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Nine in 10 people miss the black triangle warning on their medicine leaflet

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Hands holding blister with pills and patient information leaflet
Hands holding blister with pills and patient information leaflet

Adelaide University research finds most consumers and many health professionals don’t understand the black triangle symbol on medicine leaflets, a safety scheme that relies on people actually reporting side effects.

There’s a small black triangle on the leaflet of some of Australia’s most commonly prescribed medicines. It’s meant to tell you the drug is new, or being used in a new way, and that reporting any side effects matters more than usual.

Most people have never noticed it. A new study out of Adelaide University found more than 90% of consumers and a large share of health professionals cannot correctly identify what the symbol means.

What the scheme actually does

The Black Triangle Scheme started in Australia in 2018, run by the Therapeutic Goods Administration (TGA). It flags newly marketed prescription medicines, and existing medicines being used for a new condition or a different patient group, on the medicine’s product information and consumer leaflet.

These are the medicines regulators know the least about. Clinical trials can’t catch every side effect, especially rare ones or ones that show up in people who weren’t well represented in the trial. The black triangle is a prompt: if you notice something unusual after starting one of these medicines, tell someone.

What the study found

Researchers from Adelaide University, Monash University and the University Medical Center Groningen surveyed 405 people in Australia: 267 consumers and 138 health professionals (doctors, pharmacists and nurses). Twenty-one of them were interviewed in more depth.

The numbers:

  • 9.8% of consumers and 51.8% of health professionals said they were aware the scheme exists at all
  • 10.5% of consumers and 63% of health professionals had ever actually seen the symbol
  • of the people who had seen it, only 51.9% of consumers and 46.5% of health professionals could correctly say what it means
  • 29.2% of people who’d seen the symbol thought it meant the medicine had known safety problems. 37.2% thought it meant the medicine was high-risk. Neither is right

One consumer summed up the gap plainly: “I had absolutely never heard of this thing before, and nobody had ever mentioned it.”

Once the researchers explained what the symbol actually does, the reaction changed. 66.2% of participants said they’d be likely or very likely to report a side effect on a black triangle medicine after being told what it meant. One doctor called the scheme “very important,” and a consumer described it as “a good initiative.”

Why it’s not working

A symbol only works if people see it and understand it. This one is failing at both.

Interview participants blamed small font size, a colour that doesn’t stand out, and placement at the top of the first page of a leaflet most people never open. Some confused it with a manufacturing mark or an expiry date symbol. Others thought it was decorative.

Dr Eyob Alemayehu Gebreyohannes, who led the study from Adelaide University’s School of Pharmacy and Biomedical Science, put it directly:

“A system that’s meant to safeguard patients is performing well below its potential, and possible safety warnings are not being reported.”

The researchers recommend moving the symbol and its explanation into the adverse-effects section of the leaflet, where people actually look, and putting it on the medicine packaging itself. They also suggest a dispensing label sticker that prompts pharmacists to raise it with patients directly, and electronic prompts built into prescribing and dispensing software.

Checking the numbers

The Adelaide University media release says “around half of health professionals aren’t able to correctly identify the symbol.” The study itself shows something closer to 70% of health professionals failing to correctly identify it, once you account for the 37% who’d never seen the symbol at all. The clearer figure from the study: 51.8% of health professionals said they were aware the scheme existed, meaning 48.2% weren’t.

Both framings point the same direction. Awareness among health professionals is patchy, and awareness among consumers is much worse.

What it means for you

If you take regular medication, particularly anything newly prescribed or newly approved for your condition, check the leaflet for an upside-down black triangle near the medicine’s name. 

If side effects turn up that aren’t listed, or feel wrong, you don’t need to wait for your doctor to raise it.

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