Serious Adverse Drug Reaction and Their Preventability

Adverse Drug Reaction Clinical Trial

— SADR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888834
• Other study ID #: 2015Ao008
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: September 2, 2016
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: August 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients aged over 65 years

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• Adverse drug reaction

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Drugs involved in the occurrence of serious ADR		9 months	No
Secondary	Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"		9 months	No
Secondary	Preventability was assessed by using the preventability French scale.		9 months	No