Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (3): 144-147.

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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

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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