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«Prepared by the Ventilator Document Workgroup, Ethics Subcommittee of the Advisory Committee to the Director, Centers for Disease Control and ...»

-- [ Page 1 ] --

Ethical Considerations for Decision

Making Regarding Allocation of

Mechanical Ventilators during a Severe

Influenza Pandemic or Other Public

Health Emergency

Prepared by the Ventilator Document Workgroup,

Ethics Subcommittee of the Advisory Committee to the Director,

Centers for Disease Control and Prevention

July 1, 2011

Disclaimer: This document represents the recommendations of the Advisory Committee to the Director,

Centers for Disease Control and Prevention and does not necessarily represent Centers for Disease Control and Prevention views or policy. The document was approved by the Ethics Subcommittee on February 18, 20111 and by the Advisory Committee to the Director on April 28, 2011.

1 Members of the Ethics Subcommittee at the time that the document was approved include Ronald Bayer, PhD, Columbia University; Ruth Gaare Bernheim, JD, MPH, University of Virginia; LaVera Marguerite Crawley, MD, MPH, Stanford University; Norman Daniels, PhD, Harvard University; Kenneth Goodman, PhD, University of Miami; Nancy Kass, ScD, Johns Hopkins University; Bernard Lo, MD, University of California, San Francisco;

Sara Rosenbaum, JD, George Washington University Medical Center and Advisory Committee to the Director Representative; Jennifer Prah Ruger, PhD, MSc, Yale University; Pamela Sankar, PhD, University of Pennsylvania;

Marion Cassady Wheeler, Strategic Consultant and Advisory Committee to the Director Representative; and Leslie Wolf, Georgia State University 1 Ethical Considerations for Decision Making Regarding Allocation of Mechanical Ventilators during a Severe Influenza Pandemic or Other Public Health Emergency Table of Contents Table of Contents

PREAMBLE

INTRODUCTION

KEY ASSUMPTIONS

ROUTINE VERSUS EMERGENCY PRACTICE

PRIORITIES FOR VENTILATOR ALLOCATION

WHAT PRINICPLES SHOULD GUIDE VENTILATOR ALLOCATION?

Basic Biomedical Ethical Principles

Respect for Persons and their Autonomy

Beneficence

Justice

Specific Ethical Considerations

Maximizing Net Benefits

Social Worth

The Life Cycle Principle

Fair Chances versus Maximization of Best Outcomes

Incorporating Multiple Principles

WHO SHOULD MAKE VENTILATOR ALLOCATION DECISIONS?

OTHER CONSIDERATIONS

Uniform Decision Criteria versus Local Flexibility

Community Engagement

Obligations to Healthcare Professionals

Provision of Palliative Care

Withdrawal of Patients from Ventilators

Special Considerations Relating to Children

CONCLUSIONS

REFERENCES

VENTILATOR DOCUMENT WORKGROUP MEMBERS

2 PREAMBLE This document provides ethical considerations that the Ethics Subcommittee of the Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC) proposes to aid in the decision making specific to allocation of mechanical ventilators during a severe influenza pandemic. This document supplements a previous document written by the Ethics Subcommittee, Ethical Guidelines in Pandemic Influenza, and released by CDC in 2007 (1).

The 2007 document was developed in response to a request from HHS/CDC that the Ethics Subcommittee address ethical considerations in vaccine and antiviral drug distribution prioritization and in the development of interventions that create social distancing (in discourse on pandemic influenza, often referred to as non-pharmaceutical or community mitigation interventions). After release of the initial ethics document, numerous public health stakeholders requested that HHS/CDC specifically address ethical issues for allocation of mechanical ventilators. This current document is not intended to comprehensively revisit all of the topics and issues promulgated in the 2007 document; instead, it is intended to supplement the initial document. Circumstances and major issues specific to allocation of mechanical ventilators as well as issues which require alternative ethical considerations from that proposed in the original document form the basis for this supplemental document.

The intent of this document is to provide decision makers at all levels–federal, tribal, territorial, state, and local–with an overview of the complex ethical landscape associated with decision making about allocation of scarce life-sustaining healthcare resources. This document is not meant to serve as detailed guidance about allocation decisions. Rather it is intended to serve as a conceptual framework to assist the planning process. Planning will need to occur at the state, local, and institutional level to develop specific operational details and implementation steps.

Thus, this document will not address how to approach specific allocation decisions, but will instead highlight ethical standards and principles relevant to allocation of ventilators during a severe pandemic or other public health emergency and discusses some of the advantages and disadvantages inherent in different approaches to allocation. Some of the approaches are sufficiently and obviously problematic that we suggest that they not be used to guide decisions.

Other approaches have positive and negative aspects that must be considered. In the interest of encouraging broader public deliberation about ethically contested matters, we refrain from making specific recommendations and instead highlight these issues and controversies.





Although this document does not provide simple, direct recommendations, our intent is for the document to promote and enhance use of a fair and equitable process for making policy choices.

We believe it is important that state and local health departments and federal agencies work with hospitals and each other to implement fair, consistent, and coordinated triage processes for ventilator distribution using the ethical considerations discussed in this document as a framework for decision making. Development of triage plans will require input from a variety of stakeholders, including public health, medical and other health care professionals, ethics and legal experts, and representatives of patients and the public who will be impacted by the plans.

An important first step is to engage the stakeholders in a discussion about how to weigh the various ethical principles, values, and approaches reviewed in this document. In addition to preparing for how to fairly distribute limited resources, health officials should be taking appropriate steps to maximize health systems’ capabilities to safely deliver appropriate

–  –  –

INTRODUCTION

Difficult decisions are made on a regular basis in both the practice of public health and clinical medicine; however, the process for decision making, including the framework and reasoning that support ethical choices, may not always be clearly articulated. This document addresses conditions during an influenza pandemic that causes severe illness in sufficient numbers of people to overwhelm routine clinical services. The term pandemic refers largely to a geographic development: an epidemic that has spread beyond its original region to several countries or continents and that effects a large portion of the population because few people have pre-existing immunity to the causative pathogen. Pandemics are always potentially serious public health events. However, in order to call for the kind of emergency policies discussed in this document, they have to cause severe illness in large numbers and thereby create demands significantly exceeding the system’s capacity for treating patients despite attempts to increase surge capacity.

Depending on the capacity and flexibility of the healthcare system, a pandemic’s impact may vary from one region or country to another and the point at which a pandemic will become severe and overwhelm resources may vary by disease and by different communities or regions experiencing the same disease.

The timeliness of this discussion of ethical issues in pandemic influenza was highlighted by the emergence of 2009 pandemic influenza A (H1N1). This virus was officially declared by the World Health Organization as the cause of a pandemic in June 2009. The profound level of respiratory failure experienced by those who developed 2009 H1N1 associated critical illness, especially in older children and young adults, raised much concern that shortages of mechanical ventilators or alternative therapies for very severe critical illness could occur during the fall and winter 2009-2010. While hospitals were challenged by the resource intensity of care these patients required, fortunately the overall proportion of people who developed severe illness was no greater than in recent years with seasonal influenza epidemics, and in the United States there were sufficient mechanical ventilators to meet the response need.2 Although the 2009 H1N1 influenza pandemic did not produce a situation that would have required the use of this document, its emergence should serve as a reminder of the importance of being prepared for a situation if the demands for treating patients significantly exceed our health system’s capacity.

KEY ASSUMPTIONS

This document is based on a number of assumptions regarding severity of illness and the availability of resources. It is intended only for circumstances when people with severe acute respiratory failure far outnumber available and adequate mechanical ventilator supply. For most U.S. communities, such extreme imbalances are only anticipated in special circumstances (e.g., 2 Information on cases of pandemic (H1N1) 2009 influenza is posted at http://www.cdc.gov/h1n1flu/.

4 an influenza pandemic that is both widespread and severe). Federal, tribal, territorial, state, local, and private entities have undertaken extensive preparedness activities and supported rapid advancement of vaccine and antiviral treatments to reduce the potential burden of a severe influenza pandemic on communities. Advances have also been made in increasing the supply of ventilators. Currently the National Ventilator Inventory undertaken by the Office of the Assistant Secretary for Preparedness and Response together with the American Association for Respiratory Care has revealed that there are approximately 62,000 full-feature mechanical ventilators in the United States (2). Almost half (46%) of these full-feature devices were capable for use with pediatric and neonatal patients. In addition, there are approximately an additional 100,000 devices across a range of categories of respiratory equipment (not including anesthesia machines) at U.S. acute care hospitals which might be used for surge capacity. Almost half of the 100,000 additional devices have enough features to be useful for anticipated surge capacity events. Furthermore, some states and other groups have purchased additional ventilators, not included in the above counts of devices, for surge demand. There has also been significant federal investment to procure and stockpile additional ventilator assets. Despite these crucial activities, it is possible that in the event of a particularly virulent pandemic influenza virus, many hospitals and other healthcare facilities will not have adequate numbers of ventilators to support a major disaster response.

During a severe influenza pandemic, many patients with respiratory failure who are able to receive mechanical ventilation (and all associated supportive critical care components) may survive, while patients with respiratory failure who do not receive mechanical ventilation are likely to die. Thus, a major underlying assumption for this document is that advanced critical care will save lives during a severe influenza pandemic. This assumption is based on everyday experience with acute respiratory distress syndrome (ARDS), recent experience with 2009 pandemic influenza A (H1N1), and past experience with avian H5N1 influenza virus and severe acute respiratory syndrome (SARS). For 2009 pandemic influenza A (H1N1), 60-95% of critically ill patients required mechanical ventilation, and the mortality in these patients was lower than 40% and less than 20% in some countries. The level of respiratory failure in many of these patients was very severe, yet numerous patients who clearly would have died without mechanical ventilation and resource-intensive critical care survived (3-6). Although the majority of patients infected with H5N1 influenza who received mechanical ventilation have not survived (7), many persons infected with SARS who received mechanical ventilation during the 2003 outbreak did survive (8). Moreover, 40-70% of patients with acute respiratory failure (including acute lung injuries and ARDS which is predominant in current H1N1 and H5N1 cases) survive in intensive care units in U.S. hospitals under non-pandemic circumstances (9).

Another of the assumptions of this document is that cases of pandemic influenza infection will occur in waves and most likely a well-matched vaccine will not be available until the second wave. This was the experience with 2009 pandemic influenza A (H1N1). A pandemic wave is defined as a series of community outbreaks that occur nearly simultaneously across the country.

Pandemic waves typically occur in the spring, fall, or winter and more than one wave is likely;

however waves may occur during any season. In 1918-1919, for example, there were three pandemic waves, and in 1957 and 1968 there were two waves. Periods between waves (typically measured in months) are characterized by very little disease and can be a time of recovery and preparedness for a subsequent wave. For example, following the initial wave of 2009 pandemic 5 influenza A (H1N1) in North America, public health authorities prepared guidance for patients, clinicians, and other groups, and monitored first-wave influenza activity in the Southern Hemisphere.3 During a severe influenza pandemic it is anticipated that resources will be overwhelmed in the first or second wave of illness because the entire community will be at risk for illness.

Equipment for emergency respiratory care, including ventilators, may be in full use and no longer available to additional patients by the first or second wave of a severe influenza pandemic, depending on the geographical spread and timing of the waves, the symptoms of the disease, the availability of pandemic vaccine, and the local effectiveness of community mitigation strategies. This document assumes that ventilators may be in short supply in some communities as early as prior to or during the peak of the first wave of a severe influenza pandemic.



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