Does the Black Triangle on medication packets work?

An evaluation of a national initiative to report adverse reactions from new medication has found a lack of awareness and integration into routine clinical workflows, prompting calls for improved redesign and evaluation of its effectiveness.
 
Published in the British Journal of Clinical Pharmacology, the study reports on one of the Therapeutic Goods Administration’s (TGA) existing medicine safety initiatives, the Black Triangle Scheme, finding that many people do not know it exists.
 
From a survey of more than 400 patients and healthcare professionals, including GPs, only 10% of patients and 52% of healthcare professionals were aware of the Black Triangle Scheme. Many participants who had seen the symbol did not know what it meant.
 
However, once participants were shown the symbol and explained its meaning, 66% said they would be likely to report side effects linked to medicines carrying the black triangle. Many also described the scheme as valuable once they understood its purpose.
 
The scheme, which began in Australia in 2018, uses a black inverted triangle on information for certain medicines, including newly approved medicines and medicines approved for new uses.
 
Its purpose is to remind and encourage patients and health professionals to report suspected side effects, helping to build a clearer picture of medicine safety in real-world use.
 
Lead author from Adelaide University’s Quality Use of Medicines and Pharmacy Research Centre, Dr Eyob Gebreyohannes, told newsGP the scheme may not be working as intended.
 
‘The simplest reason [for the lack of general awareness] is that people can’t act on a scheme they’ve never heard of,’ he said.
 
‘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.
 
‘Many assumed it flagged a dangerous or high-risk medicine rather than a newer one under monitoring. It simply doesn’t spark the curiosity it needs to.
 
‘It’s worth GPs refreshing their own understanding first ... as it’s directly relevant to a large number of the patients GPs see every week – these aren’t obscure medicines.’
 
The scheme covers some of the ‘most widely used and talked-about drugs in the country right now’, Dr Gebreyohannes says, including heart-failure and diabetes medicines such as empagliflozin, and the newer diabetes and weight-loss medicines semaglutide and tirzepatide.
 
He adds that the scheme is ‘easy to forget’ as it’s not built into the standard clinical workflow of health professionals or into the point of care.
 
‘Even those who know about it have nothing prompting them to act in the moment,’ he said.
 
For the study, participants provided feedback on 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.
 
With GPs often the first port of call when patients experience new or unexplained symptoms after starting a medicine, participants also suggested GPs could play an important role in explaining the scheme, encouraging side-effect reporting, and discussing additional monitoring when prescribing newly approved medicines or those approved for new indications.
 
‘One simple self-check a GP can use is to ask: 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,’ Dr Gebreyohannes said.
 
Recognising this may add to an already heavy GP workload, he says rather than a prompt relying on the GP to remember, a systemic flagging of a Black Triangle medicine in prescribing software or the medical record at the point of prescribing is a reliable solution.
 
‘Keeping it visible through channels GPs already use,’ he said. ‘And for keeping patients informed, the best opportunity is the consultation itself, particularly when starting a newer medicine.’
 
Professor Rowena Ivers is Deputy Chair of the RACGP Expert Committee – Quality Care (REC–QC). While she acknowledges GPs receive ‘a lot of information from many sources’, she agrees they can help raise awareness among patients and reduce risks from adverse drug reactions.
 
‘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,’ she told newsGP.
 
‘GPs often will not see the Product Information or the Consumer Medicine Information documents as the medications are dispensed by a pharmacist, but we may review online versions and print them for patients.
 
‘I have assisted patients to report adverse effects of medications within the TGA reporting system, as people with low technological skills or health literacy may need some assistance.
 
‘The Black Triangle Scheme allows consumers or health professionals to report even minor side effects so the TGA can collate information and pick up rare or dangerous side effects that may not have otherwise been identified so the Product Information can be amended.’
 
The research follows previous calls for more robust systems to improve medicine side-effect reporting to the TGA as they are under-reported, with the REC–QC highlighting any system should not place ‘unnecessary onus’ on GPs who are already providing patient counselling about adverse drug reactions when prescribing.
 
Dr Gebreyohannes reinforces the message to remind patients that reporting is not only the GP’s job, but patients can also report a suspected side effect directly to the TGA themselves.
 
‘The encouraging side is that once people understand the scheme, they back it: about two-thirds of our participants said they’d be likely to report a side effect for a black triangle medicine once it was explained. So even a short explanation goes a long way,’ he said.
 
Moving forward, his research team is focusing on improving the scheme before re-measuring it, which would need to be done in collaboration with the TGA to co-design the symbol and its description with patients and health professionals, to make it more ‘noticeable and self-explanatory rather than abstract and easily overlooked’. This includes 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.’
 
newsgp approached the TGA for comment.
 
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adverse drug reactions Black Triangle Scheme medication harm medication safety TGA