Skip to main content
. 2024 Dec 17;47(6):186–191. doi: 10.18773/austprescr.2024.056

Table 1. Common misconceptions regarding adverse event reporting.

Misconception Truth
Adverse events should only be reported if serious, recurrent or proven. Any adverse event can be reported, even if there is only a suspicion that it was caused by a medicine or vaccine.
Adverse event reporting is limited to prescribed medicines and vaccines. Adverse events for any medicine or vaccine can be reported, including over-the-counter and complementary medicines, unapproved medicines obtained through the Special Access Scheme or Authorised Prescriber pathways. Adverse events with medical devices can also be reported.
Only the prescriber of the suspected medicine or vaccine can report. Anyone can report an adverse event, including healthcare professionals, consumers, family members and carers.
It is hard to know how and where to make the report. Adverse events can be reported online through the Therapeutic Goods Administration’s adverse event reporting website.
There is a professional development module on the Australian Commission on Safety and Quality in Healthcare’s QUM Learning hub, that provides a step-by-step guide on how to report adverse events.
Consumers can report adverse events by calling 1300 MEDICINE (1300 633 424).
A single adverse event is not worth reporting. All reports are valuable and contribute to the overall body of safety data for a medicine or vaccine. Multiple individual reports makes signal detection possible.