Trends in antidiabetic drug use and expenditure in public hospitals in Northwest China, 2012-21: a case study of Gansu Province.

BACKGROUND: Since the twenty-first century, the prevalence of diabetes has risen globally year by year. In Gansu Province, an economically underdeveloped province in northwest China, the cost of drugs for diabetes patients accounted for one-third of their total drug costs. To fundamentally reduce national drug expenditures and the burden of medication on the population, the relevant departments of government have continued to reform and improve drug policies. This study aimed to analyse long-term trends in antidiabetic drug use and expenditure in Gansu Province from 2012 to 2021 and to explore the role of pharmaceutical policy. METHODS: Data were obtained from the provincial centralised bidding and purchasing (CBP) platform. Drug use was quantified using the anatomical therapeutic chemistry/defined daily dose (ATC/DDD) method and standardised by DDD per 1000 inhabitants per day (DID), and drug expenditure was expressed in terms of the total amount and defined daily cost (DDC). Linear regression was used to analyse the trends and magnitude of drug use and expenditure. RESULTS: The overall trend in the use and expenditure of antidiabetic drugs was on the rise, with the use increasing from 1.04 in 2012 to 16.02 DID in 2021 and the expenditure increasing from 48.36 in 2012 to 496.42 million yuan in 2021 (from 7.66 to 76.95 million USD). Some new and expensive drugs changed in the use pattern, and their use and expenditure shares (as the percentage of all antidiabetic drugs) increased from 0 to 11.17% and 11.37%, but insulins and analogues and biguanides remained the most used drug class. The DDC of oral drugs all showed a decreasing trend, but essential medicines (EMs) and medical insurance drugs DDC gradually decreased with increasing use. The price reduction of the bid-winning drugs was over 40%, and the top three drugs were glimepiride 2mg/30, acarbose 50mg/30 and acarbose 100mg/30. CONCLUSIONS: The implementation of pharmaceutical policies has significantly increased drug use and expenditure while reducing drug prices, and the introduction of novel drugs and updated treatment guidelines has led to changes in use patterns.

Cancer medicines: a private vice for public benefit?

Cancer medicines have become one of the most dominant global medical technologies. They generate huge profits for the biopharmaceutical industry as well as fuel the research and advocacy activities of public funders, patient organisations, clinical and scientific communities and entire federal political ecosystems. The mismatch between the price, affordability and value of many cancer medicines and global need has generated significant policy debate, yet we see little change in behaviours from any of the major actors from public research funders through to regulatory authorities. In this policy analysis we examine whether, considering the money and power inherent in this system, any rationale global consensus and policy can be achieved to deliver affordable and equitable cancer medicines that consistently deliver clinically meaningful benefit.

Factors influencing the effects of policies and interventions to promote the appropriate use of medicines in high-income countries: A rapid realist review.

BACKGROUND: The appropriate use of medicines has long been recognized as a fundamental component of medicine policies. We aimed to extract lessons from published research on how policy contexts and mechanisms can affect the outcomes of national- or health-system level interventions to promote appropriate medicine use (defined as an increase in underutilized medications or decrease in inappropriate medication use). METHODS: We conducted a rapid realist review of published evidence concerning system-level policies to promote the appropriate use of medicines in high-income countries with universal prescription drug coverage. We searched MEDLINE and Embase to identify relevant publications. We used a realist evaluation framework to identify contexts, mechanisms, and outcomes for each intervention and to hypothesize which policy contexts and mechanisms supported successful outcomes in terms of relative changes in the prevalence of use of the specific medication classes targeted. RESULTS: From 1,318 identified studies, 18 met our inclusion criteria. 13 distinct policies were identified. Three main policy-related factors underpinned successful interventions: involving providers and patients through program interventions; central coordination through national agencies dedicated to medicine policies; and the establishment of an explicit and integrated national medicine policy strategy. CONCLUSION: Policymakers can improve coordination of national pharmaceutical policies to reduce harms from inappropriate medicines use, thus improving health outcomes through cost-effective programs.

Private sector availability and affordability of under 5 malaria health commodities in selected states in Nigeria and the Federal Capital Territory.

Background: To guarantee uninterrupted service delivery, quality-assured products must be affordable and continuously available across all sectors, including the private sector, which provides more than 60% of healthcare services in Nigeria. We investigated the private sector availability and affordability of under 5 malaria commodities to establish the level of access in this sector. Methods: We surveyed patent medicine and pharmacy stores across seven states in Nigeria and the Federal Capital Territory to establish the availability and affordability of selected malaria commodities for children under 5 years. Availability was measured as the percentage of visited outlets with the product of interest on the day of visit, while affordability was assessed by establishing if it cost more than a day's wage for the least-paid government worker to purchase a full course of malaria diagnostic test and/or medication. Results: Artemisinin-based antimalarials for uncomplicated and severe malaria were the most available commodities. SPAQ1 and SPAQ2 used for seasonal malaria chemoprevention campaign were surprisingly also available in some outlets. However, only about half (48.3% and 53.3%) of the surveyed outlets had stock of artemether/lumefantrine (AL1) and artesunate injection, respectively. The median price of surveyed products ranged from USD (United States Dollars) 0.38 to USD 2.17 per treatment/test. Except for amodiaquine tablet and artemether injection, which cost less, all other originator brands cost the same or more than the lowest-priced generic. Antimalarial products were affordable as their median prices were not more than a day's wage for the least-paid government worker. However, when the cost of testing and treatment with artemisinin-based combination therapies (ACTs) was assessed, testing and treatment with dihydroartemisinin/piperaquine were unaffordable as the they cost more than 1.5 times the daily wage of the least-paid government worker. Conclusion: The overall private sector availability of under-five malaria commodities in surveyed locations was suboptimal. Also, testing and treatment with recommended ACTs were not affordable for all surveyed products. These findings suggest the need for interventions to improve access to affordable under-five malaria commodities.

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries.

Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement (P&R) options, original empirical research is very scarce. This paper aims to provide a comprehensive international review of regulatory and P&R decisions taken for all ATMPs with centralized European marketing authorization in March 2022. Methods: A survey was distributed in July 2022 to representatives of 46 countries. Results: Responses were received from 20 countries out of 46 (43.5%). 14 countries reimbursed at least one ATMP. Six countries in this survey reimbursed no ATMPs. Conclusion: Access to ATMPs is uneven across the countries included in this study. This arises from regulatory differences, commercial decisions by marketing authorization holders, and the divergent assessment processes and criteria applied by payers. Moving towards greater equality of access will require cooperation between countries and stakeholders, for example, through the WHO Regional Office for Europe's Access to Novel Medicines Platform.

Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de Colombia

Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.

Trends, Capacity Growth, and Current State of Community Pharmacies in Saudi Arabia: Findings and Implications of a 16-Year Retrospective Study.

Purpose: Community pharmacies provide access to medicines and pharmaceutical services. Consequently, adequate availability and sufficient workforce capacity must be ensured for effective healthcare delivery. This study assessed the community pharmacy sector in Saudi Arabia, including density, workforce capacity, and evolution from 2007 to 2022. Methods: This retrospective study measured community pharmacy infrastructure and workforce capacity using international indicators and standardized measures, including community pharmacy and community pharmacist density per 10,000 people and ratio of community pharmacists per pharmacy. Several data sources and platforms were used to collect the data including the Ministry of Health, Saudi General Authority for Statistics, and Ministry of Human Resources and Social Development. Results: The number of community pharmacies increased by 89.30%, from 5466 in 2007 to 10,347 in 2022, and density increased from 2.25 to 3.22. However, density varied by region, from 3.97 to 1.95. The number of community pharmacists increased by 98.02%, from 10,932 in 2007 to 21,648 in 2022, and community pharmacist density increased from 4.51 to 6.73. However, the ratio of community pharmacists per pharmacy remained unchanged (2.0 in 2007 and 2.1 in 2022). Female pharmacists were first issued licenses to practice in community pharmacies in 2016, and the proportion of female pharmacists to total increased from 0.29% (n=42) in 2016 to 10.95% (n=2370) in 2022. The nationalization policy for community pharmacies was implemented in 2020, and the proportion of Saudi pharmacists increased from 3.08% (n=581) in 2019 to 19.90% (n=4306) in 2022, while proportion of expatriate pharmacists decreased from 96.92% (n=18,292) to 80.10% (n=17,342). Conclusion: The findings showed that the community pharmacy sector in Saudi Arabia recently experienced substantial growth comparable to high-income countries. However, further improvements are required in some regions to increase community pharmacy density. Moreover, the ratio of pharmacists per pharmacy should be improved to meet the healthcare system needs.

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.

BACKGROUND: Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. OBJECTIVES: This study reviews the FDA's five special designations for drug development regarding their safety, efficacy/clinical benefit, clinical trials, innovation, economic incentives, development timelines, and price. METHODS: We conducted a keyword search to identify studies analyzing the impact of the FDA's special designations (orphan, fast track, accelerated approval, priority review, and breakthrough therapy) on the safety, efficacy/clinical benefit, trials, innovativeness, economic incentives, development times, and pricing of new drugs. Results were summarized in a narrative overview. RESULTS: Expedited approval reduces new drugs' time to market. However, faster drug development and regulatory review are associated with more unrecognized adverse events and post-marketing safety revisions. Clinical trials supporting special FDA approvals frequently use small, non-randomized, open-label designs. Required post-approval trials to monitor unknown adverse events are often delayed or not even initiated. Evidence suggests that drugs approved under special review pathways, marketed as "breakthroughs", are more innovative and deliver a higher clinical benefit than those receiving standard FDA approval. Special designations are an economically viable strategy for investors and pharmaceutical companies to develop drugs for rare diseases with unmet medical needs, due to financial incentives, expedited development timelines, higher clinical trial success rates, alongside greater prices. Nonetheless, patients, physicians, and insurers are concerned about spending money on drugs without a proven benefit or even on drugs that turn out to be ineffective. While European countries established performance- and financial-based managed entry agreements to account for this uncertainty in clinical trial evidence and cost-effectiveness, the pricing and reimbursement of these drugs remain largely unregulated in the US. CONCLUSION: Special FDA designations shorten clinical development and FDA approval times for new drugs treating rare and severe diseases with unmet medical needs. Special-designated drugs offer a greater clinical benefit to patients. However, physicians, patients, and insurers must be aware that special-designated drugs are often approved based on non-robust trials, associated with more unrecognized side effects, and sold for higher prices.

Medicines for the People, not the Financial Markets.

Drug company marketing scandals have often made headlines. However, in recent years, a raft of new pharmaceutical industry transgressions has created crises for health care systems of high-income countries as well as poorer nations. Prices of life-saving drugs are soaring; supply shortfalls of essential medications have become common; development of new antibiotics against resistant organisms is lagging; and inequalities in access to medicines are widening. Policymakers must find new solutions to protect health systems and health.

Interface policies bridging outpatient and hospital sectors in Europe: can cross-sectorial collaboration in reimbursement and procurement improve access to affordable medicines?

INTRODUCTION: Pharmaceutical systems are frequently characterized by fragmentation, and competences for outpatient and inpatient sectors sit with different authorities, payers, and purchasers. This fragmentation of responsibilities can incentivize shifting expensive therapies and thus patients from one sector to the other. AREAS COVERED: Reimbursement and procurement policies in Europe addressing unwanted consequences of this fragmentation were identified through literature reviews and surveys with policy-makers. Good practice examples include cross-sectorial reimbursement lists managed by committees with representatives from the outpatient and hospital sectors, specific funding mechanisms, joint procurement involving purchasers from both sectors, actions against procurement contracts prohibiting generic competition, and an extension of Health Technology Assessment to the hospital sector. EXPERT OPINION: Recognizing fragmentation as a major challenge for pharmaceutical systems, policy-makers in some countries reacted by implementing policies to support cross-sectorial collaboration. However, only a handful of good practice examples exist for reimbursement and procurement policies in Europe. Though robust evaluations are lacking, there are indications that pharmaceutical policies which ensure collaboration at the interface of the outpatient and inpatient sectors would likely result in efficiency gains and better use of public budgets and may serve as lever to improve access to medicines.

In several European countries, the decision which medicines are funded by public money (reimbursement) and purchased by public institutions (public procurement) is taken independently for the outpatient sector and the hospital sector. There are different payers and procurers per sector, and even within a sector. Patients may be transferred between the sectors for financial reasons because one payer aims to shift the financial burden for the medication to the other sector.Policy-makers have understood the importance of better collaboration between the sectors, and some European countries introduced policies addressing the issue.The article presents examples of how reimbursement and procurement policies can be designed to improve the collaboration between the outpatient and hospital sectors. Committees that decide whether or not a medicine should be covered may contain representatives from both sectors; they may be mandated to take decisions that apply to medicines for outpatient use and administered in hospitals. Purchasers of both sectors may procure jointly a medicine. Supporting tools, such as the assessment of a medicine to support the decision on coverage and the price, may be used in both sectors. Financing solutions can reduce the incentive for one sector to shift a medicine to the other sector.These measures can help that patients gain improved access to affordable medicines. However, despite the introduction of such interface policies in some countries, policy-makers still need to continue working on overcoming the fragmentation in the pharmaceutical system.

Broken Promises: Racism and Access to Medicines in Canada.

BACKGROUND: Discriminatory policies, attitudes, and practices have had deleterious impacts on the health of Black, Indigenous, and other racialized groups. The aim of this study was to investigate racism as barrier to access to medicines in Canada. The study investigated the characteristics of structural racism and implicit biases that affect medicines access. METHODS: A scoping review using the STARLITE literature retrieval approach and analysis of census tract data in Toronto, Ontario, Canada, were undertaken. Government documents, peer-reviewed articles from public policy, health, pharmacy, social sciences, and gray literature were reviewed. RESULTS: Structural racism that created barriers to access to medicines and vaccines was identified in policy, law, resource allocation, and jurisdictional governance. Institutional barriers included health care providers' implicit biases about racialized groups, immigration status, and language. Pharmacy deserts in racialized communities represented a geographic barrier to access. CONCLUSION: Racism corrupts and impedes equitable allocation and access to medicine in Canada. Redefining racism as a form of corruption would obligate societal institutions to investigate and address racism within the context of the law as opposed to normative policy. Public health policy, health systems, and governance reform would remove identified barriers to medicines, vaccines, and pharmaceutical services by racialized groups.

Infliximab Pricing in International Economic Evaluations in Inflammatory Bowel Disease to Inform Biologic and Biosimilar Access Policies: A Systematic Review.

Background. Policies mandating the use of lower cost biosimilars in patients with inflammatory bowel disease (IBD) have created concerns for patients who prefer their original biologic. Purpose. To inform the cost-effectiveness of biosimilar infliximab treatment in IBD by systematically reviewing the effect of infliximab price variation on cost-effectiveness for jurisdictional decision making. Data Sources. MEDLINE, Embase, Healthstar, Allied and Complementary Medicine, Joanna Briggs Institute EBP Database, International Pharmaceutical Abstracts, Health and Psychosocial Instruments, Mental Measurements Yearbook citation databases, PEDE, CEA registry, HTA agencies. Study Selection. Economic evaluations of infliximab for adult or pediatric Crohn's disease and/or ulcerative colitis published from 1998 through 2019 in which drug price was varied in sensitivity analysis were included. Data Extraction. Study characteristics, main findings, and results of drug price sensitivity analyses were extracted. Studies were critically appraised. The cost-effective price of infliximab was determined based on the stated willingness-to-pay (WTP) thresholds for each jurisdiction. Data Synthesis. Infliximab price was examined in sensitivity analysis in 31 studies. Infliximab showed favorable cost-effectiveness at a price ranging from CAD $66 to $1,260 per vial, depending on jurisdiction. A total of 18 studies (58%) demonstrated cost-effectiveness ratios above the jurisdictional WTP threshold. Limitations. Drug prices were not always reported separately, WTP thresholds varied, and funding sources were not consistently reported. Conclusion. Despite the high cost of infliximab, few economic evaluations examined price variation, limiting the ability to infer the effects of biosimilar introduction. Alternative pricing strategies and access to treatment could be considered to enable IBD patients to maintain access to their current medications. Highlights: In an effort to reduce public drug expenditures, Canadian and other jurisdictional drug plans have mandated the use of lower cost, but similarly effective, biosimilars in patients with newly diagnosed inflammatory bowel disease or require a nonmedical switch for established patients. This switch has created concerns for patients and clinicians who want to maintain the ability to make treatment decisions and remain with the original biologic.It is customary for economic evaluations to assess the robustness of results to variations in high-cost items such as medications. In the absence of economic evaluations of biosimilars, examining biologic drug price in sensitivity analysis provides insight into the cost-effectiveness of biosimilar alternatives. A total of 31 economic evaluations of infliximab for the treatment of inflammatory bowel disease varied the infliximab price in sensitivity analysis.The infliximab price deemed to be cost-effective within each study ranged from CAD $66 to CAD $1,260 per 100-mg vial. A total of 18 studies (58%) demonstrated an incremental cost-effectiveness ratio above the jurisdictional willingness-to-pay threshold. If policy decisions are based on price, then originator manufacturers could consider reducing the price or negotiating alternative pricing models to enable patients with inflammatory bowel disease to remain on their current medications.

The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges.

Introduction: In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. Methods: This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. Results: The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. Conclusion: This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines.

An increasing proportion of new drugs approved for market worldwide are now high cost, specialty medicines. Pharmaceutical marketers face the challenge of convincing payers, prescribers, and patients that the cost and complexity of care associated with specialty medicines is worth the trouble, and now offer patient support programs, free of charge, to patients prescribed their drug. We conducted a secondary, qualitative, interpretive analysis of 24 interviews with leaders of patient groups and members of hospital formulary committees in Australia to describe the work of pharmaceutical company-employed or contracted nurses who provide support to patients prescribed specialty medicines, and to prompt discussion around the policy implications of relying on industry-funded nursing care within publicly funded health systems. Participants affirmed the value of specialist, holistic, person-centered nursing care, but perceived gaps within the public health system related to the availability and provision of nursing care for people living with chronic disease. Consequently, participants described the pharmaceutical industry as addressing health system gaps through sponsorship or direct provision of medication-related nursing care, but recognized that care was contingent on commercial interest. Participants highlighted a number of ethical and policy concerns stemming from industry-funded nursing care of people prescribed specialty medicines related to patient safety, continuity of care, inducement to prescribe, and health equity. This analysis suggests that outsourcing necessary medication-related care to pharmaceutical companies has implications for the health system and equitable, sustainable pharmaceutical policy that extend far beyond the care encounter.

Exploring the effectiveness of demand-side retail pharmaceutical expenditure reforms : Cross-country evidence from weighted-average least squares estimation.

Increasing expenditures on retail pharmaceuticals bring a critical challenge to the financial stability of healthcare systems worldwide. Policy makers have reacted by introducing a range of measures to control the growth of public pharmaceutical expenditure (PPE). Using panel data on European and non-European OECD member countries from 1990 to 2015, we evaluate the effectiveness of six types of demand-side expenditure control measures including physician-level behaviour measures, system-level price-control measures and substitution measures, alongside a proxy for cost-sharing and add a new dimension to the existing empirical evidence hitherto based on national-level and meta-studies. We use the weighted-average least squares regression framework adapted for estimation with panel-corrected standard errors. Our empirical analysis suggests that direct patient cost-sharing and some-but not all-demand-side measures successfully dampened PPE growth in the past. Cost-sharing schemes stand out as a powerful mechanism to curb PPE growth, but bear a high risk of adverse effects. Other demand-side measures are more limited in effect, though may be more equitable. Due to limitations inherent in the study approach and the data, the results are only explorative.

A cross-country utilization patterns comparison of high expenditure therapeutic groups between Portugal and six European countries: the two sides of the Portuguese coin.

BACKGROUND: Understanding variability in prescribing patterns through comparative drug utilization studies can contribute to improve an efficient, effective and safe use of medicines. OBJECTIVES: To perform a cross-country comparison of consumption patterns of ambulatory high expenditure therapeutic groups between Portugal and six European countries and simulate potential cost-saving scenarios through the adoption of the different prescribing patterns of studied countries. METHODS: Cross-country comparison of 2019 drug consumption patterns between Portugal, Denmark, England, Finland, the Netherlands, Norway, and Spain. Analysis comprised antihypertensive drugs, glucose lowering drugs (GLD), insulins, lipid lowering drugs (LLD) and oral anticoagulants. Cost-saving analysis were performed using the Portugal average annual cost/daily defined dose and the potential reduction in expenditure simulating other European countries consumption pattern scenarios. RESULTS: Portugal had the lowest consumption uptake of metformin and the highest consumption of GLD (30.1%) and LLD (8.5% vs <3%) fixed-dose combinations. Annual cost-savings scenarios showed that Portugal would have saved between 53 M€ and 305 M€ if it had the same prescribing patterns than Norway or the Netherlands, respectively. CONCLUSIONS: Different utilization patterns across countries were found. Although Portugal has the lowest gross domestic product per capita among the countries studied, it had the highest uptake of newly and costly drugs.

Antimicrobial Sales Comparison before and after the Implementation of Nationwide Restriction Policy in Saudi Arabia.

Antimicrobial dispensing without a prescription has been identified as a significant contributor to the burgeoning crisis of antimicrobial resistance. To combat this, the Saudi Ministry of Health introduced a stringent antimicrobial restriction policy in mid-2018, mandating prescriptions for all antimicrobial drug dispensations at pharmacies. Therefore, this study aimed to assess the immediate impact of this policy on retail antimicrobial sales. To do so, we analyzed annual sales data from 2017 to 2019 sourced from the IQVIA-MIDAS® database, which included a range of antimicrobials, such as antibiotics, antifungals, and other related agents. The analysis revealed a notable reduction in overall antimicrobial sales by 23.2%, decreasing from 818.9 million SAR in 2017 to 648.4 million SAR in 2019. While the Wilcoxon signed-rank test indicated a statistically significant median reduction in total antimicrobial sales post-policy implementation (p = 0.0397), it is important to acknowledge that the long-term effects and adherence to the policy require further investigation. Notably, sales of amoxicillin dropped by 70% in 2019 compared to 2017, contributing largely to the decline. Conversely, a continuous increase in sales of some antimicrobial drugs following the restriction policy was observed, led by amoxicillin/clavulanic acid. Our data support the implementation of antimicrobial restriction measures as an effective means of controlling excessive antimicrobial sales and dispensing without prescriptions.