Abstract
BackgroundThe high HIV prevalence in South Africa may potentially be shaping the local adverse drug reaction (ADR) burden. We aimed to describe the prevalence and characteristics of serious ADRs at admission, and during admission, to two South African children’s hospitals.MethodsWe reviewed the folders of children admitted over sequential 30-day periods in 2015 to the medical wards and intensive care units of each hospital. We identified potential ADRs using a trigger tool developed for this study. A multidisciplinary team assessed ADR causality, type, seriousness, and preventability through consensus discussion. We used multivariate logistic regression to explore associations with serious ADRs.ResultsAmong 1050 patients (median age 11 months, 56% male, 2.8% HIV-infected) with 1106 admissions we found 40 serious ADRs (3.8 per 100 drug-exposed admissions), including 9/40 (23%) preventable serious ADRs, and 8/40 (20%) fatal or near-fatal serious ADRs. Antibacterials, corticosteroids, psycholeptics, immunosuppressants, and antivirals were the most commonly implicated drug classes. Preterm neonates and children in middle childhood (6 to 11 years) were at increased risk of serious ADRs compared to infants (under 1 year) and term neonates: adjusted odds ratio (aOR) 5.97 (95% confidence interval 1.30 to 27.3) and aOR 3.63 (1.24 to 10.6) respectively. Other risk factors for serious ADRs were HIV infection (aOR 3.87 (1.14 to 13.2) versus HIV-negative) and increasing drug count (aOR 1.08 (1.04 to 1.12) per additional drug).ConclusionsSerious ADR prevalence in our survey was similar to the prevalence found elsewhere. In our setting, serious ADRs were associated with HIV-infection and the antiviral drug class was one of the most commonly implicated. Similar to other sub-Saharan African studies, a large proportion of serious ADRs were fatal or near-fatal. Many serious ADRs were preventable.
Highlights
The high Human immunodeficiency virus (HIV) prevalence in South Africa may potentially be shaping the local adverse drug reaction (ADR) burden
South Africa was home to an estimated 280,000 children living with HIV in 2017, of which an estimated 58% were on antiretroviral treatment (ART) [2]
ADR adverse drug reaction; ICU intensive care unit; RCWMCH Red Cross War Memorial Children’s Hospital; RMMCH Rahima Moosa Mother and Child Hospital independent associations with serious ADRs: preterm neonates, adjusted odds ratio with 95% confidence interval (CI) 5.97 (1.30 to 27.3) versus referent category of infants and term neonates; middle childhood, aOR 3.63 (1.24 to 10.6) versus infants and term neonates; HIV-infection, aOR 3.87 (1.14 to 13.2) versus HIV-negative; and increasing drug count, aOR 1.08 (1.04 to 1.12) per additional drug
Summary
The high HIV prevalence in South Africa may potentially be shaping the local adverse drug reaction (ADR) burden. We aimed to describe the prevalence and characteristics of serious ADRs at admission, and during admission, to two South African children’s hospitals. South Africa was home to an estimated 280,000 children living with HIV in 2017, of which an estimated 58% were on antiretroviral treatment (ART) [2]. Despite this high prevalence of HIV, and despite ART’s notorious potential to cause adverse drug reactions (ADRs) and drug-drug interactions, drug safety is a relatively understudied field in South Africa. Local paediatric drug safety data could potentially contribute to clinical decisionmaking and health programme policy-making
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