1. Chapter 3 ETHICAL FRAMEWORK [ENTER FACILITATOR’S NAME AND CONTACT INFORMATION] Developed by Troutman Sanders LLP Developed for the Virginia Department of Health Funded by Centers for Disease Control and Prevention

2. 2Ethical Framework

3. 3 Toolkit Presentations Instructions for Use  Toolkit Presentations are intended to be a companion to the Hospital Implementation Guide and should not be used in isolation.  The Presentations are intended to serve as a starting point for the facilitator. The facilitator should thoroughly review the Presentation prior to use in Implementation Team, CRAG or Subcommittee meetings and customize the Presentation to meet the unique needs of the meeting participants.  Pay particular to attention to the information provided in brackets ([ ]), which must be completed by the facilitator prior to use.  Included in the “Notes” section of each slide are the following types of information: Slide Type, which indicates whether the slide is for information or discussion, serves as a placeholder, or is some combination thereof Planning Guide Section(s), which will direct the facilitator to the corresponding sections of the Planning Guide and Hospital Implementation Guide for further information Special Instructions, which provides directions for the facilitator to customize the slide for the intended audience Speaker’s Notes, which provides more detailed information to supplement the material on the slide  Refer to the Hospital Implementation Guide for further guidance and helpful hints on effectively completing the process described in the Planning Guide.

4. 4Ethical Framework CRAG Members  [Enter names and departments of each CRAG member]

5. 5Ethical Framework  Add slides from Altered Standards Overview and/or Chapter 1 presentation, as needed, to re-introduce the CRAG to the concept of altered standards and critical resource shortage response planning, especially if new members are involved.

6. 6Ethical Framework Introduction

7. 7Ethical Framework Why Ethics?  Decisions during a CRSE involve complex, challenging ethical issues, including the allocation of scarce resources  An ethical framework will help ensure that the CRSRP and associated Protocols are developed in an ethical manner  Ideally, the application of an ethical framework will produce a CRSRP and Protocols that are accepted as ethically sound  While existing frameworks may be helpful, Planning Units should create their own framework which reflects their unique culture and values

8. 8Ethical Framework Strong Foundation Operational Infrastructure Education & Communication Building the CRSRP Protocol Ad Hoc Ethical Framework

9. 9 Three Step Process Step 1: Identify Ethical Principles Step 2: Define the Goal Step 3: Determine Implementation Specifications

10. 10Ethical Framework Step 1: Identify Ethical Principles

11. 11Ethical Framework Ethical Principles Substantive Principles  Individual Liberty  Protection of the public from harm  Proportionality  Distributive justice and fairness  Beneficence  Non-maleficence  Privacy  Duty to provide care  Reciprocity  Respect for Autonomy  Equity  Trust  Solidarity  Stewardship Procedural Principles  Reasonable  Open and Transparent  Inclusive  Responsive  Accountable

12. 12Ethical Framework Prioritization of Ethical Principles Substantive  Individual Liberty  Protection of the public from harm  Proportionality  Distributive justice and fairness  Beneficence  Non-maleficence  Privacy  Duty to provide care  Reciprocity  Respect for autonomy  Equity  Trust  Solidarity  Stewardship Procedural  Reasonable  Open and transparent  Inclusive  Responsive  Accountable High Medium Low

13. 13Ethical Framework Ethical Principle Prioritization High PriorityMedium PriorityLow Priority

14. 14Ethical Framework BREAK

15. 15Ethical Framework Step 2: Define the Goal

16. 16Ethical Framework  Protecting the functionality of society  Protecting societal and community infrastructure  Preventing morbidity and mortality  Greatest good for the greatest number  Greatest good for the greatest number with “side constraints”  Greatest number of people benefited  Greatest number of lives saved  Greatest number of life years saved  Greatest number of quality life years saved Potential Goals

17. 17Ethical Framework “Protecting the Functionality of Society”  Modify practices and allocate resources to protect the societal infrastructure and prevent it from breaking down under the stress of the disaster  Prioritize for prophylaxis and treatment those people who are essential to preserving the functionality of society  Who is essential to protecting the functioning of society? Health care providers? Public Health Officials? Legislators? Police officers? Truck drivers? Janitors? Sewage workers?  Will the answer depend on the disaster or the type of care that is being modified or allocated?

18. 18Ethical Framework “Prevent Morbidity and Mortality”  Modify practices and allocate resources to prevent illness and death  Prioritize for prophylaxis and treatment those people who are most likely to become ill, make others ill, or die without the intervention  Will the prioritization change based on the disaster or the type of care that is being modified or allocated?

19. 19Ethical Framework “Greatest Good for Greatest Number”  Widely used in critical resource shortage response planning literature  Not clear exactly what it means Greatest number of lives saved? Greatest number of life years saved? Greatest number of quality life years saved? Greatest number of people benefited?

20. 20Ethical Framework “Greatest Good for Greatest Number with Side Constraints”  Greatest good for the greatest number + Respect for persons + Non-maleficence + Justice  Greatest good for the greatest number + Refraining from harming individuals and communities + Providing equal opportunity to access resources to those in priority groups + Employing the least restrictive interventions likely to be effective

21. 21Ethical Framework Prophylaxis v. Treatment

22. 22Ethical Framework Choose a Goal  Protecting the functionality of society  Protecting societal and community infrastructure  Preventing morbidity and morality  Greatest good for the greatest number  Greatest good for the greatest number with “side constraints”  Greatest number of people benefited  Greatest number of lives saved  Greatest number of life years saved  Greatest number of quality life years saved

23. 23Ethical Framework BREAK

24. 24Ethical Framework Step 3: Determine Implementation Specifications

25. 25Ethical Framework Withdrawal and Reallocation  Will providers be allowed to withdraw resources from one patient to give them to another patient?  If so, under what general circumstances?

26. 26Ethical Framework How will you decide who gets the ventilator?

27. 27Ethical Framework Minnesota’s Reallocation Criteria

28. 28Ethical Framework Consider that…  If you are not willing to withdraw treatment, then you are essentially providing care on a first come, first served basis.  If you are willing to withdraw care, will this be construed as valuing one person’s life more than another’s life?

29. 29Ethical Framework Withholding of Resources  Will providers be allowed to withhold a critical resource from one patient to conserve it for a future patient?  If so, under what general circumstances?  Is the answer different for durable v. consumable resources?

30. 30Ethical Framework Consider that …  If you are not willing to withhold care, you will essentially be providing care on a first come, first served basis.  If you are willing to withhold care, you may have unused, available resources that are not being provided to a patient in need.

31. 31Ethical Framework “Inclusion” and “Exclusion” Criteria  Many of the existing allocation algorithms include “inclusion” and “exclusion” criteria Inclusion Criteria Those patient characteristics which indicate a need for the Critical Resource Exclusion Criteria Those patient characteristics that remove a patient from consideration for the Critical Resource even when the inclusion criteria are met

32. 32Ethical Framework Example Exclusion Criteria Ontario Health Plan for Influenza Pandemic Christian MD, et al. (Nov 2006) “Development of a Triage Protocol for Critical Care During an Influenza Pandemic.” CMAJ, 175(11): 1377-1381. Available online at: http://www.cmaj.ca/cgi/reprint/175/11/1377 (last visited March 9, 2009).http://www.cmaj.ca/cgi/reprint/175/11/1377

33. 33Ethical Framework Example Exclusion Criteria New York Vent Allocation Guidance Powell T, et al. (Mar 2008) “Allocation of Ventilators in a Public Health Disaster.” Disaster Medicine and Public Health Preparedness, 2(1): 20-26.

34. 34Ethical Framework Example Exclusion Criteria Task Force for Mass Critical Care Working Group Devereaux A, et al. (2008) “Definitive Care for the Critically Ill During a Disaster: A Framework for Allocation of Scarce Resources in Mass Critical Care.” Chest, 133: 51S-66S. Available online at: http://www.chestjournal.org/content/133/5_suppl/51S.full (last visited March 9, 2009). http://www.chestjournal.org/content/133/5_suppl/51S.full

35. 35Ethical Framework Example Exclusion Criteria Utah Pan Flu Hospital and ICU Triage Utah Department of Health (Aug 2008) “Utah Pandemic Influenza Hospital and ICU Triage Guidelines.” http://www.uha- utah.org/Disaster%20Prep%20Materials/PANDEMIC%20FLU%20TRIAGE%2008-12-08.pdf (last visited March 9, 2009).http://www.uha- utah.org/Disaster%20Prep%20Materials/PANDEMIC%20FLU%20TRIAGE%2008-12-08.pdf

36. 36Ethical Framework CA’s Exclusion Criteria Guidance Acceptable  Likelihood of survival  Change in quality of life  Duration of benefit  Urgency of need  Amount of resources required Inappropriate  Ability to pay  Social worth  Patient contribution to disease  Past use of resources California Department of Public Health. (2007). “California Department of Public Health Standards and Guidelines for Healthcare Surge During Emergencies, Volume I: Hospitals.” Available online at:http://bepreparedcalifornia.ca.gov/NR/rdonlyres/0DB13C5F-89DC-4B94-850B-EF12EA221FF3/0/volume1_hospital_FINAL.pdf (last visited September 25, 2009).http://bepreparedcalifornia.ca.gov/NR/rdonlyres/0DB13C5F-89DC-4B94-850B-EF12EA221FF3/0/volume1_hospital_FINAL.pdf

37. 37Ethical Framework Inappropriate Exclusion Criteria  Ability to pay?  Social worth?  Race or ethnicity?  Religion?  Gender?  Patient contribution to disease?  Past use of resources?  Age? If so, what is the cut-off?  Severe baseline cognitive impairment?  Known severe dementia?  Metastatic malignant disease?  End stage organ failure?  Severe and irreversible neurological event or condition?  Advanced and irreversible immunocompromise?  Advanced untreatable neuromuscular disease?  Known chromosomal or untreatable disorders fatal in first 2 years of life?

38. 38Ethical Framework Questions?