User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version

Closed 26 Oct 2022

Opened 28 Sep 2022

Overview

The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia.

The TGA have created a trial (beta) version of the DAEN – medicines with updated technology to improve its performance, reliability and user experience.

The beta version was created to address a decline in the older database's performance and reliability, including longer response times and time-out issues for users. Many of these issues were due to unprecedented interest in the safety of medicines and vaccines, leading to increased adverse event reporting to the TGA and more people searching the DAEN - medicines.

About medicine adverse event reports

Adverse events are unintended and sometimes harmful occurrences associated with the use of a therapeutic good, such as a medicine or vaccine. The therapeutic good may have caused the event, or it may be a coincidence that the event occurred after its use. Adverse events can also be reported for other types of therapeutic good, including medical devices.

Adverse events can range in severity – from mild, expected reactions such as the headache, nausea and body aches associated with a medicine or vaccine, to more severe events that can result in birth defects or lead to a fatal outcome. 

We encourage people to report adverse events even when it is not clear that a medicine was the cause. Adverse event reports reflect the observations of the person who reported them. Publishing adverse event reports does not mean that the details of the event have been confirmed, or that the event has been determined to be related to a medicine.

Why your views matter

We are seeking feedback on your experience of the beta version of the DAEN – medicines, currently available on the TGA website alongside the older version.

Your feedback will help to inform possible future user experience improvements.

What happens next

A summary of the feedback we recieve will be published on this page and shared with relevant stakeholders.

We are continually reviewing how we can better communicate about adverse events with consumers, health professionals and industry and are actively working on improvements. Future improvements may include expanding the level of information in the DAEN - medicines, consistent with international best practice, while still safeguarding personal privacy.

Audiences

  • Non-government organisations
  • Health professionals
  • General public
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Biologicals

Interests

  • Regulatory policy