03 Aug The tiny black triangle on some medicines — and why parents should know what it means
A small black triangle on some medicine information leaflets is meant to help keep patients safer. But new Australian research suggests most people do not know what it means — and that could mean important side effects are going unreported.
Have you ever noticed a small black triangle on a prescription medicine leaflet? Many people haven’t. And even among those who have seen it, most do not know what it means.
New research led by Adelaide University has found that more than 90 per cent of consumers and about half of health professionals surveyed could not correctly identify the symbol. Researchers say that matters because the black triangle is designed to help detect possible side effects from newer medicines once they are being used widely in the community.
Australia’s Black Triangle Scheme was introduced nationally in 2018 by the Therapeutic Goods Administration. The symbol appears in medicine information documents for some newer prescription medicines, and for some existing medicines being used in significantly different ways, such as for a new condition or patient group. It does not mean the medicine is unsafe. It means the medicine is being monitored more closely, and that patients and health professionals are encouraged to report suspected side effects.
Dr Eyob Alemayehu Gebreyohannes, from Adelaide University’s School of Pharmacy and Biomedical Science, says the findings suggest the system is not reaching the people it is meant to help.
“Our findings suggest that most people don’t know about the scheme or the meaning of the symbol,” Dr Gebreyohannes said.
“Less than 10% of consumers and 52% of health professionals were aware of the scheme and a significant number of people who had noticed the symbol didn’t understand what it meant.
“This indicates that a system that’s meant to safeguard patients is performing well below its potential and possible safety warnings are not being reported.”
The study, published in the British Journal of Clinical Pharmacology, surveyed more than 400 people, including consumers and health professionals. The researchers found that while awareness was low, people were more likely to say they would report side effects once they understood what the symbol meant.
The black triangle can apply to medicines used for a wide range of conditions, including diabetes and weight loss, heart failure, cancer, sleep therapies and vaccines.
For families, the message is not to be frightened by the symbol. Medicines in Australia still need to meet safety and quality standards before they can be supplied. But once a medicine is being used by many more people in everyday life, some uncommon or unexpected side effects may become clearer. Reporting helps regulators build a fuller picture of medicine safety.
“This is important because once a medicine reaches the market, much of what we learn about safety comes from real-world use – patients and clinicians noticing and reporting effects that didn’t surface in clinical trials,” Dr Gebreyohannes said.
Image/source: Therapeutic Goods Administration, Australian Government.
For parents and carers, this is especially relevant when a child, teenager or family member starts a new prescription medicine. It is worth reading the consumer medicine information, asking the pharmacist what side effects to watch for, and checking what to do if something unexpected happens.
A suspected side effect might include a rash, swelling, dizziness, unusual tiredness, stomach symptoms, mood changes, sleep problems, breathing symptoms or anything that starts after a medicine is introduced and feels out of the ordinary. It does not have to be a proven side effect before it can be reported.
Importantly, people can report suspected side effects directly to the TGA. They do not need to wait for a doctor or pharmacist to do it for them, although it is still wise to speak with a health professional, especially if symptoms are worrying or the medicine is for a serious condition.
The researchers have recommended that the black triangle symbol be made more visible, including in the adverse-effects section of medicine information or potentially on packaging itself. They also suggest electronic prompts during prescribing and dispensing, and pharmacy label stickers that remind pharmacists to explain the symbol to patients.
For now, the practical advice is simple: if you see a black triangle on a medicine leaflet, treat it as a prompt to pay attention, ask questions, and report anything unusual.
Do not stop a prescribed medicine suddenly without medical advice, unless you are having a severe reaction or have been told to stop. For urgent symptoms such as trouble breathing, swelling of the face or throat, chest pain, collapse or a severe allergic reaction, call 000.
For less urgent concerns, speak with your GP or pharmacist and ask whether the side effect should be reported to the TGA.
