中国药物警戒 ›› 2020, Vol. 17 ›› Issue (12): 867-870.
DOI: 10.19803/j.1672-8629.2020.12.04

• 法规与管理研究 • 上一篇    下一篇

国际药物警戒最新进展与启示

陈锋   

  1. 国家药品监督管理局信息中心,北京 100044
  • 收稿日期:2020-06-10 修回日期:2020-12-07 出版日期:2020-12-15 发布日期:2020-12-07
  • 作者简介:陈锋,男,博士,研究员,医药信息。

Latest Development of International Pharmacovigilance and Its Implications

CHEN Feng   

  1. Center for Information,NMPA,Beijing 100044,China
  • Received:2020-06-10 Revised:2020-12-07 Online:2020-12-15 Published:2020-12-07

摘要: 作为全球药物警戒发展风向标的世界卫生组织国际药物监测项目成员国年会,是关注国际药物警戒热点与最新进展的重要窗口。本文以2019年召开的第42届年会为背景,分析了当前国际药物警戒最新发展动向及相关启示,认为药物警戒工作范围从不良反应监测拓展到药物滥用、误用和用药错误检测、报告与预防,工作重心正逐步从以药品安全为中心转向患者安全为中心,迫切需要进一步增强社会药物警戒意识和简化公众参与途径;另外,以人工智能为代表的新一代信息技术在药物警戒领域应用中正在取得突破,积极推进智慧监管和智慧安全监测已成国际共识。

关键词: 药物警戒意识, 用药错误, 智慧安全监测, 人工智能

Abstract: As a predictor of development of global pharmacovigilance, the Annual Meeting of WHO Program of International Drug Monitoring (PIDM) is an important event for us to find out hotspots and latest progress in pharmacovigilance worldwide. Based on the agenda of the 42nd Annual Conference held in 2019, this paper analyzes the latest developments of global pharmacovigilance and implications for China. It is believed that the scope of pharmacovigilance has been expanded from adverse reaction monitoring to the detection, reporting and prevention of drug abuse, misuse and medication errors, and that the focus is gradually shifting from drug safety to patient safety. Therefore, there is an urgent need to continue to enhance the awareness of social drug vigilance and streamline public participation. In addition, the application of new generation information technology represented by artificial intelligence (AI) in the field of pharmacovigilance is making a breakthrough, and it has become an international consensus to actively promote smart supervision and smart safety surveillance.

Key words: pharmacovigilance awareness, medication error, smart safety surveillance, artificial intelligence

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