The Hematopoietic Cell Transplant Pharmacist: Roles, Responsibilities, and Recommendations from the ASBMT Pharmacy Special Interest Group

Clemmons, Amber B.; Alexander, Mhairi E.; DeGregory, Kathlene; Kennedy, LeAnne

doi:10.1016/j.bbmt.2017.12.803

Cited by 26 publications

(31 citation statements)

References 56 publications

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“…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 roles and competencies of the clinical pharmacist involved in HSCT have been defined by several organizations. 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 – 13 ). Both documents endorse pharmacist roles with medication management, patient care, transitions of care, education, and research.…”

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: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…Late complications related to hepatic dysfunction in HCT survivors are most often due to cGVHD, iatrogenic causes, hepatitis B (HBV) or hepatitis C (HCV) reactivation, or iron overload. 2,62 As the etiology of liver dysfunction in HCT survivors is complex, the investigation should include a review of medications by an HCT pharmacist, 63 physical examination, medical history, liver function tests, pre-transplant infection history, time course of liver dysfunction after HCT, presence of GVHD at other sites, and number of blood transfusions before and after HCT. 2,62 With~60% of allogeneic HCT recipients developing cGVHD in the post-HCT period, careful consideration must be given to the liver GVHD in the presence of new liver dysfunction.…”

Section: Liver Complicationsmentioning

confidence: 99%

“…72 Of note, several DAAs are potent inhibitors of CYP3A4 and/ or p-glycoprotein, which are responsible for the metabolism of commonly prescribed medications in HCT survivors; careful review of drug-drug interactions and adverse effects of DAAs by an HCT pharmacist is recommended before initiation of therapy. 63,69 Iron Overload Iron overload (IOL) primarily occurs via red blood cell (RBC) transfusion and hemolysis, or decreased erythropoiesis after cytotoxic chemotherapy in patients with hematologic malignancies. IOL is toxic to tissues and organs, and confers a poor prognosis in the post-HCT setting.…”

Section: Liver Complicationsmentioning

confidence: 99%

Long‐term Follow‐up of Hematopoietic Stem Cell Transplant Survivors: A Focus on Screening, Monitoring, and Therapeutics

et al. 2020

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Annually, ~50,000 patients undergo hematopoietic stem cell transplantation (HCT) worldwide with almost 22,000 of these patients receiving HCT in the United States. HCT is a curative option for a wide range of hematologic malignancies, and advances in transplantation medicine have resulted in an increase in HCT survivors. It is anticipated that the number of HCT survivors will more than double from 242,000 in 2020 to ~500,000 in 2030. Survivors of HCT are at an increased risk of developing late complications due to exposure to chemotherapy and/or radiation in the pre‐, peri‐, and post‐HCT phases and these cumulative exposures have the potential to damage normal tissue. This tissue damage leads to the early onset of chronic health conditions resulting in premature mortality in HCT survivors, who have a 15‐year cumulative incidence of severe or life‐threatening chronic health conditions exceeding 40%. Due to the significant burden of morbidity in HCT survivors and the delay in the development of long‐term complications, this delicate patient population requires life‐long monitoring due to the risk for neuropsychological, cardiac, pulmonary, renal, hepatic, ocular, skeletal, cardiac, endocrine, fertility, and sexual health complications, as well as secondary neoplasms. This review will focus on recent advances in screening, monitoring, and therapeutics for late‐occurring or long‐term complications in HCT survivors.

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“…12 Although this represents one strategy to meet the demands of emerging CAR T cell therapy, clinical pharmacists practicing in hematopoietic stem cell transplant (HSCT) and hematology/oncology practice settings have demonstrated their ability to fulfill roles in complex medication management, policy development, and quality improvement as essential members of the multidisciplinary team. 16,19,20 Therefore, HCST and hematology/oncology clinical pharmacists have the skills and training to absorb the responsibilities in emerging CAR T cell therapy.…”

Section: Emerging Role Of the Car T Pharmacistmentioning

confidence: 99%

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

Booth

Kusoski

Kennerly-Shah

2020

J Oncol Pharm Pract

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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.

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The Hematopoietic Cell Transplant Pharmacist: Roles, Responsibilities, and Recommendations from the ASBMT Pharmacy Special Interest Group

Cited by 26 publications

References 56 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

Long‐term Follow‐up of Hematopoietic Stem Cell Transplant Survivors: A Focus on Screening, Monitoring, and Therapeutics

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

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