Discovery of new adverse drug reactions. A review of the Food and Drug Administration's spontaneous reporting system
A. C. Rossi and D. E. Knapp
Recently, several studies of spontaneous reporting systems (SRSs) have
reported on the published literature's role in producing first reports of
new adverse drug reactions. In order to provide further information on
other components of SRS, the Food and Drug Administration's SRS was
examined with regard to its effectiveness and efficiency in identifying new
adverse drug reactions and the form, consistency, and timeliness of its
communication of new adverse drug reactions to the medical community. While
there was evidence that the literature was more effective in producing
first reports of new adverse drug reactions for the years compared, there
was reason to conclude that FDA's SRS was capable of making a contribution
to the alerting process. Moreover, direct participation by practitioners in
FDA's SRS was found to be the most efficiently obtained FDA source of new
adverse drug reaction reports.
