Levetiracetam prescription profile in children younger than 4 years treated at a tertiary care hospital in Chile. / Perfil de prescripción de levetiracetam en niños menores de cuatro años atendidos en un hospital de alta complejidad de Chile.

Introduction. Levetiracetam (LEV) is an antiepileptic drug approved by the Chilean Institute of Public Health as concomitant therapy for epileptic seizures in children older than 4 years of age. However, it is widely prescribed from the neonatal period, which makes it necessary to evaluate its off-label use. Objective. To determine the prescription-indication profile of LEV in the treatment of epileptic seizures in children younger than 4 years in a tertiary care hospital in southern Chile. Population and method. Observational, descriptive, and retrospective study. The medical records of patients who started treatment with LEV between 2014 and 2019 were reviewed, and data on sociodemographic, pharmacological, and clinical variables were collected. The analysis was based on the description of the profile of patients, prescriptions, follow-up, and safety. Results. A total of 68 patients were included: 40 (58.8%) were males, 49 (72.1%) were born at a gestational age ≥ 37 weeks. The main etiology of epilepsy was structural (35.3%); LEV was mostly used in children diagnosed with central nervous system malformation (17.6%), and monotherapy was the prevailing dosage (55.9%). LEV was used for focal seizures in 50% of cases. Five children (7.3%) had psychiatric disorders, classified as probable adverse drug reactions. Conclusion. LEV was used in children with various diagnoses, with a low rate of adverse events. The profile of drug use varied in the different age groups. Future studies are needed to identify effectiveness, especially in newborn infants and patients with refractory epilepsy.

Introducción. El levetiracetam (LEV) es un antiepiléptico aprobado por el Instituto de Salud Pública de Chile como terapia concomitante en crisis epilépticas en niños mayores de cuatro años. Sin embargo, es ampliamente indicado desde el periodo neonatal, lo que hace necesario evaluar su utilización fuera de ficha técnica. Objetivo. Determinar el perfil de prescripción-indicación de LEV en el tratamiento de las crisis epilépticas en menores de cuatro años en un hospital de alta complejidad del sur de Chile. Población y método. Estudio observacional, descriptivo y retrospectivo. Se revisaron las historias clínicas de quienes iniciaron tratamiento con LEV entre 2014 y 2019, y se recopilaron datos sobre variables sociodemográficas, farmacológicas y clínicas. El análisis se basó en la descripción del perfil de los pacientes, prescripción, seguimiento y seguridad. Resultados. Se incluyeron 68 pacientes: 40 (58,8 %) de sexo masculino, 49 (72,1 %) con edad gestacional ≥ 37 semanas. La etiología principal de la epilepsia fue de tipo estructural (35,3 %); el LEV se utilizó principalmente en niños diagnosticados con malformación del sistema nervioso central (17,6 %) y predominó la monoterapia (55,9 %). En el 50 % se usó LEV para crisis focales. Cinco niños (7,3 %) presentaron trastornos de tipo psiquiátrico clasificados como probables reacciones adversas al medicamento. Conclusión. El LEV se utilizó en niños con diferentes diagnósticos con baja frecuencia de eventos adversos. El perfil de utilización varió en los diferentes grupos etarios. Es necesario identificar en futuros estudios la efectividad especialmente en el recién nacido y en epilepsias refractarias.

Adverse events associated with antimicrobial compounds in a general hospital in Chile / Efectos adversos asociados al uso de antibióticos en un hospital general

ABSTRACT Background: Antimicrobial compounds are associated with a wide range of adverse events (AE) and some of them can be potentially preventable. Aim: To characterize AE associated with antimicrobial compounds. Patients and Methods: Retrospective analysis of AEs reported to the National Pharmacological Surveillance System from 2014 to 2017 in a regional hospital. Severity, causality and preventability were analyzed. Results: Sixty events were observed in 56 patients aged 2 months to 96 years. Cases were registered mostly in hospitalized patients. The most frequent AEs were skin disorders (56.7%), followed by hepatobiliary (13.3%), and CNS events (10%). Blood, kidney, respiratory gastrointestinal and immunological disorders were less frequently registered, including cases with anaphylactic shock and Stevens-Johnson syndrome (SJS). Causal analysis indicated a definitive association in 8.3%, probable in 70% and possible in 22%. Skin lesions were mostly associated with beta-lactams, hepatobiliary disorders with antituberculosis drugs and CNS manifestations with carbapenems. Cutaneous, neurological, and hepatobiliary events appeared at a median of 4, 2.5 and 10.5 days after starting the medication, respectively. AEs were managed with withdrawal of the suspected drug (83.3%) and other auxiliary therapies. AEs were categorized as severe in 22% and one case with SJS had a fatal outcome (1.7%). Preventability analysis revealed 25% of potentially avoidable events. Conclusions: Antimicrobial AE involved a wide diversity of compounds, occurred in different hospitalization units, affected patients of a wide age range and attacked different systems or organs. An important fraction was potentially avoidable.

Antecedentes: Los compuestos antimicrobianos están asociados a una amplia gama de eventos adversos (EA) y algunos de ellos pueden ser potencialmente prevenibles. Objetivos: Caracterizar los EA asociados a compuestos antimicrobianos. Pacientes y Métodos: Análisis retrospectivo de EA reportados al Sistema Nacional de Farmacovigilancia desde 2014 la 2017 en un hospital regional. Se incluyó un análisis de gravedad, causalidad y de posible prevención. Resultados: Se observaron 60 eventos en 56 pacientes de 2 meses a 96 años. Los casos se registraron principalmente en pacientes hospitalizados. Los EA más frecuentes fueron los trastornos de la piel (56,7%), seguidos de los hepatobiliares (13,3%) y del sistema nervioso central (10%). Los hematológicos, renales, respiratorios, gastrointestinales e inmunológicos se registraron con menos frecuencia, incluidos casos con shock anafiláctico y síndrome de Stevens-Johnson (SSJ). El análisis de causalidad indicó una asociación definitiva en 8.3%, probable en 70% y posible en 21.7%. Las lesiones cutáneas se asociaron principalmente a betalactámicos, los trastornos hepatobiliares a fármacos antituberculosos y las manifestaciones del SNC a carbapenémicos. Los eventos cutáneos, neurológicos y hepatobiliares se presentaron en una mediana de 4, 2,5 y 10,5 días después de iniciar el medicamento, respectivamente. Los EA se manejaron con el retiro del fármaco sospechoso (83,3%) y otras terapias auxiliares. Los EA se clasificaron como graves (21,7%) y un caso con SSJ tuvo un desenlace fatal (1,7%). Un 25% de los eventos fue potencialmente evitable. Conclusiones: Los resultados de este trabajo revelan que los AE por antimicrobianos involucran una amplia diversidad de compuestos, ocurren en diferentes unidades de hospitalización, afectan a pacientes de un amplio rango de edad y atacan diferentes sistemas u órganos.

Adverse events associated with antimicrobial compounds in a general hospital in Chile.

BACKGROUND: Antimicrobial compounds are associated with a wide range of adverse events (AE) and some of them can be potentially preventable. AIM: To characterize AE associated with antimicrobial compounds. PATIENTS AND METHODS: Retrospective analysis of AEs reported to the National Pharmacological Surveillance System from 2014 to 2017 in a regional hospital. Severity, causality and preventability were analyzed. RESULTS: Sixty events were observed in 56 patients aged 2 months to 96 years. Cases were registered mostly in hospitalized patients. The most frequent AEs were skin disorders (56.7%), followed by hepatobiliary (13.3%), and CNS events (10%). Blood, kidney, respiratory gastrointestinal and immunological disorders were less frequently registered, including cases with anaphylactic shock and Stevens-Johnson syndrome (SJS). Causal analysis indicated a definitive association in 8.3%, probable in 70% and possible in 22%. Skin lesions were mostly associated with beta-lactams, hepatobiliary disorders with antituberculosis drugs and CNS manifestations with carbapenems. Cutaneous, neurological, and hepatobiliary events appeared at a median of 4, 2.5 and 10.5 days after starting the medication, respectively. AEs were managed with withdrawal of the suspected drug (83.3%) and other auxiliary therapies. AEs were categorized as severe in 22% and one case with SJS had a fatal outcome (1.7%). Preventability analysis revealed 25% of potentially avoidable events. CONCLUSIONS: Antimicrobial AE involved a wide diversity of compounds, occurred in different hospitalization units, affected patients of a wide age range and attacked different systems or organs. An important fraction was potentially avoidable.

[Comparison of two methods to assess causality of adverse drug reactions]. / Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009.

BACKGROUND: Assessment of causality is an essential part of pharmacological surveillance. AIM: To compare the causality assessment of suspected adverse drug reactions (ADRs) using algorithms proposed by Karch-Lasagna (K & L) and the World Health Organization (WHO). MATERIAL AND METHODS: All spontaneous reports of suspected ADRs in a pediatric ward of a regional hospital were included. Causality was categorized as definitive, probable, possible, conditional or unlikely. The agreement between K & L and WHO algorithms was assessed using binomial test proportions and kappa coefficients. RESULTS: One hundred thirty reports of ADRs in 126 patients aged 2 to 11 years were analyzed. The suspected medications were antineoplastic drugs in 59% of cases and antimicrobials in 23%. The most common affected system was the skin and appendages in 35%. Using K & L algorithm, causality was categorized as definitive in 10% of cases, probable in 28.5%, possible in 35.4%, conditional in 23.1% and unlikely in 3.0%. Using WHO algorithm, the figures were 2.3, 34.6, 59.2, 2.3 and 1.5%, respectively. The degree of agreement between K & L and WHO algorithms was 32.3% (kappa = 0.004). CONCLUSIONS: K & L attributed a higher level of ADR causality than WHO algorithm.

Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 / Comparison of two methods to assess causality of adverse drug reactions

Background: Assessment of causality is an essential part of pharmacological surveillance. Aim: To compare the causality assessment of suspected adverse drug reactions (ADRs) using algorithms proposed by Karch-Lasagna (K & L) and the World Health Organization (WHO). Material and Methods: All spontaneous reports of suspected ADRs in a pediatric ward of a regional hospital were included. Causality was categorized as definitive, probable, possible, conditional or unlikely. The agreement between K & L and WHO algorithms was assessed using binomial test proportions and kappa coefficients. Results: One hundred thirty reports of ADRs in 126 patients aged 2 to 11 years were analyzed. The suspected medications were antineoplastic drugs in 59% of cases and antimicrobials in 23%. The most common affected system was the skin and appendages in 35%. Using K & L algorithm, causality was categorized as definitive in 10% of cases, probable in 28.5%, possible in 35.4%, conditional in 23.1% and unlikely in 3.0%. Using WHO algorithm, the figures were 2.3, 34.6, 59.2, 2.3 and 1.5%, respectively. The degree of agreement between K & L and WHO algorithms was 32.3% (kappa = 0.004). Conclusions: K & L attributed a higher level of ADR causality than WHO algorithm.