Safety through reporting

Lynn M Weekes
Med J Aust 2015; 202 (4): 168. || doi: 10.5694/mja15.00192
Published online: 2 March 2015

Using a medicine or medical device has inherent risks. Based on current medical knowledge, not all adverse events can be prevented, underscoring the importance of continuous evaluation and monitoring of harms associated with the use of therapeutic products.

An estimated one in 10 patients have had an adverse reaction to a therapeutic product in the past 6 months. Of these reactions, half would have been moderate to severe, and most are not reported. Around 400 000 general practitioner consultations each year involve a medicine-related problem, yet the Therapeutic Goods Administration (TGA) received only 17 500 reports in 2013, of which only 700 (4%) were from GPs.

Reporting adverse events is a crucial part of ensuring the safety and effectiveness of therapeutic products in Australia. This reporting triggers meaningful actions by regulatory agencies, manufacturers and sponsors. Sometimes just a single report can initiate action.

NPS MedicineWise and the TGA have developed two online learning modules to support health professionals to report adverse events associated with therapeutic products ( and contribute to the TGA's ongoing safety monitoring activities. Key features include a detailed explanation of the importance of reporting adverse events in an increasingly active health system, how to build reporting into practice, and what happens to reports once they are submitted to the TGA.

These modules build skills to actively participate in continuous safety monitoring by identifying, documenting and reporting adverse events. They also promote a culture of adverse event notification in clinical practice.

Reporting adverse events relating to the use of medicines, vaccines or medical devices to the TGA is one way health professionals can contribute to safer use of therapeutic goods across the health system and reduce the threat to patient safety. Everyone shares in this responsibility.

  • Lynn M Weekes

  • NPS MedicineWise



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