藥駕(即在藥物影響下駕駛)可誘發(fā)交通事故,是重要的公共健康問題。美國食品藥品管理局(FDA)為促進(jìn)相關(guān)研究,于2015年1月發(fā)布了《供企業(yè)用評價藥物影響駕駛機(jī)動車能力指導(dǎo)原則(草案)》,詳細(xì)闡述了精神活性藥物損害駕駛能力研究的一般要求。介紹該指導(dǎo)原則的主要內(nèi)容:評估駕駛損害的需要、評價藥物對駕駛影響的分層方法以及相關(guān)藥品說明書的撰寫,期望對我國相關(guān)規(guī)范的制訂、研究工作的開展以及藥品說明書的撰寫有所幫助。

Drug driving (driving under the inference of drugs) can induce motor vehicle accidents (MVAs) and is a major public health problem. FDA issued the draft “Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry” in January, 2015 to promote the research in this area. The general principles of research on driving ability damaged by psychoactive drug are elaborated. The main contents of the guidance are introduced here, including the need to evaluate driving impairment, the tiered approach to evaluate drug effects on driving as well as the drugs' labeling. It is expected to be helpful to create corresponding guidance, do such research, and write its labeling in our country.