Automating Surveillance for the Analysis of Adverse Event Case Reports

The traditional method of manually reviewing large numbers of adverse event reports is not conducive to efficiently maintaining an up-to-date safety profile of a drug or to rapidly responding to inquiries on adverse events. The development of a computerized system was undertaken to perform the preliminary scrutiny of enormous quantities of information by evaluating the unique contents of each case report and quantifying the results. This paper will focus on how a computerized surveillance system identifies, in a patient’s record, concomitant drugs and preexisting medical conditions known to be associated with the adverse event under surveillance. The automated capability is not meant to replace the function of the expert medical reviewer but to assist in rapidly drawing attention to case reports that require further skilled review. Automating surveillance can improve the quality of AE review and also allow more efficient use of limited resources.