Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014

Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8. doi: 10.1002/pds.3979. Epub 2016 Feb 10.


Purpose: Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014.

Methods: Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings.

Results: In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories.

Conclusions: By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords: US Food and Drug Administration; adverse drug reaction reporting systems; pharmacoepidemiology.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards*
  • Drug Industry*
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Humans
  • United States
  • United States Food and Drug Administration