GEDEFO-SEFH management of antineoplastic extravasations survey results.

INTRODUCTION: Extravasation is a potentially severe complication of intravenous administration of antineoplastic drugs. The limited data makes it difficult to develop an optimal management scheme. The objective of this study is to describe the clinical practice in the extravasation management of antineoplastic agents in Spanish centers. METHODS: An online survey was distributed to oncology pharmacists using the email distribution list of the Spanish Society of Hospital Pharmacists. Respondents were surveyed on the standard operational protocol (SOP) of extravasation, tissue damage risk classification, and specific measures of extravasation management. RESULTS: A total of 68 surveys were completed. A specific extravasation SOP was available in 82.4% centers. The pharmacist participates in the authorship (100%) and actively collaborates in extravasation management (76.5%). A tissue damage risk classification based on the three categories was mostly adopted (48.2%) and 73.2% applied specific criteria based on concentration and/or extravasated volume. Extravasation management was mainly performed with the application of physical measures and/or antidotes (91.2%). High variability in the choices of pharmacological and/or physical measures recommended is outstanding. CONCLUSION: The results of this study highlight the involvement of Spanish pharmacists in extravasation management, the application of physical measures and/or pharmacological measures as the method of choice in extravasation management, as well as the existing discrepancies in tissue damage risk classification and management recommendations.

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)

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.

Resultados de una encuesta nacional sobre conocimiento y uso de pseudociencias por parte de los pediatras / Results of a national survey on knowledge and use of complementary and alternative medicine by paediatricians

Introducción: El uso de determinadas pseudociencias en niños está documentado en España. El objetivo principal del estudio es estimar el grado de conocimiento, la recomendación y el uso de algunas pseudoterapias por parte de los pediatras españoles. Material y métodos: Estudio transversal, descriptivo y de ámbito nacional, mediante encuesta en línea, enviada por correo electrónico a pediatras socios de la Asociación Española de Pediatría (AEP), entre junio y julio de 2020. (AU)

Introduction: The use of certain Complementary and Alternative Medicines (CAM) in children has been documented in Spain. The main aim of this study is to estimate the knowledge, recommendations, and use of CAM by Spanish paediatricians. Material and methods: A national study was conducted from June to July 2020 using an online questionnaire. Two e-mails were sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP). (AU)

Results of a national survey on knowledge and use of complementary and alternative medicine by paediatricians.

INTRODUCTION: The use of certain Complementary and Alternative Medicines (CAM) in children has been documented in Spain. The main aim of this study is to estimate the knowledge, recommendations, and use of CAM by Spanish paediatricians. MATERIAL AND METHODS: A national study was conducted from June to July 2020 using an online questionnaire. Two e-mails were sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP). RESULTS: Out of 1414 responses received, acupuncture was considered as a science by 31.8%. Homeopathy was recommended to parents by 28.1%. CAM was used by 21.3% of physicians, at least once, to improve their own health. Only 3.8% had ever replaced a conventional treatment with CAM. The following variables were associated with a greater disposition to prescribe homeopathy: female, age over 45 years old, paediatricians working in Primary Care, and paediatricians working in private healthcare. CONCLUSIONS: This AEP Committee on Medicines questionnaire provides new data that should be considered alarming and should ask for a serious thinking on the use of CAM in Spain. Some paediatricians are recommending parents to give treatments not supported by scientific evidence to their children. This practice could be potentially harmful, especially when conventional treatment is being replaced.

Clasificación del daño tisular de antineoplásicos: Consenso del Grupo Español de Farmacia Oncológica / Classification of antineoplastic drug-induced tissue damage: a Consensus of the Spanish Oncology Pharmacy Group

Objetivo: Realizar un consenso de expertos utilizando el método Delphipara la clasificación del potencial de daño tisular de los antineoplásicosque facilite la toma de decisiones ante una extravasación.Método: El panel de evaluadores estaba formado por siete farmacéuticos del grupo de trabajo de extravasaciones. Otro actuó comocoordinador. Se revisó la probabilidad de daño tisular a partir de ochodocumentos de referencia. Se clasificaron en cuatro categorías: vesicante, irritante de alto riesgo, irritante de bajo riesgo y no irritante. Serealizaron dos rondas; tras éstas los fármacos con consenso < 70% sediscutieron en grupo de forma no anónima. Se analizó para cada ronda:la mediana del grado de consenso y ámbito intercuartílico (AIQ25-75),el grado de concordancia por categoría de daño tisular y el porcentaje de antineoplásicos con grado de consenso > 85% y del 100%.Se analizaron de forma separada los fármacos con discordancias declasificación entre los documentos consultados. Se utilizó el programaestadístico SPSS v23.0. (AU)

Objective: To reach at an expert consensus, using the Delphi method, forclassifying the tissue-damaging potential of antineoplastic drugs, in order tofacilitate the decision-making process in the event of extravasations.Method: The panel of expert evaluators was made up of seven pharmacists belonging to the working group on extravasations. Other memberserved as coordinator. The likelihood of tissue damage was reviewed on thebasis of eight reference documents. Four categories of drugs were established: vesicant (V); high risk irritant (HRI); low risk irritant (LRI) and non-irritant(NI). Two rounds of surveys were performed. The drugs with an agreementof less than 70% after the two rounds were discussed non-anonymously by thegroup. For each of the rounds the following was analysed: median ofthe degree of consensus and the interquartile range (IQR25-75), degreeof agreement by tissue damage category, and percentage of antineoplastics reaching a degree of consensus of over 85% and of 100%. Drugswhose classification differed in the various reference documents were assessed separately. SPSS v23.0 statistical software was used. (AU)

[Off-label pediatric medicines in Spain]. / Medicamentos fuera de ficha técnica en Pediatría.

Since 2009, the use of off-label and unlicensed drugs has been regulated in Spain. In pediatrics, this exceptional use is more common than in other medical specialties. It varies from 10% to 90% of all prescriptions in children. This variability is due to differences in methodology, classification and sources of information used, and also to the different pediatrics subspecialties. In addition, the knowledge of several pediatricians on this issue is limited and more than half do not comply with the law, in many cases due to ignorance. However, the use of off-label and unlicensed drugs is legal and necessary. The Medicines Committee of the Spanish Association of Pediatrics (CM-AEP) considers that it is necessary to improve the existing information on medicines in the pediatric population. Therefore, the CM-AEP works out a document where suggestions and actions are proposed to achieve it, because children's health deserves it.

[Results of a national survey on knowledge and use of complementary and alternative medicine by paediatricians]. / Resultados de una encuesta nacional sobre conocimiento y uso de pseudociencias por parte de los pediatras.

INTRODUCTION: The use of certain Complementary and Alternative Medicines (CAM) in children has been documented in Spain. The main aim of this study is to estimate the knowledge, recommendations, and use of CAM by Spanish paediatricians. MATERIAL AND METHODS: A national study was conducted from June to July 2020 using an online questionnaire. Two e-mails were sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP). RESULTS: Out of 1,414 responses received, acupuncture was considered as a science by 31.8%. Homeopathy was recommended to parents by 28.1%. CAM was used by 21.3% of physicians, at least once, to improve their own health. Only 3.8% had ever replaced a conventional treatment with CAM. The following variables were associated with a greater disposition to prescribe homeopathy: female, age over 45 years old, paediatricians working in Primary Care, and paediatricians working in private healthcare. CONCLUSIONS: This AEP Committee on Medicines questionnaire provides new data that should be considered alarming and should ask for a serious thinking on the use of CAM in Spain. Some paediatricians are recommending parents to give treatments not supported by scientific evidence to their children. This practice could be potentially harmful, especially when conventional treatment is being replaced.

[Pharmaceutical care and home delivery of medication to patients with chronic myeloid leukemia]. / Atención farmacéutica y envío domiciliario de medicación a pacientes con leucemia mieloide crónica.

OBJECTIVES: To describe the implementation of a new model face to face and remote pharmaceutical care with home delivery of tyronsine kinase inhibitors medicines for patients with chronic myeloid leukemia. METHODS: Patients with chronic myeloid leukemia were selected to start this new model of care. Four characteristics were taken into account for the choice: chronicity of the disease, frequency of doctor visits, pharmaceutical care value and conservation of tyronsine kinase inhibitors medicines at room temperature. RESULTS: Out of 68 patients with chronic myeloid leukemia and treated with tyronsine kinase inhibitors, 42 were selected due to the frequency of their hematologist visits. An introductory letter and a questionnaire about their preferences were sent to these patients.Sixteen of them expressed their desire to participate. The legal department designed a confidentiality contract, as well as a model of informed consent. A logistic distribution model based on defined routes and timetables was established. Prior to inclusion, pharmaceutical care was performed in a face to face consultation and the communication way was established for the followings remote consultations. Home delivery had a monthly cost of 13.2 € (including VAT) per patient. All the patients who started this program continue in it. To date, 5 deliveries per patient have been conducted. CONCLUSIONS: It is possible to establish an alternative model of pharmaceutical care with home delivery of medication, keeping the pharmacist-patient relationship, avoiding travel, ensuring the confidentiality and rationalizing the stocks.

Objetivo: El objetivo de este artículo es describir la puesta en marcha de un modelo de envío domiciliario y atención farmacéutica presencial y no presencial a pacientes con leucemia mieloide crónica en tratamiento con inihibidores de tirosin kinasa. Método: Los pacientes diagnosticados de leucemia mieloide crónica fueron seleccionados como población susceptible de recibir este nuevo modelo de atención. Esta elección respondía a cuatro características: cronicidad de la patología, periodicidad de las consultas médicas, valor del seguimiento farmacéutico y conservación a temperatura ambiente de los medicamentos. Resultados: De 68 pacientes diagnosticados de leucemia mieloide crónica en tratamiento con inhibidores de tirosin kinasa se eligieron 42 por acudir a las consultas médicas de hematología con una periodicidad superior a tres meses. Se les envió una carta de presentación y un cuestionario sobre sus preferencias. Dieciséis expresaron su deseo de participar en el nuevo modelo. El departamento jurídico redactó un contrato para garantizar la confidencialidad, así como un modelo de consentimiento informado. Se estableció un modelo logístico de reparto basado en rutas y horarios definidos. Previo a la inclusión en el programa, se realizó una consulta de atención farmacéutica presencial y se estableció el medio de comunicación para las próximas consultas no presenciales. El envío de medicación tuvo un coste mensual de 13,2€ (con IVA) por paciente. Todos los pacientes que iniciaron el programa continúan en él. Se han realizado hasta la fecha, 5 envíos por paciente. Conclusiones: Es posible instaurar un modelo alternativo de atención farmacéutica con envío domiciliario de medicación, manteniendo la relación farmacéutico-paciente, evitando desplazamientos, garantizando la confidencialidad y racionalizando el stock.

Atención farmacéutica y envío domiciliario de medicación a pacientes con leucemia mieloide crónica / Pharmaceutical care and home delivery of medication to patients with chronic myeloid leukemia

Objetivo: El objetivo de este artículo es describir la puesta en marcha de un modelo de envío domiciliario y atención farmacéutica presencial y no presencial a pacientes con leucemia mieloide crónica en tratamiento con inihibidores de tirosin kinasa. Método: Los pacientes diagnosticados de leucemia mieloide crónica fueron seleccionados como población susceptible de recibir este nuevo modelo de atención. Esta elección respondía a cuatro características: cronicidad de la patología, periodicidad de las consultas médicas, valor del seguimiento farmacéutico y conservación a temperatura ambiente de los medicamentos. Resultados: De 68 pacientes diagnosticados de leucemia mieloide crónica en tratamiento con inhibidores de tirosin kinasa se eligieron 42 por acudir a las consultas médicas de hematología con una periodicidad superior a tres meses. Se les envió una carta de presentación y un cuestionario sobre sus preferencias. Dieciséis expresaron su deseo de participar en el nuevo modelo. El departamento jurídico redactó un contrato para garantizar la confidencialidad, así como un modelo de consentimiento informado. Se estableció un modelo logístico de reparto basado en rutas y horarios definidos. Previo a la inclusión en el programa, se realizó una consulta de atención farmacéutica presencial y se estableció el medio de comunicación para las próximas consultas no presenciales. El envío de medicación tuvo un coste mensual de 13,2 Euros (con IVA) por paciente. Todos los pacientes que iniciaron el programa continúan en él. Se han realizado hasta la fecha, 5 envíos por paciente. Conclusiones: Es posible instaurar un modelo alternativo de atención farmacéutica con envío domiciliario de medicación, manteniendo la relación farmacéutico-paciente, evitando desplazamientos, garantizando la confidencialidad y racionalizando el stock (AU)

Objectives: To describe the implementation of a new model face to face and remote pharmaceutical care with home delivery of tyronsine kinase inhibitors medicines for patients with chronic myeloid leukemia. Methods: Patients with chronic myeloid leukemia were selected to start this new model of care. Four characteristics were taken into account for the choice: chronicity of the disease, frequency of doctor visits, pharmaceutical care value and conservation of tyronsine kinase inhibitors medicines at room temperature. Results: Out of 68 patients with chronic myeloid leukemia and treated with tyronsine kinase inhibitors, 42 were selected due to the frequency of their hematologist visits. An introductory letter and a questionnaire about their preferences were sent to these patients.Sixteen of them expressed their desire to participate. The legal department designed a confidentiality contract, as well as a model of informed consent. A logistic distribution model based on defined routes and timetables was established. Prior to inclusion, pharmaceutical care was performed in a face to face consultation and the communication way was established for the followings remote consultations. Home delivery had a monthly cost of 13.2 Euros (including VAT) per patient. All the patients who started this program continue in it. To date, 5 deliveries per patient have been conducted Conclusions: It is possible to establish an alternative model of pharmaceutical care with home delivery of medication, keeping the pharmacist-patient relationship, avoiding travel, ensuring the confidentiality and rationalizing the stocks (AU)