Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Incidence of adverse drug reactions in a paediatric ward of a Malaysian hospital: A prospective observational study

Muslimah Ithnin¹, Mohd Dzulkhairi Mohd Rani¹, Zuraidah Abd Latif², Paveethra a/p Kani³, Asmalita Syaiful¹, Tengku Amatullah Madeehah Tengku Mohd¹, Khairun Nain Nor Aripin¹

¹Faculty of Medicine and Health Sciences, Universiti Sains Islam Malaysia, Menara B, Pandan Indah 55100 Kuala Lumpur; ²Pediatric Department; ³Pharmacy Department, Hospital Ampang, 68000 Selangor, Malaysia.

For correspondence:- Khairun Aripin Email: khairun@usim.edu.my

Accepted: 18 June 2018 Published: 28 July 2018

Citation: Ithnin M, Rani MD, Latif ZA, Kani Pa, Syaiful A, Mohd TA, et al. Incidence of adverse drug reactions in a paediatric ward of a Malaysian hospital: A prospective observational study. Trop J Pharm Res 2018; 17(7):1423-1431 doi: 10.4314/tjpr.v17i7.28

© 2018 The authors.
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Abstract

Purpose: To investigate the incidence, characteristics and risk factors of adverse drug reactions (ADRs) in hospitalized children in a Malaysian hospital.

Methods: Patients admitted to the Paediatric Department of Hospital Ampang in Kuala Lumpur, Malaysia were monitored for occurrence of ADRs by spontaneous reporting or daily review of their case notes. Characteristics of ADRs were categorised and ADRs were analysed for causality, severity and preventability. Multivariate analyses were performed to determine associations between certain selected risk factors and ADR occurrence.

Results: In 423 paediatric patients admitted in Hospital Ampang (436 admissions), the ADR incidence rate was 8.0 % (95 % CI, 5 - 11 %). The most commonly involved medications were systemic antibacterial drugs (77.4 %). About 61.3 % of the ADRs were of probable causality and 12.9 % were definitely preventable. No severe ADRs were detected, with 41.9 % being moderate and 58.1 % being mild, based on a severity scale. Younger children (OR = 3.387, 95 % CI, 1.377, 8.334) and the number of systemic antibacterial drugs given (OR = 1.469, 95 % CI 1.201, 1.798) were potential risk factors associated with ADRs.

Conclusion: ADRs occur at a significant rate in the Malaysian children admitted to the hospital studied. Further studies are needed to provide drug safety data for the paediatric population in Malaysia

Keywords: Adverse drug reaction, Children, Paediatric, Drug safety