Vacunas frente a la COVID-19: perfil de seguridad tras un año de seguimiento / COVID-19 vaccines: safety profile after one year of follow-up

Introducción: Tras declararse la pandemia mundial por el coronavirus COVID-19, se instauraron medidas para com-batirlo, destacando la existencia de vacunas frente a la COVID-19: dos de ARN mensajero [ARNm] y dos de vector viral no replicante [VVNR]. Nuestro objetivo fue contribuir a la ampliación del perfil de seguridad de dichas vacunas mediante la detección y notificación de reacciones adversas (RAs) en un área sanitaria con 174.398 tarjetas sanitarias durante el año 2021.Método: Estudio observacional descriptivo retrospectivo realizado en un hospital de segundo nivel. Las fuentes de detección de las RAs fueron: Sistema de Codificación del Centro al Alta del Paciente Ingresado [SIAC] y notificación espontánea. Los datos empleados fueron extraídos de la historia clínica electrónica y recogidos en un documento de Microsoft Excell. Resultados: De las 654 RAs detectadas, 36 pertenecieron a vacunas frente a la COVID-19, detectándose el 72 % mediante notificación espontánea y siendo el 91,67 % graves. Se produjeron en 29 pacientes (mediana de edad: 61 años; 51,72 % mujeres), dos de ellos con infección previa por COVID-19. El 50 % de las RAs sucedieron tras la segun-da dosis. Destacaron: trombosis venosa profunda (TVP), tromboembolismo pulmonar (TEP) y miopericarditis con vacunas de ARNm; y vasculitis y miocarditis en VVNR. Conclusiones: Aunque la bibliografía disponible señala que la frecuencia de RAs graves con dichas vacunas suele ser rara, resulta importante su seguimiento. El alto porcentaje de RAs detectadas por notificación espontánea refle-ja la implicación de los profesionales sanitarios en la ampliación del perfil de seguridad. (AU)

Introduction: After declaring the global pandemic due to the coronavirus COVID-19, measures were established to combat it, highlighting the existence of COVID-19 vaccines: two messenger RNA [mRNA] and two non-replicating viral vector [VVNR].Our objective was to contribute to expanding the safety profile of these vaccines through the detection and notifica-tion of adverse reactions (ARs) in a health area with 174,398 health cards during the year 2021.Method: Retrospective descriptive observational study carried out in a second level hospital. The sources of detec-tion of the ADRs were: Coding System of the Center at the Discharge of the Admitted Patient [SIAC] and spontaneous notification. The data used were extracted from the electronic medical record and collected in a Microsoft Excell document.Results: Of the 654 ARs detected, 36 belonged to COVID-19 vaccines, 72 % being detected by spontaneous noti-fication and 91.67 % being serious. They occurred in 29 patients (median age: 61 years; 51.72 % women), two of them with previous COVID-19 infection. 50 % of the ARs occurred after the second dose. They highlighted: deep vein thrombosis (DVT), pulmonary thromboembolism (PTE) and myopericarditis with mRNA vaccines; and vasculitis and myocarditis in VVNR.Conclusions: Although the available bibliography indicates that the frequency of serious ARs with these vaccines is usually rare, their follow-up is important. The high percentage of ADRs detected by spontaneous notification reflects the involvement of healthcare professionals to expanding the safety profile. (AU)

Seguridad y tolerabilidad de cabozantinib en cáncer renal y hepatocarcinoma / Safety and tolerability of cabozantinib in renal cancer and hepatocarcinoma

ntroducción: Cabozantinib es un fármaco indicado en el tratamiento de cáncer renal y hepatocarcinoma con efi-cacia demostrada en ensayos clínicos. Sin embargo, cuando analizamos su perfil de seguridad, los propios ensayos pivotales muestran un elevado porcentaje de efectos adversos, siendo necesario en muchos casos reducir la dosis o interrumpir el tratamiento debido a la toxicidad. Por ello, nuestro estudio pretende analizar la tolerabilidad y seguridad de cabozantinib en nuestra población. Método: Estudio observacional, retrospectivo y unicéntrico. Se evaluaron diferentes variables relacionadas con la seguridad y tolerabilidad del fármaco. Para valorar la toxicidad se utilizaron los criterios del National Cancer Institu-te (CTCAE versión 5.0). La tolerancia se evaluó basándose en la presencia de efectos adversos durante el tratamiento con cabozantinib. Se realizó un análisis estadístico descriptivo e inferencial de los datos. Resultados: Se incluyeron un total de 17 pacientes (edad media: 63,5 años). Todos ellos presentaron efectos ad-versos. Las principales toxicidades presentadas de cualquier grado fueron astenia, diarrea, toxicidad cutánea, hipo-magnesemia, hipertransaminemia y síndrome palmo-plantar. Un 41,2% fueron de grado 3, siendo las principales reacciones adversas la hipertransaminemia y la hipomagnesemia. Un 23,5% necesitaron un ingreso hospitalario debido a la toxicidad del fármaco. Un 94,1% de pacientes precisaron reducción de dosis por toxicidad a 40 mg. Conclusiones: Cabozantinib presenta un perfil de seguridad poco favorable con un alto porcentaje de efectos ad-versos que obligan a la reducción de dosis o a la interrupción del tratamiento. (AU)

Introduction: Cabozantinib is a drug indicated for the treatment of renal cancer and hepatocarcinoma with pro-ven efficacy in clinical trials. However, when we analyze its safety profile, the pivotal trials themselves show a high percentage of adverse effects, making it necessary in many cases to reduce the dose or interrupt treatment due to toxicity. Therefore, our study aims to analyze the tolerability and safety of cabozantinib in our population. Method: Observational, retrospective and single-center study. Different variables related to the safety and tolera-bility of the drug were evaluated. To assess toxicity, the National Cancer Institute criteria (CTCAE version 5.0) were used. Tolerance was assessed based on the presence of adverse effects during treatment with cabozantinib. A des-criptive and inferential statistical analysis of the data was performed. Results: A total of 17 patients were included (mean age: 63.5 years old). All of them presented adverse effects. The main toxicities presented of any grade were asthenia, diarrhea, skin toxicity, hypomagnesemia, hypertransamine-mia, and palmoplantar syndrome. 41.2% were grade 3 toxicity, the main adverse reactions being hypertransamine-mia and hypomagnesemia. Hospital admission due to drug toxicity was required by 23.5%. Dose reduction to 40 mg due to toxicity was required by 94.1% of patients. Conclusions: Cabozantinib has an unfavorable safety profile with a high percentage of adverse effects that require dose reduction or treatment interruption. (AU)

Evaluación del consumo de antibióticos en la Unidad de Cuidados Intensivos desde 2016 a 2020 en un hospital de segundo nivel / Evaluation of the anti-bacterial agents compsumption in the Intensive Care Unit from 2016 to 2020 in a second-level hospital

Objetivo: La monitorización del consumo de antimicrobianos en los hospitales es una medida necesaria para evaluar el uso racional de estos medicamentos. El indicador principal para realizar esta monitorización y conocer la presión o exposi-ción de los antimicrobianos a nivel hospitalario es la dosis diaria definida (DDD) por cada 100 estan-cias y día (e-d). El objetivo principal es analizar la evolución de la utilización de antibióticos en una Unidad de Cuidados Intensivos (UCI) de un hospital de segundo nivel a lo largo de 5 años.Métodos: Estudio observacional, retrospectivo que analiza el consumo de antibióticos en la UCI, rea-lizando una comparativa con respecto a los datos globales del hospital, utilizando como unidad de medida las DDD/100 e-d.Resultados: Se incluyeron 28 medicamentos, co-rrespondientes a 25 principios activos. La media de consumo hospitalario global fue de 67,98; ascen-diendo a 89,17 en la UCI. Se tiende a reducciones en los consumos hasta 2020, donde despuntan antibióticos como azitromicina o ceftriaxona. En la UCI los más consumidos en 2016 fueron merope-nem y amoxicilina/clavulánico, seguidos de cipro-floxacino y piperacilina/tazobactam. Sin embargo, en 2020 meropenem y amoxicilina/clavulánico, aunque con valores más bajos, continúan siendo los más empleados, mientras que ciprofloxacino pasa a ser uno de los menos consumidos.Conclusiones: El análisis de DDD/100 e-d en la UCI es una herramienta útil para monitorizar el con-sumo de antimicrobianos y ver las tendencias de consumos, lo que permitirá implementar medidas que promuevan el uso racional y seguro de estos fármacos. (AU)

Objective: Monitoring the consumption of anti-microbials in hospitals is a necessary measure to evaluate the rational use of these drugs. The main indicator to carry out this monitoring and to know the pressure or exposure of antimicrobials at the hospital level is the defined daily dose (DDD) for every 100 stays and day (s-d). The main objective is to analyze the evolution of the use of antibiotics in an Intensive Care Unit (ICU) of a second level hospital over 5 years. Methods: It was carried out an observational, retrospective study that analyzes the consumption of antibiotics in the ICU, making a comparison with the global data of the hospital, using DDD/100 s-d as the unit of measurement.Results: 28 drugs were included, corresponding to 25 active ingredients. The mean global hospital consumption was 67.98; rising to 89.17 in the ICU. There was a trend towards reductions in consump-tion until 2020, when antibiotics such as azithromy-cin or ceftriaxone stand out. In the ICU, the most consumed drugs in 2016 were meropenem and amoxicillin/clavulanate, followed by ciprofloxacin and piperacillin/tazobactam. However, in 2020, meropenem and amoxicillin/clavulanate, in spite of showing lower values, continued to be the most used ones, while ciprofloxacin became one of the least used.Conclusions: The analysis of DDD/100 s-d in the ICU is a useful tool to monitor the consumption of antimicrobials and see consumption trends, which will allow the implementation of measures that promote the rational and safe use of these drugs. (AU)

[Process of medical nutrition therapy]. / Proceso de tratamiento médico nutricional.

Introduction: Medical nutrition therapy is a very useful tool in maintaining and recovering the health of patients with disease-related malnutrition, although its implementation can be complex and is not without risks. Quality processes are understood as sets of activities that are related or interact to transform input elements into results. From the SENPE Management Work Group we present the process of medical nutrition therapy (PMNT), which aims to facilitate the management of clinical nutrition of a multidisciplinary nutrition support team in a hospital setting. This paper describes the seven sub-processes PMNT is comprised of, in addition to a previous nutritional screening sub-process. Each sub-process is divided into a first section with a technical sheet detailing its general aspects, while a second section proposes key objectives, quality indicators, and standards for their evaluation. .

Introducción: El tratamiento médico nutricional es de gran utilidad en el mantenimiento y recuperación de la salud de los pacientes con desnutrición relacionada con la enfermedad, aunque su implementación puede ser compleja y no está exenta de riesgos. Se entiende por proceso aquel conjunto de actividades que están mutuamente relacionadas o que interactúan para transformar elementos de entrada en resultados. Desde el Grupo de Trabajo de Gestión de la SENPE presentamos el Proceso de Tratamiento Médico Nutricional (PTMN), que tiene por objetivo facilitar la gestión de la nutrición clínica, pensando en un equipo de soporte nutricional multidisciplinar de atención al paciente hospitalizado. En este documento se describen los siete subprocesos que constituyen el PTMN, además de un subproceso previo de cribado nutricional. Cada subproceso se divide en una primera sección con una ficha técnica en la que se detallan sus aspectos generales, mientras que en la segunda sección se proponen objetivos clave, indicadores de calidad y estándares para su evaluación.

Proceso de tratamiento médico nutricional / Process of medical nutrition therapy

El tratamiento médico nutricional es de gran utilidad en el mantenimiento y recuperación de la salud de los pacientes con desnutrición relacionada con la enfermedad, aunque su implementación puede ser compleja y no está exenta de riesgos. Se entiende por proceso aquel conjunto de actividades que están mutuamente relacionadas o que interactúan para transformar elementos de entrada en resultados. Desde el Grupo de Trabajo de Gestión de la SENPE presentamos el Proceso de Tratamiento Médico Nutricional (PTMN), que tiene por objetivo facilitar la gestión de la nutrición clínica, pensando en un equipo de soporte nutricional multidisciplinar de atención al paciente hospitalizado.En este documento se describen los siete subprocesos que constituyen el PTMN, además de un subproceso previo de cribado nutricional. Cada subproceso se divide en una primera sección con una ficha técnica en la que se detallan sus aspectos generales, mientras que en la segunda sección se proponen objetivos clave, indicadores de calidad y estándares para su evaluación. (AU)

Medical nutrition therapy is a very useful tool in maintaining and recovering the health of patients with disease-related malnutrition, although its implementation can be complex and is not without risks. Quality processes are understood as sets of activities that are related or interact to transform input elements into results. From the SENPE Management Work Group we present the process of medical nutrition therapy (PMNT), which aims to facilitate the management of clinical nutrition of a multidisciplinary nutrition support team in a hospital setting.This paper describes the seven sub-processes PMNT is comprised of, in addition to a previous nutritional screening sub-process. Each sub-process is divided into a first section with a technical sheet detailing its general aspects, while a second section proposes key objectives, quality indicators, and standards for their evaluation. (AU)

Improving patient safety through a pharmacist-led medication reconciliation programme in nursing homes for the elderly in Spain.

Background Medication errors frequently occur during transitions of care and may have damaging consequences, especially amongst the elderly. Some studies show that quality improvement initiatives with a focus on medication reconciliation have resulted in better health outcomes and a reduced number of readmissions. Objective The primary objective of this study was to quantify and classify medication reconciliation errors detected by a pharmacist and taking place during transitions of care between nursing homes and the health system. Secondary objectives were to assess the relation between error frequency and polypharmacy or between error frequency and the transition type and to describe the medication concerned by this error. Setting Five elderly nursing homes of the health care area in Ferrol (Spain) between January 2013 and December 2017 Method A prospective descriptive study on medication discrepancies found during pharmacist's medication reconciliation. This was performed at first admission and after every transition of care upon the patient's return to the nursing home. Interventions were categorized according to the consensus terminology. Main outcome measure Number and type of medication errors, percentage of transitions of care and percentage of patients who suffered at least one reconciliation error were measured. Results At least one medication error was found in 16% of the 2123 studied care transitions, summing up 417 reconciliation errors in 273/981 patients (28%). Wrong dosing (48%) and medication omissions (31%) were the most frequently detected errors. High-risk medication was involved in 40% of the cases. A positive association between polypharmacy (≥ 5 chronic medications) and the frequency of reconciliation errors was found. On the other hand, different transition types did not show a difference in error frequency. Conclusion Reconciliation errors were found in almost 30% of our patients. Unlike other studies, visits to outpatient specialist clinics were included as another type of healthcare transition, encompassing an important percentage of reconciliation errors. The pharmacist helped to reduce these errors in a particularly fragile population such as institutionalized patients.

[Indicators monitoring the process of specialized nutritional support. Grupo de Nutrición de la SEFH]. / Indicadores de monitorización del proceso de soporte nutricional especializado.

OBJECTIVE: To identify and develop monitoring indicators of the process of specialized nutritional support that will allow measuring the level of adherence to the established practice standards. METHODS: Those practice standards considered to be key elements of the process were selected to develop performance indicators. The construction of these indicators combined the scientific evidence with expert opinion. Key goals were identified within each standard provided that its consecution would allow increasing the achievement of the standard. Particular improvement initiatives associated to each key goal were generated. Lastly, monitoring indicators were defined allowing undertaking a follow-up of the implementation of the improvement initiatives or either to assess the level of achievement of the key goals identified. RESULTS: Nineteen practice standards were selected representative of the critical points of the process. The strategic map for each standard has been defined, with the identification of 43 key goals. In order to achieve these key goals, a portfolio of improvements has been generated comprising 56 actions. Finally, 44 monitoring indicators have been defined grouped into three categories: 1. Numeric: they assess the level of goal achievement; 2. Dichotomic (yes/no): they inform on the execution of the improvement actions; 3. Results of the practice audits. CONCLUSIONS: We have made available monitoring indicators that allow assessing the level of adherence to the practice standards of the process of specialized nutritional support and the impact of the implementation of improvement actions within this process.

Indicadores de monitorización del proceso de soporte nutricional especializado / Indicators monitoring the process of specialized nutritional support

Objetivo: Identificar y desarrollar indicadores de monitorización del proceso de soporte nutricional especializado, que permitan medir el grado de cumplimiento de los estándares de práctica establecidos. Método: Se seleccionaron los estándares de práctica considerados aspectos clave del proceso sobre los que desarrollar indicadores de rendimiento. La construcción de indicadores combinó la evidencia científica con la opinión de expertos. Se identificaron los objetivos clave dentro de cada estándar cuya consecución permitiera incrementar el alcance del mismo. Se generaron iniciativas de mejora concretas vinculadas a cada objetivo clave. Por último, se definieron indicadores de monitorización que permitieran realizar un seguimiento de la implantación de las iniciativas de mejora, o bien valorar el grado de consecución de los objetivos clave identificados. Resultados: Se han seleccionado 19 estándares de práctica representativos de los aspectos críticos del proceso. Se ha definido el mapa estratégico de cada estándar, identificándose un total de 43 objetivos clave. A fin de alcanzar estos objetivos clave se ha generado una cartera de mejoras integrada por 56 acciones. Por último, se han definido 44 indicadores de monitorización agrupados en tres categorías: 1. Numéricos: valoran el grado de cumplimiento del objetivo; 2. Dicotómicos (si/no): Informan de la ejecución de las acciones de mejora; 3. Resultados de las auditorías de la práctica. Conclusiones: Se dispone de indicadores de monitorización que permiten evaluar el cumplimiento de los estándares de práctica del proceso de soporte nutricional especializado y el impacto de la implantación de acciones de mejora en el mismo (AU)

Objective: To identify and develop monitoring indicators of the process of specialized nutritional support that will allow measuring the level of adherence to the established practice standards. Methods: Those practice standards considered to be key elements of the process were selected to develop performance indicators. The construction of these indicators combined the scientific evidence with expert opinion. Key goals were identified within each standard provided that its consecution would allow increasing the achievement of the standard. Particular improvement initiatives associated to each key goal were generated. Lastly, monitoring indicators were defined allowing undertaking a follow-up of the implementation of the improvement initiatives or either to assess the level of achievement of the key goals identified. Results: Nineteen practice standards were selected representative of the critical points of the process. The strategic map for each standard has been defined, with the identification of 43 key goals. In order to achieve these key goals, a portfolio of improvements has been generated comprising 56 actions. Finally, 44 monitoring indicators have been defined grouped into three categories: 1. Numeric: they assess the level of goal achievement; 2. Dichotomic (yes/no): they inform on the execution of the improvement actions; 3. Results of the practice audits. Conclusions: We have made available monitoring indicators that allow assessing the level of adherence to the practice standards of the process of specialized nutritional support and the impact of the Implementation of improvement actions within this process (AU)

Síndrome de la bolsa de orina púrpura en dos pacientes institucionalizados / Purple urine bag syndrome in two institutionalised patients

El síndrome de la bolsa de orina púrpura (PUBS, por sus siglas en inglés) es una entidad poco frecuente, pero muy llamativa caracterizada por una reacción química que involucra la orina, el plástico y ciertas enzimas de algunas bacterias productoras de sulfatasas y fosfatasas, como Proteus mirabilis, Escherichia coli y Morganella morganii, entre otras. Como consecuencia de dicha reacción la sonda vesical y la bolsa pueden teñirse de color rojo, azul o púrpura. Este fenómeno suele producirse en pacientes pluripatológicos, portadores de sonda vesical y en el seno de una infección del tracto urinario. Describimos dos casos clínicos de PUBS en dos pacientes institucionalizados portadores de sonda vesical permanente(AU)

Purple urine bag syndrome (PUBS) is an uncommon but particularly striking phenomenon characterised by a chemical reaction involving the urine, plastic and certain enzymes from some sulphatase- and phosphatase-producing bacteria, including Proteus mirabilis, Escherichia coli and Morganella morganii, amongst others. Following this reaction, the catheter and the bag may be stained red, blue or purple. This phenomenon tends to occur in patients with multiple pathology and with urinary catheters, as part of a urinary tract infection. We describe two clinical cases of PUBS in institutionalised patients with permanent urinary catheters(AU)

[Purple urine bag syndrome in two institutionalised patients]. / Síndrome de la bolsa de orina púrpura en dos pacientes institucionalizados.

Purple urine bag syndrome (PUBS) is an uncommon but particularly striking phenomenon characterised by a chemical reaction involving the urine, plastic and certain enzymes from some sulphatase- and phosphatase-producing bacteria, including Proteus mirabilis, Escherichia coli and Morganella morganii, amongst others. Following this reaction, the catheter and the bag may be stained red, blue or purple. This phenomenon tends to occur in patients with multiple pathology and with urinary catheters, as part of a urinary tract infection. We describe two clinical cases of PUBS in institutionalised patients with permanent urinary catheters.