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

Monica A. Muñoz (), Gerald J. Dal Pan, Yu-Jung Jenny Wei, Hong Xiao, Chris Delcher, Andrew Giffin, Nabila Sadiq and Almut G. Winterstein
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Monica A. Muñoz: US Food and Drug Administration
Gerald J. Dal Pan: US Food and Drug Administration
Yu-Jung Jenny Wei: University of Florida
Hong Xiao: University of Florida
Chris Delcher: University of Kentucky
Andrew Giffin: US Food and Drug Administration
Nabila Sadiq: US Food and Drug Administration
Almut G. Winterstein: University of Florida

Drug Safety, 2024, vol. 47, issue 4, No 7, 377-387

Abstract: 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 counties with > 17.6 reports versus ≤ 5.5 reports/100,000 residents in the highest and lowest reporting quartile, respectively. Controlling for drug utilization, counties with higher reporting rates had higher proportions of individuals age ≥ 65 years (e.g., 2.4% reporting increase per 1% increase in individuals age > 65, incidence rate ratio (IRR): 1.024, 95% confidence interval (CI): 1.017–1.030), higher proportions of females (IRR: 1.027, 95% CI 1.012–1.043), uninsured (IRR: 1.009, 95% CI 1.005–1.013), higher median log household incomes (IRR: 1.897, 95% CI 1.644–2.189) and more mental health providers per 100,000 residents (IRR: 1.003, 95% CI 1.001–1.004). Lower reporting was observed in counties with higher proportions of individuals age ≤ 18 years (IRR: 0.966, 95% CI 0.959–0.974), American Indian or Alaska Native individuals (IRR: 0.991, 95% CI 0.986–0.996), individuals not proficient in English (IRR: 0.978, 95% CI 0.965–0.991), and individuals residing in rural areas within a county (IRR: 0.998, 95% CI 0.997–0.998). Conclusions Observed variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations.

Date: 2024
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DOI: 10.1007/s40264-024-01397-6

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