Despite being used for many years, Australia’s Black Triangle system is unfamiliar to most consumers, raising concerns that important drug safety initiatives are missing opportunities to improve adverse drug event reporting.
Research: Perceptions of the Black Triangle Scheme among Australian healthcare professionals and consumers: A mixed methods study examining reporting intentions and suggested improvements. Image credit: Microgen/Shutterstock.com
Research published in British Journal of Clinical Pharmacology find Perceptions of Australia’s Black Triangle Plan Low overall, especially among consumers. The system was introduced in Australia in 2018 to remind people of the importance of reporting adverse drug events with newly approved or newly marketed medicines.
Why Black Triangle Medicines Require Special Monitoring
Information about adverse events reported by consumers or health care professionals regarding newly approved or marketed medicines greatly contributes 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 scheme used by drug regulatory authorities to closely monitor the safety profile of new drugs. To remind healthcare professionals and patients (consumers) of the importance of reporting adverse drug events associated with new drugs, product information documents include a black inverted triangle. A triangle indicates that the drug is subject to additional, more intensive monitoring.
The Black Triangle concept was first introduced in the UK in the 1970s and has been gradually adopted by other European countries since 2013. In Australia, this system was introduced in 2018. However, despite awareness campaigns, previous studies have found that awareness among consumers was low and there was little evidence that the scheme increased reporting of adverse drug events.
Given the clinical significance of the Black Triangle Scheme, the current study was designed to assess healthcare professionals’ and consumers’ perceptions of the scheme, its impact on future intentions to report adverse drug events, and proposed improvements.
The study included a total of 267 adult consumers living in Australia and 138 health professionals (physicians, pharmacists, and nurses) practicing in Australia. Both consumers and healthcare professionals first participated in a 10- to 15-minute online survey. Among the initial 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
Approximately 24% of study participants reported being aware of the Black Triangle Scheme. Specifically, approximately 52% of healthcare professionals and only 10% of consumers were aware of the scheme. This corresponds to the absolute difference of: 42.1%.
Approximately 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 symbol’s purpose as a reminder to report adverse drug events.
Misconceptions were common among participants who had previously seen the black triangle symbol. 29% of these participants believed the symbol indicated a drug with known safety issues, while 37% interpreted it as a symbol for a high-risk drug.
After seeing the black triangle symbol and its description, approximately 66% of participants said they were likely or very likely to report an adverse drug event associated with a drug with this symbol.
In follow-up interviews, participants suggested various strategies to raise awareness, including social media, television, posters, and printed labels. The majority also agree that this symbol, in its current form and placement within pharmaceutical leaflets, It’s easy to miss. Interview participants also emphasized that simply recognizing symbols is not enough. People need to understand why reporting adverse drug events is important, how to submit a report, and what the system aims to achieve.
When the purpose of this system was explained to the participants, the majority thought it was “very important” and “a good initiative” to improve drug safety. Participants expressed mixed opinions regarding the impact of this system on their intention to report future adverse drug events. Others suggested that the system could unintentionally discourage reporting of drugs without black triangles, if people believe that drugs do not require reporting of adverse drug events.
Increased awareness could strengthen drug safety reporting
The research found that awareness of the Black Triangle Scheme was significantly lower among consumers than among healthcare professionals in Australia. Once the purpose of the program was explained, most participants perceived the program favorably and said they would be more likely to report adverse drug events. Notably, participants also expressed concerns about the visibility and meaning of the black triangle symbol.
Based on the findings of this study, the researchers highlight the need to include consumer-friendly explanations alongside the black triangle symbol in consumer drug information and product information documents to improve consumer understanding of the system and encourage them to report adverse drug events to health regulatory bodies. The symbol and its explanation can be placed in the adverse drug events section of the drug leaflet to improve visibility.
For medicines listed in the Black Triangle Scheme, the inclusion of a cautionary label is A visual cue to start a discussion between pharmacists and consumers about the importance of additional monitoring and reporting suspected adverse drug events.
Awareness of the scheme can also be increased through campaigns targeted at health professionals and broader communication strategies. Participants also suggested integrating the system into medical education, prescribing software, and electronic medical records to improve awareness and support reporting of adverse drug events during routine clinical care.
Study participants were initially surveyed online, which may have excluded those with limited digital access or understanding. This may limit the generalizability of the study results. Additionally, the proportion of female participants was higher than the Australian population, which may limit the representativeness of the general Australian population.
Future large-scale studies are needed to validate these findings and provide more conclusive evidence regarding potential differences in the perception and understanding of black triangle schemes between consumers and health professionals, and between different health professional groups.
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Reference magazines:
- Gebrejohannes E. (2026). Perceptions of the Black Triangle Scheme among Australian healthcare professionals and consumers: A mixed methods study examining reporting intentions and suggested improvements. British Journal of Clinical Pharmacology. Doi: https://doi.org/10.1002/bcp.70633. https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70633
