What is an adverse reaction?
A suspected adverse reaction or event is a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or which modifies physiological function. Serious adverse reactions include those which are:
- fatal
- life-threatening
- lesion producing
- disabling
- incapacitating
- permanent or result in prolonged symptoms in the animal treated; or
- human adverse reactions to veterinary medicinal products
Why report a reaction?
While extensive testing is conducted on veterinary medicines before they are authorised, information relating to post marketing experience is very valuable in that certain safety issues may only come to light when the product is in the hands of the intended user and is being used in the field. A well defined safety profile of authorised veterinary products is essential for selecting the right treatment. Therefore, it is important that all suspected adverse reactions or events are brought to the attention of the IMB to enable it to continuously monitor the benefit: risk profile and to introduce labelling improvements as necessary.
If you would like to find out more about the IMBs veterinary pharmacovigilance activities please read the following information leaflet:
Veterinary Pharmacovigilance in Ireland: A Simple Guide to Reporting Adverse Reactions to Veterinary Medicinal Products
Who should report?
Ireland’s Animals Remedies Regulations (S.I. No. 786 of 2007) requires marketing authorisation holders to report all serious suspected adverse reactions to the IMB at the earliest opportunity and not later than 15 days following receipt of the information. In addition, the holder of an animal remedies wholesaler’s licence, an animal remedies merchant’s licence or a person registered under Regulation 33, a registered veterinary practitioner or a pharmacist is required to report suspected serious or unexpected adverse reactions or human adverse reaction to the IMB or the marketing authorisation holder within 15 days of receipt of such information.
Members of the public are also encouraged to report to the IMB.
When the source of a report is other than a health care professional, the advice of a veterinary surgeon should be sought before reporting to ensure that the information provided is accurate and comprehensive.
How does the IMB deal with reports?
When a report of a suspected adverse reaction is received by the IMB directly from a veterinarian, other health care professional or animal owner, the marketing authorisation holder of the product is notified and may be asked to provide additional information that is necessary for the IMB to conclude its assessment. All information in the report is treated in the strictest of confidence and any individual’s personal data, such as the name and address of the reporter, is not disclosed. Suspected reactions reported directly to the marketing authorisation holder are subsequently reported to the IMB.
The IMB maintains a record of each adverse reaction report in a database. The information is reviewed and on the basis of the information presented an assessment of the likely causal relationship between the administration of the suspected product(s) and the reaction(s) reported is made. Should a pattern of adverse reactions involving a specific product emerge, regulatory action may be taken which may include:
- 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 form the market; or
- revoking the marketing-authorisation for the product
The aim of each assessment is to protect both human and animal health.
How to report a reaction to the IMB
- Report a suspected adverse reaction directly by filling in the online form.
- A downloadable version of the form is also available, which can be filled in manually and sent to the IMB by e-mail to imbvetadr@imb.ie or by freepost to the address below.
‘FREEPOST’
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Members of the public, such as pet owners and farmers, can also report a suspected reaction using the forms above. Alternatively, details can be passed to the vet or the pharmacist who supplied the product who can then notify the IMB.
If you require any further information about reporting an adverse reaction to a veterinary medicine you can also contact the IMB’s Veterinary Medicines Department on (01) 676 4971 or by emailing imbvetadr@imb.ie.