Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (12): 735-739.

• Orginal Article • Previous Articles     Next Articles

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

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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