Adverse Drug Reaction Assessment in the Paediatric Population: A Non-Interventional Pharmacovigilance Study
Abstract:
Adverse drug reactions (ADRs) in children are
under-reported due to limited clinical trials, off-label prescribing, and lack
of caregiver awareness. Pharmacovigilance is essential to evaluate and prevent
drug-related harm in paediatric populations. The objective is to
identify adverse drug reactions in paediatric patients using the WHO-UMC
causality assessment scale and document the pattern and severity of adverse
events (AEs). Non-interventional observational study was
conducted in 140 paediatric subjects (< 13 years). Clinical history,
anthropometrics, and adverse events were documented. Causality was assessed
using the WHO-UMC ADR Probability Scale. Descriptive statistics were applied. The
mean age of subjects was 7.42 ± 2.94 years; 72.86% were male. All subjects had
no significant medical history. The mean ADR probability score was 0.43
± 1.46, indicating doubtful causality. A total of 53 AEs were
identified: nausea (16.35%), gastritis (8.81%), drowsiness (2.52%), rash
(2.52%), abdominal pain (1.89%), stomach pain (0.63%), and swollen eyes
(0.63%). All AEs were mild in intensity. It was Concluded
that ADR incidence in the study population was low and predominantly
mild. Causality scores indicate minimal association with drug therapy.
Strengthening paediatric pharmacovigilance programs remains essential to ensure
medication safety.
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