Serious Adverse Drug Reaction and Their Preventability

Completed

• Conditions: Adverse Drug Reaction
• Interventions: Other: Adverse drug reaction

• Registration Number: NCT02888834
• Lead Sponsor: CHU de Reims

Brief 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-10
• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-09-02
• Last Update Submitted: 2016-09-02
• Study First Posted: 2016-09-05
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged over 65 years
• Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse drug reaction	Adverse drug reaction	Patients aged over 65 years who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne between January and May 2013 were included in the study.

Primary Outcome Measures

Name	Time	Method
The different type of serious ADR were coded according to Medical Dictionary for Regulatory Activities (MedDRA version 16.0) according to lowest-level terms (LLTs), and then grouped by system organ class (SOC).	9 months

Secondary Outcome Measures

Name	Time	Method
Drugs involved in the occurrence of serious ADR	9 months
Preventability was assessed by using the preventability French scale.	9 months
Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"	9 months

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France