A PERSPECTIVE OF PHARMACOVIGILANCE USING HEALTH CARE CLAIMS DATA BASED ON COMPARISON WITH SERTRALINE POSTMARKETING SURVEILLANCE IN JAPAN
Author(s)
Hirano Y1, Asami Y1, Kuribayashi K1, Kitazaki S2, Yamamoto Y2, Fujimoto Y3
1Pfizer Japan Inc., Tokyo, Japan, 2MinaCare co.ltd, Tokyo, Japan, 3Pfizer Japan Inc, Tokyo, Japan
OBJECTIVES: A lot of pharmacoepidemiological studies have recently been utilized to evaluate drug safety for pharmacovigilance purpose in Western countriesHowever, in Japan, conventional prospective methodology of post marketing surveillance (PMS) is applied to collect safety information for new drugs to meet regulatory requirement This study aims to examine the possibility of database research as a means of pharmacovigilance in Japan. METHODS: We scanned the characteristics of sertraline-prescribed patients in a large-scale Japan health insurance claims database provided by MinaCare Co., Ltd., including more than two million individuals’ data accumulated up to September, 2013 and compared them with the PMS results conducted from December, 2006 to November, 2010. We also explored the possibility of detecting signals of adverse reactions from the claims database, using a sequence symmetry analysis which is a self-controlled study design. Diabetes mellitus, hyperlipidemia and hyperthyroidism were used as target events, whose detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency RESULTS: Most characteristics of the sertraline-prescribed patients in the claims database were similar to the PMS. The ASR (95% CI) was 0.893 (0.601, 1.301) for diabetes mellitus, 0.871 (0.708, 1.067) for hyperlipidemia, and 0.747 (0.224, 1.976) for hyperthyroidism, which showed no tendency for elevating the risk of these events after exposure to sertraline, and this was in accord with sertraline’s known safety profile. CONCLUSIONS: This study showed similar patient characteristics between the claims database and the PMS, and suggested the possibility of detecting signals of adverse reactions from the claims databaseThus, database research could be a useful option to consider for pharmacovigilance in Japan
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PMH16
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Mental Health