Differences in healthcare costs over 10 years following discharge from military service by weight trajectory.

The prevalence of overweight and obesity among military personnel has increased substantially in the past two decades. Following military discharge many personnel can receive integrated health care from the Veterans Health Administration. Prior research related to the economic impacts of obesity has not examined health care costs following the transition into civilian life following military discharge. To address this evidence gap, this study sought to compare longitudinal costs over 10 years across weight categories among VA enrollees recently discharged from the military.

Empowerment of individuals in Iranian health systems: a qualitative study using the Z-cognitive map approach.

The empowerment of people is considered as one of the most effective approaches in national healthcare systems. Identifying the effective criteria for this empowerment approach can be useful for planning enhancements. Therefore, studying and researching different aspects of people empowerment, and identifying the various relationships among related factors are of great importance. In this study - after identifying and extracting the effective factors in empowering individuals/insured persons, and interviewing health insurance and healthcare experts through content analysis - a causal model examining variables and their impact intensity through cognitive mapping is designed and drawn up. In modeling the concept of empowerment, to cover the ambiguity of expert comments, a combination of the Z-number approach with cognitive mapping has been used. Results demonstrate how various factors relate to insured empowerment. According to the results of empowerment strategies, the insurance participation strategy with the highest central index was determined as the most effective strategy, and the appropriate component for individuals gained the highest score in the centrality index. The results of this article help a lot to policy making in medical insurance.

Stakeholder perspectives of mental healthcare services in Bangladesh, its challenges and opportunities: a qualitative study.

This study explores Bangladesh's mental health services from an individual- and system-level perspective and provides insights and recommendations for strengthening it's mental health system. We conducted 13 in-depth interviews and 2 focus group discussions. Thirty-one participants were recruited using a combination of purposive and snowball sampling methods. All interviews and group discussions were audio-recorded and transcribed, and key findings were translated from Bengali to English. Data were coded manually and analysed using a thematic and narrative analysis approach. Stakeholders perceived scarcity of service availability at the peripheral level, shortage of professionals, weak referral systems, lack of policy implementation and regulatory mechanisms were significant challenges to the mental health system in Bangladesh. At the population level, low levels of mental health literacy, high societal stigma, and treatment costs were barriers to accessing mental healthcare. Key recommendations included increasing the number of mental health workers and capacity building, strengthening regulatory mechanisms to enhance the quality of care within the health systems, and raising awareness about mental health. Introducing measures that relate to tackling stigma, mental health literacy as well as building the capacity of the health workforce and governance systems will help ensure universal mental health coverage.

Understanding the barriers to integrating maternal and mental health at primary health care in Vietnam.

The prevalence of common perinatal mental disorders in Vietnam ranges from 16.9% to 39.9%, and substantial treatment gaps have been identified at all levels. This paper explores constraints to the integration of maternal and mental health services at the primary healthcare level and the implications for the health system's responsiveness to the needs and expectations of pregnant women with mental health conditions in Vietnam. As part of the RESPONSE project, a three-phased realist evaluation study, we present Phase One findings which employed systematic and scoping literature reviews, and qualitative data collection (focus groups and interviews) with key health system actors, in Bac Giang province, Vietnam, to understand the barriers to maternal mental healthcare provision, utilisation, and integration strategies. A four-level framing of the barriers to integrating perinatal mental health services in Vietnam was used in reporting findings, which comprised individual, socio-cultural, organisational, and structural levels. At the socio-cultural and structural levels, these barriers included: cultural beliefs about the holistic notion of physical and mental health, stigma towards mental health, biomedical approach to healthcare services, absence of comprehensive mental health policy, and a lack of mental health workforce. At the organisational level, there was absence of clinical guidelines on the integration of mental health in routine antenatal visits, a shortage of staff, and poor health facilities. Finally, at the provider level, a lack of knowledge and training on mental health was identified. The integration of mental health into routine antenatal visits at the primary care level has the potential help to reduce stigma towards mental health and improve health system responsiveness by providing services closer to the local level, offering prompt attention, better choice of services, and better communication while ensuring privacy and confidentiality of services. This can improve the demand for mental health services and help reduce the delay of care-seeking.

Leadership's perceptions of palliative care during the COVID-19 pandemic: a qualitative study.

CONTEXT: Palliative care played a leading role in the COVID-19 pandemic. However, little is known regarding health system leadership's perceptions. BACKGROUND: This study aimed to explore the perceptions, understanding, and utilization of palliative care before compared to during the COVID-19 pandemic among health system leadership. METHODS: Semi-structured, in-depth interviews were conducted with leaders in a large healthcare system based in Massachusetts, United States. RESULTS: 22 in-depth interviews were completed at four facilities. Emerging themes included the role of palliative care before compared to during the COVID-19 pandemic, facilitators and barriers to palliative care delivery, and recommendations for future practice. Participants reported that the COVID-19 pandemic increased palliative care utilization, reinforced positive perceptions of the specialty, and emphasized its role in maximizing healthcare efficiency. Many participants found palliative care financing to be a barrier to delivery; some had an inaccurate understanding of how palliative care is reimbursed. When asked about their recommendations for improving future practice, participants noted improvements in coordination within the healthcare system and education of healthcare providers and future physicians in primary palliative care skills. CONCLUSIONS: Our findings suggest that health leadership increasingly understand the value of palliative care and its critical role within the health system and during future public health emergencies; this was further reinforced during the COVID-19 pandemic. Healthcare leadership recognize and highlight the need to increase investments in this specialty, both financially and educationally. In doing so, health care costs will be lowered, patient satisfaction will increase, and care will be better coordinated.

Understanding the legacies of shocks on health system performance: Exploring Ireland's management of recent crises and its implications for policy.

This paper contrasts the Irish experience of the 2008 economic crisis and the Covid-19 pandemic, and the health system responses to these shocks, from the perspective of health system leaders working across both time periods. Based on semi-structured interviews with seven senior national and international officials, the research presented here forms the qualitative component of RESTORE, a five-year research project examining health system resilience and reform, funded through the Health Research Board's Research Leader Award in Ireland. Findings indicate that the financial crisis deeply impacted the Irish health system in relation to infrastructure and capacity, service delivery and workforce. Due to these legacy issues, Ireland's health system was in a relatively weak position when faced with the Covid-19 pandemic but the system proved adaptive and innovative during this time. Furthermore, the pandemic proved to be a catalyst for positive change, providing opportunities for long-term reform, alongside an immediate response to the crisis. This was facilitated by increased funding, a devolution in decision-making structures and a political commitment to the health system. Exploring lessons from the Irish response to these crises provides a case study for developing appropriate policy responses around financing and resource allocation, fostering support for healthcare among political leaders and policy makers, and preparing for future shocks. Furthermore, examining these experiences facilitates understanding around the impact of each crisis on the health system, exploring options for addressing legacy issues and considering practical steps to improve health system performance.

Comparing hospital leadership and front-line workers' perceptions of patient safety culture: an unbalanced panel study.

BACKGROUND/AIM: This article examines the relationships between workers' hospital leadership status, hospital front-line status and patient safety culture in hospitals throughout the USA. By identifying possible disparities in perception, targeted interventions can aim at decreasing differences between the two groups to increase the quality of healthcare. METHOD: Data from 1 739 083 individuals, spreading across 1810 hospitals between 2008 and 2017 were collected. 115 228 (6.63%) self-identified as leaders, and 772 505 (44.42%) self-identified as front-line workers. The participants also filled in information describing their demographics in reference to the hospital, such as how long they have worked at the facility, their working unit and their occupation. RESULTS: Results showed that leaders responded more positively to items that are directly related to management, such as 'my supervisor/manager says a good word when he/she sees a job done according to established patient safety procedures' (0.33, p<0.01), where 0.33 signifies that leaders had an average response more positive by 0.33 compared with all other occupations on a Likert scale of 1-5. Based on multiple F-tests, all items have shown a statistical significance between leadership and front-line groups. CONCLUSION: The findings highlight a compelling link between leadership roles and patient safety culture in hospitals, as well as between front-line worker status and patient safety culture. Moreover, a pronounced divergence in viewpoints regarding patient safety culture exists between hospital leaders and front-line staff. An in-depth investigation is necessary to comprehend the ramifications of these outcomes.

Understanding health system resilience in responding to COVID-19 pandemic: experiences and lessons from an evolving context of federalization in Nepal.

INTRODUCTION: The COVID-19 pandemic has tested the resilience capacities of health systems worldwide and highlighted the need to understand the concept, pathways, and elements of resilience in different country contexts. In this study, we assessed the health system response to COVID-19 in Nepal and examined the processes of policy formulation, communication, and implementation at the three tiers of government, including the dynamic interactions between tiers. Nepal was experiencing the early stages of federalization reform when COVID-19 pandemic hit the country, and clarity in roles and capacity to implement functions were the prevailing challenges, especially among the subnational governments. METHODS: We adopted a cross-sectional exploratory design, using mixed methods. We conducted a desk-based review of all policy documents introduced in response to COVID-19 from January to December 2020, and collected qualitative data through 22 key informant interviews at three tiers of government, during January-March 2021. Two municipalities were purposively selected for data collection in Lumbini province. Our analysis is based on a resilience framework that has been developed by our research project, ReBUILD for Resilience, which helps to understand pathways to health system resilience through absorption, adaptation and transformation. RESULTS: In the newly established federal structure, the existing emergency response structure and plans were utilized, which were yet to be tested in the decentralized system. The federal government effectively led the policy formulation process, but with minimal engagement of sub-national governments. Local governments could not demonstrate resilience capacities due to the novelty of the federal system and their consequent lack of experience, confusion on roles, insufficient management capacity and governance structures at local level, which was further aggravated by the limited availability of human, technical and financial resources. CONCLUSIONS: The study findings emphasize the importance of strong and flexible governance structures and strengthened capacity of subnational governments to effectively manage pandemics. The study elaborates on the key areas and pathways that contribute to the resilience capacities of health systems from the experience of Nepal. We draw out lessons that can be applied to other fragile and shock-prone settings.

Developing a responsive model to societal needs in medical education.

BACKGROUND: Responsiveness is relevant in the context of treatment and the provision of medical services. However, if we delve deeper into the subject, we must establish and develop responsiveness within the medical sciences education system. This study aims to identify the dimensions that significantly impact responsiveness in the medical education system based on a comprehensive review and expert opinions in healthcare. METHODS: The present research is descriptive-analytical in terms of its objective and follows a mixed-method approach. This study was conducted in three stages. Initially, we utilized relevant keywords related to education in databases, such as Web of Science, Scopus, ScienceDirect, OVID, CINHAL, EBSCO, Google Scholar, Iranmedex, SID, and Irandoc. Subsequently, in the expert panel session stage, the factors influencing responsiveness were identified in the comprehensive review stage, and with this thematic background, they were conceptualized. Finally, the Confirmatory Factor Analysis (CFA) technique was employed to coherently examine the relationships between variables and present the final model. RESULTS: We obtained 32 articles from the comprehensive review of studies. Four components in planning, implementation, monitoring and evaluation, and intersectoral cooperation were identified based on expert panel opinions. Based on the standardized coefficients, the components of research-based educational planning, community-oriented education evaluation indicators, and utilization of modern educational methods are statistically significant. CONCLUSION: The establishment and development of responsiveness in the medical sciences education system involve training specialized and responsive human resources through innovative educational methods that have sufficient familiarity with the multidimensional concepts of health and how to achieve them. This approach allows for practical and responsible steps toward training competent and committed physicians in line with the needs of society. On the other hand, responsiveness in the medical sciences education system can be improved by enhancing research-based educational planning and developing community-oriented evaluation indicators that can assess the number of revised educational programs based on societal needs. Therefore, understanding the critical elements in revising medical education programs, which play the most significant role in addressing societal needs and responding to changing disease patterns and new health priorities, is both a necessity and an important priority.

Concept analysis of health system resilience.

BACKGROUND: There are several definitions of resilience in health systems, many of which share some characteristics, but no agreed-upon framework is universally accepted. Here, we review the concept of resilience, identifying its definitions, attributes, antecedents and consequences, and present the findings of a concept analysis of health system resilience. METHODS: We follow Schwarz-Barcott and Kim's hybrid model, which consists of three phases: theoretical, fieldwork and final analysis. We identified the concept definitions, attributes, antecedents and consequences of health system resilience and constructed an evidence-informed framework on the basis of the findings of this review. We searched PubMed, PsycINFO, CINAHL Complete, EBSCOhost-Academic Search and Premier databases and downloaded identified titles and abstracts on Covidence. We screened 3357 titles and removed duplicate and ineligible records; two reviewers then screened each title, and disagreements were resolved by discussion with the third reviewer. From the 130 eligible manuscripts, we identified the definitions, attributes, antecedents and consequences using a pre-defined data extraction form. RESULTS: Resilience antecedents are decentralization, available funds, investments and resources, staff environment and motivation, integration and networking and finally, diversification of staff. The attributes are the availability of resources and funds, adaptive capacity, transformative capacity, learning and advocacy and progressive leadership. The consequences of health system resilience are improved health system performance, a balanced governance structure, improved expenditure and financial management of health and maintenance of health services that support universal health coverage (UHC) throughout crises. CONCLUSION: A resilient health system maintains quality healthcare through times of crisis. During the coronavirus disease 2019 (COVID-19) epidemic, several seemingly robust health systems were strained under the increased demand, and services were disrupted. As such, elements of resilience should be integrated into the functions of a health system to ensure standardized and consistent service quality and delivery. We offer a systematic, evidence-informed method for identifying the attributes of health system resilience, intending to eventually be used to develop a measuring tool to evaluate a country's health system resilience performance.

COVID-19 vaccine intercountry distribution inequality and its underlying factors: a combined concentration index analysis and multiple linear regression analysis.

Introduction: Inequitable access to COVID-19 vaccines among countries is a pressing global health issue. Factors such as economic power, political power, political stability, and health system strength contribute to disparities in vaccine distribution. This study aims to assess the inequality in vaccine distribution among countries based on these factors and identify their relationship with COVID-19 vaccine distribution. Methods: A Concentration Index (CI) analysis was conducted to evaluate inequalities in the distribution of COVID-19 vaccines among countries based on four separate variables: GDP per capita, political stability (PS), World Power Index (WPI), and Universal Health Coverage (UHC). Additionally, Multiple Linear Regression (MLR) analysis was employed to explore the relationship between vaccine distribution and these independent variables. Two vaccine distribution variables were utilized for result reliability. Results: The analysis revealed significant inequalities in COVID-19 vaccine distribution according to the countries' GDP/capita, PS, WPI, and UHC. However, the multiple linear regression analysis showed that there is no significant relationship between COVID-19 vaccine distribution and the countries' GDP/capita and that UHC is the most influential factor impacting COVID-19 vaccine distribution and accessibility. Discussion: The findings underscore the complex interplay between economic, political, and health system factors in shaping vaccine distribution patterns. To improve the accessibility to vaccines in future pandemics, Global Health Governance (GHG) and countries should consider working on three areas; enhance political stabilities in countries, separate the political power from decision-making at the global level and most importantly support countries to achieve UHC.

Models Used by Nurse Case Managers in Different Autonomous Communities in Spain: A Scoping Review.

(1) Background: The role of the nurse case manager is unknown to the population. The main objective is to analyze the existing differences within the national territory in order to make known the situation in Spain with a view to the recognition of its functions and the creation of the professional profile in an equal manner. (2) Methods: A scoping review was conducted in order to achieve the main aim. Selected articles were subjected to a critical reading, and the levels of evidence and grades of recommendation of the Joanna Briggs Institute were verified. The search field was limited to the last ten years. (3) Results: Case management models are heterogeneous in different autonomous communities in Spain. Case nurse management is qualified for high-complexity patients, follow up on chronic patients, and coordinate health assistance. (4) Conclusions: It concludes that nursing's role is crucial in the field of case management, being required in the follow-up of chronic patients of high complexity. Despite the proven health benefits, efficacy, and efficiency of case management, there are many heterogeneous models that coexist in Spain. This involves a restriction in the development of a nursing career because of the lack of a definition of its functions and competences.

The emergence and regression of political priority for refugee integration into the Jordanian health system: an analysis using the Kingdon's multiple streams model.

BACKGROUND: The prolonged presence of Syrian refugees in Jordan has highlighted the need for sustainable health service delivery models for refugees. In 2012, the Jordanian government adopted a policy that granted Syrian refugees access, free of charge, to the national health system. However since 2012, successive policy revisions have limited refugee access. This paper seeks to understand factors that initially put refugee integration into the health system on the policy agenda, as well as how these same factors later affected commitment to sustain the policy. METHODS: This paper draws on data from a document review of 197 peer-reviewed and grey literature publications, a media analysis of newspaper articles retrieved from four officially recognized newspapers in Jordan, and 33 semi-structured key informant interviews. We used Kingdon's Multiple Streams Model - a well-established tool for analyzing policy adoption - to understand how political priority developed for integration of refugees into the health system. RESULTS: We find that several factors helped bring attention to the issue, namely concerns over infectious disease transmission to host communities, high rates of chronic conditions among the refugee population and the increasingly urban and dispersed nature of refugees. At the outset of the conflict, the national mood was receptive to refugees. Politicians and government officials quickly recognized the crisis as an opportunity to secure material and technical support from the international humanitarian community. At the same time, global pressures for integrating refugees into national health systems helped move the integration agenda forward in Jordan and the region more broadly. Since 2012, there were several modifications to the policy that signal profound changes in national views around the continued presence of Syrian refugees in the country, as well as reduced external financial support which has undermined the sustainability of the policy. CONCLUSION: This case study underscores the dynamic nature of policymaking and the challenge of sustaining government commitment to the right to health among refugees. Our analysis has important implications for advocates seeking to advance and maintain momentum for the integration of refugees into national health systems.

Transitioning to sustainable, climate-resilient healthcare: insights from a health service staff survey in Australia.

BACKGROUND: More than 80 countries, including Australia, have made commitments to deliver climate-resilient and low carbon healthcare. Understanding how healthcare workers view their own and their organization's efforts to achieve sustainable and climate-resilient healthcare practice is vital to inform strategies to accelerate that transition. METHODS: We conducted an online staff survey in a large state government hospital-and-health-service organisation in Queensland, Australia, to ascertain attitudes and practices towards environmentally sustainable, climate-resilient healthcare, and views about the organizational support necessary to achieve these goals in their workplace. RESULTS: From 301 participants showed staff strongly support implementing sustainable and climate-resilient healthcare but require significantly more organizational support. Participants identified three categories of organizational support as necessary for the transition to environmentally sustainable and climate-resilient health services and systems: (1) practical support to make sustainability easier in the workplace (e.g. waste, energy, water, procurement, food, transport etc.); (2) training and education to equip them for 21st century planetary health challenges; and (3) embedding sustainability as 'business as usual' in healthcare culture and systems. CONCLUSIONS: The research provides new insight into health workforce views on how organizations should support them to realize climate and sustainability goals. This research has implications for those planning, managing, implementing, and educating for, the transition to environmentally sustainable and climate-resilient health services and systems in Queensland, Australia, and in similar health systems internationally.

The views of family physicians on National Health Insurance in Gauteng Province, South Africa.

BACKGROUND:  Universal health coverage (UHC) improves national health outcomes while addressing social inequalities in access to quality healthcare services. The district health system (DHS) is critical to the success of UHC in South Africa through the National Health Insurance (NHI) scheme. Family physicians (FPs), as champions of primary care, are central to the DHS operation and implementation of NHI. METHODS:  This was a qualitative exploratory study that used semi-structured interviews to explore FPs views and engagement on NHI policy and implementation in their districts. Ten FPs were included through purposive sampling. RESULTS:  Most of the FPs interviewed were not engaged in either policy formulation or strategic planning. The NHI bill was seen as a theoretical ideology that lacked any clear plan. Family physicians expressed several concerns around corruption in governmental structures that could play out in NHI implementation. Family physicians felt unsupported within their district structures and disempowered to engage in rollout strategies. The FPs were able to provide useful solutions to health system challenges because of the design of their training programmes, as well as their experience at the primary care level. CONCLUSION:  Healthcare governance in South Africa remains located in national and provincial structures. Devolution of governance to the DHS is required if NHI implementation is to succeed. The FPs need to be engaged in NHI strategies, to translate plans into actionable objectives at the primary care level.Contribution: This study highlights the need to involve FPs as key actors in implementing NHI strategies at a decentralised DHS governance level.

Governance, policy, and health systems responses to the COVID-19 pandemic in Thailand: a qualitative study.

Background: Since 2020, Thailand has experienced four waves of COVID-19. By 31 January 2022, there were 2.4 million cumulative cases and 22,176 deaths nationwide. This study assessed the governance and policy responses adapted to different sizes of the pandemic outbreaks and other challenges. Methods: A qualitative study was applied, including literature reviews and in-depth interviews with 17 multi-sectoral actors purposively identified from those who were responsible for pandemic control and vaccine rollout. We applied deductive approaches using health systems building blocks, and inductive approaches using analysis of in-depth interview content, where key content formed sub-themes, and different sub-themes formed the themes of the study. Findings: Three themes emerged from this study. First, the large scale of COVID-19 infections, especially the Delta strain in 2021, challenged the functioning of the health system's capacity to respond to cases and maintain essential health services. The Bangkok local government insufficiently performed due to its limited capacity, ineffective multi-sectoral collaboration, and high levels of vulnerability in the population. However, adequate financing, universal health coverage, and health workforce professionalism and commitment were key enabling factors that supported the health system. Second, the population's vulnerability exacerbated infection spread, and protracted political conflicts and political interference resulted in the politicization of pandemic control measures and vaccine roll-out; all were key barriers to effective pandemic control. Third, various innovations and adaptive capacities minimized the supply-side gaps, while social capital and civil society engagement boosted community resilience. Conclusion: This study identifies key governance gaps including in public communication, managing infodemics, and inadequate coordination with Bangkok local government, and between public and private sectors on pandemic control and health service provisions. The Bangkok government had limited capacity in light of high levels of population vulnerability. These gaps were widened by political conflicts and interference. Key strengths are universal health coverage with full funding support, and health workforce commitment, innovations, and capacity to adapt interventions to the unfolding emergency. Existing social capital and civil society action increases community resilience and minimizes negative impacts on the population.

A cross-sectional study exploring community perspectives on the impacts of COVID-19 in Nunavut and recommendations for a Holistic Inuit Qaujimajatuqangit approach to emergency response.

The goal of this study was to examine and address critical knowledge gaps and develop an understanding of both the positive and negative societal outcomes resulting from the public health measures associated with the COVID-19 pandemic in Nunavut and the interventions being undertaken to promote positive well-being. Data collection for this study included narrative, in-person interviews in Iqaluit, Rankin Inlet, Baker Lake, and Cambridge Bay between September 2022 and January 2023. A total of 70 participants were interviewed for this study. Community highlighted challenges, such as crowding and food insecurity, and concern for the collective wellbeing of the community. Strengths included financials supports, food sharing, and maintaining community connections over a distance. Recommendations included a focus on holistic health such as 1) public education and awareness about communicable disease, 2) financial supports, 3) housing, 4) access to healthcare, 5) focus on Inuit Qaujimajatuqangit, 6) mental-health and addiction supports, and 7) community spaces. Community members described both strengths and challenges they believe impacted their experiences and service delivery as well as recommendations for the future.

'Two heads are better than one.' - exploring the experiences of Ghanaian communities on the role and effect of Patient-Public Engagement in Health System Improvement.

Patient and Public Participation (PPP) is key to improving health systems. Yet, studies have shown that PPP implementations across many countries have been largely tokenistic. Particularly, in Ghana, whilst PPP is prioritised in national health policies and legislation, there appears to be little research focused on understanding PPP's role in health system improvement. The aim of this study, therefore, is to examine how PPP is working across the Ghanaian health system levels, as well as to understand the perspectives and experiences of participants on how PPP contributes to health system improvement. The qualitative study was undertaken in six communities in three districts in the Ashanti region of Ghana. Data were collected from semi-structured individual interviews. The selection of participants was purposive, based on their PPP-related roles. As a result, findings of this study may not reflect the experiences of others who are not directly involved in PPP initiatives. Thirty-five participants, mainly health service users and health professionals, were interviewed. Data were transcribed and analysed descriptively using Braun and Clarke's 2006 thematic analysis approach. Overall, participants noted PPP implementation was largely limited at higher health system levels (i.e. national, regional and district levels), but was functioning at the community level. PPP also improved access to health services, responsiveness to patient needs, community-health worker relationships, health-seeking behaviours, empowered healthcare users, and improved health outcomes. The study, therefore, recommended the need to undertake PPP across all levels of the health system to maximise PPP's role in health system improvement. Finally, the study suggested prioritising PPP, especially for resource-poor countries to complement government's efforts in improving accessibility of healthcare services to many communities and also provide a more patient-centred healthcare system responsive to patients' and public needs.

Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil.

BACKGROUND AIMS: The marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. METHODS: A survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. RESULTS: We invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. CONCLUSIONS: Considering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

Assessment of the appropriateness of stress ulcer prophylaxis use and its determinants among admitted surgical patients at Debre Berhan University Hakim Gizaw Hospital, Ethiopia. A hospital-based cross-sectional study.

Introduction: Pharmacological stress ulcer prophylaxis (SUP) has been recommended for many years to reduce the risk of clinically significant upper gastrointestinal (GI) bleeding caused by stress ulcers (SUs). Stress-related ulcer bleeding in surgical patients significantly increases morbidity and mortality. Therefore, preventing stress-induced hemorrhage is the most appropriate measure for patients who are at increased risk. However, the inappropriate use of SUP has increased in recent years, and its use in Ethiopian surgical patients has not been well studied. Objective: The aim of this study was to assess the appropriateness of SUP use and its determinants among admitted surgical patients at Debre Berhan University Hakim Gizaw Hospital (DBUHGH), Ethiopia. Methods: We randomly selected 230 patients from the whole cross-sectional group of all surgical patients at DBUHGH from 1 February to 30 June 2023. The risk of stress ulcer (SU) development was assessed using the modified American Society of Health-System Pharmacists (ASHP) guidelines. For data analysis, we used SPSS version 25. Results: The mean age of study participants was 47.2 years (SD ± 20.4), and out of the total of 230, 130 (56.5%) were women. Approximately 66% of study participants took inappropriate SUP based on ASHP guidelines criteria. The most commonly used drug class for SUP was histamine-2 receptor blockers 115 (50%). Study participants who have a Charlson Comorbidity Index Score of moderate and GI bleeding have been significantly associated with the inappropriate use of SUP. Conclusion: In our study, inappropriate SUP use was common in the surgical ward of DBUHGH. This may be an area that requires further and more focused working together among clinical pharmacists and medical professionals in an institution-specific SUP protocol that aids clinicians in identifying appropriate candidates for SUP medication.