The pharmacist’s role in chimeric antigen receptor T cell therapy

Abstract

The emergence and efficacy of chimeric antigen receptor (CAR) T cell therapy in previously incurable malignancies represents a promising paradigm shift in cancer care. However, it is not without significant clinical, operational, and financial considerations. Pharmacists should be prepared to fulfill the various roles in CAR T cell therapy provision including: policy development; electronic medical record build; patient and staff education; patient selection; procurement, storage, and handling; medication administration and supportive care; management of adverse reactions; and quality tracking. Our commentary provides an overview of the opportunities for pharmacy involvement in the implementation and maintenance of a CAR T cell therapy program with an emphasis on the importance of pharmacy involvement as part of a multidisciplinary approach to care. Although some institutions have dedicated a CAR T cell pharmacist to meet the demands of emerging CAR T cell therapy, we believe that clinical pharmacists practicing in hematopoietic stem cell transplant and hematology/oncology have the skills and training to fulfill the pharmacist’s role in CAR T cell therapy.

Chimeric Antigen Receptor-T (CAR-T) Cells as “Living Drugs”: A Clinical Pharmacist Perspective

“…Terapy. Pharmacists play an intrinsic role in all steps of the CAR-T treatment cycle (Figure 5) including governance and operational and clinical aspects, particularly toxicity management and postinfusion care [13,90].…”

“…Te operational role of pharmacists in the provision of CAR-T cell therapies is multifaceted and critical to the success of these innovative treatments and as per FACT-JACIE standards (Figure 5). Pharmacists are responsible for ensuring the provision and implementation of relevant policies by serving on drugs and therapeutics committees and by providing recommendations and developing guidelines and standard operating procedures (SOPs) regarding the transportation and handling of CAR-T cell products, administration of the product, risk management plan (RMP) management, and toxicity management [13]. Pharmacists should implement such guidelines by developing electronic medical records (EMRs) documenting patient treatment plans, lymphodepletion regimens, and toxicity management plans in conjunction with treating haematologists and provide patient and staf education and wallet card provisions (detailing patient information and health care professional (HCP) information which they can present to HCPs if needed: emergency department, pharmacy, and medical visits).…”

“…Due to the complexity of care associated with such innovative therapies, the safe provision of CAR-T cell therapy demands a multidisciplinary team (MDT) approach [12]. ATMP pharmacists have a key role in the management of CAR-T cell therapies within the MDT such as selection, coordination, ordering, procurement, preparation, and dispensing of the CAR-T cell product, providing education to staf and patients, and supporting toxicity management [13]. Te duties and specifc training for pharmacists are defned by the European Society of Blood and Marrow Transplant and the European Haematology Association (EBMT-EHA) [14], yet these therapies are evolving at such rapid pace with widening indications that a more fexible approach is required with consideration of earlier training modules in the area of "Living Drugs" for clinical pharmacists.…”

Role of Pharmacists

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The pharmacist has a key role in the management of CAR-T therapies. Selection, ordering, reception, storage, preparation of the product for infusion, and dispensing of CAR-T therapies are some of the pharmacy service responsibilities (Black 2018;Moreno-Martínez et al 2020;Booth et al 2020). The pharmacist requires specific training, ensuring coordination with all the professionals in the multidisciplinary team who are involved in the management of these therapies, as summarized in Table 41.1.The pharmacist must also know which types of CARs are available and can arrive in the future.

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