Only one in 10 Australians know the Black Triangle safety symbol

Despite years of use, Australia’s Black Triangle Scheme remains unfamiliar to most consumers, raising concerns that a key medicine safety initiative may be missing opportunities to improve adverse drug event reporting.

Study: Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed-methods study exploring reporting intentions and suggested improvements. Image credit: Microgen/Shutterstock.com

A study published in the British Journal of Clinical Pharmacology finds that awareness of Australia’s Black Triangle Scheme is low overall, particularly among consumers. The scheme was introduced in 2018 in Australia to remind people of the importance of reporting adverse drug events for newly approved or newly marketed medicines.

Why Black Triangle medicines need extra monitoring

Consumer- or healthcare professional-reported information on adverse drug events for newly approved or marketed medicines significantly contributes to safe medical practice. However, underreporting remains a major challenge, limiting regulatory authorities’ ability to monitor medicine safety.

The Black Triangle Scheme is a pharmacovigilance scheme used by drug regulatory bodies to closely monitor safety profiles of new medicines. To remind healthcare professionals and patients (consumers) about the importance of reporting adverse drug events associated with new medicines, a black inverted triangle is included on the product information document. The triangle indicates that the medicine is subject to additional and more intensive monitoring.

The Black Triangle concept was first introduced in the 1970s in the UK and, since 2013, has been gradually adopted in other European countries. In Australia, the scheme was introduced in 2018. However, despite awareness campaigns, previous studies have found both low awareness among consumers and little evidence that the scheme increased adverse drug event reporting.

Given the clinical implications of the Black Triangle Scheme, the current study was designed to evaluate healthcare professionals’ and consumers’ awareness of the scheme, its influence on intentions to report future adverse drug events, and suggested improvements.

The study included a total of 267 adult consumers living in Australia and 138 healthcare professionals (doctors, pharmacists, nurses) who were practicing in Australia. Both consumers and healthcare professionals initially participated in a 10- to 15-minute-long online survey. Of the initial survey respondents, 11 healthcare professionals and 10 consumers participated in 20- to 60-minute individual semi-structured interviews.

 Most participants misunderstood the Black Triangle symbol

About 24% of the study participants reported being aware of the Black Triangle Scheme. Specifically, about 52% of healthcare professionals and only 10% of consumers were aware of the scheme. This corresponded to an absolute difference of 42.1%.

About 10% of consumers and 63% of healthcare professionals reported having previously viewed the Black Triangle symbol. However, less than 50% of these participants correctly identified the purpose of the symbol as a reminder to report adverse drug events.

Misconceptions were common among participants who had previously seen the Black Triangle symbol. While 29% of these participants believed that the symbol identified a medicine with known safety issues, 37% interpreted it as a symbol of high-risk medicines.

After seeing the Black Triangle symbol and its description, about 66% of participants said they were likely or very likely to report adverse drug events associated with a medicine carrying the symbol.

During the follow-up interview, the participants suggested various strategies to improve awareness, including social media, television, posters and printed labels. The majority also reported that the symbol, in its current form and placement within medicine leaflets, is easy to miss. Interview participants also emphasized that simply recognizing the symbol is not enough; people need to understand why adverse drug event reporting matters, how to submit a report, and what the scheme is intended to achieve.

When the purpose of the scheme was explained to the participants, the majority considered it as “very important” and a “good initiative” to enhance medicine safety. Regarding the impact of the scheme on their intention to report adverse drug events in the future, the participants expressed mixed views. Some also noted that the scheme could unintentionally discourage reporting for medicines without a Black Triangle if people assumed those medicines did not require adverse drug event reporting.

Improving awareness could strengthen medicine safety reporting

The study finds substantially lower awareness of the Black Triangle Scheme among consumers than among healthcare professionals in Australia. Once the scheme’s purpose was explained, most participants viewed it favorably and said they would be more likely to report adverse drug events. Notably, the participants also raised concerns about the visibility and meaning of the Black Triangle symbol.

Given the study findings, the researchers highlight the need to incorporate a more consumer-friendly description alongside the Black Triangle symbol in consumer medicine information and product information documents to improve consumers’ understanding of the scheme and encourage them to report adverse drug events to health regulatory bodies. The visibility of the symbol and its description can be improved by placing it in the adverse drug event section of medicine leaflets.

For medicines listed in the Black Triangle Scheme, incorporating a cautionary advisory label could serve as a visual cue to initiate discussions between pharmacists and consumers about additional monitoring and the importance of reporting suspected adverse drug events.

Awareness of the scheme can also be increased through targeted campaigns for healthcare professionals and broader communication strategies. Participants also suggested integrating the scheme into healthcare education, prescribing software, and electronic medical records to improve awareness and support adverse drug event reporting during routine clinical care.

The study participants were initially surveyed online, which may have excluded individuals with limited digital access or understanding. This may limit the generalizability of the study findings. Furthermore, the proportion of female participants was higher than in the Australian population, which may limit the representativeness of the Australian general population.

Larger-scale future research is needed to validate these findings and provide more conclusive evidence regarding potential differences between consumers and healthcare professionals, and among different healthcare professional groups, in awareness and understanding of the Black Triangle Scheme.

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