An Adverse Event Is Not Always Obvious: A Practical Guide for Australian Listed Medicine Sponsors

For sponsors of listed medicines, pharmacovigilance does not begin when a report reaches the PV team. It begins when someone, somewhere in the organisation, first receives information about a possible adverse reaction.

That information might come through a customer complaint, an email to the sales team, a social media comment, a distributor or a conversation with a healthcare professional. It may not look like a conventional adverse event report, and the person receiving it may not realise that it requires further assessment.

This is where gaps in a sponsor’s pharmacovigilance system can emerge.

For Australian sponsors of listed medicines, including complementary medicines and supplements, having a process for collecting and managing safety information is essential. The challenge is ensuring that relevant information is recognised, documented and escalated, regardless of where it originates.