| Budget Amount *help |
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2012: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2011: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
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| Research Abstract |
We evaluated the effectiveness of warning letters published by pharmaceutical regulatory agencies in Japan on communication of drug safety and risk by quantitative analysis of the national health insurance claims database (NHICD). We then explored what factors may have affected risk communication. The implementation rate of the hepatitis virus-monitoring test was only 1.6% of all MTX-administrated RA patients, with little difference before and after the official announcement by warning letter. The implementation rates of inpatient hepatitis B virus or hepatitis C virus monitoring in hospitals equipped with drug information management room (DIMR) and drug safety information management systems (DSIMS) were higher than those in hospitals without these systems. Thus, DIMRs and DSIMS efficiently transmit medication safety information.
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