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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs Responsible for Cognitive Side Effects | Drug | identification of road traffic accidents associated with drugs responsible for psychomotor side effects |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Lelong-Boulouard, PhD, PharmD | Contact | +33231064670 | lelongboulouard-v@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Véronique Lelong-Boulouard, PhD, PharmD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital, Department of Pharmacology | Recruiting | Caen | Normandy | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35939367 | Derived | Chretien B, Nguyen S, Dolladille C, Morice PM, Heraudeau M, Loilier M, Fedrizzi S, Bourgine J, Cesbron A, Alexandre J, Bocca ML, Freret T, Lelong-Boulouard V. Association between road traffic accidents and drugs belonging to the antiseizure medications class: A pharmacovigilance analysis in VigiBase. Br J Clin Pharmacol. 2023 Jan;89(1):222-231. doi: 10.1111/bcp.15481. Epub 2022 Aug 21. |
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| 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 |