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. |