中国首个预防瑞复美~胎儿暴露的风险最小化项目

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

目的讨论新基公司瑞复美(来那度胺)Rev Care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Rev Care 3个核心要素。同时开发了i-access IT系统,作为Rev Care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Rev Care执行的关键环节,该项目给他们日常工作带来的影响有限。Rev Care在自来那度胺上市后的前18个月的执行中依从率高,中国至今未报告发生任何服用来那度胺后的妊娠案例,证明了Rev Care项目在控制瑞复美的胎儿暴露风险方面的有效性。结论作为中国的首个PPP,Rev Care需要公司与处方医师及药师的紧密沟通与合作,在项目实施的前18个月得到了医护人员的普遍接受并达到了较高的依从率,具有可操作性,同时该项目也能有效降低瑞复美的胎儿暴露风险,从而保护使用该药的中国患者的安全。

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.