Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system
Daniel, Gregory W.
MetadataShow full item record
CitationGagne, 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.
AbstractWe 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.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:12064371