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

dc.contributor.authorMouton, Johannes P
dc.contributor.authorFortuin-de Smidt, Melony C
dc.contributor.authorJobanputra, Nicole
dc.contributor.authorMehta, Ushma
dc.contributor.authorStewart, Annemie
dc.contributor.authorde Waal, Reneé
dc.contributor.authorTechnau, Karl-Günter
dc.contributor.authorArgent, Andrew
dc.contributor.authorKroon, Max
dc.contributor.authorScott, Christiaan
dc.contributor.authorCohen, Karen
dc.date.accessioned2020-01-08T09:26:47Z
dc.date.available2020-01-08T09:26:47Z
dc.date.issued2020-01-04
dc.date.updated2020-01-05T04:13:43Z
dc.description.abstractAbstract 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.
dc.identifier.apacitationMouton, J. P., Fortuin-de Smidt, M. C., Jobanputra, N., Mehta, U., Stewart, A., de Waal, R., ... Cohen, K. (2020). Serious adverse drug reactions at two children’s hospitals in South Africa. http://hdl.handle.net/11427/30716en_ZA
dc.identifier.chicagocitationMouton, Johannes P, Melony C Fortuin-de Smidt, Nicole Jobanputra, Ushma Mehta, Annemie Stewart, Reneé de Waal, Karl-Günter Technau, et al "Serious adverse drug reactions at two children’s hospitals in South Africa." (2020) http://hdl.handle.net/11427/30716en_ZA
dc.identifier.citationBMC Pediatrics. 2020 Jan 04;20(1):3
dc.identifier.ris TY - Journal Article AU - Mouton, Johannes P AU - Fortuin-de Smidt, Melony C AU - Jobanputra, Nicole AU - Mehta, Ushma AU - Stewart, Annemie AU - de Waal, Reneé AU - Technau, Karl-Günter AU - Argent, Andrew AU - Kroon, Max AU - Scott, Christiaan AU - Cohen, Karen AB - 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. DA - 2020-01-04 DB - OpenUCT DP - University of Cape Town KW - Adverse drug reaction KW - Pharmacoepidemiology KW - Prevalence KW - Trigger tool KW - HIV LK - https://open.uct.ac.za PY - 2020 T1 - Serious adverse drug reactions at two children’s hospitals in South Africa TI - Serious adverse drug reactions at two children’s hospitals in South Africa UR - http://hdl.handle.net/11427/30716 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12887-019-1892-x
dc.identifier.urihttp://hdl.handle.net/11427/30716
dc.identifier.vancouvercitationMouton JP, Fortuin-de Smidt MC, Jobanputra N, Mehta U, Stewart A, de Waal R, et al. Serious adverse drug reactions at two children’s hospitals in South Africa. 2020; http://hdl.handle.net/11427/30716.en_ZA
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.subjectAdverse drug reaction
dc.subjectPharmacoepidemiology
dc.subjectPrevalence
dc.subjectTrigger tool
dc.subjectHIV
dc.titleSerious adverse drug reactions at two children’s hospitals in South Africa
dc.typeJournal Article
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