中国药物警戒 ›› 2014, Vol. 11 ›› Issue (2): 85-87.

• 政策与法规研究 • 上一篇    下一篇

从酮康唑口服制剂使用现状看我国的药品风险管理的不足

何勇1, 陈小毛2   

  1. 1池州市人民医院药剂科, 安徽 池州247000;
    2池州市药品不良反应监测中心,安徽 池州,247000
  • 收稿日期:2013-07-29 修回日期:2016-02-03 出版日期:2014-02-08 发布日期:2016-02-03
  • 作者简介:何勇,男,副主任药师,临床药学

Analysis of Drug Risk Management Deficiencies from Current Status of Using Ketoconazole Oral Formulations

HE Yong1, CHEN Xiao-mao2   

  1. 1Department of Pharmacy, Chizhou People's Hospital, Anhui Chizhou 247000, China；
    2Chizhou Adverse Drug Reaction Monitoring Center, Anhui Chizhou 247000, China
  • Received:2013-07-29 Revised:2016-02-03 Online:2014-02-08 Published:2016-02-03

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摘要： 药品风险管理是保证患者用药安全,使用药风险最小化,利益最大化的重要措施,有效的风险管理能减少药品对公众的损害。由于我国药品风险管理工作起步较晚,制度不完善,在实施过程中还存在一些问题。本文根据国内酮康唑口服制剂的流通、销售及使用现状,同时结合工作实际,浅析目前国内药品风险管理体系中存在的一些问题,并提出相关建议。

关键词: 酮康唑口服制剂, 药品风险管理, 药品召回

Abstract: Drug risk management is the important measure to ensure drug use safety of patients, which can minimize the risks and maximize the benefits of drug use. Effective drug risk management can reduce the damage to patients induced by drugs. But there are still some problems in the implementation process as the domestic works of drug risk management lack experience and the system is not perfect. Based on the circulation, sale and use situation of the high-risk oral formulation of ketoconazole and combined with experience of working, the author identified some problems in current domestic drug risk management system and put forward some suggestions for improvement.

Key words: ketoconazole oral formulations, drug risk management, drug recall

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