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Reacciones adversas a medicamentos en un hospital pediátrico de alta complejidad: 6 años de experiencia.

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Title: Reacciones adversas a medicamentos en un hospital pediátrico de alta complejidad: 6 años de experiencia.
Alternate Title: Adverse drug reactions in a high-complexity pediatric hospital: a six-year experience.
Authors: Rolland, Maximiliano1,2 maxi.rolland93@gmail.com, Hernández, Rubén2,3, Canales, Paulina1, Gutiérreza, Javiera1
Source: Andes Pediatrica. mar/abr2026, Vol. 97 Issue 2, p212-220. 9p.
Subjects: DRUG side effects, PEDIATRICS, HOSPITALS, MEDICATION safety, PHARMACEUTICAL industry, EPIDEMIOLOGY, CRITICAL care medicine
Abstract (English): Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality in the pediatric population, particularly due to the frequent use of medications in off-label indications. Objective: To characterize the epidemiology of ADRs in a high-complexity pediatric hospital. Patients and Method: A descriptive, observational, and retrospective cohort study was conducted at the Hospital Dr. Exequiel González Cortés (HEGC) between 2018 and 2023. HEGC is a high-complexity, teaching, and self-managed pediatric hospital, and is one of the seven hospitals of the Southern Metropolitan Health Service. It has 168 beds and provides coverage to an estimated pediatric population of 254,000 children. Hospitalized and outpatient patients with reported ADRs were included. Demographic variables, involved drugs, causality (Naranjo algorithm), severity (WHO criteria), and affected physiological systems were analyzed. Results: A total of 787 ADR reports were recorded in 718 patients, with a median age of 8 years. The highest incidence occurred in the Critical Care Unit. The main therapeutic groups involved were antibacterials (18.6%), antineoplastics (18.4%), and psycholeptics (9.7%). The most affected systems were the immune system (35.7%), nervous system (15%), and digestive system (7%). Regarding severity, 63.5% of ADRs were moderate, 26.7% were severe, with no fatal events reported. Conclusion: This study shows that ADRs are frequent in pediatric patients, with a higher incidence in the critical care setting. It highlights the need for improving ADR reporting and developing pharmacovigilance strategies to optimize the safety of drug prescribing in pediatrics. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Las reacciones adversas a medicamentos (RAM) son una causa relevante de morbimortalidad en la población pediátrica, especialmente debido al frecuente uso de fármacos en indicaciones "off-label". Objetivo: Caracterizar la epidemiología de las RAM en un hospital pediátrico de alta complejidad. Pacientes y Método: Estudio observacional, descriptivo y de cohorte retrospectiva en el Hospital Dr. Exequiel González Cortés (HEGC) entre 2018 y 2023. El HEGC es un hospital pediátrico de alta complejidad, docente, autogestionado y forma parte de los siete hospitales del Servicio de Salud Metropolitano Sur (SSMS). Cuenta con 168 camas y brinda cobertura a una población estimada de 254.000 niños. Se incluyeron pacientes hospitalizados y ambulatorios que presentaron reportes de RAM. Se analizaron variables demográficas, fármacos involucrados, causalidad (algoritmo de Naranjo), severidad (criterios OMS) y sistemas fisiológicos afectados. Resultados: Se registraron 787 reportes de RAM en 718 pacientes, con una mediana de edad de 8 años. La mayor incidencia de RAM se observó en la Unidad de Paciente Crítico (UPC). Los principales grupos terapéuticos involucrados fueron antibacterianos (18,6%), antineoplásicos (18,4%) y psicolépticos (9,7%). El sistema más afectado fue el inmune (35,7%), seguido del nervioso (15%) y digestivo (7%). En cuanto a la severidad, un 63,5% de las RAM fueron moderadas, un 26,7% graves y no hubo RAM letales. Conclusión: Este estudio muestra que existe una mayor incidencia de RAM en las unidades de cuidados de pacientes críticos. Destaca la importancia de mejorar la notificación y desarrollar estrategias de farmacovigilancia activa con el fin optimizar la seguridad en la prescripción de medicamentos en niños el inmune (35,7%), seguido del nervioso (15%) y digestivo (7%). En cuanto a la severidad, un 63,5% de las RAM fueron moderadas, un 26,7% graves y no hubo RAM letales. Conclusión: Este estudio muestra que existe una mayor incidencia de RAM en las unidades de cuidados de pacientes críticos. Destaca la importancia de mejorar la notificación y desarrollar estrategias de farmacovigilancia activa con el fin optimizar la seguridad en la prescripción de medicamentos en niños. [ABSTRACT FROM AUTHOR]
Copyright of Andes Pediatrica is the property of Revista Chilena de Pediatria and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Reacciones adversas a medicamentos en un hospital pediátrico de alta complejidad: 6 años de experiencia.
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  Data: Adverse drug reactions in a high-complexity pediatric hospital: a six-year experience.
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  Data: <searchLink fieldCode="AR" term="%22Rolland%2C+Maximiliano%22">Rolland, Maximiliano</searchLink><relatesTo>1,2</relatesTo><i> maxi.rolland93@gmail.com</i><br /><searchLink fieldCode="AR" term="%22Hernández%2C+Rubén%22">Hernández, Rubén</searchLink><relatesTo>2,3</relatesTo><br /><searchLink fieldCode="AR" term="%22Canales%2C+Paulina%22">Canales, Paulina</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Gutiérreza%2C+Javiera%22">Gutiérreza, Javiera</searchLink><relatesTo>1</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22Andes+Pediatrica%22">Andes Pediatrica</searchLink>. mar/abr2026, Vol. 97 Issue 2, p212-220. 9p.
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  Data: <searchLink fieldCode="DE" term="%22DRUG+side+effects%22">DRUG side effects</searchLink><br /><searchLink fieldCode="DE" term="%22PEDIATRICS%22">PEDIATRICS</searchLink><br /><searchLink fieldCode="DE" term="%22HOSPITALS%22">HOSPITALS</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICATION+safety%22">MEDICATION safety</searchLink><br /><searchLink fieldCode="DE" term="%22PHARMACEUTICAL+industry%22">PHARMACEUTICAL industry</searchLink><br /><searchLink fieldCode="DE" term="%22EPIDEMIOLOGY%22">EPIDEMIOLOGY</searchLink><br /><searchLink fieldCode="DE" term="%22CRITICAL+care+medicine%22">CRITICAL care medicine</searchLink>
– Name: Abstract
  Label: Abstract (English)
  Group: Ab
  Data: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality in the pediatric population, particularly due to the frequent use of medications in off-label indications. Objective: To characterize the epidemiology of ADRs in a high-complexity pediatric hospital. Patients and Method: A descriptive, observational, and retrospective cohort study was conducted at the Hospital Dr. Exequiel González Cortés (HEGC) between 2018 and 2023. HEGC is a high-complexity, teaching, and self-managed pediatric hospital, and is one of the seven hospitals of the Southern Metropolitan Health Service. It has 168 beds and provides coverage to an estimated pediatric population of 254,000 children. Hospitalized and outpatient patients with reported ADRs were included. Demographic variables, involved drugs, causality (Naranjo algorithm), severity (WHO criteria), and affected physiological systems were analyzed. Results: A total of 787 ADR reports were recorded in 718 patients, with a median age of 8 years. The highest incidence occurred in the Critical Care Unit. The main therapeutic groups involved were antibacterials (18.6%), antineoplastics (18.4%), and psycholeptics (9.7%). The most affected systems were the immune system (35.7%), nervous system (15%), and digestive system (7%). Regarding severity, 63.5% of ADRs were moderate, 26.7% were severe, with no fatal events reported. Conclusion: This study shows that ADRs are frequent in pediatric patients, with a higher incidence in the critical care setting. It highlights the need for improving ADR reporting and developing pharmacovigilance strategies to optimize the safety of drug prescribing in pediatrics. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Las reacciones adversas a medicamentos (RAM) son una causa relevante de morbimortalidad en la población pediátrica, especialmente debido al frecuente uso de fármacos en indicaciones "off-label". Objetivo: Caracterizar la epidemiología de las RAM en un hospital pediátrico de alta complejidad. Pacientes y Método: Estudio observacional, descriptivo y de cohorte retrospectiva en el Hospital Dr. Exequiel González Cortés (HEGC) entre 2018 y 2023. El HEGC es un hospital pediátrico de alta complejidad, docente, autogestionado y forma parte de los siete hospitales del Servicio de Salud Metropolitano Sur (SSMS). Cuenta con 168 camas y brinda cobertura a una población estimada de 254.000 niños. Se incluyeron pacientes hospitalizados y ambulatorios que presentaron reportes de RAM. Se analizaron variables demográficas, fármacos involucrados, causalidad (algoritmo de Naranjo), severidad (criterios OMS) y sistemas fisiológicos afectados. Resultados: Se registraron 787 reportes de RAM en 718 pacientes, con una mediana de edad de 8 años. La mayor incidencia de RAM se observó en la Unidad de Paciente Crítico (UPC). Los principales grupos terapéuticos involucrados fueron antibacterianos (18,6%), antineoplásicos (18,4%) y psicolépticos (9,7%). El sistema más afectado fue el inmune (35,7%), seguido del nervioso (15%) y digestivo (7%). En cuanto a la severidad, un 63,5% de las RAM fueron moderadas, un 26,7% graves y no hubo RAM letales. Conclusión: Este estudio muestra que existe una mayor incidencia de RAM en las unidades de cuidados de pacientes críticos. Destaca la importancia de mejorar la notificación y desarrollar estrategias de farmacovigilancia activa con el fin optimizar la seguridad en la prescripción de medicamentos en niños el inmune (35,7%), seguido del nervioso (15%) y digestivo (7%). En cuanto a la severidad, un 63,5% de las RAM fueron moderadas, un 26,7% graves y no hubo RAM letales. Conclusión: Este estudio muestra que existe una mayor incidencia de RAM en las unidades de cuidados de pacientes críticos. Destaca la importancia de mejorar la notificación y desarrollar estrategias de farmacovigilancia activa con el fin optimizar la seguridad en la prescripción de medicamentos en niños. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Andes Pediatrica is the property of Revista Chilena de Pediatria and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – TitleFull: Reacciones adversas a medicamentos en un hospital pediátrico de alta complejidad: 6 años de experiencia.
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              Text: mar/abr2026
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