9th Annual Scientific Meeting: Methodological Issues in Assessing the Impact of CNS Drugs on Driving Performance
Chairs: Tom Macek, PharmD, PhD; Tom Roth, PhD
As CNS drugs are known to potentially increase the risk of impaired driving performance. Although the effects of sleep deprivation, sleep disorders and alcohol on performance have been systematically assessed, the methodological approaches to the assessment of CNS agents on driving performance have not. Various direct and indirect methods to assess the potential impact of medications or other substances on driving performance have been developed. These methods include a broad spectrum of measures of vigilance, divided attention , or other aspect of psychomotor functioning as well as simulated driving and on the road driving tasks to measure the potential impact on driving performance. There is, however, limited regulatory guidance for the standardized assessment of medications or other substances on driving impairment. More importantly there is no consensus of how to translate the results of these studies in risk of impaired driving
In recent years, the National Highway Traffic Safety Administration convened an international panel of experts to address the effects of medications or illicit substances on driving performance. While the effects of illicit drugs on driving performance are relatively well known, the NHTSA panel determined that one of the major impediments to the classification of the potential risk of impairment for OTC and prescription medications is the lack of a common, standardized protocol to assess this risk.
In 2012, the panel developed a tiered, parallel process involving pharmacological, toxicological, epidemiological reviews and a standardized behavioral assessment for the impact of drugs on driving performance. The consensus test battery to assess the impact for assessing impaired driving abilities includes measures of alertness/arousal, attention and processing speed, reaction time and psychomotor function, sensory-perceptual function, and executive function.
The proposed symposium would review the potential for CNS agents to impair driving performance, discuss clinical, statistical, and epidemiological currently available data, discuss the advantages and limitations of various clinical, epidemiological and statistical methods in evaluating the effects of medications or other substances on driving performance, as well as the perspectives of governmental transportation and other regulatory agencies on the systematic assessment of CNS-acting agents on driving performance.
Specifically, the goals of this session will be to discuss the:
- Relatedness of sleepiness and drug effects on driving performance
- Methodological approaches and limitations in the assessment of drugs on driving performance
- Innovative methodologies to assess accident risk performance data
- Impact of the recommended NHTSA standardized assessment of medications in development or currently marketed medications
- Impact of NHTSA recommendations on risk assessment by government highway and transportation agencies