中国药物警戒 ›› 2013, Vol. 10 ›› Issue (3): 144-147.

• 政策与法规研究 • 上一篇    下一篇

美国FDA基于品种的药品风险管理计划研究与制定

李淑芳1, 潘文灏2   

  1. 1.沈阳医学院奉天医院药剂科,辽宁沈阳110024；
    2.辽宁中医药大学附属医院药剂科,辽宁沈阳110032
  • 收稿日期:2012-11-15 修回日期:2016-03-09 出版日期:2013-03-08 发布日期:2016-03-09
  • 作者简介:李淑芳,女,副主任药师,医院药学。

The Study and Development of FDA Drug Risk Management Plan in View of Specific Drug

LI Shu -fang1, PAN Wen -hao2   

  1. 1.The Fengtian Hospital of Shenuyang Medical University, Liaoning Shenyang 110024, China;
    2.The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning Shenyang 110032, China
  • Received:2012-11-15 Revised:2016-03-09 Online:2013-03-08 Published:2016-03-09

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摘要： 目的 研究美国食品药品监督管理局（简称FDA）对ER/LA 阿片类镇痛药风险干预与管理计划制定,为我国此类药品风险管理计划的制定提供参考。方法 运用文献研究方法,对ER/LA 阿片类镇痛药风险管理计划的制定进行介绍。结果与结论 美国ER/LA 阿片类镇痛药风险管理计划已很系统,风险沟通方法多样,并且尽可能减少对卫生保健系统产生负担。我国可针对现存问题,借鉴美国经验,完善我国相关类似药品风险管理计划的制定。

关键词: 缓释长效, 阿片类镇痛药, 风险评估与减低计划

Abstract: Objective To research the risk intervention and management plan about ER/LA opioid analgesic which developed by the United States Food and Drug Administration(FDA), and provide suggestions to the development of risk management plan about similar drugs in our country. Methods By literature research method, the development of risk management plan about ER/LA opioids analgesics was studied. Results and Conclusion Risk management plan about ER/LA opioid analgesics in the United States has been systematized gradually. It has various kinds of risk communication Methods and pays much more attention to reduce the burden to health care system. In the light of the existing problems, we should draw lessons from American experience and perfect similar drugs risk management plan in our country.

Key words: ER/LA, opioid analgesics, REMS

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