Unnecessary Barriers Research Articles

The mifepristone REMS: A needless and unlawful barrier to care✰

Mifepristone (brand name Mifeprex) is a prescription drug that has been safely used in the United States for twenty years to end early pregnancies and, more recently, to treat early miscarriages. Although the U.S. Food and Drug Administration (FDA) acknowledges that mifepristone's safety and efficacy are “well-established by both research and experience” [1], it imposes a Risk Evaluation and Mitigation Strategy (“REMS”) that severely restricts where, how, and from whom this medication can be obtained. Most notably, FDA requires that mifepristone be dispensed at a hospital, clinic, or medical office—not by mail or through a retail or mail-order pharmacy—even though patients can receive all evaluation and counseling via telemedicine and can self-administer the mifepristone tablet, unsupervised, at the location of their choice. Of more than 20,000 FDA-approved drugs [2], mifepristone is the only one FDA requires patients to pick up in a clinical setting even though they do not have to take it under clinical supervision [3].FDA's singular restrictions on mifepristone are not only clinically unjustified, but unlawful. On behalf of leading medical associations, individual physicians, and reproductive justice advocates, our organization, the American Civil Liberties Union, has taken FDA to court—twice—because the agency's restrictions on mifepristone do not satisfy the strict constraints Congress established for REMS programs and erect profound and unnecessary barriers to care in violation of the U.S. Constitution.

How the Politics of Big Pharma Is Undermining COVID-19 Public Health Policy in Canada

In December 2020 a former NATO commander in Iraq appointed to lead vaccination logistics in the Public Health Agency of Canada announced that the country would adopt a “whole-of-nation” approach to achieve the goal of vaccinating all Canadians by the summer. Two months away from the summer, four into the announcement, and with 400 million doses procured to vaccinate 38 million people several times over, less than 3% of Canadians have received two doses of the leading, authorized products. A range of explanations have been proffered for the delay, including that the Liberal Trudeau Government is treating Big Pharma unfairly, thus causing unnecessary barriers to vaccine supplies. We argue that the assertion does not stand up to scrutiny. As our analysis will show, Canadian pharmaceutical policy is extremely corporate friendly and has been so for decades. This has led to both a predictably rocky vaccine effort and to the continuing failure by the government to guarantee equitable access to medically necessary drugs, prior to, during, and beyond the COVID-19 pandemic.

Jehovah's Witness Patients “Going the Extra Mile” for Bloodless LVAD Implantation

<h3>Purpose</h3> Due to their religious beliefs, Jehovah's Witnesses (JWs) do not accept blood products; consequently, these patients with end-stage heart failure frequently seek a center willing to perform bloodless left ventricular assist device (LVAD) implantation. We assessed the challenges JWs confront in obtaining access to care, based on our center's experience orchestrating bloodless LVAD implantation. <h3>Methods</h3> We retrospectively reviewed the medical records of 36 patients - 18 JWs and 18 non-JWs - undergoing LVAD implantation at our center. <h3>Results</h3> Our findings revealed that JWs travelled a significantly greater distance to receive treatment than non-JWs (median: 293 (107.75, 667.5) vs 32.5 miles (15.3, 74.5), <i>P</i> = 0.006). Pre-operative characteristics, including INTERMACS profiles and re-operative status at implant, were comparable between the two groups (<i>P</i> > 0.05 for all). However, all JWs underwent concomitant surgeries at the time of bloodless LVAD implantation, as compared to 67% of non-JWs (<i>P</i> = 0.019). Length of stay, discharge location, and peri-operative outcomes were not significantly different (<i>P</i> > 0.05). We found that JWs currently face barriers in the <i>availability, appropriateness, preference</i>, and <i>timeliness</i> of access to care (Figure 2). In particular, being refused implantation at centers nearer to their residence causes JWs to travel excessive distances in hopes of treatment; however, long-distance travel may prolong the time until treatment and may not be an option for patients with financial or logistical challenges. <h3>Conclusion</h3> Our center's experience has shown that JWs face unnecessary barriers in access to care, but they can be successfully operated on with the use of optimization protocols and open communication between the patient and care team. Further research is needed to elucidate the challenges JWs face in accessing care and identify potential solutions which balance ethical considerations with patient autonomy.

The Relationship between Stakeholder Theory and Corporate Social Responsibility: Differences, Similarities, and Implications for Social Issues in Management

AbstractAlthough stakeholder theory and corporate social responsibility (CSR) have evolved into major theoretical frameworks for exploring social issues in management, there is a limited and often misleading understanding of the relationship between them that inhibits the management field from adopting a social orientation to a full extent. Our aim is to remove unnecessary barriers that preclude collaboration between scholars in the stakeholder theory and CSR camps; empower organizational scholars and practitioners with a more nuanced language for dealing with social issues in management; and enable the creation of a coherent and integrative theoretical foundation in the area of social issues in management that has previously been at a disadvantage to other areas in management. In our conceptual analysis, we argue that stakeholder theory and CSR provide distinct but complementary theoretical frameworks with some overlap. The actual decision to choose a particular framework depends on the problem one wants to solve and the settings of that problem.

The Change We Want to See Means Embracing the Changes We Must Make

Back to table of contents Previous article Next article ProfessionalFull AccessThe Change We Want to See Means Embracing the Changes We Must MakePatrick Runnels, M.D., M.B.A.Patrick RunnelsSearch for more papers by this author, M.D., M.B.A.Published Online:25 Feb 2021https://doi.org/10.1176/appi.pn.2021.3.31AbstractChange from what we know and how we are accustomed to practicing may mean giving up some things we value in return for something better. This article is part of a series written by APA’s Council on Advocacy and Government Relations.Reflect, for a moment, on the vision you formed at the beginning of your career as a psychiatrist to make the world a better place. Now consider all the barriers you encounter day in and day out trying to realize that vision. Most psychiatrists I meet see those barriers—those defects—as the cost of doing business. They provide outstanding care in broken systems despite it all, spending untold amounts of time overcoming unnecessary barriers just so individuals actually get the care we know they deserve.Now consider how health care is changing. The phrase that encapsulates the perpetually-around-the-corner transformation we’ve been promised since the passage of the Patient Protection and Affordable Care Act is value-based care. It’s a phrase that can serve as a vessel for all our hopes and dreams for how the health care system should change while, at the same time, not really promising or committing to any specifics. For those of us who work in population health, it connotes an enormously complex set of principles, structures, and workflows employed in the service of transformational change, constantly butting up against incentives and a culture that are still aligned with the old way of doing things. Whether or not value-based care is the future or simply a way station on the journey toward something totally different is unclear. But wherever we land will look and feel quite different.In terms of realizing the collective vision we developed at the beginning of our careers, this is great news. Yet change from what we know and how we are accustomed to practicing is uncomfortable and messy and may mean giving up some things we value in return for something better. Put flatly: Our practices and our value proposition will change.Systems, institutions, and health care professions participating in value-based payment models have become laboratories of innovation. Because this is all pretty new and we don’t really know what we’re doing, most of that innovation will fail. Yet, policy is informed by the real-world innovations that pan out despite it all. And as it applies to the needs of the individual patients we serve, along with the populations for which we will become responsible, the opportunity is tremendous. This experimentation will yield tremendous learning about how to advocate for the future of our practices and of treatment more broadly.So, we have an emerging challenge in advocacy that requires us, along with thinking about the present, to think outside the framework of how we practice now, to consider how we thought things ought to be when we started this. And then we need to create a vision of where we will be in 10 years and identify the steps it will take to get there. We have wonderful laboratories to guide us, but nothing much will happen without all of us embracing the fact that things should be—and can be—much different.That it makes us nervous is understandable. But this is a generational opportunity we can’t miss. I, for one, am up to the challenge. ■If you would like to be active in advocacy, go to psychiatry.org/advocacy, where you can learn how to get involved in shaping pro-psychiatry public policy, including becoming a member of APA’s Congressional Advocacy Network and signing up to receive the Advocacy Updates newsletter and alerts.Patrick Runnels, M.D., M.B.A., is a member of APA’s Council on Advocacy and Government Relations. ISSUES NewArchived

Poverty Eradication as a Priority Indicator of the United Nations Sustainable Development Goals

The paper considers the problem of eliminating poverty as one of the key goals of the world community at the beginning of the 20th century. The difficulty is that poverty is multidimensional in terms of socio-economic characteristics. Since the early 20th century, the United Nations has sought to unite member states’ efforts to address the issues of inequality, economic growth, climate change, energy, natural resources, and the environment, as well as those of peace and justice, which are cornerstones of poverty eradication. The goals and the means to achieve them have been identified as prerequisites for poverty eradication in accordance with the Sustainable Development Agenda 2030. The paper reviews the conditions to guarantee the poor and vulnerable access to basic services at affordable prices, equal rights to economic resources and ownership of factors such as land without unnecessary barriers.

ОЦЕНКА НЕОБХОДИМОСТИ ПРИНЯТИЯ ПРАВОВОЙ НЕЙТРАЛЬНОСТИ ИНТЕЛЛЕКТУАЛЬНЫХ СИСТЕМ

The article considers the assessment of the need to adopt the legal neutrality of intelligent systems (IP). The author comes to the conclusion that IP is successfully used in various fields today, but in order to eliminate the multiple risks associated with their use, it is necessary to adopt appropriate laws and develop a legal policy regarding the regulation of relations involving IP. The set of principles governing the above-mentioned relations should include the principle of legal neutrality of IP to ensure that unnecessary barriers are not erected to realize the benefits of IP.

Not What Anyone Signed up for: Unnecessary and Insurmountable Barriers Encountered in Conducting Clinical Trials in COVID-19.

Not What Anyone Signed up for: Unnecessary and Insurmountable Barriers Encountered in Conducting Clinical Trials in COVID-19.

ПРАВОВЫЕ СРЕДСТВА ЗАБОТЫ ГОСУДАРСТВА О СЕМЬЕ В РЕСПУБЛИКЕ БЕЛАРУСЬ В ФОРМАХ ЗАЩИТЫ СЕМЬИ И УКРЕПЛЕНИЯ БРАКА

The article analyzes individual measures aimed at protecting and strengthening the institutions of marriage and family in the Republic of Belarus, in particular, the establishment of a differentiated rate of state duty charged for divorce in both judicial and administrative procedures, as well as the provision of basic and additional term for divorcing spouses to take reconciliation measures. The article is based both on the norms of international legal acts and their interpretation by the authorized bodies, as well as on the norms of the national legislation of the Republic of Belarus and current statistical data. The article draws a number of conclusions: on the non-uniform application of security terminology in relation to the institutions of marriage and family; on the irrational approach to setting the rates of state fees charged for divorce in an administrative procedure; on unnecessary administrative barriers in the form of a two-month term for registration of a divorce in administrative procedure.

Effects of One Stop Border Posts (OSBPs) Trade Facilitation Initiative on the Movement of Goods along the Rwandan Customs Posts

Despite a critical role played by cross-border movement of goods in international trade, the former is made complex and unpredictable by various factors. In Rwanda as is the case in other parts of the world, one stop border posts (OSBPs) adopted at the East African Community level have been implemented and operationalised to facilitate cross-border trade and movement of goods. This paper aims to assess the effects of OSBPs trade facilitation initiative on the movement of goods along the Rwandan customs posts using multi-level model. The main findings reveal that the implementation of OSBPs initiative has significantly and positively affected the movement of goods along the Rwandan customs posts giving an impression that the implementation of OSBPs trade facilitation initiative has considerably contributed to the improvements in the level of trade facilitation; and hence, streamlined and expedited the movement of goods along the Rwandan customs posts by removing unnecessary barriers.

MANDATORY LABELLING OF NANOFOOD AND THE WTO AGREEMENTS

Labelling of food products that contain new technologies has been adopted to inform consumers and address concerns over uncertainty of the technologies. Even though food labelling is significant, the implementation of mandatory labelling measures for nanofood within the domestic legislation is only possible if the measure is aligned with the World Trade Organisation (WTO) regulations. This paper examines whether mandatory labelling measure for nanofood would be permissible under the WTO agreements, i.e. the Technical Barriers to Trade Agreement and the Sanitary and Phytosanitary Agreement. The study adopts a doctrinal approach and content analysis by examining relevant legal provisions in the WTO agreements, cases decided by the WTO, and other documents on nanofood labelling. Findings suggest that the labelling measure amounts to unnecessary barriers to international trade. The mandatory labelling is not an international labelling standard and the practice is trade restrictive. Some recommendations presented at the end of this paper shall give invaluable insights into the implementation of mandatory labelling for nanofood if any country decides to introduce the measures in their food information system.

Removing Unnecessary Medical Barriers to Contraception: Celebrating a Decade of the U.S. Medical Eligibility Criteria for Contraceptive Use.

In 2010, the Centers for Disease Control and Prevention (CDC) released the U.S. Medical Eligibility Criteria for Contraceptive Use, providing recommendations for health care providers on safe use of contraception for people with certain characteristics or medical conditions. Adapted from World Health Organization guidance, the goal of the recommendations is to remove unnecessary medical barriers to contraception. Over the past decade, CDC has updated recommendations based on new evidence, collaborated with national partners to disseminate and implement the guidelines, and conducted provider surveys to assess changes in attitudes and practices around contraception safety and provision. CDC remains committed to supporting evidence-based guidelines for safe use of contraception, as the basis for improving access to contraception and high-quality family planning services, reducing unintended pregnancy, and improving reproductive health in the United States.

Impact of the Covid19 Outbreak on Macedonian Trade Flows

Reduced demand and the disruptions in value chains, as a result of the coronavirus, are expected to have a significant impact on the external sector, especially in economies such as Macedonian, whose manufacturing sectors are more integrated into global supply chains. Hence, the main purpose of the paper is to see to what extent and in which segments the new conditions have reflected on exports and imports in the Macedonian economy, and to review the measures and activities taken in order to mitigate short-term challenges and facilitate cross-border trade. The paper analyzes the trend and the changes that occur both on the import and export side, in general, by selected products and by countries. The data generally refer to a last 5 years. For more particular and specific analyzes, they cover the period from January 2019 until June 2020, on a quarterly basis. The main used research methods are: analysis and synthesis, statistical, historical and inductive-deductive method. The results have shown that the decline in economic activity and demand globally, including in the European Union, and thus in the most important Macedonian export partners, directly affects export sector in the country. Economy also faces serious import problems, especially due to its heavy dependence on materials needed for industrial production processes that are usually imported from the hardest-hit markets in Europe. The trade measures are mainly designed to avoid unnecessary barriers to trade and disruption of global supply chains.

Maternity (Family) Capital as a Support Program for Families with Children: Implementation Results and Development Prospects (Part Two)

Maternity (family) capital (hereinafter referred to as M(F)C) is a certain amount of funds allocated to families with children from the state budget with the goal of creating conditions providing families with children with The article analyzes the theoretical and practical issues of the development of the M(F)C program, the statistics of Rosstat, the Ministry of Labour and Social Protection and the Pension Fund of the Russian Federation, characterizing M(F)C. The article is divided into two parts due to its large volume. The first part of the article explores the conceptual and applied aspects of the origin and development of the M(F)C program. The genesis of the idea of maternal capital and the path from idea to bill is considered. The baseline parameters, such as the size of the capital, the period of action, the directions of use and the conditions governing access to funds M(F)C are analyzed. The second part shows how the initial parameters were adjusted: the extension of the period of action, the reduction of the period preceding the possibility of use, the clarification of the rules of documentation of the right to M(F)C, the removal of unnecessary administrative barriers for filing and consideration of applications, improving the conditions of use by adding new directions. The statistics of M(F)C, changes in the direction of its use and expenditures on these areas are analyzed. Proposals are presented to develop the M(F)C program, to expand its use to better support families with children

International trade of waste in the sector-spatial dimensions

Introduction. Global circular trade involves countries that specialize in exporting goods in which they have a comparative advantage and import other goods from their trading partners. This process of international exchange requires the transportation of goods from the country of production to the country of consumption. Therefore, the expansion of international trade is likely to increase the use of transport. It is confirmed that the leading countries in the export-import of waste in various industries are at the same time components of circular core, around which circular value chains are formed.The aim is to do a systematic analysis of the spatial-component structure of trade in waste and scrap and to identify leading countries, development priorities in industries (pharmaceuticals, clinical, household, rubber waste, polymers, silk and cotton waste).Results. The paper analyzes the spatial-component structure of trade in waste and scrap and identifies the leading countries, development priorities in the industries (pharmacy, clinical, household, rubber waste, polymers, silk and cotton waste). The main problematic aspects are illegal waste trade and growing smuggling, which cause serious negative social consequences and actualize the inclusive component in substantiating the paradigm of the global inclusive circular economy. It has been investigated that waste reduction combined with prudent use of resources has the potential to address the gap due to natural resource scarcity and global growing population or consumption. It is substantiated that the formation of circular trade will contribute to: the definition of priority materials for trade and the required level of processing capacity; harmonization of material quality standards; promoting the demand for used goods and secondary raw materials; removing unnecessary regulatory barriers and avoiding environmentally harmful activities such as non-compliance, poorly regulated nature and informal recovery.Perspectives. Further research on international waste trade in the sectoral-spatial dimension will need to be continued in the context of the environmental and economic impacts of COVID-19, which diversifies and increases the amount of medical waste.

The business and practice of psychiatric advanced practice nursing in long term care

Given the state of health care in the U.S. and the growing health care needs addressed by the Affordable Care Act of 2010, the Institute of Medicine (IOM) released The Future of Nursing: Leading Change, Advancing Health which identified challenges faced by the U.S. health care system and the significant role of nursing as a part of the solution ( Institute of Medicine, 2011 Institute of Medicine The future of nursing: Leading change, advancing health. The National Academies Press, Washington, DC2011 Google Scholar ). Among the top challenges to health care include an aging population and rising chronic diseases ( Institute of Medicine, 2011 Institute of Medicine The future of nursing: Leading change, advancing health. The National Academies Press, Washington, DC2011 Google Scholar ). While nurses, particularly advanced practice registered nurses (APRNs), are poised to fill provider shortages and to address health care needs across the health care system, there is a substantial need to deliver services in the community, especially long-term care (LTC) and assisted living facilities where, as of 2010, only 2.4% of APRNs work ( Dodaro, 2008 Dodaro G.L. Long-term fiscal outlook: Long-term federal fiscal challenge driven primarily by health care. https://www.gao.gov/products/GAO-08-912TDate: 2008 Google Scholar ; Institute of Medicine, 2011 Institute of Medicine The future of nursing: Leading change, advancing health. The National Academies Press, Washington, DC2011 Google Scholar ; Steinwald, 2008 Steinwald A.B. Primary care professionals: Recent supply trends, projections, and valuation of services. https://www.gao.gov/new.items/d08472t.pdfDate: 2008 Google Scholar ). In response to this demographic forecast, the Institute of Medicine, 2011 Institute of Medicine The future of nursing: Leading change, advancing health. The National Academies Press, Washington, DC2011 Google Scholar recommended that the Medicare program remove restrictions governing APRN practice. Other federal agencies, such as the Department of Veterans Affairs and the Indian Health Service allow most APRNs full practice authority regardless of state practice laws ( Indian Health Services, n.d Indian Health Services. (n.d.). Part 3 - Professional services, chapter 4 - Nursing: Advanced practice nurses: Scope of practice. Retrieved July 24, 2019 from https://www.ihs.gov/ihm/pc/part-3/p3c4/. Google Scholar ; Department of Veterans Affairs, 2016 Department of Veterans Affairs Advanced practice registered nurses. https://www.federalregister.gov/documents/2016/12/14/2016-29950/advanced-practice-registered-nursesDate: 2016 Google Scholar ; Sofer, 2017 Sofer D. VA grants most APRNs full practice authority. American Journal of Nursing. 2017; 117: 14https://doi.org/10.1097/01.NAJ.0000513271.43979.37 Crossref Scopus (4) Google Scholar ); yet, the Centers for Medicare and Medicaid Services (CMS) continue to defer to the state practice laws regarding APRNs' practice ( Centers for Medicare and Medicaid Services, 2012 Centers for Medicare and Medicaid Services Nursing facility services (codes 99304-99318). https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm4246.pdfDate: 2012 Google Scholar ), which greatly affects LTC residents' access to health care in states with more restrictive practice laws. The Federal Trade Commission, 2014 Federal Trade Commission Policy perspectives: Competition and the regulation of advanced practice nurses. https://www.ftc.gov/reports/policy-perspectives-competition-regulation-advanced-practice-nursesDate: 2014 Google Scholar concurs with the IOM that APRNs offer a unique solution to the provider shortage and lack of healthcare access, and that removing unnecessary APRN practice barriers can promote competition in the healthcare market and reduce healthcare costs.

Science progresses through open disagreement: Rejoinder to Fine (2020).

In her commentary on Buss and von Hippel (2018), Fine (2020) makes 2 primary claims. First, she argues that Buss and von Hippel’s methods and data do not support their conclusions. Second, she argues that Buss and von Hippel made unsubstantiated accusations of ideological bias regarding Fine (2017), thereby creating unnecessary barriers to constructive scientific debate. In this rejoinder, we acknowledge some of her methodological criticisms but provide additional analyses of our data that support our original conclusions. We also expand on Buss and von Hippel’s criticisms of Fine (2017) to clarify why we regard her work as ideologically biased and why we think concerns about bias should be more commonplace in scientific debate.

Constructing unnecessary barriers to constructive scientific debate: A response to Buss and von Hippel (2018).

Constructing unnecessary barriers to constructive scientific debate: A response to Buss and von Hippel (2018).

Help or hindrance: Exploring nurse practitioners' perceptions of transition to practice legislation.

Fourteen states have adopted transition to practice (TP) legislation, which requires newly certified nurse practitioners (NPs) to practice under a senior clinician. States have adopted such legislation despite vast evidence indicating NPs provide safe care. The purpose of this study is to explore NPs' perceptions of the effects of this legislation and to describe communication between NPs and senior clinicians working in TP states. Using a cross-sectional, descriptive design, we surveyed a convenience sample of NPs working in TP states. Descriptive statistical analysis and qualitative content analysis were conducted. Most respondents believed TP legislation posed unnecessary regulatory barriers but also believed it promoted professional development. No statistically significant relationships between professional characteristics, regulatory variations, and these perceptions were identified. Given the increasing number of states considering TP legislation, and the vast variability in TP models, additional research into the effects of this regulation is needed.

When I See You: Opening Eyes and Closing Jails.

When I See You: Opening Eyes and Closing Jails.