Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)
Overview
- Phase
- Not Applicable
- Intervention
- Drugs Responsible for Cognitive Side Effects
- Conditions
- Accident, Traffic
- Sponsor
- University Hospital, Caen
- Enrollment
- 500000
- Locations
- 1
- Primary Endpoint
- Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Road traffic accidents with medicines
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
Intervention: Drugs Responsible for Cognitive Side Effects
Outcomes
Primary Outcomes
Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
Time Frame: 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 Outcomes
- 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)
- 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)