title: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Drug Safety Division, Chugai Pharmaceutical Co., Ltd., 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, Japan. udagawayko@chugai-pharm.co.jp.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Udagawa
authors.affiliation: Project and Lifecycle Management Unit, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Ohno
authors.affiliation: Clinical Development Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Nakagawa
authors.affiliation: Drug Safety Division, Chugai Pharmaceutical Co., Ltd., 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, Japan.
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Sugimoto
authors.affiliation: Drug Safety Division, Chugai Pharmaceutical Co., Ltd., 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, Japan.
authors.forename: Joji
authors.initials: J
authors.lastname: Mochizuki