Spontaneous Reporting Systems: Achieving Less Spontaneity and More Reporting

Abstract

The purpose of this article is to highlight and analyze possible improvements to spontaneous reporting systems, in particular, and drug safety, in general. Part I of this article will provide a background on adverse drug reactions and spontaneous reporting systems, with particular emphasis on the MedWatch reporting system currently used in the United States. Part II will discuss physician attitudinal studies performed worldwide that have attempted to highlight the reasons for the underreporting of adverse reactions and problems with reporting systems. Part III will analyze problems identified with spontaneous reporting systems and potential improvements of them.