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

Clinical Pharmacology and Therapeutics
Joshua J GagneSebastian Schneeweiss

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.

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Citations

Nov 1, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Joshua J GagneNiteesh K Choudhry
Feb 11, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Joshua J GagneSebastian Schneeweiss
Dec 3, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·John D SeegerSebastian Schneeweiss
Aug 8, 2013·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Amanda R PatrickSebastian Schneeweiss
Jul 15, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ying LiCarol Friedman
Nov 26, 2015·Pharmacoepidemiology and Drug Safety·Grace WanggeJoshua J Gagne
Aug 15, 2018·Clinical Pharmacology and Therapeutics·Shirley V WangMehdi Najafzadeh
Feb 16, 2019·Circulation. Cardiovascular Quality and Outcomes·Sebastian SchneeweissKrista F Huybrechts
May 1, 2019·Journal of Thrombosis and Haemostasis : JTH·Chandrasekar GopalakrishnanKrista F Huybrechts
Jan 9, 2013·Pharmacoepidemiology and Drug Safety·Christina DeFilippo MackTil Stürmer
May 3, 2014·Pharmacoepidemiology and Drug Safety·Joshua J GagneSebastian Schneeweiss
Apr 4, 2020·Statistics in Medicine·Laine E ThomasDouglas E Schaubel
Mar 28, 2013·Journal of Clinical Pharmacy and Therapeutics·K SaiY Saito
Apr 11, 2013·Clinical Pharmacology and Therapeutics·P LePenduN H Shah
Jul 31, 2014·Epidemiology·Shirley V WangJeremy A Rassen
Dec 23, 2015·Clinical Pharmacology and Therapeutics·S V WangD B Bartels
May 22, 2013·Clinical Pharmacology and Therapeutics·P K Honig
Sep 10, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Mia AakjærMorten Andersen

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