Suspected adverse drug reactions (ADRs) trends in older Italian patients: an analysis from the National Pharmacovigilance Network.

Background: The clinical management of older populations is a social and clinical challenge. These subjects are more vulnerable to adverse drug reactions (ADRs) due to multi morbidity, polypharmacy, and physio-pathological changes.

Methods: We performed a study using data from the National Network of Pharmacovigilance of Italy available from 2001 to 2012, which include all spontaneous reports of suspected ADRs.

Results: Our study showed that 29,036 reports of suspected ADRs were recorded in 2012. Those for patients aged ≥ 65 years were 11,426 that correspond to a reporting rate of 923.6 reports per million inhabitants. On the contrary, the reporting rate for total population was of 489 reports per million inhabitants. The evaluation of level of severity showed that 37% of reports of suspected ADRs in patients aged ≥ 65 years were serious compared to 30% in the general population. Furthermore, 27% of reports recorded for older patients showed that they required more hospitalization or long-term care in comparison with the 21% for the general population, with a relevant impact on National Health Service costs.

Conclusion: These data suggest the need to optimize the clinical strategy for older patients due to the multiple factors that increase the susceptibility to ADRs. There is a high need to potentiate clinical trials on older patients to adopt new diagnostic-therapeutic pathways in real life.