Adverse Drug Reactions in Paediatric In-Patients in a South African Tertiary Hospital Memela Makiwane, MMed (Clin Pharm), FCCP (SA), MBChB, PGDip PharmMed, Dip HIV Man, 1 Eric Decloedt, BSc(Hons), FCCP(SA), MMed(Clin Pharm), PhD, 1 Maxwell Chirehwa, BSc(Hons), MSc, PhD, 2 Bernd Rosenkranz, MD, PhD, FFPM, 1 and Mariana Kruger, MMed(Paed), MPhil, PhD 3 * 1 Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town 8000, South Africa 2 Division of Epidemiology and Biostatistics, Stellenbosch University, Cape Town 8000, South Africa 3 Department of Paediatrics and Child Health, Stellenbosch University, Cape Town 8000, South Africa *Correspondence: Mariana Kruger, Department of Paediatrics and Child Health, Stellenbosch University, PO Box 241, Cape Town 8000, South Africa. Tel: þ27 21 9389220. E-mail <marianakruger@sun.ac.za> ABSTRACT Background: The prevalence of adverse drug reaction (ADR) rates in children in sub-Saharan Africa is unknown. Objectives: To describe the prevalence of ADRs in paediatric in-patients at a tertiary hospital in South Africa. Methods: This is a prospective study during a 3-month study period. Data collected included age, sex, diagnosis, medicines received and ADRs experienced. Causality were assessed, using the 10- question Naranjo probability scale and classified according to the Hartwig severity scale. Results: There were 61 ADRs in 18.4% (52 of 282) of patients. Median age of patients was 1.4 years (interquartile range: 0.5–5.3 years). ADR was the primary admission reason in 31%. The majority of the ADRs were moderate 45.9% (28 of 61), and only 11.5% severe (7 of 61). Paediatric oncology patients suffered significantly more ADRs (56.5%; 13 of 23) [odds ratio 7.3 (3.0–17.9), p < 0.01], followed by HIV-infected patients (42.9%; 9 of 21). Conclusion: The prevalence of ADRs was 18.4%, while 31% was the reason for admission. KEYWORDS : adverse drug reactions, prevalence, paediatric, in-patient, tertiary hospital, South Africa BACKGROUND The World Health Organization (WHO) defines an adverse drug reaction (ADR) as a response to a medi- cine that is noxious and unintended and occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease [1]. The importance of ADRs has been documented by four systematic reviews conducted between 1966 and 2012 in different paedi- atric therapeutic settings [2–5], revealing that up to 39% of admissions are precipitated by ADRs, often requiring more specialized care. However, the reported prevalence of ADRs varies from country to country in both high-income countries (HICs) [6] and low- to middle-income countries (LMICs) [7–9]. Limited and V C The Author 2018. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com  389 Journal of Tropical Pediatrics, 2019, 65, 389–396 doi: 10.1093/tropej/fmy067 Advance Access Publication Date: 13 December 2018 Original paper Downloaded from https://academic.oup.com/tropej/article/65/4/389/5245251 by guest on 09 June 2023