DTP药房冷链药品质量管理现状及风险管理前置化措施探讨  

Exploring the current status of quality management of cold chain medicines in DTP pharmacies and the measures for pre-emptive risk management

作　　者：王木兰 林鹏 涂司武 陈珍珍 王洪桥 WANG Mulan;LIN Peng;TU Siwu;CHEN Zhenzhen;WANG Hongqiao(Jiangxi Drug Inspection Center,Nanchang 330029,China)

机构地区：[1]江西省药品检查员中心,南昌330029

出　　处：《中国药房》2025年第4期395-400,共6页China Pharmacy

基　　金：江西省药品监督管理局科研项目(No.2023GL22,No.2024GL14)。

摘　　要：目的调研直接面向患者(DTP)药房冷链药品质量管理现状并提出风险管理前置化措施,为做好冷链药品质量管理提供参考。方法基于国家相关法规要求,采用调查问卷、电话采访、实地访问的方式,于2023年11月-2024年2月对我国J省的DTP药房冷链药品收货、储存、发货、配送环节中的质量管理情况进行调研,找出冷链药品经营过程中质量管理的常见问题,分析原因并提出可行的风险管理前置化措施。结果与结论122家DTP药房参与了问卷调查,30家DTP药房的负责人参与了实地访问和电话访问。部分DTP药房存在人员配备或培训不足、质量体系文件制定不全面或执行不充分、冷链设施设备配备或管理不到位、冷链药品储存与配送不规范等问题,冷链药品的经营质量管理存在一定风险。建议DTP药房采取加强人员配备和培训工作、完善质量体系文件、强化设施设备的配备与管理、规范储运操作并强化监督考核等前置化措施,社会各方也应从保障冷链药品储运安全出发协同治理,以减少冷链药品经营过程中质量安全问题的发生,保障患者用药安全有效。OBJECTIVE To investigate the current status of quality management of cold chain medicines in direct-to-patient(DTP)pharmacies and propose measures for pre-emptive risk management,providing references for the quality risk management of cold chain medicines.METHODS Based on the requirements of national regulations,a survey was conducted on the quality management of cold chain medicines in DTP pharmacies of J Province from November 2023 to February 2024,focusing on the receipt,storage,distribution,and delivery processes,using questionnaires,telephone interviews,and on-site visits.Common quality management issues in the operation of cold chain medicines were identified,and the causes of these issues were analyzed to propose feasible pre-emptive risk management measures.RESULTS&CONCLUSIONS A total of 122 DTP pharmacies participated in the questionnaire survey,and personnel from 30 DTP pharmacies participated in on-site and telephone interviews.Typical problems were identified in some DTP pharmacies,including insufficient personnel allocation or training,incomplete or inadequate implementation of quality system documentation,inadequate provision or management of cold chain facilities and equipment,and non-compliant storage and distribution of cold chain medicines.These issues posed certain risks to the quality management of cold chain medicines.It is recommended that DTP pharmacies strengthen personnel allocation and training,improve quality system documentation,enhance the provision and management of facilities and equipment,standardize storage and transportation operations,and strengthen supervision and assessment as pre-emptive measures.In addition,all sectors of society should also collaborate in governance from the perspective of ensuring the safety of cold chain drug storage and transportation,in order to mitigate the risk of quality and safety issues during the distribution of cold chain drugs and guarantee the safe and effective use of medications for patients.

关 键 词：直接面向患者药房 冷链药品 质量管理 风险管理 前置化管理 

分 类 号：R952[医药卫生—药学]