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Published on: August 30, 2018
Safety of Antibiotics in Hospitalized Children in Romania: A Prospective Observational Study
Noémi-Beátrix Bulik1, Andreea Farcaș2, Camelia Bucșa2
1Department of Pharmaceutical Chemistry, 'Iuliu Hațieganu' University of Medicine and Pharmacy, 400010 Cluj-Napoca, Romania.
Insights
Antibiotic use in hospitalized children frequently causes adverse drug reactions (ADRs), particularly gastrointestinal issues in those under two. Monitoring these pediatric antibiotic ADRs is crucial for patient safety.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Drug Safety
Background:
- Antibiotics are widely prescribed for pediatric inpatients.
- Adverse drug reactions (ADRs) are a common concern in children receiving antibiotics.
Purpose of the Study:
- To determine the frequency and types of antibiotic-associated ADRs in pediatric inpatients.
- To evaluate the causality, avoidability, and severity of these ADRs.
Main Methods:
- A prospective observational study was conducted over six months in Romania.
- 266 pediatric inpatients receiving antibiotics were monitored for ADRs.
- ADRs were assessed for causality, avoidability, and severity.
Main Results:
- 25 out of 266 children (9.4%) experienced 30 ADRs.
- ADRs were more frequent in children ≤2 years old (52.0%).
- Gastrointestinal ADRs, especially diarrhea (26.7%), and hematological ADRs were most common. Ceftriaxone was the most frequent culprit (53.3%).
Conclusions:
- Antibiotics frequently cause ADRs in young children, with gastrointestinal symptoms being prevalent.
- Close monitoring for antibiotic-associated ADRs in pediatric patients is essential.
- Some ADRs were deemed avoidable, highlighting potential for improved prescribing practices.
Abstract:
Antibiotics are among the most prescribed drugs in pediatric inpatients and are frequently associated with adverse drug reactions (ADRs) in children. This study aimed to assess the frequency and type of ADRs related to the use of antibiotics in pediatric inpatients through a prospective observational study, conducted over 6 months, covering the winter and spring seasons when the incidence of infections peaks in Romania. ADRs were evaluated for causality, avoidability and severity. Among the 266 included children, 25 (9.4%) experienced 30 ADRs. ADR frequency tended to be higher in ≤2-year-olds (13 of 25, 52.0%) than in other age categories. Gastrointestinal and hematological ADRs were most frequently observed. Diarrhea was the most common ADR associated with antibiotics (8 of 30, 26.7%). Ceftriaxone (16 of 30, 53.3%), cefuroxime, ceftazidime and azithromycin (3 of 30, 10.0% each) were most commonly responsible for ADRs. After causality assessment, 2 (6.7%) ADRs were considered definite, 12 (40.0%) probable and 16 (53.3%) possible. One ADR was classified as definitely avoidable and one as possibly avoidable. Seven children required treatment for ADRs. Antibiotic treatment was discontinued in 4 children. Antibiotics frequently caused ADRs in ≤ 2-year-olds and were commonly associated with gastrointestinal symptoms. Close monitoring of antibiotic-associated ADRs remains important in the pediatric population.
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