[Incorporation of patient-reported outcomes into pharmacy and dermatology departments, in psoriasis and atopic dermatitis patients, as a tool to improve the healthcare quality and health outcomes]. / Incorporación de resultados informados por pacientes con psoriasis y dermatitis atópica en las consultas de atención farmacéutica y dermatología: herramienta que mejora la calidad asistencial y resultados en salud.

INTRODUCTION: Patient-reported outcomes (PROs) provide subjective information about their disease, treatment, and quality of life. OBJECTIVE: To introduce a new system of work coordinated between pharmacists and dermatologists, based on the collection and analysis of PROs to assess its clinical impact as well as patients satisfaction. METHOD: A prospective single-centre observational study was conducted under clinical conditions and included adult patients diagnosed with psoriasis (PS) and atopic dermatitis (AD) between April-2021 and February-2022. Pharmacists and dermatologists agreed on this systematic work. A REDCap® database was designed to facilitate data collection and the subsequent analysis. RESULTS: A total of 288 and 41 patients with PS and AD, respectively, were included. Those who started treatment showed significant improvement with a decrease in PROs and clinical parameters (p < 0.001). The pharmacist made 168 and 7 recommendations to dermatologists for PS and AD patients, respectively, of which 66.07% and 57.1% were accepted. The most common recommendations were «consult with rheumatologist¼ (20.83%), «extend drug regimen¼ (19.64%) and «consider change in treatment¼ (11.90%). Adverse events were reported in 55 and 17 patients with PS and AD, respectively. Of 103 patients, 75% were «very satisfied¼ and 20% «satisfied¼ with the system. CONCLUSIONS: This new working system helps to evaluate the short and long-term effectiveness of treatments and also to identify adverse events, alarm symptoms and co-morbidities in order to optimize therapies. Collaboration between pharmacists and dermatologists reduces decision-making time and patients appreciate better clinical care leading to higher patient satisfaction.

Farmacia hospitalaria ecológica: un enfoque sostenible del proceso de utilización de medicamentos en un hospital de tercer nivel / Green hospital pharmacy: A sustainable approach to the medication use process in a tertiary hospital

Background Sustainable management of healthcare waste has a positive impact on the global environment. In order to reduce it, the sustainable practice of the pharmacotherapeutic process in all its stages is essential. Objective To analyze the sustainability strategies proposed by the pharmacy service to reduce drug waste derived from the pharmacotherapeutic process. Secondary objectives: to analyze the stage of the pharmacotherapeutic process and the number and type of drugs involved. Methods The study was carried out in a tertiary level hospital. To coordinate the proposals, a referent pharmacist from every pharmacy department area was selected. Four stages of the process were evaluated (procurement, validation, dispensing and compounding), patients concerned were classified as outpatients or inpatients, and drugs potentially involved were analyzed by the administration route: into oral or parenteral. Results 28 ideas were proposed, which could affect more than 1200 drugs. 39.3% would affect the validation process, 17.9% the procurement management, 17.9% dispensing and 7.1% the compounding. Implementation feasibility and acceptability of these proposals were evaluated. Those with the greatest potential were: limiting the duration of treatments when possible, favoring the implementation of computer prescription order entry, favoring the use of the oral route over the parenteral route, and implementing computers in the preparation areas to avoid the use of paper guides. Discussion In our study, many ideas have been proposed by hospital pharmacists to improve the sustainability of the medication use process. When assessing these proposals by impact and feasibility, according to our results, shorten as much as possible the duration of treatments, computerization of the medication use process and oral administration over intravenous should be prioritized in order to reduce environmental impact. (AU)

Antecedentes La gestión sostenible de los residuos sanitarios tiene un impacto positivo en el medio ambiente mundial. Para reducirlo, es esencial la práctica sostenible del proceso farmacoterapéutico en todas sus etapas. Objetivo Analizar las estrategias de sostenibilidad propuestas por el servicio de farmacia para reducir los residuos de medicamentos derivados del proceso farmacoterapéutico. Objetivos secundarios: Analizar la etapa del proceso farmacoterapéutico y el número y tipo de medicamentos implicados. Métodos El estudio se realizó en un hospital de tercer nivel. Para coordinar las propuestas se seleccionó un farmacéutico referente de cada área del servicio de farmacia. Se evaluaron cuatro etapas del proceso (Adquisición, validación, dispensación y formulación), se clasificaron los pacientes afectados como ambulatorios u hospitalizados y se analizaron los fármacos potencialmente implicados según la vía de administración: oral o parenteral. Resultados Se propusieron 28 ideas, que podrían afectar a más de 1.200 medicamentos. El 39,3% afectarían al proceso de validación, el 17,9% a la gestión, el 17,9% a la dispensación y el 7,1% a la formulación. Se evaluó la viabilidad de la aplicación y la aceptabilidad de estas propuestas. Las de mayor potencial fueron: limitar la duración de los tratamientos cuando sea posible, favorecer la implantación de la entrada de órdenes de prescripción por ordenador, favorecer el uso de la vía oral frente a la parenteral e implantar ordenadores en las áreas de preparación para evitar el uso de guías en papel. Conclusiones En nuestro estudio, son muchas las ideas propuestas por los farmacéuticos de hospital para mejorar la sostenibilidad del proceso de utilización de medicamentos... (AU)

Cost avoided in drugs derived from theparticipation of patients in oncologyclinical trials

Introduction: Cancer is the second leading cause of death globally. About one in six deaths is due to this disease. The economic impact of cancer is increasing and has a high prevalence leading to high economic burden for the Health System mainly related to oncologic pharmacotherapies. The objective of this study is to calculate pharmaceutical expenditure savings as a consequence of patient’s involvement in Oncology Clinical Trials.Material and methods: Retrospective observational study. In order to determine savings in oncology drugs, cancer treatments of patients participating in oncology clinical trials in April 2018 in a tertiary hospital in Spain were analyzed. Taking into account that the sponsor of the clinical trial provides the study medication free of charge, the costs savings were calculated comparing with the cost that would have supposed to treat the patient if they would have been received was standard regime for the type of tumor under study in clinical practice.Results: The cost avoided in the 50 oncology clinical trials analyzed was 1,564,943.59 euros. The average avoided cost per OCT was 31,298.87 euros, and the average avoided cost per patient was 10,096.41 euros.Conclusions: The participation of patients in oncology clinical trials provides an important economic saving, since it reduces the costs in the acquisition of medicines when they are provided free of charge by the sponsor of the study. (AU)

Introducción: El cáncer es la segunda causa de muerte a nivel mundial. Aproximadamente una de cada seis muertes se debe a esta enfermedad. El cáncer es una enfermedad de alta incidencia y el impacto derivado de la atención a pacientes oncológicos supone una importante carga económica para el Sistema Sanitario. El objetivo de este trabajo es calcular el coste evitado en medicamentos derivado de la participación de pacientes en Ensayos Clínicos de Oncología.Material y métodos: Estudio observacional retrospectivo. Se realiza un corte de datos en abril de 2018, se seleccionan todos los EECC activos en oncología y se incluyen los pacientes que habían participado en los mismos independientemente de la fecha de inclusión.Para determinar el coste evitado se calculó la diferencia entre el coste del esquema de tratamiento que el paciente está recibiendo dentro del EC con aportación gratuita de los medicamentos en investigación, y el coste que supondría el esquema de tratamiento que hubiese recibido en el supuesto de no haber participado en dicho EC.Resultados: El coste evitado en los 50 EECC analizados fue de 1.564.943,59 euros. El coste evitado medio por EC fue de 31.298,87 euros, y el coste evitado medio por paciente fue de 10.096,41 euros.Conclusiones: La participación de pacientes en EECC de oncología proporciona un importante ahorro económico, ya que reduce los costos en la adquisición de medicamentos cuando son proporcionados gratuitamente por el promotor del estudio. (AU)

Adaptaciones de la dispensación hospitalaria a pacientes con hemofilia durante la pandemia COVID-19 en España y su influencia en la adherencia / Adaptations of hospital dispensing to haemophilia patients during the COVID-19 pandemic in Spain and its influence on adherence

Introducción: El estado de alarma decretado por la pandemia del virus SARS COV-2 del 14 de marzo hasta el 21 de junio, ha supuesto un desafío para el área de pacientes externos de los Servicios de Farmacia. Nos centramos en los pacientes con hemofilia que se administran factores de la coagulación de forma crónica para prevenir hemorragias.Objetivos: Analizar durante este periodo el porcentaje de pacientes que han recogido su medicación, han mantenido la adherencia al tratamiento y las barreras encontradas para ello. Cuantificar el número y gravedad de episodios hemorrágicos (EH) sufridos y su relación con la pandemia. Analizar la prevalencia y gravedad de COVID en hemofílicos.Métodos: Uno objetivo, utilizando los registros del hospital y otro subjetivo, mediante encuesta oral durante la consulta de atención farmacéutica presencial o telemática.Resultados: El 80% de los pacientes retiraron medicación durante el periodo de estudio, un 30% en domicilio. El último mes las dispensaciones a domicilio se acompañaron de consulta telemática.Un 24% de pacientes disminuyó su adherencia respecto al 2019. Las principales causas fueron dificultad para acudir al hospital, y percepción de no necesitar tratamiento ante la inactividad.No se registraron más EH o ingresos por causas imputables a la pandemia.No hubo ningún enfermo COVID-19 grave y la incidencia de pacientes con síntomas leves fue similar a la población general.Conclusión: La mayoría de los pacientes con hemofilia pudieron acceder a su medicación. La adherencia se redujo. Los EH no aumentaron por causas atribuibles a la pandemia. La incidencia de COVID-19 fue similar a la población. (AU)

Introduction: The state of alarm decreed by the SARS COV-2 virus pandemic from March 14th to June 21st, has meant a challenge for the outpatient area of the pharmacy services. We focus on hemophilia patients who are chronically administered clotting factors to prevent bleeding.Objectives: To analyse during this period the percentage of patients who have collected their medication, maintained adherence to treatment and the barriers encountered in doing so. To quantify the number and severity of haemorrhagic episodes (HD) suffered and their relationship with the pandemic. Analyse the prevalence and severity of COVID in haemophiliacs.Methods: One objective, using hospital records, and one subjective, using an oral survey during the face-to-face or telematic pharmaceutical care consultation.Results: 80% of patients withdrew medication during the study period, 30% at home. In the last month, home deliveries were accompanied by telematic consultation.24% of patients decreased their adherence with respect to 2019. The main causes were difficulty in going to hospital, and perception of not needing treatment in the face of inactivity.There were no more HD or admissions for reasons attributable to the pandemic.There were no serious COVID-19 patients and the incidence of patients with mild symptoms was similar to the general population.Conclusion: Most haemophilia patients were able to access their medication. Adherence was reduced. HD did not increase due to causes attributable to the pandemic. The incidence of COVID-19 was similar to the population. (AU)

Impacto de la pandemia por COVID-19 en la actividad de un Servicio de Farmacia a través de los indicadores de actividad y calidad / Impact of the COVID-19 pandemic on the activity of a Pharmacy Service through activity and quality indicators

Objetivo: El objetivo de este trabajo fue analizar el impacto de la situación de emergencia sanitaria por COVID-19 en la actividad del Servicio de Farmacia reflejado en los indicadores del sistema de gestión de calidad. Métodos: Estudio observacional, descriptivo y retrospectivo en el que se recogieron mensualmente, entre enero y junio de 2020, los indicadores de actividad y calidad según el sistema de gestión de calidad del Servicio de FarmaciaResultados: El 45,2% de los indicadores reflejaron un incremento de actividad en el mes de marzo y el 38,7% en el mes de abril. El aumento de actividad estuvo principalmente relacionado con el área de farmacotecnia (elaboraciones no estériles); reposición de SAD (sistemas automatizados de dispensación) en Cuidados Intensivos y Urgencias; dispensación en dosis unitaria y Urgencias; inicios y elaboraciones de ensayos clínicos en medicamentos para el tratamiento de casos COVID-19. Por otro lado, disminuyó la dispensación presencial a pacientes externos y la actividad de conciliación. Se analizaron los indicadores de calidad asociados a estas actividades y se observó que todos ellos se mantuvieron dentro del objetivo de referencia.Conclusiones: El Servicio de Farmacia ha atendido a la demanda de actividad del hospital y residencias asociadas con un incremento de actividad que no se ha visto afectado en la calidad del servicio. (AU)

Objectives: To analyze the impact of health emergency situation due to COVID-19 on the activity of the Pharmacy Service reflected in quality management system. Methods: Observational, descriptive and retrospective study. Activity and quality indicators according to the quality management system of Pharmacy Service were collected each month between January and June 2020.Results: 45.2% of the indicators reflected an increase in activity in March and 38.7% in April. The increase in activity was mainly related to pharmaceutical preparations (non-sterile preparations); replacement of ADS (automated medication dispensing system) in Intensive Care Unit and Emergency Department; dispensing in unit dose and Emergency Department; beginnings and preparations of clinical trials in drugs for treatment of COVID-19. On the other hand, dispensing to outpatients and conciliation activity decreased. The quality indicators associated with these activities were analyzed and all of them remained within the reference objective.Conclusions: The Pharmacy Department met the demand for activity from the hospital and residences associated with an increase in activity without affecting the quality of the service. (AU)

Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer.

Background Palbociclib and ribociclib are novel oral agents in hormone receptor-positive metastatic breast cancer. Neutropenia is a common adverse event associated with these treatments and its clinical management often requires regimen changes, such as cycle delays and dose adjustments. Objective To provide a real-world experience of the effectiveness and toxicities associated with these drugs and to evaluate the impact of regimen changes in disease progression. Setting This study was performed at Hospital Universitario La Paz, in Spain. Methods Observational, retrospective study which included hormone receptor-positive metastatic breast cancer patients who initiated treatment with palbociclib or ribociclib between March 1st, 2018 and March 1st, 2019. Main outcome measure The primary effectiveness variable was progression-free survival. Safety evaluation was performed to determine neutropenia-incidence and severity, as well as its clinical management, including dose adjustments and treatment interruptions. Correlations between these regimen changes and effectiveness were also evaluated. Results Sixty-one patients were included, 33 treated with palbociclib and 28 with ribociclib. Palbociclib was mainly used as second line of treatment in the metastatic setting (81.8%) and ribociclib as first line (67.9%). The median progression-free survival was 12.76 months (95% CI 7.5 to not estimable) in palbociclib and not reached in ribociclib. After 12 months, the progression-free survival rate was 51.5% (95% CI 34-69) in palbociclib and 78.6% (95% CI 63-94.1) in ribociclib. Neutropenia was the most common adverse event with an incidence rate of 87.9% in palbociclib and 82.1% in ribociclib. Cycle delays were needed in more than half of the patients treated with palbociclib and ribociclib (63.6% and 64.3%). Dose adjustments were seen in 42.4% and 53.6% of the patients receiving palbociclib and ribociclib, respectively. Regimen changes did not involve statistically significant differences in 12-month PFS rates in the cohort investigated. Conclusion Palbociclib and ribociclib outcomes are comparable to those reached in the phase III trials, PALOMA-3 and MONALEESA-2, respectively, and cannot be compared as they were used in different treatment settings. The toxicity profile is favourable, being neutropenia the most common adverse event, easily managed with regimen changes. Further studies are needed to confirm the observed tendency of no detrimental impact on effectiveness of these regimen changes.

Evaluación del servicio de entrega de medicación a domicilio desde la Farmacia Hospitalaria durante la pandemia COVID-19 / Medication home delivery service set up in a Hospital Pharmacy Department during the COVID-19 pandemic

OBJETIVO: Analizar el procedimiento de entrega a domicilio de medicación de dispensación hospitalaria instaurado en el Servicio de Farmacia Hospitalaria (SFH) durante la pandemia COVID-19. Conocer el perfil de pacientes que aceptan la dispensación domiciliaria, analizar por patología las dispensaciones a domicilio y evaluar el grado de satisfacción de los pacientes mediante una encuesta telefónica. MÉTODOS: Estudio observacional, retrospectivo y descriptivo. Se analizaron las entregas de medicación a domicilio desde el SFH en el periodo del 7 de abril al 7 de mayo. Las características clínicas y demográficas de los pacientes se obtuvieron a partir del programa informático de pacientes externos del SFH e historia clínica electrónica. El grado de satisfacción de los pacientes se evaluó mediante la realización de una encuesta telefónica posterior a la entrega a domicilio. RESULTADOS: Se realizaron 2.028 entregas de medicación a domicilio abarcando toda la Comunidad Autónoma de Madrid (CAM), con un grado de aceptación del 76,82%. La patología con mayor número de entregas fue VIH. Los pacientes con enfermedades inmunomediadas fueron los que mayor aceptación reportaron. El 99% de los pacientes se mostraron satisfechos con el servicio. CONCLUSIONES: El servicio de entrega de medicación a domicilio ha sido ampliamente aceptado por los pacientes, mostrando un alto grado de satisfacción con el mismo. Se han evitado desplazamientos al hospital, disminuyendo el riesgo de contagio. Los pacientes demandan la prolongación de este servicio fuera del periodo de pandemia y sugieren que se complemente con una consulta de atención farmacéutica por telefarmacia

OBJECTIVE: To analyze the home delivery process of hospital medication set up in a Hospital Pharmacy Department (HPD) during the COVID-19 pandemic. To asses the profile of patients who accept home delivering, to analyze home dispensations by pathology and to evaluate the patient satisfaction through a telephone survey. METHODS: Observational, retrospective and descriptive study. Medication home delivery from the HPD in the period from April 7 to May 7 was analyzed. Patients demographic and clinical characteristics were obtained from the outpatient software used at the HPD and the electronic medical record. The degree of patient satisfaction was assessed by conducting a telephone survey after home delivery. RESULTS: A total of 2,028 home deliveries were made to the entire Community of Madrid, with an acceptance rate of 76,82%, being HIV the pathology with the highest number of deliveries. Patients with immune-mediated diseases were the ones with the greater acceptance rate. Overall patient satisfaction with the service was 99%. CONCLUSIONS: Medication home delivery service has been widely accepted by patients, showing a high degree of satisfaction. Avoiding trips to the hospital has reduced the risk of contagion. Patients demand the continuation of this service after the pandemic and support Pharmaceutical Care by telepharmacy

[Biosimilars: regulatory status for approval]. / Biosimilares: situación regulatoria para su autorización.

Biotecnological drugs represents the future treatment in medicine. Since the expiry of the patent of the fi rst approved biotech drug, "copying" and marketing of them can be offered by any other biotech company, these new medicines are known as biosimilar medicines. They are approved by the EMEA (European Medicines Evaluation Agency) through the European centralised procedure, the EMEA issued several stringent guidelines to approve a biosimilar drug on the European market, preclinical and clinical studies are necessary to asses the highest standards in quality, efficacy and patient safety. The World Health Organization has determined that biosimilar have the same INN than the original product.

Biosimilares: situación regulatoria para su autorización / Biosimilars: regulatory status for approval

Los medicamentos biotecnológicos representan el futuro en la medicina. Al expirar la patente de algunos de ellos, aparecen las primeras “copias” de los mismos, que son conocidos como biosimilares. Éstos son producidos por otro fabricante, utilizando nuevas líneas celulares, nuevos procesos y diferentes métodos analíticos. Por ello, su regulación queda a cargo de la Agencia Europea del Medicamento (EMEA) a través del procedimiento centralizado, la cual ha desarrollado unas guías perfectamente establecidas que definen el proceso de autorización que deben seguir los mismos, donde son necesarios estudios preclínicos y clínicos destinados a establecer su perfil de calidad, eficacia clínica y seguridad. Respecto a su denominación, la Organización Mundial de la Salud (OMS) ha determinado que los biosimilares tengan el mismo International Nonpropietary Name (INN) que su medicamento de referencia (AU)

Biotecnological drugs represents the future treatment in medicine. Since the expiry of the patent of the first approved biotech drug, “copying” and marketing of them can be offered by any other biotech company, these new medicines are known as biosimilar medicines. They are approved by the EMEA (European Medicines Evaluation Agency) through the European centralised procedure, the EMEA issued several stringent guidelines to approve a biosimilar drug on the European market, preclinical and clinical studies are necessary to assess the highest standards in quality, efficacy and patient safety. The World Health Organization has determined that biosimilar have the same INN than the original product (AU)

Documento de Consenso sobre el uso de factores estimuladores de colonias de granulocitos biosimilares para la corrección de la neutropenia asociada en pacientes con cáncer / No disponible

No disponible

Estudio de utilización de analgésicos opiáceos en un hospital general universitario / Study of opioid analgesic use in a general university hospital

Objetivo: El objetivo de este trabajo ha sido realizar un estudio de utilización de analgésicos opiáceos en el Hospital Universitario La Paz (Madrid) en el año 2008 para conocer cómo se está utilizando este grupo de medicamentos y cuál es la tendencia del consumo. Para ello, se presentan los datos de uso de opiáceos en pacientes ingresados de forma global, por hospitales y por servicios clínicos. Se exponen los datos de consumo de los 5 últimos años y se ha cuantificado el uso del resto de principios activos empleados como analgésicos en nuestro hospital. Material y métodos: Haciendo uso de la metodología recomendada por la Organización Mundial de la Salud para los estudios de utilización de medicamentos en hospitales, presentamos nuestros datos en dosis diarias definidas (DDD) por 100 estancias. Los datos de consumo se han obtenido del programa de gestión de medicamentos del Servicio de Farmacia Farma Tools (Dominion®) Resultados: El valor global de utilización de opiáceos en 2008 ha sido de 8,1 DDD/100estancias. Los principios activos más consumidos han sido la morfina parenteral y el fentanilo transdérmico, y entre los 2 representan el 83% del consumo total de opiáceos. En el análisis por hospitales apreciamos que el Hospital General y el de Traumatología son los que presentan un mayor empleo de opiáceos y siguen el mismo patrón de utilización que el global. Los servicios más representativos del consumo de opiáceos han sido las reanimaciones del Hospital General y de Traumatología, los Servicios de Oncología, Cuidados paliativos y Hematología. En estos últimos 5 años se ha producido un incremento global del consumo de aproximadamente el 20%, viéndose implicados todos los principios activos. Con relación al consumo total de analgésicos, los datos reflejan una amplia utilización en el hospital (104 DDD/100 estancias)...(AU)

Objective: The aim of this study was to analyze opioid analgesic use in the La Paz University Hospital in 2008 in order to identify patterns of use and consumption. To that end, data from inpatients were analyzed overall, as well as by hospitals and departments. We analyzed data on consumption in the previous 5 years and quantified the use of there maining active principles administered as analgesics in our hospital. Materials and methods: Following the Wold Health Organization’s guidelines for studies on medication use in hospitals, data are shown as defined daily dose (DDD) per 100hospital stays. Data on drug use were obtained from the drug management program, Farma Tools (Dominion®), which is used by the Pharmacy Service at La Paz Hospital. Results: The overall value of opioid utilization in 2008 was 8.1 DDD per 100 hospital stays. The most widely used active principles were parenteral morphine and transdermal fentanyl. Together, these drugs represented 83% of total opioid consumption. Analysis by hospital revealed that the General and Traumatology Hospitals showed the highest opioiddrug consumption and followed the same utilization pattern as overall use. The services most representative of opioid consumption in inpatients were the Recovery Room in the General and Traumatology Hospitals, Critical Care, Oncology, Hematology and Palliative Care. In the last 5 years of the study, the overall use of these drugs increased by 20%, irrespective of the active principles involved. Analysis of analgesic intake at La Paz Hospital showed widespread use (104 DDD per 100 hospital stays). Opioids represented7.4% of total analgesic consumption, the most frequently used analgesics being acetaminophen and metamizol. Conclusions: The results of our study show an increasing trend in opioid consumption in this hospital...(AU)

Hyperglycemia induced by megestrol acetate in a patient with AIDS.

OBJECTIVE: To report a case of hyperglycemia induced by megestrol acetate in a patient with AIDS. CASE SUMMARY: A 28-year-old man with AIDS developed hyperglycemia requiring insulin therapy 5 days after beginning megestrol therapy. The hyperglycemia resolved with discontinuation of the agent and treatment with insulin, and recurred 2 years later, when megestrol acetate treatment was rechallenged. In this case the patient had developed hyperglycemia and pancreatitis 1 year before, related to pentamidine therapy. DISCUSSION: To our knowledge this is the first reported case of hyperglycemia that was induced by megestrol acetate as early as 5 days after beginning therapy and confirmed by rechallenge. The mechanism of action is unclear. CONCLUSIONS: Clinicians caring for patients with AIDS-related cachexia should be aware that megestrol acetate can cause a severe but reversible hyperglycemic state.