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KMID : 1011320210130020078
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Journal of Pharmacoepidemiology and Risk Management
2021 Volume.13 No. 2 p.78 ~ p.86
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Surveillance of Adverse Drug Reactions to First-line Antituberculosis Drugs Using Common Data Model
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Byeon Sun-Ju
Park Hang-A
Kang Dong-Yoon
Choi In-Young
Choi Jeong-Hee
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Abstract
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Objective: Tuberculosis (TB) remains a major health problem with high rates of mortality in Korea. Adverse drug reactions (ADRs) to anti-TB drugs negatively affect drug compliance, lead to poor prognosis, and augment socioeconomic costs. However, the prevalence and risk factors of ADR to anti-TB drugs have seldom been studied in a large population in Korea. We investigated the incidence and risk factors of ADRs to first-line anti-TB drugs by using an electronic health record (EHR)-based common data model (CDM) for ADRs.
Methods: EHR-based CDM (Jan. 2013-Dec. 2017) from three university hospitals were used to obtain information about ADRs. The ‘index date’ was the first day that anti-TB medication was used. ADRs were defined as laboratory abnormalities (described in more detail in the main text) measured on +8?+90 days from the index date. Comorbidities and concomitant drugs were considered as confounding factors. Analyses with multinomial logistic regressions were performed using the R program.
Results: A total of 7,288 patients were enrolled in the study. The incidence of ADR was 122/5,623 (2.20%) for leukopenia, 56/3,740 (1.50%) for anemia, 66/5,756 (1.15%) for thrombocytopenia, 21/4,948 (0.42%) for hyperbilirubinemia, 179/4,527 (3.95%) for high aspartate aminotransferase (AST), 201/4,527 (4.44%) for high aminotransferase (ALT), 1,184/2,742 (43.18%) for hyperuricemia and 44/5,111 (0.86%) for elevated Cr. The risk factors were different for each ADR.
Conclusion: Laboratory abnormalities were common ADRs, and CDM is a useful tool for the active surveillance of ADRs to anti- TB drugs.
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KEYWORD
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Adverse drug reaction, Tuberculosis, Common data model
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