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.
Acknowledgments
The authors would like to acknowledge Dr Richard Hill, medical officer at the Therapeutic Goods Administration, for supplying the necessary data from the Australian pharmacovigilance database.
Author contributions
Conception and design: R Li. Analysis and interpretation of data: R Li, K Curtis, C Van, STR Zaidi, R Castelino. Drafting of paper: R Li. Revising it critically for intellectual content: R Li, K Curtis, C Van, STR Zaidi, R Castelino. Final approval of version to be published: R Li, K Curtis, C Van, STR Zaidi, R Castelino. All authors agree to be accountable for all aspects of this publication.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.