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- Title
Active Safety Monitoring of Newly Marketed Medications in a Distributed Data Network: Application of a Semi-Automated Monitoring System.
- Authors
Gagne, J J; Glynn, R J; Rassen, J A; Walker, A M; Daniel, G W; Sridhar, G; Schneeweiss, S
- 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 health-care data. In a retrospective analysis, we show 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). Over >5 years of monitoring, rate differences (RDs) in comparisons of rosuvastatin with atorvastatin were −0.1 cases of rhabdomyolysis per 1,000 person-years (95% confidence interval (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 with 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 the three drug-outcome pairs.
- Subjects
DRUG monitoring; ELECTRONIC health records; COHORT analysis; RETROSPECTIVE studies; CONFIDENCE intervals; RHABDOMYOLYSIS
- Publication
Clinical Pharmacology & Therapeutics, 2012, Vol 92, Issue 1, p80
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/clpt.2011.369