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BackgroundCorticosteroids are one of the few drugs that have shown a reduction in mortality in coronavirus disease 2019 (COVID-19). In the RECOVERY trial, the use of dexamethasone reduced 28-day mortality compared to standard care in hospitalized patients with suspected or confirmed COVID-19 requiring supplemental oxygen or invasive mechanical ventilation. No benefit in patients not requiring respiratory support at randomization was observed. However, we believe that the use of corticosteroids in patients with COVID-19 pneumonia might not be subject to a decision based solely on oxygen needs. Evidence has shown that 30% of COVID-19 patients with mild symptoms at presentation will progress to acute respiratory distress syndrome (ARDS), particularly patients in whom laboratory inflammatory biomarkers associated with COVID-19 disease progression are detected. We postulated that dexamethasone treatment in hospitalized patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease might lead to a decrease in the development of ARDS, and thereby reduce death.Methods/designThis is a multicenter, randomized, controlled, parallel, open-label trial testing dexamethasone in 252 adult patients with COVID-19 pneumonia who do not require supplementary oxygen on admission, but are at risk factors for development ARDS. Risk for development ARDS is defined as levels of lactate dehydrogenase >245 U/L, C-reactive protein >100 mg/L, and lymphocyte count of 9/L. Eligible patients will be randomly assigned to receive either dexamethasone or standard of care. Patients in the dexamethasone group will receive an intravenous dose of 6 mg once daily from day 1 to day 3, followed by an oral dose of 6 mg once daily from day 4 to day 7. The primary outcome is a composite of development of moderate ARDS and all-cause mortality during the 30-day period following enrollment.DiscussionIf our hypothesis is correct, the results of this study will provide additional insights about the management and progression of this specific subpopulation of patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease.Trial registrationClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.

Hereditary fructose intolerance is a metabolic disease due to an aldolase B deficiency. Our objective was to ascertain the social and health care needs of those with this deficiency.A prospective, observational study was performed. A survey of social and health care needs was conducted to hereditary fructose intolerance patients living in Spain.Most patients had been diagnosed, mainly by genetic analysis in children and based on fructose overload in adults. Population surveyed had no sequelae (72.34%) or disability (64%), and 83.33% of children and 52.38% of adults were taking drugs (p.05) (2.06 drugs on average). Most patients had attended medical visits in the past two years, mainly in metabolic disease units (42.5%) and/or nutrition units (42.5%), but less than a half attended reference centers (mostly children [p0.05]). Although 48% were satisfied with health care, they felt discriminated in recreational activities, school, health and/or daily activities. The most reliable sources of information were the specialized care physician (69.39%) and patients' association (59.18%). Fifty-five percent reported no problem in any quality of life dimension, although some had problems in daily activities, pain, and anxiety.Although hereditary fructose intolerance is less disabling than other rare diseases, it is important to know the needs of those who suffer from it. Although time to diagnosis has shortened, the poorer health care and satisfaction with it perceived in adults makes it necessary to emphasize the needs of this population, and the critical need of training and information of health care professionals.

Resumen Introduccion La intolerancia hereditaria a la fructosa es una enfermedad metabolica debida a una deficiencia en la aldolasa B. Nuestro objetivo es conocer las necesidades sociosanitarias del colectivo. Metodologia Estudio observacional prospectivo en el que se difundio una encuesta de necesidades sociosanitarias a pacientes con intolerancia hereditaria a la fructosa residentes en Espana. Resultados La mayoria disponian de diagnostico, confirmado principalmente por analisis genetico en menores y sobrecarga de fructosa en adultos, no padecian secuelas (72,34%) ni discapacidad (64%) y el 83,33% de ninos tomaban medicamentos frente al 52,38% de adultos (p Conclusiones Aunque su perfil no sea tan discapacitante como el de otras enfermedades raras, es importante conocer las necesidades del paciente con intolerancia hereditaria a la fructosa. Aunque se han reducido los tiempos en el diagnostico, la menor atencion y satisfaccion sanitaria en adultos hace necesario incidir en las necesidades de esta poblacion, siendo clave la formacion e informacion de los profesionales sanitarios.

Background Corticosteroids are one of the few drugs that have shown a reduction in mortality in coronavirus disease 2019 (COVID-19). In the RECOVERY trial, the use of dexamethasone reduced 28-day mortality compared to standard care in hospitalized patients with suspected or confirmed COVID-19 requiring supplemental oxygen or invasive mechanical ventilation. Evidence has shown that 30% of COVID-19 patients with mild symptoms at presentation will progress to acute respiratory distress syndrome (ARDS), particularly patients in whom laboratory inflammatory biomarkers associated with COVID-19 disease progression are detected. We postulated that dexamethasone treatment in hospitalized patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease might lead to a decrease in the development of ARDS and thereby reduce death. Methods/design This is a multicenter, randomized, controlled, parallel, open-label trial testing dexamethasone in 252 adult patients with COVID-19 pneumonia who do not require supplementary oxygen on admission but are at risk factors for the development of ARDS. Risk for the development of ARDS is defined as levels of lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L, and lymphocyte count of 9/L. Eligible patients will be randomly assigned to receive either dexamethasone or standard of care. Patients in the dexamethasone group will receive a dose of 6 mg once daily during 7 days. The primary outcome is a composite of the development of moderate or more severe ARDS and all-cause mortality during the 30-day period following enrolment. Discussion If our hypothesis is correct, the results of this study will provide additional insights into the management and progression of this specific subpopulation of patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease. Trial registration ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.

In February 2018, Resolution 189/2018 was published in the Autonomous Community of Madrid with the objective of centralizing the procedure for the acquisition, preparation, distribution, and dispensing of methadone to Centres for the Comprehensive Care of Drug Addiction Patients within the Madrid Health Service under the responsibility of a Hospital Pharmacy Service. The Hospital Pharmacy Service began this activity in March 2018. This is the first time that the comprehensive management of a methadone maintenance plan has been centralized in an Hospital Pharmacy Service for the care of drug-dependent patients in the Autonomous Community of Madrid. At the beginning of the Project, the previous workflow was analysed, the pharmaceutical laboratory was adapted, and the methadone acquisition procedure was designed. A communication channel with the Centres for the Comprehensive Care of Drug Addiction Patients was implemented and application forms were designed. Corresponding control procedures were established given that the medication under consideration was a narcotic. Standard procedures for the acquisition of methadone, of containers for personalized dosing in Centres for the Comprehensive Care of Drug Addiction Patients, and transport routes were designed and contracted out through public tender in compliance with the Public Administration Contract Law. A tender has also been awarded for the implementation of a computerized management system and automated dispensing systems, which are currently undergoing installation. The pharmacotherapeutic protocol of the Methadone Maintenance Plan of the Autonomous Community of Madrid is also being updated. Over 18 months, 5,300 L of methadone solution have been prepared and 2,844 individual prescriptions have been dispensed. High levels of perceived satisfaction were reported via a questionnaire administered to the Centre for the Comprehensive Care of Drug Addiction Patients staff. The response rate was 92%. Overall satisfaction was very satisfied/quite satisfied (91%) and satisfied (9%). These results highlight the high level of satisfaction (quite satisfied or very satisfied: 81.8%) with the effectiveness and speed of resolution of incidents by the Hospital Pharmacy Service staff. This process incorporates the knowledge and experience of hospital pharmacists into this healthcare field, as well as taking advantage of existing resources, facilities, and procedures. All these aspects lead to an efficient, effective, and safe approach to this clinical-care activity and enable a change in the pharmacotherapeutic health care model for opioid- dependent patients.En febrero de 2018 se publicó en la Comunidad de Madrid la Resolución 189/2018 con el objetivo de centralizar el procedimiento de adquisición, elaboración, distribución y dispensación de metadona a los Centros de Atención Integral a Drogodependientes del Servicio Madrileño de Salud bajo la responsabilidad de un servicio de farmacia hospitalaria. El servicio de farmacia hospitalaria inició esta actividad en marzo de 2018, siendo la primera vez que se centraliza en un servicio de farmacia hospitalaria la gestión integral del plan de mantenimiento con metadona para la atención de pacientes drogodependientes en la Comunidad de Madrid. Al inicio del proyecto se analizó el circuito anterior, se adaptó el laboratorio de farmacotecnia y se diseñó el procedimiento de adquisición de metadona. Se implementó una vía de comunicación con los Centros de Atención Integral a Drogodependientes, diseñándose formularios de solicitud y se establecieron los correspondientes procedimientos de control derivados de su naturaleza estupefaciente. Se han diseñado y adjudicado, cumpliendo la Ley de Contratos de la Administración Pública, procedimientos normalizados para la adquisición de metadona, envases para la dosificación personalizada en los Centros de Atención Integral a Drogodependientes y rutas de transporte. Asimismo, se ha adjudicado un concurso para la implementación de un sistema informático de gestión y sistemas automatizados de dispensación, actualmente en vías de instalación. También se está actualizando el protocolo farmacoterapéutico del Plan de mantenimiento con metadona de la Comunidad de Madrid. En año y medio se han elaborado 5.300 litros de metadona solución y se han dispensado 2.844 prescripciones individualizadas. Disponemos de resultados de calidad percibida por los profesionales de los Centros de Atención Integral a Drogodependientes mediante una encuesta de satisfacción. La tasa de respuesta fue del 92%. El grado de satisfacción global fue: 91% muy satisfecho/bastante satisfecho y 9% satisfecho. Destaca el alto grado de satisfacción (bastante o muy satisfecho) del 81,8% con la eficacia y rapidez de la resolución de incidencias por parte de los profesionales del servicio de farmacia. Este proceso permite incorporar el conocimiento y experiencia de los farmacéuticos especialistas a este ámbito asistencial, así como aprovechar recursos, instalaciones y procedimientos ya existentes. Todo ello redunda en un abordaje eficiente, eficaz y seguro de esta actividad clínico-asistencial y posibilitar un cambio de modelo de asistencia farmacoterapéutica de los pacientes dependientes de opiáceos.

Introducción y objetivo: Conocer y analizar la experiencia autorreferida del tratamiento de los pacientes VHC que iniciaron tratamiento con agentes antivirales directos (AAD), a tiempo real, de forma proactiva e integrada en el proceso asistencia! de atención farmacéutica. Material y métodos: Estudio observacional y transversal desarrollado entre abril (inicio del Plan Estratégico Nacional) y diciembre de 2015 en la Consulta Externa del Servicio de Farmacia. Se utilizó como herramienta un cuestionario prospectivo cumplimentado por los pacientes donde se recogieron variables relacionadas con la calidad de vida vinculadas con la salud (CVRS), adherencia, efectos adversos (EA), satisfacción con el tratamiento, y valoración y utilidad del programa formativo implementado por el Servicio de Farmacia. Se realizó un análisis descriptivo de todas las variables incluidas en el estudio y se analizó la influencia de las diferentes variables en el grado de adherencia y CVRS. El análisis de las diferencias entre los dos grupos se realizó mediante el test de chi cuadrado y el cálculo de las OR con un modelo de regresión logística simple. Se utilizó el programa SPSS® versión 20, y se estableció una significación estadística para valores de p < 0,05. Resultados: Se recogieron155 encuestas de las 226 enviadas, tasa de respuesta del 68,6%.En referencia a la CVRS (valoración del estado físico y emocional), un 38,7% de los pacientes refieren que su estado físico y emocional es mucho mejor desde el inicio del tratamiento. La presencia de EA y una peor información global de su enfermedad se asoció con un peor estado físico y emocional (p < 0,05). La adherencia reportada fue del 84,5% y el tratamiento fue valorado como muy bueno o bueno por el 87% de los pacientes. Un 52,9% de los pacientes no tuvieron efectos adversos relacionados con la medicación y el proceso formativo realizado por el farmacéutico especialista en la primera consulta fue valorado por el 96,7% de los pacientes como muy bueno o bueno. Conclusiones: La experiencia autorreferida obtenida a través de un contacto directo y permanente con los pacientes permite obtener información sobre aspectos importantes del tratamiento. Creemos que estas herramientas deben incorporarse a los procedimientos de atención farmacéutica como una forma de mantener la continuidad. Además, inducen al paciente a una autoevaluación de diversos aspectos de su propio tratamiento, que pueden ayudar a conseguir una mayor implicación en el mismo y contribuir a conseguir el máximo resultado en salud posible de la farmacoterapia. Background and objective: To learn about and analyze the self-reported treatment experience of HCV patients who started treatment with direct acting antivirals agents (DAA), at a real-time, proactive and integrated into the pharmaceutical care healthcare process, using a prospective questionnaire completed by patients as clinical tool. Material and methods: Observational and cross-sectional study conducted between April (start of the National Strategic Plan) and December 2015 in the Outpatient Pharmacy Service. The questionnaire includes variables related to health related quality of life (HRQOL), adherence, adverse effects (AEs), satisfaction, and usefulness of the Pharmacy Service implemented training program. A descriptive analysis of all variables included in the study was conducted and the influence of different variables analyzed in the degree of adherence and HRQOL. The analysis of the differences was performed using chi-square test and simple logistic regression model for calculation of OR. We use SPSS version 20 program and statistical significance for values of p < 0.05 was considered. Results: 155 of the 226 surveys returned, with a response rate of 68.6%. Referring to the HRQOL (evaluation of physical and emotional state), 38.7% of patients reports that their physical and emotional state is much better from the start of treatment. The presence of EA and worse global information of their disease was associated with worse physical and emotional state (p < 0.05). Reported adherence was 84.5% and the treatment was evaluated as very good or good by 87% of patients. 52.9% had no adverse effects related to the medication and the training process performed by the specialist pharmacist at the first visit 96.7% of patients assessed as very good or good. Conclusions: Self-reported experience acquired through direct and constant contact with patients provides information on important aspects of treatment. We believe that these tools should be incorporated into pharmaceutical care procedures as a way to maintain continuity in patients direct contact. They also induce patients to a self-assessment of various aspects of their own treatment, which can help achieve greater involvement in it and can contribute to achieve the maximum health outcome in pharmacotherapy.

Background: The most widely used validated instrument to assess the complexity of medication regimens is the Medication Regimen Complexity Index (MRCI). Objective: This study aimed to translate, adapt, and validate a reliable version of the MRCI adapted to Spanish (MRCI-E). Methods: The cross-cultural adaptation process consisted of an independent translation by 3 clinical pharmacists and a backtranslation by 2 native English speakers. A reliability analysis was conducted on 20 elderly randomly selected patients. Two clinical pharmacists calculated the MRCI-E from discharge treatments and 2 months later. For the validity analysis, the sample was augmented to 60 patients. Convergent validity was assessed by analyzing the correlation between the number of medications; discriminant validity was stratified by gender; and predictive validity was determined by analyzing the ability to predict readmission and mortality at 3 and 6 months. Results: The MRCI-E retained the original structure of 3 sections. The reliability analysis demonstrated an excellent internal consistency (Cronbach’s α=0.83), and the intraclass correlation coefficient exceeded 0.9 in all cases. The correlation coefficient with the number of medications was 0.883 ( P

To determine the level of support, knowledge and perceptions of pre-exposure prophylaxis (PrEP) by Infectious Disease Specialists and Hospital Pharmacists in Spain.Cross-sectional study through an on-line 31-item survey (sociodemographical data, employment status/experience, knowledge of PrEP, use, identified barriers and economic issues). A univariate analysis was performed to evaluate the variables associated with support for PrEP, and compare the assessments by Specialists and Pharmacists. The questions about support for PrEP and agreement with the indication approval were repeated after showing data from published studies. The significance of the change in the answers was analyzed using the McNemar Test.211 questionnaires were received (80.1% from Pharmacists). 40.3% had low/no familiarity with PrEP (46.2% Pharmacists vs. 16.7% Physicians; p0.01). A 53.6% of them would support the use of PrEP (49.7% Pharmacists vs. 69% Physicians; p = 0.038). The minimum acceptable efficacy in order to support PrEP was 85.0 ± 15.5% (82.6 ± 12.1% by Physicians vs. 85.6 ± 15.0% by Pharmacists; p = 0.02). The variables associated with support were: medical profession (OR = 2.26; 95%CI 1.1-4.6; p = 0.038) and lower demand for efficacy (difference = 10.5%; 95%CI 6.9 to 14.1; p0.001). After receiving the information, there was an increase in their support for use and indication approval. Most participants (81.5%) did not support its reimbursement. The main barriers identified were: an increase in risk behaviour (24.1%), increase in sexually transmitted diseases (19.0%), resistance (16.6%) and cost (16.0%).More than half of participants were familiar with PrEP. The majority of them would support its use and the approval of the indication, but would not reimburse it. The use of PrEP in real practice is currently low.Objetivo: Determinar el grado de apoyo, conocimientos y percepciones respecto a la profilaxis preexposición (PrEP) de los médicos infectólogos y farmacéuticos hospitalarios en España. Métodos: Estudio transversal mediante encuesta de 31 ítems (datos sociodemográficos, situación laboral/experiencia, conocimiento sobre PrEP, uso, opiniones, barreras detectadas y aspectos financieros). Se realizó un análisis univariante para evaluar las variables relacionadas con el apoyo a PrEP y comparar las valoraciones de médicos y farmacéuticos. Las preguntas sobre apoyo a la PrEP y el acuerdo sobre aprobar la indicación se repitieron tras mostrar datos de estudios publicados. Se analizó la significación del cambio en la respuesta mediante la prueba de McNemar. Resultados: Se recibieron 211 cuestionarios (80,1% farmacéuticos). El 40,3% estuvieron nada/poco familiarizados con la PrEP (46,2% farmacéuticos vs. 16,7% médicos; p0,01). El 53,6% apoyaría su uso (49,7% farmacéuticos vs. 69% médicos; p = 0,038). La eficacia mínima considerada aceptable fue 85,0 ± 15,5% (82,6 ± 12,1% médicos vs. 85,6 ± 15,0% farmacéuticos; p = 0,02). Las variables relacionadas con el apoyo fueron: profesión médica (OR = 2,26 IC95% 1,1-4,6; p = 0,038) y menor exigencia de eficacia (diferencia 10,5% IC95% 6,9-14,1; p0,001). Tras recibir la información, aumentaron el apoyo al uso y la aprobación. El 81,5% no apoyaron la financiación. Las principales barreras señaladas fueron: aumento de conductas de riesgo (24,1%), aumento de enfermedades de transmisión sexual (19,0%), resistencias (16,6%) y coste (16,0%). Conclusiones: Más de la mitad de los encuestados estaban familiarizados con la PrEP. La mayoría apoyaría su uso y la aprobación de la indicación, pero no la financiaría. El uso en la práctica real de la PrEP es escaso en la actualidad.

The present article briefly reviews the main types of pharmacoeconomic analyses that evaluate the costs associated with HIV infection and the efficiency of antiretroviral therapy in general. The results of several pharmacoeconomic analyses applied to the selection of antiretroviral drugs in distinct clinical scenarios are also presented. Finally, we analyze the advantages, in terms of efficiency, of lopinavir/ritonavir as induction-maintenance therapy, both in terms of saving the direct costs of treatment and in possibly reducing the costs due to the management of the adverse effects of nucleoside analogs.

Objetivo: Presentar una metodología de evaluación preventiva de riesgos de errores de medicación en la incorporación de nuevos medicamentos a la práctica asistencial, así como una descripción de las acciones derivadas de dicha actuación. Material y métodos: Se estableció un Procedimiento Normalizado de trabajo que define el proceso de evaluación de riesgos de los nuevos medicamentos adquiridos por el Servicio de Farmacia antes de ser incorporados al circuito de distribución/dispensación. El farmacéutico cumplimenta la Ficha de Evaluación de Riesgos, cuestionario que facilita el análisis de las características del medicamento y orienta sobre las medidas de seguridad que se deben adoptar en función de los resultados. Resultados: Se evaluaron 64 medicamentos. En 35 (54,6%) se aplicó alguna medida preventiva de seguridad: incorporación a la Guía de Administración de medicamentos por sonda nasogástrica (3 fármacos), aplicación de la instrucción Técnica de cambio de concentración/presentación segura (7), incorporación al listado de medicamentos que contienen Látex (3), remisión de notas informativas a los profesionales sanitarios (12), adopción de medidas para almacenamiento seguro (6), incorporación de material educativo en los folletos informativos para pacientes externos (12), incorporación de interacciones farmacológicas a la base de datos (2), inicio de procedimiento de resolución de expediente (1) y comunicación a la AEMPS de errores potenciales por similitud de envases (2). Conclusiones: La implantación de esta evaluación preventiva de riesgos puede resultar una herramienta muy útil a la hora de tomar las medidas para minimizar la probabilidad de que se produzca un error de medicación, antes de que se incorpore a los circuitos de distribución/dispensación. Objective: Submit a preventive assessment methodology for the risk of medication errors when incorporating new drugs in clinical practice as well as a description of the types of actions arising from such action. Materials and methods: A Standard Operating Procedure was established which defines and plans the process of assessing the risks of new drugs purchased by the Pharmacy Services before being incorporated into the distribution and dispensation channels. The pharmacist responsible for each area fills the Risk Assessment Form, a questionnaire that facilitates the analysis of the product characteristics and provides guidance on safety measures to be taken depending on the results of that assessment. If it is confirmed that the drug requires some additional security measures to be taken, all professionals and technical staff of the Pharmacy Services shall be informed of measures to be taken. Results: Between 2011 and 2013, 64 drugs were assessed. 35 of them (54.6%) required some additional security measure to be applied before being incorporated into clinical practice. Conclusions: The implementation of the method of preventive risk assessment for new drugs purchased by the Pharmacy Services can be a very useful tool when taking the measures deemed necessary to minimize the likelihood of a medication error occurring before they are incorporated into the distribution/dispensing channels put in place by the Pharmacy Services.

Background According to several studies, despite of the existence of several published guidelines for dosing adjustments based on renal function, inappropriate prescribing is a common drug-related problem in inpatient care. Objective We developed and implemented a system for drug dosage adjustment integrated into the Hospital computer provider order entry system. This system allows pharmacists to identify patients with reduced renal function, identify medication orders that may require dosage modifications based on renal function, and generate an alert with a recommendation of specific dosage adjustment. Using the Summary of Product Characteristics and two drug databases (Micromedex 2.0® and Lexicomp®), specific dosage guidelines for drugs used in patients with renal impairment were established. Setting A 264-bed tertiary teaching hospital. Methods We performed a quasi-experimental, one-group, pretest–posttest study to assess the efficacy of this intervention program. We compared the differences between the frequency of appropriate orders pre- and post-test using the McNemar test. Main outcome measures: the frequency of appropriate orders before the recommendation (pre-test) and after the recommendation (post-test). Results Before the intervention, the frequency of appropriate prescribing based on renal function was 65 %. After the intervention, this frequency was 86 % (p

The present article briefly reviews the main types of pharmacoeconomic analyses that evaluate the costs associated with HIV infection and the efficiency of antiretroviral therapy in general. The results of several pharmacoeconomic analyses applied to the selection of antiretroviral drugs in distinct clinical scenarios are also presented. Finally, we analyze the advantages, in terms of efficiency, of lopinavir/ritonavir as induction-maintenance therapy, both in terms of saving the direct costs of treatment and in possibly reducing the costs due to the management of the adverse effects of nucleoside analogs.