Section 19A in practice: Assessing the provision of overseasāregistered medicines to mitigate the impact of medicine shortages in Australia
Date
2025
Authors
Janetzki, J.
Ward, M.
Hall, K.
Casey, A.
Pratt, N.
Ellett, L.K.
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Journal article
Citation
British Journal of Clinical Pharmacology, 2025; 1-11
Statement of Responsibility
Jack Janetzki, Michael Ward, Kelly Hall, Anna-Kemp Casey, Nicole Pratt, Lisa Kalisch Ellett
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Abstract
Aim: To evaluate the utilization of Section 19A (S19A) medicines subsidized by the Pharmaceutical Benefits Scheme (PBS) in Australia and assess their role in maintain- ing access to medicines during shortages. Methods: Time series analysis was conducted on aggregate PBS dispensing data. Monthly dispensing volumes standardized to the Australian population, were exam- ined for 15 medicines that had S19A listings between February 2016 and July 2024. Results: In the year following PBS listing, S19A medicines accounted for more than half of dispensing volume for 63% of medicines (12), demonstrating substantial uptake. However, dispensing volumes for each medicine overall were frequently lower than pre-S19A PBS listing levels, suggesting that overall supply did not fully recover. Delays between PBS approval of S19A medicines and their first dispensing were observed for several products. These delays, alongside heterogeneous patterns of uptake across medicines, indicate that the S19A pathway does not uniformly restore access. For some medicines, limited awareness among prescribers or logistical barriers may have restricted timely use. Conclusion: The S19A pathway is an important regulatory mechanism to mitigate medicine shortages and maintain patient access to essential treatments. Despite sub- stantial uptake for many medicines, delays and inconsistent recovery highlight oppor- tunities to improve its effectiveness. Policy refinement should focus on reducing time to patient access and addressing implementation barriers to ensure continuity of care during supply disruptions.
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OnlinePubl
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Ā© 2025 British Pharmacological Society.