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Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm

Content Provider	SAGE Publishing
Author	Shin, Hyunah Cha, Jaehun Lee, Youngho Kim, Jong-Yeup Lee, Suehyun
Copyright Year	2021
Abstract	Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.
Related Links	https://journals.sagepub.com/doi/pdf/10.1177/14604582211033014?download=true
ISSN	14604582
Issue Number	3
Volume Number	27
Journal	Health Informatics Journal (JHI)
e-ISSN	17412811
DOI	10.1177/14604582211033014
Language	English
Publisher	Sage Publications UK
Publisher Date	2021-07-21
Publisher Place	London
Access Restriction	Open
Rights Holder	© The Author(s) 2021
Subject Keyword	pharmacovigilance adverse drug reaction real-world data electronic health record Korean Adverse Event Reporting System
Content Type	Text
Resource Type	Article
Subject	Health Informatics

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