中国药物警戒 ›› 2015, Vol. 12 ›› Issue (12): 735-739.

• 药物警戒专栏 • 上一篇    下一篇

中国首个预防瑞复美 胎儿暴露的风险最小化项目

詹骁靖1, 李敏1, 邹建军1   

  1. 1新基医药信息咨询(上海)有限公司,中国上海200020;
    2新基医药,美国 新泽西州07922;
    3新基(澳大利亚)独立股份公司,澳大利亚 墨尔本3004
  • 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: LONDON Calvin,男,新基公司亚太合规资深总监,医疗行业的合规。E-mail:clondon@celgene.com
  • 作者简介:詹骁靖,女,硕士, 药物安全。

First Risk Minimization Program for Preventing Foetal Exposure of Revlimid in China

ZHAN Xiao-jing1,LI Min1,ZOU Jian-jun1,BWIRE Robert2,LONDON Calvin3*   

  1. 1Celgene Pharmaceutical (Shanghai) Co. Ltd, Shanghai 200020, China;
    2Celgene Corporation, New Jersey 07922, United States;
    3Celgene Pty Australia, Melbourne 3004, Australia
  • Received:2016-02-02 Revised:2016-02-02 Online:2015-12-08 Published:2016-02-02

摘要: 目的讨论新基公司瑞复美 (来那度胺)RevCare 在中国的项目设计、实施以及在实施后的前18个月的成果。方法根据中国市场所特有的医疗实践情况,在新基全球RMP的原则与要求基础上,设定RevCare 3个核心要素。同时开发了i-access IT系统,作为RevCare 的数据库,协助该项目的依从性监控。结果处方医生及药师是 RevCare

Abstract: Objective To discuss the design, implementation, and the outcome from the first eighteen months of the Celgene product Revlimid project, RevCare . Methods RevCare was developed based on the global principles and requirements of Celgene RMP, and the unique medical practices in China. RevCare consists of 3 core elements. Meanwhile, i-access , a IT system, has been developed to serve as the database for RevCare , and also contributes to the compliance control of the program. Results Prescribers and pharmacists are key players in the program. The impact on their daily work brought by RevCare is considered as reasonable. The compliance rate of RevCare is high during the first eighteen months of implementation since the launch of Revlimid and there is no report of pregnancy related to the use of the drug. It suggests the effectiveness of the program in controlling the risk of Revlimid fetal exposure. Conclusion RevCare , the first PPP requires significant interaction and collaboration between Celgene with prescribers and pharmacists. The first eighteen months of implementation, general acceptance by the healthcare community and high levels of compliance suggest its effectiveness in minimizing risk of Revlimid fetal exposure, and consequently protecting the safety of Chinese patients in the need of medicine.

Key words: lenalidomide, risk minimization program, pregnancy prevention program, compliance, effectiveness

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