Parès Yves, Declerck Gunnar, Hussain Sajjad, Ng Romain, Jaulent Marie-Christine
INSERM, UMRS 872, Eq. 20, Paris, France.
Stud Health Technol Inform. 2013;192:903-7.
The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.
检测药物不良事件（ADEs）这项艰巨任务以及根据患者病历构建ADEs发生情况的手动报告这一繁琐过程，导致大多数不良反应未报告给卫生监管机构。SALUS个例安全报告（ICSR）报告工具是SALUS项目目前正在开发的一个组件，旨在支持向监管机构半自动报告ADEs。在本文中，我们展示了我们的ICSR报告工具的初步设计和当前状态，其特点包括：（i）通过提取电子健康记录（EHR）中包含的患者数据自动预填充报告表格；（ii）医生生成并将完整的ICSR电子提交给监管机构；（iii）将报告流程整合到医生的工作流程中以减少干扰。目标是提高ADE报告率和报告数据的质量。SALUS互操作性平台支持独立于所使用的EHR数据模型提取患者数据，并允许使用监管机构期望的格式生成报告。
