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

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2024-04-01 Epub Date: 2024-02-14 DOI:10.1007/s40264-024-01397-6

Monica A Muñoz, Gerald J Dal Pan, Yu-Jung Jenny Wei, Hong Xiao, Chris Delcher, Andrew Giffin, Nabila Sadiq, Almut G Winterstein

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引用次数: 0

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.

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美国不良事件报告的社会人口学特征：一项生态学研究。

简介：美国食品和药物管理局不良事件报告系统（FAERS）是新药安全信息的重要来源，但从这些系统收集的不良事件（AE）信息是否充分反映了整个美国人口的经历尚不得而知：研究美国消费者 AE 报告的决定因素：方法：对 2011 年至 2015 年间直接从消费者处收到的 AE 报告进行计算、绘图和四分法分析，得出美国每个县每 10 万居民的五年 AE 报告率。使用负二项回归法评估了从县健康排名中获得的县级社会人口因素与急性呼吸道感染报告率之间的关联：美国各县的报告率不尽相同，报告率最高和最低的四分位数分别为大于 17.6 份报告和小于 5.5 份报告/100,000 居民。在控制药物使用的情况下，报告率越高的县，65 岁以上人口的比例越高（例如，65 岁以上人口每增加 1%，报告率增加 2.4%，发病率比 (IRR)：1.024，95% 置信区间）：女性比例较高（IRR：1.027，95% 置信区间 (CI)：1.012-1.043），无保险（IRR：1.009，95% 置信区间 (CI)：1.005-1.013），家庭收入中位数对数较高（IRR：1.897，95% 置信区间 (CI)：1.644-2.189），每 10 万居民中有更多心理健康服务提供者（IRR：1.003，95% 置信区间 (CI)：1.001-1.004）。在18岁以下人群（IRR：0.966，95% CI 0.959-0.974）、美国印第安人或阿拉斯加原住民（IRR：0.991，95% CI 0.986-0.996）、英语不熟练人群（IRR：0.978，95% CI 0.965-0.991）和居住在农村地区人群（IRR：0.998，95% CI 0.997-0.998）比例较高的县，报告率较低：消费者AE报告中观察到的差异可能与社会人口因素和医疗服务的获取有关。由于这些因素也可能与AE易感性相对应，因此自愿性AE报告系统可能并不适合捕捉较弱势群体中新出现的药物安全问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.