Clinical Report: Evaluation of the Medicine Shortage Policy Tool in Australia

Overview

This study evaluates the effectiveness of Australia’s Serious Scarcity Substitution Instruments (SSSIs) in addressing medicine shortages. Findings indicate that two-thirds of SSSIs limited utilization declines to less than 20%.

Background

Medication shortages pose significant challenges in healthcare, particularly in Australia where over 90% of medicines are imported. The Therapeutic Goods Administration (TGA) oversees the reporting of medicine shortages, allowing pharmacists to utilize Serious Scarcity Substitution Instruments (SSSIs) to substitute medications without prescriber approval during shortages.

Data Highlights

This study analyzed national dispensing data from the Pharmaceutical Benefits Scheme (PBS) to assess the impact of SSSIs on medicine utilization.

Key Findings

• Two-thirds of SSSIs limited utilization declines to less than 20%.
• Effectiveness of SSSIs was linked to the availability of substitute products.
• SSSIs have been in use since 2021 to address shortages caused by manufacturing issues and supply chain disruptions.

Clinical Implications

Pharmacists should be aware of the SSSIs in place to manage medicine shortages.

Conclusion

The evaluation of SSSIs highlights their use as a policy tool for addressing medicine shortages.

Related Resources & Content

1. Drug Safety, Effects of Regulatory Measures on Oxycodone Prescription Practices in Queensland, Australia: An Uncontrolled Interrupted Time Series Analysis
2. The ASCO Post, Distributing Scarce Cancer Drugs Legally and Ethically
3. The ASCO Post, ASCO Survey: Drug Shortages Still a Problem Despite Slight Improvement
4. JAMA Network Open, Supply Chain Events and Risk of Drug Shortage in Canada
5. Serious Scarcity Substitution Instruments (SSSIs) | Therapeutic Goods Administration (TGA)
6. Serious shortage protocols (SSPs) | NHSBSA
7. Serious Scarcity Substitution Instruments (SSSIs) | Therapeutic Goods Administration (TGA)
8. Serious shortage protocols (SSPs) | NHSBSA
9. https://www.apsa-online.org/wp-content/uploads/2026/03/APSA-2025-Conference-Proceedings.pdf