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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.

Roxana De las salas, Department of Nursing Universidad del Norte

Assistant professor

Department of Nursing

Daniela Díaz-Agudelo, Department of Nursing Nursing Research Group Universidad del Norte

Department of Nursing

Francisco Javier Burgos-Flórez, Biomimetics Laboratory, Instituto de Biotecnología Universidad Nacional de Colombia

Biomimetics Laboratory

Claudia Vaca, Department of Pharmacy Universidad Nacional de Colombia

Departmen of Pharmacy

Dolores Vanessa Serrano-Meriño, Department of Nursing Nursing Research Group

Department of Nursing
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Received 2016-01-11
Accepted 2016-07-17
Published 2024-06-11