德拉马尼上市后研究项目药品全流程管理模式探索

Exploration of the Whole Process Management Mode of Drug in the Post Marketing Research Project of Delamanid

本文从项目药品管理、入组管理和药学监护三个环节阐述对德拉马尼上市后研究项目药品的流通、使用进行全方位把控,保证药品质量及接收发放过程的正确性,患者与项目匹配度、依从性,实时记录相关药物治疗及不良反应情况,做到用药细节全程可追溯。在符合项目管理规范的同时,进一步探索患者用药环节的科学管理方法,保证了项目患者用药规范安全有效。

In this paper,the circulation and use of drugs in the post-marketing research project of Delamani are controlled in an all-round way from the three links of project drug management,group management and pharmaceutical care,so as to ensure the quality of drugs and the correctness of the process of receiving and distributing,the matching degree and compliance of patients and projects,and the real-time recording of related drug treatment and adverse reactions,so that the details of drug use can be traced back.While conforming to the project management norms,the scientific management methods of patients'medication links were further explored to ensure the safety and effectiveness of patients'medication norms.