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

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.

Serious adverse drug reactions in sub‐Saharan Africa in the era of antiretroviral treatment: A systematic review

“…These included studies that did not distinguish between serious and non‐serious ADRs, as well as studies of “umbrella topics”, such as drug‐related harm, which did not report ADRs separately. Fifteen studies 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 were included in this systematic review (Figure 1 ).…”

“…Fourteen studies 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 47 , 48 , 49 , 50 , 51 , 52 , 53 reported as outcome the proportion of admissions attributed to ADRs. To estimate the summary proportion of admissions attributed to ADRs, we first pooled all group 1 studies and tested for heterogeneity.…”

“…The remaining 13 studies were all conducted as active surveillance studies, eight of which were in adults, 37 , 38 , 39 , 41 , 42 , 43 , 47 , 49 , 50 , 52 four in children, 36 , 40 , 51 , 53 and one in a mixed adult and pediatric population. 48 As this latter study presented data for adults and children separately, we could extract separate adult and pediatric datasets from it.…”

Evaluation of the Drug Hypersensitivity Reactions Prevalence in Hospitalized Children in Sari City from 2014 to 2018: An Original Research

“…The central nervous system medications and hormones were reported with a high rate of causing ADR in the next rank [24]. Based on a systematic analysis in two children's hospitals in an African region, systemic antibacterials, systemic corticosteroids, antivirals, psycholeptics, immunosuppressants, and analgesics were the most common categories of drugs involved in ADR [25]. β-Lactams and phenobarbital were the drugs that caused the most adverse reactions in a similar study in the southeast of Iran [3].…”

Systems Biology Approaches for Therapeutics Development Against COVID-19

“…The implementation of the above medicines reduces the mortality rate in SARS infected patients (Chu et al, 2004). Methylprednisolone may also consider the children for a maximum of five days (Mouton et al, 2020). The patients suffering from the severe immune response are advised to take glucocorticoids.…”