Prediction of adverse drug reactions in geriatric patients admitted to intensive care units.

INTRODUCTION: Intensive care units (ICUs) pose challenges in managing critically ill patients with polypharmacy, potentially leading to adverse drug reactions (ADRs), particularly in the elderly. OBJECTIVE: To evaluate whether the severity and clinical prognosis scores used in ICUs correlate with the prediction of ADRs in aged patients admitted to an ICU. METHODS: A cohort study was conducted in a Brazilian University Hospital ICU. APACHE II and SAPS 3 assessed clinical prognosis, while GerontoNet ADR Risk Score and BADRI evaluated ADR risk at ICU admission. Severity of the patients' clinical conditions was evaluated daily based on the SOFA score. ADR screening was performed daily through the identification of ADR triggers. RESULTS: 1295 triggers were identified (median 30 per patient, IQR=28), with 15 suspected ADRs. No correlation was observed between patient severity and ADRs at admission (p=0.26), during hospitalization (p=0.91), or at follow-up (p=0.77). There was also no association between death and ADRs (p=0.28) or worse prognosis and ADRs (p>0.05). Higher BADRI scores correlated with more ADRs (p=0.001). CONCLUSIONS: These data suggest that employing the severity and clinical prognosis scores used in ICUs is not sufficient to direct active pharmacovigilance efforts, which are therefore indicated for critically ill patients.

Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease.

BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.

Comparison of efficacy and safety of the new generation helixone dialyzers.

INTRODUCTION: New generation helixone dialyzers has recently been developed as part of the ongoing effort to improve dialyzer hemocompatibility and avoid adverse reactions to synthetic dialyzers. This study aimed to assess the performance and albumin loss of this new dialyzer series in hemodiafiltration and compare it with the previous generation helixone series. MATERIAL AND METHODS: A prospective study was conducted in 19 patients. Each patient underwent eight dialysis sessions with the same routine dialysis parameters; only the dialyzer varied: FX60 CorDiax, FX CorAL 60, FX600 CorDiax, FX CorAL 600, FX80 CorDiax, FX CorAL 80, FX800 CorDiax, and FX CorAL 800. The reduction ratios (RR) of urea, creatinine, ß2-microglobulin, myoglobin, kappa-free immunoglobulin light chains (κFLC), prolactin, α1-microglobulin, α1-acid glycoprotein, lambda immunoglobulin light chains (λFLC), and albumin were compared intra-individually. Dialysate albumin loss was also measured. RESULTS: All treatments were well tolerated. The mean amount of replacement fluid ranged from 31 to 34 L. Comparison of dialysis treatments showed no differences between small molecules and even up to those the size of ß2-microglobulins. Little differences were found between myoglobin, κFLC, prolactin, α1-microglobulin, and λFLC RRs, and only FX80 CorDiax was slightly superior to the others. Mean dialysate albumin losses were similar, with less than 2.5 g lost in each dialyzer. The FX80 CorDiax showed slightly higher global removal scores than the other dialyzers evaluated, except for FX CorAL 800. CONCLUSION: The new generation helixone dialyzers series has been updated to minimise the risk of adverse reactions, while maintaining the effectiveness and albumin loss achieved by the previous most advanced helixone generation.

Acute pancreatitis due to different semaglutide regimens: An updated meta-analysis.

OBJECTIVES: Some concerns persist regarding the safety of semaglutide. The objective of this updated meta-analysis is to assess the risk of acute pancreatitis with the use of semaglutide, assessing the results according to the different administration regimens. METHODS: We performed an updated meta-analysis of randomised, placebo-controlled studies of semaglutide therapy that report acute pancreatitis. This meta-analysis was performed in line with PRISMA guidelines. A global and stratified analysis according to the therapeutic scheme used was performed using the fixed-effects model. RESULTS: Twenty-one eligible trials of semaglutide, including 34,721 patients, were identified and considered eligible for the analyses. Globally, semaglutide therapy was not associated with an increased risk of acute pancreatitis (OR 0.7; 95% CI 0.5-1.2, I2 0%). When we analysed the studies according to the different schemes used, the results were similar (group with oral semaglutide: OR 0.40; 95% CI 0.10-1.60, I2 0%; group with low subcutaneous doses of semaglutide: OR 0.80; 95% CI 0.40-1.90, I2 0%; group with high subcutaneous doses of semaglutide: OR 0.70; 95% CI 0.50-1.20, I2 0%; interaction p-value=0.689). CONCLUSION: This updated meta-analysis demonstrates that the use of semaglutide is not associated with an increased risk of acute pancreatitis compared to placebo. In the stratified analysis, the results were similar with the different semaglutide regimens analysed.

Percepção dos profissionais de enfermagem sobre manejo de reação infusional a antineoplásicos: estudo qualitativo / Perception of nursing professionals on the management of infusion reactions to antineoplastics: qualitative study

Identificar a percepção dos profissionais de enfermagem sobre o manejo de reação infusional imediata a antineoplásicos. Método: Trata-se de um estudo descritivo de caráter exploratório com abordagem qualitativa realizado em um hospital no Rio Grande do Sul. Resultados: Todos os participantes afirmaram saber identificar uma reação infusional. Após a identificação da reação, nota-se que a maioria obedeceu a uma ordem de condutas a serem realizadas. Quanto aos cuidados para prevenção das reações infusionais, a maioria dos participantes mencionou a administração de medicamentos pré-quimioterápicos, como antialérgicos e antieméticos. Conclusão: Os achados demonstram que a maioria dos profissionais sabe reconhecer e manejar, porém há a necessidade de treinamentos e padronização das ações.(AU)

To identify the perception of nursing professionals about the management of immediate infusion reactions to antineoplastic drugs. Method: This is a descriptive, exploratory study with a qualitative approach carried out in a hospital in Rio Grande do Sul. Results: All the participants said they knew how to identify an infusion reaction. After identifying the reaction, it was noted that the majority followed an order of conduct to be carried out. As for precautions to prevent infusion reactions, most of the participants mentioned the administration of pre-chemotherapy drugs, such as anti-allergic and anti-emetic drugs. Conclusion: The findings show that most professionals know how to recognize and manage them, but there is a need for training and standardization of actions.(AU)

Identificar la percepción de los profesionales de enfermería sobre el manejo de las reacciones infusionales inmediatas a medicamentos antineoplásicos. Método: Se trata de un estudio descriptivo, exploratorio, con abordaje cualitativo, realizado en un hospital de Rio Grande do Sul. Resultados: Todos los participantes afirmaron saber identificar una reacción a la infusión. Después de identificar la reacción, la mayoría siguió un orden de conducta. En cuanto a las precauciones para prevenir las reacciones a la infusión, la mayoría de los participantes mencionó la administración de fármacos prequimioterápicos, como antialérgicos y antieméticos. Conclusión: Los hallazgos muestran que la mayoría de los profesionales saben reconocerlas y manejarlas, pero es necesaria la formación y la estandarización de actuaciones.(AU)

Exploring the impact of pharmacogenetics on personalized medicine: A systematic review.

INTRODUCTION: Pharmacogenetics evaluates how genetic variations influence drug responses. Nowadays, genetic tests have advanced, becoming more affordable, and its integration is supported by stronger clinical evidence. Guidelines such as those from CPIC (Clinical Pharmacogenetics Implementation Consortium) and resources like PharmGKB facilitate genotype-based prescribing; and organizations like the FDA promote genetic testing before initiating certain medications. Preventive pharmacogenetic panels seem promising, but further research on biomarkers and diverse populations is needed. The aim of this review is to analyze recent evidence on the genotype-drug response relationship to examine how the genetic profile of patients influences the clinical response to treatments, and analyze the areas of research that need further study to advance towards a genetic-based precision medicine. MATERIALS AND METHODS: A systematic search was conducted on PubMed to identify articles investigating the genotype-drug response relationship. The search strategy included terms such as "pharmacogenetics", "personalized treatment", "precision medicine", "dose adjustment", "individualizing dosing", "clinical routine", and "clinical practice." Clinical trials, observational studies, and meta-analyses published in English or Spanish between 2013 and 2023 were included. The initial search resulted in a total of 136 articles for analysis. RESULTS: 49 articles were included for the final analysis following review by 2 investigators. A relationship between genetic polymorphisms and drug response or toxicity was found for drugs such as opioids, GLP-1 agonists, tacrolimus, oral anticoagulants, antineoplastics, atypical antipsychotics, efavirenz, clopidogrel, lamotrigine, anti-TNFα agents, voriconazole, antidepressants, or statins. However, for drugs like metformin, quetiapine, irinotecan, bisoprolol, and anti-VEGF agents, no statistically significant association between genotype and response was found. CONCLUSION: The studies analyzed in this review suggest a strong correlation between genetic variability and individual drug responses, supporting the use of pharmacogenetics for treatment optimization. However, for certain drugs like metformin or quetiapine, the influence of genotype on their response remains unclear. More studies with larger sample sizes, greater ethnic diversity, and consideration of non-genetic factors are needed. The lack of standardization in analysis methods and accessibility to genetic testing are significant challenges in this field. As a conclusion, pharmacogenetics shows immense potential in personalized medicine, but further research is required.

Evaluación del perfil de seguridad del medicamento tocilizumab en pacientes sospechosos o confirmados por COVID-19 / Evaluation of the safety profile of the drug tocilizumab in patients suspected or confirmed by COVID-19

Introducción: La enfermedad de COVID-19, es una enfermedad emergente cuya patogénesis se relaciona con la tormenta de citocina, la interleucina 6 juega un papel importante en la tormenta de citocinas. El medicamento tocilizumab, es un anticuerpo monoclonal humanizado, el cual se une al receptor soluble IL-6. En pacientes con COVID-19 se ha observado que el uso de tocilizumab disminuye la inflamación exacerbada. Ante este nuevo uso del medicamento es relevante establecer el balance beneficio-riesgo en estos pacientes con COVID-19, identificando con ello las reacciones adversas a medicamentos que pueden estar relacionadas al uso de tocilizumab. Materiales y métodos: Estudio de farmacovigilancia descriptivo y transversal en una cohorte retrospectiva en pacientes sospechosos o confirmados por COVID-19 en el Instituto Nacional de Cardiología Ignacio Chávez de la Ciudad de México, México en el periodo 05 de mayo del 2020 al 20 de enero del 2021. Resultados: De los 36 pacientes participantes en este estudio, la edad promedio fue 53 años, de los cuales 30 fueron hombres y 6 fueron mujeres. Las comorbilidades identificadas en este estudio fue la hipertensión arterial sistémica, seguida de la diabetes mellitus tipo II. En la evaluación de los estudios de laboratorio se observó que 2 pacientes desarollaron neutropenia moderada, mientras que en 5 pacientes se identificó trombocitopenia leve y 2 pacientes desarrollaron trombocitopenia moderada. Las infecciones bacterianas identificadas en el estudio con el uso del medicamento fueron: 5 aislamientos de Klebsiella oxytoca, 4 a Escherichia coli y 4 a Pseudomonas aeruginosa... (AU)

Introduction: COVID-19 is a new emerging disease which pathogenesis is mediated by a cytokines storm, interleukin 6 plays an important part of this storm. Tocilizumab is a humanized monoclonal antibody that binds to the IL-6 receptor. In patient with COVID-19, exacerbated inflammation has been observed to decrease when given tocilizumab. Due to the new use of this drug is relevant to stablish the risk-benefit ratio in COVID-19 patients, by identifying the drug adverse reactions that may be related to the use of tocilizumab. Material and methods: Descriptive and cross-sectional pharmacovigilance study in a retrospective cohort in patients suspected or confirmed by COVID-19 in the National Institute of Cardiology in Mexico City, Mexico from May 5, 2020 to January 20, 2021. Outcomes: From 36 patients in this study, the average age was 53 years of which 30 were men and 6 were women. The comorbidities identified in this study were systemic arterial hypertension followed by type II diabetes mellitus. Evaluating the laboratory results we observed 2 patients developed moderate neutropenia, 5 patients presented mild thrombocytopenia and 2 patients moderate thrombocytopenia. The bacterial infections identified in the study with the use of the tocilizumab were: 5 isolates Klebsiella oxytoca, 4 isolates Escherichia coli and 4 Pseudomonas aeruginosa. Conclusion: Knowing the possible drug adverse reactions that occurred in patients with COVID-19 who were administered tocilizumab, allow us to the identify the risks associated with the drug, determining the safety profile and be alert of bacterial infections, neutropenia, and thrombocytopenia, throughout a pharmacotherapeutical follow up, thereby identifying possible associated alterations possibly restated with the use of tocilizumab. (AU)

Vacunación contra el SARS-CoV-2 en pacientes pediátricos con epilepsia: experiencia de un centro terciario en Colombia / SARS-CoV-2 vaccination in paediatric patients with epilepsy: experience of a tertiary center in Colombia

Objetivo: El objetivo de este estudio es evaluar los efectos de la vacunación contra el SARS-CoV-2 sobre el patrón convulsivo en pacientes pediátricos con epilepsia que acudieron a nuestro centro terciario en la ciudad de Bogotá, Colombia. Pacientes y métodos: Se pidió a los niños con epilepsia que fueron tratados en nuestro centro y que habían recibido la vacuna contra el SARS-CoV-2 y a sus cuidadores que informaran de su experiencia después de la vacunación. Se documentaron la edad, el sexo, la edad de inicio de la epilepsia, la duración de la epilepsia, el tipo de epilepsia, la frecuencia de las convulsiones, el número de medicamentos, el tiempo transcurrido desde la última crisis, los esquemas de vacunación y las convulsiones dos semanas después de la vacunación. Resultados: Se incluyó a 101 pacientes con epilepsia (58%, hombres; y 42%, mujeres). La edad promedio fue de 11 años, el 73% tenía epilepsia focal, y el 27%, generalizada. Veintiuno cumplían los criterios para la epilepsia refractaria y 11 tenían antecedentes personales de convulsiones febriles. Cuarenta y siete pacientes habían sido vacunados con la vacuna de Sinovac; 41, con Pfizer; 12, con Moderna; y uno, con CoronaVac. Tres pacientes presentaron convulsiones 24 horas después de la aplicación de la vacuna sin una relación clara entre la vacunación y la frecuencia de las convulsiones, y un paciente requirió ingreso en el hospital por una convulsión prolongada. Conclusión: La vacunación contra el SARS-CoV-2 en pacientes pediátricos con epilepsia es segura. Aproximadamente el 3% de los pacientes con epilepsia podría eventualmente tener convulsiones en el período posterior a la vacunación.

Aim: The objective of this study is to evaluate effects of SARS-CoV-2 vaccination on seizure pattern in paediatric patients with epilepsy that attended our tertiary center in the city of Bogotá, Colombia. Patients and methods: Children with epilepsy who were treated at our center and have had SARS-CoV-2 vaccination and their caregivers were asked to report their experience following vaccination. We documented age, sex, age at onset of epilepsy, duration of epilepsy, epilepsy type, seizure frequency, number of medications, time from last crisis, vaccination schemes, and seizures two weeks after vaccination. Results: One hundred and one patients with epilepsy were included (58%, male; and 42%, female). The average age was 11 years, 73% had focal epilepsy, and 27%, generalized. Twenty-one fulfilled criteria for refractory epilepsy and 11 had a personal history of febrile seizures. Forty-seven patients had been vaccinated with Sinovac’s vaccine; 41 patients, with Pfizer’s; 12 patients, with Moderna’s; and one, with CoronaVac’s. Three patients presented seizures 24 hours after the application of the vaccine with no clear relation between vaccination and seizure frequency, and one patient required admission to the hospital for a prolonged seizure. Conclusion: Vaccination against SARS-CoV-2 in paediatric patients with epilepsy is safe. Approximately 3% of patients with epilepsy could eventually have seizures in the post-vaccination period.(AU)

Predicción de toxicidad de la quimioterapia y radioterapia en el paciente oncológico quirúrgico

Fundamento la toxicidad asociada a los tratamientos de quimioterapia y radioterapia eleva la morbilidad y la mortalidad en los pacientes oncológicos. Objetivo diseñar un modelo predictivo de toxicidad de la quimioterapia y la radioterapia en el paciente oncológico quirúrgico. Métodos estudio analítico, de casos y controles, en pacientes oncológicos quirúrgicos que cumplieron los criterios de inclusión para la predicción de toxicidad preoperatoria, en el periodo enero a diciembre de 2022, en el Hospital Provincial Docente Oncológico María Curie, de Camagüey. Mediante el paquete estadístico Statistical Package for the Social Sciences, se seleccionó una muestra aleatoria de 334 pacientes, 197 sin toxicidad (grupo control) y 137 con toxicidad (grupo de estudio). Se realizó estimación de predictores de toxicidad mediante regresión logística binaria. Se seleccionó el modelo de mejor ajuste. Resultados el modelo en el paso tres predice un porcentaje global de 83,5 % con respecto a los valores observados. La sensibilidad resultó ser de 81,8; y la especificidad, 84,8. El modelo presentó buen poder discriminativo. Las variables en la ecuación fueron: hipertensión arterial, fracción de eyección del ventrículo izquierdo y anemia. La comparación de la predicción con la realidad, mediante curva Receiver Operating Characteristic determinó un área bajo la curva de 0,901. Conclusión se obtuvo una función de regresión logística que permitió la estimación de la probabilidad de toxicidad en pacientes oncológicos quirúrgicos electivos, la cual proporcionó una herramienta para su predicción desde el preoperatorio.

Foundation the toxicity associated with chemotherapy and radiotherapy treatments increases morbidity and mortality in cancer patients. Objective to design a predictive model of chemotherapy and radiotherapy toxicity in surgical cancer patients. Methods analytical, case-control study, in surgical oncology patients who met the inclusion criteria for the prediction of preoperative toxicity, from January to December 2022, at the María Curie Provincial Teaching Oncology Hospital in Camagüey. Using the Statistical Package for the Social Sciences, a random sample of 334 patients was selected, 197 without toxicity (control group) and 137 with toxicity (study group). Toxicity predictors were estimated using binary logistic regression. The model with the best fit was selected. Results the model in step three predicts an overall percentage of 83.5% with respect to the observed values. The sensitivity turned out to be 81.8; and the specificity, 84.8. The model presented good discriminative power. The variables in the equation were: arterial hypertension, left ventricular ejection fraction, and anemia. The comparison of the prediction with reality, using the Receiver Operating Characteristic curve, determined an area under the curve of 0.901. Conclusion a logistic regression function was obtained that allowed the estimation of the toxicity probability elective surgical cancer patients, which provided a tool for its prediction from the preoperative period.

Acontecimientos adversos en embarazadas con la vacuna tetravalente contra la gripe obtenida de cultivos celulares / Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

La vacunación de la gripe en embarazadas muestra una clara relación beneficio/riesgo. En la actualidad se están desarrollando vacunas contra la gripe utilizando nuevas plataformas. Es imprescindible analizar la seguridad de estas nuevas vacunas en este grupo poblacional, infrarrepresentado en los ensayos clínicos. En la temporada 2019-2020 se aconsejó una vacuna obtenida en cultivo celular a las embarazadas en 2comunidades autónomas. Se recogió información de los centros de vacunación y de farmacovigilancia de ambas comunidades. La tasa de notificación de casos de acontecimientos adversos tras la vacunación en embarazadas fue de 4,02/100.000 dosis administradas y, en mujeres de 18 a 64 años no embarazadas, de 5,9/100.000 dosis administradas. La tasa de acontecimientos adversos notificados fue de 8,04 y 17,74, respectivamente. No se notificaron abortos espontáneos, prematuridad ni malformaciones fetales. Este análisis señala la seguridad en embarazadas de la vacuna de la gripe obtenida de cultivos celulares.(AU)

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyze the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in 2autonomous communities. Information is collected from the vaccination and pharmacovigilance centers of both communities. The reporting rate of adverse events after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of adverse events reported was 8.04 and 17.74, respectively. No spontaneous abortions, prematurity or fetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.(AU)

Resultados negativos asociados a la medicación y reacciones adversas a medicamentos en servicio de urgencias. Estudio exploratorio de vida real / Negative outcomes associated with medication and adverse drug reactions in the emergency department. Real-life exploratory study

Introducción. El objetivo del estudio es determinar la prevalencia de los resultados negativos asociados a la medicación (RNM) y reacciones adversas a medicamentos (RAM) que tienen los pacientes que acuden al servicio de urgencias (SU) de un centro de salud. Método. Estudio observacional exploratorio, de corte transversal, en pacientes con RNM que consultan en un servicio de urgencias. La información, acorde con las variables de interés, se recolectó con un instrumento diseñado y evaluado para ello. Se aplicó un modelo de regresión logística multivariante sobre los RNM encontrados, para determinar las variables más importantes que predisponen a la aparición de RNM. Además, se determinó la evitabilidad de RNM (criterio de Baena et al.), la gravedad de RNM (clasificación de Schneider) y la causalidad de RAM (algoritmo de Naranjo). Resultados. Un total de 158 pacientes fueron incluidos en el estudio. La prevalencia de visitas al SU motivados por RNM fue 35,0 % (55 pacientes) y de RAM fue de 5,1 % (8 pacientes). El 88,0 % de los RNM se consideraron evitables y el 74,0 % fueron de gravedad leve. Por otra parte, el 37,5 % (n=3) de RAM fueron clasificadas como evitables y el 50,0 % como probables. El modelo logístico multivariado indica una posible asociación entre los RNM con bajos niveles de escolaridad, la utilización de plantas medicinales y el número de enfermedades concomitantes. Conclusiones. La visita de 1 de cada 3 pacientes al servicio de urgencias está asociado a un RNM; mientras que 1 de cada 20 lo está a una RAM. Otros estudios son necesarios (AU)

Introduction. The aim of the study is to determine the prevalence of negative outcomes associated with medication (NOMs) and adverse drug reactions (ADRs) occurring in the emergency department (ED) of a health centre.Method. An exploratory observational, cross-sectional study of patients with NOMs consulting in an ED. According to the variables of interest, the information was collected with an instrument designed and evaluated for this pur-pose.A multivariate logistic regression model was applied to the NOMs and found the most important variables predis-posing to the appearance of NOM. In addition, the avoid ability of NOM (Baena et al. criteria), the severity of NOM (Schneider classification) and the causality of ADR (Naranjo algorithm) were shown.Results. A total of 158 patients were included in the study. The prevalence of visits to the ED due to NOM was 35.0 % (55 patients) and ADR was 5.1 % (8 patients). Overall, 88.0 % of the ADRs were considered avoidable and 74.0 % were of mild severity. On the other hand, 37.5 % (n=3) of suspected ADR were classified as avoidable and 50.0 % as probable. The multivariate logistic model indicates a possible association between NOMs with lower levels of schooling, the use of medicinal plants and the number of diseases.Conclusions. The visit of 1 in 3 patients to the emergency department is associated with a NOM, while 1 in 20 is associated with an ADR. Further studies are needed. (AU)

Design and validity of the spanish version of two questionnaires related to adverse reactions to foodstuffs / Diseño y validación de la versión española de dos cuestionarios relacionados con reacciones adversas a alimentos

Introduction: there is an emerging current necessity of valid questionnaires, encompassing most of food, beverages, diseases, signs and symptoms currently related to the pathogenesis of adverse reactions to foodstuffs (ARFS) in the Spanish population. Objectives: this study aimed to design and validate two questionnaires to assess ARFS in the Spanish population, Food and Beverages Frequency Consumption Questionnaire to Identify Adverse Reactions to Foodstuffs (FBFC-ARFSQ-18); and Pathologies and Symptomatology Questionnaire associated with Adverse Reactions to Foodstuffs (PSIMP-ARFSQ-10). Methods: both questionnaires were designed adapting questionnaires from the literature; and validated, using the expert judgment method, in five phases: questionnaires development, pilot test and reliability, content validity, face validity, and ethical considerations. Questionnaires were developed using the REDCap™ tool hosted at the Universidad Politécnica de Madrid. A total of 20 Spanish experts evaluated the questionnaires. Cronbach’s alpha reliability coefficients were calculated using SPSS version 25.0 (IBM Corp., Armonk, NY-USA) and Aiken’s V coefficient values were calculated using ICaiken.exe (Visual Basic 6.0, Lima-Perú). Results: a final construct of questions was designed, ensuring no overlap, for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10. Cronbach’s alpha reliability coefficients were 0.93 and 0.94; and Aiken’s V coefficient values were 0.90 (0.78-0.96 CI) and 0.93 (0.81-0.98 CI) for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10, respectively. Conclusions: both validated questionnaires could be used to analyze the association between certain food and beverages consumption with ARFS, such as food allergies and food intolerances; also, to investigate the link between some specific diseases, signs and symptoms with ARFS.(AU)

Introducción: actualmente, existe una necesidad emergente de cuestionarios validados que abarquen la mayor parte de los alimentos, bebidas,enfermedades, signos y síntomas relacionados con la patogénesis de las reacciones adversas a los alimentos (RAA).Objetivos: diseñar y validar dos cuestionarios para evaluar las RAA en población española, el Cuestionario de Frecuencia de Consumo de Ali-mentos y Bebidas para Identificar Reacciones Adversas de Origen Alimentario (CFCAB-RAA-18); y el Cuestionario de Patologías y SintomatologíaAsociadas a Reacciones Adversas a Alimentos (PSIMP-RAA-10).Métodos: ambos cuestionarios se diseñaron adaptando cuestionarios de la literatura y se validaron, utilizando el método de juicio de expertos,en cinco fases: desarrollo de cuestionarios, prueba piloto y confiabilidad, validez de contenido, validez aparente y consideraciones éticas. Loscuestionarios se desarrollaron utilizando la herramienta REDCap™. Un total de 20 expertos evaluaron los cuestionarios. Se calcularon coefi-cientes de confiabilidad alfa de Cronbach con SPSS versión 25.0 (IBM Corp., Armonk, NY-Estados Unidos) y valores del coeficiente V de Aikencon ICaiken.exe (Visual Basic 6.0, Lima-Perú).Resultados: se diseñó una construcción final de preguntas, evitando solapamiento entre ambas herramientas. Los coeficientes de confiabilidadalfa de Cronbach fueron 0,93 y 0,94, y los valores del coeficiente V de Aiken fueron 0,90 (IC: 0,78-0,96) y 0,93 (IC: 0,81-0,98) (CFCAB-RAA-18y PSIMP-RAA-10, respectivamente).Conclusiones: ambos cuestionarios fueron validados y podrían utilizarse para analizar la asociación entre el consumo de determinados alimentosy bebidas con las RAA, como alergias e intolerancias alimentarias, así como para investigar el vínculo entre algunas enfermedades, signos ysíntomas específicos con las RAA.(AU)

Design and validity of the Spanish version of two questionnaires related to adverse reactions to foodstuffs.

Introduction: Introduction: there is an emerging current necessity of valid questionnaires, encompassing most of food, beverages, diseases, signs and symptoms currently related to the pathogenesis of adverse reactions to foodstuffs (ARFS) in the Spanish population. Objectives: this study aimed to design and validate two questionnaires to assess ARFS in the Spanish population, Food and Beverages Frequency Consumption Questionnaire to Identify Adverse Reactions to Foodstuffs (FBFC-ARFSQ-18); and Pathologies and Symptomatology Questionnaire associated with Adverse Reactions to Foodstuffs (PSIMP-ARFSQ-10). Methods: both questionnaires were designed adapting questionnaires from the literature; and validated, using the expert judgment method, in five phases: questionnaires development, pilot test and reliability, content validity, face validity, and ethical considerations. Questionnaires were developed using the REDCap™ tool hosted at the Universidad Politécnica de Madrid. A total of 20 Spanish experts evaluated the questionnaires. Cronbach's alpha reliability coefficients were calculated using SPSS version 25.0 (IBM Corp., Armonk, NY-USA) and Aiken's V coefficient values were calculated using ICaiken.exe (Visual Basic 6.0, Lima-Perú). Results: a final construct of questions was designed, ensuring no overlap, for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10. Cronbach's alpha reliability coefficients were 0.93 and 0.94; and Aiken's V coefficient values were 0.90 (0.78-0.96 CI) and 0.93 (0.81-0.98 CI) for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10, respectively. Conclusions: both validated questionnaires could be used to analyze the association between certain food and beverages consumption with ARFS, such as food allergies and food intolerances; also, to investigate the link between some specific diseases, signs and symptoms with ARFS.

Introducción: Introducción: actualmente, existe una necesidad emergente de cuestionarios validados que abarquen la mayor parte de los alimentos, bebidas, enfermedades, signos y síntomas relacionados con la patogénesis de las reacciones adversas a los alimentos (RAA). Objetivos: diseñar y validar dos cuestionarios para evaluar las RAA en población española, el Cuestionario de Frecuencia de Consumo de Alimentos y Bebidas para Identificar Reacciones Adversas de Origen Alimentario (CFCAB-RAA-18); y el Cuestionario de Patologías y Sintomatología Asociadas a Reacciones Adversas a Alimentos (PSIMP-RAA-10). Métodos: ambos cuestionarios se diseñaron adaptando cuestionarios de la literatura y se validaron, utilizando el método de juicio de expertos, en cinco fases: desarrollo de cuestionarios, prueba piloto y confiabilidad, validez de contenido, validez aparente y consideraciones éticas. Los cuestionarios se desarrollaron utilizando la herramienta REDCap™. Un total de 20 expertos evaluaron los cuestionarios. Se calcularon coeficientes de confiabilidad alfa de Cronbach con SPSS versión 25.0 (IBM Corp., Armonk, NY-Estados Unidos) y valores del coeficiente V de Aiken con ICaiken.exe (Visual Basic 6.0, Lima-Perú). Resultados: se diseñó una construcción final de preguntas, evitando solapamiento entre ambas herramientas. Los coeficientes de confiabilidad alfa de Cronbach fueron 0,93 y 0,94, y los valores del coeficiente V de Aiken fueron 0,90 (IC: 0,78-0,96) y 0,93 (IC: 0,81-0,98) (CFCAB-RAA-18 y PSIMP-RAA-10, respectivamente). Conclusiones: ambos cuestionarios fueron validados y podrían utilizarse para analizar la asociación entre el consumo de determinados alimentos y bebidas con las RAA, como alergias e intolerancias alimentarias, así como para investigar el vínculo entre algunas enfermedades, signos y síntomas específicos con las RAA.

Toxicidad muco-cutánea: un desafío en el tratamiento oncológico / Mucocutaneous toxicity: a challenge in oncological treatment

El tratamiento combinado con inhibidores de tirosina quinasa e inmunoterapia en el cáncer de pulmón avanzado con mutación del EGFR es un enfoque emergente en la investigación clínica. Algunos estudios preliminares han mostrado resultados prometedores, con mejorías en la respuesta tumoral y la supervivencia global en comparación con la monoterapia. Sin embargo, esta combinación puede aumentar el riesgo de eventos adversos, por lo que se requiere un se-guimiento estrecho y una atención médica especializada. Se presenta el caso de un varón de 57 años con adenocarcinoma de pulmón que manifestó exantema generalizado grado 3 con lesiones pápulo-pustulosas, paroniquia y tricomegalia secundario al tratamiento con la-zertinib-amivantamab. Además, el paciente desarrolló una proctalgia crónica con mal control álgico debido a la aparición de úlceras anales e hipertonía del esfínter anal. (AU)

The combined treatment with tyrosine kinase inhibitors and immunotherapy in advanced lung cancer with EGFR mutation is an emerging approach in clinical research. Some preliminary studies have shown promising results, with improvements in tumor response and overall survival compared to monotherapy. However, this combination may increase the risk of adverse events, necessitating close monitoring and specialized medical attention. We present the case of a 57-year-old male with lung adenocarcinoma who manifested grade 3 generalized exanthema with papulopustular lesions, paronychia and trichomegaly secondary to treatment with lazertinib-amivantamab. Additionally, the patient developed chronic proctalgia with poorly controlled pain due to the presence of anal ulcers and anal sphincter hypertonia. (AU)

Farmacovigilancia durante la pandemia de COVID-19 / Pharmacovigilance during the pandemic of COVID-19

Durante la pandemia de COVID-19, un papel fundamental de la Farmacovigilancia y del Centro de Farmacovigilancia de Navarra ha sido disponer de forma temprana de información deseguridad actualizada sobre los tratamientos para la infección por SARS-CoV-2 y las vacunasCOVID-19. Esto ha permitido mantener informados tanto a profesionales de la salud como a laciudadanía sobre la seguridad de dichos medicamentos y poder adoptar medidas de minimización de riesgos. A consecuencia de la pandemia han surgido nuevas actividades en el Centro de Farmacovigilancia de Navarra, como la participación activa en todas las tareas relacionadas con el seguimiento de la seguridad de los medicamentos utilizados para la infección por SARS-CoV-2 y enla vigilancia de la seguridad de las vacunas COVID-19, formando parte de los grupos de trabajo del Sistema Español de Farmacovigilancia creados para dicho seguimiento. También se ha intensificado el trabajo relacionado con la resolución de consultas, que se triplicaron en el año2021 frente a 2020 y la evaluación de las notificaciones de sospechas de reacciones adversas,que aumentaron más de siete veces en 2021 respecto a las de 2020. La pandemia de COVID-19 ha afectado profundamente al conjunto de actividades que realizael Centro de Farmacovigilancia de Navarra, pero ha servido para visibilizar su trabajo, dara conocer su finalidad y, en definitiva, para poner en valor la Farmacovigilancia. A raíz de lapandemia de COVID-19 la Farmacovigilancia ha pasado a tener un reconocimiento científico ysocial indiscutible.(AU)

Trastornos en la calidad del sueñoasociados a los inhibidores dela integrasa en el tratamiento del VIH / Sleep disorders related to HIV treatment

FUNDAMENTOS: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). MÉTODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.(AU)

BACKGROUND: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn’t find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.(AU)

Atrial fibrillation and QT prolongation after a single dose of hydroxychloroquine / Fibrilación auricular y prolongación del QT después de una dosis única de hidroxicloroquina

Non-antiarrhythmic drugs may induce QT-prolongation and increase the risk of arrhythmias. Recent studies have determined that there is a risk of atrial fibrillation (AF) due to QT prolongation. We report a case of FA associated to QT prolongation secondary to a single dose of hydroxychloroquine (HCQ) in an 83-years-old polymedicated patient admitted to our hospital due to SARS-CoV-2 infection. Quetiapine was prescribed as regular medicine after admission and a 5-days oral HCQ regimen was started for COVID-19. Thirty minutes after HCQ loading dose, FA was reported on electrocardiogram (EKG). COVID-19 treatment is leading to use off-label drugs that may generate adverse effects. It should be considered that drugs that induce QT prolongation may be triggers for atrial arrhythmias. There is not any report of sudden onset of increased QT interval with associated arrythmia after a single dose of HCQ, even in a short course treatment. (AU)

Los fármacos no antiarrítmicos pueden inducir la prolongación del intervalo QT y aumentar el riesgo de arritmias. Estudios recientes han determinado que existe riesgo de desarrollar fibrilación auricular (FA) asociada a la prolongación del intervalo QT. Presentamos un caso de FA asociado a prolongación del QT secundario a una dosis única de hidroxicloroquina (HCQ) en una paciente polimedicada de 83 años ingresada en nuestro hospital por infección por SARS-CoV-2. A la paciente se le prescribió quetiapina como parte de su medicamento habitual al ingreso y se inició tratamiento frente a COVID-19 basado en HCQ oral. Treinta minutos tras la dosis de carga de HCQ, se informó FA en el electrocardiograma (ECG). El tratamiento de COVID-19 está llevando al uso de medicamentos no aprobados que pueden generar efectos adversos. Además, debe considerarse que los fármacos que inducen la prolongación del QT pueden desencadenar arritmias auriculares. No se han reportado casos de aparición repentina de aumento del intervalo QT con arritmia asociada después de una dosis única de HCQ. (AU)

Estudio de reactogenicidad en las vacunas mRNA frente a la COVID-19 / Reactogenicity Study of mRNA Vaccines Against COVID-19

Objetivo: Comparar la reactogenicidad entre los tipos de vacuna RNAm Commirnaty® (Pfizer) y Spikevax® (Moderna) frente a la COVID-19 en población sanitaria.Métodos: Estudio de prevalencia de los efectos adversos a corto plazo y sus consecuencias tras la administración de la primera y segunda dosis en profesionales y estudiantes de una institución sanitaria. Se administró un cuestionario de síntomas y sus consecuencias a los 7 días de la vacunación. Se calculó la prevalencia e intervalo de confianza del 95% (IC95%). Las diferencias entre vacunas se cuantificaron mediante las odds ratio (OR) e IC95%.Resultados: Completaron el cuestionario 1924 y 1170 sanitarios (tasas de respuesta 62.2% y 39.1%) tras la primera y la segunda dosis, respectivamente, de la vacuna Commirnaty®, y 410 (56.0%) y 107 (15.0%), de Spikevax®. Después de la primera dosis de Comirnaty® un 67,4% presentó algún efecto adverso, y un 76,1% para Spikevax® (OR 1,5 IC95% 1,2-1,9). En general mujeres y jóvenes mostraron mayor reactogenicidad y diferencias entre vacunas. Las consecuencias de los efectos adversos fueron más frecuentes para Spikevax®. La reactogenicidad fue superior tras la segunda dosis que tras la primera, para las dos vacunas (Comirnaty® 67,4% vs. 75,6%; Spikevax® 76,1% vs. 87,9%).Conclusiones: La mayor reactogenicidad y sus consecuencias, para la primera y segunda dosis de la vacuna Spikevax® respecto a Comirnaty®, y de la segunda dosis respecto a la primera dosis de ambas vacunas, aporta conocimiento útil para la planificación de campañas de vacunación frente a la COVID-19 en el entorno sanitario. (AU)

Objective: To compare the reactogenicity between the types of mRNA Commirnaty® (Pfiz-er) and Spikevax® (Moderna) vaccines against COVID-19 in a healthcare population.Methods: Cross sectional study of short-term adverse effects and their consequences (sick leave, limitations of daily life, etc.) after the administration of the first and second doses of both vaccines in professionals and students of a health institution. A questionnaire on symptoms and their consequences was administered seven days after each vaccination dose. The prevalence and 95% confidence interval (95%CI) were calculated. Differences be-tween vaccines were quantified using the odds ratio (OR) and its 95%CI.Results: The questionnaire was completed by 1924 and 1170 healthcare providers (re-sponse rates 62.2% and 39.1%) after the first and second doses, respectively, of the Com-mirnaty® vaccine, and 410 (56.0%) and 107 (15.0%) of Spikevax®. After the first dose of Comirnaty®, 67.4% presented some adverse effect, and 76.1% for Spikevax® (OR 1.5 95%CI 1.2-1.9). In general, women and young people showed greater reactogenicity and differences between vaccines. Consequences of adverse effects were more frequent for Spikevax®. The reactogenicity was higher after the second than the first dose, for both vaccines (Comirnaty®: 67.4% vs. 75.6%; Spikevax®: 76.1% vs. 87.9%Conclusions: The greater reactogenicity and its consequences, for the first and second dose of the Spikevax® vaccine compared to Comirnaty®, and of the second dose com-pared to the first dose of both vaccines, provides useful knowledge for planning vaccination against COVID-19 campaigns in healthcare settings (AU)

Reacciones adversas a múltiples antibióticos / Adverse drug reactions to multiple antibiotics

Resumen La información sobre reacciones adversas es fundamental para conocer la seguridad real de los medicamentos comercializados. Existen casos de pacientes con síndrome de intolerancia a múl tiples drogas, una entidad poco reportada, la que puede presentarse cuando en un mismo paciente ocurren reacciones adversas a más de dos medicamentos no relacionados farmacológicamente. Se describe el caso de una mujer con diagnóstico de endocarditis por Staphylococcus aureus multisensible, que cursó con reacciones adversas a cinco antibióticos estructuralmente no relacionados y con mecanismos de acción diferentes, en dos internaciones consecutivas. Las reacciones fueron secundarias a cefazolina (tricitopenia), vancomicina (injuria renal), daptomicina (elevación de creatina fosfoquinasa) y linezolid (hepatotoxicidad) en la primera internación, y a cotrimoxazol (plaquetopenia) en la segunda. En todos los casos se observó daño transitorio en diferentes sistemas de órganos. Finalmente, se otorgó alta hospitalaria con clindamicina sin nuevas intercurrencias hasta finalizar tratamiento. Este caso podría corresponder al síndrome antes mencionado o a una entidad aún no caracterizada.

Abstract Adverse reaction reporting is essential to understand the actual safety of marketed medicines. There are cases of patients with multidrug intolerance syndrome, an under-reported entity, which can occur when adverse reactions to more than two pharmacologically unrelated drugs occur in the same patient. We describe the case of a woman diagnosed with multisensitive Staphylococcus aureus endocarditis who experienced adverse reactions to five structurally unrelated antibiotics with different mechanisms of action in two consecutive hospitalisations. The reactions were secondary to cefazolin (tricytopenia), vancomycin (renal injury), daptomycin (elevated creatine phosphokinase) and linezolid (hepatotoxicity) in the first hospitalization, and to cotrimoxazole (thrombocytopenia) in the second. Transient damage to different organ systems was observed in all cases. Finally, hospital discharge was granted with clindamycin without further intercurrences until treatment was completed. This case could cor respond to the aforementioned syndrome or to an as yet uncharacterized entity.