PDF(Pubmed)
Abstract：
In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies. Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.
摘要：
2022年12月，卫生部发布了新的评估精神药品对驾驶机动车性能影响的指南，劳动和福利（MHLW）并在日本实施。在安全信息中，关于药物对驾驶表现的影响的信息尤为重要，因为它可能与患者的社会功能有关。原则上,药品包装说明书是根据证据设计的，并提供了有关日本汽车等重型机械操作的预防措施，美国,和欧洲。通常以涉及非临床和临床研究的分层方法评估药物对驾驶表现的影响。由于汽车驾驶涉及到各种各样的功能领域，给定药物的评估方法的选择取决于它们的特征，这是一个复杂的方法。因此,为了有效和适当地评估精神药物对驾驶表现的影响，我们制定了MHLW指南，专门定义了药理学研究中使用的评估方法，用于药效学研究的神经心理学测试，以及驾驶研究是必要的情况。关于规划适当的药物开发战略，我们回顾了MHLW指南的背景及其与美国食品和药物管理局(FDA)指南的差异.
