title: The effectiveness of risk communication regarding drug safety information: a nationwide survey by the Japanese public health insurance claims data.
abstract: OBJECTIVE
  We evaluated the effectiveness of warning letters published by the pharmaceutical regulatory agency 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.
  
  
  METHODS
  We measured the implementation rate of the hepatitis virus-monitoring test among methotrexate (MTX)-treated patients; a warning letter had been issued regarding the use of MTX, as it apparently activates the hepatitis virus. Data from the NHICD, which include 99·3% of Japanese residents, were used. A total of 4,933,481 patients with rheumatoid arthritis (RA) (January-June, 2010) were the focus of this study.
  
  
  RESULTS
  The implementation rate of the hepatitis virus-monitoring test increased from 1·4% before to 1·8% after the warning letter announcement. Logistic regression analysis suggested that the installation of a drug information management room is one of the important factors affecting risk communication. Further analysis revealed that the hepatitis virus monitoring rates in hospitals without drug information management rooms increased from 2·3% to 4·1% due to the issue of the warning letter.
  
  
  CONCLUSIONS
  The warning letter from the regulatory agency plays an important role in risk communication in hospitals without drug information management rooms.
authors.affiliation: Department of Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Hagiwara
authors.forename: Shun
authors.initials: S
authors.lastname: Nakano
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Ogawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tohkin
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis* / Q000209:etiology / Q000821:virology; D003142:Communication; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007348:Insurance, Health; D007564:Japan; D016015:Logistic Models; D008297:Male; D008727:Methotrexate / Q000009:adverse effects* / Q000627:therapeutic use; D012306:Risk; D011795:Surveys and Questionnaires
chemical_list: D018501:Antirheumatic Agents; D008727:Methotrexate
keywords: drug information management room; hepatitis B virus or hepatitis C virus monitoring; methotrexate; national health insurance claims database; pharmaceuticals and medical devices safety information; risk communication