Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database.

ABSTRACT: BACKGROUND:Voluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports. OBJECTIVE:The aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals. METHODS:We performed analysis on voluntary reports of AEs in the US Food and Drug Administration AE Reporting System (FAERS) database submitted in 2016. We compared reports by consumers with those by healthcare professionals. RESULTS:The number of voluntary reports by consumers has increased since 2013 in the US. Reports by consumers were different from ones by health professionals in several important aspects such

SUBMITTER: Toki T 

PROVIDER: S-EPMC5984610 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature