Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system

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Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system

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Title: Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system
Author: Gagne, Joshua J.; Glynn, Robert J.; Rassen, Jeremy A.; Walker, Alexander M.; Daniel, Gregory W.; Sridhar, Gayathri; Schneeweiss, Sebastian

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Citation: Gagne, Joshua J., Robert J. Glynn, Jeremy A. Rassen, Alexander M. Walker, Gregory W. Daniel, Gayathri Sridhar, and Sebastian Schneeweiss. 2014. “Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system.” Clinical pharmacology and therapeutics 92 (1): 80-86. doi:10.1038/clpt.2011.369. http://dx.doi.org/10.1038/clpt.2011.369.
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Abstract: We developed a semi-automated active monitoring system that uses sequential matched-cohort analyses to assess drug safety across a distributed network of longitudinal electronic healthcare data. In a retrospective analysis, we showed that the system would have identified cerivastatin-induced rhabdomyolysis. In this study, we evaluated whether the system would generate alerts for three drug-outcome pairs: rosuvastatin and rhabdomyolysis (known null association), rosuvastatin and diabetes mellitus, and telithromycin and hepatotoxicity (two examples for which alerting would be questionable). During >5 years of monitoring, rate differences (RDs) comparing rosuvastatin to atorvastatin were -0.1 cases of rhabdomyolysis per 1,000 person-years (95% CI, -0.4, 0.1) and -2.2 diabetes cases per 1,000 person-years (95% CI, -6.0, 1.6). The RD for hepatotoxicity comparing telithromycin to azithromycin was 0.3 cases per 1,000 person-years (95% CI, -0.5, 1.0). In a setting in which false positivity is a major concern, the system did not generate alerts for three drug-outcome pairs.
Published Version: doi:10.1038/clpt.2011.369
Other Sources: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3947906/pdf/
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:12064371
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