Only one in 10 Australians know the Black Triangle safety symbol

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

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

A study published in British Journal of Clinical Pharmacology finds this awareness of Australia’s Black Triangle Plan is low overall, particularly among consumers. The system was introduced in 2018 in Australia to remind people of the importance of reporting adverse drug reactions for newly approved or newly launched drugs.

Why Black Triangle drugs need extra monitoring

Information reported by the consumer or healthcare professional about adverse drug reactions for newly approved or marketed drugs is an important contribution to safe medical practice. However, underreporting remains a major challenge, limiting the ability of regulators to monitor drug safety.

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

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

Given the clinical implications of the Black Triangle program, the present study was designed to assess healthcare professionals’ and consumers’ awareness of the scheme, its influence on intentions to report future adverse drug reactions, and suggested improvements.

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

Most participants misunderstood the Black Triangle symbol

About 24% of study participants reported being aware of the Black Triangle Plan. Specifically, approximately 52% of healthcare professionals and only 10% of consumers were aware of the program. This was an absolute difference 42.1%.

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

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

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

During the follow-up interview, participants suggested various strategies to improve awareness, including social media, television, posters, and printed labels. The majority also stated that the symbol, in its current form and its placement on drug leaflets, it’s easy to get lost. Interviewees also emphasized that simply recognizing the symbol is not enough. People need to understand why adverse drug event reporting is important, how to make a report and what the program is intended to achieve.

When the purpose of the program was explained to the participants, the majority considered it “very important” and a “good initiative” to enhance drug safety. Regarding the impact of the system on their intention to report adverse drug events in the future, participants expressed mixed views. Some also noted that the system could inadvertently discourage reporting of non-Black Triangle drugs if people assumed those drugs did not require reporting of adverse drug reactions.

Improving awareness could enhance drug safety reporting

The study finds significantly lower awareness of the Black Triangle Scheme among consumers than among health professionals in Australia. Once the purpose of the program was explained, most participants viewed it positively and said they would be more likely to report adverse drug events. In particular, participants also expressed concerns about the visibility and significance of the Black Triangle symbol.

Given the study’s findings, the researchers highlight the need to incorporate a more consumer-friendly description along with the Black Triangle symbol in consumer drug information and product information documents to improve consumers’ understanding of the system and encourage them to report adverse drug reactions to health regulatory agencies. The visibility of the symbol and its description can be improved by placing it in the adverse drug reaction section of drug leaflets.

For medicines included in the Black Triangle Scheme, the incorporation of a warning advisory label could serve as visual cue to initiate discussions between pharmacists and consumers about additional monitoring and the importance of reporting suspected adverse reactions.

Awareness of the program can also be raised through targeted campaigns for healthcare professionals and wider communication strategies. Participants also suggested integrating the program into healthcare education, prescribing software, and electronic medical records to improve awareness and support reporting of adverse drug events in routine clinical care.

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

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

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