This new Rapid Expert Consultation document from the National Academies of Sciences, Engineering & Medicine focuses on health care staffing for COVID-19 and provides guidance for decision-making in situations where staffing is not optimal and additional qualified, expert personnel cannot be obtained to meet clinical demand. The guidance adopts the overarching goals of crisis standards of care (CSC), which requires a shift in thinking from what is best for an individual patient to what is best for a group of patients or entire community in circumstances where resources are scarce. The guidance recommends two broad categories in crisis response.
Community-wide strategies attempt to reduce surge in demand for care and providers by, among other options:
- Reducing disease burden through non-pharmaceutical interventions (e.g., mandatory mask use, physical distancing, public gathering limitations)
- Transferring patients to facilities with lower census
- Curtailing delivery of elective services
- Ensuring support efforts are in place for social and psychological needs of existing staff.
When the above are no longer sufficient, health care-system-specific strategies can be added, including:
- Mobilizing staff from non-hospital entities to assist in hospital-based services
- Recruiting non-practicing clinical providers to assist licensed practitioners (including adjusting scope of practice considerations)
- Adjusting provider to patient ratios
- Changing inpatient care delivery models to a team-based approach
- Deploying telemedicine and other digital solutions.
This new guidance builds on existing consultation documents from March 2020 regarding CSC (summarized in an earlier post) and other CSC reports from the National Academies.
Supplies – Drugs
This NY Times op-ed by Kapczynski, Biddinger, and Walensky addresses distribution of remdesivir, currently the only drug with demonstrated effectiveness as a COVID-19 treatment in clinical trials. Lack of supply is likely to increase shortages, as production is limited to a small number of companies licensed by patent-holder Gilead. The authors suggest circumventing these limitations through government patent use, allowing the U.S. Department of Health and Human Services (or others as authorized by DHHS) to offer to buy remdesivir from any company that can supply it and then pay Gilead a royalty. This process has been used in the past during wartime to prevent price gouging and shortages.
This article by Fox, Stolbach & Mazer-Amirshahi and accompanying position statement from the American College of Medical Toxicology (ACMT) address shortages of prescription medications during the COVID-19 pandemic. According to the authors, medication shortages typically result from manufacturing or supply chain issues, but the pandemic has resulted in a different type of shortage caused by demand resulting from a sudden spike in patients requiring intensive care, especially generic parenteral sedatives and analgesics. The authors detail potential complications that may arise from substituting other drugs, strengths, or formulations and altering associated protocols and emphasize the importance of communication. The ACMT position statement discusses shortages due to concentration of medication manufacturing in affected countries, particularly China and India, and makes recommendations related to transparency, risk management, communication, allocation, and other issues for governments, manufacturers and distributors, hospitals and health care systems, and health care providers.
Supplies – Testing & PPE
This article by Cox & Koepsell explores the feasibility of using 3D printing to produce testing supplies in response to ongoing shortages. The authors used filament-based printing to produce 5500 testing swabs at a cost comparable to available commercial options.
This article by Imbrie-Moore et al. similarly discusses using 3D printing to enhance supply of N95 respirators. The authors developed a 3D-printable reusable silicone mask adaptor that can be outfitted with a one-quarter section of an N95 mask attached using a cartridge with an adhesive seal. This allows extension of existing N95 stock while maintaining existing filter standards.
This article by Kramer, Lo & Dickert discusses the ethical challenges surrounding CPR in the context of severe resource shortages that may arise during the pandemic. The authors make three specific recommendations: 1) acknowledging resource constraints when discussing goals of care and DNR status; 2) forgoing CPR in some circumstances, such as when follow-up resources (e.g., ICU beds) are not available, when the patient’s condition is deteriorating significantly despite providing critical care, or when staffing shortages are so severe that a typical code team would divert resources and jeopardize outcomes for other patients; and 3) ensuring safety of personnel justifies constraints on resuscitation.
Special Issue of American Journal of Bioethics
The latest issue of the American Journal of Bioethics is devoted to COVID-19. The issue has a variety of noteworthy articles, editorials, and commentaries relevant to resource allocation, crisis standards of care, health care worker safety, and other issues, including the following (among others):
- Fink, “Ethical Dilemmas in COVID-19 Medical Care: Is a Problematic Triage Protocol Better or Worse than No Protocol at All?” (discussing origins of crisis triage protocols and remaining blind spots in these approaches)
- McCullough, “In Response to COVID-19 Pandemic Physicians Already Know What to Do” (arguing that critical care management approaches are sufficient to address conditions of scarcity using the standard criteria of medical reasonableness)
- Goold, “The COVID-19 Pandemic: Critical Care Allocated in Extremis” (critiquing McCullough’s approach and arguing that conditions of widespread scarcity and exhaustion of resources require consideration existing inequities and avoiding a first-come, first-served approach)
- Janvier & Lantos, “Medically Vulnerable Clinicians and Unnecessary Risk During the COVID-19 Pandemic” (arguing that clinicians with higher risk factors should not serve in front line capacities during pandemic, even if they want to, unless there are no others available)
Peer commentaries (among many):
- Wynia & Sottile, “Ethical Triage Demands a Better Triage Survivability Score” (limitations of SOFA scores for triage and resource allocation)
- Crutchfield et al, “Ethical Allocation of Remdesivir” (allocation based on communities bearing disproportionate burden)
- Wicclair, “Allocating Ventilators During the VOCID-19 Pandemic and Conscientious Objection” (considering objections from bedside clinicians)
- Spector-Bagdady et al., “Flattening the Rationing Curve: The Need for Explicit Guidelines for Implicit Rationing during the COVID-19 Pandemic” (distinguishing medical futility vs. rationing and implicit vs. explicit rationing)
- Annas “Rationing Crisis: Bogus Standards of Care Unmasked by COVID-19” (arguing against the basis of crisis standards of care as part of a longstanding critique)
- Aulisio & May, “Why Healthcare Workers Ought to Be Prioritized in ASMR During the SARS-CoV-2 Pandemic” (arguing for allocation priority with reference to specific characteristics of the COVID-19 pandemic)
Final published versions of articles discussed in prior posts:
- McGuire et al., “Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force” (resource allocation, ethically appropriate criteria, consent, pediatric patients, community engagement, and consideration of discrimination and structural inequities)
- Auriemma et al., “Eliminating Categorical Exclusion Criteria in Crisis Standards of Care Frameworks” (avoiding categorical exclusions in CSC protocols to mitigate potential discrimination against persons with disabilities)
- Haward et al., “Should Extremely Premature Babies Get Ventilators During the COVID-19 Crisis? (consideration of specific patient populations and avoidance of biases against persons with disabilities and extremely premature babies)
- Dudzinski et al., “Ethics Lessons From Seattle’s Early Experience With COVID-19” (issues confronted in an early virus hot spot)