药物警戒中患者直接报告情况研究

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (10): 609-613.

药物警戒中患者直接报告情况研究

边蕾,赵频,杨悦^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2013-07-15 修回日期:2016-03-09 出版日期:2013-10-08 发布日期:2016-03-09
通讯作者: 杨悦,教授·博导,药事法规与政策研究、药品知识产权。E-mail：yyue315@126.com
作者简介:边蕾,在读硕士,药品政策、药品安全监测。

The Research of Patient Direct Reporting in Pharmacovigilance

BIAN Lei ,ZHAO Pin ,YANG Yue^*

College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-07-15 Revised:2016-03-09 Online:2013-10-08 Published:2016-03-09

摘要/Abstract

摘要： 目的介绍药物警戒中患者直接报告的实施情况,为我国患者直接报告提供借鉴。方法通过查阅文献,分析患者直接报告的重要性、运行情况及国际经验,结合我国国情提出相应的建议。结果与结论 患者直接报告的有定性描述较为详细、可增加ADR 报告数量和新的ADR 症状、有助于早期发现ADR 等方面的优点,作为报告系统的重要补充为监管决策提供了依据。而我国患者直接报告的水平还很低,在具体实施过程中还存在诸多问题。因此要依据现有情况,积极开展患者报告途径、报告表及其编码的研究,对患者报告的重要性进行广泛的宣传,适时提供患者教育,增强公众的报告意识。

关键词: 药品不良反应监测, 患者直接报告, 国际经验

Abstract: Objective To introduce the implementation of direct reporting of patients in pharmacovigilance, in order to provide references for our patient reporting. Methods Analyze the importance, operation and international experience of patient direct reporting by literature and make recommendations combined with China's national conditions accordingly. Results and Conclusion Patient reporting has the advantages of rich qualitative description with more details, increasing the number of ADR reports and new ADR symptoms, helping early detection of ADR and so on. It provides the evidence for regulatory decision-making as an important complement to the reporting system. In China, the level of patient reporting is still very low. Particularly in the implementation process, there are still many problems. Therefore, we should actively carry out the research of reporting routes, forms and coding based on the existing situation. We should widely publicize the importance of patient reporting, timely provide patient education, and increase the public awareness of the reporting.

Key words: adverse drug reaction monitoring, patient direct reporting, international experience

中图分类号:

R951

边蕾,赵频,杨悦. 药物警戒中患者直接报告情况研究[J]. 中国药物警戒, 2013, 10(10): 609-613.

BIAN Lei ,ZHAO Pin ,YANG Yue . The Research of Patient Direct Reporting in Pharmacovigilance [J]. Chinese Journal of Pharmacovigilance, 2013, 10(10): 609-613.

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