Clinical Trial: Serious Adverse Drug Reaction and Their Preventability

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 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%. 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.


Sponsor: CHU de Reims

Current Primary Outcome: 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). [ Time Frame: 9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: CHU de Reims

Dates:
Date Received: August 19, 2016
Date Started: January 2013
Date Completion:
Last Updated: September 2, 2016
Last Verified: August 2016