Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems

Nayoung Han,1,2 Jung Mi Oh,1,3 In-Wha Kim1 1Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea; 2College of Pharmacy, Jeju National University, Jejusi, Jeju Special Self-Governing Province, Republic of Korea; 3College of Pharmacy, Seoul National Univer...

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Autores principales:	Han N, Oh JM, Kim IW
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	off-label use adverse events adverse drug reaction reporting systems disproportionality Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/120581c1600c45da9d6e317447ef183b
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spelling	oai:doaj.org-article:120581c1600c45da9d6e317447ef183b2021-12-02T16:45:32ZAdverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems1178-203Xhttps://doaj.org/article/120581c1600c45da9d6e317447ef183b2021-08-01T00:00:00Zhttps://www.dovepress.com/adverse-events-related-to-off-label-drugs-using-spontaneous-adverse-ev-peer-reviewed-fulltext-article-TCRMhttps://doaj.org/toc/1178-203XNayoung Han,1,2 Jung Mi Oh,1,3 In-Wha Kim1 1Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea; 2College of Pharmacy, Jeju National University, Jejusi, Jeju Special Self-Governing Province, Republic of Korea; 3College of Pharmacy, Seoul National University, Seoul, Republic of KoreaCorrespondence: In-Wha KimResearch Institute of Pharmaceutical Sciences, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Republic of KoreaTel +82 2 880-7736Fax +82 2 882-9560Email iwkim2@hanmail.netPurpose: The purpose of this study was to investigate the adverse events (AEs) related to the use of off-label drugs.Materials and Methods: A cross-sectional study was carried out using available data pertaining to off-label drug were sourced from U.S. FDA spontaneous adverse drug reaction reporting database (FAERS) and Korea Adverse Event Reporting System database (KIDS-KD) for the years 2014 to 2018. The number and frequencies of AE cases were calculated. Disproportionality was analyzed using the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM) methods.Results: The reported AEs associated with off-label drug use were more common among older patients compared with younger patients. Gastric nonspecific symptoms and therapeutic procedure (4.16– 4.57%) and haemorrage term (4.16– 5.29%) were the most common AE symptoms and antithrombotic agents and immunosuppressants were the drugs most commonly reported to cause AEs in FAERS. Secondary term events (43.45– 48.62%) including inappropriate schedule of drug administration and medication error were the most common AEs, and immunosuppressants and antipsychotics were the most common AE-related drugs from KIDS-KD. The numbers of reported AEs in new drug categories such as other antineoplastic agents trended to increase from 2014 to 2018 in both datasets.Conclusion: The numbers of reported AEs with off-label drug increased annually. AEs associated with off-label drugs may have a significant impact on older patients. Healthcare experts should be concerned about prescriptions of off-label drugs, especially anticoagulants and newly developed drugs such as immunosuppressants and antineoplastic agents.Keywords: off-label use, adverse events, adverse drug reaction reporting systems, disproportionalityHan NOh JMKim IWDove Medical Pressarticleoff-label useadverse eventsadverse drug reaction reporting systemsdisproportionalityTherapeutics. PharmacologyRM1-950ENTherapeutics and Clinical Risk Management, Vol Volume 17, Pp 877-887 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	off-label use adverse events adverse drug reaction reporting systems disproportionality Therapeutics. Pharmacology RM1-950
spellingShingle	off-label use adverse events adverse drug reaction reporting systems disproportionality Therapeutics. Pharmacology RM1-950 Han N Oh JM Kim IW Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
description	Nayoung Han,1,2 Jung Mi Oh,1,3 In-Wha Kim1 1Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea; 2College of Pharmacy, Jeju National University, Jejusi, Jeju Special Self-Governing Province, Republic of Korea; 3College of Pharmacy, Seoul National University, Seoul, Republic of KoreaCorrespondence: In-Wha KimResearch Institute of Pharmaceutical Sciences, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Republic of KoreaTel +82 2 880-7736Fax +82 2 882-9560Email iwkim2@hanmail.netPurpose: The purpose of this study was to investigate the adverse events (AEs) related to the use of off-label drugs.Materials and Methods: A cross-sectional study was carried out using available data pertaining to off-label drug were sourced from U.S. FDA spontaneous adverse drug reaction reporting database (FAERS) and Korea Adverse Event Reporting System database (KIDS-KD) for the years 2014 to 2018. The number and frequencies of AE cases were calculated. Disproportionality was analyzed using the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM) methods.Results: The reported AEs associated with off-label drug use were more common among older patients compared with younger patients. Gastric nonspecific symptoms and therapeutic procedure (4.16– 4.57%) and haemorrage term (4.16– 5.29%) were the most common AE symptoms and antithrombotic agents and immunosuppressants were the drugs most commonly reported to cause AEs in FAERS. Secondary term events (43.45– 48.62%) including inappropriate schedule of drug administration and medication error were the most common AEs, and immunosuppressants and antipsychotics were the most common AE-related drugs from KIDS-KD. The numbers of reported AEs in new drug categories such as other antineoplastic agents trended to increase from 2014 to 2018 in both datasets.Conclusion: The numbers of reported AEs with off-label drug increased annually. AEs associated with off-label drugs may have a significant impact on older patients. Healthcare experts should be concerned about prescriptions of off-label drugs, especially anticoagulants and newly developed drugs such as immunosuppressants and antineoplastic agents.Keywords: off-label use, adverse events, adverse drug reaction reporting systems, disproportionality
format	article
author	Han N Oh JM Kim IW
author_facet	Han N Oh JM Kim IW
author_sort	Han N
title	Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
title_short	Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
title_full	Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
title_fullStr	Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
title_full_unstemmed	Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
title_sort	adverse events related to off-label drugs using spontaneous adverse event reporting systems
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/120581c1600c45da9d6e317447ef183b
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Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems

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