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	James L. Holly, M.D.

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Your Life Your Health - Pandemic II: Medical Ethics and Planning for a Pandemic which overwhelms the health-care delivery system

James L. Holly,M.D.

May 22, 2008

Your Life Your Health - The Examiner

Because the popular press is already making judgments about plans for the care of large populations during a pandemic, judgments which characterize the plans as "deciding who will live and who will die," and as "the old and sick are out of luck," the development of a pandemic-response plan requires a clear understanding of medical ethics. Those charged with responsibility for medical-decision making must have a clear commitment to the value of human life, a respect for every individual and an unbiased view, founded upon principle of how to bring the most good, to a bad situation.

Having read numerous reports, suggestions and proposals for how to deal with a pandemic, I am deeply impressed with the knowledge, experience, compassion, clarity of though and ethical consistency of those who are thinking about these almost unthinkable potentialities. And, I believe that as "the public" is exposed to more of their "thinking," the more "the public" will be confident that the interests and rights of everyone are being considered and protected in these deliberations. The guiding principles in this entire process are the principles of medical ethics.

Do You Have My Best Interest at Heart?

In a context different from a pandemic, a minister was speaking to a group of young people. He said, "What you really want to know is, 'do I understand your problems,' and 'do I have your best interest at heart?'" Similarly, if you reduce medical ethics to its essence, the question is does the healthcare provider understand your problem and is his/her first and primary interest, what is best for you?

There are more elegant statements of this simple equation; one is addressed in the first installment of a series of articles on bioethics in the clinical setting in the journal, Chest. Published by the John Hopkins University School of Medicine, the article is entitled, The Inescapable relevance of Bioethics for the Practicing Clinician. (Chest, 2006)

The article addresses "principlism" which involves four key principles:

"Respect for autonomy" essentially means that the patient is ultimately in charge of their own life and their own health. With some limitations, patients should have an active role, if not the controlling voice, in what happens to them. This is the foundation of my personal counseling of patients in crisis when I tell them, "Here is where you are; here is what I would recommend; the decision is yours and you must tell me what you want done." Very often, at critical moments in patient-decision making, there are choices but there are no right and wrong distinctions. There are just choices. Because medical recommendations are not absolute in their validity or outcomes, the patient must retain the responsibility for the choices which are made.
"Beneficence" means that what is done for the patient will help them and/or be good for them. And, the idea of "good" must be defined by the patient. What may "appear as good" from a medical science perspective may not "be good" from the patient's perspective for a number of potential reasons.
"Non-malfeasance" means that the clinician will do no harm to the patient. When a therapy or treatment has the potential for doing harm, the patient must know the risk and accept or reject that risk for himself or for herself. The clinician must never intentional harm the patient, particularly in end-of-life decisions.
"Principle of justice" means being fair and equitable in how every patient is treated. It addresses how patients without insurance or money are treated, and how scare resources are distributed.

These four principles and permutations of each form the foundation for decision making in cases where choices have to be made about who to treat with one modality and who to treat with another, when where there is a distinctive benefit of one over the other.

Values which guide ethical medical decision-making

Applying these principles to a pandemic requires a great deal of effort. Sometimes, during a major crisis in the case of healthcare decisions, there are no right, or wrong answers; there are only choices. One approach to the medical ethics upon which those choices must be made was published by The University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group. Entitled, Stand on Guard for Thee: Ethical Considerations in preparedness planning for pandemic influenza, the center addressed ten substantive values which must guide ethical decision-making during a pandemic.

It will easily be seen how each of these ten falls into one of the categories of "principlism" discussed above. They are:

"Individual liberty -- In a public health crisis, restrictions to individual liberty may be necessary to protect the public from serious harm. Restrictions to individual liberty should: be proportional, necessary, and relevant; employ the least restrictive means; and be applied equitably.
"Protection of the public from harm -- To protect the public from harm, health care organizations and public health authorities may be required to take actions that impinge on individual liberty. Decision makers should: weigh the imperative for compliance; provide reasons for public health measures to encourage compliance; and establish mechanisms to review decisions.
"Proportionality -- This requires that restrictions to individual liberty and measures taken to protect the public from harm should not exceed what is necessary to address the actual level of risk to or critical needs of the community.
"Privacy -- Individuals have a right to privacy in health care. In a public health crisis, it may be necessary to override this right to protect the public from serious harm.
"Duty to provide care -- Inherent to all codes of ethics for health care professionals is the duty to provide care and to responds to suffering. Health care providers will have to weigh demands of their professional roles against other competing obligations to their own health, and to family and friends. Moreover, health care workers will face significant challenges related to resource allocation, scope of practice, professional liability, and workplace conditions.
"Reciprocity -- Reciprocity requires that society support those who face a disproportionate burden in protecting the public good, and take steps to minimize burdens as much as possible. Measures to protect the public good are likely to impose a disproportionate burden on health care workers, patients, and their families.
"Equity -- All patients have an equal claim to receive the health care they need under normal conditions. During a pandemic, difficult decisions will need to be made about which health services to maintain and which to defer. Depending on the severity of the health crisis, this could curtail not only elective surgeries, but could also limit the provision of emergency or necessary services.
"Trust -- Trust is an essential component of the relationships among clinicians and patients, staff and their organizations, the public and health care providers or organizations, and among organizations within a health system. Decision makers will be confronted with the challenge of maintaining stakeholder trust while simultaneously implementing various control measures during an evolving health crisis. Trust is enhanced by upholding such process values as transparency.
"Solidarity -- As the world learned from SARS, a pandemic influenza outbreak will require a new vision of global solidarity and a vision of solidarity among nations. A pandemic can challenge conventional ideas of national sovereignty, security or territoriality. It also requires solidarity within and among health care institutions. It calls for collaborative approaches that set aside traditional values of self-interest or territoriality among health care professionals, services, or institutions.
"Stewardship -- Those entrusted with governance roles should be guided by the notion of stewardship. Inherent in stewardship are the notions of trust, ethical behavior, and good decision-making. This implies that decisions regarding resources are intended to achieve the best patient health and public health outcomes given the unique circumstances of the influenza crisis."

With this foundation, we can considered the recommendations made by The Task Force for Mass Critical Care Summit Meeting (January 26-27, 2007, Chicago, whose findings were published in Chest, May, 2008 and widely publicized and often inaccurately characterized as telling people who is "out of luck" or who "is to live and die."

Suggestions Not Demands Made by the Task Force

The article entitled, Definitive Care for the Critically Ill During a Disaster: A Framework for Allocation of Scarce Resources in Mass Critical Care, made the following "suggestions":

"Suggestion 4.1: All hospitals must operate uniformly and cooperate in order to successfully implement a triage process when resources are scarce and/or unavailable.
"Suggestion 4.2: All attempts should be made by the health-care facility to acquire scarce critical resources or infrastructure, or to transfer patients to other health-care facilities that have the appropriate ability to provide care (state, national, and even international). Critical care will be rationed only after all efforts at augmentation have been exceeded. The Task Force assumes that EMCC has become exhausted and a Tier 6+ level has been attained or exceeded.
"Suggestion 4.3: The Task Force offers a uniform approach to triaging patients during allocation of scarce resources based on objective and quantitative criteria with the following underlying principles as a foundation for this process:
1. critical care will be rationed only after all efforts at augmentation have been exceeded;
2. limitations on critical care will be proportional to the actual shortfall in resources;
3. rationing of critical care will occur uniformly, be transparent, and abide by objective medical criteria;
4. rationing should apply equally to withholding and withdrawing life-sustaining treatments based on the principle that withholding and withdrawing care are ethically equivalent; and
5. patients not eligible for critical care will continue to receive supportive medical or palliative care.
"Suggestion 4.4: The Task Force suggests that a triage officer and support team implement and coordinate the distribution of scarce resources.
"Suggestion 4.5: The Task Force suggests a systematic, retrospective review of the decisions of the triage team by a review committee.
"Suggestion 4.6: Palliative care (care which supports the comfort of a patient who is not expected to live) is a required component of mass critical care.
"Suggestion 4.7: The Task Force believes a strong commitment to the following ethical considerations is necessary in implementation of the triage process and allocation of scarce resources.
1. "Limitation of Individual Autonomy -- The fair and just rationing of scarce resources requires public health decisions based on objective factors, rather than on the choice of individual leaders, providers, or patients. All individuals should receive the highest level of care given the resources available at the time. (emphasis added)
2. "Transparency -- Governments and institutions have an ethical obligation to plan allocation through a process that is transparent, open, and publicly debated. Governmental honesty about the need to ration medical care justifies institutional and professional actions of withholding and withdrawing support from individual patients. These restrictive policies must be understood and supported by medical providers and the public, ideally with reassurances that institutions and providers will be acting in good faith and legally protected in their efforts.
3. "Justice/Fairness -- The proposed triage process relies on the principle of maximization of benefit to the population served. The triage process treats patients equally based on objective, physiologic criteria, and when these criteria do not clearly favor a particular patient, 'first come, first serve' rules will apply. The triage process addresses only those in the acute hospital setting in need of the scarce resource and will not apply to individuals with long-term reliance on the scarce resource (ie, long-term mechanical ventilation) in a long-term care facility prior to the mass casualty event. Communities and states may have different approaches to these patients. These individuals will be subject to the triage process should they need acute hospitalization, and resources will be allocated according to predefined criteria.
4. "In order to ensure 'procedural justice,' a standardized and equitable practice that conforms to the rules in place, any triage operation should be regularly and repeatedly evaluated to guarantee that the process has been followed fairly. This evaluation process will promote medical provider compliance; eliminate administrator, governmental, or physician overrule (special pleadings or 'favors'); and facilitate consistency. Owing to the critical illness of patients and the limitations of the scarce resource(s), this evaluation process will need to be efficient and frequent. Direct appeals to the triage procedure may be impractical based on the urgency with which the allocation decision must be made. Individual physicians, administrators, or government officials should not be able to overrule a 'good faith' decision made by a triage officer in compliance with the triage process. Because all patients will share the same pool of resources, the standard of care and triage process should apply to all patients, whether their condition is directly attributable to the mass casualty event or results from other underlying pathology or circumstances. If there is a challenge to procedural justice (ie, the process was not followed according to established criteria), then an appeal is indicated.
"Suggestion 4.8: Providers should be legally protected for providing care during allocation of scarce resources in mass critical care when following accepted protocols."

It is not possible for anyone to read these eight suggestions and not hear in them the humility, compassion, excellence, knowledge and caring of the work group which wrote them. It is not possible to read them without being pleased that such people are thinking about a pandemic and helping us devise a response to it.

It is incumbent upon every citizen, leader, politician, physicians, healthcare provider or administer to read these suggestions and to begin thinking about how we would respond to a pandemic in Southeast Texas.

Other Articles in the Pandemic Series

	Pandemic Part I: Exclusion Criteria for Critical Care during a Pandemic Pandemic Part III: What can and what should I do? Pandemic IV: World Health Organization (WHO) Recommendations Pandemic V: Air Quality in Your Home - HEPA Filters

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