Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
- Authors
- Lee, Suehyun; Han, Jongsoo; Park, Rae Woong; Kim, Grace Juyun; Rim, John Hoon; Cho, Jooyoung; Lee, Kye Hwa; Lee, Jisan; Kim, Sujeong; Kim, Ju Han
- Issue Date
- May-2019
- Publisher
- ADIS INT LTD
- Citation
- DRUG SAFETY, v.42, no.5, pp.657 - 670
- Journal Title
- DRUG SAFETY
- Volume
- 42
- Number
- 5
- Start Page
- 657
- End Page
- 670
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88144
- DOI
- 10.1007/s40264-018-0767-7
- ISSN
- 0114-5916
- Abstract
- Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. 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. 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(A (R)) PTs); (2) two teaching hospitals' codes for laboratory test results mapped to the Logical Observation Identifiers Names and Codes (LOINC) terms and MedDRA(A (R)) 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(A (R)) PTs. Of the standard 4514 MedDRA(A (R)) 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. 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.
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