A new analytic tool developed to assess safe use recommendations.

Abstract

Develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy. We applied the tool in the Sentinel Distributed Database to assess adherence to the labeled recommendation that patients treated with dronedarone undergo electrocardiogram (ECG) testing no less often than every 3months. Measures of length of treatment, time to first ECG, number of ECGs, and time between ECGs were assessed. We also assessed concomitant use of contraception among female users of mycophenolate per label recommendations (concomitancy 4weeks before through 6weeks after discontinuation of mycophenolate). Unadjusted results were stratified by age, month-year, and sex. We identified 21457 new episodes of dronedarone use of greater than or equal to 90days (July 2009 to September 2015); 86% had greater than or equal to one ECG, and 22% met the recommendation of an ECG no less often than every 3months. We identified 21942 new episodes of mycophenolate use among females 12 to 55years (January 2016 to September 2015); 16% had greater than or equal to 1day of concomitant contraception dispensed, 12% had concomitant contraception use for greater than or equal to 50% of the 4weeks before initiation through 6weeks after mycophenolate; younger females had more concomitancy. These results may be underestimates as the analyses are limited to claims data. We developed a tool for use in databases formatted to the Sentinel Common Data Model that can assess adherence to safe use recommendations involving patient monitoring and concomitant drug use over time.