Marzal-Alfaro María Belen, Escudero-Vilaplana Vicente, Revuelta-Herrero Jose Luis, Collado-Borrell Roberto, Herranz-Alonso Ana, Sanjurjo-Saez Maria
Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
Front Oncol. 2021 Mar 11;11:636068. doi: 10.3389/fonc.2021.636068. eCollection 2021.
The use process for chimeric antigen receptor T (CAR-T) cell drugs is complex and has been associated with a number of potentially severe complications, which requires management by a multidisciplinary team. Pharmacists are a key element in the team and have roles and responsibilities. Our objective was to develop a structured and practical guide that supports hospital pharmacist responsibilities and defines specific activities in a CAR-T cell therapy program, specifically in Europe.
A literature review was performed, and the recommendations related to pharmacy practice in CAR-T therapy programs were analyzed. A multidisciplinary team was assembled, and meetings were held to address the key tasks in the CAR-T cells' management process and to create the guide, based on national and international recommendations and in expert's opinions.
The multidisciplinary team defined the following key tasks and issued recommendations to improve patient safety, treatment efficacy, and quality: patient selection and evaluation, CAR-T cell drug order to manufacturer, apheresis and material shipment, reception of CAR-T cell drug and storing, CAR-T cell drug prescription and pharmacy verification, CAR-T cell drug thawing and dispensing, CAR-T cell drug administration, patient education, pharmacovigilance and monitoring and outcomes' record and evaluation. In each task the pharmacist's role and how it can improve patient care are defined. A checklist was created to guarantee the compliance of standard operating procedures approved in the institution to manage CAR-T cell therapy and as a tool to collect required data for outcomes' record and evaluation.
This article provides a consensus set of safety recommendations regarding CAR-T therapy management in clinical practice, easily implementable by other institutions in the European setting. The guide identifies key steps where the involvement of hospital pharmacists would improve the safety and quality of the process and is a support guide to standardize hospital pharmacists' responsibilities within the multidisciplinary team.
嵌合抗原受体T（CAR-T）细胞药物的使用过程复杂，且与许多潜在的严重并发症相关，这需要多学科团队进行管理。药剂师是该团队的关键成员，有其角色和职责。我们的目标是制定一份结构化且实用的指南，以支持医院药剂师的职责，并明确CAR-T细胞治疗项目中的具体活动，特别是在欧洲。
进行了文献综述，并分析了与CAR-T治疗项目中药学实践相关的建议。组建了一个多学科团队，并召开会议讨论CAR-T细胞管理过程中的关键任务，根据国家和国际建议以及专家意见制定该指南。
多学科团队确定了以下关键任务，并发布了旨在提高患者安全性、治疗效果和质量的建议：患者选择与评估、向制造商订购CAR-T细胞药物、单采和材料运输、接收CAR-T细胞药物及储存、CAR-T细胞药物处方与药学核查、CAR-T细胞药物解冻与调配、CAR-T细胞药物给药、患者教育、药物警戒与监测以及结果记录与评估。在每项任务中都明确了药剂师的角色以及其如何改善患者护理。创建了一份检查表，以确保机构批准用于管理CAR-T细胞治疗的标准操作程序的合规性，并作为收集结果记录与评估所需数据的工具。
本文提供了一套关于临床实践中CAR-T治疗管理的安全建议共识，欧洲其他机构可轻松实施。该指南确定了医院药剂师参与将改善该过程安全性和质量的关键步骤，是在多学科团队中规范医院药剂师职责的支持指南。
