Consensus recommendations for the role and competencies of the EBMT clinical pharmacist and clinical pharmacologist involved in hematopoietic stem cell transplantation

Langebrake, Claudia; Admiraal, Rick; Maarseveen, Erik van; Bonnin, Agnès; Bauters, Tieneke

doi:10.1038/s41409-019-0538-9

Cited by 21 publications

(18 citation statements)

References 75 publications

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“…Despite the consensus and recommendations issued by professional associations which recognize the role of hospital pharmacists in CAR-T cell therapy programs ( 12 , 16 , 20 ), there is a lack of specific information about how this can be effectively implemented in a daily basis. In a survey that detailed the administrative, logistic, and toxicity management practices on CAR-T cell therapy in the United States, pharmacists were involved in multidisciplinary committees (72% of the respondents), reimbursement process, patient education, and tocilizumab stock management, but only 20% of the respondents have a dedicated CAR-T cell pharmacist ( 41 ).…”

Section: Discussionmentioning

confidence: 99%

“…References of reviewed articles were also searched for relevant titles. Recommendations by international and national well-known hematology and pharmacy societies were also included: Foundation for the Accreditation of Cellular Therapy (FACT) ( 14 , 18 ), American Society for Blood and Marrow Transplantation (ASBMT) ( 11 ), European Society of Blood and Bone Marrow Transplantation (EBMT) ( 12 ), European Hematology Association (EHA) ( 10 ), Specialist Pharmacy Service of the United Kingdom National Health System ( 19 ), and Spanish Society of Hospital Pharmacy (SEFH) ( 20 ). Finally, the research was complemented with the summary of product characteristics of the CAR-T cell drugs approved: tisagenlecleucel ( 1 ) and axicabtagene ciloleucel ( 2 ).…”

Section: Methodsmentioning

confidence: 99%

“…The American and European societies of Blood and Bone Marrow Transplantation (ASBMT and EBMT) have published recommendations of HSCT clinical pharmacists' activities and responsibilities (11)(12)(13). Both documents endorse pharmacist roles with medication management, patient care, transitions of care, education, and research.…”

Section: Introductionmentioning

confidence: 99%

“…Unfortunately, there is little data about the pharmacist’s responsibilities to patients treated with CAR-T cell therapy. The EBMT consensus includes the pharmacist role with managing advanced therapy medicinal products, such as CAR-T cells, as they are licensed as medicines ( 12 ). The Foundation for the Accreditation of Cellular Therapy–Joint Accreditation Committee ISCT EBMT (FACT–JACIE) standards on immune effector cells therapy recognizes the role of pharmacists in the clinical team and describes the training and knowledge required ( 14 ).…”

Section: Introductionmentioning

confidence: 99%

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Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective

et al. 2021

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PurposeThe 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.MethodsA 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.ResultsThe 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.ConclusionThis 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.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective

et al. 2021

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“…Multidisciplinary collaboration among pharmacists, physicians, nurses, and coordinators is of paramount importance to ensure safe and effective care in preventing and managing drug-related problems. Pharmacists who are trained in HSCT and CAR T-cell therapy fulfill various roles in providing care for the pa-tient population, including direct patient care, medication management, policy development, transition of care, patient and staff education, supportive care, and quality tracking 2 .…”

Section: Introductionmentioning

confidence: 99%

Highlights of Pharmacist Roles in Hematopoietic Cell Transplantation and Cellular Therapy

Shi

Tharnpanich

2021

BCT

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Patients with hematological malignancies receiving hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T-cell therapy are known to have complex pharmacotherapy. To ensure safe and effective care in preventing and managing drug-related problems, pharmacists trained in HSCT and CAR T-cell therapy fulfill various roles in providing care for these patients. With polypharmacy and complex medication regimens, drug interactions are one of the major aspects that pharmacists review regularly to ensure the efficacy of treatment while minimizing toxicity. Pharmacists anticipate various complex drug interactions, understanding the possible mechanisms of drug interactions, and manage these complex drug regimens in patients undergoing HSCT and CAR T-cell therapy. In addition, antimicrobial prophylaxis is also important supportive care for immunocompromised patients. Pharmacists are capable of evaluating the risk of opportunistic infections, anticipating the type of antimicrobial prophylaxis required, and setting a policy with a robust antimicrobial regime. This can promote consistency in patient care and improve patient outcomes in terms of morbidity and mortality associated with opportunistic infections. Lastly, pharmacists are equipped with a skillset to ensure a seamless transition of care, provide education for patients and healthcare providers, promote medication adherence, and contribute to research and quality improvement.

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Standard of practice in oncology and haematology for pharmacy services

Coutsouvelis

Adams

Bortz

et al. 2020

Pharmacy Practice and Res

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Consensus recommendations for the role and competencies of the EBMT clinical pharmacist and clinical pharmacologist involved in hematopoietic stem cell transplantation

Cited by 21 publications

References 75 publications

Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective

Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective

Highlights of Pharmacist Roles in Hematopoietic Cell Transplantation and Cellular Therapy

Standard of practice in oncology and haematology for pharmacy services

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