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

AIM: To describe the serious adverse drug reactions (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.

RESULTS

Over the study period, 100 subjects were included in the study. The sex ratio was 0.96. Twenty seven percent of serious ADR were preventable. Off-label use accounted for 20% and non-compliance for 5%. Bleeding events were the most common serious ADR (36%). The drugs most frequently involved in serious ADR were antithrombotic agents (31.4%).

CONCLUSION

More than a quarter of serious ADR were preventable. Off-label use and non-compliance are the main causes identified in the occurrence of preventable serious ADR.