Using Clinical Databases to Verify the Impact of Regulatory Agency Alerts in Japan: Hepatitis B Testing Behavior After an Alert Regarding Risk of Viral Reactivation.

Background: Measures of the effectiveness of risk minimization activities are necessary for the appropriate use of drugs, and clinical databases are a low-cost method of quickly producing such results.

Objective: The aim of this study was to explore the secondary application of clinical databases in verifying the impact of risk minimization activities; specifically, whether such databases could be used to identify changes in hepatitis B virus testing behavior after an alert from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Methods: Patient data from December 1, 2010 to November 30, 2012 were extracted from the Medical Data Vision clinical database.