Dataset Information

Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions.

ABSTRACT:

Background

Adverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity and to identify risk factors.

Methods

We undertook a year-long, prospective observational cohort study of admissions to a single UK pediatric medical and surgical secondary and tertiary referral center (Alder Hey, Liverpool, UK). Children between 0 and 16 years 11 months old and admitted for more than 48 hours were included. Observed outcomes were occurrence of ADR and time to first ADR for the risk factor analysis.

Results

A total of 5,118 children (6,601 admissions) were included, 17.7% of whom experienced at least one ADR. Opiate analgesics and drugs used in general anesthesia (GA) accounted for more than 50% of all drugs implicated in ADRs. Of these ADRs, 0.9% caused permanent harm or required admission to a higher level of care. Children who underwent GA were at more than six times the risk of developing an ADR than children without a GA (hazard ratio (HR) 6.40; 95% confidence interval (CI) 5.30 to 7.70). Other factors increasing the risk of an ADR were increasing age (HR 1.06 for each year; 95% CI 1.04 to 1.07), increasing number of drugs (HR 1.25 for each additional drug; 95% CI 1.22 to 1.28) and oncological treatment (HR 1.90; 95% CI 1.40 to 2.60).

Conclusions

ADRs are common in hospitalized children and children who had undergone a GA had more than six times the risk of developing an ADR. GA agents and opiate analgesics are a significant cause of ADRs and have been underrepresented in previous studies. This is a concern in view of the increasing number of pediatric short-stay surgeries.

SUBMITTER: Thiesen S

PROVIDER: S-EPMC4225679 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Publications

Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions.

Thiesen Signe S Conroy Elizabeth J EJ Bellis Jennifer R JR Bracken Louise E LE Mannix Helena L HL Bird Kim A KA Duncan Jennifer C JC Cresswell Lynne L Kirkham Jamie J JJ Peak Matthew M Williamson Paula R PR Nunn Anthony J AJ Turner Mark A MA Pirmohamed Munir M Smyth Rosalind L RL

BMC medicine 20131107

<h4>Background</h4>Adverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity a ...[more]

PMID: 24228998

Similar Datasets

Project description:BackgroundAdverse drug events (ADEs) are an important public health problem with considerable clinical and economic costs. However there are limited studies of ADE incidence in adult inpatients in low-income countries, particularly in Ethiopia. Hence, this study aimed to assess the incidence of adverse drug events and associated factors in patients hospitalized in the medical wards of Wolaita Sodo University teaching referral hospital (WSUTRH).MethodsA prospective observational study was conducted involving 240 patients admitted to the medical wards of WSUTRH. A checklist was used for data collection, while standard tools were employed for assessing the probability and characterization of ADEs. A multifaceted approach involving daily chart review, patient interview, attendance at ward rounds and/or meetings, and staff reports were employed to collect the data. To identify factors independently associated with ADEs, logistic regression analysis was conducted using Stata version 15.ResultsPatients were followed from ward admission to discharge, accounting for 2200 patient-days of hospital stay. Overall, 976 medications were ordered during the hospital stay. Sixty-four ADEs were identified with an incidence of approximately 27 per 100 admissions and 29 per 1000 patient days. Of the total ADEs, 59% were preventable. Regarding the severity, 2% of the ADEs were severe, while 54% were moderate. The risk of ADEs increased with longer hospital stay (LOHS) (p = 0.021), in patients with blood and immune disease diagnosis (p = 0.001), use of cardiovascular medicines (p = 0.028), and an increase in the number of medications prescribed (p = 0.021).ConclusionsIn this study, ADEs were identified in about one-quarter of the participants. Longer hospital stays, blood and immune diseases, cardiovascular medicines use, and multiple medication use had increased the likelihood of ADE occurrences. The majority of the ADEs were preventable, indicating the existence of a window of opportunity to ensure patient safety.

Dataset Information

Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions.

Background

Methods

Results

Conclusions

Publications

Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions.

Similar Datasets

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