广东省人民医院超说明书用药临床管理方法与流程研究

Study on Clinical Management Methods and Process of Off-label Drug Use in Guangdong General Hospital

广东省人民医院从管理层面上开展了超说明书用药临床管理方法与流程研究,制订了超说明书用药管理规定、流程和策略,旨在规范临床超说明书用药行为。该院于2013年2月正式启动超说明书用药申请备案审批流程,首批接到5个临床专业合计22个药品超说明书用药申请,药事管理和药物治疗学委员会按规程审核,批准了8个药品的超说明书用药备案,否定了1个申请。该院采用由药事管理与药物治疗学委员会制订的超说明书用药管理办法规范临床医师超说明书用药效果显著,对进一步规范该院临床超说明书用药具有重要意义。

A study on clinical management methods and process of off-label drug use （OLDU） is carried out at man- agerial level in the Guangdong General Hospital to develop management regulations, processes and strategies of OLDU, so as to regulate OLDU behaviour in clinic. The hospital officially initiated the application-recording-approval process of OLDU in February, 2013, receiving 22 OLDU applications from 5 clinical departments in the first batch. The pharmacy management and pharmacotherapeutics committee approved eight applications and rejected one application according to regulation procedures. In this way, the Guangdong General Hospital well regulate the OLDU behaviour of physicians, which is significant to the further studies in OLDU in this hospital.