英国患者报告制度建立的浅析与启示

doi:10.19803/j.1672-8629.20230476

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (11): 1259-1263.
DOI: 10.19803/j.1672-8629.20230476

英国患者报告制度建立的浅析与启示

逄瑜¹, 刘博^2△, 吴文宇³, 田月洁^4,*, 王涛^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,北京 102629;
³深圳市药物警戒和风险管理研究院,广东深圳 518024;
⁴山东省药品不良反应监测中心,山东济南 250014;
⁵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 100076

收稿日期:2023-08-09 出版日期:2023-11-15 发布日期:2023-11-13
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）; 药品再评价政策法规及实施策略研究（2017ZX09101001-001-003）

Establishment of patient reporting scheme in the UK and its implications

PANG Yu¹, LIU Bo^2△, WU Wenyu³, TIAN Yuejie^4,*, WANG Tao^5#

¹Remegen, Yantai Shandong 265503, China;
²National Institutes for Food and Drug Control, Beijing 102629, China;
³Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518024, China;
⁴Shandong Center for ADR Monitoring, Jinan Shandong 250014, China;
⁵Center For Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China

Received:2023-08-09 Online:2023-11-15 Published:2023-11-13

摘要/Abstract

摘要： 目的通过分析英国患者报告制度的建立过程,为我国建立患者报告制度提供参考。方法通过查阅文献,分析英国“黄卡计划”中患者报告制度建立过程。结果英国开展全国试点工作,向患者直接收集不良报告,,报告数量显著提高,而后英国正式实施患者报告制度。结论英国患者报告制度是对原有“黄卡计划”的补充,只有建立患者直接报告途径才能达到患者报告制度的预期效果。我国监管机构可参考英国患者报告制度建立的经验,通过开展试点工作探索建立符合我国国情的患者报告制度。

关键词: 药物警戒, 黄卡计划, 药品不良反应, 患者报告, 制度, 英国

Abstract: Objective To analyze the process in which the UK established the patient reporting scheme and provide reference for the start of an adverse drug reaction patient reporting scheme in China. Methods Based on literature review, the process of establishing the patient reporting scheme in the UK was analyzed. Results UK launched a nationwide pilot program to collect patients’ reports directly from patients, which greatly increased the total number of ADR reports. Subsequently, the patient reporting scheme was officially implemented. Conclusion The patient reporting scheme in the UK is a supplement to the existing yellow card scheme. Only through direct patient reporting can we get the expected results of the patient reporting scheme. It is recommended that China learn from the related experience in the UK to initiate a pilot program to start a patient reporting scheme that is workable in China.

Key words: pharmacovigilance, yellow card scheme, adverse drug reaction, patient reporting, scheme, UK

中图分类号:

R951
R994.11

逄瑜, 刘博, 吴文宇, 田月洁, 王涛. 英国患者报告制度建立的浅析与启示[J]. 中国药物警戒, 2023, 20(11): 1259-1263.

PANG Yu, LIU Bo, WU Wenyu, TIAN Yuejie, WANG Tao. Establishment of patient reporting scheme in the UK and its implications[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1259-1263.

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英国患者报告制度建立的浅析与启示

Establishment of patient reporting scheme in the UK and its implications

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