Accident, Traffic
Conditions
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.
Interventions
DRUGDrugs Responsible for Cognitive Side Effects
identification of road traffic accidents associated with drugs responsible for psychomotor side effects
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactVéronique Lelong-Boulouard, PhD, PharmD
Outcome results
None listed