Pharmacovigilance

What can you expect and what is expected from you?

Pharmacovigilance (or monitoring of the safety of pharmaceuticals) is a very important, but still a relatively unknown part of the authorisation process of (veterinary) medicines. Pharmacovigilance (PV) is the collective effort of government, industry, veterinarians and (end) users, to evaluate the safety and efficacy of veterinary medicines in practice. The acquired knowledge is used for product information and product availability in order to optimize animal health, animal welfare and public health.

Veterinary PV focuses on the monitoring of the safety of all kinds of veterinary medicines, from the moment of registration and the introduction on the market. Since November 2005, prolongation of marketing authorisations is made completely dependent of a well-functioning and well-described PV system of the Marketing Authorisation Holders. European authorities nowadays can withdraw a marketing authorisation when, for example, adverse reactions were not reported adequately.

Veterinary PV focuses on:

• Undesired effects in animals (side-effects);
• Lack of expected efficacy (e.g. development of resistance);
• Off label use (effects and side effects, after use in other than authorised dosage, animal species or route of administration, or in unauthorised combination with other medicines);
• Human reactions caused by exposure to a veterinary medicine;
• Potential environmental risks;
• Validity of established withdrawal periods (residue issues).

Especially veterinary practitioners, but also other professionals in the animal health sector, will be in the position to notice adverse events and are able to supply quality reports. Many veterinarians are still unaware of the importance of such reports. PV aims at a continuous increase of knowledge of al the possible and impossible applications of veterinary medicines in practice (also after off label use), without judging the accuracy of the application of the product or the lack of skills of the reporter. Reports of (known) side effects are also still important, since we have to monitor the incidence. There is limited practical knowledge on a product when it first comes onto the market. Through PV we want to increase that knowledge by means of open communication with veterinarians and other users in order to be able to guarantee safety of veterinary medicines in practice.

To answer the many different questions from practitioners, we also depend parting many ways on the practical experience and knowledge that our clients share with us. So keep on calling, writing or e-mailing us with your questions, new experiences and remarks!