Abstract
BackgroundThe electronic surveillance for adverse drug events is largely based upon the analysis of coded data from reporting systems. Yet, the vast majority of electronic health data lies embedded within the free text of clinical notes and is not gathered into centralized repositories. With the increasing access to large volumes of electronic medical data—in particular the clinical notes—it may be possible to computationally encode and to test drug safety signals in an active manner.ResultsWe describe the application of simple annotation tools on clinical text and the mining of the resulting annotations to compute the risk of getting a myocardial infarction for patients with rheumatoid arthritis that take Vioxx. Our analysis clearly reveals elevated risks for myocardial infarction in rheumatoid arthritis patients taking Vioxx (odds ratio 2.06) before 2005.ConclusionsOur results show that it is possible to apply annotation analysis methods for testing hypotheses about drug safety using electronic medical records.
Highlights
The electronic surveillance for adverse drug events is largely based upon the analysis of coded data from reporting systems
Graham et al showed that patients having rheumatoid arthritis (RA) who took Vioxx showed significantly elevated risk for myocardial infarction (MI), which resulted in the drug being taken off the market in 2004 [3]
We identify patients in the electronic health record (EHR) who have the given condition (RA), who are taking the drug, and who suffer the adverse event (Figure 1) by using automated annotation analysis
Summary
The electronic surveillance for adverse drug events is largely based upon the analysis of coded data from reporting systems. With the increasing access to large volumes of electronic medical data—in particular the clinical notes—it may be possible to computationally encode and to test drug safety signals in an active manner. In 2004, Vioxx (rofecoxib) was taken off the market because of the increased risk of heart attack and stroke in patients who were taking the drug as a treatment for rheumatoid arthritis (RA) [3]. This case in particular generated public outcry and an appeal for better adverse drug event (ADE) detection mechanisms largely because Vioxx was on the market for four years despite murmurings of its side effects.
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