The Black Triangle Scheme: better adverse medication reporting

By ANMJ Staff|
2019-03-27T12:54:00+10:00
March 27th, 2019|

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The Therapeutic Goods Administration (TGA) is calling on health practitioners and consumers to help identify and report ‘adverse events’ related to new prescription medicines under its Black Triangle Scheme.


Launched in January 2018, the scheme encourages the reporting of adverse events as newly registered prescription medicines hit the Australian market and information about their safety and efficacy is limited to clinical trials that do not always pinpoint every possible side effect.

Under the scheme, a black triangle symbol and accompanying text appear on the first page of Product Information (PI) and Consumer Medicines Information (CMI) of included products, alerting health professionals and consumers to report suspected adverse events.

The wording states “this medicine is subject to additional monitoring in Australia” and “healthcare professionals are asked to report any suspected adverse events”.

Each adverse event reported to the TGA will be entered into a database that will be continually analysed to help identify potential emerging problems for more detailed investigation.

For medicines included in the scheme, the black triangle will appear on the PI and CMI for five years from the date of first supply and will then automatically lapse.

The presence of a black triangle does not signify known safety problems, but rather that the TGA is seeking adverse event reporting to help it build a complete picture of the medicine’s safety profile.

The scheme, which already operates widely in Europe and UK, will only apply to certain newly registered prescription medicines, except for biosimilar medicines, generic versions of already approved prescription medicines, and seasonal influenza vaccines.

All provisionally registered medicines will be included in the Black Triangle Scheme.

The black triangle will also appear in TGA related material such as the Australian Public Assessment Reports for prescription medicines and other sources of medicine information.

Find out more about the TGA’s Black Triangle Scheme, what products it applies to and how to report.

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