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

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dc.Chemicals/CASaciclovir, 59277-89-3; azithromycin, 83905-01-5, 117772-70-0, 121470-24-4; bromhexine, 3572-43-8, 611-75-6; cefoperazone, 62893-19-0, 62893-20-3; cefotaxime, 63527-52-6, 64485-93-4; ceftazidime, 72558-82-8; ceftriaxone, 73384-59-5, 74578-69-1; cefuroxime, 55268-75-2, 56238-63-2; clarithromycin, 81103-11-9; erythromycin, 114-07-8, 70536-18-4; montelukast, 151767-02-1, 158966-92-8; paracetamol, 103-90-2; penicillin V, 87-08-1; salbutamol, 18559-94-9, 35763-26-9
dc.FundingDetails21335 Ministry of Higher Education, Malaysia: USIM/RAGS/FPSK/36/50314
dc.FundingDetailsThis was a prospective observational study conducted in a paediatric general ward in Hospital Ampang. Hospital Ampang is a general hospital located in Kuala Lumpur, the capital of Malaysia. The paediatric department comprised three wards, the neonatal intensive care unit (NICU), and general wards 4A and 4B. Ward 4B was selected as the study ward and consists of 40 beds. All patients admitted to the ward and were exposed to any medication were monitored actively for occurrences of any ADRs until they were discharged. The study was designed according to WHO CIOMS International Ethical Guidelines for Health-related Research Involving Humans [7]. Ethical approval (no. NMRR-14-1009-21335(IIR) was obtained from the Medical Research and Ethics Committee (MREC) of the Malaysian Ministry of Health and the study was registered in the National Medical Research Register (research ID: 21335).
dc.FundingDetailsWe would like to thank the Director General of the Ministry of Health for his permission to publish this article. We would like to thank all the staff of Department of Paediatrics, Ampang Hospital for their kind help in conducting the research. This study was funded by a grant from Ministry of Higher Education (MOHE) Malaysia under USIM/RAGS/FPSK/36/50314. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
dc.contributor.affiliationsFaculty of Medicine and Health Sciences
dc.contributor.affiliationsUniversiti Sains Islam Malaysia (USIM)
dc.contributor.affiliationsHospital Ampang
dc.contributor.authorIthnin M.en_US
dc.contributor.authorRani M.D.M.en_US
dc.contributor.authorLatif Z.A.en_US
dc.contributor.authorKani P.A.P.en_US
dc.contributor.authorSyaiful A.en_US
dc.contributor.authorMohd T.A.M.T.en_US
dc.contributor.authorKhairun Nain Nor Aripinen_US
dc.date.accessioned2024-05-28T08:28:35Z
dc.date.available2024-05-28T08:28:35Z
dc.date.issued2018
dc.description.abstractPurpose: 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. � 2018 Ithnin M, Rani MDM, Latif ZA, Kani P, Syaiful A, Mohd TAMT, Aripin KNN.en_US
dc.description.natureFinalen_US
dc.identifier.doi10.4314/tjpr.v17i7.28
dc.identifier.epage1431
dc.identifier.issn15965996
dc.identifier.issue7
dc.identifier.scopus2-s2.0-85051126125
dc.identifier.spage1423
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85051126125&doi=10.4314%2ftjpr.v17i7.28&partnerID=40&md5=d5d044b5680936eb078c99e3e9ed367f
dc.identifier.urihttps://oarep.usim.edu.my/handle/123456789/8862
dc.identifier.volume17
dc.languageEnglish
dc.language.isoen_USen_US
dc.publisherUniversity of Beninen_US
dc.relation.ispartofOpen Accessen_US
dc.relation.ispartofTropical Journal of Pharmaceutical Research
dc.sourceScopus
dc.subjectAdverse drug reactionen_US
dc.subjectChildrenen_US
dc.subjectDrug safetyen_US
dc.subjectPaediatricen_US
dc.subjectHartwigs severity assessment scaleen_US
dc.titleIncidence of adverse drug reactions in a paediatric ward of a Malaysian hospital: A prospective observational studyen_US
dc.title.alternativeTrop. J. Pharm. Res.en_US
dc.typeArticleen_US
dspace.entity.typePublication

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