Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance

Suehyun Lee, Jongsoo Han, Rae Woong Park, Grace Juyun Kim, John Hoon Rim, Jooyoung Cho, Kye Hwa Lee, Jisan Lee, Sujeong Kim and Ju Han Kim ()
Additional contact information
Suehyun Lee: Seoul National University Biomedical Informatics (SNUBI), Seoul National University College of Medicine
Jongsoo Han: Seoul National University Biomedical Informatics (SNUBI), Seoul National University College of Medicine
Rae Woong Park: Ajou University School of Medicine
Grace Juyun Kim: Seoul National University Biomedical Informatics (SNUBI), Seoul National University College of Medicine
John Hoon Rim: Yonsei University College of Medicine
Jooyoung Cho: Yonsei University Graduate School of Medicine
Kye Hwa Lee: Seoul National University Biomedical Informatics (SNUBI), Seoul National University College of Medicine
Jisan Lee: Catholic University of Pusan
Sujeong Kim: Seattle University
Ju Han Kim: Seoul National University Biomedical Informatics (SNUBI), Seoul National University College of Medicine

Drug Safety, 2019, vol. 42, issue 5, No 8, 657-670

Abstract: Abstract Introduction Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. Objective To provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation, we developed a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD) for pharmacovigilance. Methods A CVAD consists of (1) administrative disease classifications of the International Classification of Diseases (ICD) codes mapped to the Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA® PTs); (2) two teaching hospitals’ codes for laboratory test results mapped to the Logical Observation Identifiers Names and Codes (LOINC) terms and MedDRA® PTs; and (3) clinical narratives and ADRs encoded by standard nursing statements (encoded by the International Classification for Nursing Practice [ICNP]) mapped to the World Health Organization–Adverse Reaction Terminology (WHO-ART) terms and MedDRA® PTs. Results Of the standard 4514 MedDRA® PTs from Side Effect Resources (SIDER) 4.1, 1130 (25.03%), 942 (20.86%), and 83 (1.83%) terms were systematically mapped to clinical narratives, laboratory test results, and disease classifications, respectively. For the evaluation, we loaded multi-source EHR data. We first performed a clinical expert review of the CVAD clinical relevance and a three-drug ADR case analyses consisting of linezolid-induced thrombocytopenia, warfarin-induced bleeding tendency, and vancomycin-induced acute kidney injury. Conclusion CVAD had a high coverage of ADRs and integrated standard controlled vocabularies to the EHR data sources, and researchers can take advantage of these features for EHR observational data-based extensive pharmacovigilance studies to improve sensitivity and specificity.

Date: 2019
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-018-0767-7 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:42:y:2019:i:5:d:10.1007_s40264-018-0767-7

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-018-0767-7

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().