Administrative Agencies Research Articles

Development of a scintillation proximity assay for [3H]epibatidine binding sites of Tetronarce californica muscle-type nicotinic acetylcholine receptor

The therapy of intoxication with distinct organophosphorus (OP) compounds is still limited today. Especially chemical warfare agents like tabun and soman as well as novichok intoxications are difficult to address using established oxime therapeutics. These neurotoxins inhibit acetylcholinesterase (AChE), a pivotal enzyme in the synaptic cleft. The following accumulation of acetylcholine in the synaptic cleft leads to a dysfunctional, desensitized state of nicotinic acetylcholine receptors (nAChR). Without adequate treatment, the resulting cholinergic crisis leads to death by respiratory arrest. Consequently, the research approach for new therapeutic options needs to be expanded. A promising option would be substances interacting directly with nAChRs. Therefore, screening methods for new drug candidates are needed, with affinity assays playing an important role. In the present work, a saturation and competition scintillation proximity assay (SPA) for binding studies at [3H]epibatidine binding sites, conventionally classified as orthosteric binding sites of the muscle type nAChR was developed. This method offers several advantages over other assay technologies because no separation as well as washing steps are required to remove unbound ligands. Assay precision and solvent tolerance were validated according to the guidelines for validation of bioanalytical methods of the Food and Drug Administration (FDA) and European Medicines Agency (EMA). The newly developed binding assay was successfully implemented on an automated pipetting platform and is suitable for high-throughput-screening of receptor-ligand interactions at the nAChR. Furthermore, it allows to investigate/quantify competition of highly toxic agents such as nerve agents or structurally similar pesticides at the orthosteric binding site. Related to further pharmacological results, the affinity to [3H]epibatidine binding sites can provide additional information on whether potential drug candidates would be suitable for treatment of nerve agent poisoning.

The Automated Administrative State: A Crisis of Legitimacy

The legitimacy of the administrative state is premised on our faith in agency expertise. Despite their extra-constitutional structure, administrative agencies have been on firm footing for a long time in reverence to their critical role in governing a complex, evolving society. They are delegated enormous power because they respond expertly and nimbly to evolving conditions. In recent decades, state and federal agencies have embraced a novel mode of operation: automation. Agencies rely more and more on software and algorithms in carrying out their delegated responsibilities. The automated administrative state, however, is demonstrably riddled with concerns. Legal challenges regarding the denial of benefits and rights—from travel to disability—have revealed a pernicious pattern of bizarre and unintelligible outcomes. Scholarship to date has explored the pitfalls of automation with a particular frame, asking how we might ensure that automation honors existing legal commitments such as due process. Missing from the conversation are broader, structural critiques of the legitimacy of agencies that automate. Automation abdicates the expertise and nimbleness that justify the administrative state, undermining the very case for the existence and authority of agencies. Yet the answer is not to deny agencies access to technology that other twenty-first century institutions rely upon. This Article points toward a positive vision of the administrative state that adopts tools only when they enhance, rather than undermine, the underpinnings of agency legitimacy.

Hidradenitis Suppurativa: New Targets and Emerging Treatments.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that can be challenging to treat. Biologics and targeted small molecules have become an increasingly popular area of investigation for therapeutic development for moderate-to-severe HS, though only three biologics-adalimumab, secukinumab, and bimekizumab-have received US Food and Drug Administration (FDA) or European Medicines Evaluation Agency approval for treating HS. Promising agents under investigation are targeting interleukin 17A/F, JAK/STAT pathway, interleukin 36, interleukin 1, and more.

공공재정 부정이익환수제도에 관한 고찰

The Public Finance Recovery Act was enacted in April 2019 in addition to the disciplinary surcharge system for public officials under the National Public Officials Act and the Local Public Officials Act as subsidies, R&D expenses, allowances, etc. of the state, local governments, and public organizations continue to make false claims and excessive claims. In order to prohibit public financial fraudulent claims and to recover the full amount of fraudulent income, which is unearned income, a sanction surcharge of up to five times is imposed and recovered in consideration of the intention and habitability of fraudulent claims. In this paper, after examining the concept, scope, and legal nature of public finance fraud recovery, we examine the Improper Payment lnfonnation Act of 2002, the False Claims Act, the Federal Improper Payments Coordination Act of 2015, and the Payment Integrity Information Act of 2019 in the United States, and the Subsidy Appropriation Act of Japan to seek implications for Korea In addition, we examine legal issues related to the systematization of pre- and post-systems to reduce fraudulent profits in public finance payments, securing the effectiveness of the whistleblowing system for public finance subsidy recovery, and activating the anonymous proxy reporting system, and suggest improvement measures to enhance the effectiveness of the Public Finance Recovery Act. Before recovering the illicit profits of public finance payments, relevant administrative agencies and public institutions should actively operate programs to strengthen the risk assessment and eligibility review of illicit payments, and after disbursing public finance support funds, they should strictly conduct an audit by an external auditor independent of the administrative agency and public institution to prevent illicit receipt of public finance support funds, and the results of the audit should be posted on the website of the relevant administrative agency to enhance transparency. In addition, in order to eradicate the negative organizational culture toward whistleblowers and the secret receipt of public finance support funds in Korea, whistleblowers should be allowed to file a U.S.-style qui tarn lawsuit only in cases where they make false claims to administrative agencies or public institutions. However, if the relevant administrative agency or public institution allows intervention in the lawsuit and recovers the illicit profits of public finance funds, they should be compensated 35% of the recovered amount to the whistleblower. Given the nature of fraudulent receipt of public financial support funds, the regional National Human Rights Commission's anonymous proxy reporting advisory group should be expanded in a balanced manner to ensure that the anonymous proxy reporting system is activated, and the anonymity of internal reporters should be guaranteed.

의사결정 참여가 조직 내 의사소통에 미치는 영향 - 조직목표 명확성의 조절효과

This study investigates the impact of decision-making participation on communication within public organizations, with a particular focus on how the clarity of organizational goals moderates this relationship. Using data from the 2022 Public Service Life Survey conducted by the Korea Institute of Public Administration, the research examines communication practices among public officials in central and local administrative agencies. The findings reveal that participation in decision-making is a key factor that positively influences communication across multiple levels within public organizations. Specifically, it enhances interdepartmental communication, vertical communication between different hierarchical levels, and horizontal communication among colleagues. Additionally, the clarity of organizational goals emerges as a significant contributor to improved communication, particularly between departments and among peers. However, its influence on vertical communication is less pronounced. Furthermore, the study highlights that the clarity of organizational goals strengthens the positive effect of decision-making participation on overall communication within the organization. This moderating effect is especially evident in enhancing both interdepartmental and vertical communication, although it has a limited impact on horizontal communication. These insights underscore the importance of fostering participation in decision-making and ensuring clear organizational goals to facilitate effective communication within public organizations.

한국과 일본의 중앙지방협력회의법의 비교연구

The National-Local Cooperation Council Act is the “Act on the Composition and Operation between the National and Local Government Cooperation Council (hereinafter referred to as the National-Local Cooperation Council” in Korea, and the “Act on Place of consultation between National and Local Government” in Japan. The purpose of enacting the National-Local Government Cooperation Council Act in Korea is to determine matters necessary for the composition and operation between the National and Local Government Cooperation Council, which is established to strengthen communication and cooperation between the state and local governments and to deliberate on important policies related to balanced development between local autonomy and regions. The purpose of enacting the Act on the Place of Japanese Consultation is to promote effective and efficient national and local government policies in consultation with relevant ministers and local representatives on the planning, formulation and implementation of national policies affecting local autonomy. The venue for consultation in Japanese law means a place of opportunity for the state (National government) and provinces to exchange opinions on an equal footing, that is, a “place of joint decision” through mutual consultation (meeting), and does not refer to a specific administrative agency. Korea's National and Local Government Cooperation Council is used in the same sense as the venue for Japan's consultation. Comparing the purpose of enacting the two laws, Japan, as the legal name implies, focuses on the meaning that the National and Local governments consult to effectively and efficiently promote specific policies, while Korea includes balanced regional development beyond the scope of discussing other policies, including the purpose of Japan's enactment. It can be said that the purpose of enacting the law is much wider and more diverse. Although Korea and Japan have slightly different legal names, this study aims to analyze the pros and cons of the National and Local Government Cooperation Council Act, which has similar legislative objectives and contents, and derive suggestions for Korean law.

Qualitative and Quantitative Determination of Hydroquinone Content in Skin Whitening Cosmetics Sold in Lafia-Nigeria

Hydroquinone (HQ) is a whitening or therapeutic constituent in many cosmetic products, but only allowable at a very low concentration. The abuse of HQ via frequent and prolonged usage can lead to health issues such as damage to skin and the sensitive area on the face. In Nigeria, National Agency for Food and Drug Administration and Control (NAFDAC) on its cosmetic products prohibition of bleaching agents regulations 2019, stated that no cosmetic products should contain more than 2 % of HQ alone or 1 % in combination with other lightening ingredients. This study aimed at qualitative and quantitative determination of HQ content in selected skin whitening cosmetics sold in Lafia. A total of twenty-four (24) various skin bleaching cosmetics were sampled from Lafia modern market. Thin Layer Chromatography (TLC) and uv/visible spectrophotometry were used for qualitative (identification) and quantitative (quantitation) determination of their HQ concentration, respectively. Ethanol (96 %) was used to extract HQ, and then TLC analysis at two different laboratories. At the two laboratories,nine samples (same) out of 24 were found to contain hydroquinone. The uv/visible spectrophotometric analysis indicated that the concentration of hydroquinone ranged from 0.99 % to 1.47 % in the cosmetic products studied.This study revealed that some of the products were labelled free from HQ or not labelled, and yet contained HQ, unknown to the consumers. In general, percentage hydroquinone in all the samples was less than 2 % maximum permissible limit recommended by US FDA and NAFDAC.

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial

IntroductionPostpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80%...

Analysis of heavy metals and minerals in edible vegetable oils produced and marketed in Gondar City, Northwest Ethiopia

IntroductionNowadays, food safety is regarded as one of the most critical global public health issues. Edible oil, a key ingredient in food processing, is widely used and consumed in every Ethiopian household. However, its safety is often overlooked. Currently, edible oil is produced in Ethiopia from small-scale operations to large industrial levels, as well as imported from other countries.ObjectiveThis study aimed to determine the levels of heavy metals and essential minerals in edible vegetable oils produced and marketed in Gondar City, Northwest Ethiopia.MethodsA laboratory-based cross-sectional study was conducted from May to July 2021 in Gondar City. Seventeen edible oil samples were collected using simple random sampling techniques. Heavy metal content was determined using an atomic absorption spectrophotometer with the standard procedures and techniques after microwave digestion. The efficiency and validity of the method used were evaluated by determining the limit of detection (LOD), the limit of quantification (LOQ), accuracy, and precision. The collected data were entered into Microsoft Excel and transported to Stata for analysis.ResultA total of seventeen vegetable oil samples were analyzed. The accuracy of the method was evaluated by recovery studies, which ranged from 81 to 115%, and the relative standard deviations were found to be below 15%. The concentrations of Zn, Cu, Fe, Cd, and Pb were in the range of 0.07 to 0.8 mg/l, 0.002 to 0.06 mg/l, 0.01 to 0.8 mg/l, 0.08 to 0.18 mg/l, and 0.003 to 0.27 mg/l, respectively. In general, the lead and cadmium content was higher than other metals in some of the investigated edible vegetable oils. Most values fell within the permissible quality limits for edibility as prescribed by the World Health Organization (WHO) and the National Agency for Food and Drug Administration and Control (NAFDAC). However, the levels of Pb and Cd exceeded the reference levels in some locally produced vegetable oils.ConclusionTo address the exceeded levels of heavy metals, it is imperative to implement more careful handling, processing of raw materials, and filtering practices. Producers and marketers should take the necessary precautions to prevent contamination. Strict regulatory control from responsible bodies and stakeholders is recommended to ensure the safety and metal contents of vegetable oils originating from the study area.

Three Years On: The Role of Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH) since Its Initial Approval.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disease characterized by complement-mediated hemolysis and potentially life-threatening complications. Pegcetacoplan, an inhibitor of complement components C3 and C3b, was approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2021. A recent expansion to its indication by the EMA has made pegcetacoplan available for the treatment of both complement inhibitor-naïve and -experienced patients with PNH who have hemolytic anemia, a similarly broad patient population as in the US. This approval was based on results from the Phase 3 PEGASUS study, where pegcetacoplan showed superiority over the C5 inhibitor eculizumab with regard to improving the hemoglobin level in patients with anemia despite eculizumab treatment, and the Phase 3 PRINCE study, where pegcetacoplan showed superiority over supportive care with regard to hemoglobin stabilization and improving the lactate dehydrogenase level in complement inhibitor-naïve patients. In light of this recent indication expansion by the EMA, this article describes how the strong efficacy of pegcetacoplan is linked to its mechanism of action, which provides broad hemolysis control over both intravascular and extravascular hemolysis to improve a range of disease markers and enhance patients' quality of life. Furthermore, additional data and learnings obtained from over 3 years of experience with pegcetacoplan are summarized, including long-term efficacy and safety results, real-world clinical experiences, pharmacokinetic characteristics, and extensive practical guidance for the first-to-market proximal complement inhibitor for PNH.

Inheriting the royals: royal chartered bodies in Ireland after 1922

The establishment of the Irish Free State (Saorstát Éireann) in 1922 did not occur on a blank canvas. A slew of administrative bodies and agencies with pre-1922 origins now found themselves under a new jurisdiction, still familiar in some respects but alien in others. The Irish State Administration Database indicates that the functions performed by these pre-1922 bodies included the delivery of public services and regulatory oversight. The resilience of pre-1922 bodies arguably ensured a greater degree of day-to-day administrative continuity and stability after 1922 than may otherwise have been the case.This article focuses on a particular subset of these pre-1922 entities – royal chartered bodies – carried into Saorstát Éireann and beyond. Of special interest are the peculiar legal mechanisms through which these bodies were sustained in an altered constitutional landscape. The discontinuation of a pre-1922 royal prerogative to grant and amend royal charters presented legal conundrums for royal chartered bodies and the state. This was mitigated through a mixture of tailored public and private legislation of the Oireachtas. These dynamics are interrogated through the lenses of temporality and legal pluralism.

A quantitative LC-MS/MS method for investigation of polysubstance use involving heroin and cocaine

Concurrent use of heroin and cocaine (known as the “speedball”) prevails among substance use disorder populations, especially in opioid-dependent individuals, with severe consequences and a high fatality rate. Little is known about the patterns and correlations of the concurrent use of heroin and cocaine. It is vital to investigate such a polydrug use in both humans and animals to uncover concomitant toxicity and the cause of fatal overdose (death). In this study, we aimed to shed some light on the role of cocaine in the etiology of heroin-related deaths in the context of molecular pharmacokinetics (PK). For the purpose, a high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of heroin, cocaine, and their metabolites in whole blood was developed and fully validated in accordance with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. Then, this method was used to analyze heroin, cocaine, and their metabolites in blood from the rats intraperitoneally administered non-lethal 10 mg/kg heroin or 20 mg/kg cocaine alone, or their combination that is lethal with a proximal mortality of 33 %. The obtained results from the rats that experienced the lethal toxicity revealed that the concurrent use of heroin and cocaine significantly increased the risk of fatality from overdose. Heroin significantly slowed down the elimination of cocaine and its main metabolites in blood, while cocaine significantly enhanced heroin metabolism from 6-monoacetylmorphine (6-MAM) to morphine. Similar elimination half-lives for other heroin metabolites were observed. These findings are reported for the first time in this study, facilitating our understanding of the polysubstance metabolism and severe consequences produced by the polydrug use.

Variation in levels of professionalism in healthcare policymaking during the Obama, Trump, and Biden administrations.

During the Trump administration it was widely asserted in the news media that the administration's agency appointees were less professional than appointees from previous administrations. Using qualitative data from 35 interviews with lobbyists, congressional staffers, and executive branch officials, and quantitative and qualitative data on years of relevant experience and job type at the date of nomination, it is demonstrated that indeed the Trump administration attracted less talent than the Obama and Biden administrations, which resulted in less supply and demand for expertise and thus a diminished role of expertise in the policymaking process.

Treatment of Epidermolysis Bullosa and Future Directions: A Review.

Epidermolysis bullosa (EB) comprises rare genetic disorders characterized by skin and mucosal membrane blistering induced by mechanical trauma. Molecularly, pathogenic variants affect genes encoding proteins crucial for epidermal-dermal adhesion and stability. Management of severe EB is multidisciplinary, focusing on wound healing support, ensuring that patients thrive, and complication treatment. Despite extensive research over 30years, novel therapeutic approaches face challenges. Gene therapy and protein therapy struggle with efficacy, while regenerative cell-based therapies show limited effects. Drug repurposing to target various pathogenic mechanisms has gained attention, as has in vivo gene therapy with drugs for dystrophic and junctional EB that were recently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). However, their high cost limits global accessibility. This review examines therapeutic advancements made over the past 5 years, exploiting a systematic literature review and clinical trial data.

Physico-chemical and bacteriological quality assessment of some selected sachet water brands produced in Gwale local government Area, Kano Nigeria

The proliferation of sachet water products has been fuelled by the rising demand for clean, safe drinking water in areas where access to potable water sources remains a challenge. Unfortunately, some of the sachet water producers fail to adhere to the standards set by regulatory agencies, resulting in potential health risk for the unsuspecting consumers. Therefore, critical investigation of the various parameters of these water products is needed to determine whether they meet the safety standards established by regulatory agencies. Thirty (30) different brands of sachet water (15 NAFDAC registered and 15 non-NAFDAC registered) were randomly collected (n=3) from producers in Gwale Local Government Area, Kano Nigeria to assess their physico-chemical and bacteriological quality. The parameters were determined using standard methods. The mean results of the temperature, pH, turbidity, conductivity, chloride and total hardness of the NAFDAC registered samples were found to be in the range of 25.9-29.7 oC, 6.8-7.2, 0.1-1.2 NTU, 11.0-41.8µs/cm,15.0-25.1 mg/L and 2.0-17.6 mg/L respectively, while for the non-NAFDAC registered samples, the mean range were found to be 25.8-30.8 oC, 6.6-8.7, 0.5-2.2 NTU, 13.6-46.8 µs/cm, 17.0 23.0mg/L and 15.8-25.3 mg/L for the same parameters respectively. These results are in compliance with the standards set by the National Agency for Food Drug Administration and Control (NAFDAC), Nigerian Industrial Standard (NIS) and World Health Organization (WHO) except pH values of 8.7 found in some non-NAFDAC registered samples which were a bit higher than the recommended limits. Some non- NAFDAC registered samples were found to contain aerobic mesophilic bacteria, though below the limit set by the aforementioned regulatory agencies. Statistically, there is significant difference (p>2.326) between the NAFDAC registered and the non-NAFDAC registered samples in aerobic mesophilic bacterial count but there is no significant difference in terms of coliform count between the two groups (p< 2.326). This finding highlights the need for regular microbiological monitoring so as to ensure public health safety.

Impact of Alternative Income Assistance Payment Schedules on Health and Social Service Access in Canada: Evidence from an Experimental Study

Despite mitigating the severe impacts of poverty, synchronized, monthly government income assistance payments can negatively impact people who use drugs, including disrupting service utilization. This study evaluates whether changing payment timing and frequency impacts health and social service access. This secondary analysis of an exploratory, parallel, unblinded, randomized controlled trial assessed data collected between 2015–2019 from income assistance recipients who use drugs in British Columbia, Canada (n = 194). Participants were randomly assigned for six monthly payment cycles to: (a) synchronized government schedules (control); (b) desynchronized “staggered” single monthly payments; or (c) desynchronized “split & staggered” twice-monthly payments. Generalized linear mixed models assessed utilization of, and barriers to, acute/emergency healthcare, community healthcare, psychosocial services and material/legal services. Mixed results showed increases in access to psychosocial services and material/legal services, but also increases in the barriers to community healthcare and material/legal services. Changing payment schedules may alter access to services in complex ways implicating practice, organizational and interagency adaptations for marginalized populations. Results support the importance of social service agency involvement in income assistance policy reform discussions to ensure effective service delivery. Further research should include perspectives from service providers and utilize agency administration data to better understand payment schedules and service provision dynamics.

Optimization of Judicial Review System in Non-Prosecution for Corporate Compliance

As the reform of corporate compliance progresses, the system of non-prosecution for corporate compliance grants prosecutors significant discretionary power, making it inevitable for courts to participate in corporate compliance. Issues arising from corporate compliance reform, such as insufficient time for compliance rectification hearings, inadequate third-party supervision, judicial discretion abuse, and lack of unified standards for compliance effectiveness assessment, should be addressed. This can be achieved by establishing unified standards for compliance effectiveness, improving the transparency of public hearings, emphasizing the construction of a diversified institutional framework for multi-party participation in corporate compliance, enhancing coordination and constraints among public security organs, procuratorates, courts, administrative agencies, and third-party organizations, and improving the judicial review of corporate compliance to optimize the judicial scrutiny of the non-prosecution system for corporate compliance.

Identifying strategies to improve adverse drug reporting through key informant interviews among community pharmacists in a developing country

Reporting adverse drug reactions (ADRs) is fundamental in improving medication safety. Community pharmacists (CPs) being the first point of contact for individuals seeking healthcare in a community, play a significant role in ADR reporting. However, this has been poorly implemented in many countries including Nigeria. This paper aims to explore stakeholders’ perspectives on current reporting practices and suggest ways to enhance ADR reporting among CPs in Nigeria. This qualitative study employed a purposive sampling approach to identify key informants. Key informant interviews (KIIs) were conducted with 25 carefully selected pharmacists, using a semi-structured interview guide between July 2023 and August 2023. The interview transcripts were analyzed using a thematic content approach. While a low ADR reporting trend was observed among all participating pharmacists, it was notably higher among those with less than five years of experience. The main barriers to ADR reporting, as identified by the interviewed community pharmacists were lack of awareness and knowledge, absence of motivation, and insufficient feedback from National Agency for Food Drug Administration and Control (NAFDAC). Training and awareness campaigns were the most frequently suggested methods for improving ADR reporting. Other proposed strategies included providing motivation, regular feedback, establishing mandatory reporting, and simplifying the reporting process. The study has highlighted the suboptimal ADR reporting practices among CPs in Anambra state. It underscores the significance of training, sensitization, advocacy, and other related interventions as pivotal means to enhance ADR reporting in this group. Furthermore, there is a pressing need for intervention-based studies to delve into and implement these approaches effectively.

Improving Service Quality of A Private Hospital to Provide Satisfaction Of BPJS Participants

Health services are the most basic public services that must be carried out by the government to achieve a prosperous society. It is on this basis that the Government needs to improve the quality of public health with social security, namely the National Health Insurance (JKN), through the Health Social Security Administration Agency (BPJS). The focus of this research is how on the quality of health services provided by a private hospital to BPJS participants. This is a qualitative research with a case study approach. This study aims to answer the questions about the quality of service at hospital X in Bogor City for BPJS participants and what efforts should be made to provide satisfaction to BPJS participants. Data collection was carried out by observation, documentation, and semi-structured interviews with ten BPJS participants and an expert in the field of public policy. The results of this study indicate that the service quality of hospital X in Bogor City that consists of tangible, reliability, responsiveness, assurance and empathy still needs to be improved to provide satisfaction to BPJS health participants.

Eligibility for vericiguat in a real-world, contemporary heart failure population.

Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real-world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n=346, 72% men, median age 69years) had HFrEF in 57% of cases, left ventricular ejection fraction<45% in 68%, and New York Heart Association class II-IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium-glucose cotransporter-2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). In a real-world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients.