Before a medication is registered for use in Australia, comprehensive data must be submitted to the Therapeutic Goods Administration (TGA) to support its quality, safety, and efficacy. However, this data typically only comes from clinical trials which are often conducted over a limited period and in a limited number of participants. If we consider that 3,000 subjects are required to have a 95% chance of detecting one case of an event with an incidence of 0.1%, then it becomes clear that additional adverse effects may be identified after TGA registration.
Post-marketing surveillance is an integral part of the regulatory approval process. This ongoing monitoring allows the identification of particularly rare adverse effects that may not have been encountered during clinical trials. The Black Triangle Scheme was introduced by the TGA to allow easy identification of medications subject to additional monitoring.
The following products are included in the scheme:
- Newly registered medicines (except biosimilars, generic versions of already approved medications, and seasonal influenza vaccines. Influenza vaccines will continue to be monitored by the AusVaxSafety program);
- Provisionally registered medicines including those with a provisionally approved indication; and
- Some medications with an extension of indication for a significantly different condition or a significantly different patient population. Inclusion of these medications will depend upon the weight of international evidence to support the new indication.
The black triangle symbol and accompanying text now appear at the top of the first page of the product information (PI) and consumer medicine information (CMI) for all included products. For the PI, the text reads ‘This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information in Australia. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.’ Medications will remain on the black triangle scheme for five years. However, provisionally registered medications may remain on the scheme for longer depending upon evaluation of the data used to support full registration.
The inclusion of a medication in the scheme does not imply that there are known safety issues with the drug. It is purely a means of encouraging reporting so that a comprehensive medication safety profile can be developed. Individuals should report any unfavourable or unintended sign, symptom, or disease suspected to be associated with the use of these medicines, particularly serious adverse events and those that are not currently listed in the PI and CMI.
- Onakpoya IJ. Rare adverse events in clinical trials: understanding the rule of three. BMJ Evidence-Based Medicine London: British Medical Journal; 2017.
- Therapeutic Goods Administration. Black Triangle Scheme. Woden: Therapeutic Goods Administration; 2018.