Study Finds Low Awareness of Australia's Black Triangle Drug Scheme

A study published in The British Journal of Clinical Pharmacology found limited public and professional awareness of Australia's black triangle scheme for tracking side effects of newly approved medicines. Lead researcher Eyob Gebreyohannes of the University of Adelaide said about half the healthcare professionals surveyed and one in 10 consumers knew of the scheme.

The Therapeutic Goods Administration introduced the black triangle symbol in January 2018.

It appears on product information and consumer medicine information documents for new medications and older drugs approved for new uses. The symbol signals close monitoring and does not indicate that a medicine is unsafe. Gebreyohannes reported that participants described the triangle as too small and buried in leaflets, with many mistaking it for a bullet point.

The study of 405 consumers, doctors, pharmacists and nurses found no significant increase in adverse event reports in the eight years after the scheme began. The TGA does not collect data linking specific reports to the black triangle scheme. A spokesperson said it was not practicable to identify reports tied to covered medicines.

Reports from clinicians and consumers help build a complete safety profile that can lead to updated advice. Adverse event reports rose sharply in 2021 and 2022 during the COVID-19 vaccine rollout, when public messaging encouraged submissions. Gebreyohannes noted this period showed how targeted advertising could increase reporting.

Rowena Ivers, a general practitioner and academic at the University of Wollongong, said she could not recall receiving any TGA marketing about the scheme. Claire Antrobus of the Pharmaceutical Society of Australia said the study methods carried an error margin of less than 5 percent.