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

Caen University Hospital

Status: Unknown

Conditions: Accident, Traffic

Treatments: Drug: Drugs Responsible for Cognitive Side Effects

Study type: Observational

Funder types: Other

Identifiers

NCT04480996

Pharmaco 20200619

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500,000 participants in 1 patient group

Road traffic accidents with medicines

Description:

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

Treatment:

Drug: Drugs Responsible for Cognitive Side Effects