An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance
- U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Surveillance and Epidemiology; Office of Safety II, Tokyo (Japan). Pharmaceuticals and Medical Devices Agency; DOE/OSTI
- U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Surveillance and Epidemiology
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%). Conclusions: DI was the most frequently reported adverse event in the FAERS database; however, the yield from these reports in terms of usefulness from a pharmacovigilance perspective was low. Efficient strategies are needed to identify which DI reports are more likely to contain useful information.
- Research Organization:
- Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
- Sponsoring Organization:
- USDOE Office of Science (SC), Biological and Environmental Research (BER). Biological Systems Science Division
- Grant/Contract Number:
- SC0014664
- OSTI ID:
- 1630012
- Journal Information:
- Drugs - real world outcomes, Journal Name: Drugs - real world outcomes Journal Issue: 2 Vol. 5; ISSN 2199-1154
- Publisher:
- SpringerCopyright Statement
- Country of Publication:
- United States
- Language:
- English
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