Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database |
| |
| Authors: | Kim JaYoung Kim Munsin Ha Ji-Hye Jang Junghoon Hwang Myungsil Lee Byung Koo Chung Myeon Woo Yoo Tae Moo Kim Myung Jung |
| |
| Institution: | aPharmaceutical Safety Bureau, Korea Food and Drug Administration, Osong 363-951, Republic of Korea;bInternational Trade and Statistics Officer, Director General for Planning and Coordination, Korea Food and Drug Administration, Osong 363-951, Republic of Korea;cClinical Research Division, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Osong 363-951, Republic of Korea;dRisk Analysis and Research Division, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Osong 363-951, Republic of Korea;eCollege of Pharmacy, Ewha Womans University, Seoul 120-750, Republic of Korea;fDivision of Drug Approval and Review Management, Department of Drug Evaluation, Korea Food and Drug Administration, Osong 363-951, Republic of Korea |
| |
| 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. |
| |
| Keywords: | Health insurance claims database National spontaneous reporting database Methylphenidate Signal detection WHO database |
| 本文献已被 ScienceDirect PubMed 等数据库收录！ |
|
