National expert consensus on home-administered oncologic therapies in Spain.

The diagnosis and treatment of cancer impose a significant emotional and psychological burden on patients, families, and caregivers. Patients undergo several interventions in a hospital setting, and the increasing number of patients requiring extended care and follow-up is driving the demand for additional clinical resources to address their needs. Hospital at Home (HaH) teams have introduced home-administered oncologic therapies that represent a new model of patient-centered cancer care. This approach can be integrated with traditional models and offers benefits to both patients and healthcare professionals (HCPs). Home-administered treatment programs have been successfully piloted globally, demonstrated as a preferred option for most patients and a safe alternative that could reduce costs and hospital burden. The document aims to establish the minimum recommendations for the home administration of oncologic therapies (ODAH) based on a national expert agreement. The expert panel comprised seven leading members from diverse Spanish societies and three working areas: clinical and healthcare issues, logistical and administrative issues, and economic, social, and legal issues. The recommendations outlined in this article were obtained after a comprehensive literature review and thorough discussions. This document may serve as a basis for the future development of home-administered oncologic therapy programs in Spain. .

Optimization of a home hospitalization program for hematopoietic stem cell transplantation with ehealth integration and clinical pharmacist involvement.

Home hospitalization represents an alternative to traditional hospitalization, providing comparable clinical safety for hematological patients. At-home therapies can range from the delivery of intravenous antibiotics to more complex scenarios, such as the care during the early period after hematopoietic stem cell transplantation and chimeric antigen receptor T-cell therapy. Early discharge from conventional hospitalization is feasible and helps reduce hospital resources and waiting lists. The coordinated efforts of multidisciplinary teams, including hematologists, nurses, and pharmacists, ensure patient safety and continuity of care. The traditional model of home hospitalization relies on home visits and telephone consultations with physicians and nurses. However, the use of eHealth technologies, such as MY-Medula, can enhance communication and monitoring, and thereby improve patient outcomes with no additional costs. The active involvement of a clinical pharmacist in home hospitalization programs is essential, not only for the proper logistical management of the medication but also to ensure its appropriateness, optimize treatment, address queries from the team and patients, and promote adherence. In conclusion, the implementation of hematopoietic stem cell transplantation and chimeric antigen receptor T-cell therapy home hospitalization programs that use both an eHealth tool and a multidisciplinary care model can optimize patient care and improve quality of life without increasing healthcare costs.

Implementation and operational management of marketed chimeric antigen receptor T cell (CAR-T Cell) therapy-a guidance by the GoCART Coalition Pharmacist Working Group.

Chimeric Antigen Receptor T cells (CAR-T cells) are a type of Advanced Therapy Medicinal Product (ATMP) classified as ex-vivo (cell-based) gene therapy. CAR-T cells constitute an immunotherapy that works by enabling T cells to specifically recognise cancer cells and destroy them [1]. CAR-T cells are currently licensed to treat certain blood cancers including relapsed or refractory lymphomas, B-cell acute lymphoblastic leukaemia or multiple myeloma [2]. The indications for their use are expanding and are expected to encompass other therapeutic areas. CAR-T cells are used both in children and adults [2]. CAR-T cells are biologic drugs and are therefore more complex than traditional medicinal products. T cells collected from the patient (or donor) are sent to a Good manufacturing Practice (GMP) manufacturing facility where they are genetically modified to contain a chimeric antigen receptor (CAR). This receptor is designed to recognise and target a specific protein on cancer cells. Once manufactured, they are delivered to the hospital where they are administered to the designated patient. Hospital pharmacies are central in the process of ensuring appropriate organisational governance, operational handling, clinical suitability, and pharmacovigilance [1, 3]. The GoCART Coalition Pharmacist working group's mission was to develop standards of care to advance the field of cellular therapies in Europe. The purpose of this document is to provide practical guidance on the implementation and safe operational use of marketed CAR-T cell products within hospital pharmacies primarily throughout Europe. This document outlines the key areas where pharmaceutical expertise should focus and the key considerations for the hospital pharmacy. Countries may have different requirements and there may be variation in practice between hospitals. This document is intended as a guide and the recommendations should be adapted to meet local requirements. This document does not provide clinical information relating to the use of CAR-T cell products. The Summary of medicinal Product Characteristics (SmPC) [4, 5], and national and international clinical guidelines (where in place) should be followed for the most up-to-date clinical management of CAR-T cell patients. An example is the UK "institutional readiness documents" for pharmacy which includes detailed checklists for each stage of the pathway [6]. Spain developed the Plan of Advanced Therapies in the National Health System: CAR medicines published in November 2018 [7], the CAR-T Medicines Management Procedure of the Spanish Society of Hospital Pharmacy [8] or the Hospital pharmacist's roles and responsibilities with CAR-T medicines article published also by the Spanish Oncology group of the Spanish Society of Pharmacy [9]. This guide has been designed to support the implementation of marketed CAR-T products; however, the principles may also be applicable to clinical trials. For CAR-T cell products being used in clinical trials, additional trial regulation and clinical trial protocols must be followed. This document is divided into two sections. Section 1 outlines considerations for hospital pharmacies during the implementation of a CAR-T cell service. Section 2 outlines the key operational considerations for hospital pharmacies in the patient and product pathway.

Hospital pharmacist's roles and responsibilities with CAR-T medicines.

The development and commercialization of cell therapy drugs with  chimeric antigen receptor T cells (CAR-T) represent a new challenge for  Spain's hospital pharmacy. The aim of this article is to review the key  aspects of these medicines and to describe the oncohematological  pharmacist's role within the multidisciplinary clinical team. This includes  the different phases in the transversal process that involves a therapy  with CAR-T medicines, ranging from indication to short and long term  follow-up of patients treated with this type of therapy, and emphasizing  on the management of its main adverse effects. CAR-T therapy offers  the hospital pharmacist the opportunity to work closely with the rest of  the clinical professionals involved in the process, allowing their  contribution to the development of procedures, clinical practice  guidelines of global approach, and establishing starting points when  facing future therapies of similar complexity -and even improving previously established basic processes-.

El desarrollo y la comercialización de medicamentos de terapia celular con células T con receptor de antígeno quimérico (CAR-T)  suponen un nuevo reto para la farmacia hospitalaria en España. El  objetivo de este artículo es revisar los aspectos clave de estos  medicamentos y describir el papel del farmacéutico oncohematológico  dentro del equipo clínico multidisciplinar en las diferentes fases del  proceso transversal que implica el tratamiento con medicamentos CAR- T, desde la indicación hasta el seguimiento a corto y largo plazo de los  pacientes tratados con este tipo de terapias, con una importante  mención al manejo de sus principales efectos adversos. La terapia tipo  CAR-T ofrece al farmacéutico hospitalario la oportunidad de trabajar en  estrecha colaboración con el resto de los profesionales clínicos  implicados en el proceso, permitiendo su contribución en el desarrollo de  procedimientos, guías de práctica clínica de abordaje global y  estableciendo puntos de partida para afrontar tratamientos futuros de  complejidad similar e incluso mejorar procesos base anteriormente  establecidos.

Funciones y responsabilidades del farmacéutico de hospital con los medicamentos CAR-T / Hospital pharmacist's roles and responsibilities with CAR-T medicines

El desarrollo y la comercialización de medicamentos de terapia celular con células T con receptor de antígeno quimérico (CAR-T) suponen un nuevo reto para la farmacia hospitalaria en España. El objetivo de este artículo es revisar los aspectos clave de estos medicamentos y describir el papel del farmacéutico oncohematológico dentro del equipo clínico multidisciplinar en las diferentes fases del proceso transversal que implica el tratamiento con medicamentos CAR-T, desde la indicación hasta el seguimiento a corto y largo plazo de los pacientes tratados con este tipo de terapias, con una importante mención al manejo de sus principales efectos adversos. La terapia tipo CAR-T ofrece al farmacéutico hospitalario la oportunidad de trabajar en estrecha colaboración con el resto de los profesionales clínicos implicados en el proceso, permitiendo su contribución en el desarrollo de procedimientos, guías de práctica clínica de abordaje global y estableciendo puntos de partida para afrontar tratamientos futuros de complejidad similar e incluso mejorar procesos base anteriormente establecidos

The development and commercialization of cell therapy drugs with chimeric antigen receptor T cells (CAR-T) represent a new challenge for Spain's hospital pharmacy. The aim of this article is to review the key aspects of these medicines and to describe the oncohematological pharmacist's role within the multidisciplinary clinical team. This includes the different phases in the transversal process that involves a therapy with CAR-T medicines, ranging from indication to short and long term follow-up of patients treated with this type of therapy, and emphasizing on the management of its main adverse effects. CAR-T therapy offers the hospital pharmacist the opportunity to work closely with the rest of the clinical professionals involved in the process, allowing their contribution to the development of procedures, clinical practice guidelines of global approach, and establishing starting points when facing future therapies of similar complexity -and even improving previously established basic processes