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放射性药物与容器内容物的相互作用:眼见为实。

Container-content interactions with radiopharmaceuticals: Seeing is believing.

机构信息

Department of Nuclear Medicine, CHU de Caen Normandie, Normandy University, UNICAEN, 14000 Caen, France; Department of Pharmacy, CHU de Caen Normandie, Normandy University, UNICAEN, 14000 Caen, France.

Department of Nuclear Medicine, CHU de Caen Normandie, Normandy University, UNICAEN, 14000 Caen, France; Department of Pharmacy, CHU de Caen Normandie, Normandy University, UNICAEN, 14000 Caen, France; Normandie Université, UNICAEN, INSERM U1237, PhIND, Institut Blood and Brain @ Caen Normandie, Centre Cyceron, 14000 Caen, France.

出版信息

Eur J Pharm Biopharm. 2024 Mar;196:114200. doi: 10.1016/j.ejpb.2024.114200. Epub 2024 Jan 28.

DOI:10.1016/j.ejpb.2024.114200
PMID:38286343
Abstract

This perspective article addresses the critical issue of container-content interactions in the administration of intravenous medications, with a focus on radiopharmaceuticals used in nuclear medicine. Medication administration errors pose a significant challenge to patient safety. The "five rights" framework-ensuring the right patient, drug, time, dose, and route-serves as a cornerstone for safe drug administration. In the context of radiopharmaceuticals, notable for their use in nuclear medicine, adherence to these principles is paramount due to their unique properties and role in diagnostic and therapeutic procedures. The article explores the impact of container materials, particularly in syringes, on radiopharmaceutical stability and administration accuracy. It delves into the complexities of sorption phenomena, highlighting studies demonstrating its occurrence and potential consequences, including variations in administered doses and compromised diagnostic or therapeutic outcomes. Noteworthy factors influencing sorption include the type of radiopharmaceutical, container composition, molecular properties, and dilution. Findings revealing residual activity in syringes and identifying specific components, such as lubricants, silicon gaskets, and plungers, contributing to adsorption are presented. Migration of metal contaminants from container to content is discussed, emphasizing the potential impact on radiochemical yield and stability. There is a need for comprehensive studies to characterize drug-container interactions and poses crucial questions about the true benefit patients derive from prescribed activities. It challenges current practices, suggesting a need for tailored activity levels, container validation protocols, and rigorous testing of hospital preparations. Ultimately, this perspective paper calls for a deeper understanding of these interactions, urging regulatory consideration and standardization to ensure optimal drug administration and patient outcomes.

摘要

这篇观点文章探讨了静脉药物给药中容器-内容物相互作用的关键问题,重点关注核医学中使用的放射性药物。药物给药错误对患者安全构成重大挑战。“五正确”框架——确保正确的患者、药物、时间、剂量和途径——是安全给药的基石。在放射性药物的背景下,由于其在诊断和治疗程序中的独特特性和作用,这些原则的遵守至关重要。文章探讨了容器材料(特别是注射器)对放射性药物稳定性和给药准确性的影响。它深入研究了吸附现象的复杂性,强调了研究表明其发生的情况及其潜在后果,包括给药剂量的变化和诊断或治疗结果受损。影响吸附的重要因素包括放射性药物的类型、容器组成、分子特性和稀释度。研究结果揭示了注射器中残留的活性,并确定了特定成分,如润滑剂、硅垫圈和柱塞,会导致吸附。还讨论了从容器到内容物的金属污染物迁移问题,强调了对放射性化学产率和稳定性的潜在影响。需要进行全面研究来描述药物-容器相互作用,并对患者从规定活动中获得的真正益处提出了关键问题。它挑战了当前的实践,建议需要制定适当的活动水平、容器验证协议和对医院制剂的严格测试。最终,这篇观点文章呼吁更深入地了解这些相互作用,敦促监管部门考虑和标准化,以确保最佳的药物给药和患者结果。

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