It is known that psychoactive drugs may produce impairment of attention and skills involved in driving performance and thus may increase the risk of traffic accident involvement. Several reliable and sensitive methods are available to assess different aspects of driving performance in safe conditions. They include various laboratory tests which explore psychomotor performance and cognitive functions (selective and divided attention, speed of reaction, sustained attention), electrophysiological measures (spectral analysis of resting EEG, multiple sleep latency test, saccadic eye movement) and other more complex measures such as driving simulators and on-the-road actual driving tests. Various combinations of these techniques should be used to demonstrate potential drug-induced changes in driving or skills related to driving in standardized placebo-controlled studies with healthy volunteers and/or patients. In my opinion, in addition to efficacy, behavioural toxicity should be assessed during drug development in order to obtain a reliable evaluation of the benefit/risk ratio for the patients and should be included in the registration file of all new psychoactive drugs. (A)
Samenvatting