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Analysis of 431 Cases of Serious Adverse Drug Reaction/Event Caused by Shenmai Injection

Xu Rongqin1, Fu Wen2, Yang Yue1*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Yunnan Center for ADR Monitoring, Yunnan Kunming 650101, China
  • 出版日期:2016-12-20 发布日期:2017-02-08

Analysis of 431 Cases of Serious Adverse Drug Reaction/Event Caused by Shenmai Injection

Xu Rongqin1, Fu Wen2, Yang Yue1*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Yunnan Center for ADR Monitoring, Yunnan Kunming 650101, China
  • Online:2016-12-20 Published:2017-02-08
  • Contact: Yang Yue, professor, doctoral tutor. Major research area: drug regulations and policy. Tel: 13998236315, E-mail: yyue315@126.com.

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摘要： Objective To analyze the serious cases of adverse drug reaction/adverse drug event (ADR/ADE) caused by Shenmai injection (SMI) produced by enterprises in Yunnan in 5 years and to provide references for reducing the risks of clinical drug use. Methods A total of 431 cases of serious ADR/ADE caused by SMI by Yunnan enterprises reported in adverse drug reaction monitoring system in China between January 2009 and December 2013 were analyzed. Results and Conclusion The serious ADR/ADE caused by SMI was related to the clinical irrational use, product features and inadequate instructions. Therefore, it is suggested that medical staff should regulate drug use process in accordance with the instructions; enterprises should actively carry out post-marketing safety studies to reduce the risk of drug use.

关键词: Yunnan Province, Shenmai injection (SMI), adverse drug reaction (ADR), serious case of ADR report

Abstract: Objective To analyze the serious cases of adverse drug reaction/adverse drug event (ADR/ADE) caused by Shenmai injection (SMI) produced by enterprises in Yunnan in 5 years and to provide references for reducing the risks of clinical drug use. Methods A total of 431 cases of serious ADR/ADE caused by SMI by Yunnan enterprises reported in adverse drug reaction monitoring system in China between January 2009 and December 2013 were analyzed. Results and Conclusion The serious ADR/ADE caused by SMI was related to the clinical irrational use, product features and inadequate instructions. Therefore, it is suggested that medical staff should regulate drug use process in accordance with the instructions; enterprises should actively carry out post-marketing safety studies to reduce the risk of drug use.

Key words: Yunnan Province, Shenmai injection (SMI), adverse drug reaction (ADR), serious case of ADR report

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