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Published on: August 30, 2018
Risk factors for adverse drug reactions in pediatric inpatients: A cohort study
Paulo Henrique Santos Andrade1, Iza Maria Fraga Lobo2, Wellington Barros da Silva1
1Universidade Federal de Sergipe, São Cristóvão, Sergipe, Brazil.
Insights
Identifying risk factors for adverse drug reactions (ADR) in pediatric inpatients is crucial. Prior ADR history and specific medications like antibacterials and antiepileptics increase a child's ADR risk.
Area of Science:
- Pediatric Pharmacology
- Clinical Pharmacy
- Drug Safety
Background:
- Adverse drug reactions (ADRs) pose a significant risk in pediatric healthcare.
- Understanding pediatric ADR risk factors is essential for improving patient safety.
Purpose of the Study:
- To identify key risk factors associated with adverse drug reactions (ADRs) in hospitalized children.
- To inform targeted interventions for ADR prevention in pediatric populations.
Main Methods:
- A prospective cohort study was conducted in a general pediatric ward in Northeast Brazil.
- Data were collected over two stages from August 2015 to August 2016, including children aged 0-14 years 11 months.
- Univariate and multivariate Cox regression analyses were employed to identify risk factors.
Main Results:
- A total of 173 children (208 admissions) experienced 66 ADRs, with an incidence rate of 3/100 patient days.
- Gastrointestinal disorders were the most frequent ADR type (28.8%).
- Significant risk factors identified included prior ADR history (HR 2.44), meglumine antimonate (HR 4.98), systemic antibacterials (HR 2.75), and antiepileptic drugs (HR 3.84).
Conclusions:
- Prior history of ADRs and the use of specific medications are significant risk factors for ADRs in pediatric inpatients.
- These findings highlight the need for vigilant monitoring and risk management strategies in pediatric pharmacotherapy.
- Targeting interventions based on identified risk factors can help reduce ADR incidence in children.
Purpose:
The present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients.
Methods:
A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0-14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used.
Results:
A total of 173 children (208 admissions) and 66 ADR classified as "definite" and "probable" were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19-5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21-20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08-6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40-10.56) were identified risk factors for ADR.
Conclusions:
We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.
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