Invasive assessment of coronary microvascular dysfunction and cardiovascular outcomes across the full spectrum of CHD: a meta-analysis.

INTRODUCTION AND OBJECTIVES: Coronary microvascular dysfunction (CMD) is highly prevalent and is recognized as an important clinical entity in patients with coronary heart disease (CHD). Nevertheless, the association of CMD with adverse cardiovascular events in the spectrum of CHD has not been systemically quantified. METHODS: We searched electronic databases for studies on patients with CHD in whom coronary microvascular function was measured invasively, and clinical events were recorded. The primary endpoint was major adverse cardiac events (MACE), and the secondary endpoint was all-cause death. Estimates of effect were calculated using a random-effects model from published risk ratios. RESULTS: We included 27 studies with 11 404 patients. Patients with CMD assessed by invasive methods had a higher risk of MACE (RR, 2.18; 95%CI, 1.80-2.64; P<.01) and all-cause death (RR, 1.88; 95%CI, 1.55-2.27; P<.01) than those without CMD. There was no significant difference in the impact of CMD on MACE (interaction P value=.95) among different invasive measurement modalities. The magnitude of risk of CMD assessed by invasive measurements for MACE was greater in acute coronary syndrome patients (RR, 2.84, 95%CI, 2.26-3.57; P<.01) than in chronic coronary syndrome patients (RR, 1.77, 95%CI, 1.44-2.18; P<.01) (interaction P value<.01). CONCLUSIONS: CMD based on invasive measurements was associated with a high incidence of MACE and all-cause death in patients with CHD. The magnitude of risk for cardiovascular events in CMD as assessed by invasive measurements was similar among different methods but varied among CHD populations.

Bronchiectasis, lymphadenopathies related to BAFF overexpression and lymphoplasmacytic cystitis as adverse events associated with prolonged use of rituximab in systemic autoimmune rheumatic diseases.

BACKGROUND: The long-term use of rituximab (RTX) has been gaining ground in the treatment of systemic autoimmune diseases. The adverse events (AEs) associated with its use different to infections are being reported. METHODS: A cohort of patients with SAIDs treated at a high-complexity center in Cali (southwestern Colombia) with follow-up from January 2008 to December 2022 were examined to search for potential AEs associated with prolonged use of RTX. RESULTS: From 178 patients with long-term use of RTX 3 (1.68%) had lymphadenopathies with lymphoid follicular hyperplasia related to BAFF overexpression, 4 (2.24%) with bronchiectasis, and 4 (2.24%) with lymphoplasmacytic cystitis. CONCLUSION: Bronchiectasis, lymphoid follicular hyperplasia related to BAFF overexpression, and lymphoplasmacytic cystitis may be life-threatening long-term AEs in patients with prolonged use of RTX.

Epidemiology of adverse events in Intensive Medicine units.

The severity of the critically ill patient, the practice of diagnostic procedures and invasive treatments, the high number of drugs administered, a high volume of data generated during the care of the critically ill patient along with a technical work environment, the stress and workload of work of professionals, are circumstances that favor the appearance of errors, turning Intensive Medicine Services into risk areas for adverse events to occur. Knowing their epidemiology is the first step to improve the safety of the care we provide to our patients, because it allows us to identify risk areas, analyze them and develop strategies to prevent the adverse events, or if this is not possible, be able to manage them. This article analyzes the main studies published to date on incidents related to safety in the field of critically ill patients.

Evaluation of tolerance to mercaptopurine in patients with inflammatory bowel disease and gastrointestinal intolerance to azathioprine / Evaluación de la tolerancia a la mercaptopurina en los pacientes con enfermedad inflamatoria intestinal e intolerancia gastrointestinal a la azatioprina

Background Thiopurines such as azathioprine (AZA) and mercaptopurine (MP) are commonly utilized to treat inflammatory bowel disease (IBD). Their use is frequently restricted due to gastrointestinal intolerance (GI). Previous retrospective studies have reported that AZA-intolerant patients may benefit from a switch to MP; yet the effectiveness of this strategy has not been prospectively evaluated.AimsTo assess GI tolerance to MP in patients who are intolerant to AZA, and to identify clinical predictors of GI intolerance to AZA or MP.MethodsA prospective, observational, single-cohort study was performed in 92 thiopurine-naïve IBD patients. They were started on a 50mg dose of AZA and escalated to 2.5mg/kg per day by week 2. Those with GI intolerance were rechallenged with a 50% dose of AZA, after which another dose escalation attempt was made. If symptoms persisted, they were switched to MP.ResultsThirty (32.6%) of the recruited patients suffered from GI intolerance to AZA. Of these, 15 did not present recurrence of symptoms after rechallenge with lower doses. Of 15 intolerant patients, 14 were switched to MP. Within the MP cohort, 8 patients (57%) were also intolerant to MP, 5 (36%) had no symptoms, and 1 (7%) was lost to follow-up. Female gender was the only independent predictor of GI intolerance to AZA.ConclusionsUp to half of the AZA-intolerant patients tolerated a 50% dose rechallenge that was successfully escalated. A switch to MP was tolerated in over a third of cases whom rechallenge failed. Our strategy (challenge–rechallenge–switch) achieved an overall GI tolerance to thiopurines in most of the patients. (AU)

Antecedentes Las tiopurinas como la azatioprina (AZA) y la mercaptopurina (MP) se utilizan comúnmente para tratar la enfermedad inflamatoria intestinal (EII). Su uso está frecuentemente restringido debido a la intolerancia gastrointestinal. Estudios retrospectivos anteriores han informado que los pacientes intolerantes a la AZA pueden beneficiarse de un cambio a MP; sin embargo, la eficacia de esta estrategia no ha sido evaluada prospectivamente.ObjetivosEvaluar la tolerancia gastrointestinal a MP en pacientes que son intolerantes a AZA e identificar predictores clínicos de intolerancia gastrointestinal a AZA o MP.MétodosSe realizó un estudio prospectivo, observacional y de cohorte única en 92 pacientes con EII que nunca habían recibido tiopurinas. Comenzaron con una dosis de 50mg de AZA y se aumentó a 2,5mg/kg por día en la semana 2. En aquellos con intolerancia gastrointestinal se administró una dosis del 50% de AZA que se fue incrementando en función de la tolerancia. Si los síntomas persistían, se cambiaba a MP.ResultadosTreinta (32,6%) de los pacientes reclutados presentaron intolerancia gastrointestinal a la AZA. De estos, 15 no presentaron recurrencia de los síntomas después de la nueva exposición. De los 15 pacientes que no toleraron una dosis más baja, 14 recibieron MP. De los que recibieron MP, 8 pacientes (57%) también eran intolerantes a MP, 5 (36%) no tenían síntomas y uno (7%) se perdió durante el seguimiento. El género femenino fue el único predictor independiente de intolerancia gastrointestinal a la AZA.ConclusionesHasta la mitad de los pacientes intolerantes a la AZA toleran una nueva exposición al 50% de la dosis. Se toleró un cambio a MP en más de un tercio de los casos en los que la reexposición fracasó. Nuestra estrategia logró la tolerancia gastrointestinal a tiopurinas en la mayoría de los pacientes. (AU)

Current perspectives on the use of artificial intelligence in critical patient safety.

Intensive Care Units (ICUs) have undergone enhancements in patient safety, and artificial intelligence (AI) emerges as a disruptive technology offering novel opportunities. While the published evidence is limited and presents methodological issues, certain areas show promise, such as decision support systems, detection of adverse events, and prescription error identification. The application of AI in safety may pursue predictive or diagnostic objectives. Implementing AI-based systems necessitates procedures to ensure secure assistance, addressing challenges including trust in such systems, biases, data quality, scalability, and ethical and confidentiality considerations. The development and application of AI demand thorough testing, encompassing retrospective data assessments, real-time validation with prospective cohorts, and efficacy demonstration in clinical trials. Algorithmic transparency and explainability are essential, with active involvement of clinical professionals being crucial in the implementation process.

Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas / Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Análisis de eventos adversos en los servicios de cirugía general y aparato digestivo. Estudio multicéntrico / Analysis of adverse events in general surgery: A multicenter study

Introducción: El conocimiento de los eventos adversos (EA) en los hospitales de agudos es un aspecto de especial relevancia en la seguridad del paciente. Su incidencia oscila entre un 3-17% y la cirugía se relaciona con la aparición de entre un 46-65% de todos los EA. Material y métodos: Se realiza un estudio observacional, descriptivo, retrospectivo y multicéntrico, con la participación de 31 hospitales de agudos españoles, para la determinación y análisis de los EA en los servicios de cirugía general. Resultados: La prevalencia de EA fue del 31,53%. Los tipos de EA más frecuentes fueron de tipo infeccioso (35%). Los pacientes con mayores grados de ASA, mayor complejidad y un tipo de ingreso urgente son factores asociados a la presencia de EA. A la mayoría de los pacientes se les atribuyó una categoría de daño F (daño temporal al paciente que requiera iniciar o prolongar la hospitalización) (58,42%). El 14,69% de los EA son considerados graves. El 34,22% de los EA se consideraron evitables. Conclusiones: La prevalencia de EA en los pacientes de cirugía general y del aparato digestivo (CGAD) es elevada. La mayor parte de los EA fueron de tipo infeccioso. El EA más frecuente fue la infección de herida o sitio quirúrgico. Los pacientes con mayores grados de ASA, mayor complejidad y un tipo de ingreso urgente son factores asociados a la presencia de EA. La mayoría de los EA detectados han supuesto un daño leve o moderado sobre los pacientes. Alrededor de un tercio de EA fueron evitables.(AU)

Introduction: Knowledge of adverse events (AE) in acute care hospitals is a particularly relevant aspect of patient safety. Its incidence ranges from 3% to 17%, and surgery is related to the occurrence of 46%-65% of all AE. Material and methods: An observational, descriptive, retrospective, multicenter study was conducted with the participation of 31 Spanish acute-care hospitals to determine and analyze AE in general surgery services. Results: The prevalence of AE was 31.53%. The most frequent types of AE were infectious (35%). Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. The majority of patients (58.42%) were attributed a category F event (temporary harm to the patient requiring initial or prolonged hospitalization); 14.69% of AE were considered severe, while 34.22% of AE were considered preventable. Conclusions: The prevalence of AE in General and GI Surgery (GGIS) patients is high. Most AE were infectious, and the most frequent AE was surgical site infection. Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. Most detected AE resulted in mild or moderate harm to the patients. About one-third of AE were preventable.(AU)

Implementation of esophageal endoscopic submucosal dissection in Spain: Results from the nationwide registry. / Implementación de la disección endoscópica submucosa esofágica en España: resultados del registro nacional.

INTRODUCTION AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique. MATERIAL AND METHODS: Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection. RESULTS: A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n=79; 95%CI: 68%-84%) and 63.7% (n=65; 95%CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n=55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n=25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14months, 20patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%). CONCLUSIONS: In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events.

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions. / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas.

OBJECTIVE: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. METHODS: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. RESULTS: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. CONCLUSIONS: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.

[Translated article] Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs.

OBJECTIVE: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyse the clinical relevance of drug-drug interactions in the development of adverse events. METHODS: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. RESULTS: The study included 146 patients. 82 (56.16%) were women, whose median age was 65 years (22-95). the number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least 1 interaction being 62.33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11.84%). 11 AEs were potentially related to any TDDI. 7 patients required contact with hospital assistance for AE management. 8 patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. CONCLUSIONS: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.

Analysis of adverse events in general surgery. Multicenter study.

INTRODUCTION: Knowledge of adverse events (AE) in acute care hospitals is a particularly relevant aspect of patient safety. Its incidence ranges from 3% to 17%, and surgery is related to the occurrence of 46%-65% of all AE. MATERIAL AND METHODS: An observational, descriptive, retrospective, multicenter study was conducted with the participation of 31 Spanish acute-care hospitals to determine and analyze AE in general surgery services. RESULTS: The prevalence of AE was 31.53%. The most frequent types of AE were infectious (35%). Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. The majority of patients (58.42%) were attributed a category F event (temporary harm to the patient requiring initial or prolonged hospitalization); 14.69% of AE were considered severe, while 34.22% of AE were considered preventable. CONCLUSIONS: The prevalence of AE in General and GI Surgery (GGIS) patients is high. Most AE were infectious, and the most frequent AE was surgical site infection. Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. Most detected AE resulted in mild or moderate harm to the patients. About one-third of AE were preventable.

Fatores associados ao comprometimento da segurança do paciente na unidade de terapia intensiva / Factors associated with the commitment of patient safety in the intensive care unit / Factores asociados al compromiso de la seguridad del paciente en la unidad de cuidados intensivos

Objetivo: conhecer os fatores associados ao comprometimento da segurança do paciente. Método: trata-se de um artigo de revisão integrativa da literatura a partir das bases de dados Scientific Electrônic Library Online, PubMed e Literatura Latino-americana e do Caribe em Ciências da Saúde, realizada entre abril e maio de 2022. Resultados: foi visto os principais fatores que corroboram para o comprometimento da segurança, sendo a utilização inadequada dos equipamentos, falta de rotina e ausência de protocolo no setor. Foi detectado a problemática da carga exacerbada de trabalho. Conflitos na equipe também foi tido como um preditor para existência de evento adverso. E por fim, o quesito da subnotificação dos erros. Conclusão: é visto a necessidade da gestão reverter esses problemas, para que a assim a porcentagem de erros seja diminuída.

Objective: to know the factors associated with compromised patient safety. Method: this is an integrative literature review article based on the Scientific Electronic Library Online, PubMed and Latin American and Caribbean Literature in Health Sciences databases, carried out between April and May 2022. Results: it was seen the main factors that corroborate for the compromise of safety, being the inadequate use of equipment, lack of routine and lack of protocol in the sector. The problem of exacerbated workload was detected. Conflicts in the team was also considered a predictor for the existence of an adverse event. And finally, the issue of underreporting of errors. Conclusion: the need for management to reverse these problems is seen, so that the percentage of errors is reduced.

Objetivos:conocer los factores asociados a la seguridad del paciente comprometida. Método: este es un artículo de revisión integradora de la literatura basado en las bases de datos Scientific Electronic Library Online, PubMed y Latin American and Caribbean Literature in Health Sciences, realizado entre abril y mayo de 2022. Resultados: se vieron los principales factores que corroboran para el compromiso de seguridad, siendo el uso inadecuado de equipos, falta de rutina y falta de protocolo en el sector. Se detectó el problema de la sobrecarga de trabajo. Los conflictos en el equipo también fueron considerados predictores de la existencia de un evento adverso. Y por último, el tema del subregistro de errores. Conclusión: se ve la necesidad de que la gestión revierta estos problemas, de modo que se reduzca el porcentaje de errores.

Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination / Dor de cabeça como evento adverso pós-vacinação mais prevalente após a vacinação contra Covid-19

BACKGROUND: In 2020, the first vaccines were approved, according to the WHO. However, speculations arose regarding their efficacy and post-vaccination adverse events (AEFV). OBJECTIVE: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil. METHODS: This is a quantitative, observational, cross-sectional, and prevalence study. Data were provided by the Post-Vaccination Adverse Event Information System (SI-AEFV), from reported cases from January to September 2021. Data were analyzed, and the research was approved by the UFPI Research Ethics Committee. RESULTS: A total of 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as an AEFV after vaccination against SARS-CoV-2. In most cases, patients were from Teresina (67.62%), of brown race/ethnicity (52.67%), female (79.00%), and the majority were not healthcare professionals (54.27%). The most common age of patients, with the original data, was 33 years. After data correction, the most common age was 28 years. The majority of these cases were not severe (96.44%), and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%).CONCLUSION: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was brown women aged 30 to 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of events, the vast majority were considered non-severe, and no deaths were mentioned, demonstrating the safety of immunobiologicals.

FUNDAMENTO: Em 2020, foram aprovadas as primeiras vacinas, segundo a OMS. No entanto, surgiram especulações quanto à sua eficácia e eventos adversos pós-vacinais (EAPV). OBJETIVO: Avaliar a prevalência de cefaleia como EAPV da vacina SARSCoV-2 no Piauí, Brasil. MÉTODOS: Trata-se de um estudo quantitativo, observacional, transversal e de prevalência. Os dados foram fornecidos pelo Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-AEFV), dos casos notificados no período de janeiro a setembro de 2021. Os dados foram analisados ​​e a pesquisa foi aprovada pelo Comitê de Ética em Pesquisa da UFPI. RESULTADOS: Foram analisados ​​2.008 casos. Cefaleia foi relatada em 752 casos (27,99%) como EAPV após vacinação contra SARS-CoV-2. Na maioria dos casos, os pacientes eram procedentes de Teresina (67,62%), de raça/etnia parda (52,67%), do sexo feminino (79,00%) e a maioria não era profissional de saúde (54,27%). A idade mais comum dos pacientes, com os dados originais, era de 33 anos. Após correção dos dados, a idade mais comum foi 28 anos. A maioria desses casos não foi grave (96,44%), e a maioria dos casos esteve associada à primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca (43,18%).CONCLUSÃO: Assim, conclui-se a partir da análise parcial dos resultados de que cefaleia é o evento adverso mais comum após vacinação contra SARS-CoV-2. O perfil dos pacientes com mais notificações foi de mulheres pardas com idade entre 30 e 40 anos que receberam a primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca. Quanto à gravidade dos eventos, a grande maioria foi considerada não grave e não foram mencionados óbitos, demonstrando a segurança dos imunobiológicos.

Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2 / Importance of post-marketing surveillance of SARS-CoV-2 vaccines

Introducción: La vacunación ha sido una de las intervenciones sanitarias más costo-efectivas, por su impacto en el control de las enfermedades inmunoprevenibles. La pandemia ocasionada por SARS-CoV-2 condujo al desarrollo mundial de más de doscientas vacunas en diferentes fases de investigación con diversas plataformas. Objetivo: Caracterizar la evaluación del control de calidad de las vacunas contra SARS-CoV-2 y los eventos adversos de las aprobadas contra otros agentes patógenos en las diferentes etapas del ensayo preclínico y clínico. Métodos: Se realizó una búsqueda en Google Académico y PubMed/Medline de artículos publicados entre 1969 y marzo de 2021. Se seleccionaron los de mayor relevancia. Desarrollo: Las vacunas se desarrollaron en un corto tiempo ante la pandemia de COVID-19, sin comprometer el adecuado control de los ensayos clínicos. Aunque resultan seguras, no están exentas de eventos adversos; por ello se debe vigilar su seguridad durante el proceso de poscomercialización. Muchas de ellas han comprometido su seguridad. Conclusiones: Las vacunas deben poseer inmunogenicidad, eficacia y seguridad comprobadas. Los eventos adversos pueden surgir en cualquier etapa de la investigación; por tanto, resulta fundamental la vigilancia en la fase de poscomercialización(AU)

Introduction: Vaccination has been one of the most cost-effective health interventions, due to its impact on the control of immunopreventable diseases. The pandemic caused by SARS-CoV-2 led to the worldwide development of more than two hundred vaccines in different phases of research with diverse platforms. Objective: To characterize the quality control assessment of vaccines against SARS-CoV-2 and adverse events of those approved against other pathogens at different stages of preclinical and clinical trials. Methods: We searched Google Scholar and PubMed/Medline for articles published between 1969 and March 2021. The most relevant articles were selected. Development: Vaccines were developed in a short time in the face of the COVID-19 pandemic, without compromising the adequate control of clinical trials. Although they are safe, they are not free of adverse events; therefore, their safety should be monitored during the post-marketing process. Many of them have compromised their safety. Conclusions: Vaccines should possess proven immunogenicity, efficacy and safety. Adverse events can arise at any stage of research; therefore, post-marketing surveillance is essential(AU)

Evaluation of tolerance to mercaptopurine in patients with inflammatory bowel disease and gastrointestinal intolerance to azathioprine.

BACKGROUND: Thiopurines such as azathioprine (AZA) and mercaptopurine (MP) are commonly utilized to treat inflammatory bowel disease (IBD). Their use is frequently restricted due to gastrointestinal intolerance (GI). Previous retrospective studies have reported that AZA-intolerant patients may benefit from a switch to MP; yet the effectiveness of this strategy has not been prospectively evaluated. AIMS: To assess GI tolerance to MP in patients who are intolerant to AZA, and to identify clinical predictors of GI intolerance to AZA or MP. METHODS: A prospective, observational, single-cohort study was performed in 92 thiopurine-naïve IBD patients. They were started on a 50mg dose of AZA and escalated to 2.5mg/kg per day by week 2. Those with GI intolerance were rechallenged with a 50% dose of AZA, after which another dose escalation attempt was made. If symptoms persisted, they were switched to MP. RESULTS: Thirty (32.6%) of the recruited patients suffered from GI intolerance to AZA. Of these, 15 did not present recurrence of symptoms after rechallenge with lower doses. Of 15 intolerant patients, 14 were switched to MP. Within the MP cohort, 8 patients (57%) were also intolerant to MP, 5 (36%) had no symptoms, and 1 (7%) was lost to follow-up. Female gender was the only independent predictor of GI intolerance to AZA. CONCLUSIONS: Up to half of the AZA-intolerant patients tolerated a 50% dose rechallenge that was successfully escalated. A switch to MP was tolerated in over a third of cases whom rechallenge failed. Our strategy (challenge-rechallenge-switch) achieved an overall GI tolerance to thiopurines in most of the patients.

Sistemas de notificación de eventos adversos como estrategia para la cultura de calidad y seguridad del paciente / Adverse event reporting systems as a strategy for a culture of quality and patient safety

Introducción: el objetivo de los Sistemas de Notificación de Eventos Adversos, Eventos Centinela y Cuasifallas, es conocer la frecuencia con la que se presentan y generar las estrategias para su disminución y la no repetición de dichos eventos. Se debe informar al personal de salud involucrado en los procesos de atención, principalmente a quienes tienen contacto directo con los pacientes. Desarrollo: se realizó una revisión bibliográfica conceptual y de investigación sobre los sistemas de notificación de eventos adversos. La búsqueda y selección de artículos publicados de 2016 a 2021, fue en la base de datos PubMed y el índice de revistas de acceso abierto Medigraphic, mediante los siguientes criterios de búsqueda en español e inglés: sistemas de notificación, evento adverso, evento centinela, sistema VENCER, Instituto Mexicano del Seguro Social, Secretaría de Salud; así como el uso del operador booleano AND: Notificatión AND adverse event, notification system AND sentinel event, adverse event AND quality plan. Se obtuvo un aproximado de 194 resultados, de los cuales se seleccionaron los artículos que se apegaban al objetivo de esta revisión. Conclusiones: con la presente revisión bibliográfica se muestra que la notificación de los eventos adversos por parte del personal de la salud involucrados en los procesos de atención, adquiere especial relevancia cuando ésta es proporcional a la adquisición de luna cultura de calidad y seguridad en la atención de los pacientes... (AU)

Abstract Introduction: The objective of the Notification Systems for Adverse Events, Sentinel Events and Near Failures is to know the frequency with which they occur and to generate strategies for their reduction and non-repetition of said events. Health personnel involved in the care processes should be informed, mainly those who have direct contact with patients. Development: A conceptual and research literature review on adverse event reporting systems was carried out. The search and selection of articles published from 2016 to 2021 was in the PubMed database and the Medigraphic open access journal index, using the following search criteria in Spanish and English: notification systems, adverse event, sentinel event, VENCER system, Mexican Institute of Social Security, Ministry of Health, as well as the use of the boolean operator AND: Notification AND adverse event, notification system AND sentinel event, adverse event AND quality plan. An approximate of 194 results were obtained, from which the articles that met the objective of this review were selected. Conclusions: This bibliographic review shows that the notification of adverse events by health personnel involved in care processes acquires special relevance when it is proportional to the acquisition of a culture of quality and safety in care. from the patients.

Implicaciones jurídicas de los sistemas de notificación y registro de eventos adversos en la esfera sanitaria / [Legal implications of notification and registration systems for adverse events in the healthcare sphere]

La notificación de eventos adversos constituye uno de los instrumentos esenciales de cara a la consecución de mejoras significativas en materia de seguridad del paciente. El presente trabajo pretende concretar las implicaciones jurídicas de las pautas sentadas a nivel internacional (OMS, Consejo de Europa y UE) de cara al establecimiento de un marco legal nacional favorable a la notificación de eventos adversos en la esfera sanitaria. (AU)

The reporting of adverse events is one of the key elements in achieving significant improvements in the field of patient safety. Based on international guidelines (WHO, Council of Europe and EU) this paper aims to analyse their juridical implications when settling a national legal framework for reporting adverse events in the sphere of healthcare. (AU)

Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders / Perfil de seguridad a largo plazo y usos fuera de indicación de los inhibidores de JAK en dermatología

JAK inhibitors target specific inflammatory cytokines involved in various inflammatory diseases. Four molecules have been approved for dermatological use: upadacitinib, baricitinib, abrocitinib and topical ruxolitinib. Off-label prescriptions for other dermatological conditions have been reported. We conducted a narrative review of the literature to assess the long-term safety profile of currently approved JAK inhibitors in dermatology, and their off-label use in skin disorders. We performed literature searches with Pubmed and Google Scholar from January 2000 to January 2023, using the keywords “Janus kinase inhibitors”, “JAK inhibitors”, “off-label”, “dermatology”, “safety”, “adverse events”, “ruxolitinib”, “upadacitinib”, “abrocitinib” and “baricitinib”. Our search yielded a total of 37 dermatological disorders with studies supporting the use of these JAK inhibitors. Preliminary studies indicate that JAK inhibitors generally have a favorable safety profile and can be considered as an option in many dermatological disorders (AU)

Los inhibidores de JAK actúan bloqueando la acción de ciertas citoquinas inflamatorias involucradas en varias enfermedades inflamatorias. Cuatro moléculas han sido aprobadas para uso en dermatología: upadacitinib, baricitinib, abrocitinib y ruxolitinib tópico. Se han reportado usos fuera de indicación para diferentes enfermedades dermatológicas. Se realizó una revisión narrativa de la literatura sobre la seguridad a largo plazo de los inhibidores de JAK aprobados en dermatología y su uso fuera de indicación en enfermedades dermatológicas, mediante búsquedas bibliográficas en Pubmed y Google Scholar desde enero de 2000 hasta enero de 2023, incluyendo las palabras clave: «Janus kinase inhibitors», «JAK inhibitors», «off-label», «dermatology», «safety», «adverse events», «ruxolitinib», «upadacitinib», «abrocitinib» y «baricitinib». Se encontraron un total de 37 trastornos dermatológicos con estudios que respaldan el uso de estos fármacos. Los estudios preliminares indican que los inhibidores de JAK tienen un perfil de seguridad generalmente favorable y pueden considerarse una opción en muchas enfermedades dermatológicas (AU)