Adverse drug reactions in neonates: a prospective study

Rivas, Ana Belén; Arruza, Luis; Pacheco, Enrique; Portolés, Antonio; Diz, Jorge; Vargas, Emilio

doi:10.1136/archdischild-2015-309396

Cited by 25 publications

(25 citation statements)

References 28 publications

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“…The most commons ADRs linked to systemic antibiotics were digestive for older children, while hematologic were for neonates. Similar findings were reported by Belen-Rivas et al [19].…”

Section: Discussionsupporting

confidence: 92%

“…These results differ with the findings of Shamna et al [39], who found that moderate ADRs were the most common. According with Naranjo's algorithm, the majority of ADRs were classified as probable; also Belen-Rivas [19] reported that the majority of ADRs were probable. The evaluation of ADRs is predisposed by the definitions, the methodology of detection, classification, and the study setting included.…”

Section: Discussionmentioning

confidence: 99%

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Pharmacovigilance in Pediatric Population

Salas¹,

Soto²

2019

Pharmacovigilance

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Pharmacology in pediatric population has specific needs in pharmacovigilance. The lack of studies in children leads mostly to "off-label" prescribing and to an increased frequency of adverse drug reactions. Additionally, younger ages, male sex, prolonged and previous hospitalization, indication of antibiotics, and the number of prescribed drugs are factors associated with a higher risk of ADRs. Consequently, ADRs represent an additional burden of morbidity. This chapter will be focused on the most common adverse drug reactions in children (including infants and newborns), challenges, and new legislative tools in pediatric pharmacovigilance by using the Word Health Organization global individual case safety report database (VigiAccess) and results from a Latin American study.

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“…The most commons ADRs linked to systemic antibiotics were digestive for older children, while hematologic were for neonates. Similar findings were reported by Belen-Rivas et al [19].…”

Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Pharmacovigilance in Pediatric Population

Salas¹,

Soto²

2019

Pharmacovigilance

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“…Sin embargo, dado que el período de observación fue de seis meses, el estudio permitió determinar la incidencia y el comportamiento de las reacciones adversas en los pacientes estudiados, y se encontraron datos similares a los reportados en otros estudios (22,24,26).…”

Section: Factores De Riesgo Asociados a La Aparición De Las Reaccioneunclassified

Adverse drug reactions in neonates of neonatal intensive care unit in Barranquilla, Colombia

Salas

Díaz-Agudelo

2016

biomedica

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Contribución de los autores:Roxana De las Salas: propuesta de investigación, gestión de los recursos, dirección y ejecución del proyecto Daniela Díaz-Agudelo: participación en el diseño de investigación y en la recolección de datos Las dos autoras participaron en la discusión de resultados y en la escritura del manuscrito. Introducción. La aparición de reacciones adversas a medicamentos es un tema relevante debido a la escasez de datos sobre la seguridad de los medicamentos en la población neonatal. Objetivo. Determinar el comportamiento de las reacciones adversas a medicamentos en neonatos hospitalizados en dos servicios de neonatología de Barranquilla, Colombia. Materiales y métodos. Se hizo un estudio descriptivo, prospectivo y de corte transversal de período de farmacovigilancia intensiva centrada en el paciente. El seguimiento y la vigilancia de la aparición de reacciones adversas a medicamentos en neonatos se extendieron durante seis meses. Se utilizaron el algoritmo de Naranjo para evaluar la causalidad, la escala modificada de Hartwig y Siegel para establecer la gravedad y los criterios de Schumock y Thornton para determinar la posibilidad de evitarlas. Resultados. De los 284 pacientes en seguimiento, se detectaron 123 reacciones adversas en 78 neonatos, es decir, una incidencia de 27,4 % (78/284); la densidad de la incidencia fue de 30,60 reacciones adversas por 1.000 pacientes por día (78/2.549). El sistema orgánico más afectado fue el digestivo (33,6 %); los antibióticos sistémicos fueron los más implicados en las reacciones adversas. La mayoría de estas fueron leves (58,5 %), el 83 % se clasificaron como probables, el 16,2 %, como posibles, y el 0,8 %, como definitivas. Reacciones adversas a medicamentos en neonatos hospitalizados Conclusiones. La incidencia de las reacciones adversas a medicamentos en neonatos fue alta, especialmente en los pacientes prematuros (menos de 38 semanas).Palabras clave: efectos colaterales y reacciones adversas relacionados con medicamentos; recién nacidos; cuidado intensivo neonatal; farmacovigilancia; Colombia. doi: http://dx.doi.org/10.7705/biomedica.v37i1.3192 Adverse drug reactions in neonates hospitalized in neonatal intensive care units in Barranquilla, ColombiaIntroduction: The appearance of adverse drug reactions in neonates is an important issue due to the lack of drug safety data. Objective: To identify the behavior of adverse drug reactions (ADR) in hospitalized neonates at two intensive care units in Barranquilla, Colombia. Materials and methods: We conducted a cross-sectional prospective descriptive study based on patientcentered intensive pharmacosurveillance. We followed up and monitored the appearance of ADRs for six months. We used Naranjo's algorithm to assess causality, modified Hartwig and Siegel assessment scale to establish severity and Schumock and Thornton criteria to determine ADR preventability. Results: We detected 123 adverse drug reactions in 78 neonates of the 284 monitored. The cumulative incidence of ADRs was 27.4% (78/284); incidence den...

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“…However, these reports did not specify the frequency of ADRs in children under 6 years of age and seemed to show underestimated rates, as other studies have reported higher incidences 10 . In addition, younger ages (children from 1 month to 2 years old), male sex, prolonged and previous hospitalization, indication of antibiotics and a higher number of prescribed drugs are factors associated with a higher risk of ADRs 10 , 11 . In the case of Colombia, no specific data about ADRs frequency and characteristics has been described for this population, which is considered a priority in the sustainable development goals.…”

Section: Introductionmentioning

confidence: 99%

Adverse drug reactions in hospitalized colombian children

Salas¹,

Díaz-Agudelo²,

Burgos-Flórez

et al. 2016

Colomb Med

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Introduction: The occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children. Objective: To describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia. Methods: A prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability. Results: Of a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22 to 2.22, p= 0.001) and in those who used systemic antibiotics (RR= 1.82; 95% CI= 1.17 to 2.82, p= 0.005). Conclusions: Adverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics.

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Adverse drug reactions in neonates: a prospective study

Abstract: There is a high incidence of ADRs in hospitalised newborns, which increases with the number of prescriptions.

Cited by 25 publications

References 28 publications

Pharmacovigilance in Pediatric Population

Pharmacovigilance in Pediatric Population

Adverse drug reactions in neonates of neonatal intensive care unit in Barranquilla, Colombia

Adverse drug reactions in hospitalized colombian children

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