Alatawi Yasser M, Hansen Richard A
a Department of Health Outcomes Research and Policy , Auburn University, Harrison School of Pharmacy , Auburn , AL , USA.
Expert Opin Drug Saf. 2017 Jul;16(7):761-767. doi: 10.1080/14740338.2017.1323867. Epub 2017 May 9.
To examine how closely reporting rates in the FDA Adverse Event Reporting System (FAERS) reflect expected rates of known adverse drug events (ADEs).
We selected three groups of drugs to reflect hypothesized variation in sensitivity to reporting, including statins, biologics, and narrow therapeutics index drugs (NTI). The numbers of ADEs in FAERS were divided by utilization estimates from ambulatory health care data (NAMCS/NHAMCS) to calculate a reported proportion. One sample z-test for proportions compared the proportion of ADEs reported to an expected ADE proportion derived from drug labels, reference databases, and peer-reviewed papers.
The majority of drug-ADE pairs showed significant under-reporting. For example, roughly 0.01% to 44% of statin events were reported (z-test p < 0.0001). Biological (0.002% to >100%) and NTI (20% to >100%) drugs had relatively higher reporting rates. Roughly 20% to 33% of the minimum number of expected serious events were reported with biologics and NTI drugs.
This study supports previous evidence of under-reporting of ADEs in spontaneous reporting data. But, under-reporting varies considerably by the type of drug and the type of ADEs, and this variability in under-reporting should be considered when interpreting safety signals.
研究美国食品药品监督管理局不良事件报告系统（FAERS）中的报告率与已知药物不良事件（ADE）预期发生率的接近程度。
我们选择了三组药物以反映报告敏感性的假设差异，包括他汀类药物、生物制剂和治疗指数窄的药物（NTI）。将FAERS中ADE的数量除以门诊医疗数据（NAMCS/NHAMCS）的使用估计值，以计算报告比例。单样本z检验用于比较报告的ADE比例与从药物标签、参考数据库和同行评审论文得出的预期ADE比例。
大多数药物 - ADE对显示报告不足。例如，他汀类药物事件报告的比例约为0.01%至44%（z检验p < 0.0001）。生物制剂（0.002%至>100%）和NTI药物（20%至>100%）的报告率相对较高。生物制剂和NTI药物报告的预期严重事件最少数量约为20%至33%。
本研究支持了自发报告数据中ADE报告不足的先前证据。但是，报告不足因药物类型和ADE类型的不同而有很大差异，在解释安全信号时应考虑这种报告不足的变异性。
