Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice.

Background: Data related to adverse drug reactions (ADRs), specifically immune-related adverse events (irAEs), in long-term treatment with immunotherapy in real-world practice is scarce, as is general information regarding the management of ADRs. Objectives: To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. Methods: In a prospective observational study cancer patients ≥18 years of age who were treated with a monotherapy regime of PD-1/PD-L1 inhibitors were evaluated. The study period was from November 2017 to June 2019 and patients were followed up until June 2021. Patients were contacted monthly by telephone and their electronic health records were reviewed. Each ADR was graded according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). Results: Out of 99 patients, 86 met the inclusion criteria. Most were male (67.4%), with a median age of 66 (interquartile range, IQR: 59-76). The most frequent cancer was non-small cellular lung cancer (46 cases, 53.5%), followed by melanoma (22, 25.6%). A total of 74 patients (86%) were treated with anti-PD-1 drugs and 12 (14%) were treated with anti-PD-L1 drugs. The median treatment durations were 4.9 (IQR: 1.9-17.0) and 5.9 months (IQR: 1.2-12.3), respectively. Sixty-three patients (73%) developed from a total of 156 (44% of the total number of ADR) irADRs, wherein the most frequent were skin disorders (50 cases, 32%, incidence = 30.5 irADRs/100 patients per year [p-y]), gastrointestinal disorders (29, 19%, 17.7 irADRs/100 p-y), musculoskeletal disorders (17, 11%, 10.4 irADRs/100 p-y), and endocrine disorders (14, 9%, 8.6 irADRs/100 p-y). A total of 22 irADRs (14%) had a latency period of ≥12 months. Twelve irADRs (7.7%) were categorized as grade 3-4, and while 2 (1.3%) were categorized as grade 5 (death). Sixty-one irADRs (39.1%) in 36 patients required pharmacological treatment and 47 irADRs (30.1%) in 22 patients required treatment with corticosteriods. Conclusion: The majority of patients treated with anti-PD1/PDL1-based immunotherapy experienced adverse reactions. Although most of these reactions were mild, 11.5% were categorized as grade 3 or above. A high percentage of the reactions were immune-related and occurred throughout the treatment, thereby indicating that early identification and close monitoring is essential.

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.

Survey of oncohematological pharmaceutical care situation in Spain.

OBJECTIVE: To learn about the baseline of Oncohematological Pharmacy Units in Spanish hospitals in order to identify areas for  improvement. METHOD: A survey in line with the objectives set in GEDEFO 2020  Strategic Plan of Pharmaceutical Care for oncohematological patients  was designed. The survey was hosted on GEDEFO's website during  March and April 2017. Activity data for 2016 was collected. Results: A total of 95 hospitals responded to the survey. Out of which, 76% had an integrated information system of  pharmacotherapeutic process management, where a variability in  technological and organizational processes were found. The  oncohematological pharmacist led the implementation of the principles  of medicine, based on evidence and results obtained in routine clinical  practice. It was shown that 88% of hospitals had standardized  protocols. As for safety practices, in 83% of hospitals,  oncohematological pharmacists actively participated in the development  and maintenance of risk management program, implemented to prevent  errors. Preparation was centralized in 89% of hospitals. Variability was observed in pharmaceutical care depending on  where the patient was attended. In 92% of hospitals, pharmacists  served as reference for Oncohematology, although with different levels  of training. Major deficiencies were observed in training programs and  teaching. Of all oncohematological pharmacists, 53% had been a  researcher over the past three years. CONCLUSIONS: These results mark the starting point for Spanish  Oncohematological Pharmacy Units to develop strategies for improving  the quality of pharmaceutical care offered to oncohematological patients  and led by GEDEFO, heads of service, and oncohematological  patients themselves.

Objetivo: Conocer la situación basal de las unidades de farmacia  oncohematológica de los hospitales españoles para detectar ámbitos de  mejora.Método: Se diseñó una encuesta acorde con los objetivos establecidos en el Plan Estratégico de Atención Farmacéutica al paciente  oncohematológico del Grupo de Farmacia Oncológica de la  Sociedad Española de Farmacia Hospitalaria (GEDEFO 2020). La  encuesta se alojó en la página web de GEDEFO durante marzo y abril de  2017. Se recogieron datos de actividad del año 2016.Resultados: Respondieron la encuesta 95 hospitales. Un 76%  disponían de un sistema de información integral de gestión del proceso farmacoterapéutico, encontrándose variabilidad en los procesos  tecnológicos y organizativos. El farmacéutico oncohematológico lideraba  la aplicación de los principios de medicina basada en la evidencia y de  los resultados obtenidos en la práctica clínica habitual, y se comprobó  que un 88% de los hospitales contaba con protocolos estandarizados. En  cuanto a prácticas de seguridad, en un 83% de los hospitales el  farmacéutico oncohematológico participaba activamente en el desarrollo  y mantenimiento del programa de gestión de riesgos  aplicado a la prevención de errores. La preparación estaba centralizada  en un 89% de los hospitales. Se observó variabilidad en la atención  farmacéutica en función de dónde se atendía al paciente. En el 92% de  los hospitales existía farmacéutico  de referencia para oncohematología,  aunque con distintos niveles de capacitación. Las mayores deficiencias  se observaron en los programas de formación y docencia. Un 53% de  los farmacéuticos oncohematológicos había sido investigador en los  últimos tres años.Conclusiones: Estos resultados marcan el punto de partida de las  unidades de farmacia oncohematológicas españolas para el desarrollo de estrategias de mejora de la calidad de la atención farmacéutica ofrecida a los pacientes oncohematológicos liderado por GEDEFO, jefes de  servicio y los propios farmacéuticos oncohematológicos.