Veterinary pharmacovigilance in the European context.

ABSTRACT

Pharmacovigilance (or pharmaco-surveillance) is the surveillance of adverse drug reactions (ADRs) which are noxious and of unintended reactions which occur at doses normally used in animals in accordance with the terms of the marketing authorization. From this definition, the scope of veterinary pharmacovigilance should be clearly defined, especially with regard to associated problems of lack of efficacy, resistance, effects in man, residues, etc. Priorities should be established concerning adverse effects in animals in order to set up an operational system. Methodological tools are being developed such as causality assessment, thesaurus, data banks, alert systems. The situation of veterinary pharmacovigilance in countries is very different. The existing systems are based on two different conceptions a pharmacovigilance of the administrative type, made by authorities; a pharmacovigilace of the interactive type, made in veterinary universities, linked with the authorities. In industry, the importance of pharmacovigilance is increasing; collaborations have been set up but should certainly be developed. Finally, the sensitization of the veterinary practitioners, which play a key-role in the system of spontaneous reporting of ADRs, is to be developed in many ways interaction during or after the report, publication of data, concrete actions, improvement of side-effect warnings and prevention, etc. Veterinary pharmacovigilance should be a very interesting area of cooperation between the field, universities, industry and regulation authorities.