Hagiwara Hiromi, Nakano Shun, Ogawa Yoshihiro, Tohkin Masahiro
Department of Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan.
J Clin Pharm Ther. 2015 Jun;40(3):273-8. doi: 10.1111/jcpt.12256. Epub 2015 Mar 6.
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.
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.
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.
The warning letter from the regulatory agency plays an important role in risk communication in hospitals without drug information management rooms.
我们通过对国家医疗保险索赔数据库（NHICD）进行定量分析，评估了日本药品监管机构发布的警示信在药物安全性和风险沟通方面的有效性。然后，我们探究了哪些因素可能影响了风险沟通。
我们测量了甲氨蝶呤（MTX）治疗患者中肝炎病毒监测测试的实施率；由于MTX明显会激活肝炎病毒，已就其使用发布了警示信。使用了来自NHICD的数据，该数据库涵盖了99.3%的日本居民。本研究聚焦于2010年1月至6月期间的4933481名类风湿性关节炎（RA）患者。
警示信发布后，肝炎病毒监测测试的实施率从之前的1.4%提高到了1.8%。逻辑回归分析表明，设立药物信息管理室是影响风险沟通的重要因素之一。进一步分析显示，由于警示信的发布，没有药物信息管理室的医院中肝炎病毒监测率从2.3%提高到了4.1%。
监管机构发出的警示信在没有药物信息管理室的医院的风险沟通中发挥着重要作用。
