对FDA扩展访问计划的药剂师领导工作流程的评估.
Blake T Barta1, Ann McGee2, Beth McLendon Arvik2
1Duke University Hospital, Durham, NC, and University of North Carolina at Chapel Hill Eshelman School of Pharmacy, Chapel Hill, NC, USA.
概括
药剂师需要大量的资源来管理扩展访问计划 (EAP). 这项研究发现,未获得补偿的EAP服务每年花费大约196,500美元,突出了同情使用药物计划的财务可持续性.
科学领域:
- 药房实践 在药房实践.
- 调查性药物管理研究
- 扩展访问程序 扩展访问程序
背景情况:
- 扩展获取计划 (EAP) 便于患者在临床试验之外获得试验药物.
- 关于药剂师领导的工作流程和管理EAP请求的资源需求的数据有限.
- 医疗保健系统在维持EAP服务方面面临挑战,原因是缺乏对相关劳动力成本的补偿.
研究的目的:
- 药剂师需要对个体患者和小人群 EAP 管理试验药物的资源进行表征.
- 为了确定医疗机构收到的EAP请求类型.
- 分享一个由药剂师领导的工作流来管理EAP请求.
主要方法:
- 回顾性,单中心,观察性研究.
- 审查2017年8月1日至2023年2月11日期间提交给杜克大学医院 (DUH) 的EAP请求.
- 分析机构政策对EAP批准率的影响.
主要成果:
- 在要求药品和治疗 (P&T) 委员会批准的机构政策之后提交的168个EAP申请中,有162个 (96.4%) 获得批准.
- 预计2023年杜哈尔大学未获得补偿的EAP服务的年化成本约为196,500美元.
- 该研究确定了EAP管理的重大劳动力资源需求.
结论:
- 药剂师领导的EAP服务工作流程是必不可少的,但资源密集.
- 缺乏EAP服务的报销对医疗保健系统构成了财务挑战.
- 需要进一步的战略来确保同情使用计划的财务可持续性.
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