Keynote Address: International Adverse Reaction Surveillance

Abstract

Much progress is being made in international adverse drug reaction surveillance. International communication has increased with the increasing number of international conferences. A consensus on the rationale and needs for post-marketing surveillance is developing around two types of information sources—formal phase IV studies and the important spontaneous adverse reaction reports. The United States is working actively to improve its system, and on the horizon are many electronic innovations for handling, processing, and using spontaneous reports. This is a high priority for the FDA. Recognition of the controversial aspects of adverse reactions is important. Finally, activities in the United States and worldwide are linked cooperatively with the World Health Organization, which can serve to facilitate the growing needs for effective communications in this important area.