Memela Makiwane1, Eric Decloedt1, Maxwell Chirehwa2, Bernd Rosenkranz1, Mariana Kruger3. 1. Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa. 2. Division of Epidemiology and Biostatistics, Stellenbosch University, Cape Town, South Africa. 3. Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
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.
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-infectedpatients (42.9%; 9 of 21). CONCLUSION: The prevalence of ADRs was 18.4%, while 31% was the reason for admission.