Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records

Background: Drug-induced thrombocytopenia (DITP) is a severe adverse reaction and a significantly under-recognized clinical problem in children. However, for post-marketing pharmacovigilance purposes, detection of DITP signals is crucial. This study aimed to develop a signal detection model for DITP...

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Autores principales:	Xiaolu Nie, Lulu Jia, Xiaoxia Peng, Houyu Zhao, Yuncui Yu, Zhenping Chen, Liqiang Zhang, Xiaoling Cheng, Yaqi Lyu, Wang Cao, Xiaoling Wang, Xin Ni, Siyan Zhan
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	drug-induced thrombocytopenia signal detection children electronic medical records post-marketing pharmacovigilance Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/1d95ab4d2f3e412ab7ef2fe0e21d3209
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spelling	oai:doaj.org-article:1d95ab4d2f3e412ab7ef2fe0e21d32092021-11-12T06:31:21ZDetection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records1663-981210.3389/fphar.2021.756207https://doaj.org/article/1d95ab4d2f3e412ab7ef2fe0e21d32092021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.756207/fullhttps://doaj.org/toc/1663-9812Background: Drug-induced thrombocytopenia (DITP) is a severe adverse reaction and a significantly under-recognized clinical problem in children. However, for post-marketing pharmacovigilance purposes, detection of DITP signals is crucial. This study aimed to develop a signal detection model for DITP using the pediatric electronic medical records (EMR) data.Methods: This study used the electronic medical records collected at Beijing Children’s Hospital between 2009 and 2020. A two-stage modeling method was developed to detect the signal of DITP. In the first stage, we calculated the crude incidence by mining cases of thrombocytopenia to select the potential suspected drugs. In the second stage, we constructed propensity score–matched retrospective cohorts of specific screened drugs from the first stage and estimated the odds ratio (OR) and 95% confidence interval (CI) using conditional logistic regression models. The novelty of the signal was assessed by current evidence.Results: In the study, from a total of 839 drugs, 21 drugs were initially screened as potentially inducing thrombocytopenia. In total, we identified 18 positive DITP associations. Of these, potential DITP risk of nystatin (OR: 1.75, 95% CI: 1.37–2.22) and latamoxef sodium (OR: 1.61, 95% CI: 1.38–1.88) were two new DITP signals in both children and adults. Six associations between thrombocytopenia and drugs including imipenem (OR: 1.69, 95% CI: 1.16–2.45), teicoplanin (OR: 4.75, 95% CI: 3.33–6.78), fusidic acid (OR: 2.81, 95% CI: 2.06–3.86), ceftizoxime sodium (OR: 1.83, 95% CI: 1.36–2.45), ceftazidime (OR: 2.16, 95% CI: 1.58–2.95), and cefepime (OR: 5.06, 95% CI: 3.77–6.78) were considered as new signals in children.Conclusion: This study developed a two-stage algorithm to detect safety signals of DITP and found eighteen positive signals of DITP, including six new signals in a pediatric population. This method is a promising tool for pharmacovigilance based on EMR data.Xiaolu NieXiaolu NieLulu JiaXiaoxia PengHouyu ZhaoYuncui YuZhenping ChenLiqiang ZhangXiaoling ChengYaqi LyuWang CaoXiaoling WangXin NiSiyan ZhanSiyan ZhanFrontiers Media S.A.articledrug-induced thrombocytopeniasignal detectionchildrenelectronic medical recordspost-marketing pharmacovigilanceTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	drug-induced thrombocytopenia signal detection children electronic medical records post-marketing pharmacovigilance Therapeutics. Pharmacology RM1-950
spellingShingle	drug-induced thrombocytopenia signal detection children electronic medical records post-marketing pharmacovigilance Therapeutics. Pharmacology RM1-950 Xiaolu Nie Xiaolu Nie Lulu Jia Xiaoxia Peng Houyu Zhao Yuncui Yu Zhenping Chen Liqiang Zhang Xiaoling Cheng Yaqi Lyu Wang Cao Xiaoling Wang Xin Ni Siyan Zhan Siyan Zhan Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
description	Background: Drug-induced thrombocytopenia (DITP) is a severe adverse reaction and a significantly under-recognized clinical problem in children. However, for post-marketing pharmacovigilance purposes, detection of DITP signals is crucial. This study aimed to develop a signal detection model for DITP using the pediatric electronic medical records (EMR) data.Methods: This study used the electronic medical records collected at Beijing Children’s Hospital between 2009 and 2020. A two-stage modeling method was developed to detect the signal of DITP. In the first stage, we calculated the crude incidence by mining cases of thrombocytopenia to select the potential suspected drugs. In the second stage, we constructed propensity score–matched retrospective cohorts of specific screened drugs from the first stage and estimated the odds ratio (OR) and 95% confidence interval (CI) using conditional logistic regression models. The novelty of the signal was assessed by current evidence.Results: In the study, from a total of 839 drugs, 21 drugs were initially screened as potentially inducing thrombocytopenia. In total, we identified 18 positive DITP associations. Of these, potential DITP risk of nystatin (OR: 1.75, 95% CI: 1.37–2.22) and latamoxef sodium (OR: 1.61, 95% CI: 1.38–1.88) were two new DITP signals in both children and adults. Six associations between thrombocytopenia and drugs including imipenem (OR: 1.69, 95% CI: 1.16–2.45), teicoplanin (OR: 4.75, 95% CI: 3.33–6.78), fusidic acid (OR: 2.81, 95% CI: 2.06–3.86), ceftizoxime sodium (OR: 1.83, 95% CI: 1.36–2.45), ceftazidime (OR: 2.16, 95% CI: 1.58–2.95), and cefepime (OR: 5.06, 95% CI: 3.77–6.78) were considered as new signals in children.Conclusion: This study developed a two-stage algorithm to detect safety signals of DITP and found eighteen positive signals of DITP, including six new signals in a pediatric population. This method is a promising tool for pharmacovigilance based on EMR data.
format	article
author	Xiaolu Nie Xiaolu Nie Lulu Jia Xiaoxia Peng Houyu Zhao Yuncui Yu Zhenping Chen Liqiang Zhang Xiaoling Cheng Yaqi Lyu Wang Cao Xiaoling Wang Xin Ni Siyan Zhan Siyan Zhan
author_facet	Xiaolu Nie Xiaolu Nie Lulu Jia Xiaoxia Peng Houyu Zhao Yuncui Yu Zhenping Chen Liqiang Zhang Xiaoling Cheng Yaqi Lyu Wang Cao Xiaoling Wang Xin Ni Siyan Zhan Siyan Zhan
author_sort	Xiaolu Nie
title	Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
title_short	Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
title_full	Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
title_fullStr	Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
title_full_unstemmed	Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records
title_sort	detection of drug-induced thrombocytopenia signals in children using routine electronic medical records
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/1d95ab4d2f3e412ab7ef2fe0e21d3209
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Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records

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