title: Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database.
abstract: Data mining is critical for signal detection in pharmacovigilance systems. In this study, we compared signals between spontaneous reporting data and health insurance claims data for a socially issued drug, methylphenidate. We implemented data-mining tools for signal detection in both databases: Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Chi-squared test, and Information Component (IC), in addition to a Relative Risk (RR) tool in the claims database. The claims database generated 15, 15, 36, 1, and 1 adverse drug reactions (ADRs) by ROR, PRR, chi-square, IC, and RR, respectively. The World Health Organization (WHO) spontaneous database generated 91, 91, 137, and 96 ADRs by ROR, PRR, chi-square, and IC, respectively. We found seven potential matching associations from the claims and WHO databases, but only one of them was present in the Korean spontaneous reporting database. In Korea, spontaneous reporting is still underreported and there is a small amount of data for Koreans. Signal comparison between the claims and WHO databases can provide additional regulatory insight.
authors.affiliation: Pharmaceutical Safety Bureau, Korea Food and Drug Administration, Osong 363-951, Republic of Korea.
authors.forename: JaYoung
authors.initials: J
authors.lastname: Kim
authors.forename: Munsin
authors.initials: M
authors.lastname: Kim
authors.forename: Ji-Hye
authors.initials: JH
authors.lastname: Ha
authors.forename: Junghoon
authors.initials: J
authors.lastname: Jang
authors.forename: Myungsil
authors.initials: M
authors.lastname: Hwang
authors.forename: Byung Koo
authors.initials: BK
authors.lastname: Lee
authors.forename: Myeon Woo
authors.initials: MW
authors.lastname: Chung
authors.forename: Tae Moo
authors.initials: TM
authors.lastname: Yoo
authors.forename: Myung Jung
authors.initials: MJ
authors.lastname: Kim
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining / Q000379:methods; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced; D006801:Humans; D007344:Insurance Claim Reporting; D008774:Methylphenidate / Q000009:adverse effects*; D016017:Odds Ratio; D060735:Pharmacovigilance; D056910:Republic of Korea; D058028:Research Report; D012306:Risk; D017603:Signal Detection, Psychological
chemical_list: D008774:Methylphenidate