中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 766-768.
DOI: 10.19803/j.1672-8629.2021.08.14

• 法规与管理研究 • 上一篇    下一篇

我国基本药物不良反应报告与监测情况浅析

于洪礼1, 逄瑜1, 邵波1, 肖爱丽1, 于冬梅*   

  1. 1国家药品监督管理局药品评价中心,北京 100045;
    *国家市场监督管理总局食品审评中心,北京 100070
  • 收稿日期:2020-02-03 出版日期:2021-08-15 发布日期:2021-08-17
  • 通讯作者: *于冬梅,女,硕士,工程师,药品和特殊医学用途保健食品。E-mail：maidouwang@163.com
  • 作者简介:于洪礼,男,硕士,主管药师,中药上市后安全性研究。
  • 基金资助:
    重大新药创制国家科技重大专项2015年度（2015ZX09501004-001-001）

Current Adverse Drug Reaction Reporting and Monitoring of Essential Medicines in China

YU Hongli1, PANG Yu1, SHAO Bo1, XIAO Aili1, YU Dongmei*   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    *Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China
  • Received:2020-02-03 Online:2021-08-15 Published:2021-08-17

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摘要： 目的 分析近年来我国基本药物不良反应报告与监测情况,为临床安全用药提供参考。方法 收集我国2015年~2019年国家药品监督管理部门发布的《国家药品不良反应监测年度报告》,汇总分析国家基本药物不良反应/事件（ADR/ADE）报告情况。结果 近年来国家基本药物ADR/ADE报告总体数量呈递增趋势,与我国药品总体报告变化趋势保持一致。结论 在国家基本药物制度完善的同时,应关注国家基本药物相关ADR,促进临床安全使用。

关键词: 基本药物, 国家药品不良反应监测年度报告, 药品不良反应/事件

Abstract: Objective To analyze the levels of reporting and monitoring of adverse drug reactions of essential medicines in recent years in China so as to provide reference for clinical safe use. Methods The Annual Reports on National ADR Monitoring issued by the National Medical Products Administration between 2015 and 2019 were collected while those on ADR/ADE involving national essential medicines were summarized and analyzed. Results From 2015 to 2019, reports of ADR/ADE caused by essential medicines in China kept increasing, which was consistent with the overall trend of reports in China. Conclusion With the improvement of regulations on essential medicines in China, ADR related to essential medicines deserve attention in order to promote the safe clinical use.

Key words: essential medicines, annual reports on national ADR monitoring, ADR/ADE

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