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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. [ABSTRACT FROM AUTHOR]

Patients with epilepsy often require long-term treatment with antiseizure medications, and their impact on daily activities, particularly driving, is of significant concern. The recently published "Guideline for Evaluating Effects of Psychotropic Drugs on the Performance to Drive a Motor Vehicle" in Japan provides a framework that can be referred to for not only the evaluation of new drugs but also the reevaluation of approved drugs. This study conducted a literature review regarding the effects of carbamazepine, valproate, lamotrigine, lacosamide, and levetiracetam, which are frequently prescribed for epilepsy, on driving performance following the guideline's tiered evaluation approach. Analyses of pharmacological, pharmacodynamic, and adverse events suggested that these drugs primarily affect arousal function. Driving studies showed that acute administration of carbamazepine, but not chronic monotherapy with carbamazepine, valproate, lamotrigine, and levetiracetam, significantly impairs driving performance. Epidemiological studies have not identified a definitive association between these drugs and traffic accidents. Initial administration of these five antiseizure medications may affect driving performance, warranting special attention, but the influence appears to diminish with continued use. Nevertheless, while long-term administration of these five drugs may not have a clinically meaningful effect on driving performance, safe driving is not guaranteed for each individual patient, and appropriate individualized guidance is important in clinical practice., (© 2024 The Author(s). Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsychopharmacology.)

An increase in older drivers has been widely recognized in Japan; accordingly, screening to prevent traffic accidents is a crucial issue for safe driving. As a preliminary study, we examined the association between on-road driving performance and cognition or physical performance in older individuals. The survey was conducted in 2020, and the participants were recruited in Katagami City, Akita, Japan. The Road Test was used to assess on-road driving performance. The physical assessment comprised the usual walking speed (UWS) and grip strength (GS), and the cognitive evaluation consisted of the National Center for Geriatrics and Gerontology Functional Assessment Tool (NCGG-FAT) and the Japanese version of Stroke Drivers' Screening Assessment (J-SDSA). A multiple regression model was also applied to examine the association between on-road driving performance and the physical items or cognitive domains of the NCGG-FAT and the J-SDSA in older individuals. Twenty-one participants (mean age ± standard deviation [SD], 77.0 ± 5.5 years) were included in this study. A correlation analysis showed that the on-road test score was correlated with performances on the UWS (r = 0.53, p =.002), the word list memory (WM) test (r = 0.44, p =.046), the trail-making test-A (TMT-A) (r = −0.44, p =.048), the SDSA dot cancelation (DC) test (r = −0.63, p =.002), and the SDSA squares matrix compass test (SM) (r = 0.54, p =.048). According to a stepwise linear regression, the on-road test score was associated with the UWS (β = −0.01, p =.003) and the SDSA DC (β = 4.89, p =.01), with an adjusted R2 = 0.54. The results of the study suggested that the UWS and sustainable attention might be potential factors influencing on-road driving performance. Our preliminary findings warrant further investigation. [ABSTRACT FROM AUTHOR]