Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study.

ABSTRACT:

Introduction

The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, but whether adverse event (AE) information collected from these systems adequately captures experiences of the overall United States (US) population is unknown.

Objective

To examine determinants of consumer AE reporting in the USA.

Methods

Five-year AE reporting rate per 100,000 residents per US county were calculated, mapped, and quartiled for AE reports received directly from consumers between 2011 and 2015. Associations between county-level sociodemographic factors obtained from County Health Rankings and AE reporting rates were evaluated using negative binomial regression.

Results

Reporting rates were variable across US coun

SUBMITTER: Munoz MA 

PROVIDER: S-EPMC10955028 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature