Pharmacovigilance in perspective

Pharmacovigilance is more than spontaneous reporting alone, and the evaluat ion of marketed medicines is more than just pharmacovigilance. The position ing 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 provisi on of the information needed for the evaluation of the benefits and risks o f drugs is in the first place a scientific challenge. In addition, there ar e important ethical, logistical, legal, financial and commercial constraint s. Good pharmacovigilance practice needs to be developed to ensure that dat a are collected and used in the right way and for the right purpose. Pharmacovigilance, and more generally the study of the benefits and risks o f drugs, plays a major role in pharmacotherapeutic decision-making, be it i ndividual, regional, national or international. In addition, pharmacovigila nce is becoming a scientific discipline in its own right. A variety of changes are laking place in the complex system of drug develop ment, regulation and distribution. Pharmacovigilance should be proactive in monitoring their possible consequences.