Pinturaud Marine, Vasseur Michèle, Odou Pascal
Centre Hospitalier Universitaire de Lille, Institut de Pharmacie, 59037 Lille, France.
Centre Hospitalier Universitaire de Lille, Institut de Pharmacie, 59037 Lille, France; Faculté de pharmacie de Lille, Unité Grita EA7365, 59000 Lille, France.
Bull Cancer. 2018 Dec;105 Suppl 2:S205-S213. doi: 10.1016/S0007-4551(19)30051-7.
CHIMERIC ANTIGEN RECEPTOR T-CELLS: Chimeric Antigen Receptor T-cells (CART) belongs to a new class of medicine, Advanced Therapy Medicinal Product, such as define by the European Regulation 1394/2007, and more exactly to the category of gene therapy medicinal product. Their status of medicine, as well as genetically modified organisms, imposes a particular circuit at hospital while maintaining a way over the Hospital Pharmacy. The manipulation of genetically modified cells is not usual in pharmacy. It requires, besides the acquisition of new skills, a not insignificant reorganization of the teams and the rooms of the pharmacy as well as an adapted training of the staff. A good communication is essential between the various actors of the circuit. The hospital pharmacist plays a key role in the implementation of a circuit adapted to this new type of medicine. This article aims to identify the roles of the hospital pharmacist and more generally of the pharmacy in the management of CART. We shall detail the specificities of this type of medicine in every stage of the circuit and the adaptations necessary to realize to guarantee the quality and the safety of the treatment by CART. Beyond the implementation of the circuit in the hospital, the pharmacist has an important role to be played in the follow-up of the patients after administration in view of the complexity of the side effects and a certain role in the training of the teams to this new medicine. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene.
医院药剂师在一类先进治疗药物产品(嵌合抗原受体T细胞)管理中的作用:嵌合抗原受体T细胞(CART)属于一类新型药物,即先进治疗药物产品,如欧洲法规1394/2007所定义的,更确切地属于基因治疗药物产品类别。它们作为药物以及基因改造生物体的地位,在医院中规定了一个特殊流程,同时医院药房也起到主导作用。在药房中对基因改造细胞进行操作并不常见。这除了需要掌握新技能外,还需要对药房团队和工作区域进行重大重组,以及对工作人员进行适应性培训。在整个流程的各个参与者之间进行良好的沟通至关重要。医院药剂师在实施适应这类新型药物的流程中发挥着关键作用。本文旨在确定医院药剂师以及更广泛意义上的药房在CART管理中的作用。我们将详细阐述这类药物在流程每个阶段的特殊性以及为确保CART治疗的质量和安全性而必须做出的调整。除了在医院实施该流程外,鉴于副作用的复杂性,药剂师在给药后对患者的随访中也发挥着重要作用,并且在对团队进行这种新药的培训方面也发挥一定作用。本文是在吉利德合作伙伴(Kite和新基)的机构支持下完成的“CAR-T细胞:一场治疗革命?”增刊的一部分。