Raymond Li1, Kate Curtis1, Syed Tabish Razi Zaidi2,3, Connie Van1, Ronald Castelino1. 1. Faculty of Medicine and Health, University of Sydney , Camperdown, Australia. 2. Faculty of Medicine and Health, University of Leeds , Leeds, England. 3. National Institute for Health Research (NIHR), Yorkshire and Humber Patient Safety Translational Research Centre , West Yorkshire, England.
Abstract
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.
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.
Keywords:
Australia; Pharmacovigilance; black triangle; drug safety; reporting system
Authors: André Said; Leonard Freudewald; Natalie Parrau; Matthias Ganso; Martin Schulz Journal: Medicine (Baltimore) Date: 2021-03-19 Impact factor: 1.817