The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The TGA has launched a new web-based service to make it easier for consumers to report side effects, also known as adverse events, associated with medicines and vaccines.
It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators.1
In recent years evidence has emerged that adverse event reports from consumers contain information that is useful for monitoring the safety of therapeutic products, but there is low awareness of available reporting systems.2,3
Each year the TGA receives more than 17,000 reports of suspected adverse events to medicines and vaccines. In 2013 about 3% of these reports came from consumers, compared with 55% coming via pharmaceutical companies, 17% from state and territory health departments, 10% from hospitals and hospital pharmacists and the remainder from community pharmacists and general practitioners.
The new web-based reporting service for consumers is one of a range of initiatives being implemented by the TGA to encourage reporting among this group. Other activities include:
- a consumer brochure outlining what and how to report adverse events
- awareness activities and messages targeted at consumers
- consumer research to help plan further activities to raise awareness.
There is an international trend for regulators to encourage reporting by consumers and the release of the new consumer-focused web reporting option forms part of the TGA’s effort in this area.
References
- Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: A systematic review Drug Saf 2006:29(5);385-396 - external site.
- Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technology Assessment 2011;15 - external site.
- Robertson J, Newby DA. MJA Low awareness of adverse drug reaction reporting systems: a consumer survey 199(10):684-6 18/11/2013 - external site.