What can we learn from parents about enhancing participation in pharmacovigilance?

To investigate parents' views and experiences of direct reporting of a suspected ADR in their child.

We audio-recorded semi-structured qualitative interviews with parents of children with suspected ADRs. Our sample included parents with (n = 17) and without (n = 27) previous experience of submitting a Yellow Card.

Parents in both groups described poor awareness of the Yellow Card Scheme. Parents who had participated in the Yellow Card Scheme were generally happy to report their child's ADR via the Scheme and valued the opportunity to report concerns independently of health practitioners. They expressed motivations for reporting that have not previously been described linked to the parental role, including how registering a concern about a medicine helped to resolve uncomfortable feelings about their child's ADR. Parents who had not previously submitted a Yellow Card expressed uncertainty about the legitimacy of their involvement in reporting and doubts about the value of the information that they could provide.

Promoting wider participation in pharmacovigilance schemes will depend on raising public awareness. Additionally, our findings point to the need to empower lay people to submitting reports and to reassure them about the value of their reports.