IX. Add I.4.1. Paediatric population

Often a single paediatric group is chosen below a selected age threshold. Although childhood is a period of rapid change and no threshold is likely to define a homogenous group, this succeeds in defining a population with marked developmental, physiological and psychological differences from adults (see GVP P.IV.).

Separate presentation of suspected adverse reactions that are detected in the paediatric population and use of both clinical and statistical methods seem to be justified to improve the detection of signals for the paediatric population. Statistical disproportionality tools should be applied to ICSRs reported for children to increase the ability to detect signals in the paediatric population from spontaneous ICSR databases. Within-group disproportionality statistics that are significantly higher than those in the nonpaediatric group should be highlighted for additional consideration (9) . Additionally, given the lower number of ICSRs usually received for the paediatric population compared to the adult population, it is recommended to use a lower thresholds based on the number of ICSRs received.

An additional aid to focusing on paediatric safety issues can be provided by a list of adverse events (a targeted medical events list) that tend to have more serious outcomes in children than adults. This list should be used to reduce missed signals that are more clinically relevant in the paediatric population, otherwise not flagged by other methods. More extensive discussion of pharmacovigilance in the paediatric population are available in GVP P.IV. on paediatric pharmacovigilance. The age threshold for paediatric signal detection should be chosen to align with the upper age limit from this guideline.