药物错误的不成比例分析和表征在EudraVigilance:探索性别和年龄组的发现
Victor Pera1, Jan A Kors2, Erik M van Mulligen2
1Department of Medical Informatics, Erasmus University Medical Center, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. v.pera@erasmusmc.nl.
Drug safety
|September 19, 2024
概括
这项研究分析了EudraVigilance中的药物错误 (MEs),在某些年龄组和疫苗,氧化,素和里瓦洛克萨班等药物中发现了不成比例报告 (SDR) 的特定信号.
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 公共卫生 公共卫生
背景情况:
- 药物错误 (MEs) 是药物安全监测中的一个重大问题.
- 欧洲药品署EudraVigilance数据库中关于ME的先前研究缺乏按性别和年龄的详细表征.
- 这项研究通过在人口亚组中对ME进行广泛的信号检测来弥补这一差距.
研究的目的:
- 在EudraVigilance中描述与药物错误 (ME) 相关的个案安全报告 (ICSR).
- 确定30种最常报告的药物不成比例报告 (SDR) 的信号,按性别和年龄组分层.
- 探索以前在文献中没有记录的新型SDR.
主要方法:
- 2002年至2021年间,从EudraVigilance获得的ICSRs的分析.
- 使用标准化监管活动医学词典 (MedDRA) 术语对ME的定义.
- 使用报告几率比率 (ROR) 识别SDR,以较低的95%置信区间为≥1和至少3个ICSR.
- 按性别和多个年龄类别 (0-1个月至>85岁) 分析子组.
- 使用热图来视觉识别突出的SDR.
主要成果:
- 在9662345份EudraVigilance报告中,有2.8% (267,262) 包含了中小企业,总共为300324个中小企业.
- 最常见的ME是"不适当的产品施用时间表"",错误的剂量施用"和"产品使用过程中的错误技术".
- MEs在女性中更频繁 (55.4%),并与严重的健康结果相关 (59.5%).
- 总共有847个SDR被确定;在疫苗 (HPV,疹), oxycodone, risperidone 和 rivaroxaban 中发现了显著的SDR,特别是在特定的年龄组 (例如2个月至2岁).
- 与整体数据库相比,oxycodone,risperidone和rivaroxaban的SDR在2个月至2岁的年龄组中显示出明显更高的ROR.
结论:
- 本研究提供了EudraVigilance中ME ICSRs和SDRs的全面表征,突出了特定年龄组的重大发现.
- 疫苗,氧化,里瓦洛克萨班和皮的新型SDR需要监管机构和利益相关者进一步调查.
- 最频繁报告的ME表明需要进行根源分析和针对性预防策略,涉及医疗保健提供者,制造商和监管机构.
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