Journal Article

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

Brajovic S, Piazza-Hepp T, Swartz L, et al. Pharmacoepidemiology and drug safety. 2012;21:565-70; discussion 571-2.

The Food and Drug Administration is piloting a new system that allows triggered reporting of suspected adverse drug events, with data automatically supplied from existing electronic medical record systems. This study evaluates the quality of such reports and identifies areas where the reports could be improved.