中国药物警戒 ›› 2015, Vol. 12 ›› Issue (12): 740-743.

• 药物警戒专栏 • 上一篇    下一篇

西部地区部分省份药品不良反应报告主体实证研究

张雪梅1, 2, 郭佳栋1, 2, 冯变玲1, 2*, 杨世民1, 2   

  1. 1西安交通大学药学院药事管理与临床药学系,陕西 西安 710061；
    2西安交通大学药品安全与政策研究中心,陕西 西安 710061
  • 收稿日期:2016-02-02 修回日期:2016-02-02 出版日期:2015-12-08 发布日期:2016-02-02
  • 通讯作者: 冯变玲,女,博士,副教授,药事管理。E-mail：fengbl@mail.xjtu.edu.cn
  • 作者简介:张雪梅,女,在读硕士,药事管理。
  • 基金资助:
    国家社会科学基金资助项目（13BGL132）

Investigation on Work State of Adverse Drug Reaction Reporting in Some West Provinces

ZHANG Xue-mei1, 2, GUO Jia-dong1, 2, FENG Bian-ling1, 2, *, YANG Shi-min1, 2   

  1. 1Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Shanxi Xi'an, 710061, China;
    2Center for Drug Safety and Policy Research, Xi'an Jiaotong University, Shanxi Xi'an 710061, China
  • Received:2016-02-02 Revised:2016-02-02 Online:2015-12-08 Published:2016-02-02

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摘要： 目的调查西部地区部分省份药品不良反应（ADR）报告主体的工作现状,分析其存在的问题以提出切实可行的建议。方法以陕西和四川省药品生产企业、药品经营企业、医疗机构为研究对象,采用问卷调查法,进行抽样调查,使用SPSS 18.0统计软件对回收问卷所得数据处理分析。结果回收有效问卷198份,可基本了解西部地区部分省份各ADR报告主体关于ADR工作的现状,包括机构设置、人员配备、制度建设、经费支持、培训学习、报告情况、工作评价等基本情况。结论西部地区部分省份关于不良反应监测部门建设情况良好;在人员的培训学习方面,陕西省有待进一步加强。关于ADR工作的人员、经费、信息反馈等方面提出相关建议。

关键词: 陕西和四川省, 药品不良反应, 药品生产企业, 药品经营企业, 医疗机构

Abstract: ObjectiveTo investigate the present situation of ADR monitoring of the reporting entities in some west provinces and analyze the existing problems and provide practical recommendations. MethodsThe drug manufacturers, drug distributors and medical institutions of Shanxi and Sichuan province were employed as the subjects. The returned questionnaires were analyzed via SPSS 18.0. Results198 questionnaires were received. The informations of the ADR monitoring present situation were obtained in terms of structure, staff, system, fund, training, reporting and valuation. ConclusionThe ADR monitoring situation was in good condition. It is necessary to strengthen the training in Shanxi province, and the staff, fund, information feedback should be improved.

Key words: Shanxi and Sichuan province, ADR, drug manufacturer, drug distributor, medical institution

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