中国药物警戒 ›› 2017, Vol. 14 ›› Issue (9): 545-550.

• 法规与管理研究 • 上一篇    下一篇

基于多指标综合评价方法的药品安全指数构建

魏芬芳1, 冯霄婵1,2, 钟翎3, 毛秋荣3, 成斌3, 肖霄3, 王茜3, 杨悦1,2*   

  1. 1 沈阳药科大学工商管理学院,辽宁 沈阳 110016;
    2 沈阳药科大学国际食品药品政策与法律研究中心,辽宁 沈阳 110016;
    3 深圳市药品不良反应监测中心,广东 深圳518000
  • 收稿日期:2017-11-06 修回日期:2017-11-06 出版日期:2017-09-20 发布日期:2017-11-06
  • 通讯作者: 杨悦,女,博士,教授,药事法规与药品政策。E-mail:yyue315@vip.126.com。
  • 作者简介:魏芬芳,女,在读硕士,药事管理。
  • 基金资助:
    2017年深圳市科技创新委基础研究(自由探索)项目(JCYJ20170307160336416):深圳市药品安全风险评估模型的研究

Construction of Drug Safety Index Based on Multi-index Comprehensive Evaluation

WEI Fen-fang1, FENG Xiao-chan1,2, ZHONG Ling3, MAO Qiu-rong3, CHENG Bin3, XIAO Xiao3, WANG Qian3, YANG Yue1,2, *   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2 International Food & Drug Policy and Law Research Center, Liaoning Shenyang 110016, China;
    3 Center for ADR Monitoring of Shenzhen, Guangdong Shenzhen 518000, China
  • Received:2017-11-06 Revised:2017-11-06 Online:2017-09-20 Published:2017-11-06

摘要: 目的 旨在建立药品安全评估指标体系,并构建药品安全指数。方法 采取文献研究、实地调研方式识别和监测药品安全风险来源,建立药品安全指标体系和指数。结果 药品安全指数可对多个地区同一时间段内与药品安全相关的多个评估指标进行综合评估。结论 根据综合评估结果提出针对性的药品安全风险管理强化的对策和意见,为政府和药品监管机构提供决策支撑和参考。

关键词: 药品安全, 风险评估, 指标, 指数

Abstract: Objective To establish a drug safety assessment indicator system and build a drug safety index. Methods The sources of drug safety risks were identified and monitored by means of literature research and field research, and drug safety indicator system and indexes were established. Results The drug safety index provided a comprehensive assessment of multiple safety indicators related to drug safety in multiple regions over the same time period. Conclusion Based on the comprehensive evaluation Results, the countermeasures and opinions on the strengthening of drug safety risk management were put forward, which provided decision support and reference for government and drug regulatory agencies.

Key words: drug safety, risk assessment, indicators, index

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