德国医生,药剂师和消费者发送的药物不良反应报告中提供的信息的比较分析
Patrick Christ1,2, Diana Dubrall1,2, Matthias Schmid2
1Research Division, Federal Institute for Drugs and Medical Devices, Bonn, Germany.
Drug safety
|November 21, 2023
概括
关于药物不良反应 (ADR) 的消费者报告是有价值的,并且在完整性方面与医生和药剂师的报告相似. 报告员类型之间的协作可以提高ADR数据的研究质量.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全监测监测 药物安全监测
- 医疗保健信息学 医疗保健信息学
背景情况:
- 医疗保健专业人员和消费者报告了药物不良反应 (ADR).
- 之前关于记者差异的研究往往缺乏完整性分析或过时.
- 在HCP报告中,医生和药剂师之间的区别经常被忽视.
研究的目的:
- 分析和比较德国医生,药剂师和消费者的ADR报告的完整性.
- 为了评估不同类型的报告员患者的人口统计差异.
- 为了确定报告人组之间特定信息完整性的差异.
主要方法:
- 来自EudraVigilance (德国,2018-2021年) 的自发ADR报告的分析.
- 包括来自医生 (n=69,976),药剂师 (n=42,396) 和消费者 (n=121,144) 的报告.
- 使用vigiGrade分数和对赔率比率的逻辑回归进行完整性评估.
主要成果:
- 消费者ADR报告增加,而医生和药剂师报告每年下降.
- 药剂师和消费者的报告显示,女性患者的比例更高.
- 医生报告的整体完整性 (vigiGrade分数) 比消费者和药剂师报告略高.
结论:
- 消费者ADR报告的完整性与HCP报告相似,突出了它们的重要价值.
- 具体信息的完整性因报告员类型而异,这表明协作报告可以改进数据.
- 根据报告者类型对ADR报告的分层分析对研究目标有益.
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