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KMID : 1011320180100010032
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Journal of Pharmacoepidemiology and Risk Management
2018 Volume.10 No. 1 p.32 ~ p.35
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Unlabeled ADR Study Based on In-Hospital Individual Case Safety Reports and KAERS Database
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Hwang So-Yeon
Kang Dong-Yoon
Kim Nam-Hee
Lee Jin
Cho Yoon-Sook
Jung Sun-Young
Lee Ju-Yeun
Kang Hye-Ryun
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Abstract
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Objective: The purpose of this study was to evaluate unlabeled adverse drug reactions (ADRs) and to establish supporting data for the addition of new ADRs to the domestic drug labeling.
Methods: We retrospectively reviewed chart of unlabeled adverse event among in-hospital individual case safety report (ICSR) database in the Seoul National University Hospital from 2010 to 2016. We chose unlabeled drug-ADR combinations by assessing domestic drug labeling of all the cases and searched Korea Adverse Event Reporting System (KAERS) database collected during the same period and United States FDA (USFDA) drug package insert, and Micromedexⓡ to validate the occurrence of the same drug-ADR combinations in other domestic institutes and other countries.
Results: Among 33,348 ICSR of SNUH, a total of 614 (1.84%) unlabeled cases were identified during the study period. Out of 614 cases, 60 (9.8%) cases with 20 drug-ADR combinations were repeatedly reported at least two times. When searched in KAERS database, 1,371 (0.05%) corresponding cases were found among 2,519,113 case reports. Among 20 drug-ADR combinations, six combinations were already included in US FDA drug package insert, and other five combinations were unlabeled in US FDA drug package insert but described in Micromedexⓡ. The other nine drug-ADR combinations were neither labeled in FDA drug package insert nor described in Micromedexⓡ.
Conclusion: By assessment of drug labeling status of ICSR data in a single institute and comparison with KAERS data, USFDA drug package insert, description in Micromedexⓡ, we could select potential candidate drugs requiring revision of a package insert related with adverse reactions.
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KEYWORD
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Pharmacovigilance, Adverse drug reaction, Voluntary patient safety event reporting, Food and Drug Administration
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