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01-12-2020 | Human Immunodeficiency Virus | Research article

Serious adverse drug reactions at two children’s hospitals in South Africa

Authors: Johannes P. Mouton, Melony C. Fortuin-de Smidt, Nicole Jobanputra, Ushma Mehta, Annemie Stewart, Reneé de Waal, Karl-Günter Technau, Andrew Argent, Max Kroon, Christiaan Scott, Karen Cohen

Published in: BMC Pediatrics | Issue 1/2020

Abstract

Background

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.

Methods

We 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.

Results

Among 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).

Conclusions

Serious 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.

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Title: Serious adverse drug reactions at two children’s hospitals in South Africa
Authors: Johannes P. Mouton
Melony C. Fortuin-de Smidt
Nicole Jobanputra
Ushma Mehta
Annemie Stewart
Reneé de Waal
Karl-Günter Technau
Andrew Argent
Max Kroon
Christiaan Scott
Karen Cohen
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Human Immunodeficiency Virus
Published in: BMC Pediatrics / Issue 1/2020
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-019-1892-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Serious adverse drug reactions at two children’s hospitals in South Africa

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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