Evaluation of rapid drug safety communication materials for patients in Japan

Since 2011, pharmaceutical companies in Japan have been required to issue two types of documents regarding severe adverse drug reactions reported post-marketing, namely the Rapid Safety Communication Materials for Patients and Related Materials. However, adequacy these has not yet systematically assessed. The aim this study was evaluate materials. Communications were obtained from Pharmaceuticals Medical Devices Agency (PMDA) website. or PMDA Three assessors independently scored using Centers Disease Control Prevention Clear Index (CCI). In addition, contents descriptions materials analyzed. total, 13 seven drugs Almost all contained "main message" "call action". average CCI scores 68.8 74.3 (out 100), respectively. Further, none evaluated above threshold score (i.e., ≥ 90%). Descriptions "language", "state science", "risk" adequate. particular, terminology used seemed difficult patients understand. conclusion, Japanese require improvement. Furthermore, a system evaluating prior publication should be established.