Specific signal detection measures aimed at older recipients of medicines are a reasonable precaution given the high frequency of concomitant use of multiple medicines and the possibility of impaired physiological elimination mechanisms (see GVP P.V.).

The age threshold at which such measured should be implemented has not been clearly established. Although the proportion of patients for whom suspected adverse reactions are reported increases with age, some research has suggested that this can be explained by more common use of medicines (10). Thus it may be better to choose a threshold based on increased exposure rather than possible increased susceptibility. Alternatively, a consistent approach is to use the same age group in routine signal detection as selected for other pharmacovigilance activities (see GVP P.V).

For routine signal detection processes it is recommended that ICSRs from patients above the chosen age threshold should be clearly identified and that, as for the paediatric population, within-group disproportionality statistics that are significantly higher than those within the non-geriatric group should be highlighted for additional consideration.