The effectiveness of risk communication regarding drug safety information: A nationwide survey by the Japanese public health insurance claims data

我们通过对国家健康保险索赔数据库（NHICD）的定量分析，评估了日本药品监管机构发布的警告信在药品安全性和风险沟通方面的有效性。然后，我们探讨了哪些因素可能影响风险沟通。所有甲氨蝶呤类风湿性关节炎患者肝炎病毒监测检测的实施率仅为1.6%，正式警告信公告前后差异不大。配备药品信息管理室（DIMR）和药品安全信息管理系统（DSIMS）的医院对住院患者乙型或丙型肝炎病毒监测的实施率高于未配备该系统的医院。因此，DIMRs和DSIMS有效地传递了药物安全信息。

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.