Introduction

Professor David H. Lawson of Scotland reports on international progress in pharmacoepidemiology, but reminds that the large automated data bases powerful enough to generate important signals or confirm signals from spontaneous voluntary monitoring exist primarily in North America. The Grahame-Smith Working Party in the United Kingdom has issued a clear call for structured postmarketing surveillance of new chemical entities, particularly those that will be widely used. Dr. Robert C. Nelson from the US Food and Drug Administration adds specific, powerful examples of applications of data from multiple sources, including the spontaneous voluntary adverse reaction reporting system and its unique and powerful contribution as a signal generator. Dr. Roger M. Sachs combines the skills and training of a physician and an attorney and directs them into the perspective of a user of the tools of pharmacoepidemiology. His report reflects his experience in public policy debate about the issue of the relative safety of various nonsteroidal antiinflammatory drugs.