Mining multi-item drug adverse effect associations in spontaneous reporting systems

BMC Bioinformatics

Proceedings

Carol Friedman¹  Herbert S Chase¹  Rave Harpaz¹ 

[1] Department of Biomedical Informatics, Columbia University, 622 West 168th St., VC5, 10032, New York, NY, USA;

关键词: Association Rule;    Adverse Drug Event;    Association Rule Mining;    Adverse Event Reporting System;    Spontaneous Reporting System;   

DOI  :  10.1186/1471-2105-11-S9-S7

来源: Springer

【 摘 要 】

BackgroundMulti-item adverse drug event (ADE) associations are associations relating multiple drugs to possibly multiple adverse events. The current standard in pharmacovigilance is bivariate association analysis, where each single drug-adverse effect combination is studied separately. The importance and difficulty in the detection of multi-item ADE associations was noted in several prominent pharmacovigilance studies. In this paper we examine the application of a well established data mining method known as association rule mining, which we tailored to the above problem, and demonstrate its value. The method was applied to the FDAs spontaneous adverse event reporting system (AERS) with minimal restrictions and expectations on its output, an experiment that has not been previously done on the scale and generality proposed in this work.ResultsBased on a set of 162,744 reports of suspected ADEs reported to AERS and published in the year 2008, our method identified 1167 multi-item ADE associations. A taxonomy that characterizes the associations was developed based on a representative sample. A significant number (67% of the total) of potential multi-item ADE associations identified were characterized and clinically validated by a domain expert as previously recognized ADE associations. Several potentially novel ADEs were also identified. A smaller proportion (4%) of associations were characterized and validated as known drug-drug interactions.ConclusionsOur findings demonstrate that multi-item ADEs are present and can be extracted from the FDA’s adverse effect reporting system using our methodology, suggesting that our method is a valid approach for the initial identification of multi-item ADEs. The study also revealed several limitations and challenges that can be attributed to both the method and quality of data.

【 授权许可】

CC BY   
© Harpaz et al; licensee BioMed Central Ltd. 2010