EudraVigilance Veterinary - Frequently Asked Questions

What Is Pharmacovigilance?
It is the process of monitoring, evaluating and improving the safety of medicines in use. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Healthcare professionals (e.g. Veterinarians) have a role too, in reporting suspected side effects of medicines to government agencies or pharmaceutical companies.

What is a side effect?
This is an unwanted response to a medicine. It may rarely be a positive experience but it is usually negative. It may manifest as symptoms (e.g. headache, nausea) or as an illness (liver or kidney problems). These are also called ‘adverse drug reactions’ or ‘adverse reactions’.

How common are side effects ?
Adverse reactions can occur with any medicine. Known adverse Reactions related to the administration of a particular medicine are clearly listed in the information to prescribers (the Summary of Product Characteristics (SPC)) and in the package leaflet available to the patient.
Side effects can vary from patient to patient. Many patients will get no side effects whatsoever. Even when they do happen, in most situations the benefit of the medicine to that individual patient can still maintain a positive balance. If side effects become troublesome, however, you must promptly inform a veterinarian or in case a human being is involved a doctor.

What is a serious adverse reaction ?
A serious adverse reaction is an adverse reaction which results in death, is life threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated. Reactions in humans related to the use of veterinary medicines are treated as serious with regard to the reporting requirements.

What should one do in case of serious reactions?
It can be very difficult to determine cause and effect of a drug and a serious reaction. The Veterinarian who is familiar with the medical history of the patient is best placed to make an assessment. If a side effect is possibly related to the medicine, the Veterinarian or Healthcare Professional should report to the government authorities and/or to the pharmaceutical company concerned. For European veterinary medicines, the European Medicines Agency collects all such reports within a central database called EudraVigilance Veterinary.

Frequently asked questions, and common errors in data entry can be found here