Pharmacovigilance: a science or fielding emergencies?

Pharmacovigilance involves the assessment of risks and benefits of medicine s. There are legal and regulatory aspects of this process, and the licensin g of a new medicine is always provisional. The systems, in the past, have h ad limited statistical involvement, either in terms of personnel who are st atistically trained, or in terms of statistical methods. This is changing. The high profile activities of pharmacovigilance have often been emergencie s, though most is routine activity. Application of statistical thinking and of techniques is being done to help detect adverse effects of medicines ra ther earlier so that some emergencies may be avoided. Copyright (C) 2000 Jo hn Wiley & Sons, Ltd.