RESUMEN

Adverse events (AEs), and particularly adverse drug events (ADEs), represent a health problem as they can cause permanent damage or death. Understanding the frequency, location, and causes of ADEs can prevent harm to patients. The Global Trigger Tool, produced by the Institute for Healthcare Improvement (GTT/IHI), is widely used to identify AEs. Recognizing the profile of patients who suffer ADEs can reveal clinical or individual characteristics that predispose to the occurrence of AEs. A cross-sectional study was carried out through a retrospective analysis of 120 medical charts of patients discharged from hospital between October 2020 and April 2021. Patients over 18 years old, with a length of stay of more than 24 h, were included. The list of triggers used was from the medication module of the GTT/IHI, which was adapted for use in the institution. Two primary reviewers and a medical reviewer applied this tool. The primary reviewers independently assessed the randomized charts. A meeting to achieve consensus among the reviewers was held every 2 weeks to validate the identified ADEs; classifications were based on harm severity. Multivariate logistic regression was utilized to assess the variables that predicted the occurrence of ADEs, using the backward stepwise method. A total of 43 ADEs were identified, with a frequency of 36 per 100 admissions (43/120). Of these, five ADEs (12%) were responsible for patients being admitted to hospital. In the case of in-hospital ADEs, there were 42.2 per 1000 patients/day. The clinical manifestation of altered kidney function (16%) and the anatomical drug group of the nervous system (33%) were the most frequent ADEs. The multivariate logistic regression model was significant (×2 = 44.960, P < .001), indicating that factors such as: known drug allergy [odds ratio 5.728; 95% confidence interval (CI): 1.249, 26.274, P = .025]; being clinically hospitalized (odds ratio 7.504; 95% CI: 1.654, 34.037; P = .009); number of medicines used (odds ratio 1.100; 95% CI: 1.054, 1.148; P < .001); and being under the care of internal medicine (odds ratio 3.633; 95% CI: 1.257, 10.511; P = .017) were predictor variables associated with the occurrence of ADEs. A significant percentage of hospitalized patients experienced at least one ADE, with rates surpassing those found in similar studies. The GTT/IHI effectively assessed medication-related harm, emphasizing the need for tailored triggers based on population characteristics. Predictor variables can inform preventive strategies. Overall, the tool facilitated a localized risk assessment of medication use.

Asunto(s)

RESUMEN

BACKGROUND: One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer. OBJECTIVE: We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention. METHODS: This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the χ2 test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies. RESULTS: The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025. CONCLUSIONS: Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60828.

Asunto(s)

RESUMEN

AIMS: This systematic review aimed to investigate the occurrence of moderate and severe adverse drug reactions (ADRs) to antimicrobials among hospitalized children. METHODS: The PubMed/Medline, Cochrane Library, Embase, Web of Science, Scopus, Lilacs and CINAHL databases were searched in April 2023 to systematically review the published data describing the characteristics of moderate and severe ADRs to antimicrobials among hospitalized children. The search was carried out without date restrictions, up to the search date (April, 2023). RESULTS: At the end of the selection process, 30 articles met the inclusion criteria. Cutaneous reactions were the primary serious clinical manifestations in most articles (19/30), followed by erythema multiforme (71 cases), Stevens-Johnson syndrome (72 cases), and toxic epidermal necrolysis (22 cases). The main antimicrobials involved in moderate and severe ADRs were penicillins, cephalosporins and sulfonamides. Regarding the primary outcomes, 30% (9/30) of the articles reported deaths, and 46.7% (14/30) of studies reported increased lengths of hospital stay, need for intensive care, and transfer to another hospital. Regarding the main interventions, 10% (3/30) of the articles mentioned greater monitoring, suspension, medication substitution or prescription of specific medications for the symptomatology. CONCLUSIONS: The findings of this review could be used to identify areas for improvement and help health professionals and policymakers develop strategies. In addition, we emphasize the importance of knowing about ADRs so that there is adequate management to avoid undesirable consequences.

Asunto(s)

RESUMEN

INTRODUCTION: Prescription is the node of medication management and use that most frequently presents medication errors, according to various studies. This study aims to analyze prescriptions before and after the incorporation of a multidisciplinary round in the pediatric intensive care area and its implication in the occurrence of adverse drug events. METHODS: This is an uncontrolled before and after study. RESULTS: 100 patients were studied before and 100 after, range 1-17 years, mean age: 6.4 SD: 8.7. 55.5% (n = 111) were men. A prescription error was detected before the intervention of 12% (n = 12) and after 0% of the intervention, 0%, p = 0.001. A total of 45 adverse events were detected, that is, 45 adverse events per 100 admissions and 38, that is, 38 events per 100 admissions, before and after the intervention respectively (p > 0.05). CONCLUSION: The intervention was useful to reduce prescription error in this sample of patients.

Introducción: La prescripción es el nodo del manejo y uso de medicamentos que con mayor frecuencia presenta errores de medicación, según diversos estudios. Este estudio tiene como objetivo analizar las prescripciones antes y después de la incorporación de una ronda multidisciplinar en el área de cuidados intensivos pediátricos y su implicación en la ocurrencia de eventos adversos por medicamentos. Métodos: Se trata de un estudio antes y después, no controlado. Resultados: Se estudiaron 100 pacientes antes y 100 después, rango 1-17 años, edad media: 6.4 DE: 8.7. El 55.5% (n = 111) eran varones. Se detectó un error de prescripción antes de la intervención del 12% (n = 12) y después de intervención, del 0%, p = 0.001. Se detectó un total de 45 eventos adversos por 100 ingresos y 38 eventos por 100 ingresos, antes y después de la intervención respectivamente (p > 0.05). Conclusión: La intervención fue útil para disminuir el error de prescripción en esta muestra de pacientes.

Asunto(s)

RESUMEN

OBJECTIVE: To assess regional and national mortality and years of life lost (YLL) related to adverse drug events in Brazil. METHODS: This is an ecological study in which death records from 2009 to 2018 from the Mortality Information System were analyzed. Codes from the International Classification of Diseases 10th revision (ICD-10) that indicated drugs as the cause of death were identified. The number of deaths and the YLL due to adverse drug events were obtained. Crude, age- and gender-specific, and age-adjusted mortality rates and YLL rates per 100,000 inhabitants were formed by year, age group, gender, and Brazilian Federative Unit. Rate ratios were calculated by comparing rates from 2009 to 2018. A joinpoint regression model was applied for temporal analysis. RESULTS: For the selected ICD-10 codes, a total of 95,231 deaths and 2,843,413 YLL were recorded. Mortality rates from adverse drug events increased by a mean of 2.5% per year, and YLL rates increased by 3.7%. Increases in rates were observed in almost all age groups for both genders. Variations in rates were found between Federative Units, with the highest age-adjusted mortality and YLL rates occurring in the Distrito Federal. CONCLUSIONS: The numbers and rates of deaths and YLL increased during the study period, and variations in rates of deaths and YLL were observed between Brazilian Federative Units. Information on multiple causes of death from death certificates can be useful for quantifying adverse drug events and analyzing them geographically, by age and by gender.

Asunto(s)

RESUMEN

OBJECTIVE: To determine prevalence, causes and risk factors of ADE in hospitalized patients. METHODS: Analytical, observational, case-control study of patients with ADE. For statistical analysis, the following were calculated: percentages, frequencies, averages; odds ratio, χ2 test and multiple binary logistic regression. Data analysis was carried out with the Statistical Package, for the Social Sciences 23 program. RESULTS: A 132 patients were registered: 66 cases (26 EM and 40 RAM) and 66 controls; with average age of 35 years (SD 17.41). The prevalence of adverse drug events was 3.6%. The most frequently reported medications: antibiotics and anti-inflammatories. The frequency of adverse events by gender was: 39.3% men and 60.7% women. The services with the greatest patient care: emergencies, surgery; the most frequent route of administration: intravenous (32.3%). The main symptoms: skin. (32.3%) frequent symptoms: cutaneous. Associated symptoms RAM: type A pruritus (OR: 8.5; p = 0.001; IC95%: 0.035-0.393), type B pruritus (OR: 11; p = 0.001; CI95%: 0.021-0.368) urticaria (OR: 19; p = 0.005; IC95%: 0.007-0.412). Risk factors Associated EAM: female (OR: 2.6; p = 0.05; CI95%: 1.33-5.43), history of allergy (OR: 3.4; p = 0.033; CI95%: 1.04-8.40), prolonged hospital stays (OR: 5.4; p = 0.023; IC95%: 3.82-6.74). CONCLUSIONS: Patient safety is a priority when prescribing any drug, which represents a key point in prevention.

OBJETIVO: Determinar la prevalencia, causas y factores de riesgo asociados con eventos adversos a medicamentos en pacientes hospitalizados. MÉTODOS: Estudio de casos y controles, observacional, analítico, llevado a cabo en pacientes con eventos adversos a medicamentos. Para el análisis estadístico se calcularon: porcentajes, frecuencias, promedios; razón de momios, prueba de χ2 y regresión logística binaria múltiple. El análisis de los datos se efectuó con el programa Statistical Package, for the Social Sciencies 23. RESULTADOS: Se registraron 132 pacientes: 66 casos (26 EM y 40 RAM) y 66 controles, con edad promedio de 35 años (DS 17.41). La prevalencia de eventos adversos a medicamentos fue del 3.6%. Los medicamentos reportados con mayor frecuencia: antibióticos y antiinflamatorios. La frecuencia de eventos adversos por género fue: 39.3% hombres y 60.7% mujeres. Los servicios con mayor atención de pacientes: urgencias y cirugía; vía de administración más frecuente: intravenosa (32.3%). Los principales síntomas fueron los cutáneos. Los síntomas asociados con reacción adversa a medicamentos: prurito tipo A (RM: 8.5; p = 0.001; IC95%: 0.035-0.393), prurito tipo B (RM: 11; p = 0.001; IC95%: 0.021-0.368) urticaria (RM: 19; p = 0.005; IC95%: 0.007-0.412). Los factores de riesgo asociados con eventos adversos a medicamentos: mujer (RM: 2.6; p = 0.05; IC95%: 1.33-5.43), antecedente de alergia (RM: 3.4 p = 0.033; (IC95%: 1.04-8.40) y estancia hospitalaria prolongada (RM: 5.4; p = 0.023; IC95%: 3.82-6.74). CONCLUSIONES: La seguridad de los pacientes es una prioridad al momento de prescribir cualquier fármaco, lo que representa un punto clave en la prevención.

Asunto(s)

RESUMEN

AIMS: Neonates hospitalized in neonatal intensive care units (NICUs) commonly experience adverse drug reactions (ADRs). Thus, we aimed to develop and validate a tool for predicting ADRs in neonates hospitalized in NICUs. METHODS: A nested case-control study in an open cohort with neonates admitted to the NICU of a maternity hospital in Natal, Brazil was conducted from January 2019 to January 2022 [Correction added on 4 December 2023, after first online publication: 2023 has been changed to 2019 in the preceding sentence.]. Neonates with ADR were randomly paired with 2 controls. For the development of the tool, a multivariate logistic regression was applied on 2/3 of the sample (cases with respective controls). The model's fit was evaluated using the Hosmer-Lemeshow test for calibration and the Brier score for performance assessment. Validation of the tool was performed by determining the area under the receiver operating characteristic curve with bootstrap adjusted c-statistics. RESULTS: In all, 450 neonates (150 cases and 300 controls) were included in the study. We identified 5 independent risk factors for ADR, 4 related to the neonate (current mechanical ventilation, heart rate ≥178 beats/min, intravenous medications, ≥5 prescription medications) and 1 to the mother (gestational hypertension). The tool had a classification cut-off point of ≥15, and its total score ranged from 0 to 34. In validation, the tool had an area under the receiver operating characteristic curve of 0.74 (95% confidence interval [CI] 0.66-0.81) with sensitivity of 52.02% (95% CI 47.40-56.64) and specificity of 81.35% (95% CI 77.75-84.95). CONCLUSION: The tool demonstrated adequate discriminative ability and utilized 5 commonly monitored variables in the NICU.

Asunto(s)

RESUMEN

The use of triggers for the active search and detection of adverse drug events (ADEs) has been gaining ground within pharmacovigilance services. Thus, the main objective of the study was to propose a new list of triggers to be used in a center specialized in hematology in Rio de Janeiro, Brazil. The update of the list of triggers consisted of revising the current list, with the exclusion and inclusion of new triggers. To verify the performance of the new list of triggers, a cross-sectional study was conducted in which the new triggers were used to investigate the occurrence of ADEs in patients attended in the emergency unit or hospitalized from January to March 2022. For each suspected ADEs, the patient's profile and adverse drug reactions (ADRs) were characterized regarding causality and severity. The performance of the triggers and their ability to capture ADEs were estimated using the following indicators: frequency of the trigger per 100 medical records, frequency of ADEs per 100 records, and positive predictive value (PPV). To evaluate the overall performance of the proposed new list, the PPV was estimated. A total of 374 prescriptions for triggers were identified in 186 medical records. The most efficient in the detection of possible ADEs were: lidocaine, loperamide, bisacodyl, filgrastim and glycerin clyster. The overall PPV of the new suggested list was 48% versus 10% of the previous list. This study demonstrated the importance of an updated list of triggers for the monitoring of ADEs and improvement of the care provided.

A utilização de rastreadores para a busca ativa e detecção de eventos adversos a medicamentos (EAM) tem ganhado espaço nos serviços de farmacovigilância. Assim, o objetivo principal do estudo foi propor uma nova lista de rastreadores para ser empregada em um centro especializado em hematologia do Rio de Janeiro, Brasil. A atualização da lista de rastreadores consistiu na revisão da lista atual, com a exclusão e inclusão de rastreadores. Para verificar o desempenho da nova lista de rastreadores, realizou-se um estudo transversal em que os novos rastreadores foram utilizados para investigar a ocorrência de EAM em pacientes atendidos na emergência ou hospitalizados no período de janeiro a março de 2022. Para cada suspeita de EAM identificada, caracterizaram-se o perfil do paciente e as reações adversas a medicamentos (RAM) quanto à causalidade e gravidade. O desempenho dos rastreadores e sua capacidade de captação de EAM foram calculados por meio dos indicadores: frequência do rastreador por 100 prontuários, frequência de EAM por 100 prontuários e valor preditivo positivo (VPP). Para avaliar o desempenho global da nova lista proposta, calculou-se o VPP. Foram identificadas 374 prescrições de rastreadores em 186 prontuários. Os mais eficientes na detecção de possíveis EAM foram: lidocaína, loperamida, bisacodil, filgrastim e clister de glicerina. O VPP global da nova lista sugerida foi 48% contra 10% da lista anterior. Este estudo demonstrou a importância de uma lista de rastreadores atualizada para o monitoramento dos EAM e o aprimoramento da assistência prestada.

El uso de rastreadores en la búsqueda y detección activa de eventos adversos de medicamentos (EAM) viene ganando espacio dentro de los servicios de farmacovigilancia. Por lo tanto, el objetivo principal de este estudio fue proponer una nueva lista de rastreadores que se utilizarán en un centro de hematología especializado en Río de Janeiro, Brasil. La actualización de la lista de rastreadores consistió en la revisión de la lista actual, con la exclusión e inclusión de rastreadores. Para verificar el desempeño de la nueva lista de rastreadores, se realizó un estudio transversal en el que se utilizaron los nuevos rastreadores para investigar la aparición de EAM en pacientes atendidos en urgencias u hospitalizados en el periodo de enero a marzo de 2022. Para cada sospecha de EAM identificados, el perfil del paciente y las reacciones adversas a medicamentos (RAM) se caracterizaron por su causalidad y gravedad. El desempeño de los rastreadores y su capacidad para capturar EAM se calcularon mediante los indicadores: frecuencia del rastreador por cada 100 registros médicos, frecuencia de EAM por cada 100 registros médicos y valor predictivo positivo (VPP). Para evaluar el desempeño general de la nueva lista propuesta, se calculó el VPP. Se identificaron 374 recetas de rastreadores en 186 registros médicos. Los más eficientes en la detección de posibles EAM fueron lidocaína, loperamida, bisacodilo, filgrastim y enema de glicerina. El VPP general de la nueva lista sugerida fue del 48% frente al 10% de la lista anterior. Este estudio demostró la importancia de una lista actualizada de rastreadores para monitorear EAM y mejorar la atención brindada.

Asunto(s)

RESUMEN

OBJECTIVE: To determine prevalence, causes and risk factors of ADE in hospitalized patients of a General Hospital. METHODS: Observational and analytical case-control study, carried out in patients hospitalized for adverse drug events, treated at the Hospital General Dr. Eduardo Vázquez N, in Puebla, Mexico, between, June 2019 to June 2021. For the statistical analysis, percentages, frequencies, means, odds ratio, χ2, and multiple binary logistic regression were used. Data were analyzed using the Statistical Package for the Social Sciences 23 program. RESULTS: A total of 132 patients (66 cases and 66 controls) were registered. Of the group of cases, 26 patients treated for medication error and 40 with adverse drug reaction were reported. The prevalence of adverse drug events was 3.6%. The drugs and factors associated with the most reported adverse events were: antibiotics, anti-inflammatories; average age of 35 years (SD: 17.41); gender: 39.3% men, 60.7% women; services re-ported with the greatest attention: Emergencies and Surgery; frequent route of administration: intravenous (32.3%); main symptoms: skin; symptoms associated with adverse drug reactions: type A pruritus [OR: 8.5, p = 0.001(CI95%: 0.035-0.393)], type B pruritus [OR: 11, p = 0.001 (CI95%: 0.021-0.368)]; urticaria [OR: 19, p = 0.005(CI95%: 0.007-0.412)]. Risk factors associated with adverse events were: female gender [OR: 2.6, p = 0.05 (CI95%: 1.33-5.43)], history of allergy [OR: 3.4, p = 0.033 (CI95%: 1.04-8.40)] and prolonged hospital stay [OR: 5.4, p = 0.023 (CI95%: 3.82-6.74)]. CONCLUSIONS: The majority of ADEs were EM or ADR type A, both preventable reactions, so patient safety should be a priority when prescribing.

OBJECTIVO: Determinar la prevalencia, causas y factores de riesgo en pacientes hospitalizados por eventos ad-versos a medicamentos. MÉTODOS: Estudio de casos y controles, observacional y analítico, llevado a cabo en pacientes hospitalizados por eventos adversos a medicamentos, atendidos en el Hospital General Dr. Eduardo Vázquez N, Puebla, México, entre junio de 2019 y junio de 2021. Para el análisis estadístico se utilizaron porcentajes, frecuencias, promedios, razón de momios, χ2 y regresión logística binaria múltiple. Los datos se analizaron con el programa Statistical Package, for the Social Sciencies 23. RESULTADOS: Se registraron 132 pacientes (66 casos y 66 controles). Del grupo de casos se informaron 26 pacientes atendidos por error de medicación y 40 con reacción adversa a medicamentos. La prevalencia de eventos adversos a medicamentos fue del 3.6%. Los medicamentos y factores asociados con eventos adversos más reportados fueron: antibióticos, antiinflamatorios; edad promedio de 35años (DE: 17.41); sexo: 39.3% hombres, 60.7% mujeres; servicios reportados con mayor atención: Urgencias y Cirugía; vía administración frecuente: intravenosa (32.3%); síntomas principales: cutáneos; síntomas asociados con reacciones adversas a medicamentos: tipo A prurito [RM: 8.5, p = 0.001(IC95%: 0.035-0.393)], tipo B prurito [RM:11, p = 0.001 (IC95%: 0.021-0.368)]; urticaria [RM: 19, p = 0.005(IC95%: 0.007-0.412)]. Los factores riesgo asociados con eventos adversos fueron: género femenino [RM: 2.6, p = 0.05 (IC95%: 1.33-5.43)], antecedente de alergia [RM: 3.4, p = 0.033 (IC95%: 1.04-8.40)] y estancia intrahospitalaria prolongada [RM: 5.4, p = 0.023 (IC95%: 3.82-6.74)]. CONCLUSIONES: La mayor parte de los eventos adversos a medicamentos se originan por errores de medicación o reacciones adversas a fármacos tipo A; sin embargo, ambos pueden prevenirse. La seguridad del paciente debe ser prioridad al momento de prescribir cualquier tipo de medicamento.

Asunto(s)

RESUMEN

OBJECTIVE: Although adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal intensive care unit (NICU), identifying causative drugs, temporal profile and associated factors. DESIGN: Prospective observational study. SETTING: NICU of a public maternity hospital in Natal/Brazil. PARTICIPANTS: All neonates admitted to the NICU for more than 24 hours and using at least one medication were followed up during the time of hospitalisation. PRIMARY OUTCOME MEASURES: Incidence rate and risk factors for ADRs. The ADRs were detected by an active search in electronic medical records and analysis of spontaneous reports in the hospital pharmacovigilance system. RESULTS: Six hundred neonates were included in the study, where 118 neonates had a total of 186 ADRs. The prevalence of ADRs at the NICU was 19.7% (95% CI 16.7% to 23.0%). The most common ADRs were tachycardia (30.6%), polyuria (9.1%) and hypokalaemia (8.6%). Tachycardia (peak incidence rate: 57.1 ADR/1000 neonates) and hyperthermia (19.1 ADR/1000 neonates) predominated during the first 5 days of hospitalisation. The incidence rate of polyuria and hypokalaemia increased markedly after the 20th day, with both reaching a peak of 120.0 ADR/1000 neonates. Longer hospitalisation time (OR 0.018, 95% CI 0.007 to 0.029; p<0.01) and number of prescribed drugs (OR 0.127, 95% CI 0.075 to 0.178; p<0.01) were factors associated with ADRs. CONCLUSION: ADRs are very common in NICU, with tachycardia and hyperthermia predominant in the first week of hospitalisation and polyuria and hypokalaemia from the third week onwards.

Asunto(s)

RESUMEN

INTRODUCTION: Adverse drug reactions (ADRs) to antiseizure therapy can worsen the quality of life, reduce adherence, and potentially lead to treatment discontinuation and uncontrolled seizures. OBJECTIVES: The aim of the study was to develop a prognostic model for ADRs to antiseizure therapy in adult patients with epilepsy from Colombia. METHODS: This case-control study included adult patients with epilepsy, who were separated into two groups: one group with ADRs to antiseizure therapy (cases), as determined by a complete evaluation conducted by an epileptologist, and another group without ADRs (controls). Variables were analyzed to identify statistical differences between the two groups and were then selected to construct a prognostic model using logistic regression. The Bonferroni method was applied for multiple comparisons. RESULTS: Three hundred fifty-four patients with epilepsy were studied. One hundred and fifty (42%) patients had ADRs and 204 (57%) patients did not have ADs. A total of 362 ADRs were reported, with a third of them being general symptoms and most frequently occurring with older-generation antiseizure drugs (58%). Female sex, drug-resistant epilepsy, LEV, and CZP were risk factors, whereras the presence of tumoral etiology, absence of seizure triggers, and VPA were identified as protective factors. A prognostic model was constructed using previously reported risk factors for ADRs to antiseizure therapy and other variables available in this population study. In the multivariable analysis, the number of previously used antiseizure drugs (1, 2, or ≥3), TPM, CZP, LEV, PHT, and female sex were predictors of ADRs. The corrected p-values were estimated by the Bonferroni method; however, not all the variables achieved statistical significance with this adjustment. CONCLUSIONS: In adult patients with epilepsy from Colombia, we found that the number of previously used antiseizure drugs, TPM, CZP, LEV, PHT, and female sex were predictive factors for ADRs to antiseizure therapy.

Asunto(s)

RESUMEN

OBJETIVO: El propósito de este trabajo es estudiar la prevalencia de eventos adversos medicamentosos (EAM) en pacientes hospitalizados durante el período 2019-2020 en Chile. Además, como parte de la investigación, se realizó una validación del método que etiqueta la ocurrencia de EAM en base a los diagnósticos de egreso de los casos analizados. Diseño: La prevalencia de EAM fue estudiada para cerca de 1,7 millones de pacientes, para los cuales se analizó, además de los diagnósticos CIE10 de egreso, información sociodemográfica e indicadores de resultado sanitario de la atención, tales como el peso GRD, largo de estadía y mortalidad. Para la validación del método de identificación de EAM, se seleccionó una muestra aleatoria representativa estratificada por sexo y especialidad médica del año 2019 en un hospital público de Chile, cuyos resúmenes de egreso fueron analizados por un grupo de expertos de forma retrospectiva. Resultados: Los resultados muestran una prevalencia de EAM u otras sustancias de 2,7% y 3,1% en los egresos hospitalarios de los años 2019 y 2020 a nivel nacional y una precisión del instrumento de al menos un 83,3% (IC 90%). Conclusiones: Este estudio permite describir un fenómeno por medio de la estimación basada en datos reales, el cual es esencial para el diseño de políticas públicas en salud y estudios que apunten a enriquecer la calidad y seguridad del paciente.

OBJETIVE: To study the prevalence of adverse drug events (ADE) in hospitalized patients in Chile. As part of our research, we also assessed the validity of the method used to identify the occurrence of an ADE based on the discharge diagnoses of the patient. Design: The study included 1,7 million patients hospitalized during 2019-2020. We analyzed the following variables for each patient: ICD-10 discharge diagnoses, sociodemographic information, and clinical outcome indicators, i.e., diagnosis-related group (DRG) weight, length of stay, and mortality. To validate the method for the identification of ADEs, first, we generated a random representative sample of patients, stratified by sex and medical specialty, hospitalized in a Chilean public hospital in 2019, and then we compared the outcome of the method with the opinion of a group of clinical experts that reviewed each patient's discharge summary retrospectively. Results: The prevalence of ADEs in hospitalized patients in Chile during 2019 and 2020 was 2,7% and 3,1%, respectively. The precision of the method used to identify ADEs was 83,3% or higher (CI 90%). Conclusions: This paper uses nationwide data to describe the prevalence of ADEs and their correlation with different factors associated with the patient, the patient's disease, and the health service. These studies are essential to designing public health policies that effectively address healthcare quality and patient safety.

Asunto(s)

RESUMEN

BACKGROUND: Adverse drug reactions (ADRs) are of great concern in clinical practice. Pharmacogenetics can identify individuals and groups at increased risk of developing ADRs, enabling treatment adjustments to improve outcomes. The study aimed to determine the prevalence of ADRs related to drugs with pharmacogenetic evidence level 1A in a public hospital in Southern Brazil. RESEARCH DESIGN AND METHODS: ADR information was collected from the pharmaceutical registries from 2017 to 2019. Drugs that have pharmacogenetic evidence level 1A were selected. Public genomic databases were used to estimate the genotypes/phenotypes frequency. RESULTS: During the period, 585 ADRs were spontaneously notified. Most were moderate (76.3%), whereas severe reactions accounted for 33.8%. Additionally, 109 ADRs caused by 41 drugs presented pharmacogenetic evidence level 1A, representing 18.6% of all notified reactions. Depending on the drug-gene pair, up to 35% of individuals from Southern Brazil could be at risk of developing ADRs. CONCLUSIONS: Relevant amount of ADRs were related to drugs with pharmacogenetic recommendations on drug labels and/or guidelines. Genetic information could guide and improve clinical outcomes, decreasing ADR incidence and reducing treatment costs.

Asunto(s)

RESUMEN

INTRODUCTION: Post-marketing data on coronavirus vaccines are limited. This study evaluated adverse reactions reported to a statewide hotline after the administration of a coronavirus disease-2019 (COVID-19) vaccine. METHODS: We collected reports between 1 December 2020 through 30 August 2021 of any individual 12 years of age and older who received an FDA EUA-approved vaccine and experienced an adverse reaction. For each case, we collected vaccine brand, demographics, adverse reaction type, severity, onset of reaction, duration, and outcome. Relative risk analyses were conducted to investigate factors associated with vaccine adverse reactions. RESULTS: 638 adverse drug reaction cases were recorded. The majority identified as female (70.8%) and the median age was 56. Implicated brands were Pfizer BNT162b2 (46.6%), Moderna mRNA-1273 (43.41%), and Janssen Ad26.COV2.S (8.78%). Although the lowest number of cases was with Janssen, this vaccine had the highest incident rate based on reactions per 100,000 doses. Adverse reactions with the highest incidence were systemic reactions (92.7%), injection-site reactions (8.5%), and local non-injection-site reactions (10.4%), with most judged as minor severity. Relative risk was higher for Moderna compared to Pfizer for injection-site non-severe (RR 2.01) and injection-site severe (RR 1.94) reactions. Janssen had a higher risk of headache, dyspnea, and vision changes compared to Pfizer, and a higher risk of headache compared to Moderna. The relative risk for fever, chills, and lymphadenopathy was higher for the second dose than the first dose for all patients. CONCLUSION: This observational study analyzing adverse drug reactions of the COVID-19 vaccine found that most complaints concerned systemic reactions. We found reaction differences among vaccine brands, between first and second doses for some effects, and selected recurrent events. Poison control centers are uniquely positioned to conduct post-marketing surveillance for the new vaccines as they are available 24/7 to the public and are healthcare providers. Further post-marketing studies are essential to provide a holistic safety profile of COVID-19 vaccines.

Asunto(s)

RESUMEN

BACKGROUND: Adverse drug events (ADE) and medication errors (ME) provide large numbers of victims. Older people are more susceptible to these events, due to the continuing search for several chronic degenerative disease treatments. The Third Global Patient Safety Challenge announced the objective of reducing unnecessary polypharmacy, encouraging deprescription, and aiming to ensure the prescription of medications in an appropriate manner, based on the best evidence and taking into account the individual factors of people. OBJECTIVE: To evaluate whether Pharmaceutical Care (PC), when inserted in a geriatric ward and the context of person-centered health care, cooperates with the safety of pharmacotherapy in older individuals in Brazil. METHODS: This is an investigative, single-arm, preliminary study. INCLUSION CRITERIA: individuals aged ≥60 years and admitted to the geriatric ward between August 2019 to January 2020. The PC (with the practice of pharmacotherapeutic follow-up, medication reconciliation, and pharmacotherapy review) was made available to identify ADE and ME, as well as the associated factors and clinical outcomes, were analyzed. RESULTS: 60 participants were included. It was found that, on hospital admission, 93.3% of them were polymedicated and 86.7% had a history of using potentially inappropriate medications (PIM). ADE and ME were detected in 43 individuals (71.7%) and, in total, 115 incidents were identified, with drugs that act on the nervous system associated with them (31.9%). Acceptance of the PC's recommendations reached the rate of 85.2%. Polypharmacy (p=0.03) and the presence of multiple diseases (p=0.03) had an effect on the presentation of ADE and ME. The number of medications in use decreased in the comparison between admission and hospital discharge (p<0.0001). CONCLUSION: This investigative study indicated that ADE and ME are linked to the polypharmacy in use at the beginning of hospitalization. On the other hand, we showed that the PC (inserted in the multidisciplinary team) contributed to the deprescribing of medications at hospital discharge. Therefore, the PC can provide improvements in this scenario.

Asunto(s)

RESUMEN

OBJECTIVE: To study the prevalence of adverse drug events (ADE) in hospitalized patients in Chile. As part of our research, we also assessed the validity of the method used to identify the occurrence of an ADE based on the discharge diagnoses of the patient. DESIGN: The study included 1,7 million patients hospitalized during 2019-2020. We analyzed the following variables for each patient: ICD-10 discharge diagnoses, sociodemographic information, and clinical outcome indicators, i.e., diagnosis-related group (DRG) weight, length of stay, and mortality. To validate the method for the identification of ADEs, first, we generated a random representative sample of patients, stratified by sex and medical specialty, hospitalized in a Chilean public hospital in 2019, and then we compared the outcome of the method with the opinion of a group of clinical experts that reviewed each patient's discharge summary retrospectively. RESULTS: The prevalence of ADEs in hospitalized patients in Chile during 2019 and 2020 was 2,7% and 3,1%, respectively. The precision of the method used to identify ADEs was 83,3% or higher (CI 90%). CONCLUSIONS: This paper uses nationwide data to describe the prevalence of ADEs and their correlation with different factors associated with the patient, the patient's disease, and the health service. These studies are essential to designing public health policies that effectively address healthcare quality and patient safety.

Asunto(s)

RESUMEN

Introduction: Immunosuppressants (ISS) are the most crucial tools used in the therapeutic regimens of transplant recipients. Nevertheless, these drugs are not the only ones adopted by patients; therefore, knowing the possible drug-drug interactions (DDIs) between immunosuppressants and other drugs commonly used in kidney transplant recipients is essential to ensure the effectiveness and safety of treatments. In this way, the objective is analyzing the DDIs between the immunosuppressants and other commonly used medications on kidney transplant adult recipients with active medical records undergoing post-transplant follow-up for 4.4 years (mean). Methods: First, we performed a cross-sectional study based on patients' records, in which the patient's profile and drugs used were examined, and after we analyzed DDIs by the Micromedex Drug Interactions® database. Results: We analyzed 176 patients with a mean age of 47.6(± 12.5); most were male (67.7%), and the majority received a kidney from a deceased donor (81.4%). Patients were exposed to 15.0 (± 5.4) different medicines after the transplantation, and 7.4 (± 4.0) of these medicines were simultaneous. After analyzing the DDIs according to the severity of interaction, documentation quality interaction effect, clinical management and probable interaction mechanism, the most frequent interaction was with tacrolimus, classified as moderate, and the 3 major causes of interaction occurred with azathioprine according to the Micromedex database. The primary medicines involved with immunosuppressant interactions were proton pump inhibitors, ranitidine, domperidone, amlodipine, enalapril, allopurinol, cyclobenzaprine, amitriptyline, fluoxetine, and ciprofloxacin. These DDIs' effects were related to, mainly, increase their immunosuppressant activity. Conclusion: Although the immunosuppressants analyzed lacked many clinical DDIs significance with other medicines, the healthcare team needs to monitor their DDIs' effects to prevent and minimize side effects in transplanted recipients.

Asunto(s)

Asunto(s)

RESUMEN

OBJECTIVE: To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS: Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS: Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS: The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Asunto(s)

RESUMEN

Off-label use of azithromycin, hydroxychloroquine, and ivermectin (the "COVID kit") has been suggested for COVID-19 treatment in Brazil without clinical or scientific evidence of efficacy. These drugs have known adverse drug reactions (ADR). This study aimed to analyze if the sales of drugs in the "COVID kit" are correlated to the reported number of ADR after the COVID-19 pandemic began. Data was obtained from the Brazilian Health Regulatory Agency (Anvisa) website on reported sales and ADRs for azithromycin, hydroxychloroquine, and ivermectin for all Brazilian states. The period from March 2019 to February 2020 (before the pandemic) was compared to that from March 2020 to February 2021 (during the pandemic). Trend adjustment was performed for time series data and cross-correlation analysis to investigate correlation between sales and ADR within the same month (lag 0) and in the following months (lag 1 and lag 2). Spearman's correlation coefficient was used to assess the magnitude of the correlations. After the pandemic onset, sales of all investigated drugs increased significantly (69.75% for azithromycin, 10,856,481.39% for hydroxychloroquine, and 12,291,129.32% for ivermectin). ADR levels of all medications but azithromycin were zero before the pandemic, but increased after its onset. Cross-correlation analysis was significant in lag 1 for all drugs nationwide. Spearman's correlation was moderate for azithromycin and hydroxychloroquine but absent for ivermectin. Data must be interpreted cautiously since no active search for ADR was performed. Our results show that the increased and indiscriminate use of "COVID kit" during the pandemic correlates to an increased occurrence of ADRs.

Asunto(s)