[Analysis of an incident notification system and register in a critical care unit]. / Análisis del registro de un sistema de notificación de incidentes en una unidad de cuidados críticos.

OBJECTIVE: To analyse the incident communicated through a notification system and register in a critical care unit. METHODOLOGY: A cross-sectional descriptive study was conducted by performing an analysis of the records of incidents communicated anonymously and voluntarily from January 2007 to December 2013 in a critical care unit of adult patients with severe trauma. STUDY VARIABLES: incident type and class, professional reports, and suggestions for improvement measures. A descriptive analysis was performed on the variables. RESULTS: Out of a total of 275 incidents reported, 58.5% of them were adverse events. Incident distributed by classes: medication, 33.7%; vascular access-drainage-catheter-sensor, 19.6%; devices-equipment, 13.3%, procedures, 11.5%; airway tract and mechanical ventilation, 10%; nursing care, 4.1%; inter-professional communication, 3%; diagnostic test, 3%; patient identification, 1.1%, and transfusion 0.7%. In the medication group, administrative errors accounted for a total of 62%; in vascular access-drainage-catheter-sensor group, central venous lines, a total of 27%; in devices and equipment group, respirators, a total of 46.9%; in airway self-extubations, a total of 32.1%. As regards to medication errors, 62% were incidents without damage. Incident notification by profession: doctors, 43%, residents, 5.6%, nurses, 51%, and technical assistants, 0.4%. CONCLUSIONS: Adverse events are the most communicated incidents. The events related to medication administration are the most frequent, although most of them were without damage. Nurses and doctors communicate the incidents with the same frequency. In order to highlight the low incident notification despite it being an anonymous and volunteer system, therefore, it is suggested to study measurements to increase the level of communication.

Elemental diet preventative effects for adverse events during chemotherapy in patients with esophageal cancer - A systematic review and meta-analysis.

Introduction: The effectiveness of an elemental diet (ED) for preventing adverse events (AEs) during chemotherapy for patients with esophageal cancer (EC) remains unclear. The aim of this meta-analysis was to comprehensively assess the efficacy of ED for preventing AE in EC patients during chemotherapy. Medline (via PubMed), Embase, the Cochrane Library, and Web of Science were searched to retrieve prospective and randomized studies published before April 12, 2023. The odds ratio (OR) of each AE was calculated using Review Manger 5.4.1. The risk of bias was assessed, and a random effect model-based meta-analysis was used to analyze the available data. Four prospective and randomized studies involving 237 patients were identified after a systematic search. Regarding gastrointestinal toxicities, the findings indicated a trend toward a decrease in the risk of mucositis (OM) (OR = 0.54, 95 % CI: 0.25-1.14), constipation (OR = 0.87, 95 % CI: 0.49-1.53), and anorexia (OR = 0.99, 95 % CI: 0.32-3.05), as well as an increasing trend in the risk of diarrhea (OR = 1.48, 95 % CI: 0.79-2.79), among patients treated with ED. However, none of these reached statistical significance. For hematological toxicities, the risk of all-grade neutropenia (OR = 0.28, 95 % CI: 0.14-0.57), grade ≥ 2 leucopenia (OR = 0.43, 95 % CI: 0.22-0.84), grade ≥ 2 neutropenia (OR = 0.34, 95 % CI: 0.17-0.67), and grade ≥ 3 neutropenia (OR = 0.28, 95 % CI: 0.12-0.63) was significantly decreased. There is no firm evidence confirming the preventive effect of an ED against OM or diarrhea. However, an ED may potentially be helpful in preventing neutropenia and leucopenia.

Introducción: La efectividad de una dieta elemental (DE) para prevenir eventos adversos (EA) durante la quimioterapia en pacientes con cáncer de esófago (CE) sigue sin estar clara. Este metaanálisis evalúa la eficacia de DE para prevenir EA en pacientes con CE durante quimioterapia. Se realizaron búsquedas en Medline (con PubMed), Embase, Biblioteca Cochrane y Web of Science para recuperar estudios prospectivos y aleatorios publicados antes del 12/04/2023. La razón de probabilidad (RP) de cada EA se calculó usando Review Manger 5.4.1. Se evaluó el riesgo de sesgo y se utilizó un metaanálisis basado en modelo de efectos aleatorios para analizar los datos disponibles. Después de una búsqueda sistemática, se identificaron cuatro estudios prospectivos y aleatorios con 237 pacientes. En cuanto a las toxicidades gastrointestinales, los hallazgos indicaron una tendencia hacia una disminución en el riesgo de mucositis (OM) (OR = 0,54, IC 95 %: 0,25-1,14), estreñimiento (OR = 0,87, IC 95 %: 0,49-1,53) y anorexia (OR = 0,99, IC 95 %: 0,32-3,05) y una tendencia creciente en el riesgo de diarrea (OR = 1,48, IC 95 %: 0,79-2,79) entre los pacientes tratados con DE. Sin embargo, no hubo muestras estadísticas significativas. Para toxicidades hematológicas, el riesgo de neutropenia de todos los grados (RP = 0,28; IC del 95 %: 0,14-0,57), leucopenia grado ≥ 2 (RP = 0,43; IC del 95 %: 0,22-0,84), neutropenia grado ≥ 2 (RP = 0,34; IC del 95 %: 0,17-0,67) y neutropenia grado ≥ 3 (RP = 0,28; IC del 95 %: 0,12-0,63) disminuyó significativamente. Ninguna evidencia firme confirmó el efecto preventivo de DE frente a OM o la diarrea. Una DE sería útil previniendo neutropenia y leucopenia.

Patient safety in the intensive care department.

Patient safety is a priority for all healthcare systems. Despite this, too many patients still suffer harm as a consequence of healthcare. Furthermore, it has a significant impact on family members, professionals and healthcare institutions, resulting in considerable economic costs. The critically ill patient is particularly vulnerable to adverse events. Numerous safe practices have been implemented, acknowledging the influence of human factors on safety and the significance of the well-being of professionals, as well as the impact of critical episodes at hospital discharge on patients and their families. Training and engagement of professionals, patients and families are of paramount importance. Recently, artificial intelligence has demonstrated its ability to enhance clinical safety. This update on "Patient Safety" reviews all these aspects related to one of the most pivotal dimensions of healthcare quality.

Instruments and Warning Signs for Identifying and Evaluating the Frequency of Adverse Events in Intermediate and Long-Term Care Centres: A Narrative Systematic Review.

INTRODUCTION: There is a lack of data about adverse events (AE) in intermediate and long-term care centers (ILCC). We aimed to synthesize the available scientific evidence on instruments used to identify and characterize AEs. We also aimed to describe the most common adverse events in ILCCs. MATERIAL AND METHODS: A narrative systematic review of the literature was conducted according to Prisma recommendations. The PubMed database was searched for articles published between 2000 and 2021. Two reviewers independently screened and reviewed the studies through blind and independent review. We evaluated bias risk with Cochrane's risk of bias tool. Disagreements were resolved by consensus. Discrepancies that were not resolved by discussion were discussed with a third reviewer. Descriptive data was extracted and qualitative content analysis was performed. RESULTS: We found 2191 articles. Based on the inclusion and exclusion criteria, 272 papers were screened by title and abstract, and 66 studies were selected for full review. The instruments used to identify AEs were mostly tools to identify specific AEs or risks of AEs (94%), the remaining 6% were multidimensional. The most frequent categories detected medication-related AEs (n=26, 40%); falls (n=7, 11%); psychiatric AEs (6.9%); malnutrition (4.6%), and infections (4.6%). The studies that used multidimensional tools refer to frailty, dependency, or lack of energy as predictors of AEs. However, they do not take into account the importance of detecting AEs. We found 2-11 adverse drug events (ADE) per resident/month. We found a prevalence of falls (12.5%), delirium (9.6-89%), pain (68%), malnutrition (2-83%), and pressure ulcers (3-30%). Urinary tract infections, lower respiratory tract infections, skin and soft tissue infections, and gastroenteritis were the most common infections in this setting. Transitions between different care settings (from hospitals to ILCC and vice versa) expose AE risk. CONCLUSION: There are many instruments to detect AEs in ILCC, and most have a specific approach. Adverse events affect a significant proportion of patients in ILCC, the nurse-sensitive outcomes, nosocomial infections, and adverse drug events are among the most common. The systematic review was registered with Prospero, ID: CRD42022348168.

Hepatoxicity induced by clozapine: Case report and brief review.

INTRODUCTION: Antipsychotics are drugs that can produce transient elevations of hepatic enzymes. Clozapine is an atypical antipsychotic used in treatment-resistant schizophrenia and there is evidence that it can produce elevations of hepatic transaminases, expression of liver damage in a hepatocellular pattern. METHODS: Case report and non-systematic review of the relevant literature. CASE PRESENTATION: A 39-year-old woman with a diagnosis of paranoid schizophrenia attended the emergency department of a general hospital for nausea, vomiting and jaundice that appeared after the initiation of clozapine. There was no clinical improvement during hospitalisation, and death occurred after 44 days. LITERATURE REVIEW: Clozapine can increase the liver enzyme levels transiently and asymptomatically; however, there are clinical criteria that recommend the withdrawal of the antipsychotic. CONCLUSIONS: This is the third case reported in the literature of a fatal outcome of clozapine-induced hepatotoxicity.

Perception of the safety culture in a critical area.

INTRODUCTION: Critical care Area (CCA) is one of the most complex in the hospital system, requiring a high number of interventions and handling of amounts of information. Therefore, these areas are likely to experience more incidents that compromise patient safety (PS). AIM: To determine the perception of the healthcare team in a critical care area about the patient safety culture. METHOD: Cross-sectional descriptive study, September 2021, in a polyvalent CCA with 45 beds, 118 health workers (physicians, nurses, auxiliary nursing care technicians). Sociodemographic variables, knowledge of the person in charge in PS and their general training in PS and incident notification system were collected. The validated Hospital Survey on Patient Safety Culture questionnaire, measuring 12 dimensions was used. Positive responses with an average score ≥75%, were defined as an area of strength while ≥50% negative responses were defined as an area of weakness. Descriptive statistics and bivariate analysis: X2 and t-Student tests, and ANOVA. Significance p ≤ 0.05. RESULTS: 94 questionnaires were collected (79.7% sample). The PS score was 7.1 (1.2) range 1-10. The rotational staff scored the PS with 6.9 (1.2) compared to 7.8 (0.9) for non-rotational staff (p = 0.04). A 54.3% (n = 51) was familiar with the incident reporting procedure, 53% (n = 27) of which had not reported any in the last year. No dimension was defined as strength. There were three dimensions that behaved like a weakness: security perception: 57.7% (95% CI: 52.7-62.6), staffing: 81.7% (95% CI: 77.4-85.2) and management support: 69 .9% (95% CI: 64.3-74.9). CONCLUSIONS: The assessment of PS in the CCA is moderately high, although the rotational staff has a lower appreciation. Half of the staff do not know the procedure for reporting an incident. The notification rate is low. The weaknesses detected are perception of security, staffing and management support. The analysis of the patient safety culture can be useful to implement improvement measures.

Prone positioning in COVID-19 patients with acute respiratory distress syndrome and invasive mechanical ventilation.

OBJECTIVE: To identify adverse events related to prone positioning in COVID-19 patients with severe disease and acute respiratory distress syndrome, to analyze the risk factors associated with the development of anterior pressure ulcers, to determine whether the recommendation of prone positioning is associated with improved clinical outcomes. METHODS: Retrospective study performed in 63 consecutive patients with COVID-19 pneumonia admitted to intensive care unit on invasive mechanical ventilation and treated with prone positioning between March and April 2020. Association between prone-related pressure ulcers and selected variables was explored by the means of logistic regression. RESULTS: A total of 139 proning cycles were performed. The mean number of cycles were 2 [1-3] and the mean duration per cycle was of 22h [15-24]. The prevalence of adverse events this population was 84.9 %, being the physiologic ones (i.e., hypo/hypertension) the most prevalent. 29 out of 63 patients (46%) developed prone-related pressure ulcers. The risk factors for prone-related pressure ulcers were older age, hypertension, levels of pre-albumin <21mg/dl, the number of proning cycles and severe disease. We observed a significant increase in the PaO2/FiO2 at different time points during the prone positioning, and a significant decrease after it. CONCLUSIONS: There is a high incidence of adverse events due to PD, with the physiological type being the most frequent. The identification of the main risk factors for the development of prone-related pressure ulcers will help to prevent the occurrence of these lesions during the prone positioning. Prone positioning offered an improvement in the oxygenation in these patients.

Evaluation of tracheal intubations in a paediatric intensive care unit.

INTRODUCTION: Tracheal intubation is a frequent procedure in paediatric intensive care units (PICUs) that carries a risk of complications that can increase morbidity and mortality. PATIENTS AND METHODS: Prospective, longitudinal, observational study in patients intubated in a level III PICU between January and December 2020. We analysed the risk factors associated with failed intubation and adverse events. RESULTS: The analysis included 48 intubations. The most frequent indication for intubation was hypoxaemic respiratory failure (25%). The first attempt was successful in 60.4% of intubations, without differences between procedures performed by staff physicians and resident physicians (62.5% vs 56.3%; P = .759). Difficulty in bag-mask ventilation was associated with failed intubation in the first attempt (P = .028). Adverse events occurred in 12.5% of intubations, and severe events in 8.3%, including 1 case of cardiac arrest, 2 cases of severe hypotension and 1 of oesophageal intubation with delayed recognition. None of the patients died. Making multiple attempts was significantly associated with adverse events (P < .002). Systematic preparation of the procedure with cognitive aids and role allocation was independently associated with a lower incidence of adverse events. CONCLUSIONS: In critically ill children, first-attempt intubation failure is common and associated with difficulty in bag-mask ventilation. A significant percentage of intubations may result in serious adverse events. The implementation of intubation protocols could decrease the incidence of adverse events.

Incidence and risk factors of adverse events in pediatric hemato-oncological patients: A cohort study.

BACKGROUND: Pediatric hemato-oncological (HO) patients are highly susceptible to the occurrence of adverse events (AE), nevertheless few research has been done in this field. Our aim was to describe the incidence, type, severity and preventability of AE in these patients, including bone marrow transplant (BMT) patients, and to identify patient's risk factors for having an AE. METHODS: Retrospective cohort study. Children under 18yo hospitalized at the HO or BMT ward in 2016 were eligible for the study. Type of AE, severity and preventability were described as absolute and relative frequencies. Cumulative incidence of patients with at least one AE (CI_AE) and the rate of occurrence of all AE were calculated. Risk factors (sex, recovery probability, comorbidities and being a BMT patient) were analyzed using logistic regression. RESULTS: 114 patients were included, 58% were male, average age was 8.7yo and 25 were BMT patients. 44 had at least one AE, with CI_AE of 38.6% (95%CI 29.7-47.5). Overall rate of occurrence of AE was 2.5 cases per 100 patients-day (95%CI 2.15-2.98). For BMT and non-BMT patients they were 2.8 (95%CI 2.2-3.6) and 2.5 (95%CI 1.98-3.1) respectively. Healthcare related infection was the most frequent AE. Most AE were moderate and with high preventability. Being a BMT patient was the only independent factor associated with the occurrence of at least one AE (OR=11.5, p<0.001). CONCLUSIONS: Our findings suggest that AE tend to be moderate and preventable in HO pediatric patients. BMT patients seem to be at greater risk of having an AE. Strategies focused on patient safety need to account for their specific characteristics.

[Adverse events and essential actions for patient safety]. / Eventos adversos y acciones esenciales para la seguridad del paciente.

INTRODUCTION: The adverse events (AE) in hospitalized patients occur with increasing frequency due to the increase in complexity of medical care, which implies a greater risk of committing a human error inherent to the care, constituting a serious threat to the safety of the patient. MATERIAL AND METHODS: Cross-sectional study, including patients older than 16years, with hospital stay longer than 24h and discharge from the general surgery service, patients treated in emergency observation units or other hospital services were not considered. AE were identified, classified by cause according to the essential actions for patient safety (EAPS), and compliance with the EAPS was verified. RESULTS: 352 clinical records were reviewed, 61 (17%) were positive on screening. Of the positives, 66% resulted in AE (47 cases). The prevalence of AE was 13%. The AE were: 40% related to procedures; 39% with infections; 17% with medication; 4% with patient identification. The EAPS with the best rating was EAPS5 and the lowest rating was EAPS4. The night shifts with the greatest opportunity area, only with 40% and 44% correct procedures. CONCLUSIONS: The study shows that the two methodologies used, one to identify AE and the other to establish its causes and classification according to the EAPS, demonstrated usefulness and synergy for patient safety, when detecting AE, as well as determining their causes and evaluate compliance with the EAPS.

Neurological manifestations associated with COVID-19 vaccine.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has spread rapidly, giving rise to a pandemic, causing significant morbidity and mortality. In this context, many vaccines have emerged to try to deal with this disease. OBJECTIVE: To review the reported cases of neurological manifestations after the application of COVID-19 vaccines, describing clinical, analytical and neuroimaging findings and health outcomes. METHODS: We carried out a review through bibliographic searches in PubMed. RESULTS: We found 86 articles, including 13 809 patients with a wide spectrum of neurological manifestations temporally associated with COVID-19 vaccination. Most occurred in women (63.89%), with a median age of 50 years. The most frequently reported adverse events were Bell's palsy 4936/13 809 (35.7%), headache (4067/13 809), cerebrovascular events 2412/13 809 (17.47%), Guillain-Barré syndrome 868/13 809 (6.28%), central nervous system demyelination 258/13 809 (1.86%) and functional neurological disorder 398/13 809 (2.88%). Most of the published cases occurred in temporal association with the Pfizer vaccine (BNT162b2), followed by the AstraZeneca vaccine (ChAdOX1-S). CONCLUSIONS: It is not possible to establish a causal relationship between these adverse events and COVID-19 vaccines with the currently existing data, nor to calculate the frequency of appearance of these disorders. However, it is necessary for health professionals to be familiar with these events, facilitating their early diagnosis and treatment. Large controlled epidemiological studies are necessary to establish a possible causal relationship between vaccination against COVID-19 and neurological adverse events.

Hepatoxicity Induced by Clozapine: Case Report and Brief Review. / Hepatotoxicidad inducida por clozapina: reporte de caso y revisión breve de la literatura.

INTRODUCTION: Antipsychotics are drugs that can produce transient elevations of hepatic enzymes. Clozapine is an atypical antipsychotic used in treatment-resistant schizophrenia and there is evidence that it can produce elevations of hepatic transaminases, expression of liver damage in a hepatocellular pattern. METHODS: Case report and non-systematic review of the relevant literature. CASE PRESENTATION: A 39-year-old woman with a diagnosis of paranoid schizophrenia attended the emergency department of a general hospital for nausea, vomiting and jaundice that appeared after the initiation of clozapine. There was no clinical improvement during hospitalisation, and death occurred after 44 days. LITERATURE REVIEW: Clozapine can increase the liver enzyme levels transiently and asymptomatically; however, there are clinical criteria that recommend the withdrawal of the antipsychotic. CONCLUSIONS: This is the third case reported in the literature of a fatal outcome of clozapine-induced hepatotoxicity.

Factors attributable to the cancellation of programmed surgeries.

OBJECTIVE: To analyze the factors attributable to the cancellation of surgeries of a third level health institution in the city of Valledupar, Cesar / Colombia (2017-2018). MATERIAL AND METHODS: Descriptive, retrospective, cross-sectional study. Data from the hospital surgical unit adverse case file were collected for 6 surgical specialties. RESULTS: They showed that in 2017 there was a surgical suspension of 4% of the total of scheduled surgeries that were (3339), for 2018 the rate was 3% with a total of scheduled surgeries (1733). The reason for the suspension for both periods was the factor related to the patient's adverse conditions with 45.9 and 38.5% respectively. The specialty most affected for these cases was the specialty of general surgery with the same percentage value in both periods of 4%. CONCLUSION: The results give us an idea of the factors present for the cancellation of scheduled surgeries and the need to apply measures to guarantee patient safety.

OBJETIVO: Analizar los factores atribuibles a la cancelación de cirugías de una institución de salud de tercer nivel en la ciudad de Valledupar, Cesar, Colombia (2017-2018). MATERIAL Y MÉTODOS: Estudio descriptivo, retrospectivo, transversal. Se recopilaron datos del archivo de casos adversos de la unidad quirúrgica del hospital para 6 especialidades quirúrgicas. RESULTADOS: Mostraron que en 2017 hubo una suspensión quirúrgica del 4% del total de cirugías programadas que fueron (3339), para 2018 la tasa fue del 3% con un total de cirugías programadas (1733). La razón de la suspensión para ambos períodos fue el factor relacionado con las condiciones adversas del paciente con 45.9 y 38.5% respectivamente. La especialidad más afectada para estos casos fue la especialidad de cirugía general con el mismo valor porcentual en ambos períodos del 4%. CONCLUSIÓN: Los resultados nos dan una idea de los factores presentes para la cancelación de cirugías programadas y la necesidad de aplicar medidas para garantizar la seguridad del paciente.

[Detection of adverse events in thyroid and parathyroid surgery using trigger tool and Minimum Basic Data Set (MBDS)]. / Detección de eventos adversos en la cirugía tiroidea y paratiroidea utilizando la herramienta trigger y el Conjunto Mínimo de Datos Básicos (CMBD).

OBJECTIVES: To compare the ability of the trigger tool) and the Minimum Basic Data Set (MBDS) in detecting adverse events (AE) in hospitalized surgical patients with thyroid and parathyroid disease. METHODS: A descriptive, cross-sectional observational study, retrospective and cross-sectional study was conducted from May 2014 to April 2015 analysing retrospectively data on of patients submitted to thyroidectomy and parathyroidectomy in order to detect AE through the identification of triggers (an event often associated to an AE) and the MBDS. triggers and AE were located by systematic review of clinical documentation. The MBDS was got from the data base. Once an AE was detected, it was characterized. RESULTS: 203 AE were identified in 251 patients, being the 90.04% detected by trigger tool and 10.34% by MBDS. 126 patients had at least one AE (50.2%). Without the cases in which uncontrolled pain was the only AE, the percentage of patients that suffering AE was 38.65%. 187 AE were considered preventable and 16 AE were considered unpreventable. The trigger tool and the MBDS demonstrated a sensitivity of 91.27 and 13.49%, a specificity of 4.8 and 100%, a positive predictive value of 49,15 and 100%, and a negative predictive value of 35.29 and 53.42%, respectively. The triggers with more predictive power in AE detection were «antiemetic administration¼ and «calcium administration¼. CONCLUSIONS: Trigger tool shows higher sensitivity for detecting AE than the MBDS. All the detected AE were considered low severity and most of them were preventable.

Factores asociados con caídas de pacientes y su relación con la valoración de riesgo / Patient fall risk factors and their relationship with fall risk assessment

Introducción: la seguridad como atributo de la calidad de atención incluye las actividades orientadas a reducir o mitigar un evento adverso. Las caídas intrahospitalarias son un problema grave y una de las principales causas de lesiones, incapacidad e incluso muerte. El profesional de la salud debe realizar la valoración del riesgo del paciente, determinando la probabilidad de sufrir una caída según sus condiciones individuales. Objetivo: describir los factores asociados con caídas de pacientes en el Hospital de San José de Bogotá y su relación con la valoración del riesgo en el período 2018. Metodología: estudio descriptivo de corte transversal de 90 historias clínicas de pacientes adultos que presentaron este evento adverso. Las variables cuantitativas se reportan como frecuencias absolutas y relativas. Según la Resolución 8430 de 1993 del Ministerio de Salud y Protección Social de Colombia, este estudio se clasifica sin riesgo. Resultados: la edad promedio fue 55 años, 81% estaban clasificados de bajo riesgo, 21% alto, siendo 51% de las valoraciones acorde con la situación del paciente; 38% de las caídas ocurrieron en el baño y con mayor frecuencia (43%) en el turno de la mañana, 27% requirió exámenes adicionales y 12% aumentó la estancia hospitalaria. Conclusión: las caídas constituyen un fenómeno frecuente independiente de la causa de hospitalización, por lo que la "clasificación del riesgo" exige evaluación permanente para conocer los factores predisponentes e intervenir en las causas para mejorar los resultados en salud y favorecer el aprendizaje organizacional.

Introduction: patient safety, as an attribute of quality care, includes actions aimed at reducing or mitigating an adverse event. In-hospital falls are a serious problem and a leading cause of injury, disability, and even death. Patients should be evaluated for fall risk by the healthcare provider, to determine their likelihood of falling, consonantly with their individual features. Objective: to describe patient fall risk factors at Hospital de San José in Bogotá and their relationship to fall risk assessment during 2018. Methodology: a descriptive cross-sectional study including 90 adult patients in whom this adverse event was reported in their medical records. Quantitative variables were reported as absolute and relative frequencies. This study was classified as non-risk in accordance with Resolution 8430 of 1993 issued by the Colombian Ministry of Health and Social Protection. Results: the mean age of participants was 55 years, 81% were classified as low risk, 21% as high risk, and in 51% risk assessment correlated with their comorbid conditions; 38% of falls occurred in the bathroom, most of them (43%) in the morning shift, 27% required further scrutiny and 12% were associated with prolonged hospitalization. Conclusion: patient falls are a common event, regardless of the reason for hospitalization, thus, "risk classification" requires permanent evaluation to identify predisposing factors and the implementation of proper interventions to improve health outcomes and promote organizational learning.

Relación entre las variantes genéticas UGT y HLA y eventos adversos asociados al uso de lamotrigina. Revisión sistemática

Introducción: La lamotrigina (LTG) es un fármaco antiepiléptico aromático, en los humanos se usa principalmente en el campo de la neurología y psiquiatría. Existen eventos adversos (EA), secundarios al uso de anticonvulsivantes, por ejemplo, la necrólisis epidérmica tóxica (NET), y el síndrome de Steven Johnson (SSJ), su incidencia está estimada en 1 de 1000 a 10000 exposiciones con una mortalidad mayor al 35 %. Objetivo: Describir la relación entre la presentación de eventos adversos y los polimorfismos de la UGT y HLA en pacientes que usaron lamotrigina. Metodología: Se realizó una revisión sistemática de la literatura, incluyendo una búsqueda en las bases de datos, con estudios del tipo ensayos clínicos controlados aleatorizados y estudios observacionales de cohortes, casos y controles. Resultados: La búsqueda inicial encontró un total de 96 artículos, de los cuales luego de aplicar los criterios de inclusión y exclusión quedaron 8. Conclusiones: Al momento del desarrollo de este estudio, no hay suficiente evidencia que relacione como factor de causalidad las variantes de las HLA y UGT con la predicción de los eventos adversos (EA), con el uso de lamotrigina. Además, es importante decir que en Colombia no tenemos estudios, y que no conocemos estas variantes genéticas por lo tanto la extrapolación no se puede realizar, llevando a recomendar que se deben hacer estudios en población colombiana con las variantes planteadas como posibles relacionadas con los EA a lamotrigina.

Introduction: Lamotrigine (LTG) is an aromatic antiepileptic drug, mainly used in humans in the field of neurology and psychiatry. There are secondary adverse events (AEs) related to the use of anticonvulsants, for example, toxic epidermal necrolysis (TEN) and Steven Johnson syndrome (SJS). Their incidence is estimated at 1 in 1,000 to 10,000 exposures with a mortality greater than 35%. Objective: To describe the relationship between the presentation of adverse events and UGT and HLA polymorphisms in patients who used lamotrigine. Methodology: A systematic review of the literature was carried out, including a database search, with studies such as randomized controlled clinical trials and observational cohort and case-control studies. Results: The initial search found a total of 96 articles. After applying the inclusion and exclusion criteria, only 8 were considered. Conclusions: At the time of the development of this study, there was not enough evidence to relate HLA and UGT variants as a causal factor to predict adverse events (AEs) due to the use of lamotrigine. Furthermore, it is important to say that in Colombia there are no studies, and that we do not know these genetic variants, therefore it is not possible to extrapolate it. Thus the recommendation is that studies should be carried out in the Colombian population using variants proposed as possibly relating AEs. to lamotrigine.

Detección de eventos adversos en pacientes internados en clínica médica utilizando la herramienta Global Trigger Tool / Detection of adverse events in patients interned in medical clinic using the Global Trigger Tool

Resumen Introducción : El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos : Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados : Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días pa ciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% com plicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadís ticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparado res. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con cur vas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión : Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con cur vas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

Abstract Introduction : The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. Methods : Cross-sectional study based on retrospec tive review of randomized medical records using the GTT tool. Results : A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant asso ciation with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). Discussion : The number of events per 100 admis sions was higher than that reported in the literature, but there were no differences in events per 1000 patient-days. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

Eventos adversos em crianças submetidas a cirurgias orofaciais / Adverse events in children submitted to orofacial surgery / Eventos adversos en niños sometidos a cirugía orofacial

Objetivo: Identificar os eventos adversos no pós-operatório imediato de queiloplastia e/ou palatoplastia em crianças e comparar os eventos identificados aos notificados ao Núcleo de Segurança do Paciente. Métodos: Estudo descritivo, retrospectivo e quantitativo, realizado em um hospital público e terciário brasileiro. Os dados foram coletados por meio da descrição nos registros de enfermagem e comparados aos notificados ao Núcleo de Segurança do Paciente, referente a junho e dezembro de 2019. Os resultados foram submetidos a análise estatística descritiva. Resultados: A amostra constou de 203 crianças, das quais 51% (n=103) apresentaram evento adverso. Foram identificados 176 eventos adversos, de 8 tipos, com prevalência da laringite pós-extubação (n=50; 28%), edema de língua (n=34; 19%) e lesão de comissura labial (n=25; 14%). Destes, apenas 5% (n=9) foram notificados ao Núcleo de Segurança do Paciente. Conclusão: Os eventos adversos prevalentes se relacionaram a cavidade oral e tecidos adjacentes, e a subnotificação foi expressiva. (AU)

Objective: To identify adverse events in the immediate postoperative period of cheiloplasty and/or palatoplasty in children and compare the identified events to those notified to the Patient Safety Center. Methods: Descriptive, retrospective and quantitative study, carried out in a Brazilian public and tertiary hospital. Data were collected through descriptions in nursing records and compared to those notified to the Patient Safety Center, referring to June and December 2019. The results were subjected to descriptive statistical analysis. Results: The sample consisted of 203 children, of which 51% (n=103) had an adverse event. A total of 176 adverse events of 8 types were identified, with prevalence of post-extubation laryngitis (n=50; 28%), tongue edema (n=34; 19%) and labral commissure lesion (n=25; 14%). Of these, only 5% (n=9) were notified to the Patient Safety Center. Conclusion: The prevalent adverse events were related to the oral cavity and adjacent tissues, and underreporting was significant. (AU)

Objetivo: Identificar eventos adversos en el postoperatorio inmediato de queiloplastia y/o palatoplastia en niños y comparar los eventos identificados con los notificados al Centro de Seguridad del Paciente. Métodos: Estudio descriptivo, retrospectivo y cuantitativo, realizado en un hospital público y terciario brasileño. Los datos se recolectaron mediante descripciones en registros de enfermería y se compararon con los notificados al Centro de Seguridad del Paciente, referidos a junio y diciembre de 2019. Los resultados fueron sometidos a análisis estadístico descriptivo. Resultados: La muestra estuvo conformada por 203 niños, de los cuales el 51% (n = 103) tuvo un evento adverso. Se identificaron un total de 176 eventos adversos de 8 tipos, con prevalencia de laringitis posextubación (n=50; 28%), edema de lengua (n=34; 19%) y lesión de la comisura del labrum (n=25; 14%). De estos, solo el 5% (n=9) fueron notificados al Centro de Seguridad del Paciente. Conclusion: Los eventos adversos prevalentes se relacionaron con la cavidad bucal y los tejidos adyacentes y el subregistro fue significativo. (AU)

Granulomatous Reaction in a Patient With Metastatic Melanoma Treated With Ipilimumab: First Case Reported With Isolated Cutaneous Findings. / Reacción granulomatosa en paciente con melanoma metastásico tratado con ipilimumab: primer caso descrito presentando clínica cutánea únicamente.

Granulomatous sarcoidosis-like reactions affecting multiple organ systems at one time have infrequently been described within weeks to months after initiation of Ipilimumab. We present the first case of a 67-year-old man with isolated cutaneous granulomatous reaction involving the trunk, extremities, and face after eighteen months of treatment with ipilimumab for metastatic melanoma. This case documents the eruption of isolated cutaneous granulomatous reaction as a late treatment-related adverse effect of ipilimumab, highlighting the importance of adequate, prolonged follow-up.

Reacciones adversas medicamentosas en ancianos de Matanzas, Cuba 2014-2019 / Adverse drug reactions in the elderly of Matanzas, Cuba 2014-2019

Resumen Objetivo: Caracterizar las sospechas de reacciones adversas a medicamentos que se presentaron en los adultos mayores en Matanzas, en el periodo 2014 al 2019. Materiales y Método: Estudio de serie de casos en Farmacovigilancia (FV). Se revisó la base de datos de reportes de sospecha de reacciones adversas a los medicamentos de la Unidad Coordinadora Provincial de Farmacovigilancia, entre 2014 y 2019. Resultados: Se evaluaron un total de 1926 reportes de reacciones adversas por medicamentos en ancianos, representaron el 24,3 % del total. Predominaron las mujeres (56,7 %) y el grupo de edad entre 60 y 69 años (51,4%). Prevaleció la erupción cutánea (13,4 %). Los antimicrobianos y los antiinflamatorios no esteroideos, fueron los que se asociaron más con las RAM en piel, así como del sistema digestivo. La tos estuvo relacionada con el captopril. Predominaron las reacciones adversas por medicamentos de baja frecuencia (55,2%), moderadas (83,8%) y las probables (77,1%) según imputabilidad. Conclusiones: El perfil de seguridad en ancianos en la provincia de Matanzas muestra un predominio de reacciones adversas frecuentes, moderadas y probables en mujeres con edades entre 60 a 69 años. Los antimicrobianos, los inhibidores de la enzima convertidora de angiotensina y los antiinflamatorios no esteroideos fueron los fármacos más notificados por los médicos y farmacéuticos produciendo síntomas a nivel del sistema digestivo y la piel.

Abstract Objective: To characterize suspected adverse drug reactions that occurred in older adults in Matanzas, from 2014 to 2019. Materials and methods: Pharmacovigilance (FV) case series study. The database of reports of suspected adverse drug reactions of the Provincial Pharmacovigilance Coordinating Unit, between 2014 and 2019, was reviewed. Results: A total of 1926 reports of adverse drug reactions in the elderly were evaluated, representing 24, 3% of the total. Women (56.7%) and the age group between 60 and 69 years (51.4%) predominated. Skin rash prevailed (13.4%). Antimicrobials and non-steroidal anti-inflammatory drugs were the ones most associated with ADRs in the skin, as well as in the digestive system. Cough was related to captopril. Adverse drug reactions of low frequency (55.2%), moderate (83.8%) and probable (77.1%) prevailed according to immutability. Conclusions: The safety profile in the elderly in the province of Matanzas shows a predominance of frequent, moderate and probable adverse reactions in women aged between 60 and 69 years. Antimicrobials, angiotensin-converting enzyme inhibitors and non- steroidal anti-inflammatory drugs were the drugs most reported by doctors and pharmacists, producing symptoms at the level of the digestive system and the skin.