SADR: Serious Adverse Drug Reaction and Their Preventability
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Adverse drug reaction
|
Outcome Measures
Primary Outcome Measures
- 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
- Drugs involved in the occurrence of serious ADR [9 months]
- Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown" [9 months]
- Preventability was assessed by using the preventability French scale. [9 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged over 65 years
-
Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu de Reims | Reims | France | 51092 |
Sponsors and Collaborators
- CHU de Reims
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 2015Ao008