Browsing by Subject "Adverse drug reaction"
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- ItemOpen AccessSerious adverse drug reactions at two children’s hospitals in South Africa(2020-01-04) Mouton, Johannes P; Fortuin-de Smidt, Melony C; Jobanputra, Nicole; Mehta, Ushma; Stewart, Annemie; de Waal, Reneé; Technau, Karl-Günter; Argent, Andrew; Kroon, Max; Scott, Christiaan; Cohen, KarenAbstract 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.
- ItemOpen AccessThe Prevalence of Antiretroviral-Therapy-related Adverse Reactions, Hospitalisation, and Mortality among People Living with HIV in Africa-A systematic review and Meta-Analysis(2022) Moirana, Elizabeth Lorivi; Shung, King Maylene; Hohlfeld, AmeerIntroduction: Medicines are an important component of any health system. Even though the importance of medicines in the health system is indisputable, one of the major concerns remains the risk of adverse drug reactions when used by consumers. Adverse drug reactions place a burden on the healthcare system, usually as a result of complications requiring hospital admission or extended hospital admissions. In Africa, about 28.6% of adverse drug reactions reported in Africa were due to antiretroviral therapy. Recently, the adoption of the “test and treat” policy by the World Health Organisation increased the number of people receiving antiretroviral therapy. Therefore, this systematic review was conducted to explore the magnitude of antiretroviral therapy-related adverse drug reactions hospitalisations, and mortalities in the region, following the increase in people initiating therapy, and the implications to the service delivery component of the healthcare system. Methods: In March 2021, PubMed, EBSCOHost, and SCOPUS, databases were systematically searched for appropriate articles. The selection of articles was based on predefined inclusion and exclusion criteria. Data from included articles were extracted as per a set of defined criteria into a data extraction form. A meta-analysis was done using Stata package software 15.0 using Stata “metaprop” command. Results: The pooled prevalence of adverse drug reactions hospitalisations in all studies was 26.5% (95% confidence interval:18.4,35.4) and that of mortality was 6.1% (95% confidence interval:2.1,11.7). The most prevalent adverse reactions reported include hepatotoxicity, kidney injury, lactic acidosis, skin, neurologic, and hematologic reactions. The antiviral implicated, are non-nucleoside reverse transcriptase inhibitors, nucleoside/tide reverse transcriptase inhibitors, and protease inhibitors. The pediatric population was underrepresented as only two studies included pediatric patients. The economic impact of adverse reactions was impossible to estimate, as only one study reported on financial implications. Conclusion: Antiretroviral therapy-related adverse reactions hospitalisations and mortalities have a high prevalence in Africa. There are concerns about age-related morbidities and lifestyle diseases as risk factors related to adverse reactions. To adequately combat adverse reactions associated with antiretrovirals, African country health systems need multidisciplinary actions to strengthen strategies for prediction, identification, reporting, and prevention of adverse reaction occurrence.