Propuesta de protocolo de dispensación activa de antineoplásicos orales para pacientes de novo en un servicio de farmacia hospitalaria / Proposal of an active dispensation protocol of oral antineoplasics for newly diagnosed patients for an outpatient hospital pharmacy service

Introducción: La propuesta para elaboración de un protocolo de dispensación activa de antineoplási-cos orales para pacientes de novo responde a una necesidad detectada por el Servicio de Oncología y el Servicio de Farmacia de Consulta Externa y Urgencias del Hospital México. Actualmente los pacientes recién diagnosticados retiran los medica-mentos sin la dispensación activa por el farmacéu-tico, lo cual puede comprometer la adherencia al tratamiento. Objetivo: Proponer un protocolo de dispensación activa de antineoplásicos orales para pacientes de novo para la farmacia de consulta externa del Hospital México que le permita al personal farma-céutico brindar este servicio.Método: Se realizó una búsqueda bibliográfica sobre los cánceres de próstata, pulmón y mama. Se seleccionaron los medicamentos a incluir en el programa. Se elaboró un protocolo de dispensación activa y los materiales educativos dirigidos a los pacientes atendidos por el Servicio de Farmacia de Consulta Externa y Urgencias del Hospital México con prescripción de antineoplásicos orales. Resultados: Se incluyeron 11 antineoplásicos ora-les no contemplados en otros servicios de atención farmacéutica del Hospital México. Se desarrolló el procedimiento de dispensación activa según los lineamientos de la Caja Costarricense de Seguro Social para medicamentos de compra. Se elabora-ron 11 boletines educativos para pacientes. Conclusiones: El protocolo de dispensación activa de antineoplásicos orales propuesto permitirá que la farmacia de consulta externa del Hospital México brinde este servicio de forma estandarizada a los pacientes. (AU)

Introduction: New patients prescribed with oral an-tineoplasics do not receive any indications on how to take their treatments properly. The outpatient pharmacy service of the Hospital México is in need for a protocol for active dispensing of oral antineo-plasics to promote therapy adherence. Objective: The aim of this work was to propose an active dispensing protocol of oral antineoplasics for the outpatient pharmacy service of the Hospi-tal México that enables pharmacists to offer this service to patients. Method: A literature review was conducted on pul-monary, prostate and breast cancer, as well as on different pharmaceutical care programs to develop the active dispensing protocol and the information materials for patients. Results: 11 oral antineoplasics were included in the program. A protocol for active dispensing of oral antineoplasics was developed, according to the guidelines of the Caja Costarricense de Seguro Social. Eleven patient information brochures were made. Conclusion: The active dispensing program of oral antineoplasics developed will allow the outpatient pharmacy service of the Hospital México to offer a standardize service to patients. (AU)

Adherencia y calidad de vida en los pacientes con leucemia linfocítica crónica tratados con antineoplásicos orales / Adherence and quality of life in patients with chronic lymphocytic leukemia treated with oral antineoplastic drugs

Objetivos: evaluar la adherencia y la calidad de vida de los pacientes con leucemia linfocítica crónica tratados con antineoplásicos orales. Comparar la adherencia y la calidad de vida según el fármaco recibido y según la línea de tratamiento.Métodoestudio descriptivo prospectivo realizado de junio a noviembre de 2021 en un hospital terciario. Se incluyeron pacientes con leucemia linfocítica crónica, atendidos en la consulta de Farmacia Oncológica y tratados con antineoplásicos orales desde al menos 6 meses antes de la inclusión en el estudio. Se estimó la adherencia mediante el cuestionario Morisky’s 8 item Medication Adherence Scale y el recuento de medicación sobrante, considerándose adherentes si su tasa de adherencia era ≥ 90%. Para evaluar la calidad de vida, se utilizó el cuestionario EQ-5D-3L del grupo EuroQol, la escala Functional Assessment of Chronic Illness Therapy – Fatigue y el QLQ-C30 de la European Organization for Research and Treatment of Cancer. Se programaron 2 entrevistas: en el momento de la inclusión y a los 3 meses. Se revisó la historia clínica, recogiéndose variables demográficas y clínicas. El análisis estadístico se realizó con el programa SPSS® 25.0.Resultadosse incluyeron 23 pacientes, todos fueron adherentes según el recuento de medicación, 20 presentaron adherencia alta, y 3 media, según Morisky’s 8 item Medication Adherence Scale. Los resultados del cuestionario EQ-5D-3L mostraron que los pacientes eran autónomos para su cuidado personal y sus actividades cotidianas, el 69,6% no tenían problemas de movilidad, el 78,3% no tenía ansiedad/depresión y el 56,5% presentaba algún tipo de dolor. (AU)

Objective: To evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and QoL according to treatment subgroups and treatment-line subgroups.MethodsWe conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital. Patients treated at the Oncology Pharmacy with a diagnosis of chronic lymphocytic leukemia and treatment with oral antineoplastics for at least 6 months before inclusion in the study were included. Adherence was assessed using Morisky’s 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥ 90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3 months. Variable collected: demographic data, clinical data (disease and treatment); and response (scores obtained from questionnaires and adherence rate). The data statistical analysis was carried out with SPSS® 25.0 software.ResultsTwenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients medium adherent to treatment according to Morisky’s 8 item Medication Adherence Scale. (AU)

Diseño y validación de una escala de adherencia a antineoplásicos orales / Design and validation of an adherence scale to oral antineoplastic drugs

Objetivo: diseñar y validar una escala para medir la adherencia a antineoplásicos orales. Disponer de una herramienta sencilla, validada y aplicable a la rutina asistencial que permitirá detectar e identificar la falta de adherencia para establecer estrategias que permitan mejorarla y optimizar la calidad de los servicios sanitarios.Métodoestudio de validación de una escala diseñada para evaluar la adherencia a antineoplásicos orales en una muestra de pacientes ambulatorios que recogen su medicación en 4 hospitales españoles. Se analizará su validez y fiabilidad, elaborada a partir de un estudio previo de metodología cualitativa, mediante la teoría clásica de los test y el análisis Rasch. Se examinará su funcionamiento, el ajuste de los ítems, la estructura de respuesta y de las personas a las predicciones del modelo, así como la dimensionalidad, la fiabilidad ítem-persona, la adecuación del nivel de dificultad de los ítems a la muestra, y el funcionamiento diferencial de los ítems en función del sexo. (AU)

Objective: To design and validate a questionnaire to measure adherence to oral antineoplastic drugs. The availability of a simple, validated tool that can be applied to routine care will make it possible to detect and identify non-adherence in order to establish strategies to improve adherence and optimize the quality of healthcare services.MethodValidation study of the questionnaire designed to assess adherence to antineoplastic drugs in a sample of outpatients who collect their medication in two Spanish hospitals. Its validity and reliability will be analyzed, based on a previous qualitative methodology study, using classical test theory and Rasch analysis. We will examine its performance, item fit, response structure and person fit to the predictions of the model, as well as dimensionality, item-person reliability, the appropriateness of the level of difficulty of the items to the sample, and the differential performance of the items according to gender.

Design and validation of an adherence scale to oral antineoplastic drugs. / Diseño y validación de una escala de adherencia a antineoplásicos orales.

OBJECTIVE: To design and validate a questionnaire to measure adherence to oral antineoplastic drugs. The availability of a simple, validated tool that can be applied to routine care will make it possible to detect and identify non-adherence in order to establish strategies to improve adherence and optimize the quality of healthcare services. METHOD: Validation study of the questionnaire designed to assess adherence to antineoplastic drugs in a sample of outpatients who collect their medication in two Spanish hospitals. Its validity and reliability will be analyzed, based on a previous qualitative methodology study, using classical test theory and Rasch analysis. We will examine its performance, item fit, response structure and person fit to the predictions of the model, as well as dimensionality, item-person reliability, the appropriateness of the level of difficulty of the items to the sample, and the differential performance of the items according to gender.

[Translated article] Design and validation of a scale to measure adherence to oral antineoplastic drugs.

OBJECTIVE: Design and validate a scale to measure adherence to oral antineoplastic drugs. The availability of a simple, validated tool that can be applied to routine care will make it possible to detect and identify non-adherence in order to establish strategies to improve adherence and optimize the quality of healthcare services. METHOD: Validation study of the scale designed to assess adherence to antineoplastic drugs in a sample of outpatients who collect their medication in two Spanish hospitals. Its validity and reliability will be analyzed, based on a previous qualitative methodology study, using classical test theory and Rasch analysis. We will examine its performance, item fit, response structure and person fit to the predictions of the model, as well as dimensionality, item-person reliability, the appropriateness of the level of difficulty of the items to the sample, and the differential performance of the items according to gender.

Adherence and quality of life in patients with chronic lymphocytic leukemia treated with oral antineoplastic drugs. / Adherencia y calidad de vida en los pacientes con leucemia linfocítica crónica tratados con antineoplásicos orales.

OBJECTIVE: To evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and QoL according to treatment subgroups and treatment-line subgroups. METHODS: We conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital. Patients treated at the Oncology Pharmacy with a diagnosis of chronic lymphocytic leukemia and treatment with oral antineoplastics for at least 6 months before inclusion in the study were included. Adherence was assessed using Morisky's 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥ 90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy - Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3 months. Variable collected: demographic data, clinical data (disease and treatment); and response (scores obtained from questionnaires and adherence rate). The data statistical analysis was carried out with SPSS® 25.0 software. RESULTS: Twenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients medium adherent to treatment according to Morisky's 8 item Medication Adherence Scale. The results of the EQ-5D-3L questionnaire showed that the patients were all of them autonomous in their personal care and daily activities, 69.6% did not have any mobility problems and 78.3% did not have anxiety/depression; 56.5% had some type of pain. Eighteen patients had no fatigue, and 5 had mild/moderate fatigue according to Functional Assessment of Chronic Illness Therapy - Fatigue scale. The results of the EORTC QLQ-C30 questionnaire showed that patients had a high /healthy functional level, a good quality of life and a low level of symptoms. Analysis by treatment subgroups and by treatment-line subgroups did not show statistically significant differences in adherence or quality of life. CONCLUSIONS: Patients diagnosed with chronic lymphocytic leukemia and treated with oral antineoplastic therapies showed a high adherence rate and referred a good quality of life.

[Translated article] Adherence and quality of life in patients with chronic lymphocytic leukemia treated with oral antineoplastic drugs.

OBJECTIVE: To evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and quality of life according to treatment subgroups and treatment-line subgroups. METHODS: We conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital.  Patients with chronic lymphocytic leukaemia, seen at the Oncology Pharmacy and treated with oral antineoplastic drugs for at least 6 months prior to inclusion in the study were included. Adherence was assessed using Morisky's 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy - Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3 months. The clinical history was reviewed and demographic and clinical variables were collected. The data statistical analysis was carried out with SPSS® 25.0 software. RESULTS: Twenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients médium adherent to treatment according to Morisky's 8 item Medication Adherence Scale. The results of the EQ-5D-3L questionnaire showed that the patients were all of them autonomous in their personal care and daily activities, 69.6% did not have any mobility problems and 78.3% did not have anxiety/depression; 56.5% had some type of pain. Eighteen patients had no fatigue, and 5 had mild/moderate fatigue according to Functional Assessment of Chronic Illness Therapy - Fatigue scale. The results of the EORTC QLQ-C30 questionnaire showed that patients had a high /healthy functional level, a good quality of life and a low level of symptoms. Analysis by treatment subgroups and by treatment-line subgroups did not show statistically significant differences in adherence or quality of life. CONCLUSIONS: Patients diagnosed with chronic lymphocytic leukemia and treated with oral antineoplastic therapies showed a high adherence rate and referred a good quality of life.

Interacciones entre antineoplásicos orales y alimentos / Interactions between oral antineoplastic drugs and foods

Actualmente, la administración de antineoplásicos se realiza mayoritariamente por vía parenteral, sin embargo, la vía oral está cada vez más extendida en oncología por presentar beneficios importantes, como mayor comodidad o seguridad para el paciente. Sin embargo, la vía oral supone nuevos retos son las interacciones fármaco-alimentos (iAM), que puede dar lugar a importantes variaciones en la biodisponibilidad del fármaco. Esta mini-revisión se inicia comentando en una breve introducción algunos aspectos centrales sobre los inhibidores de tirosin-kinasa (TKI) y su mecanismo de acción y los planteamientos que han ido llevando a la aparición de TKI de segunda y tercera generación. Posteriormente y centrado en el tema interacción fármaco-alimentos se comentan algunos resultados y conclusiones de 47 artículos seleccionados de un total de 55 donde se describen distintos tipos de iAM que atañen a los TKI y otros antineoplásicos orales y que afectan a la biodisponibilidad de los mismos y los factores determinantes de dichas interacciones (p. ej. tipo de alimento, las reacciones físico-químicas entre fármaco y alimento, la fisiología postprandial). También resume algunos ejemplos bien definidos de dichas iAM, así como de las posibles consecuencias positivas de la coadministración de medicamentos y alimentos. La revisión termina con pautas futuras a considerar en este tipo de interacciones (estatus nutricional del paciente, farmacogenética relacionada con las isoformas del citocromo P450, cronoterapia y cronofarmacia relacionada con los genes CLOCK, efectos del consumo de compuestos bioactivos y perfiles dietéticos) y con unas conclusiones. Por todo ello, el conocimiento profesional de estos aspectos juega un papel fundamental a la hora de garantizar el éxito terapéutico. (AU)

Nowadays, the intravenous administration of antineoplastic drugs is more common than oral administration. However, oral chemotherapy on oncology is increasing due to some advantages, such as the comfort and safety of the patient. Nevertheless, oral administration implies new challenges as the food and drugs interactions that can change the drug’s bioavalability. Present mini-review stars with a short introduction in main aspects of the tyrosine kinase inhibitors (TKI), their action mechanism as well as the stages that have giving rise to the second and third generations of TKI are reviewed. Dealing with drugfood interaction the review discusses some results and conclusions derived from 47 articles selected from a total of 55 ones in which some food-drug interaction affecting bioavailability of TKI and other oral antineoplastics are described, as well as some determinant factors of such interactions (e.g. type of food, food and drug physicochemical reactions, postprandial physiology). Some well-defined and known examples of those interactions are commented as well the possible positive consequences of food and drug coadministration. The review ends with future remarks (e.g nutritional status, farmacogenetics related to the Cytochrome P450, chronotherapy and chronopharmacy related to CLOCK genes, the effects of bioactive compounds and dietary profiles) and with some conclusions. For all this, the professional knowledge and background seem fundamental in order to warrantee therapeutic success. (AU)