Adverse Drug Reaction Clinical Trial
Official title:
Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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