Examining the Impact of Certificate of Need Laws on the Utilization and Reimbursement of Cataract Surgeries Among Medicare Beneficiaries.

Background: Cataract surgery is an effective and commonly utilized procedure and can significantly improve quality of life and restore economic productivity. Certificate of need (CON) laws aim to regulate healthcare facility expansion and equipment acquisition to curtail costs, enhance quality, and ensure equitable access to care. However, little is known about the impact of CON laws on cataract surgery utilization and reimbursement. Objectives: To compare utilization and reimbursement for non-complex cataract surgery in CON and non-CON states. Methods: This retrospective database review analyzed publicly available data from the Centers for Medicare and Medicaid Services from 2017 to 2021 to identify the Medicare beneficiaries who underwent non-complex cataract surgery using Current Procedural Terminology code 66984 in Medicare outpatient hospitals. Utilization and reimbursement patterns were analyzed in states with and without CON laws using the compound annual growth rate, with reimbursement adjusted by the US Bureau of Labor Statistics Consumer Price Index. Results: The Centers for Medicare and Medicaid Services reported 893 682 non-complex cataract surgeries in the study period; of these, 609 237 were in CON and 280 215 in non-CON states. Inflation-adjusted reimbursement increased in both CON (1.17%) and non-CON (1.83%) states, while the reimbursement in non-CON states was greater than the national average adjusted reimbursement (1.67%). Utilization of non-complex cataract surgery declined during the study period in both CON and non-CON states. A larger decline in utilization was observed in CON states (-7.32%) than in non-CON states (-6.49%). Utilization was slightly higher in non-CON than in CON states for each year except 2019. Discussion: Utilization of non-complex cataract surgery by Medicare beneficiaries declined over the study period in both CON and non-CON states, possibly impacted by the COVID-19 pandemic. Inflation-adjusted reimbursement adjusted for Consumer Price Index increased more in non-CON than CON states, possibly reflecting shifts in market dynamics in CON-regulated states. Conclusions: Surgeons and policymakers should consider the implications of CON laws on the utilization and reimbursement of cataract surgery. Further study is necessary to ascertain whether these trends persist beyond 2021.

Optimizing the regulation of nursing in the Asian context: Development and application of a legal framework.

PURPOSE: It is essential to regulate nursing to protect the population's health. As regulation constantly changes in response to societal trends, periodic reviews of nursing regulations become imperative. Therefore, we developed a legal framework by extracting essential elements for nursing regulation and explored its potential application. METHODS: This study consisted of two parts. First, the legal framework for nursing regulation was developed through reviewing literature that mentions the content that can be included in nursing regulations, and through a content validity assessment by five experts. Second, this legal framework was applied to the nursing laws of China, Hong Kong, Japan, and Taiwan to confirm the suitability of the framework. RESULTS: In the first part of the study, the legal framework for nursing regulation consisting of seven categories (purpose, definitions, standards for practice, license acquisition and registration to practice, regulatory body, protection of the legal authority of nurses, offences/penalties and disciplinary procedures) and 17 items was developed. As a result of applying this framework to nursing laws in four countries, the average utilization rate for all 17 items was 68.4%. The matching scores between the framework and the law were over 60% for all four laws. CONCLUSION: Regulations, especially in the form of legislation, must be carefully considered because laws involve enforcement and potential penalties. This study is significant for identifying essential nursing regulation elements and offering a practical reference tool, expected to be widely utilized in future nursing policy and regulatory research.

Does environmental regulation truly enhance corporate green environmental investment? Evidence from the supervision of independent directors in listed companies.

With the increasingly prominent environmental issues in China, the government and citizens alike have intensified their focus on corporate investments in green environmental protection. Nevertheless, as government regulations become more stringent, there is substantial debate over whether environmental regulatory policies can consistently encourage listed companies to increase green environmental investments. Simultaneously, independent board supervision plays a crucial role in promoting the compliance and sustainability of listed companies regarding environmental protection. This paper selected a sample of 246 Chinese listed companies from 2010 to 2019, and used a fixed effects model to examine the impact of environmental regulation on the environmental investment of listed companies in China. Moreover, we used a mediation effect model to analyze the role of independent director supervision in influencing the relationship between environmental regulation and companies' green environmental investment. Additionally, we discuss the heterogeneous impact of environmental regulations on corporate environmental investments. Our findings are as follows: first, during the sample period, the tightening of environmental regulations significantly reduces the growth of environmental investment among the studied firms. As government environmental regulatory policies gradually intensify, the negative impact on environmental investments by listed companies becomes increasingly evident. Second, independent directors help alleviate the adverse impacts of environmental regulations on the environmental investment levels of listed companies. This suggests that the inclusion of independent directors in board governance plays a role in assessing government environmental regulatory policies and overseeing corporate decisions related to environmental investment. Lastly, the heterogeneity analysis indicates that environmental regulation significantly negatively impacts the environmental investment of listed companies in pollution-intensive industries and those located in the western regions. Furthermore, environmental regulatory policies impose greater constraints on the environmental investments of small-sized listed companies compared to their large-sized counterparts.

Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review.

Background: Regulatory pathways adopted by the United States Food Drug and Administration (FDA) and Australian Therapeutic Goods Administration (TGA) enable expedited approval of medicines that are thought to offer significant clinical advantage over existing options for severe diseases. Objectives: To review Australian accessibility to medicines approved through the FDA breakthrough therapy designation (BTD) process including timelines and approvals by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS). Methods: Retrospective review of published reports from the FDA, TGA, PBAC and PBS for BTDs from 1 January 2013-31 August 2023. Uniform data about BTD and milestone dates were collected. Analysis included all BTDs approved by FDA until 31-August-2022. Main outcome measures: Rates of approval by TGA and PBAC, and PBS-listing; and median (interquartile range, IQR) time from FDA submission to FDA approval, and FDA approval to TGA approval, PBAC approval and PBS listing for cancer and non-cancer medicines. Results: Of 237 BTDs across 156 medicines, 68% were approved by the TGA, and 37% were listed on the PBS. Median (IQR) time from FDA submission to FDA approval was shorter for cancer compared to non-cancer; 179 days (140-210) vs 232 days (181-245), p < 0.02. Time from FDA approval to PBS listing was similar for cancer and non-cancer; median 744 days (IQR, 549-1136) and 733 days (IQR 440-960) respectively, with improvements for cancer BTDs noted for 2018-2022 compared to 2013-2017; 566 days (IQR 319-831) vs 880 days (IQR 620-1362), p < 0.02 but not for non-cancer BTDs. Conclusion: BTD medicines are accessible in Australia approximately 2 years after FDA approval. Since 2018, time to PBS listing for cancer therapies improved, mirroring shorter FDA approval times for this category. Further understanding of clinical studies and context by therapeutic area may improve timely and safe access to life-saving medicines.

Research on government regulation methods for the spatial layout of retail pharmacies: practice in Shanghai, China.

BACKGROUND: In China, retail pharmacies are critical sources for obtaining medications and play a vital role in residents' daily access to drugs and treatment of common illnesses. Effectively guiding the placement of these pharmacies in areas of need through government regulation is crucial for enhancing medication access. In this study, we used population and retail pharmacy spatial distribution data from Shanghai to design guidance and supplementary methods for optimizing the spatial layout of retail pharmacies and medical insurance designated pharmacies based on regional characteristics. METHODS: Population distribution, road traffic network, administrative division and retail pharmacy data from Shanghai in 2018 were collected from relevant government departments. ArcGIS 10.3 was used to map the retail pharmacies and population distribution. Based on the spatial distribution of population and the service standards of pharmacies, service circles with insufficient pharmacies were identified, and supplementary methods for retail pharmacies and medical insurance designated pharmacies were developed. RESULTS: In 2018, Shanghai had 3009 retail pharmacies, each serving an average of 6412 residents. The city was divided into 2188 basic pharmaceutical service circles, each within a 15-minute walking distance. The results indicated that there were 1387 service circles without any pharmacies, 151 of which had populations exceeding 5000. Additionally, 356 service circles had pharmacies but lacked medical insurance designated ones. After supplementation, 841 retail pharmacies were planned to be added in residential areas. Compared with before, the coverage area and population served of the pharmacies increased significantly. CONCLUSIONS: This study mapped the spatial distribution of population and retail pharmacies in Shanghai, and designed government guidance and supplementary methods for optimizing the layout of retail pharmacies. The findings offer valuable insights for government agencies in low- and middle-income countries to improve the spatial distribution of retail pharmacies.

The relationship between trust in federal oversight of vaccine safety and willingness to participate in COVID-19 clinical trials: a repeated measures study of Philadelphia residents (September 2021 - March 2023).

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic. METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance). RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [ß = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (ß = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (ß = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (ß = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness. CONCLUSION: Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

Aprimoramento da Estrutura Normativa: a consolidação de normas do SUS e as atualizações do Decreto nº 12.002, de 2024 / Enhancement of the Regulatory Framework: The Consolidation of SUS Standards and updates to Decree No. 12,002, of 2024 / Mejora de la Estructura Normativa: La Consolidación de Normas del SUS y actualizaciones al Decreto N° 12.002, de 2024

O processo de consolidação depende de uma boa redação e elaboração dos atos normativos e é consequência inerente do aprimoramento de normas. Nesse sentido, apresenta-se as inovações do Decreto n.º 12.002, de 2024, relativas à consolidação, que dizem respeito, sobretudo, à obrigatoriedade de manutenção da consolidação normativa por meio da realização de alteração da norma consolidada e de medidas periódicas de revisão dessas normas. Essa manutenção constante dos atos consolidados preserva a necessidade de melhoria normativa, essencial para garantir segurança jurídica, transparência no ambiente democrático e cumprir as determinações da Organização para a Cooperação e o Desenvolvimento Econômico voltadas para política regulatória. A saúde, como pioneira no processo de consolidação dos seus atos normativos infralegais, tem a vanguarda no aprimoramento de normas e deve ser exemplo para outros órgãos.

The process of consolidation depends on good drafting and preparation of normative acts and is an inherent consequence of the improvement of regulations. In this regard, the innovations of Decree No. 12,002 of 2024 concerning Consolidation are presented, which mainly pertain to the mandatory maintenance of normative consolidation through amendments to the consolidated norms and periodic reviews of these norms. This constant maintenance of consolidated acts preserves the need for regulatory improvement, which is essential to ensure legal certainty, transparency in the democratic environment, and compliance with OECD regulatory policy directives. The health sector, as a pioneer in the consolidation of its infralegal normative acts, leads in the improvement of regulations and should serve as an example for other bodies.

El proceso de consolidación depende de una buena redacción y elaboración de los actos normativos y es una consecuencia inherente de la mejora de las normas. En este sentido, se presentan las innovaciones del Decreto nº 12.002 de 2024 relativas a la Consolidación, que se refieren principalmente a la obligatoriedad de mantener la consolidación normativa mediante la realización de modificaciones a la norma consolidada y de medidas periódicas de revisión de estas normas. Este mantenimiento constante de los actos consolidados preserva la necesidad de mejora normativa, esencial para garantizar seguridad jurídica, transparencia en el ambiente democrático y cumplir con las determinaciones de la OCDE dirigidas a la política regulatoria. La salud, como pionera en el proceso de consolidación de sus actos normativos infralegales, está a la vanguardia en la mejora de las normas y debe ser un ejemplo para otros órganos.

Trends in hospital price transparency after implementation of the CMS Final Rule.

OBJECTIVE: To assess trends in hospital price disclosures after the Centers for Medicare & Medicaid Services (CMS) Final Rule went into effect. DATA SOURCES AND STUDY SETTING: The Turquoise Health Price Transparency Dataset was used to identify all US hospitals that publicly displayed pricing from 2021 to 2023. STUDY DESIGN: Price-disclosing versus nondisclosing hospitals were compared using Pearson's Chi-squared and Wilcoxon rank sum tests. Bayesian structural time-series modeling was used to determine if enforcement of increased penalties for nondisclosure was associated with a change in the trend of hospital disclosures. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: As of January 2023, 5162 of 6692 (77.1%) US hospitals disclosed pricing of their services, with the majority (2794 of 5162 [54.1%]) reporting their pricing within the first 6 months of the final rule going into effect in January 2021. An increase in hospital disclosures was observed after penalties for nondisclosure were enforced in January 2022 (relative effect size 20%, p = 0.002). Compared with nondisclosing hospitals, disclosing hospitals had higher annual revenue, bed number, and were more likely to be have nonprofit ownership, academic affiliation, provide emergency services, and be in highly concentrated markets (p < 0.001). CONCLUSIONS: Hospital pricing disclosures are continuously in flux and influenced by regulatory and market factors.

Establishment of Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT): a multi-stakeholder public-private partnership-based organization to accelerate the transformation of clinical trials.

Clinical trials have evolved with digital technologies and tend towards patient-centricity. A multi-stakeholder approach is needed to address the emerging complexities in clinical trials. In particular, the introduction of digital technologies and an emphasis on patient-centricity are the major trends in clinical trials. In response, we established a public-private partnership-based organization named Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT). Eleven organizations in total, from academia, industry, and regulatory agencies, participate in ARICTT. Based on multi-stakeholder collaboration from academia, industry, and government/regulatory bodies, we collected and prioritized current topics in clinical trials based on an internal survey. We established a three-year roadmap with axes that were termed trend, goal, structure, theme, topic, and method. In addition, we planned the development of recommendations based on real-world cases with feasibility studies. We developed appropriate organizational structure to fulfill the roadmap of ARICTT. The selected topics were decentralized clinical trials during the first year, followed by the three topics that were awarded the highest priority according to the internal survey: advances in the informed consent process, supporting sites using digital technology, and an effective recruitment strategy. We developed a case-based recommendation paper presenting an overview of the regulatory landscape and practical considerations with explanatory cases. We also designed and conducted fully decentralized trials to evaluate considerations in real-world settings for the selected topics. Overall engagement and communication were supported by the online platform and annual symposiums. In conclusion, we established a multi-stakeholder, public-private partnership-based organization to accelerate the transformation of clinical trials.

La débil garantía constitucional del derecho a la protección de la salud en España: una propuesta de reforma / A frágil garantia constitucional do direito à proteção da saúde na Espanha: uma proposta de reforma / The weak constitutional guarantee of the right to health protection in Spain: a reform proposal

Objetivo: discutir el derecho a la protección de la salud en España y su no inclusión en la categoría de derecho fundamental. Metodología: Revisión crítica de documentos normativos españoles e internacionales - Constitución, leyes y tratados internacionales - desde la perspectiva del análisis de la salud como un derecho fundamental. Resultados: La garantía y efectividad del derecho a la salud en España no son satisfactorias, ya que a partir de la regulación legislativa y, a menudo, administrativa del tema, surgen reclamaciones jurídicas bien definidas y exigibles ante los órganos jurisdiccionales, como derechos subjetivos individuales. Esto faculta al legislador introducir retrocesos significativos en la determinación del alcance del derecho a la salud. Conclusión: Se impone una reforma constitucional que signifique la reconfiguración de un derecho y su inclusión en la lista de aquellos considerados fundamentales en la Sección 1ª del Capítulo II del Título I de la Constitución, a fin de dotarlo de un contenido esencial, vinculante para el legislador y para que él mismo sea beneficiario de una garantía jurisdiccional directa y máxima, tanto ordinaria como extraordinaria ante el Tribunal Constitucional.

Objetivo: discutir o direito à proteção da saúde na Espanha e o seu não enquadramento na categoria de direito fundamental. Metodologia: revisão crítica de documentos normativos espanhóis e internacionais ­ Constituição, Leis e tratados internacionais na perspectiva de análise da saúde como um direito fundamental. Resultados: a garantia e efetividade do direito à saúde na Espanha não são satisfatórios visto que a partir da regulamentação legislativa e, muitas vezes, administrativa do tema, surgem reivindicações jurídicas bem definidas e exigíveis perante os órgãos judiciais, como direitos subjetivos individuais. Isso permite ao legislador introduzir retrocessos significativos na determinação do alcance do direito à saúde. Conclusão: Impõe-se uma reforma constitucional que signifique a reconfiguração de um direito e sua inclusão na lista daqueles considerados fundamentais na Seção 1ª do Capítulo II do Título I da Constituição, a fim de dotá-lo de um conteúdo essencial, vinculativo para o legislador e para que ele mesmo seja beneficiário de uma garantia jurisdicional direta e máxima, tanto ordinária quanto extraordinária perante o Tribunal Constitucional.

Objective: to discuss the right to health protection in Spain and its non-inclusion in the category of fundamental rights. Methodology: Critical review of Spanish and international normative documents - Constitution, laws, and international treaties - from the perspective of analyzing health as a fundamental right. Results: The guarantee and effectiveness of the right to health in Spain are not satisfactory, as from the legislative and often administrative regulation of the topic, well-defined and enforceable legal claims arise before judicial bodies, as individual subjective rights. This allows the legislator to introduce significant setbacks in determining the scope of the right to health. Conclusion: A constitutional reform is necessary to reconfigure a right and include it in the list of those considered fundamental in Section 1 of Chapter II of Title I of the Constitution, in order to endow it with an essential content, binding for the legislator, and so that it itself benefits from direct and maximum jurisdictional guarantee, both ordinary and extraordinary, before the Constitutional Court.

How external and agency characteristics are related to coordination in homecare - findings of the national multicenter, cross-sectional SPOTnat study.

BACKGROUND: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare. METHODS: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination. RESULTS: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes. CONCLUSION: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher.

Triumphs and trials with the UK abortion law: The power of collaboration in abortion reform.

The UK is usually viewed as having liberal abortion regulations, providing good access to abortion care within a publicly funded health service. However, the underlying laws are authoritarian, dating from an era when public executions drew large crowds and 67 years before women were able to vote. Abortion is only legal when two doctors certify it meets the permitted grounds, and the penalty for self-managed abortion is up to life imprisonment for both the woman and any accomplice. These laws had prevented the use of mifepristone and misoprostol at home. Changes to the regulations for misoprostol in 2018 and mifepristone in 2020 permitted home use, but the government announced they were rescinding the approval for mifepristone in 2022. This article discusses how, despite the opposition of government, significant progressive changes to the abortion laws were achieved. Early medical abortion at home is now protected in law, and safe access zones protect patients and staff from harassment and intimidation from protesters. Despite this progress, increasing numbers of women are facing criminal investigation and face long prison sentences if convicted. The need for decriminalization and for abortion care to be regulated like all other health care is the next pressing issue.

The "Creuseurs" ("Diggers"), at the Center of the World's Push for EVs, are in Peril: Part Two-Obstacles and Opportunities to Improve Conditions for Miners.

In part one, we reported on some of the shocking working conditions that the Electronics Watch team found on our visit to cobalt mines in the DRC. Now, we look at the vested interests in Congolese politics, the mining industry, the Congolese government's desire to regulate the cobalt supply chain, and what else might be done to improve conditions.

The "Creuseurs" ("Diggers"), at the Center of the World's Push for EVs, are in Peril: Part One-The Precarious Reality of Artisanal Mines.

Electronics Watch travelled to Kolwezi in the province of Lualaba, in the south of the Democratic Republic of Congo. Two worlds live side by side here, without ever crossing paths. On the one hand, the world of industrial mines, with their huge machines. On the other, the tens of thousands of "diggers" in small-scale artisanal mines, armed with a simple crowbar to exploit a mineral vein, in extremely dangerous conditions. The DRC alone has 80% of the world's cobalt stocks needed to manufacture batteries to serve the demand for electric vehicles, and no less than 30% of this stock is mined in an artisanal way. One to two million Congolese people depend on this production directly or indirectly, while world demand is booming.

Consumer preferences and willingness to pay for safe pork products in rural Kenya.

Designing interventions to support the safe development of rapidly growing livestock value chains in sub-Saharan Africa requires a clear understanding of consumer demands. This study aimed to determine purchase patterns, consumers' preferences, and willingness to pay for safe pork attributes; specifically, the presence of a veterinary inspection stamp and the cleanliness of the butchery. A discrete choice experiment-based survey was used to investigate the purchasing behavior of 401 pork consumers: 253 buying raw pork for household consumption, and 148 buying cooked pork for out-of-home consumption. The study findings indicate that the average quantity of pork purchased by consumers was approximately 0.4 Kg per transaction, with the majority of consumers making several purchases per week. The average price per Kg of pork was KES 310 (Approx. 2.60 USD) at the time of the study. Data from the choice experiment showed that consumers were willing to pay a price premium of KES 245 (Approx. 2.1 USD) and KES 164 (Approx. 1.4 USD) per Kg for evidence of better veterinary meat inspection and higher butchery hygiene respectively; further, these were the two most important attributes they considered while making a pork purchase decision. These findings highlight the potential to leverage consumers' willingness to pay to improve the food safety within pork value chains in this context. Investing to increase consumer awareness on food safety issues should be considered to generate an effective market demand, especially in rural areas with relatively lower literacy levels.

Research on safety risk control of prepared foods from the perspective of supply chain.

Prepared foods bring great convenience to people's lives, but they also entail safety risks in all aspects, from production to sales. The cooperation of the supply chain and the supervision of the government are key to promoting the safety management of prepared foods. This paper considers the government's regulation, focuses on the interaction relationship between the producer and the retailer of prepared foods, and builds an evolutionary game model to analyze the influence of collaborative decision-making between prepared food producers and retailers in preventing and controlling food safety risks under the government's regulatory strategy. The research finds that: (1) Under certain conditions, there are three stable equilibrium strategies within the prepared foods supply chain: bilateral low-safety inputs, unilateral high-safety inputs, and bilateral high-safety inputs. (2) Government regulators can influence the safety input behaviors of prepared food supply chain enterprises by adjusting investigation probabilities and punishment severity. (3) The safety input behaviors of these enterprises are influenced by various factors, including costs, revenues, brand image, reputation, and the consequences associated with contractual violations. This paper represents the first systematic analysis of prepared food safety from a supply chain perspective. It fills a gap in the existing literature in this area, offering guidance and suggestions for prepared food supply chain enterprises, as well as references and recommendations for government regulators.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Experiences and challenges with the new European Clinical Trials Regulation.

BACKGROUND: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. METHODS: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. RESULTS: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. CONCLUSIONS: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. TRIAL REGISTRATION: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022).

[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

Assessing Mental Healthcare Worker Experiences of Workplace Fairness and Organizational Value: A National Survey of Peer-Support Specialists.

BACKGROUND: Peer-support specialists-individuals with diagnosed mental illnesses who provide support services to other adults with diagnosed mental health issues-often feel stigmatized and undervalued at work, leading to negative personal- and job-related outcomes. Given their important link to positive service user outcomes, this study assessed how peer-support specialists perceive fairness and feel valued in the workplace. METHODS: Peer-support specialists (N = 274) were recruited online from peer-support specialist listservs, social media groups, and patient-run organizations to take a cross-sectional survey that included a 14-item scale on how workplace fairness relates to job satisfaction and four questions on how valued they felt by administrators, clinicians, the people they serve, and fellow peer-support specialists. Descriptive and bivariate statistics were used to assess total scores and differences by gender and race. FINDINGS: Ranging in age from 20 to 77 years and identifying predominantly as White (81.0%) and female (62.9%), respondents noted that fair practices in the workplace would increase their job satisfaction, with no significant differences observed by gender or race. Most peer-support specialists felt valued by the people they serve (97.1%) and fellow peer-support specialists (92.7%). However, fewer reported feeling valued by administrators (64.6%) and clinicians (60.6%). CONCLUSIONS/APPLICATION TO PRACTICE: Peer-support specialists value fairness at the workplace and feel undervalued by some staff. This study highlights peer-support specialists' important role in behavioral health services and suggests that healthcare professionals, including occupational health specialists, are important stakeholders in creating fairer workplaces and increasing peer-support specialists' sense of being valued, leading to improved personal and organizational outcomes.