Impact of a New Consumer Form on Adverse Event Reporting to the United States Food and Drug Administration.

Consumers and health care professionals (HCPs) can voluntarily report adverse experiences associated with drug products to the Food and Drug Administration Adverse Event Reporting System (FAERS). Consumers and HCPs used the same general voluntary reporting form (GVR) until mid-2013 when a consumer voluntary reporting form (ConVR) written in plain language was implemented.To examine the effect of the ConVR on the quality and quantity of consumer reports submitted directly to FAERS.We conducted a descriptive analysis of consumer and HCP 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 via 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%, +40.3%), dechallenge and rechallenge information (+19%, +29.4%), and medical history (+27%). Our structured assessment also classified more reports received on the ConVR as well documented (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).Our findings suggest that the ConVR has contributed positively to both the quality and quantity of consumer reports. This article is protected by copyright. All rights reserved.