Antivirals for Pandemic Influenza Guidance on Developing a Distribution and Dispensing Program (2008) / Chapter Skim
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3 Ethics, Decision Making, and Communication
3 Ethics, Decision Making, and Communication
Pages 39-52
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From page 39... ...
Depending on communities' levels of preparedness, responding to an influenza pandemic could be an overwhelming challenge for individuals, organizations, and government leaders. Preparing for the pandemic will require considering and communicating about contingencies in advance, developing an ethical compass to guide allocation decisions, and establishing mechanisms to ensure that antiviral use (like all other aspects of pandemic response)
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From page 40... ...
Many of the ethical frameworks that have been promulgated so far include ethical principles and goals, some include strategies and sample allocation plans based on detailed assumptions about the pandemic being planned for, and all of them include what might be described as "integrity factors" or ethical commitments based on respect for persons and the public (Kass, 2005, 2008)
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From page 41... ...
Ethical Principles Ethical principles, the second element in an ethical framework to guide resource allocation might include safeguarding population health, protecting public safety, preserving social order, promoting fairness on the basis of morally relevant characteristics (substantive fairness) , and following fair procedures (procedural fairness)
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From page 42... ...
T��� he proactive development of an ethical framework to guide allocation ���� can support consistent decisions across sectors������������������������������ and serve as a rationale����� �������������� and basis of communication ���������������������������������������������� across the United States���������������������� . Such principles and goals will provide a needed������������������������������������������������ ������������������������������������������������������ basis for flexibility in response to local cir ������������������������������������� cumstances��������������������������������������������������������������� and accountability in assessing and adjusting scarce resource allocation strategies as the epidemiological��������������������������������� ������������������������������������������������ �������������������������������� characteristics����������������� of the pandemic become known.
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From page 43... ...
The process led to the development of 13 priority recommendations, 1 of which related specifically to ethical decision making: Develop clear and practically useful guidance for making ethical decisions around the use of scarce resources and other difficult choices in a severe pandemic. Stakeholders shared concerns about decision making in regard to the distribution of scarce resources such as antivirals and "suggested creating ethical decision making guidance through a detailed process that begins with the federal funding of community-level conversations and deliberations on these topics.
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From page 44... ...
FDA advisory committees such as those on antiviral drugs and on drug safety and risk management are charged with considering a wider range of drugs from a regulatory perspective, and NVAC has the role of advising the National Vaccine Program Office on policy issues related to vaccine safety and effectiveness. There is no advisory body similar to ACIP constituted to advise the federal government and the medical and public health communities on the use of antivirals and other dimensions of a public health response during an influenza pandemic.
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From page 45... ...
and changes in those priorities on the basis of new information • The nature of and systems to capture antiviral adverse events, and implications of drug safety issues for the program course of action • Surveillance of antiviral resistance in the pandemic strain of influ enza and implications for antiviral use • New, unapproved antiviral products or use of drugs in combina tion for treatment or prophylaxis • Standard protocols (including algorithms for diagnosis) • Mobilization of private-sector stockpiles • Professional licensure issues • Triggers for midstream changes in algorithms and guidelines Meetings of the advisory body also would serve as a forum for the public discussion of the issues identified above and others.
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From page 46... ...
In order to use expertise and established lines of communication, this advisory body would ideally include members with appropriate expertise from ACIP, NVAC, the FDA Vaccine Research and Biologics Advisory Committee, and the National Biodefense Science Board (NBSB) . Additional members may be needed, including ex officio senior representatives from CDC, FDA, the National Vaccine Program Office, and the National Institutes of Health, as well as other relevant departments (such as the Departments of Homeland Security, Defense, and Veterans' Affairs)
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From page 47... ...
This area of communication is particularly important because the issue of scarcity raises the specter of panic. Some commentators on pandemic influenza planning express concern about the potential of widespread public panic to motivate a "run" on limited supplies and create a major problem for securing antiviral stockpiles (and maintaining order)
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From page 48... ...
Communication About Drug Risks and Benefits; Dispensing Site Instructions It is well understood that antivirals may have considerable benefits in an influenza pandemic, but they are pharmaceutical products, and like all such products, they present risks. Also, it is important to understand that the risk–benefit profile of antivirals may change during the pandemic, if serious and unexpected adverse events emerge or if resistance develops rapidly, thus modifying the drug's effectiveness.
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From page 49... ...
Timeliness of communication by public health authorities will be of the essence, especially given the vast array of information sources that likely will be available to comment on various aspects of the pandemic -- this may be one of the more striking differences between the social context of the 1918 pandemic and the contemporary context. The federal advisory body recommended above would play a central role in providing the best scientific guidance to address all dimensions of the pandemic response, including the use of antiviral drugs to contain and mitigate the pandemic.
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From page 50... ...
The overall linguistic and cultural diversity of the nation, coupled with documented gaps in overall health literacy and knowledge of public response from previous influenza pandemics, suggest that these factors should be considered when designing optimal delivery systems for antiviral distribution and conveying relevant information and education. Noting that the most important asset in any large-scale public health emergency is the public, the committee recommends the following: Recommendation 3-3: The committee recommends that state, tribal, and local public health officials preparing for an influenza pandemic develop partnerships with (1)
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From page 51... ...
Closing Observations In addition to logistic and scientific considerations such as establishing and testing dispensing sites and conducting surveillance of antiviral resistance, planning antiviral dispensing for pandemic influenza requires the following: 1. Obtain public input, within a framework of agreed-on ethical principles and goals, on what is to be done 2.
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