Research Article: Prescription Medicines and the Risk of Road Traffic Crashes: A French Registry-Based Study

Date Published: November 16, 2010

Publisher: Public Library of Science

Author(s): Ludivine Orriols, Bernard Delorme, Blandine Gadegbeku, Aurore Tricotel, Benjamin Contrand, Bernard Laumon, Louis-Rachid Salmi, Emmanuel Lagarde, Munir Pirmohamed

Abstract: Using three nationwide databases in France, Ludivine Orriols, Emmanuel Lagarde, and colleagues provide evidence that prescribed medicines contribute to the risk of experiencing a road traffic crash.

Partial Text: The association between the use of benzodiazepines and the risk of road traffic crashes has now been documented with consistent results in several studies [1]–[13], but the effect of other medicines has been less assessed and results of available studies are often inconsistent [14]. This lack of assessment is particularly true for opioids [2],[8],[9],[12],[15],[16] and antidepressants [1],[12],[16],[17]. Psychoactive medicines may impair driving abilities owing to their action on the central nervous system (e.g., sedation in the morning following administration of a hypnotic), whereas other medicines may affect psychomotor functions by their action on physiological functions (e.g., hypoglycaemic seizures related to diabetic treatment) or because of centralised side effects (e.g., the depressant potential of carisoprodol on the central nervous system). In the European Union, it is mandatory for pharmaceutical companies to provide data about the effects of a medicine on the ability to drive and to use machinery prior to the medicine being allowed on the market. In 2003, the European Medicine Agency requested the standardized classification of medicines according to four levels of driving impairment risk, from level 0 (no or negligible risk) to level 3 (major risk), in order to provide health care professionals and patients with full information on the effects of medicines on driving abilities. The European DRUID project (Driving Under the Influence of Drugs, alcohol and medicines) identified 16 classification systems worldwide [18]. In 2006, the International Council on Alcohol, Drugs and Traffic Safety (ICADTS) proposed a medication classification system on the basis of the Belgium, Spanish, and French classification systems. In France, a multidisciplinary group of experts was appointed to classify all medicines according to four levels of risk in terms of their effect on driving performance [19]. A graded pictogram was designed to be printed on the outer packaging of all level 1 to 3 medicines (Figure 1). Pharmaceutical companies gradually implemented this policy from 2005 to 2008. Level 1, 2, and 3 medications are labeled with instructions that are relevant to driving for patients. The aim of our study was to estimate the association between medicine use, as estimated using prescribed medicine dispensation data from a health care reimbursement database, and the risk of injurious road traffic crashes, as well as the fraction of crashes attributable to medicine use in France.

We found evidence for an increased risk of being responsible for a road traffic crash for users of prescribed medicines defined as presenting a level 2 or level 3 risk of driving impairment according to the French medication classification system. The fraction of road traffic crashes attributable to levels 2 and 3 medicine use was 3.3% [2.7%–3.9%].



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