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

Abstract

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. The percentages of patients tested for hepatitis B virus DNA (HBV-DNA), hepatitis B surface antigen (HBsAg), and hepatitis B surface antibody (HBsAb)/hepatitis B core antibody (HBcAb) were compared 1 year before (consecutive 6-month periods A and B) and 1 year after (consecutive 6-month periods C and D) a PMDA alert regarding viral reactivation in patients receiving immunosuppressive agents. Results: Data for 9866 patients in the clinical database were analyzed. After the PMDA alert, the percentage of patients tested for HBV-DNA linearly increased in periods A to D: 4.70 % (n = 262/5571), 5.78 % (n = 330/5710), 6.52 % (n = 398/6101), and 7.59 % (n = 479/6315). However, no changes were observed in the rates of HBsAg and HBcAb/HBsAb testing (around 50 and 70 %, respectively). Overall testing rates appeared to differ depending on disease and drug type. Conclusion: These findings suggest that the PMDA alert was effective at recommending HBV-DNA testing. This secondary application of clinical databases may be effective for verifying the impact of risk minimization activities.