Jack Janetzki

Background and aims: Australia experienced a prolonged varenicline shortage beginning June 2021, disrupting access to a key smoking cessation therapy. Section 19A (S19A) of the Therapeutic Goods Act permitted temporary importation of overseas‐approved products to mitigate this impact. We aimed to examine dispensing trends for varenicline and alternative therapies during the shortage and evaluate the effectiveness of S19A interventions. Design: Retrospective study using interrupted time series analysis with two intervention points: shortage impact June 2021 and mitigation with S19A medicines May 2022. Setting: Australia; national Pharmaceutical Benefits Scheme (PBS) dispensing data. Cases: Aggregate monthly dispensings of varenicline, bupropion and nicotine products from January 2018 to May 2025. Measurements: Defined Daily Dose per 100 000 population per day (DDD/100 000/day); estimated missed varenicline doses calculated by comparing expected vs. actual dispensings. Results: Varenicline use declined from 96.14 DDD/100 000/day (Feb 2018) to 0.29 (Mar 2022). S19A imports commenced 11 months after the shortage began, accounting for 38% of dispensings between May 2022 and June 2024. The decline equated to 1319 fewer individuals receiving varenicline for one year at standard dosing. Bupropion use increased from 5.71 to 16.63 DDD/100 000/day post‐shortage, while nicotine use declined. Pre‐shortage varenicline levels were not restored. Summary: The varenicline shortage in Australia from June 2021 substantially disrupted subsidised smoking cessation pharmacotherapy. Regulatory interventions and increased bupropion use partially mitigated the impact but were insufficient to maintain prior access.

Aims: Lisdexamfetamine, a long‐acting stimulant for attention‐deficit hyperactivity disorder (ADHD), has experienced widespread shortages in Australia since late 2023, raising concerns about treatment continuity and shifts in stimulant use patterns. This study assessed the impact of shortages in South Australia (SA) and Western Australia (WA) by triangulating prescription dispensing and wastewater‐based epidemiology (WBE). Methods: Monthly Pharmaceutical Benefits Scheme (PBS) dispensing data for lisdexamfetamine and dexamfetamine were converted to defined daily doses (DDD) per 1000 population per day. Concurrently, bimonthly wastewater samples from metropolitan sites were analysed for amphetamine and methamphetamine concentrations, with methamphetamine serving as a control as its use was unlikely to be affected by the shortage. Data were compared from February 2022 to December 2024. Results: In WA, lisdexamfetamine DDDs increased from 5.59 to 13.02 and dexamfetamine from 2.55 to 6.03 per 1000 population per day, doubling combined stimulant DDDs from 8.14 to 19.05. In SA, lisdexamfetamine DDDs rose from 1.05 to 5.00. Wastewater amphetamine levels fluctuated (WA: 5.07–17.10; SA: 0.79–3.46 doses/day/1000 people) but declined sharply during shortages, while methamphetamine levels remained high (peaking at 62.65 in WA and 66.22 in SA). Conclusions: Triangulation revealed variations in lisdexamfetamine use during shortages and highlighted potential behavioural responses. While these behaviours may partly explain differences between prescription dispensing and wastewater amphetamine levels, they do not fully account for the observed temporal patterns. Nonetheless, triangulating these data sources offers valuable insights for monitoring medicine use and informing public health and policy responses during supply disruptions.

Objective: To evaluate the real-world impact of Stage 1 of Australias 60-day dispensing policy on medicine utilisation and contextualise changes in dispensing with medicine shortages. Methods: We conducted an interrupted time series analysis of aggregated national monthly dispensing data from the Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme for the 247 medicines included in Stage 1 of the 60-day dispensing policy. Data from January 2020 to October 2025 were analysed, with September 2023 defined as policy implementation. Linear regression assessed changes in monthly dispensing trends before and after implementation, accounting for autocorrelation and seasonal variation. A relative change of at least 5% in the post-intervention dispensing slope compared with the pre-intervention slope was prespecified as a potentially clinically meaningful change. Therapeutic Goods Administration shortage reports were used to contextualise observed changes. Results: Of 247 medicines, 131 (53%) had increasing and 116 (47%) had decreasing post-intervention dispensing trends; of which 86 (66%) and 71 (61%), were statistically significant, respectively. However, only 8 medicines (3%) demonstrated at least 5% relative change in dispensing slope, six of which had reported shortages. Medicine-specific changes coincided with shortages, product deletions and therapeutic substitution, complicated attribution of changes to the 60-day dispensing policy. Conclusion: Stage 1 of Australias 60-day dispensing policy was not associated with widespread changes in dispensing for most included medicines. Limited changes were plausibly influenced by concurrent shortages and other supply-related events. These findings provide reassurance that extended dispensing did not result in major increases in medicine utilisation at the population level, although continued monitoring is warranted as policy uptake expands.

Purpose: To describe nationwide dispensing patterns of methylphenidate in Australia before and during recent prolonged supply shortages, and to assess the extent to which Section 19A (S19A) overseas substitutes contributed to population‐level utilisation during the shortage period. Secondary aims were to compare methylphenidate dispensing with other ADHD medicines, examine changes in dispensing across individual strengths and formulations and quantify delays between S19A approval and Pharmaceutical Benefits Scheme (PBS) listing. Methods: An interrupted time series (ITS) and descriptive analysis of population‐level dispensing patterns was conducted using publicly available monthly dispensing data from the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (January 2020–March 2026). Data were standardised to dispensings and defined daily doses (DDD) per 100 000 population. Methylphenidate shortages were identified using the Therapeutic Goods Administration Medicines Shortages database and shortage months were designated where there was at least 1 day of shortage in a month. S19A approvals, PBS listing and lapse dates were obtained from the S19A approvals database to determine delays to subsidised access. Results: Dispensing of ADHD medicines increased substantially from 2020 to 2025. Methylphenidate dispensing increased overall but plateaued from late 2024 onward, coinciding with widespread supply disruptions affecting multiple strengths and formulations. DDD ITS analysis demonstrated abrupt reductions in methylphenidate strengths (particularly 36 and 54 mg) during shortages, with partial compensatory increases for some other strengths. Fifteen overseas‐registered methylphenidate products received S19A approval; however, of the 14 listed on the PBS, time to PBS listing ranged from 83 to 166 days (median 162 days). After PBS listing, S19A products contributed to 1.3% of all methylphenidate dispensings between July 2025 and March 2026. Conclusion: Methylphenidate dispensing in Australia became unstable during extensive supply shortages from late 2024. Although numerous S19A products were approved, there was minimal uptake of S19A PBS‐listed products at the population level. As ADHD medicine utilisation continues to rise, strengthened national strategies to improve supply chain resilience, transparency and responsiveness are required.

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.

Introduction: Medicine shortages can disrupt glaucoma management and necessitate therapeutic substitution. Understanding how shortages affect access to first-line treatments for glaucoma is important for optometrists when monitoring intraocular pressure control, and pharmacists when counselling patients and coordinating care during periods of limited medicine availability. Timolol, a non-selective beta-blocker, is a first-line treatment for glaucoma and ocular hypertension and has experienced international shortages in recent years. Between August 2024 and May 2025, Australia experienced a nationwide shortage of timolol-containing eye drops, raising concerns regarding continuity of care, access to treatment, and therapeutic substitution. Aim: To descriptively examine the impact of the 2024–2025 timolol eye drop shortage on dispensing patterns of antiglaucoma medicines in Australia and assess the contribution of imported products in mitigating the shortage. Method: A retrospective drug utilisation study was conducted using publicly available aggregate Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS dispensing data from January 2020 to August 2025. Monthly dispensings of antiglaucoma preparations (ATC S01E) were standardised per 100,000 population and analysed using descriptive time-series methods. Dispensing trends were compared before, during, and after the shortage, with stratification by timolol formulation, therapeutic class, and product type (locally supplied versus overseas imports). Results: The late 2024 and early 2025 timolol shortage was associated with a sustained decline in dispensing of single-ingredient extended-release timolol, decreasing from approximately 40 dispensings per 100,000 population per month before the shortage to 1.07 by March 2025. Dispensing of standard-release timolol increased temporarily in October 2024 before declining in a similar pattern. Overseas imports accounted for 24.3% of all timolol dispensings during the shortage period and peaked at 87% of timolol dispensings in March 2025. Despite regulatory approval of imported products, overall timolol utilisation remained below pre-shortage levels. Alternative therapeutic classes, including prostaglandin analogues and carbonic anhydrase inhibitors, showed modest increases in dispensing, suggesting potentially limited therapeutic substitution. Conclusion: The timolol shortage disrupted access to a cornerstone first-line treatment for glaucoma. Regulatory intervention through the approval of imported products partially mitigated the shortage but did not restore utilisation to pre-shortage levels in Australia. Future shortage management strategies should prioritise rapid policy activation and closer alignment of imported products with formulations routinely available in Australia.

Medication shortages are a considerable and ongoing issue in healthcare, disrupting consumer access to medicines. Since 2021, Australia's national medicines regulator has issued Serious Scarcity Substitution Instruments (SSSIs), allowing pharmacists to substitute a specific therapeutically equivalent strength and/or formulation of a medicine without prior approval from a prescriber. The impact of SSSIs on utilisation of medicines has not been investigated. To determine whether SSSIs are effective in addressing medicine shortages and meeting patients' needs. This retrospective cohort study used aggregated pharmacy claims to examine the utilisation of 12 medicines, which had an SSSI. We calculated the percentage change in defined daily doses dispensed per 1000 population per day in the 11 months after SSSI implementation, compared with the previous 2 years. A percentage change of less than 20% was used to indicate success. Following medicine shortages, utilisation fell for 10 of the 12 medicines examined. For eight of these medicines (amoxicillin, cefalexin, estradiol, fluoxetine, insulin degludec with insulin aspart, isosorbide mononitrate, vigabatrin, and warfarin) decreases in utilisation were minimised to < 20%. On average, SSSIs where all permitted substitute products were scarce (e.g., abatacept) were associated with larger decreases in use (between - 22 and - 68%) than those for which none or only some of the substitutes were in shortage (between - 45 and + 7%, respectively). While product shortages led to decreases in medicines consumption, SSSIs appeared to be successful in limiting decreases. However, SSSIs were less likely to be successful when many of the permitted substitute products were also scarce.

Background: Fertility rates in Australia have been declining over recent decades, reaching a record low total fertility rate of 1.48 births per woman in 2024. Concurrently, vasectomy remains widely accessible and increasingly normalised as a permanent contraceptive option. Despite extensive commentary on falling birth rates, no contemporary Australian study has examined vasectomy rates relative to birth rates over time. We aimed to compare population level vasectomy and birth rates across Australian jurisdictions and age groups. Study design: Nationwide retrospective time-series study. Retrospective population-based study using Medicare Benefits Schedule item 37623 to identify vasectomy procedures performed between July 2015 and December 2024. Rates were calculated per 100,000 male population using quarterly Australian Bureau of Statistics (ABS) population estimates and summarised as rolling 12-month averages. Birth rates were derived using matched ABS data for women across equivalent age strata (18–24, 25–34, 35–44 years). Results: Vasectomy rates increased nationally from 32 per 100,000 in 2016 to 55 per 100,000 in 2023 before declining modestly in 2024. Birth rates declined from 5,200 to 3,800 per 100,000 over the same period. Trends were consistent across states and age groups, with the greatest vasectomy uptake in men aged 35–44 years. Conclusion: Australia is undergoing a demographic shift characterised by rising vasectomy uptake and declining fertility. We have observed changing secular trends in two related but distinct demographic indicators of reproductive intention. Ongoing monitoring of permanent and long-acting contraception is essential to understand evolving population dynamics and inform reproductive health policy. Short summary for non-experts: This nationwide study demonstrates that rising vasectomy uptake in Australia coincides with declining birth rates, particularly among men aged 35–44 years. Monitoring permanent contraceptive use alongside fertility trends may help clinicians and policymakers better understand changing reproductive intentions and inform future reproductive health planning. Short summary for non-experts: Australia’s birth rate has fallen to record lows, raising growing concerns about how changing reproductive choices may shape future society and healthcare needs. In this study, we found that vasectomy rates increased steadily across Australia between 2016 and 2024 while birth rates declined, particularly among adults aged 35-44 years. These findings suggest Australian men are increasingly choosing permanent contraception and highlight the need for ongoing monitoring of reproductive health trends to inform future policy and service planning.

Background: Medication shortages are a considerable and ongoing issue in healthcare, disrupting consumer access. Since 2021, Australia’s national medicines regulator has issued Serious Scarcity Substitution Instruments (SSSIs), allowing pharmacists to substitute a specific therapeutically equivalent strength and/or formulation of a medicine without prior approval from a prescriber. The impact of SSSIs on utilisation of medicines has not been investigated. Objective: Determine whether SSSIs are effective in addressing medicine shortages and meeting patient need. Methods: This retrospective cohort study used aggregated pharmacy claims to examine the utilisation of 12 medicines which had an SSSI. We calculated the percentage change in defined daily doses dispensed per 1000 population per day in the 11 months after SSSI implementation, compared with the previous two years. A percentage change of less than 20% was used to indicate success. Results: Following product shortages, utilisation fell for 10 of the 12 medicines examined. For eight of these medicines (amoxicillin, cefalexin, estradiol, fluoxetine, insulin degludec with insulin aspart, isosorbide mononitrate, vigabatrin, and warfarin) decreases in utilisation were minimised to <20%. On average, SSSIs where all permitted substitute products were scarce (e.g. abatacept) were associated with larger decreases in use (between -22% and -68%) than those for which none or only some of the substitutes were in shortage (between -45% and +7%, respectively). Conclusions: While product shortages led to decreases in medicines consumption, SSSIs appeared to be successful in limiting decreases. However, SSSIs were less likely to be successful when many of the permitted substitute products were also scarce. Key points: This study is the first to evaluate the effectiveness of Australia’s Serious Scarcity Substitution Instruments (SSSIs) in mitigating medicine shortages using national dispensing data and interrupted time series analysis. Two-thirds of SSSIs successfully limited utilisation declines to less than 20%, with effectiveness strongly linked to the availability of substitute products. By demonstrating variable utilisation outcomes across medicines, this study adds empirical evidence to international debates on substitution policies, suggesting that nationally standardised frameworks like Australia’s SSSIs may function best when supported by robust supply intelligence. SSSIs are a valuable policy tool for maintaining continuity of care during shortages, but timely implementation and ensuring substitute supply are critical for optimal impact.