Veterinary Pharmacovigilance in the UK
This article is about Veterinary Medicines. For Human Medicines, see the Yellow Card Scheme.
The Veterinary Pharmacovigilance Unit (formerly known as the Suspect Adverse Reaction Surveillance Scheme) of the Veterinary Medicines Directorate (VMD) operates a system similar to the Human Yellow Card Scheme. It is used in the UK to gather information on Suspected Adverse Events (SAEs) to veterinary medicines (in animals and humans) including suspected lack of expected efficacy, environmental problems, residues in foodstuffs and other aspects of veterinary pharmacovigilance. SAEs can be reported by anyone including animal owners, but veterinary surgeons report most frequently. Marketing authorisation holders are legally obliged to inform the VMD of any adverse events which are reported to them.
The following must be reported by marketing authorisation holders within 15 days:
- Serious SAEs (suspected adverse events that result in death, are life-threatening, results in significant disability or incapacity, are a congenital anomaly/birth defect, or that results in permanent or prolonged signs in the animals treated)
- Human adverse reactions (a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine)
- unintended transmission of an infectious agent through a veterinary medicinal product
All other adverse events must be reported in a Periodic Safety Update Report. All SAEs (to animals and humans) should be reported by veterinary surgeons as this is considered good professional conduct (RCVS Guide to Professional Conduct).
Reporters can submit reports online at https://www.gov.uk/report-veterinary-medicine-problem. Hard copies of the reporting forms can also be requested from the VMD or downloaded and printed from the website animal reporting form or human reporting form
The reports are monitored and analysed by the Pharmacovigilance team of the VMD, who make reports to the Veterinary Products Committee. Where the Secretary of State for Environment, Food and Rural Affairs considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a contraindication, or add a new precautionary measure.