美国FDA药品风险评估与减低策略实施研究

doi:10.19803/j.1672-8629.2020.12.05

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (12): 871-876.
DOI: 10.19803/j.1672-8629.2020.12.05

美国FDA药品风险评估与减低策略实施研究

卫付茜^1,2, 张威^1,2, 杨悦^1,2*

¹沈阳药科大学工商管理学院,辽宁沈阳 110016;
²沈阳药科大学药品监管科学研究院,辽宁沈阳 110016

收稿日期:2020-03-20 修回日期:2020-12-07 出版日期:2020-12-15 发布日期:2020-12-07
通讯作者: ^*杨悦,女,博士,教授,药事管理与法规。E-mail:yyue315@vip.126.com
作者简介:卫付茜,女,在读硕士,药事管理与法规。

Implementation of US FDA's Drug Risk Evaluation and Mitigation Strategies

WEI Fuqian^1,2, ZHANG Wei^1,2, YANG Yue^1,2*

¹School of Business Administration,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China;
²Academy of Drug Regulatory Sciences,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China

Received:2020-03-20 Revised:2020-12-07 Online:2020-12-15 Published:2020-12-07

摘要/Abstract

摘要： 目的分析美国FDA风险评估与减低策略政策实施现状及运行方式,为我国《药品管理法》中药品风险管理计划条款落实提供参考。方法查阅中外文献以及FDA批准的风险评估与减低策略,对已经批准和撤销的独立风险评估与减低策略及单一共享系统风险评估与减低策略进行分析。结果风险评估与减低策略作为风险管理计划的一种类型,是动态的风险管理工具。并非所有药品都需要风险评估与减低策略,风险干预工具的优先使用原则应当由简入繁,由易到难。无论采取什么样的风险管理工具,风险管理计划必须直接干预到医生和患者。结论我国应探索《药品管理法》设定的风险管理计划执行路径,建立适应性的药品风险管理计划实施路径和配套文件,对药品风险进行动态控制。

关键词: 风险评估与减低策略, 药品, 风险, FDA, 风险管理工具

Abstract: Objective To analyze the current implementation and operation methods of the US FDA’s Risk Evaluation and Mitigation Strategies (REMS), and to provide reference for the implementation of the drug risk management plan specified in the Drug Administration Law of China.Methods Chinese and foreign literature and the FDA-approved REMS were reviewed, and the single system and shared system for implementation of REMS that had been approved and revoked were analyzed.Results As a risk management plan, REMS is a dynamic risk management tool. Not all drugs require REMS. The principle of prioritizing the use of risk minimization tools should be from simple to complex, from easy to difficult. Regardless of the risk management tool adopted, the risk management plan has to intervene with doctors and patients directly.Conclusion China should explore ways to execute the risk management plan specified by the Drug Administration Law, establish an adaptive method of implementing the drug risk management plan and formulate supporting documents in order to control drug risks dynamically.

Key words: risk evaluation and mitigation strategies, drug, risk, FDA, risk management tools

中图分类号:

卫付茜, 张威, 杨悦. 美国FDA药品风险评估与减低策略实施研究[J]. 中国药物警戒, 2020, 17(12): 871-876.

WEI Fuqian, ZHANG Wei, YANG Yue. Implementation of US FDA's Drug Risk Evaluation and Mitigation Strategies[J]. Chinese Journal of Pharmacovigilance, 2020, 17(12): 871-876.

参考文献

[1] Ning YY,Yang Y.Implication of American drug risk management for China[J].Chinese Journal of New Drugs(中国新药杂志),2010,19(23):2120-2123.
[2] FDA.Risk Evaluation and Mitigation Strategies| REMS[EB/OL].(2019-08-08)[2020-03-13].https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
[3] Zhao P,Xu MT,Yang Y.Analysis on Current Situation and Trend of FDA's Risk Evaluation and Mitigation Strategy[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2013,10(4):210-214.
[4] FDA.Approved Risk Evaluation and Mitigation Strategies (REMS)-REMS Report[EB/OL].(2020-02-28)[2020-02-28].https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
[5] FDA.SUMMARY REVIEW (022405Orig1s000)[EB/OL].(2011-04-01)[2020-03-09].https:/www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000SumR.pdf.
[6] FDA.LETTER (NDA 022405)[EB/OL].(2011-04-06)[2020-03-09].https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s000ltr.pdf.
[7] FDA.Approved Risk Evaluation and Mitigation Strategies (REMS)(vandetanib (Caprelsa))[EB/OL].(2017-05-16)[2020-03-02].https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=Indv RemsDetails.page&REMS=11.
[8] FDA.Label (VIVITROL (naltrexone for extended-release injectable suspension))[EB/OL].(2006-04-13)[2020-03-09].https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf.
[9] FDA.Label(VIVITROL (naltrexone for extended-release injectable suspension))[EB/OL].(2019-09-06)[2020-03-09].https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021897s045lbl.pdf.
[10] FDA.NDA 021897/S-005&S-010[EB/OL].(2010-03-22)[2020-03-09].https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf.
[11] FDA.NDA 021897/S-020,S-023(SUPPLEMENT APPROVAL)[EB/OL].(2013-07-29)[2020-03-09].https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf.
[12] Zhao P,Bian L,Yang Y.FDA's Risk Evaluation and Mitigation Strategy and the Inspirations to Our Country[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2013,10(3):140-144.
[13] Jasmanda W,Juhaeri The US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) Program-Current Status and Future Direction[J].Clinical Therapeutics,2016,38(12):2526-2532.
[14] FDA.Letter-Supplement Approvals (Remove Rems Element)[EB/OL].(2014-05-07)[2020-03-10].https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf.
[15] FDA.Drugs@FDA:FDA-Approved Drugs[EB/OL].(2020-03-02)[2020-03-02].https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf.

美国FDA药品风险评估与减低策略实施研究

Implementation of US FDA's Drug Risk Evaluation and Mitigation Strategies

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[2]	马美英, 赵晓佩, 张梦瑶, 胡一琳. 我国药品追溯码编码制度研究探讨[J]. 中国药物警戒, 2024, 21(2): 167-172.
[3]	张建, 方慧华. 某院活血化瘀类中药注射剂使用评价标准建立的探索[J]. 中国药物警戒, 2024, 21(2): 185-189.
[4]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[5]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[6]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[7]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[8]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[9]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[10]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[11]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[12]	方志娥, 李承贤, 柏兆方, 赵旭, 王伽伯, 肖小河. 马兜铃酸致肝癌的客观性研究与思考[J]. 中国药物警戒, 2024, 21(1): 20-24.
[13]	熊玮仪, 任经天. 抗肿瘤药说明书安全性信息上市后修订的考虑要点[J]. 中国药物警戒, 2024, 21(1): 94-97.
[14]	刘敏, 陈艳, 刘文东, 王海学. 药物临床试验期间安全性数据快速报告的更新与思考[J]. 中国药物警戒, 2024, 21(1): 98-101.
[15]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.