Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.
Drug Saf. 2024 Apr;47(4):377-387. doi: 10.1007/s40264-024-01397-6. Epub 2024 Feb 14.
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.
To examine determinants of consumer AE reporting in the USA.
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.
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).
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.
食品和药物管理局不良事件报告系统（FAERS）是新药物安全信息的重要来源，但尚不清楚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（美国）人口的情况。
研究美国消费者不良事件报告的决定因素。
计算并绘制了 2011 年至 2015 年期间消费者直接报告的每 100,000 名居民的五年不良事件报告率，并按四分位距进行了划分。使用负二项回归评估从县健康排名中获得的县级社会人口因素与不良事件报告率之间的关联。
美国各县之间的报告率存在差异，最高报告率 quartile 为每 100,000 名居民中有> 17.6 份报告，最低报告率 quartile 为≤ 5.5 份报告/ 100,000 名居民。在控制药物利用的情况下，报告率较高的县，≥ 65 岁的个体比例较高（例如，≥ 65 岁的个体每增加 1%，报告增加 2.4%，发病率比（IRR）：1.024，95%置信区间（CI）：1.017-1.030），女性比例较高（IRR：1.027，95% CI 1.012-1.043），无保险（IRR：1.009，95% CI 1.005-1.013），中位数对数家庭收入较高（IRR：1.897，95% CI 1.644-2.189），每 100,000 名居民的心理健康提供者较多（IRR：1.003，95% CI 1.001-1.004）。报告率较低的县，≤ 18 岁的个体比例较高（IRR：0.966，95% CI 0.959-0.974），美国印第安人或阿拉斯加原住民个体（IRR：0.991，95% CI 0.986-0.996），英语不熟练的个体（IRR：0.978，95% CI 0.965-0.991），以及居住在县内农村地区的个体（IRR：0.998，95% CI 0.997-0.998）。
观察到的消费者不良事件报告差异可能与社会人口因素和医疗保健获取有关。由于这些因素也可能与 AE 易感性相关，因此自愿不良事件报告系统可能无法为更脆弱人群中出现的药物安全问题提供最佳信息。
