How We Monitor Safety
The HPRA monitors the safety of veterinary medicines by recording and assessing reports of adverse events (a process known as pharmacovigilance).
An adverse event is any observation that is unfavourable and unintended and that occurs after the use of a veterinary medicine. We receive adverse event reports from marketing authorisation holders, veterinarians and animal owners.
Adverse event reports may relate to one of the following:
• adverse reactions in the treated animal following recommended use of the product;
• adverse reactions in the treated animal following off-label use;
• lack of expected efficacy reports (the product not working as intended);
• effects in humans following exposure to a veterinary medicine;
• violations of residue limits;
• impact on the environment;
How does the HPRA deal with reports?
We record each adverse event report in our database. An assessment is made of the likely causal relationship between the administration of the suspected product(s) and the reported event(s). The report is then uploaded to a European central database. If a report is received from a veterinarian, other health care professional or animal owner, the marketing authorisation holder of the product is notified. All information in the report is treated in the strictest of confidence and we do not publicly disclose an individual’s personal data, such as the name and address of the reporter. However, unless we are given the liberty to discuss the details of the report with the company concerned, it is not possible to investigate it fully with the company concerned.
The database of adverse reactions is regularly monitored and should a trend of adverse reactions involving a specific product emerge, regulatory action may be taken in order to protect human and/or animal health. Such action could include:
• enhanced monitoring of the medicine in question;
• labelling changes such as new safety warnings, contraindications or human safety information;
• product recall of a particular batch of product;
• suspending the sale and supply of the product from the market; or
• revoking the marketing-authorisation for the product concerned.