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医疗机构放射性药品安全监管风险挑战与对策分析

Challenges to Regulation of Safety of Radiopharmaceuticals in Medical Institutions and Countermeasures
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摘要 放射性药品在疾病诊断与治疗中具有不可替代的作用,随着医疗机构放射性药品的广泛使用,安全管理风险日益凸显。本文结合药监机构对医院日常监督检查中发现的放射性药品管理问题,分析医疗机构放射性药品储存、使用及废弃物处置等环节存在的风险隐患及其成因,探讨医疗机构加强放射性药品管理的措施办法,提出健全专业化放射性药品监管体系、优化医疗机构放射性药品全流程管控机制、推动放射性药品信息化监管建设以及构建放射性药品科普传播矩阵等优化策略,以期为完善医疗机构放射性药品全生命周期监管提供参考。 Radiopharmaceuticals play an irreplaceable role in diagnosis and treatment of diseases.With amendments to national guidelines and the wide use of radiopharmaceuticals in medical institutions,risks to safety management have become increasingly prominent.This article analyzes the potential risks and contributing factors to the storage,usage,and waste disposal of radiopharmaceuticals in medical institutions based on problems identified during routine supervision and inspections.Optimization strategies are proposed,including establishing a specialized regulatory system,improving whole-process control mechanisms,boosting the development of information-based regulatory platforms,and building a science communication matrix for public education.The article is intended to provide references for improving the whole-life-cycle regulation of radiopharmaceuticals in medical institutions.
作者 陈醒 贾令茹 陈志民 韩泽业 沈盈盈 孙杨杨 张心悦 CHEN Xing;JIA Ling-ru;CHEN Zhi-min;HAN Ze-ye;SHEN Ying-ying;SUN Yang-yang;ZHANG Xin-yue(Unit for Drug and Instrument Supervision and Inspection of Wuxi Joint Logistic Support Center,Nanjing 210000,China;Wuxi Joint Logistic Support Center,Wuxi 214000,China)
出处 《解放军药学学报》 2025年第3期300-303,共4页 Pharmaceutical Journal of Chinese People's Liberation Army
关键词 放射性药品 放射性药品风险分析 放射性药品安全监管 radiopharmaceuticals radiopharmaceuticals risk analysis radiopharmaceuticals regulation of safety
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