Effect of the black triangle scheme and its online educational campaign on the quantity and quality of adverse drug event reporting in Australia: a time series analysis.

Objectives: The black triangle scheme was introduced to Australia in January 2018 to improve the significant under-reporting of adverse drug events (ADEs). The authors investigated the impact of the black triangle scheme on the quantity and quality of ADE reports submitted to the Therapeutic Goods Administration.

Methods: An interrupted time series analysis with segmented regression was conducted to compare the quantity of ADE reports pre and post the black triangle intervention for the period between January 2017 and December 2018. The quality of reports was measured by the ability to apply the World Health Organization - Uppsala Monitoring Center algorithm to evaluate a causal relationship between the medicine and ADE.

Results: A total of 384 ADE reports were extracted for the 33 medicines approved in 2017 and 135 ADE reports for the 36 black triangle medicines. Time series analysis showed that there was a monthly increase of 0.41 reports per medicine (95%CI, 0.02-0.80, p = 0.039) post the black triangle intervention. There was a higher proportion for high quality reports for black triangle medicines versus 2017 medicines (22.2% vs 7.6%, p < 0.001).

Conclusion: The black triangle scheme was marginally successful in improving ADE reporting and additional strategies are required to enhance the overall pharmacovigilance system in Australia.