Australian Study Reveals Critical Gaps in Black Triangle Scheme Awareness for Medicine Safety Reporting
核心洞察
A study in the British Journal of Clinical Pharmacology found only 10% of Australian consumers and 52% of healthcare professionals are aware of the TGA's Black Triangle Scheme.
The scheme, launched in 2018, uses a black inverted triangle to flag newly approved medicines and older drugs with new indications for enhanced side-effect monitoring.
Once the scheme was explained, 66% of participants said they would be likely to report side effects for black triangle medicines, indicating strong latent support.
A new study published in The British Journal of Clinical Pharmacology has exposed a stark awareness gap surrounding Australia's Black Triangle Scheme, a national medicine safety initiative designed to encourage reporting of suspected adverse drug reactions for newly approved medications. The research, led by Dr Eyob Gebreyohannes of the University of Adelaide's Quality Use of Medicines and Pharmacy Research Centre, surveyed more than 400 participants including consumers, GPs, pharmacists, and nurses, and found that only 10% of consumers and 52% of healthcare professionals knew the scheme existed.
"The simplest reason [for the lack of general awareness] is that people can't act on a scheme they've never heard of," Dr Gebreyohannes told newsGP. "The symbol itself isn't doing its job – it's not self-explanatory and it's easy to miss. Some participants didn't register it as meaningful at all ... and even among those who had noticed it, fewer than half could correctly say what it was for."
How the Scheme Works — and Why It Matters
Australia's Black Triangle Scheme was launched in January 2018 by the Therapeutic Goods Administration (搜索) (TGA), modeled on similar programs in Europe and the United Kingdom. The black inverted triangle appears on product information and consumer medicine information documents for certain medicines, accompanied by text explaining the drug is either new or being used differently. The symbol does not indicate a medicine is unsafe; rather, it signals that the drug is being monitored closely to build a more complete safety profile in real-world use.
The scheme covers some of the most widely prescribed medications in Australia today, including heart-failure and diabetes medicines such as empagliflozin, and the newer diabetes and weight-loss drugs semaglutide and tirzepatide. "These aren't obscure medicines," Dr Gebreyohannes noted.
Dr Rowena Ivers, a practising GP and Deputy Chair of the RACGP Expert Committee – Quality Care, explained that each report matters because rare side effects can take years to emerge. "Even if it seems very minor it's important to report that, because it protects other people and it means that [the TGA] can gather data, look at it over time and see patterns emerging," she said.
A Scheme Not Integrated into Clinical Workflow
A key finding of the study is that the Black Triangle Scheme is not embedded into routine clinical practice. Dr Gebreyohannes noted the scheme is "easy to forget" because it is not built into standard clinical workflows or point-of-care systems. "Even those who know about it have nothing prompting them to act in the moment," he said.
Many participants who had seen the symbol did not understand its meaning, with some dismissing it as a bullet point. "Many assumed it flagged a dangerous or high-risk medicine rather than a newer one under monitoring," Dr Gebreyohannes said. "It simply doesn't spark the curiosity it needs to."
The TGA does not collect data on whether the black triangle prompted a specific adverse event report. A TGA spokesperson said it was "not practicable" to identify reports specifically for medicines covered by the scheme. Dr Gebreyohannes pointed out that in the eight years since the scheme's introduction, there has not been a "significant increase" in adverse drug event reports, suggesting the initiative is not functioning as intended.
Latent Support and Proposed Solutions
Despite the low awareness, the study revealed strong latent support for the scheme once its purpose was explained. Approximately 66% of participants said they would be likely to report side effects linked to medicines carrying the black triangle after understanding its function. "The encouraging side is that once people understand the scheme, they back it," Dr Gebreyohannes said. "So even a short explanation goes a long way."
Participants proposed several practical improvements, including adding Black Triangle alerts to prescribing software and electronic medical records, improving education for health professionals, and making the symbol more visible at the point of care. Other suggestions included making the triangle larger, placing it in a more prominent position on packaging, and using brighter colors to make the symbol and associated text stand out.
Dr Gebreyohannes recommended that GPs adopt a simple self-check: "Is this medicine relatively new to the market, or has its indication changed recently? If so, it's likely covered by the Black Triangle Scheme." However, recognizing the heavy workload GPs already carry, he emphasized that systemic flagging in prescribing software would be a more reliable solution than relying on individual clinicians to remember.
Calls for Broader Reform
Claire Antrobus, senior manager of practice guidance and publications with the Pharmaceutical Society of Australia (搜索) (PSA), noted that the study's error margin of less than 5% provides "a clear sign that awareness of the black triangle scheme is low — interestingly, not just for consumers but also for health professionals." The PSA has long advocated for a more comprehensive incident monitoring program for medicine safety, which would include a national incident logging and monitoring system covering general practice, community pharmacy, residential aged care, and disability care.
Professor Ivers, who is also a practising GP, said she could not recall ever receiving any marketing or information from the TGA about the scheme, and that more training for relevant health workers was "always a good idea." She added that GPs can play an important role: "As GPs we have a role in advising people of the risks and benefits of new medications, and as part of our continuous relationship with patients we can monitor side effects or encourage our more able patients to themselves report adverse effects."
Next Steps
Dr Gebreyohannes and his research team are now focusing on improving the scheme before re-measuring its impact, collaborating with the TGA to co-design the symbol and its description with patients and health professionals. The goal is to make it more "noticeable and self-explanatory rather than abstract and easily overlooked," including rethinking where the information sits in the medicine leaflet.
"There's little value in re-testing awareness if nothing has changed in the meantime," Dr Gebreyohannes said. "Once changes like these are in place, a re-evaluation would make real sense — ideally a larger study designed to compare consumers, GPs, pharmacists and nurses more robustly, measuring awareness before and after. But the order matters: improve first, then evaluate."