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
Highlights
The World Health Organisation (WHO) defines an adverse drug reactions (ADRs) as ‘a response to a drug which is noxious, and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function’ [1]
This study aims to provide further data on the incidence of paediatric ADRs occurring in Malaysian children admitted to hospital and to identify possible risk factors
When subdividing the patients by ages, patients were categorised based on the guideline on Clinical Investigation of Medicinal Products in the Paediatric Population; infants 28 days until below two years and children above two years until below twelve years [16]
Summary
The World Health Organisation (WHO) defines an ADR as ‘a response to a drug which is noxious, and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function’ [1]. ADRs remain a hazard in the medical treatment of children where previous systematic reviews. A multinational surveillance study published in 2012 found that the ADR incidence in Malaysian paediatric patients was second highest at 19.1%, based on a single study ward [5]. The Malaysian group had the highest incidence of serious ADRs at 7.6 %, among the 5 participating countries. ADRs were the cause of admission in 1.7 % of the children admitted to the Malaysian study ward. Another study analysed paediatric ADRs reported to the Malaysian drug control authority between 2000 and 2013 and found a dramatic increase in paediatric ADRs reported by healthcare personnel, from 115 reports in 2000 to 3527 in 2011 [6]. Over half of the paediatric ADRs reported were vaccine related
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