基于国际药物警戒经验探讨收集患者报告的意义

doi:10.19803/j.1672-8629.20230247

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (9): 978-981.
DOI: 10.19803/j.1672-8629.20230247

• 药物警戒质量管理规范实践专栏 • 上一篇下一篇

基于国际药物警戒经验探讨收集患者报告的意义

逄瑜¹, 刘博^2,Δ, 吕少俐¹, 王涛³, 邢颖¹, 秦星宇¹, 田月洁^4,*, 吴文宇^5#

¹荣昌生物制药（烟台）股份有限公司,山东烟台 265503;
²中国食品药品检定研究院化学药品检定所,北京 102629;
³国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022;
⁴山东省药品不良反应监测中心,山东济南 250014;
⁵深圳市药物警戒和风险管理研究院,广东深圳 518024

收稿日期:2023-04-21 出版日期:2023-09-15 发布日期:2023-09-14
通讯作者: ^*田月洁,男,硕士,主任药师,药物警戒。E-mail: tyuejie@163.com。^＃为共同通信作者。
作者简介:逄瑜,女,硕士,主管药师,药物警戒。^△为并列第一作者。
基金资助:
国家自然科学基金资助项目（72274065）

Exploring the significance of collecting patient reports based on international pharmacovigilance experience

PANG Yu¹, LIU Bo^2,Δ, LYU Shaoli¹, WANG Tao³, XING Ying¹, QIN Xingyu¹, TIAN Yuejie^4,*, WU Wenyu^5#

¹Remegen, Yantai Shandong 265503, China;
²Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
³Center for Drug Reevaluation, NMPA/NMPA key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
⁴Shandong Center for ADR Monitoring, Ji'nan Shandong 250014, China;
⁵Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518024, China

Received:2023-04-21 Online:2023-09-15 Published:2023-09-14

摘要/Abstract

摘要： 目的探讨《药物警戒质量管理规范》（Good Pharmacovigilance Practice, GVP）中企业收集患者报告的重要性及必要性。方法结合其他国家对患者报告的研究结果,讨论患者报告的价值,从而揭示收集患者报告的重要性。结果和结论 患者报告是医生报告的有利补充,有利于信号的发现,企业需要重视患者报告,建立患者报告收集途径并保证其顺畅。

关键词: 患者报告, 药物警戒, 药品不良反应, 药物警戒质量管理规范, 药品上市许可持有人

Abstract: Objective To explore the significance of enterprises collecting patient reports as stated in Good Pharmacovigilance Practice (GVP). Methods Review the literature about the research findings from various nations and discuss the value of patient reports to reveal the importance of collecting patient reports. Results and Conclusion Patient reports are a beneficial supplement to doctor reports and are conducive to signal detection. Enterprises should take patient reports seriously, establish paths for collecting patient reports, and ensure the paths work efficiently.

Key words: patient reports, pharmacovigilance, adverse drug reaction, good pharmacovigilance practice, marketing authorization holder

中图分类号:

R917

逄瑜, 刘博, 吕少俐, 王涛, 邢颖, 秦星宇, 田月洁, 吴文宇. 基于国际药物警戒经验探讨收集患者报告的意义[J]. 中国药物警戒, 2023, 20(9): 978-981.

PANG Yu, LIU Bo, LYU Shaoli, WANG Tao, XING Ying, QIN Xingyu, TIAN Yuejie, WU Wenyu. Exploring the significance of collecting patient reports based on international pharmacovigilance experience[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 978-981.

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基于国际药物警戒经验探讨收集患者报告的意义

Exploring the significance of collecting patient reports based on international pharmacovigilance experience

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