Safety through reporting: online learning modules for health professionals

2 December 2014

Given your expertise and direct contact with patients as a health professional, you are among those best-placed to provide high quality adverse event reports relating to medicines, vaccines and medical devices.

These two interactive online learning modules will build on your existing expertise and encourage you to use your skills to assist the TGA in its ongoing safety monitoring activities.

On completion, you will be eligible for professional development points.

The modules will provide you with a deeper understanding of why patients and the TGA rely on you to report adverse events. The new online learning modules:

  • provide a detailed explanation of the importance of reporting adverse events
  • reiterate the need for you to share the responsibility of reporting
  • explain how to build reporting into practice
  • explain what happens to reports once they are submitted to the TGA.

Online learning modules

The two Safety through reporting modules are:

The importance of reporting adverse events

Transcript

It's estimated that one in 10 of our patients would have had an adverse reaction to a therapeutic product in the past six months – half of these would have been moderate to severe and most will go unreported.

For example, around 400,000 GP consultations annually involve a medicine-related problem, yet the TGA received only 17,500 reports in 2013, of which only 700, or just 4% were from GPs.

Our patients rely on us to report adverse events.

Using a medicine or device has inherent risks. The truth is we'll never know everything about the impact of any medicine or device, even something as universal as paracetamol.

Clinical trials don't end at registration — the harm–benefit analysis is ongoing. Clinical trials have limitations — they are short, have a relatively small number of participants and often exclude important populations. For some devices, trials may not be possible at all.

This means that the available evidence may not be relevant for many of our patients.

And some events can not be predicted.

Ensuring the safe and effective use of medicines, vaccines and devices is everyone's responsibility.

The TGA needs to know about suspected adverse events, especially those relating to new medicines or vaccines and devices, or those with serious outcomes.

Your reports are vitally important. It might be the last piece of information required for the TGA to make a decision and may result in a safety alert being published, changes to product labelling, added warnings, or even cancellation of product registration.

Adverse event reporting is the responsibility of every health professional. By reporting, we can be confident that every time we prescribe a medicine, administer a vaccine or use a medical device, we have an up-to-date risk–benefit profile.

Safety through reporting: Share the responsibility

Complete the module, stay informed and receive CPD points.

Earn professional development points

RACGP QI&CPD accredited category 2

The Royal Australian College of General Practitioners (RACGP)

Reporting adverse events with medicines and vaccines

This activity has been approved for 2 (category 2) points (activity ID number 13586) for the 2014-2016 triennium in the RACGP QI&CPD Program.

Reporting adverse events with medical devices

This activity has been approved for 2 (category 2) points (activity ID number 13593) for the 2014-2016 triennium in the RACGP QI&CPD Program.

ACRRM logo

Australian College of Rural & Remote Medicine (ACRRM)

Reporting adverse events with medicines and vaccines

This activity has been accredited for 1 core point (code O1435NPMW) in the ACRRM PD Program.

Reporting adverse events with medical devices

This activity has been accredited for 1 core point (code O1434NPMW) in the ACRRM PD Program.

Accredited for pharmacists' CPD

Royal College of Nursing, Austalia (RCNA)

Reporting adverse events with medicines and vaccines

This activity is endorsed by APEC number 061110344 as authorised by Royal College of Nursing, Australia (RCNA) according to approved criteria. Attendance attracts 1 RCNA CNE points as part of RCNA's Life Long Learning Program.

Reporting adverse events with medical devices

This activity is endorsed by APEC number 061110344 as authorised by Royal College of Nursing, Australia (RCNA) according to approved criteria. Attendance attracts 1 RCNA CNE points as part of RCNA's Life Long Learning Program.

RCNA logo

Australian Pharmacy Council (APC)

Reporting adverse events with medicines and vaccines

Accreditation number: CX140051. These activities have been accredited for 1 hour of group 2 CPD (or 2 CPD credits) suitable for inclusion in an individual pharmacist's CPD plan.

View PSA competency standards.

Reporting adverse events with medical devices

Accreditation number: CX140051. These activities have been accredited for 1 hour of group 2 CPD (or 2 CPD credits) suitable for inclusion in an individual pharmacist's CPD plan.

View PSA competency standards.

More information from the TGA

Explore the TGA website and find information related to this presentation with the links below.