How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice.

Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process. Observations were performed between March and November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant to the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution, or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature, and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.

Proyecto Trazam: aplicación móvil para la trazabilidad de preparaciones elaboradas en un servicio de farmacia / Trazam project: A mobile application for the tracking of compounded preparations in a Pharmacy Department

Introducción el objetivo principal es describir el diseño e implementación de una aplicación para dispositivos móviles para facilitar el seguimiento de las preparaciones elaboradas en el servicio de farmacia hospitalaria. Los objetivos secundarios fueron evaluar el tiempo dedicado a la resolución de incidencias relacionadas con la dispensación/distribución de las preparaciones pre y postimplantación de la aplicación, conocer el grado de satisfacción de los usuarios y disponer de información cualitativa y cuantitativa del proceso que permita establecer indicadores de seguimiento. Métodos se definieron los requisitos a cumplir por el aplicativo informático, los fármacos susceptibles de entrar en el sistema y los circuitos de entrega. Se procedió al desarrollo de la aplicación por parte del proveedor e integración con los programas informáticos de prescripción/validación. Se crearon y añadieron los códigos QR de identificación en los puntos de entrega de medicamentos en las unidades de destino. Se adquirieron los dispositivos móviles necesarios. Primera etapa de formación de usuarios en la aplicación y prueba piloto en una planta de hospitalización. Posteriormente se inició la fase de expansión y consolidación. Resultados el 86,9% de las preparaciones estériles elaboradas en el servicio de farmacia hospitalaria se han incorporado al sistema, incluyendo quimioterapia, nutriciones parenterales de adultos y otras preparaciones estériles no peligrosas. Se han incluido en la aplicación las salas de hospitalización, los hospitales de día y 2 sedes externas. La media de preparaciones trazadas mensualmente es de 5.403 (DE = 297,3) (AU)

Introduction The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App. Methods Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation. Results The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application (AU)

Trazam project: A mobile application for the tracking of compounded preparations in a Pharmacy Department. / Proyecto Trazam: aplicación móvil para la trazabilidad de preparaciones elaboradas en un servicio de farmacia.

INTRODUCTION: The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App. METHODS: Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation. RESULTS: The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application. DISCUSION: The proposed application enables hospital staff to easily and intuitively track preparations compounded in the pharmacy, irrespective of the computer program used for prescription. It has significantly reduced the need for manual record-keeping and has mitigated incidents associated with the distribution of sterile preparations.

[Translated article] Trazam project: A mobile application for tracking preparations compounded in a pharmacy department.

INTRODUCTION: The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include: i) evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, ii) assessing users satisfaction with the application, and iii) establishing a panel of quality indicators based on the data extracted from the App. METHODS: 1) Defining application requirements, identifying drugs to be included in the software and outlining different workflows. 2) Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. 3) The subsequent phase focused on expansion and consolidation. RESULTS: The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalisation wards, day care units and two external sites. On average, 5403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 min per day). The App regularly provides valuable management data for optimising workflow in the compounding area. Additionally, users have expressed satisfaction with the application. DISCUSION: The proposed application enables hospital staff to easily and intuitively track preparations compounded in the Pharmacy, irrespective of the computer program used for prescription. It has significantly reduced the need for manual record-keeping and has mitigated incidents associated with the distribution of sterile preparations.

Impact of the COVID-19 pandemic on the psychological well-being of adolescents by gender identity.

OBJECTIVE: To describe the impact of the COVID-19 pandemic on the psychological well-being of adolescents in Catalan schools by gender identity, and to compare coping strategies adopted to manage the health crisis and their relationship with the self-perceived impact of COVID-19 on mental health. METHOD: Cross-sectional study in educational centres that includes 1171 adolescents over 15 years old from October to November 2021. Multivariate logistic regression models were built to evaluate the association between coping strategies with self-perceived impact of the pandemic on mental health. RESULTS: A greater proportion of girls perceived a worsening in mental health than boys due to COVID-19 (36.9% and 17.8%, respectively). The main emotions reported for both girls and boys were worry and boredom. The study found an association between positive coping strategies with less adverse mental health among girls, whereas unhealthy habits were associated with a higher probability of declaring worsening of mental health for both girls and boys. CONCLUSIONS: This study demonstrated the negative impact of the COVID-19 pandemic on psychological well-being in adolescents and a clearly worse impact on girls. It is important to keep monitoring the medium- and long-term secondary impacts of the pandemic on mental health outcomes of adolescents and to gather information that can improve services for the development of healthy coping strategies during health crises like COVID-19, which include gender perspective.

Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN / Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project

Objetivo: este estudio corresponde a la primera etapa del proyecto MEDPAIN «Actualización de mezclas analgésicas por vía parenteral: estudios de utilización, compatibilidad y estabilidad», y tiene por objetivo la elaboración de un mapa a nivel nacional del empleo de mezclas analgésicas en los hospitales y los centros sociosanitarios. Material y método estudio transversal, basado en una encuesta dirigida a farmacéuticos hospitalarios, durante el período diciembre 2020 - abril 2021. Se diseñó un cuestionario multirrespuesta en la plataforma RedCap® para su difusión a través de la lista de distribución de la Sociedad Española de Farmacia Hospitalaria. Se definió mezcla analgésica como la combinación de 2 o más principios activos, de los cuales al menos uno es analgésico. Una misma combinación de fármacos a distintas concentraciones, o administrada por diferentes vías, se consideró una misma mezcla a efectos de este estudio. Se registraron variables relacionadas con el centro participante y otras relacionadas con las mezclas analgésicas: composición farmacológica de la mezcla, vía de administración, frecuencia de uso, indicación, tipo de paciente (adulto/pediátrico), ámbito en el que se utiliza (hospitalario/domicilio) y lugar de preparación. Resultados se recibieron un total de 67 encuestas válidas (55,4%) procedentes de 13 comunidades autónomas. Los 67 centros sanitarios comunicaron un total de 462 mezclas analgésicas. La mediana de mezclas informadas por centro participante fue de 6 (RIC p25-p75 = 4,0-9,0). La mayoría de las mezclas notificadas se utilizan en adultos (93,9%) y en el ámbito hospitalario (91,8%); mayoritariamente se trata de mezclas protocolizadas y de uso frecuente. El 21,4% se preparan en el servicio de farmacia. En las mezclas descritas aparecen 26 fármacos distintos; predominan los analgésicos opioides, presentes en el 87,4% de las mezclas. El fármaco coadyuvante más frecuente es el midazolam. ... (AU)

Objetive: This study is the first part of the MEDPAIN project “Update of analgesic parenteral admixtures: studies of use, compatibility and stability”, and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. Methods Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020–April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. Results A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. ... (AU)

[Translated article] Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project.

OBJECTIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Mortality in Catalonia during the summer of 2022 and its relation with high temperatures and COVID-19 cases.

Purpose: To analyse the association between the mortality during the summer 2022 and either high temperatures or the COVID-19 wave with data from the Catalan Health Care System (7.8 million people). Methods: We performed a retrospective study using publicly available data of meteorological variables, influenza-like illness (ILI) cases (including COVID-19) and deaths. The study comprises the summer months of the years 2021 and 2022. To compare the curves of mortality, ILI and temperature we calculated the z-score of each series. We assessed the observed lag between curves using the cross-correlation function. Finally, we calculated the correlation between the z-scores using the Pearson correlation coefficient (R2). Results: During the study period, 33,967 deaths were reported in Catalonia (16,416 in the summer of 2021 and 17,551 in the summer of 2022). In 2022, the observed lag and the correlation between the z-scores of temperature and all-cause deaths was 3 days and R2 = 0.86, while between ILI and all-cause deaths was 22 days and R2 = 0.21. This high correlation between temperature and deaths increased up to 0.91 when we excluded those deaths reported as COVID-19 deaths, while the correlation between ILI and non-COVID-19 deaths decreased to -0.19. No correlation was observed between non-COVID deaths and temperature or ILI cases in 2021. Conclusion: Our study suggests that the main cause of the increase in deaths during summer 2022 in Catalonia was the high temperatures and its duration. The contribution of the COVID-19 seems to be limited.

Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures.

Protein drugs, such as monoclonal antibodies, have proved successful in treating cancer and immune system diseases. The structural complexity of these molecules requires careful handling to ensure integrity and stability of the drug. In this study, a failure mode and effects analysis was performed based on a Gemba Walk method in a Swedish University Hospital. The Gemba Walk is focused on pharmacists observing the actual supply process steps from distributor, pharmacy cleanroom to patient administration. Relevant protein drugs are chosen based on sales statistics within the hospital and the corresponding wards were observed. Further is the Double Diamond design method used to identify major risks and deliver mitigation strategies. The study identified potential stress factors such as temperature, shock by impact, shaking, vibration and light exposure. There were also risks associated with porters' and healthcare professionals' lack of awareness and access to information. These risk factors may cause loss of efficacy and quality of the protein drug, potentially leading to patient safety concerns. In this study, a simulation is also performed to list measures that theoretically should be in place to ensure the quality of the protein drug, for example validated and protocol-based compounding in cleanroom, training and validated transports.

Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project. / Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN.

OBJETIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Treatment of Porokeratosis Ptychotropica With a Topical Combination of Cholesterol and Simvastatin.

This case report describes 2 patients with Ptychotropic porokeratosis who were treated with a combination of cholesterol and simvastatin.

Impact of the COVID-19 pandemic on the psychological well-being of adolescents by gender identity / Impacto de la COVID-19 en el bienestar emocional de adolescentes según identidad de género

Objective: To describe the impact of the COVID-19 pandemic on the psychological well-being of adolescents in Catalan schools by gender identity, and to compare coping strategies adopted to manage the health crisis and their relationship with the self-perceived impact of COVID-19 on mental health. Method: Cross-sectional study in educational centres that includes 1171 adolescents over 15 years old from October to November 2021. Multivariate logistic regression models were built to evaluate the association between coping strategies with self-perceived impact of the pandemic on mental health. Results: A greater proportion of girls perceived a worsening in mental health than boys due to COVID-19 (36.9% and 17.8%, respectively). The main emotions reported for both girls and boys were worry and boredom. The study found an association between positive coping strategies with less adverse mental health among girls, whereas unhealthy habits were associated with a higher probability of declaring worsening of mental health for both girls and boys. Conclusions: This study demonstrated the negative impact of the COVID-19 pandemic on psychological well-being in adolescents and a clearly worse impact on girls. It is important to keep monitoring the medium- and long-term secondary impacts of the pandemic on mental health outcomes of adolescents and to gather information that can improve services for the development of healthy coping strategies during health crises like COVID-19, which include gender perspective.(AU)

Objetivo: Describir el impacto de la COVID-19 en el bienestar emocional de adolescentes en Cataluña y comparar las estrategias de afrontamiento adoptadas durante la pandemia y su relación con el impacto autopercibido de la COVID-19 en la salud mental según identidad de género. Método: Estudio transversal en centros educativos de Cataluña incluyendo 1171 alumnos/as mayores de 15 años, de octubre a diciembre de 2021. Mediante modelos de regresión logística multivariante se evaluó la asociación entre las estrategias de afrontamiento y el impacto autopercibido de la pandemia en la salud mental. Resultados: Una mayor proporción de chicas que de chicos percibía un empeoramiento en su salud mental por la COVID-19 (36,9% y 17,8%, respectivamente). Las principales emociones reportadas tanto en chicas como en chicos fueron preocupación y aburrimiento. Se observó una asociación entre estrategias de afrontamiento positivas y una menor probabilidad de declarar un empeoramiento en la salud mental a raíz de la pandemia en las chicas, mientras que otras estrategias relacionadas con hábitos poco saludables se asociaron a una mayor probabilidad de declarar un empeoramiento de la salud mental en chicas y chicos. Conclusiones: Este estudio demuestra el impacto negativo de la pandemia de COVID-19 en el bienestar psicológico de los/las adolescentes, especialmente en las chicas. Es importante seguir monitorizando el impacto de la COVID-19 a medio y largo plazo en la salud mental de los/las adolescentes y disponer de información que pueda mejorar los servicios para el desarrollo de estrategias de afrontamiento saludables durante crisis de salud como la COVID-19 considerando una perspectiva de género.(AU)

Tobacco cessation among smokers under substance use treatment for alcohol and/or cannabis: study protocol and pilot study.

BACKGROUND: Approximately 80% of people with a substance use disorder (SUD) are smokers. Starting SUD treatment offers the opportunity to also quit smoking. The ACT-ATAC project aims to identify the predictors associated with smoking cessation among persons treated for alcohol and/or cannabis use disorder in Barcelona. This manuscript reports its methodology and the experience of carrying it out during the COVID-19 pandemic. METHODS: Mixed methods project with three substudies. Substudy 1 (S1) comprises heterogeneous discussion groups among clinicians. S2 has two prospective cohorts composed of smokers under treatment for alcohol and/or cannabis use disorder and the clinicians in charge of these patients. Participating smokers will be followed for 12 months and interviewed about their substance use and the tobacco cessation services received using the Spanish version of the users' Knowledge, Attitudes, and Services (S-KAS) scale. The clinicians will be asked about their self-reported practices in smoking cessation using the Knowledge, Attitudes, and Practices (S-KAP) scale. S3 comprises heterogeneous discussion groups with smokers. Data will be triangulated using qualitative and quantitative analyses. To facilitate the recruitment process, the researchers have introduced several strategies (design clear protocols, set monthly online meetings, extend the project, provide gift cards, etc.). DISCUSSION: The results of S1 were used to develop the questionnaires. S2 required some adjustments due to the COVID-19 pandemic, particularly the follow-up interviews being conducted by phone instead of face-to-face, and the recruitment rhythm was lower than expected. Recruitment will last until reaching at least 200-250 users. The fieldwork could not have been possible without the collaboration of the ACT-ATAC team and the introduction of several strategies. Trial registration The ACT-ATAC project has been successfully registered at Clinicaltrials.gov [NCT04841655].

Comparative effectiveness and safety of homologous two-dose ChAdOx1 versus heterologous vaccination with ChAdOx1 and BNT162b2.

Small trials have suggested that heterologous vaccination with first-dose ChAdOx1 and second-dose BNT162b2 may generate a better immune response than homologous vaccination with two doses of ChAdOx1. In this cohort analysis, we use linked data from Catalonia (Spain), where those aged <60 who received a first dose of ChAdOx1 could choose between ChAdOx1 and BNT162b2 for their second dose. Comparable cohorts were obtained after exact-matching 14,325/17,849 (80.3%) people receiving heterologous vaccination to 14,325/149,386 (9.6%) receiving homologous vaccination by age, sex, region, and date of second dose. Of these, 464 (3.2%) in the heterologous and 694 (4.8%) in the homologous groups developed COVID-19 between 1st June 2021 and 5th December 2021. The resulting hazard ratio (95% confidence interval) is 0.66 [0.59-0.74], favouring heterologous vaccination. The two groups had similar testing rates and safety outcomes. Sensitivity and negative control outcome analyses confirm these findings. In conclusion, we demonstrate that a heterologous vaccination schedule with ChAdOx1 followed by BNT162b2 was more efficacious than and similarly safe to homologous vaccination with two doses of ChAdOx1. Most of the infections in our study occurred when Delta was the predominant SARS-CoV-2 variant in Spain. These data agree with previous phase 2 randomised trials.

Evaluation of desensitization protocols to betalactam antibiotics.

WHAT IS KNOWN AND OBJECTIVE: Betalactam antibiotics are the most frequent cause of hypersensitivity reactions. Rapid drug desensitization (RDD) is a technique that induces temporary tolerance to a drug allowing a patient to receive the optimal agent. The increased use of RDD and the lack of standardization among available protocols in terms of formulation, starting dose, number of steps and dosing frequency make it essential to determine the safety and appropriate management of these protocols, especially regarding reconstitution, diluents, stability and drug administration in order to guarantee reproducibility. We reviewed betalactam desensitization protocols in a tertiary hospital, in accordance with currently published practices and evaluated its use on patients over a period of three years. METHODS: (a) We performed a literature search in PubMed, MEDLINE and Google Scholar databases for case reports and/or systematic reviews describing desensitization protocols for betalactam antibiotics. Pharmacokinetic parameters and physicochemical stability were checked for each antibiotic. (b) We retrospectively reviewed inpatients undergoing our antibiotic desensitization protocols from February 2018 to January 2021. Data and outcomes of desensitization procedures were analysed. RESULTS: We developed nine RDD protocols: meropenem, ceftriaxone, ceftazidime, ampicillin, ceftolozane/tazobactam, cloxacillin, piperacillin/tazobactam, amoxicillin/clavulanate and penicillin G sodium. Five antibiotics have RDD protocols for two different doses, adjusted to patients with impaired renal function. Detailed data (diluent, total dose, volume, concentrations, duration and stability) of the protocol of each antibiotic used are provided. 28 desensitizations were performed in 17 patients, three of them with confirmed allergies by skin test. 26 out of 28 (92.9%) of them were successfully completed, including those three with positive skin results. The pathogens most frequently involved were E. faecalis and P. aeruginosa; both frequently associated with bacterial resistance. Meropenem, ceftriaxone and ceftazidime were the antibiotics most desensitized. 25 out of 26 (96.1%) procedures were successful in resolving the infection. WHAT IS NEW AND CONCLUSIONS: Detailed information about compounding, dilution and stability is crucial to ensure safe and successful desensitization processes, as well as good coordination between the Allergy and Pharmacy departments. The increase in bacterial resistance to many of the commercially available antibiotics limits the therapeutic options for treating multidrug-resistant infections; in those situations, antibiotic desensitization may be a key therapeutic option. Although there is a broad consensus in limiting the use of RDD to patients with confirmed allergy, in usual clinical practice its application in those strongly suspected of having type I hypersensitivity is still observed. Our betalactam desensitization protocols have shown themselves to be safe and effective, as evidenced by data from the 17 patients on whom they have been tested.

Daily sitting time and its association with non-communicable diseases and multimorbidity in Catalonia.

BACKGROUND: Non-communicable diseases (NCDs) account for 71% of deaths worldwide and individual behaviours such as sedentariness play an important role on their development and management. However, the detrimental effect of daily sitting on multiple NCDs has rarely been studied. This study sought (i) to investigate the association between sitting time and main NCDs and multimorbidity in the population of Catalonia and (ii) to explore the effect of physical activity as a modifier of the associations between sitting time and health outcomes. METHODS: Cross-sectional data from the 2016 National Health Survey of Catalonia were analyzed, and multivariable logistic regression, adjusting for socio-demographics and individual risk factors (tobacco and alcohol consumption, diet, hyperlipidaemia, hypertension, body mass index) was used to estimated odds ratios (ORs) and 95% confidence intervals (CIs) of the association between sitting time and NCDs. RESULTS: A total of 3320 people ≥15 years old were included in the study. Sitting more than 5 h/day was associated with a higher risk of cardiovascular disease (OR 1.90, 95% CI: 1.21-2.97), respiratory disease (OR 1.61, 95% CI: 1.13-2.30) and multimorbidity (OR 2.80, 95% CI: 1.53-5.15). Sitting more than 3 h/day was also associated with a higher risk of multimorbidity (OR 2.26, 95% CI: 1.23-4.16). Physical activity did not modify the associations between sitting time and any of the outcomes. CONCLUSIONS: Daily sitting time might be an independent risk factor for some NCDs, such as cardiovascular disease, respiratory disease and multimorbidity, independently of the level risk of physical inactivity.

Robotic chemotherapy compounding: A multicenter productivity approach.

INTRODUCTION: The aim of this study is to compare productivity of the KIRO Oncology compounding robot in three hospital pharmacy departments and identify the key factors to predict and optimize automatic compounding time. METHODS: The study was conducted in three hospitals. Each hospital compounding workload and workflow were analyzed. Data from the robotic compounding cycles from August 2017 to July 2018 were retrospectively obtained. Nine cycle specific parameters and five productivity indicators were analysed in each site. One-to-one differences between hospitals were evaluated. Next, a correlation analysis between cycle specific factors and productivity indicators was conducted; the factors presenting a highest correlation to automatic compounding time were used to develop a multiple regression model (afterwards validated) to predict the automatic compounding time. RESULTS: A total of 2795 cycles (16367 preparations) were analysed. Automatic compounding time showed a relevant positive correlation (ǀrs|>0.40) with the number of preparations, number of vials and total volume per cycle. Therefore, these cycle specific parameters were chosen as independent variables for the mathematical model. Considering cycles lasting 40 minutes or less, predictability of the model was high for all three hospitals (R2:0.81; 0.79; 0.72). CONCLUSION: Workflow differences have a remarkable incidence in the global productivity of the automated process. Total volume dosed for all preparations in a cycle is one of the variables with greater influence in automatic compounding time. Algorithms to predict automatic compounding time can be useful to help users in order to plan the cycles launched in KIRO Oncology.

Liver transplantation in the Intensive Care Unit: twenty years experience in a center medium income on Peru / Trasplante hepático en la Unidad de Cuidados Intensivos: veinte años de experiencia en un centro de mediano ingreso en el Perú

ABSTRACT Liver transplantation is the major treatment for end-stage liver disease. Postoperative care is a great challenge to reduce morbidity and mortality in patients. In this sense, management in the liver ICU allows hemodynamic management, coagulation monitoring, renal support, electrolyte disturbances, respiratory support and early weaning from mechanical ventilation and evaluation of the liver graft. Objective: The present study shows the results of the management of liver transplant patients in 20 years of experience in a transplant center in a low- to middle-income country. Materials and methods: The medical records of 273 adult patients in the ICU in the immediate postoperative liver transplant were reviewed, from March 20, 2000 to November 30, 2020, including the effect of the pandemic caused by COVID-19. Liver-kidney, retransplanted, SPLIT, and domino transplant patients were excluded. Results: The most frequent etiology for LTx was NASH (35%), the mean age was 49 years, MELD Score ranged 15 - 20 (47.5%), 21 - 30 (46%) > 30 (6.2%). ICU pre transplant stay 7%, average ICU stay: 7.8 days. APACHE average admission: 14.9 points. Weaning extubation of 91.8% patients in ICU and Fast Track in 8.2%. The most frequent respiratory complication was atelectasis 56.3%, pneumonia (31.3%); AKI 1 (60.9%), and 11.1% with hemodyalisis support (AKI3). Immunosuppression: Tacrolimus (8.9%). Post-operative ICU mortality was 6.2%. Conclusions: The management of liver transplantation in the ICU is essential to achieve optimal results in patients who present advanced liver disease and require advanced life support in the immediate postoperative period and thus optimize graft survival.

RESUMEN El trasplante de hígado es el principal tratamiento para la enfermedad hepática en etapa terminal. El cuidado postoperatorio es un gran desafío para disminuir la morbimortalidad en los pacientes. En este sentido, el manejo en la UCI hepática permite manejo hemodinámico, monitoreo de coagulación, soporte renal, alteraciones electrolíticas, soporte respiratorio y destete temprano de ventilación mecánica y evaluación del injerto hepático. Objetivo: El presente estudio muestra los resultados del manejo de pacientes trasplantados de hígado en 20 años de experiencia en un centro de trasplante en un país de ingresos bajos a medios. Materiales y métodos: Se revisaron las historias clínicas de 273 pacientes adultos en UCI en el posoperatorio inmediato de trasplante hepático, desde el 20 de marzo de 2000 hasta el 30 de noviembre de 2020, incluyendo el efecto de la pandemia provocada por el COVID-19. Se excluyeron los pacientes con trasplante de hígado-riñón, retrasplantados, SPLIT y dominó. Resultados: La etiología más frecuente para LTx fue NASH (35%), la edad promedio fue de 49 años, MELD Score varió 15 - 20 (47,5%), 21 - 30 (46%) > 30 (6,2%). Estancia pretrasplante en UCI 7%, estancia media en UCI: 7,8 días. Admisión media APACHE: 14,9 puntos. Extubación weaning del 91,8% de los pacientes en UCI y Fast Track en el 8,2%. La complicación respiratoria más frecuente fue atelectasia 56,3%, neumonía (31,3%); FRA 1 (60,9%) y 11,1% con soporte de hemodiálisis (FRA 3). Inmunosupresión: Tacrolimus (8,9%). La mortalidad postoperatoria en la UCI fue del 6,2%. Conclusiones: El manejo del trasplante hepático en UCI es fundamental para lograr resultados óptimos en pacientes que presentan enfermedad hepática avanzada y requieren soporte vital avanzado en el postoperatorio inmediato y así optimizar la supervivencia del injerto.

Associations of BNT162b2 vaccination with SARS-CoV-2 infection and hospital admission and death with covid-19 in nursing homes and healthcare workers in Catalonia: prospective cohort study.

OBJECTIVE: To determine associations of BNT162b2 vaccination with SARS-CoV-2 infection and hospital admission and death with covid-19 among nursing home residents, nursing home staff, and healthcare workers. DESIGN: Prospective cohort study. SETTING: Nursing homes and linked electronic medical record, test, and mortality data in Catalonia on 27 December 2020. PARTICIPANTS: 28 456 nursing home residents, 26 170 nursing home staff, and 61 791 healthcare workers. MAIN OUTCOME MEASURES: Participants were followed until the earliest outcome (confirmed SARS-CoV-2 infection, hospital admission or death with covid-19) or 26 May 2021. Vaccination status was introduced as a time varying exposure, with a 14 day run-in after the first dose. Mixed effects Cox models were fitted to estimate hazard ratios with index month as a fixed effect and adjusted for confounders including sociodemographics, comorbidity, and previous medicine use. RESULTS: Among the nursing home residents, SARS-CoV-2 infection was found in 2482, 411 were admitted to hospital with covid-19, and 450 died with covid-19 during the study period. In parallel, 1828 nursing home staff and 2968 healthcare workers were found to have SARS-CoV-2 infection, but fewer than five were admitted or died with covid-19. The adjusted hazard ratio for SARS-CoV-2 infection after two doses of vaccine was 0.09 (95% confidence interval 0.08 to 0.11) for nursing home residents, 0.20 (0.17 to 0.24) for nursing home staff, and 0.13 (0.11 to 0.16) for healthcare workers. Adjusted hazard ratios for hospital admission and mortality after two doses of vaccine were 0.05 (0.04 to 0.07) and 0.03 (0.02 to 0.04), respectively, for nursing home residents. Nursing home staff and healthcare workers recorded insufficient events for mortality analysis. CONCLUSIONS: Vaccination was associated with 80-91% reduction in SARS-CoV-2 infection in all three cohorts and greater reductions in hospital admissions and mortality among nursing home residents for up to five months. More data are needed on longer term effects of covid-19 vaccines.