日间化疗中心的PIVAS开展GCP试验用药品调配工作的流程探讨

Discussion of GCP Trial Drug Dispensing Workflow in PIVAS of Daytime Chemotherapy Center

目的:探索药物临床试验质量管理规范(GCP)试验用药品调配工作的新型管理模式。方法:结合本院日间化疗中心的静脉用药集中调配中心(PIVAS)(简称“日间PIVAS”)的相关经验,对临床试验用药品调配任务确认与开展工作流程中的各个节点,以及其他需要注意的事项进行探讨。结果:新的临床试验立项成功后,首先由申办方监查员与项目负责人确认项目中涉及的药品是否需要在日间PIVAS进行集中配置,然后将相关资料递交至PIVAS进行申请备案。日间PIVAS药师经启动培训并经授权后方可参与相关项目试验用药品的调配工作。医师在医院管理信息系统为受试者开具医嘱后,由研究护士将药品从GCP药房取出并交到日间PIVAS收药窗口。药师接受药品后进行摆药校对,然后由经项目组培训并授权的冲配药师进行混合调配,由审核药师对配置完毕的输液成品进行核对、贴标签等操作。此外,日间PIVAS会定期汇总在调配流程各个环节中关于试验用药品配置情况的反馈信息以及经费管理情况,以提升流程的规范性。结论:日间PIVAS开展临床试验用药品调配工作能保证药品批次的合理安排,保障用药的流畅有序,并可满足不同药品的稳定性要求,可提高试验用药品的调配管理水平,进一步推动我国药物临床试验项目的开展。

OBJECTIVE:To explore the new management model of Good Clinical Practice(GCP)trial drug dispensing.METHODS:Base on the relevant experience of Pharmacy Intravenous Admixture Services(PIVAS)in daytime chemotherapy center(“daytime PIVAS”for short)of our hospital,the nodes and other matters needing attention were discussed in the workflow of confirmation and development of drug dispensing tasks for clinical trials.RESULTS:After the successful approval of the new clinical trial,the supervisor of the sponsor and the principal investigator should first confirm whether the drugs involved in the project needed to be centrally dispensed in the daytime PIVAS,and then submitted the relevant data to PIVAS for filing.Daytime PIVAS pharmacists could participate in trial drug dispensing of relevant projects only after starting training and authorization.After the doctor issued the medical order for the subjects in the hospital information system,the research nurse took the drugs out of the GCP pharmacy and handed them to the daytime PIVAS drug receiving window.After receiving the drugs,the pharmacist would check the dispensing,and then the preparation pharmacist trained and authorized by the project team would mix and dispense the drugs.The reviewed pharmacist would check and label the prepared infusion.In addition,daytime PIVAS would regularly summarize the feedback information on the trial drug dispensing and fund management in all links of dispensing process,so as to improve the standardization of the process.CONCLUSIONS:Daytime PIVAS for clinical trial drug can arrange batches more rationally,ensure smooth and orderly infusion,and meet different drug stability requirements,which can improve trial drug dispensing management and further promote the development of drug clinical trial projects in China.