Resolving a Double Standard for Risk Management of ThalidomideAn Evaluation of Two Different Risk Management Programmes in Japan

被引：0
作者：
Nobuhiro Ooba
Tsugumichi Sato
Hikaru Watanabe
Kiyoshi Kubota
机构：
[1] University of Tokyo,Department of Pharmacoepidemiology, Faculty of Medicine
[2] Drug Safety Research Unit Japan,undefined
来源：
Drug Safety | 2010年 / 33卷
关键词：
Multiple Myeloma; Thalidomide; Double Standard; Childbearing Potential; Administrative Office;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Background: Thalidomide, once withdrawn because of its teratogenicity, has now been re-launched worldwide. In Japan, thalidomide has been imported by individual doctors since around the year 2000. In October 2008, it was approved for the treatment of multiple myeloma (MM) by the Ministry of Health, Labour and Welfare (MHLW) on the condition that the manufacturer implemented a risk management programme termed the Thalidomide Education and Risk Management System (TERMS). It is likely that the imports of thalidomide will be used off-label to treat diseases other than MM. Thus, the MHLW is also planning to introduce a web-based registration system, referred to as the Safety Management System for Unapproved Drugs (SMUD), for thalidomide imported by individual doctors.
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页码：35 / 45
页数：10
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