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Completed

NCT Number: NCT02888834

Serious Adverse Drug Reaction and Their Preventability

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.

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Key information

Conditions

Adverse Drug Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Reims

Reims, France, 51092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Adverse drug reaction

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Drugs involved in the occurrence of serious ADR

    Time frame: 9 months

  2. Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"

    Time frame: 9 months

  3. Preventability was assessed by using the preventability French scale.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: SADR

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2016
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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