Automating Surveillance for the Analysis of Adverse Event Case Reports
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Drug Infomarion Journal. Vol. 31. pp. 825-832. 1997 Rinted in the USA. All righu r t ~ e ~ c d .
AUTOMATING SURVEILLANCE FOR THE ANALYSIS OF ADVERSE EVENT CASE REPORTS LIONEL0. BENSON,MD, MPH Executive Director, Clinical Operations & Product Safety
LINDAMARC,MPH Epidemiologist, Product Safety & Epidemiology Astra Merck Inc., Wayne, Pennsylvania
The traditional method of manually reviewing large numbers of adverse event reports is not conducive to eficiently 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 pelform the preliminary scrutiny of enormous quantities of information by evaluating the unique contents of each case report and quantibing 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 eficient use of limited resources. Key Words: Adverse event; Surveillance; Computer assisted surveillance
INTRODUCTION
THE MAIN PURPOSE of adverse event (AE) surveillance is to detect changes in trends or distribution in order to initiate investigative or control methods (1). A surveillance system should use methods that are practicable, uniform, and rapid. Distinct from complying with applicable laws, regulations, and guidelines on AE reporting, surveillance enables diligent monitoring of a product’s safety profile. The traditional method of manually re-
Reprint address: Lionel 0. Benson, MD. MPH, Executive Director, Clinical Operations & Product Safety, Astra Merck Inc., 725 Chesterbmk Boulevard, Wayne, PA 19087.
viewing large numbers of AE reports is not conducive to the rapid evaluation of a drug’s safety profile. Limited resources are generally available to perform labeling reviews, to answer inquiries from regulatory agencies and health care professionals, and to adequately prioritize adverse events for routine surveillance. In order to contribute to the AE evaluation process conducted by an expert reviewer, a computerized system was developed to rapidly identify drugs and medical conditions known to be associated with the disease under review.
AUTOMATING SURVEILLANCE “Is the drug (suspect drug) a possible cause of the AE?’ is a frequently asked question.
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Lionel 0. Benson and Linda Marc
In evaluating case reports to determine the relationship between a suspect drug and an AE, the expert reviewer is required to identify other preexisting medical conditions and concomitant medications known to be associated with the adverse event in question. This remains a very
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