NCT02888834

Serious Adverse Drug Reaction and Their Preventability

Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%. Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability. Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Detailed description

Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%. Age itself is not a risk factor for ADRs but is a factor of severity of ADR. According to the World Health Organization (WHO), more than half of all ADRs are considered to be preventable in elderly subjects. They are most often the result of a mistake during the prescription phase, or the monitoring phase, or may be due to poor compliance or inappropriate self-medication. Drug prescription is based on guidelines derived from clinical trial that have not included elderly subject with multiple comorbidities. Data regarding drug safety from clinical trials alone are insufficient, hence the need to continue the monitoring of ADR after drug marketing. Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability. Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Conditions

• Adverse Drug Reaction

Interventions

Type	Name	Description
OTHER	Adverse drug reaction

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2016-09-05
• Last updated: 2016-09-05

Locations

1 site across 1 country: France