Sunday, February 10, 2008

Review of Online Book - Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary

Today I am presenting sections from the online book:

Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary
Stanley M. Lemon, Margaret A. Hamburg, P. Frederick Sparling, Eileen R. Choffnes, and Alison Mack, 2007

I will concentrate primarily on the issues that affect ventilator shortages. This is only a small part of the book. The pdf file runs 250 pages.


This book is available complete for free as a pdf file at:
http://www.nap.edu/catalog/11917.html

Available from The National Academies Press at http://www.nap.edu

This book presents a fairly complete and balanced view of the ethical issues to date regarding pandemics.

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The book begins with a quote from Goethe:
“Knowing is not enough, we must apply;
Willing is not enough, we must do.”

The following excerpts are from the workshop discussion:

Addressing Shortages: Medical Care
While it is widely acknowledged that an infectious disease pandemic is likely to overwhelm the U.S. medical system, the federal government has given scant attention - and even less money - to redressing this situation. “There is a great gaping gap here,” said speaker D.A. Henderson, who criticized government planners for focusing on what he believed to be “fringe things,” such as stockpiling and delivering countermeasures of questionable efficacy, rather than concentrating its efforts on “a problem which we know we are going to have.” He attributed the lack of progress toward addressing this critical and predictable need to poor communication between public health officials and hospital administrators, as well as between HHS and CDC.

Although individual hospitals are attempting to prepare themselves for pandemic influenza by conducting surge capacity trials, Henderson observed that few facilities are prepared to handle a worst-case scenario in which patients could exceed capacity by 30 to 40 percent. He predicted that under those conditions hospitals would begin to turn away patients, including some who desperately need care. In order to accommodate them, Henderson recommended the creation of alternate regional sites staffed by volunteer caregivers. He also noted that plans for medical care during a pandemic need to address such issues as liability, the credentialing of volunteers, nonpaying patients or patients without adequate health insurance, the cancellation of elective surgical procedures, and pandemic associated losses in hospital revenue.

Workshop participants considered a variety of gaps that exist in pandemic preparations at the hospital level. According to one estimate, if an influenza pandemic occurred today, demand for ventilators would exceed supply by nearly 200 percent (Bartlett, 2006)

Addressing Shortages: Global Supply Chains
Another far-reaching concern regarding the U.S. pandemic influenza strategy is its failure to recognize America’s dependence on and interdependence with fast-moving global markets. Forum member Michael Osterholm observed, for example, that the vast majority of medicines in the U.S. are manufactured abroad or made from precursor materials that are manufactured abroad. Furthermore, critical supplies such as oxygen are delivered just in time to hospitals and other end-users and are therefore dependent upon fuel, which is also largely foreign in origin.

Duty to Care
Health-care workers on the front lines in infectious disease outbreaks (e.g., smallpox, Ebola, and SARS) have consistently fulfilled their duty to care for patients even when it has cost them their lives (see Heymann, page 33). Ruderman and colleagues report, however, that during the SARS crisis in Canada, “serious concerns arose . . . about the extent to which health-care providers would tolerate risk of infection,” leading to the anticipation of a potential crisis during a pandemic (Ruderman et al., 2006).


Ethical Guidelines for Clinicians
An influenza pandemic is likely to produce extraordinary shortages in medical care. Hospital resources—both human and material—may be stretched beyond their limits. In order to manage the many ethical dilemmas inherent in this situation, physicians and hospital administrators will need specific guidelines,
Lo said (see Lo and White, page 192). His observations were echoed by several workshop participants, some of whom spoke from a personal perspective, as they themselves will be called to play certain roles in a pandemic. Among the challenges that pandemic influenza will present to clinicians, one of the likeliest and most daunting will be a grave shortage of mechanical ventilators. Such a shortage, Lo observed, will require physicians to choose which patients will receive the life-saving use of a ventilator and which will die without respiratory therapy. There will be no time to weigh alternatives in a pandemic, Lo argued, so it will be important to develop clear criteria ahead of time for when to triage patients, along with guidelines and procedures for addressing problems that will arise as the triage system is implemented, such as handling disagreements with family members and managing patients in respiratory failure who do not receive mechanical ventilation.

Lo urged pandemic planners to anticipate the ethical and legal dilemmas that doctors and other health-care providers will face in a “worst-case” ventilator shortage and to create, with input from the public and specialists in various disciplines, guidelines and procedures for dealing with shortages of ventilators another medical supplies. While suggesting that rules for triage should maximize the number of lives saved, Lo also pointed out that physicians must rely on limited evidence to predict a patient’s prognosis. Triage rules, he said, should be administered by an external authority, not the physicians dealing with the patients, and they should be implemented by physicians and other health-care workers in such a way that their fairness cannot be doubted. Fairness in allocating scare resources will be necessary to secure public trust in the process, Lo observed, but it will not be sufficient. Triage policies and priorities must also reflect popular will, he said. Moreover, the policies must be communicated clearly and in a way that people will understand. And they must be presented in a way that leads society to accept the idea that, during an infectious disease emergency, some patients will die who might otherwise have been saved under normal circumstances. Lo also stressed the importance of providing the public with ready access to the data, reasoning, and deliberative processes that support such triage guidelines. Unfortunately, Hearne observed, some states have not only failed to engage the public in pandemic planning, but they have actively excluded them from the process and have kept their plans secret, even from hospital workers and other health-care providers.

Civic Engagement
Since the nation’s experience with the aftermath of Hurricane Katrina, many Americans have come to be extremely cynical about government efforts meant to protect them from disaster, Hearne observed. As a result, she said, broad changes in public health law will be needed to prevent a potentially disastrous breakdown in public health authority during a pandemic.

Ethics in the Midst of Uncertainty
While recognizing the ideal of public participation in pandemic planning, workshop participants nonetheless agreed that public health professionals must expect most people to be entirely unprepared when the next pandemic strikes.

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The following excerpts dealing with ventilators are from the included paper:

INTENSIVE CARE UNIT TRIAGE DURING AN INFLUENZA
PANDEMIC: THE NEED FOR SPECIFIC CLINICAL GUIDELINES
Bernard Lo, M.D.
University of California, San Francisco
Douglas B. White, M.D.
University of California, San Francisco

During a severe influenza pandemic, a dire shortage of breathing machines— mechanical ventilators—is projected. According to one estimate, a pandemic will require 198 percent of the current supply of ventilators (Bartlett, 2006). If this happens, many people in respiratory failure who need mechanical ventilation in order to survive will not receive it. This grave shortage of ventilators will raise unprecedented allocation dilemmas that ought to be addressed before a pandemic strikes.

Ventilators should be considered a scarce resource to be allocated according to public health guidelines rather than by the decisions of individual physicians and patients.

Guidelines for allocating scarce medical resources during a pandemic will require several levels of specificity. At the broadest level, state public health laws express a general societal agreement that during a public health emergency the decisions of individual physicians and patients will be constrained by public health policies (Gostin, 2000). At the next level of specificity—the level of clinical care decisions—hospitals and physicians need criteria for triaging various patients who need mechanical ventilators when the demand greatly exceeds supply during a pandemic. To minimize overall loss of life during a pandemic, priority should be given to patients who require mechanical ventilation but who are highly likely to survive after only a few days on the ventilator. Finally, at the most specific level, frontline physicians need guidance in implementing these triage priorities in specific clinical cases.

Ventilator Shortages During a Pandemic
Suppose for the sake of a dramatic example that an ICU in the midst of a pandemic has only one available bed and ventilator. In the emergency department are several patients in respiratory failure, all of whom will die without mechanical ventilation. It is not feasible, given staff shortages, to keep these patients alive by manually squeezing a bag to drive air into the lungs. One patient is a 30-year-old whose only medical problem is respiratory failure, presumably from influenza. Another patient has not only respiratory failure from influenza but also hypotension and renal failure. The presence of these additional problems means that the second patient has a worse prognosis than the first (Graf and Janssens, 2005). Additionally, there are two other patients in the emergency department with respiratory failure who also will die without mechanical ventilation. One is a 22-year-old with an acute asthma attack who has no clinical evidence of influenza. Another is a 58-year-old who requires emergency coronary bypass surgery for continued myocardial ischemia despite optimal medical management.

These latter two patients are expected to survive if they receive just a few days of mechanical ventilation. Thus the shortage of ventilators will affect not only patients with influenza but also those who have respiratory failure from other causes.

Ethical Guidelines for Triage of Mechanical Ventilators During a Pandemic
A scarcity of ventilators during a pandemic will require an allocation policy based on different ethical guidelines than those governing usual clinical care. The term triage is commonly applied to the process of sorting, classifying, and assigning priority to patients when available medical resources are not sufficient to provide care to all who need it

The first ethical guideline for ventilator use during a pandemic is that increasing the number of lives saved may take priority over patient autonomy. Public health officials, working in concert with clinical experts and public representatives, should set guidelines for prioritizing patients who need mechanical ventilation.
Individual physicians and patients must then make decisions that are consistent with these guidelines.

The second guideline is that patients with a high likelihood of surviving after a few days of mechanical ventilation should receive the highest priority. Characterizing this group will be difficult, however, because data are incomplete and uncertain.

The third guideline is that during a public health emergency fairness and perceptions of fairness are crucial.

The fourth guideline is that transparency is essential during a public health emergency. The public needs to know how ventilators will be allocated in order to trust that the allocation is fair. Triage priorities and policies should be explicit. The public should have ready access to the triage guidelines, the data and the reasoning underlying them, and the process by which they were derived.

Applying Triage Principles to Specific Cases
Even if there is wide agreement on the triage principle of minimizing loss of life during a pandemic, hospitals and health-care workers will still face many difficult decisions when making triage decisions in specific cases. Before a pandemic occurs, it will be important to identify these dilemmas, analyze them, and reach some agreement on how to resolve them.

During Triage, Should Patients Already on Ventilators Be Reassessed?
We have framed the problem of allocating ventilators as “the last bed in the ICU.” In reality, the situation is more complex because patients already in the ICU on ventilators may have a worse prognosis than new patients with respiratory failure. Suppose, for example, that one of the ICU patients is a 38-year-old man with influenza who has developed multi-organ failure and whose condition has worsened during five days of intensive care. His prognosis now is worse than that of a new patient who presents with respiratory failure as her only medical problem, with no other organ failure. Or suppose that there is also a 68-year-old patient with chronic emphysema and respiratory failure who is gradually improving but who is likely to require several weeks of ventilator support as his lungs slowly improve. Keeping such current ICU patients on ventilators leaves fewer ventilators available to other patients in respiratory failure, who will die without them and who are likely to survive after receiving ventilation for only a few days. Therefore, allowing patients already in the ICU to remain on ventilators without regard to new patients with respiratory failure is likely to decrease the total number of lives saved. On the other hand, removing patients from ventilators who are not improving after several days would violate the usual ethical guideline that a physician should act in the best interests of patients and be faithful to them.

What Other Considerations Should Be Taken into Account During Triage?
We have identified a high likelihood of survival and a short-term need for mechanical ventilation as two criteria for giving high priority to patients with respiratory failure during a pandemic. If there is still a shortage of ventilators after these criteria have been applied, a number of other criteria might be considered. Such criteria might include the likely duration of life and the likely quality of life in a patient after treatment or the existence of personal behaviors that may have led to the respiratory failure, such as smoking or non-adherence with asthma medications. Judgments about quality of life and personal behaviors are more subjective that a strict medical prognosis and inevitably involve value judgments over which reasonable people may disagree. Because incorporating these considerations into triage decisions would heighten concerns about unfairness, they are best avoided during a public health emergency.

How Will Disagreements by Family Members Be Managed?
Civilians have no experience with triage, unlike military personnel who are familiar with the approach. Faced with the death of a relative which might be averted with mechanical ventilation, families might strongly object to foregoing the use of the ventilator. In light of this, several issues likely to face frontline physicians should be addressed before a pandemic strikes. Would it be feasible, for example, to create timely appeals mechanisms for decisions regarding ventilator use? During public health emergencies, governments have the police powers to enforce public health measures; will there be police in hospitals to enforce triage decisions about ventilators? And how can the risk of violence be minimized?

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