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[扩大准入、同情用药和试验后准入中的药学服务:临床研究人员的视角]

[Pharmaceutical services in expanded access, compassionate use, and post-trial access: the perspective of clinical researchers].

作者信息

Silva Maria Bárbara Faria Cardoso da, Silva Cecilia Ferreira da, Silva Mario Jorge Sobreira da

机构信息

Instituto Nacional de Câncer, Rio de Janeiro, Brasil.

Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.

出版信息

Cad Saude Publica. 2025 Jun 27;41(5):e00128824. doi: 10.1590/0102-311XPT128824. eCollection 2025.

Abstract

This study sought to understand the flows of pharmaceutical services and the contributions of pharmacists in expanded access programs, compassionate use, and the post-trial access of medications, from the perspective of healthcare professionals experienced in clinical research. A organizacional case study was conducted at an oncology hospital in Rio de Janeiro, followed by the administration of a questionnaire to pharmacists from different regions of Brazil. The study was grounded in Denzin's theoretical framework of interpretive interactionism. Data were analyzed using an explanatory construction technique and interpreted via thematic content analysis. In total, three thematic axes emerged: the operationalization of pharmaceutical services; the clinical responsibilities of the pharmacist; and continuous quality improvement. A total of ten professionals participated in the organizational case study phase, and 12 responded to the questionnaire. The results indicated convergent needs, underscoring the importance of optimizing logistical and operational activities, drug therapy monitoring, continuing education, pharmacovigilance, information dissemination, and healthcare quality. These findings have the potential to inform future guidelines to enhance program processes, address regulatory gaps, and provide better support for healthcare.

摘要

本研究旨在从临床研究经验丰富的医疗专业人员的角度,了解药品服务流程以及药剂师在扩大用药项目、同情用药和试验后药物获取方面的贡献。在里约热内卢的一家肿瘤医院进行了组织案例研究,随后向巴西不同地区的药剂师发放了问卷。该研究基于丹曾的解释性互动主义理论框架。使用解释性构建技术对数据进行分析,并通过主题内容分析进行解读。总共出现了三个主题轴:药品服务的实施;药剂师的临床职责;以及持续质量改进。共有10名专业人员参与了组织案例研究阶段,12人回复了问卷。结果表明存在趋同需求,强调了优化后勤和运营活动、药物治疗监测、继续教育、药物警戒、信息传播和医疗质量的重要性。这些发现有可能为未来的指南提供参考,以加强项目流程、填补监管空白并为医疗保健提供更好的支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb82/12212296/3fc6d358d774/1678-4464-csp-41-05-PT128824-gf1.jpg

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