在食品和药物管理局不良事件报告系统中对重复不良事件报告特征的评估
Scott Janiczak1, Sarah Tanveer2, Karen Tom3
1Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD, USA. Scott.Janiczak@fda.hhs.gov.
Drug safety
|June 4, 2025
概括
在FDA不良事件报告系统 (FAERS) 中,重复报告是常见的,通常来自国际和医疗保健专业人员. 这些重复共享类似的叙述,但在编码数据上有所不同,影响安全监督.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全监督 药品安全监督
- 监管科学 监管科学
背景情况:
- 食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 对于监测药物和生物产品安全至关重要.
- 重复报告,定义为同一事件的多次提交,同一患者同时使用同一产品,可以通过阻碍安全信号的识别和评估来危害公共卫生监督.
研究的目的:
- 描述FAERS数据库中与重复报告相关的特征和贡献因素.
- 为了比较重复和非重复的不良事件报告的特征.
主要方法:
- 手动评估个案安全报告 (ICSR) 的方便样本,将其分类为重复或非重复.
- 在重复报告和非重复报告之间比较结构化和非结构化数据字段 (例如报告类型,报告人,国家,数据源,结果).
- 在重复集中评估信息相似性,使用七个数据元素和来自变压器的双向编码器表示 (SBERT) 进行叙述相似性.
主要成果:
- 在2297份报告中,39% (901) 是重复的,形成237个独特的套件.
- 复制报告更有可能来自国外 (82%对37%),来自医疗保健专业人员 (89%对68%),提及其他监管数据库 (42%对11%),描述已公布的病例 (34%对11%),并具有严重的结果 (97%对83%).
- 编码信息在重复集合中经常存在差异 (只有16%的一致性),而叙述显示出高度相似性 (重复的SBERT中位数为0.87对非重复的0.48).
结论:
- 鉴定了复制FAERS报告的属性和贡献因素的差异,可能为预防,检测和管理策略提供信息.
- 需要进一步的研究,以了解这些发现的全部含义,并利用监管和技术进步来缓解重复报告的问题.
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