Behavioral Science Division, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.
Department of Health Informatics, Kyoto University Graduate School of Medicine & School of Public Health, Kyoto, Japan.
Drug Discov Ther. 2021 May 11;15(2):101-107. doi: 10.5582/ddt.2021.01028. Epub 2021 Apr 30.
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 the Related Materials. However, the adequacy of these documents has not yet been systematically assessed. The aim of this study was to evaluate the adequacy of these two types of materials. The Rapid Safety Communications for Patients were obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) website. The Related Materials were obtained from pharmaceutical companies or the PMDA website. Three assessors independently scored the Rapid Safety Communication for Patients and the Related Materials using the Centers for Disease Control and Prevention Clear Communication Index (CCI). In addition, the contents and descriptions of the materials were analyzed. In total, 13 materials for seven drugs were assessed. Almost all materials contained the "main message" and "call to action". However, the average CCI scores for the Rapid Safety Communication for Patients and Related Materials for Patients were 68.8 and 74.3 (out of 100), respectively. Further, none of the evaluated materials were scored above the CCI threshold score (i.e., ≥ 90%). Descriptions regarding "language", "state of science", and "risk" were not adequate. In particular, the terminology used in materials seemed difficult for patients to understand. In conclusion, the Japanese Rapid Communication Materials for Patients require improvement. Furthermore, a system for evaluating these materials prior to publication should be established.
自 2011 年以来，日本的制药公司被要求发布两种与上市后报告的严重药物不良反应相关的文件，即快速安全通讯材料和相关材料。然而，这些文件的充分性尚未得到系统评估。本研究旨在评估这两种材料的充分性。快速安全通讯材料是从药品和医疗器械管理局（PMDA）的网站上获得的。相关材料是从制药公司或 PMDA 的网站上获得的。三位评估员使用疾病控制与预防中心明确沟通指数（CCI），分别对快速安全通讯材料和相关材料进行独立评分。此外，还对材料的内容和描述进行了分析。总共评估了七种药物的 13 种材料。几乎所有的材料都包含“主要信息”和“行动呼吁”。然而，快速安全通讯材料和相关材料的平均 CCI 得分分别为 68.8 和 74.3（满分 100 分）。此外，没有一份评估材料的 CCI 得分超过阈值分数（即≥90%）。关于“语言”、“科学状况”和“风险”的描述不充分。特别是，材料中使用的术语似乎让患者难以理解。总之，日本的快速通讯材料需要改进。此外，应该建立一个在发布前评估这些材料的系统。
