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 80 % (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.

Background: Adverse drug reactions (ADRs) cause significant morbidity and mortality. Improved assessment of ADRs to identify the causal relationship, the severity, and the preventability will aid ADRs prevention or reduce patient burden. Objective: The aim of this study was to develop mobile apps in assisting clinical decision in ADR assessments of causality, severity, and preventability using validated tools. The usability of the apps was assessed. Methods: We designed mobile apps using validated assessment tools for ADRs. They are the Liverpool ADRs Causality Assessment Tool, Hartwig's Severity Assessment Scale, and the Modified Schumock and Thronton Preventability Scale. The apps were named Adverse Drug ReactionCausality, Adverse Drug ReactionSeverity, and Adverse Drug RxnPreventability. A survey was conducted using the System Usability Scale (SUS) to assess the usability of the developed apps among health care professionals. Results: These apps are available for download through Google Play Store for free since January 2015. From the survey, the mean SUS score was 70.9 based on 26 responses from the pediatric ward of Hospital Ampang, Malaysia. Conclusions: The developed apps received an overall acceptable usability among health care professionals. The usage of these apps will improve detection, assessment, and avoidance of future ADRs. They will also contribute to future research on ADRs, thus increasing drug safety.