Pharmacovigilance in perspective.

Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information needed for the evaluation of the benefits and risks of drugs is in the first place a scientific challenge. In addition, there are important ethical, logistical, legal, financial and commercial constraints. Good pharmacovigilance practice needs to be developed to ensure that data are collected and used in the right way and for the right purpose. Pharmacovigilance, and more generally the study of the benefits and risks of drugs, plays a major role in pharmacotherapeutic decision-making, be it individual, regional, national or international. In addition, pharmacovigilance is becoming a scientific discipline in its own right. A variety of changes are taking place in the complex system of drug development, regulation and distribution. Pharmacovigilance should be proactive in monitoring their possible consequences.