Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)

Study Overview
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Brief Summary
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Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed Description
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Some medications are responsible of a wide range of cognitive and psychomotor side effects that may make it unsafe to drive and lead to risks of road accidents .The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of road traffic accidents following treatment with different class of drugs responsible for pyschomotor sides effects.

Official Title
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Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)

Conditions
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Accident, Traffic

Intervention / Treatment
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* Drug: Drugs Responsible for Cognitive Side Effects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/03/2020 Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ) Patients treated with at least one liable nervous system drugs (ATC class N) or that can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain barrier (ATC class A04, C02A, L) Exclusion Criteria: Chronology not compatible between the drug and the road traffic accident

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Road traffic accidents with medicines<br>Road traffic accidents cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Drugs Responsible for Cognitive and Psychomotor Side Effects | Drug: Drugs Responsible for Cognitive Side Effects<br>* identification of road traffic accidents associated with drugs responsible for psychomotor side effects<br>* Other names: Drugs Responsible for Pyschomotor Side Effects;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases | Identification of cases with association between each individual of different class of drugs responsible for cognitive ans psychomotor side effects and road traffic accidents cases | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between two drugs of the same class, leading to an over-reporting of road traffic accidents | Association between two drugs in the different class studied and road traffic accidents cases to search for a potential interaction between two drugs of the same class, leading to an over-reporting of road traffic accidents | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020 | 
| Description of the population of patients having a road traffic accident related to taking medication | Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs | Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020 |