely described in veterinary pharmacovigilance, are observations that are unfavourable and unintended that happen 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; and
- an environment impact, for example, contamination.
What is the new adverse event reporting service?
The new adverse event reporting service allows veterinary professionals, 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.
You can also report reactions that occur in humans handling animal medicines, or reactions that occur after an animal has been exposed to a human medicine. For a full list of what you can and cannot report, click here.
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 made
The service has been designed with users in mind, whether that be pet owners or animal health professionals. It includes additional user-focused guidance to support the completion of high-quality reports, helping to ensure the VMD receives the most complete and useful information possible.
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.
Your feedback matters
The service has been tested with a small group of vets and animal owners, and VMD has 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.
The service is launching as a beta version. VMD is 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.
Why reporting adverse events matters
Adverse event reporting is a vital part of how the VMD monitors the safety of animal medicines once they are in use. Every report submitted, however minor it may seem, contributes to a fuller picture of how medicines are performing in practice, and helps the VMD and pharmaceutical companies identify and respond to potential safety concerns.
VMD’s deputy chief executive 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.”
