J Pharmacoepidemiol Risk Manage.
2021 Sep;13(2):78-86. 10.56142/2021.13.2.78.
Surveillance of Adverse Drug Reactions to First-line Antitu berculosis Drugs Using Common Data Model
- Affiliations
-
- 1Department of Pathology, Hallym University College of Medicine, Chuncheon, Korea
- 2Allergy and Clinical Immunology Research Center, , Hallym University College of Medicine, Chuncheon, Korea
- 3Department of Emergency Medicine, Hallym University College of Medicine, Chuncheon, Korea
- 4Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Korea
- 5Department of Medical Informatics, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 6Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- KMID: 2534666
- DOI: http://doi.org/10.56142/2021.13.2.78
Abstract
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.
