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

• Conditions: Accident, Traffic
• Interventions: Drug: Drugs Responsible for Cognitive Side Effects

• Registration Number: NCT04480996
• Lead Sponsor: University Hospital, Caen

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-06
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Road traffic accidents with medicines	Drugs Responsible for Cognitive Side Effects	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

Primary Outcome Measures

Name	Time	Method
Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020	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

Secondary Outcome Measures

Name	Time	Method
Association 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	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
Description of the population of patients having a road traffic accident related to taking medication	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020	Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs

Trial Locations

Locations (1)

Caen University Hospital, Department of Pharmacology; 🇫🇷 Caen, Normandie, France