欧美药物警戒中电子化医疗保健数据的应用研究

Study on Application of Electronic Healthcare Records in Pharmacovigilance in US and EU

目的为进一步促进我国药品不良反应监测工作提供思路和参考。方法研究国外利用电子化医疗保健数据开展药物警戒工作的现状和具体应用,归纳与分析其中的不足,为基于我国医院信息系统开展药品不良反应监测、上市后临床研究提出建议。结果与结论利用电子化医疗保健数据开展药品不良反应监测与药物警戒可以从真实世界获取数据,在源头提高报告质量、减少漏报;加强主动监测可以弥补自发报告的不足,是提升工作质量和工作价值的良好途径;应借鉴国外先进经验与技术,加强我国医院信息系统建设与信息综合利用。

Objective To provide thought and references for the promotion of ADR monitoring in China. Methods Study on the current state and the practical application by using of data from electronic healthcare records for pharmacovigilance. The shortcomings were summarized and analyzed, suggestions on improving ADR monitoring and post-marketing clinical studies were put forward based on HIS. Results＆amp;Conclusion It can get data from the real world to carry out the ADR monitoring by using the HIS, improving the quality of ADR reporting at source and reducing the omission.To strengthen active surveillance can make up for the inadequacy of spontaneous reporting. It is a good way to improve the quality and the value of ADR monitoring. We should draw lessons from foreign advanced experience and technology, strengthen the HIS construction and information comprehensive utilization.