四川省医疗机构集中采购药品科学化管理标准操作规程和质控标准OA
Standard Operating Procedures and Quality Control Standards for the Scientific Management of Centrally Procured Drugs in Sichuan Province Medical Institutions
目的 建立四川省医疗机构集中采购(简称"集采")药品科学化管理的标准操作规程与质控标准,推动国家药品集采政策落地落实,确保各级医疗机构在执行国家药品集采政策中实现标准化、常态化与制度化管理.方法 依据国家集采政策要求,结合医疗机构管理实际,采用多轮问卷调研、德尔菲专家咨询法和共识会议相结合的研究路径,系统梳理并论证集采药品全流程管理的关键节点与控制要素.结果 成功构建了涵盖组织架构、采购量测算、合同分配、短缺应对、使用监测、质量监管及临床评价激励等 14 个关键环节的全流程管理体系,形成了标准化的操作规程与质控标准.结论 该套标准为医疗机构提供了可复制、可操作的管理工具,有助于提升该省集采药品管理的科学化、精细化水平,保障临床用药安全、有效与经济,为深化医药卫生体制改革提供了坚实的实践支撑.
Objective To establish the standard operating procedures(SOPs)and quality control standards for the scientific management of centrally procured drugs in medical institutions of Sichuan Province,thereby facilitating the effective im-plementation of national centralized drug procurement policies and ensuring standardized,routine,and systematic management across all levels of medical institutions.Methods Based on national centralized procurement policy requirements and the prac-tical management needs of medical institutions,this study adopted a multi-method approach,including iterative questionnaire sur-veys,Delphi expert consultation,and consensus meetings,to systematically identify and evaluate key processes and control ele-ments in the end-to-end management of centrally procured drugs.Results A comprehensive management framework encompas-sing 14 critical components was successfully developed,including organizational structure,procurement volume estimation,con-tract allocation,shortage response,usage monitoring,quality supervision,and clinical evaluation incentives.Standardized opera-ting procedures and quality control criteria support this framework.This framework is supported by standardized operating proce-dures and quality control criteria.Conclusions The formulated standards provide medical institutions with replicable and ac-tionable management tools,contributing to the enhancement of scientific and refined management of centrally procured drugs.These measures help ensure the safety,efficacy,and cost-effectiveness of clinical drug use,providing robust,practical support for deepening the reform of the pharmaceutical and healthcare systems.
李小丝;杨勇
医药卫生
药品集中带量采购医疗机构标准操作规程质量控制标准科学化管理
Centralized drug procurement with volumeMedical institutionsStandard operating proceduresQuality control standardsScientific management
《医药导报》 2026 (5)
741-746,6
国家卫生健康委员会药政司国家药物政策研究项目(国卫药政政策便函[2025]22号).
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