Behind the scenes: facilitators and barriers to developing state scarce resource allocation plans for the COVID-19 pandemic.

BACKGROUND: In response to COVID-19, many states revised, developed, or attempted to develop plans to allocate scarce critical care resources in the event crisis standards of care were triggered. No prior analysis has assessed this plan development process, including whether plans were successfully adopted. RESEARCH QUESTION: How did states develop or revise scarce resource allocation plans during the COVID-19 pandemic and what were the barriers and facilitators to their development and adoption at the state level? STUDY DESIGN AND METHODS: Plan authors and state leaders completed a semi-structured interview February to September 2022. Interview transcripts were qualitatively analyzed for themes related to plan development and adoption according to the principles of grounded theory. RESULTS: Thirty-six participants from 34 states completed an interview, from states distributed across all U.S. regions. Among participants' states with plans that existed prior to 2020 (n=24), 17 were revised and adopted in response to COVID-19. Six states wrote a plan de novo, with the remaining states failing to develop or adopt a plan. Thirteen states continued to revise their plans in response to disability or aging bias complaints or to respond to evolving needs. Many participants expressed that urgency in the early days of the pandemic prevented an ideal development process. Facilitators of successful plan development and adoption include: coordination or support from the state department of health and existing relationships with key community partners, including aging and disability rights groups and minoritized communities. Barriers include: lack of perceived political interest in a plan and development during a public health emergency. INTERPRETATION: To avoid repeating mistakes from the early days of the COVID response, states should develop or revise plans with community engagement and consider maintaining a standing committee with diverse membership and content expertise to periodically review plans and advise state officials on pandemic preparedness.

Using a web platform for equitable distribution of COVID-19 monoclonal antibodies: a case study in resource allocation.

While medical countermeasures in COVID-19 have largely focused on vaccinations, monoclonal antibodies (mAbs) were early outpatient treatment options for COVID-positive patients. In Minnesota, a centralized access platform was developed to offer access to mAbs that linked over 31,000 patients to care during its operation. The website allowed patients, their representative, or providers to screen the patient for mAbs against Emergency Use Authorization (EUA) criteria and connect them with a treatment site if provisionally eligible. A validated clinical risk scoring system was used to prioritize patients during times of scarcity. Both an ethics and a clinical subject matter expert group advised the Minnesota Department of Health on equitable approaches to distribution across a range of situations as the pandemic evolved. This case study outlines the implementation of this online platform and clinical outcomes of its users. We assess the impact of referral for mAbs on hospitalizations and death during a period of scarcity, finding in particular that vaccination conferred a substantially larger protection against hospitalization than a referral for mAbs, but among unvaccinated users that did not get a referral, chances of hospitalization increased by 4.1 percentage points.

Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.

Ferguson v. City of Charleston Redux: Motivated Reasoning and Coercive Interventions in Pregnancy.

Criminalization of perinatal substance use disorder and other coercive interventions in pregnancy (such as forced cesarean delivery or involuntary hospitalization for bed rest) directly affect the well-being of children and their families and, potentially, of all women of reproductive capacity. Untenable legal and policy approaches that occasion such incursions not only persist but affect a growing number of women. They are antithetical to healthy pregnancies, healthy children, and healthy families; they have the potential to reduce prenatal care seeking, divert attention and resources away from critical mental health and maternal and child support services, and epigenetically affect maternal and infant bonding. Punitive and coercive interventions contravene long-established guidance by professional associations that advocate for public health approaches and ethical frameworks to guide practice. Harmful policies persist because of motivated reasoning by clinicians, members of the judiciary, and ill-informed legislators who rely on personal experience and anecdote rather than evidence to fashion policy. Compounding the problem are inadequate substance use treatment resources and professional associations that choose not to hold their members accountable for violating their ethical obligations to their patients. Pediatricians must advocate for the cessation of coercive interventions within their institutions and their larger communities. All health care professionals should collaborate at the local, state, and national level to provide policymakers and legislators with data emphasizing the negative effects of punitive and coercive policies aimed at pregnant women and their children.

Key populations and human rights in the context of HIV services rendition in Ghana.

BACKGROUND: In line with its half century old penal code, Ghana currently criminalizes and penalizes behaviors of some key populations - populations deemed to be at higher risk of acquiring or transmitting Human Immunodeficiency Virus (HIV). Men who have sex with men (MSM), and sex workers (SWs) fit into this categorization. This paper provides an analysis of how enactment and implementation of rights-limiting laws not only limit rights, but also amplify risk and vulnerability to HIV in key and general populations. The paper derives from a project that assessed the ethics sensitivity of key documents guiding Ghana's response to its HIV epidemic. Assessment was guided by leading frameworks from public health ethics, and relevant articles from the international bill of rights. DISCUSSION: Ghana's response to her HIV epidemic does not adequately address the rights and needs of key populations. Even though the national response has achieved some public health successes, palpable efforts to address rights issues remain nascent. Ghana's guiding documents for HIV response include no advocacy for decriminalization, depenalization or harm reduction approaches for these key populations. The impact of rights-restricting codes on the nation's HIV epidemic is real: criminalization impedes key populations' access to HIV prevention and treatment services. Given that they are bridging populations, whatever affects the Ghanaian key populations directly, affects the general population indirectly. The right to the highest attainable standard of health, without qualification, is generally acknowledged as a fundamental human right. Unfortunately, this right currently eludes the Ghanaian SW and MSM. The paper endorses decriminalization as a means of promoting this right. In the face of opposition to decriminalization, the paper proposes specific harm reduction strategies as approaches to promote health and uplift the diminished rights of key populations. Thus the authors call on Ghana to remove impediments to public health services provision to these populations. Doing so will require political will and sufficient planning toward prioritizing HIV prevention, care and treatment programming for key populations.

Ethical Guidance for Disaster Response, Specifically Around Crisis Standards of Care: A Systematic Review.

BACKGROUND: Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. OBJECTIVES: To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). SEARCH METHODS: We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. SELECTION CRITERIA: We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. DATA COLLECTION AND ANALYSIS: Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. MAIN RESULTS: Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in recent years, CSC plans have rarely been implemented within the United States to date, although some components are common (e.g., triage is used in US emergency departments regularly). Conversely, countries outside the United States more commonly implement CSCs within a natural disaster or humanitarian crisis response, and may offer significant insight into ethics and disaster response for US-based practitioners. CONCLUSIONS: This systematic review identifies the most oft-used and -discussed ethical concepts and principles used in disaster planning around CSCs. Although discussion of more nuanced issues (e.g., health equity) are present, the majority of items substantively engaging in ethical discussion around disaster planning do so regarding triage and why ethics is needed in disaster response generally. Public health implications. A significant evolution in disaster planning has occurred within the past decade; ethical theories and frameworks have been put to work. For ethical guidance to be useful, it must be practical and implementable. Although high-level, abstract frameworks were once prevalent in disaster planning-especially in the early days of pandemic planning-concerns about the ethically difficult concept of CSCs pervade scholarly articles. Ethical norms must be clearly stated and justified and practical guidelines ought to follow from them. Ethical frameworks should guide clinical protocols, but this requires that ethical analysis clarifies what strategies to use to honor ethical commitments and achieve ethical objectives. Such implementation issues must be considered well ahead of a disaster. As governments and health care systems plan for mass casualty events, ethical guidance that is theoretically sound and practically useful can-and should-form an important foundation from which to build practical guidance for responding to disasters with morally appropriate means.

Partner notification in the context of HIV: an interest-analysis.

Codes of confidentiality play an essential role in the intimate discourses in many learned professions. Codes with various prescriptions exist. The Hippocratic Oath for example, prescribes rewards to the secret keeper, for keeping secret what ought to be kept secret, and punishments for failing. In public health practice, partner notification, arguably is one endeavor that tests the durability of this secret keeping doctrine of the health professional. We present an interest-analysis of partner notification in the context of HIV service rendition. Using principles-based analysis, the interests of the individual, the state/public health, and the bioethicist's are discussed. The public health interests in partner notification, which are usually backed by state statutes and evidence, are premised on the theory that partners are entitled to knowledge. This theory posits that knowledge empowers individuals to avoid continuing risks; knowledge of infection allows for early treatment; and that knowledgeable partners can adapt their behavior to prevent further transmission of infection to others. However, persons infected with HIV often have counter interests. For instance, an infected person may desire to maintain the privacy of their health status from unnecessary disclosure because of the negative impacts of disclosure, or because notification without a matching access to HIV prevention and treatment services is detrimental. The interest of the bioethicist in this matter is to facilitate a resolution of these conflicted interests. Our analysis concludes that governmental interests are not absolute in comparison with the interests of the individual. We reiterate that any effort to morally balance the benefits of partner notification with its burdens ought to first recognize the multivalent nature of the interests at play.

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza.

BACKGROUND: Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI). METHODS: We critically analyzed the Ghana NISPPI's sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks. RESULTS: This paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI's text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them. CONCLUSIONS: Our analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan's content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.

Social justice in pandemic preparedness.

Pandemic influenza planning in the United States violates the demands of social justice in 2 fundamental respects: it embraces the neutrality of procedural justice at the expense of more substantive concern with health disparities, thus perpetuating a predictable and preventable social injustice, and it fails to move beyond lament to practical planning for alleviating barriers to accessing care. A pragmatic social justice approach, addressing both health disparities and access barriers, should inform pandemic preparedness. Achieving social justice goals in pandemic response is challenging, but strategies are available to overcome the obstacles. The public engagement process of one state's pandemic ethics project influenced the development of these strategies.

How clinical trials really work rethinking research ethics.

Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.

Attending to social vulnerability when rationing pandemic resources.

Pandemic plans are increasingly attending to groups experiencing health disparities and other social vulnerabilities. Although some pandemic guidance is silent on the issue, guidance that attends to socially vulnerable groups ranges widely, some procedural (often calling for public engagement), and some substantive. Public engagement objectives vary from merely educational to seeking reflective input into the ethical commitments that should guide pandemic planning and response. Some plans that concern rationing during a severe pandemic recommend ways to protect socially vulnerable groups without prioritizing access to scarce resources based on social vulnerability per se. The Minnesota Pandemic Ethics Project (MPEP), a public engagement project on rationing scarce health resources during a severe influenza pandemic, agrees and recommends an integrated set of ways to attend to the needs of socially vulnerable people and avoid exacerbation of health disparities during a severe influenza pandemic. Among other things, MPEP recommends: 1. Engaging socially vulnerable populations to clarify unique needs and effective strategies; 2. Engaging socially vulnerable populations to elicit ethical values and perspectives on rationing; 3. Rejecting rationing based on race, socioeconomic class, citizenship, quality of life, length of life-extension and first-come, first-served; 4. Prioritizing those in the general population for access to resources based on combinations of risk (of death or severe complications from influenza, exposure to influenza, transmitting influenza to vulnerable groups) and the likelihood of responding well to the resource in question. 5. Protecting critical infrastructures on which vulnerable populations and the general public rely; 6. Identifying and removing access barriers during pandemic planning and response; and 7. Collecting and promptly analyzing data during the pandemic to identify groups at disproportionate risk of influenza-related mortality and serious morbidity and to optimize the distribution of resources.