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.

中文翻译：

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南非两家儿童医院的药物不良反应严重。

背景技术南非的艾滋病高流行率可能正在影响当地的药物不良反应（ADR）负担。我们的目的是描述南非两所儿童医院入院时和住院期间严重ADR的患病率和特征。方法我们回顾了2015年连续30天进入各医院医疗病房和重症监护室的儿童的病历。我们使用为本研究开发的触发工具确定了潜在的ADR。一个多学科小组通过共识讨论评估了ADR的因果关系，类型，严重性和可预防性。我们使用多元logistic回归探索与严重ADR的关联。结果在1050名患者（中位年龄11个月，男性56％，HIV感染2.8％）中，有1106例入院，我们发现40例严重ADR（3。每100个药物暴露入院者中有8个），包括9/40（23％）可预防的严重ADR和8/40（20％）致命或接近致命的严重ADR。抗生素，皮质类固醇，精神抑制药，免疫抑制剂和抗病毒药是最常见的药物类别。与婴儿（1岁以下）和足月新生儿相比，早产儿和中年儿童（6至11岁）患严重ADR的风险增加：调整后的优势比（aOR）为5.97（95％置信区间为1.30至27.3）分别为3.63（1.24至10.6）。严重ADR的其他危险因素是HIV感染（aOR 3.87（1.14至13.2）与HIV阴性）和增加的药物计数（每增加一种药物，aOR 1.08（1.04至1.12））。结论在我们的调查中，严重的ADR患病率与其他地方的患病率相似。在我们的环境中 严重的ADR与HIV感染有关，抗病毒药物类别是最常见的一种。与其他撒哈拉以南非洲地区的研究类似，严重的ADR中有很大一部分是致命的或接近致命的。许多严重的ADR是可以预防的。