摘要
个体化药学服务作为临床药学工作的重要内容,正处于快速发展阶段,以基因检测、血药浓度监测等技术作为核心支撑内容,离不开规范化的检测实验室.而目前个体化药物治疗实验室建设标准的研究较少,仅有几篇关于精准医学实验室建设的报道,尚未形成标准化的建设和运行管理体系,严重制约我国精准药学服务的开展.因此,在个体化药物治疗实验室的建设中,亟须建立标准化的质量管理体系,以保障精准检测的安全高效和实验室的有效运行.本共识由全国多家专业机构的个体化医学专家形成.共识形成前进行了充分调研和讨论,进行了专家意见的综合,最终形成了个体化药物治疗实验室建设标准专家共识.旨在为医疗机构建设个体化药物治疗实验室提供参考意见.
Abstract
As an integral part of clinical pharmacy practice,individualized pharmaceutical service is currently developing rap-idly with core supports of genetic testing,blood drug concentration monitoring and other technologies.Standardized testing labora-tories are urgently needed.However,little researches have addressed the construction standards of personalized drug therapy labo-ratories.Only few reports focused upon the construction of precision medicine laboratories.Lacking a standardized construction and operation management system leads to severe constraints on the development of precision pharmaceutical services in China.Therefore it is imperative to establish a standardized quality management system to ensure the safety and efficiency of precise test-ing and an effective operation of laboratory.Through extensive researches,thorough discussions and intensive synthesis of expert opinions,this consensus was compiled by individualized medical experts from multiple professional institutions across mainland China.It was intended to provide references for constructing personalized drug therapy laboratories at medical institutions in China.