Road traffic crash risk associated with benzodiazepine and z-hypnotic use after implementation of a colour-graded pictogram: a responsibility study.

AIMS: To assess potential change in medicine exposure and association with the risk of road traffic crash across a time period that started before the implementation of a grading system warning of the effect of medicine on driving performance. METHODS: Data from three French national databases were extracted and matched: the national health care insurance database, police reports and the national police database of injurious crashes. Drivers involved in such crashes in France, from July 2005 to December 2011 and identified by their national identifier, were included. Association with the risk of crash was estimated using a case-control analysis comparing benzodiazepine and z-hypnotic use among drivers responsible or not responsible for the crash. RESULTS: Totals of 69 353 responsible and 73 410 non-responsible drivers involved in an injurious crash were included. Exposure to benzodiazepine anxiolytics was associated with an increased risk of being responsible for a road traffic crash during the pre-intervention period (OR = 1.42 [1.24-1.62]). The association disappeared in the post-intervention period, but became significant again thereafter. The risk of being responsible for a crash increased in users of z-hypnotics across the study period. CONCLUSIONS: Our results question the efficacy of the measures implemented to promote awareness about the effects of medicines on driving abilities. Prevention policies relating to the general driving population, but also to healthcare professionals, should be reviewed.

Long-term chronic diseases and crash responsibility: a record linkage study.

OBJECTIVE: To assess the population impact of chronic conditions on the risk of road traffic crashes. METHODS: Data from three French national databases were extracted and matched: the national health care insurance database, police reports and the national police database of injurious crashes. Exposure to chronic conditions were compared between responsible and nonresponsible drivers. Analysis was performed using the Lasso (least absolute shrinkage and selection operator) method. RESULTS: 69,630 drivers involved in an injurious crash in France between 2005 and 2008, were included. 6210 (8.9%) were suffering from at least one long-term disease. When adjusted for prescription of medicines, blood alcohol, demographic driver characteristics and crash characteristics, increased risk of being responsible for a crash was found in drivers registered in the French healthcare database with the following long-term diseases: epilepsy (odds ratio [OR]=2.53 [1.53-4.20]), type 1 diabetes (OR=1.47) [1.12-1.92], alcoholic liver disease (OR=3.37 [1.40-8.13]), asthma (OR=1.72 [1.13-2.60]) and specific personality disorders (OR=1.35 [1.05-1.74]). No association was found for cardiovascular diseases or Alzheimer's disease. CONCLUSION: The results update the list of medical conditions that may impair driving skills. However, results should be considered cautiously with regards to potential regulatory driving judgments that could have a negative impact on patients' social life.

Prescription of antiepileptics and the risk of road traffic crash.

Studies assessing the impact of epilepsy and its medication on the risk of road traffic crashes have shown inconsistent results. The aim in this study was to assess this risk using French databases. Data from three French national databases were extracted and matched: the national health care insurance database, police reports, and the national police database of injurious crashes. Only antiepileptics prescribed predominantly in epilepsy were studied (phenobarbital, phenytoin, ethosuximide, valproic acid, vigabatrin, tiagabin, levitiracetam, zonisamide, and lacosamide). A case-control analysis comparing responsible and non-responsible drivers and a case-crossover analysis were performed. Drivers (72 685) involved in an injurious crash in France between July 2005 and May 2008, were included. Drivers exposed to prescribed antiepileptic medicines (n = 251) had an increased risk of being responsible for a crash (OR 1.74 [1.29-2.34]). The association was also significant for the most severe epileptic patients (n = 99; OR = 2.20 [1.31-3.69]). Case-crossover analysis found no association between crash risk and treatment prescription. Patients with prescription of antiepileptic drugs should be cautioned about their potential risk of road traffic crash. This risk is however more likely to be related to seizures than to the effect of antiepileptic medicines.

Risk of injurious road traffic crash after prescription of antidepressants.

OBJECTIVE: To estimate the risk of road traffic crash associated with prescription of antidepressants. METHOD: Data were extracted and matched from 3 French national databases: the national health care insurance database, police reports, and the national police database of injurious crashes. A case-control analysis comparing 34,896 responsible versus 37,789 nonresponsible drivers was conducted. Case-crossover analysis was performed to investigate the acute effect of medicine exposure. RESULTS: 72,685 drivers, identified by their national health care number, involved in an injurious crash in France from July 2005 to May 2008 were included. 2,936 drivers (4.0%) were exposed to at least 1 antidepressant on the day of the crash. The results showed a significant association between the risk of being responsible for a crash and prescription of antidepressants (odds ratio [OR] = 1.34; 95% CI, 1.22-1.47). The case-crossover analysis showed no association with treatment prescription, but the risk of road traffic crash increased after an initiation of antidepressant treatment (OR = 1.49; 95% CI, 1.24-1.79) and after a change in antidepressant treatment (OR = 1.32; 95% CI, 1.09-1.60). CONCLUSIONS: Patients and prescribers should be warned about the risk of crash during periods of treatment with antidepressant medication and about particularly high vulnerability periods such as those when a treatment is initiated or modified.

Road traffic crashes and prescribed methadone and buprenorphine: a French registry-based case-control study.

BACKGROUND: Opioids have been shown to impair psychomotor and cognitive functioning in healthy volunteers with no history of opioid abuse. Few or no significant effects have been found in opioid-dependant patients in experimental or driving simulation studies. The risk of road traffic crash among patients under buprenorphine or methadone has not been subject to epidemiological investigation so far. The objective was to investigate the association between the risk of being responsible for a road traffic crash and the use of buprenorphine and methadone. METHODS: Data from three French national databases were extracted and matched: the national health care insurance database, police reports, and the national police database of injurious crashes. Case-control analysis comparing responsible versus non responsible drivers was conducted. RESULTS: 72,685 drivers involved in an injurious crash in France over the July 2005-May 2008 period, were identified by their national health care number. The 196 drivers exposed to buprenorphine or methadone on the day of crash were young, essentially males, with an important co-consumption of other substances (alcohol and benzodiazepines). Injured drivers exposed to buprenorphine or methadone on the day of crash, had an increased risk of being responsible for the crash (odds ratio (OR)=2.02, 95% confidence interval (CI): 1.40 and 2.91). CONCLUSIONS: Users of methadone and buprenorphine were at increased risk of being responsible for injurious road traffic crashes. The increased risk could be explained by the combined effect of risky behaviors and treatments.

Prescription medicines and the risk of road traffic crashes: a French registry-based study.

BACKGROUND: In recent decades, increased attention has been focused on the impact of disabilities and medicinal drug use on road safety. The aim of our study was to investigate the association between prescription medicines and the risk of road traffic crashes, and estimate the attributable fraction. METHODS AND FINDINGS: We extracted and matched data from three French nationwide databases: the national health care insurance database, police reports, and the national police database of injurious crashes. Drivers identified by their national health care number involved in an injurious crash in France, between July 2005 and May 2008, were included in the study. Medicines were grouped according to the four risk levels of the French classification system (from 0 [no risk] to 3 [high risk]). We included 72,685 drivers involved in injurious crashes. Users of level 2 (odds ratio [OR]  = 1.31 [1.24-1.40]) and level 3 (OR  = 1.25 [1.12-1.40]) prescription medicines were at higher risk of being responsible for a crash. The association remained after adjustment for the presence of a long-term chronic disease. The fraction of road traffic crashes attributable to levels 2 and 3 medications was 3.3% [2.7%-3.9%]. A within-person case-crossover analysis showed that drivers were more likely to be exposed to level 3 medications on the crash day than on a control day, 30 days earlier (OR  = 1.15 [1.05-1.27]). CONCLUSION: The use of prescription medicines is associated with a substantial number of road traffic crashes in France. In light of the results, warning messages appear to be relevant for level 2 and 3 medications and questionable for level 1 medications. A follow-up study is needed to evaluate the impact of the warning labeling system on road traffic crash prevention.

The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

PURPOSE: To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area. DATA SOURCES: The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies. Original articles published in English or French, between 1 April 1979 and 31 July 2008, were considered for inclusion. We excluded descriptive studies, studies limited to alcohol or illicit drug involvement and investigations of injuries other than from traffic crashes. Studies based on laboratory tests, driving simulators or on-the-road driving tests were also excluded. Eligible studies had to evaluate the causal relationship between the use of medicinal drugs and the risk of traffic crashes. Study quality was assessed by two independent experts, according to a grid adapted from the strengthening the reporting of observational studies in epidemiology (STROBE) statement. RESULTS: Twenty two studies of variable methodological quality were included. Definition of drug exposure varied across studies and depended on the data sources. Potential confounding due to the interaction between the effects of the medicinal drug and disease-related symptoms was often not controlled. The risk of motor-vehicle crashes related to benzodiazepines has been amply studied and demonstrated. Results for other medicinal drugs remain controversial. CONCLUSION: There is a need for large studies, investigating the role of individual substances in the risk of road traffic crashes.

[Adverse drug reactions: a pilot study on patient reporting through patient associations]. / Signalement d'événements indésirables par les patients : étude pilote réalisée avec la collaboration d'associations de patients.

BACKGROUND: The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events. METHODS: A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients. RESULTS: According to the analysis of the first 200 reports, received from June 2006 to August 2007, the reported adverse events are mostly serious in terms of consequences on patients' quality of life and expected. The quality of information shows that the proposed tools are adequate and could be used in case of a future change in legislation allowing patient reporting of adverse events. CONCLUSION: The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.