Introduction:
Biosimilars contribute to healthcare system sustainability worldwide. To promote biosimilar utilization, various policy interventions have been implemented internationally, yet evidence regarding their population-level impact remains limited. The Ministry of Health, Labour and Welfare (MHLW) introduced a 1,500 JPY (9.4 USD) incentive to promote biosimilar initiation for home care patients in April 2020, which was expanded to outpatient treatments in April 2022.

Aims:
This study described nationwide trends in biosimilar utilization and biologic expenditures surrounding policy implementation in Japan.

Methods:
A nationwide serial cross-sectional study was conducted using the publicly available national database (NDB) Open Data, which anonymously aggregated reimbursement claims data on an annual basis. The study period was from FY2019 (April 2019-March 2020) to FY2023 (April 2023-March 2024).
Prescribed units of biosimilars per 100,000 inhabitants were analyzed across outpatient and inpatient settings, with means (95% CI) calculated across 47 prefectures.
Additionally, this study calculated biologic expenditures based on the defined unit price by MHLW. Expenditure analyses were restricted to biologics with approved biosimilars as of FY2023 to ensure comparability across years.

Results:
The means (95% CI) of biosimilar prescription units per 100,000 inhabitants were 3700 (3487–3913) in FY2019, and 5051 (4781–5320) in FY2020, 6510 (6119-6901) in FY2021, 7701 (7242-8160) in FY2022, and 9020 (8532-9507) in FY2023, representing a 146% increase from FY2019 to FY2023.
The expenditure for biosimilars and their reference biologics decreased from 3,036 million USD in FY2019 to 2,561 million USD in FY2023, representing a 16% reduction. However, the biosimilar expenditure increased from 153 million USD (5% of total expenditures) in FY2019 to 469 million USD (18% of total expenditures) in FY2023.

Conclusions:
Biosimilar utilization increased substantially, accompanied by a shift in expenditure from reference biologics to biosimilars and an overall reduction in biologic expenditures.

Key words: biosimilar, pharmaceutical policy, drug expenditure

Introduction: China established its pharmacovigilance system in 2019, placing primary responsibility for drug safety on the Marketing Authorization Holder (MAH). A pilot MAH system was launched in 10 provinces in 2016. However, the real-world impact of this legislation on medication safety has not yet been examined from a judicial perspective.

Aims: This study aims to evaluate the real-world effectiveness of China's 2019 pharmacovigilance legislation for medication safety using judicial data. It also seeks to identify weaknesses in the pharmacovigilance system.

Method: We analyzed 379 drug safety litigation cases from China Judgments Online and the Peking University Law Science Database, covering December 2014 to November 2024. Key indicators included the proportion of drug safety litigation cases, the average compensation amount, the proportion of MAH responsibility determinations, and the classification of drug-related problems (DRP). Interrupted time series and breakpoint regression were used to evaluate the 2019 policy effects, and difference-in-differences was used to analyze the 2016 MAH pilot.

Results: The median compensation was 209,933 yuan. Medical institutions accounted for 93.1% of responsible entities, while MAH accounted for only 4.5%. Post-policy, drug safety litigation (β₃=-0.0291, p=0.043) and average compensation (β₃=-25,543, p=0.018) decreased from rising trends, while MAH responsibility attribution showed no statistically significant change. The most common drug issues were insufficient monitoring (59.4%) and lack of informed consent (39.1%), with informed consent cases increasing post-policy (53.3%→63.4%, p=0.059).

Conclusions: The establishment of the pharmacovigilance system was observed to be associated with a reversal of trends in the proportion of drug safety litigation and compensation amounts, but MAH liability has not yet been reflected in judicial outcomes. Challenges remain in drug monitoring and informing obligations. Judicial case data can provide a legal perspective for evaluating the effectiveness of the pharmacovigilance system.

Keywords: Pharmacovigilance; Drug Safety Litigation; Interrupted Time Series Analysis

Introduction: Antibiotic shortages are increasing globally and may significantly affect patient care due to their role in acute infections. As medicine supply chains become increasingly globalised, standardised reporting is important to determine whether shortages reflect country-specific issues or concurrent international supply disruptions. However, little is known about how antibiotic shortages are defined and reported across countries.

Aims: To map the public reporting of antibiotic shortages across OECD countries and describe differences in reporting definitions, frequency, and duration of reported shortages.

Methods: Publicly available medicine shortage databases from OECD countries were searched for systemic antibiotic shortages (ATC code J01) reported between 1 January and 31 December 2025. Data collected included shortage definitions, number of shortages, distinct antibiotic types affected, and shortage duration. Antibiotics were categorised according to the WHO AWaRe classification.

Results: Twenty-one OECD countries with publicly available shortage databases were included. Definitions and reporting criteria varied substantially between countries, including shortages defined as “demand exceeding supply” and those affecting patient care. Reported antibiotic shortages ranged from 4 in Israel to 133 in Canada, while the number of distinct antibiotic types affected ranged from 2 in Israel to 35 in the Czech Republic. Median shortage duration ranged from 25 days in Iceland and Colombia to 365 days in Denmark, Finland, and France. Access antibiotics were most commonly reported, followed by Watch antibiotics, while Reserve antibiotics were least commonly reported.

Conclusions: Public reporting of antibiotic shortages varies substantially across OECD countries, particularly regarding definitions and inclusion criteria. These differences likely affect the reported frequency and duration of shortages and limit meaningful international comparison. More standardised reporting frameworks are needed to support global monitoring of antibiotic shortages.

Keywords: antibiotic shortages; OECD; medicine shortages

Introduction: Catastrophic health expenditure affects millions of households in India, with medicines contributing substantially to out-of-pocket costs among patients on long term pharmacotherapy. Despite its clinical relevance, medication economic stress remains poorly quantified, and no India specific instrument had measured this construct across behavioral and decisional dimensions prior to this study. Understanding its prevalence and predictors is essential to addressing cost related nonadherence.

Aims: To quantify the prevalence and severity of medication economic stress using the newly developed Medication Economic Stress and Decision-Making Scale (MESDS) and identify sociodemographic factors independently associated with this burden among patients with chronic diseases.

Methods: A cross-sectional study was conducted among 507 adults with chronic diseases attending a single tertiary care hospital in Karnataka, India. Data were collected using validated 21-item MESDS, Modified Kuppuswamy Socioeconomic Status Scale, and a structured data collection form. MESDS severity categories were based on thresholds established during scale development. Statistical analyses were performed.

Results: The mean MESDS score was 34.33 ± 14.10 (range: 6.00–76.67). Overall, 28.8% of participants experienced low stress, 57.0% moderate stress, 13.2% high stress, and 1.0% severe stress. Median monthly medicine expenditure was INR 2,000 (IQR: 1,000–4,000). Insurance coverage was independently associated with a 10.8-point reduction in MESDS score (β = −0.385; p < 0.001). Family income (β = −0.199; p < 0.001), socioeconomic class (β = −0.108; p = 0.032), and household size (β = 0.171; p = 0.012) were additional independent predictors. The model explained 44.4% of variance in MESDS scores (Adjusted R² = 0.427).

Conclusions: More than 70% of participants experienced at least moderate medication economic stress. Insurance coverage and socio-economic factors were independently associated with MESDS scores. These findings may inform medication financing policies and support pharmacist-led economic counseling and affordability screening initiatives.

Keywords: Medication economic stress, out-of-pocket expenditure, chronic disease, socioeconomic factors.

Introduction:
Attention-deficit/hyperactivity disorder (ADHD) frequently persists into adulthood, yet data on its lifespan economic burden in Hong Kong remain scarce. We estimated the treated ADHD and its long-term economic burden from the caregiver, service provider and society perspectives.

Aims:
To estimate the treated ADHD and its long-term economic burden from the caregiver, service provider and society perspectives.

Methods:
Using electronic health records data from the Hong Kong Hospital Authority(HA), we included individuals born on or after 1 January 1997 who received at least one approved ADHD medication in Hong Kong (methylphenidate, atomoxetine and lisdexamfetamine) between 2001 and 2025. The index date was the first ADHD medication dispensing. Annual rate ware calculated using matching resident population denominators from the Hong Kong Census and Statistics Department. Caregiver cost included total co-payments plus productivity loss. Provider costs were calculated using the HA Annual Report unit cost. Societal cost was the sum of provider costs and caregiver productivity losses. All unit costs were adjusted for inflation to 2025.

Results:
A 57,680 patients’ cohort were identified. Of these, 76.7% were male, the median age at first treatment was 8 years, and total follow-up was 451,187 person-years. The treated ADHD incidence rose from 1.8 per 100,000 from 2001, reaching 271 per 100,000 in 2025. Total caregivers cost was HK$1.02 billion, of which 64% was indirect cost from productivity loss. Total provider cost was HK$4.71 billion, of which more than half, about 63%, came from outpatient care. Total societal cost was HK$5.36 billion.

Conclusions:
The rate of ADHD medication dispensing has risen markedly since 2001, carrying a substantial and growing societal cost. And a large part of the cost in caregiver is indirect cost, underscoring the need for family-centered support alongside service planning.

Introduction: GLP-1 medicines offer significant cardio-renal benefits for type 2 diabetes (T2D) and obesity. Despite high consumer demand for weight loss, subsidised access in high-income countries is generally limited to people with T2D. The scale of private access, the primary pathway of access for weight loss, is largely unknown.

Aims: We aimed to quantify population-level trends in publicly subsidised and private access of GLP-1 medicines in Australia.

Method: We used national pharmaceutical sales data to quantify use of GLP-1 medicines listed for T2D in Australia, May 2020 - April 2025. We used Pharmaceutical Benefits Scheme dispensing claims to measure subsidised access; we estimated private access as the difference between sales and subsidised dispensings. We measured GLP-1 use as number of units sold/dispensed and defined daily dose (DDD)/1000 population/day.

Results: Since May 2020, total sales of GLP-1 medicines increased almost 10-fold, despite significant disruptions during shortages. Most growth was in private access, driven by semaglutide and rapid uptake of tirzepatide. In the year May 2024-April 2025, over 6 million units of GLP-1 medicines were sold, predominantly semaglutide (63.3%) and tirzepatide (30.7%). Half (47.8%) of GLP-1 medicines were accessed privately, including 26.9% of semaglutide and all tirzepatide. We estimate approximately 480,000-500,000 people accessed GLP-1 medicines each month, with 180,000-240,000 people accessing privately.

Conclusion: GLP-1 medicines use has increased dramatically, with approximately half a million Australians using GLP-1 medicines each month, almost half through private access. Our findings underscore significant demands outside of subsided access, most likely for weight loss, and highlight substantial pressures for health systems meeting this demand.

Keywords: GLP-1 medicines, diabetes, obesity, equity of access