An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance.
INTRODUCTION: The most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is "drug ineffective" (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports.
METHODS: We characterized all FAERS reports coded with the MedDRA PT "drug ineffective" received between 1 September 2012 and 31 August 2016 using all other FAERS reports as a comparator. Additionally, we conducted a manual evaluation to identify informative data elements in the report narratives.
RESULTS: During the study period, 247,513 (6.4% of all FAERS reports) DI reports were entered in FAERS. Compared with non-DI reports, DI reports were more likely to be reported by consumers (69.8 vs. 48.1%) and less likely to report a serious outcome (26.2 vs. 56.3%). Most DI reports (88%) were from the USA. Manual evaluation of 552 sample US reports identified 43 reports (7.8%) deemed "useful"; a higher proportion of "useful" reports provided a batch or lot number (39.5 vs. 17.2%) and were coded with additional PTs beyond "drug ineffective" (83.7 vs. 59.2%), the most frequent of which were "product quality issue" (23.3%) and "product substitution issue" (18.6%).
|ジャーナル名||Drugs - real world outcomes|
|投稿者||Misu, Takashi; Kortepeter, Cindy M; Munoz, Monica A; Wu, Eileen; Dal Pan, Gerald J|
|組織名||Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;U.S. Food and Drug Administration, Silver Spring, MD, USA.;Office of Safety II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.;Cindy.Kortepeter@fda.hhs.gov.|