美国异维A酸上市后风险控制措施研究

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (12): 748-752.

美国异维A酸上市后风险控制措施研究

刘思齐¹, 刘文源², 杨悦^1*

1沈阳药科大学工商管理学院,辽宁沈阳 110016；
2沈阳军区总医院,辽宁沈阳 110016

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: 杨悦,女,教授,博导,药事法规与药品政策。E-mail：yyue315@126.com
作者简介:刘思齐,女,在读硕士,药事管理。

Research on Isotretinoin Post-Marketing Risk Control in America

LIU Si-qi¹, LIU Wen-yuan², YANG Yue^{1, *}

1College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
2Shenyang Military General Hospital, Liaoning Shenyang 110016, China

Received:2016-02-02 Revised:2016-02-02 Online:2015-12-08 Published:2016-02-02

摘要/Abstract

摘要： 目的通过研究美国异维A酸上市后风险控制措施,以期为我国建立完善的药品上市后风险管理体系提供参考。方法通过查阅FDA药品上市后风险管理指南及法规,分析美国对异维A酸致畸和致抑郁甚至自杀风险的干预措施,并与我国采取的相关风险控制措施进行对比。结果美国实施一系列的风险管理措施,如随处方一起发放的用药指南,处方医生、患者、药房、批发商必须遵守一定的安全用药规定,定期评估风险控制效果并不断完善等,在很大程度上控制异维A酸使用风险。结论美国药品上市后风险管控思路和措施对我国具有一定的借鉴意义。

关键词: 异维A酸, 风险评估与减低策略, iPLEDGE

Abstract: ObjectiveTo research isotretinoin post-marketing risk control in America, and make reference for developing sophisticated drug post-marketing risk management system in our country. MethodsDrug post-marketing risk management regulation and guidance of America were looked up, the risk control measurements against teratogenesis and depression induced by isotretinoin were analyzed, and the risk control carried out by America and China were compared. ResultsFDA conducts a series of risk manage measures, such as medication guide dispensed with prescription, specific requirement which prescribers, patients, pharmacies and wholesalers must follow to assure safe use, evaluating the effect of risk mitigation periodically and improving accordingly, as a result, they control the risk to a large extent. ConclusionDrug post-marketing risk control concepts and designs are useful references for China.

Key words: isotretinoin, risk evaluation and mitigation strategies, iPLEDGE

中图分类号:

刘思齐, 刘文源, 杨悦. 美国异维A酸上市后风险控制措施研究[J]. 中国药物警戒, 2015, 12(12): 748-752.

LIU Si-qi, LIU Wen-yuan, YANG Yue. Research on Isotretinoin Post-Marketing Risk Control in America[J]. Chinese Journal of Pharmacovigilance, 2015, 12(12): 748-752.