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Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia

BACKGROUND: The characteristics and incidence of adverse drug events (ADEs) among pediatric cancer patients in developing countries have not been well characterized. ADEs & medication errors associated with cancer chemotherapy in children need to be analyzed on their incidence and severity. The...

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Autores principales: Tola, Wayessa Olika, Melaku, Tsegaye, Fufa, Diriba, Sheleme, Tadesse
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9923905/
https://www.ncbi.nlm.nih.gov/pubmed/36782170
http://dx.doi.org/10.1186/s12887-023-03891-9
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author Tola, Wayessa Olika
Melaku, Tsegaye
Fufa, Diriba
Sheleme, Tadesse
author_facet Tola, Wayessa Olika
Melaku, Tsegaye
Fufa, Diriba
Sheleme, Tadesse
author_sort Tola, Wayessa Olika
collection PubMed
description BACKGROUND: The characteristics and incidence of adverse drug events (ADEs) among pediatric cancer patients in developing countries have not been well characterized. ADEs & medication errors associated with cancer chemotherapy in children need to be analyzed on their incidence and severity. The purpose of this study was hence, to assess the incidence of adverse drug events and contributing factors among pediatric cancer patients at Jimma university medical center, Jimma, Ethiopia. METHOD: A prospective observational method was used to study adverse drug events in pediatrics admitted to the pediatric oncology unit of Jimma University medical center between October and December 2020. The ADEs were identified using multifaceted approaches involving daily chart review, interviews of Parents/caregivers (and/or children themselves), attendance at ward rounds, and voluntary staff reports. Both univariate and multivariate logistic regression were used to assess the predictors of the identified ADEs. Those factors that showed association at p-value < 0.25 in the univariate analysis were added to the backward multivariate logistic regression model and the significant association was checked at p-value < 0.05. RESULT: A total of 73 (46 male and 27 female) patients were included in the study. A total of 466 ADEs were identified with an incidence of 638.36 ADEs per 100 patients, 38.35 ADEs per 100 patient days, and 2.34 ADEs per chemotherapy cycle. The most common ADEs were hematologic toxicities (anemia 55(11.8%), neutropenia 52(11.16%) & thrombocytopenia 31(6.65%)), and gastrointestinal effects (nausea 46(9.87%), vomiting 46(9.87%), anorexia 41(8.8%). Out of 466 ADEs, 150 (32.19%) were classified as common terminology criteria for adverse events (CTCAE) as Grade 1, 199 (42.70%) as Grade 2, 64(13.73%) as Grade 3, 48(10.30%) as grade 4 and 5(1.07%) as Grade 5. Severe acute malnutrition (SAM) is the most common comorbidity present, 20(27.40%) followed by pneumonia, 4(5.50%). Presence of comorbidity (AOR 12.700, CI 1.978–81.549), cancer type (AOR 13.332, CI 3.288–54.059), use of 4 or more chemotherapy drugs (AOR 6.179, CI 1.894–20.165) and length of hospital stay more than 8 days (AOR 5.367, CI 1.167–24.684) were associated with the risk of developing grades 3 and 4 ADEs. CONCLUSION: Adverse drug events were common in the pediatric oncology ward of JUMC. In particular, children with multiple chemotherapy drugs and those with the comorbid condition were at greater risk for adverse drug events. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-023-03891-9.
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spelling pubmed-99239052023-02-14 Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia Tola, Wayessa Olika Melaku, Tsegaye Fufa, Diriba Sheleme, Tadesse BMC Pediatr Research BACKGROUND: The characteristics and incidence of adverse drug events (ADEs) among pediatric cancer patients in developing countries have not been well characterized. ADEs & medication errors associated with cancer chemotherapy in children need to be analyzed on their incidence and severity. The purpose of this study was hence, to assess the incidence of adverse drug events and contributing factors among pediatric cancer patients at Jimma university medical center, Jimma, Ethiopia. METHOD: A prospective observational method was used to study adverse drug events in pediatrics admitted to the pediatric oncology unit of Jimma University medical center between October and December 2020. The ADEs were identified using multifaceted approaches involving daily chart review, interviews of Parents/caregivers (and/or children themselves), attendance at ward rounds, and voluntary staff reports. Both univariate and multivariate logistic regression were used to assess the predictors of the identified ADEs. Those factors that showed association at p-value < 0.25 in the univariate analysis were added to the backward multivariate logistic regression model and the significant association was checked at p-value < 0.05. RESULT: A total of 73 (46 male and 27 female) patients were included in the study. A total of 466 ADEs were identified with an incidence of 638.36 ADEs per 100 patients, 38.35 ADEs per 100 patient days, and 2.34 ADEs per chemotherapy cycle. The most common ADEs were hematologic toxicities (anemia 55(11.8%), neutropenia 52(11.16%) & thrombocytopenia 31(6.65%)), and gastrointestinal effects (nausea 46(9.87%), vomiting 46(9.87%), anorexia 41(8.8%). Out of 466 ADEs, 150 (32.19%) were classified as common terminology criteria for adverse events (CTCAE) as Grade 1, 199 (42.70%) as Grade 2, 64(13.73%) as Grade 3, 48(10.30%) as grade 4 and 5(1.07%) as Grade 5. Severe acute malnutrition (SAM) is the most common comorbidity present, 20(27.40%) followed by pneumonia, 4(5.50%). Presence of comorbidity (AOR 12.700, CI 1.978–81.549), cancer type (AOR 13.332, CI 3.288–54.059), use of 4 or more chemotherapy drugs (AOR 6.179, CI 1.894–20.165) and length of hospital stay more than 8 days (AOR 5.367, CI 1.167–24.684) were associated with the risk of developing grades 3 and 4 ADEs. CONCLUSION: Adverse drug events were common in the pediatric oncology ward of JUMC. In particular, children with multiple chemotherapy drugs and those with the comorbid condition were at greater risk for adverse drug events. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-023-03891-9. BioMed Central 2023-02-13 /pmc/articles/PMC9923905/ /pubmed/36782170 http://dx.doi.org/10.1186/s12887-023-03891-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Tola, Wayessa Olika
Melaku, Tsegaye
Fufa, Diriba
Sheleme, Tadesse
Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title_full Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title_fullStr Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title_full_unstemmed Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title_short Adverse drug events and contributing factors among pediatric cancer patients at Jimma University medical center, Southwest Ethiopia
title_sort adverse drug events and contributing factors among pediatric cancer patients at jimma university medical center, southwest ethiopia
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9923905/
https://www.ncbi.nlm.nih.gov/pubmed/36782170
http://dx.doi.org/10.1186/s12887-023-03891-9
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