Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration.
STUDY OBJECTIVE: Consumers and healthcare professionals can voluntarily report adverse experiences associated with drug products to the United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Consumers and healthcare professionals used the same general voluntary reporting form (GVR) until mid-2013, when a consumer voluntary reporting form (ConVR), written in plain language, was implemented. The objective of this study was to examine the effect of the ConVR on the quality and quantity of consumer reports submitted directly to FAERS.
DESIGN: Descriptive; quasi-experimental.
DATA SOURCE: FAERS database.
MEASUREMENTS AND MAIN RESULTS: We identified all consumer and healthcare professional reports received directly by the FDA from January 1, 2011, through December 31, 2015. Report quality was defined by the completeness of 15 individual data fields and a structured tool measuring clinical documentation. An interrupted time series design was used to evaluate the impact on the quantity of consumer reports. Consumer reports submitted on the ConVR generally included more patient, product, and event data in the structured data fields than those submitted on the GVR. Fields with the greatest absolute percentage difference after the ConVR was introduced included race/ethnicity (+77.2%), product start and stop dates (+43% and +40.3%, respectively), dechallenge and rechallenge information (+19.1% and +29.4%, respectively), and medical history (+27%). Our structured assessment also classified more reports received on the ConVR as well documented relative to the GVR consumer reports (64.9% vs 37.8%, p<0.01). The time series model demonstrated an immediate increase of 499 consumer reports in the month following the ConVR's implementation (p<0.01).
CONCLUSION: Our findings suggest that the ConVR has contributed positively to both the quality and quantity of consumer reports in FAERS.
|投稿者||Munoz, Monica A; Delcher, Chris; Dal Pan, Gerald J; Kortepeter, Cindy M; Wu, Eileen; Wei, Yu-Jung Jenny; Xiao, Hong; Winterstein, Almut G|
|組織名||Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;U.S. Food and Drug Administration, Silver Spring, Maryland.;Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University;of Florida, Gainesville, Florida.;Department of Pharmacy Practice and Science, College of Pharmacy, University of;Kentucky, Lexington, Kentucky.;Department of Epidemiology, College of Medicine and College of Public Health and;Health Professions, University of Florida, Gainesville, Florida.;Center for Drug Evaluation and Safety (CoDES), University of Florida,;Gainesville, Florida.|