Extended dispensing intervals for pancreatic enzyme extract without access destabilisation: a national retrospective study evaluating supply resilience during policy changes and medicine shortages in Australia

OBJECTIVE: This study aims to describe national trends in pancreatic enzyme replacement therapy (PERT) dispensing in Australia and assess changes following the introduction of 60-day prescription dispensing, in the context of medicine shortages and market changes. METHODS: Publicly available Pharmaceutical Benefits Scheme (PBS) data for pancreatic enzyme extract dispensings were analysed from February 2014 to October 2025. Monthly dispensing rates per 100,000 population were calculated using Australian Bureau of Statistics population estimates. Medicine shortage periods, including sustained shortages in 2025, were identified using the Therapeutic Goods Administration (TGA) database. Interrupted time-series analyses were conducted to evaluate changes in dispensing of 5000 U, 10,000 U, 25,000 U, and 35,000 U strengths before (July 2021-August 2023) and after (October 2023-October 2025) implementation of 60-day dispensing. RESULTS: PERT dispensing increased from 33 to 85 dispensings per 100,000 population per month between February 2014 and October 2025 (160% increase). Dispensing patterns varied across formulations in response to market changes. Following the introduction of the 35,000 U strength in July 2021, its share of total dispensings increased, whereas dispensing of the discontinued 40,000 U strength declined from November 2020. Interrupted time-series analyses indicated a statistically significant immediate change in dispensing only for the 5000 U strength of PERT. Statistically significant changes in dispensing were observed following introduction of the policy for the 25,000 and 35,000 strengths, but the absolute difference in dispensings per 100,000 population per month was minimal. CONCLUSIONS: PERT use in Australia has increased over time, reflecting growing clinical need. Although medicine shortages influenced utilisation patterns across strengths, the introduction of 60-day dispensing was not associated with significant changes in PBS dispensing of PERT. Ongoing monitoring is warranted given reliance on a single-brand therapy.