1. NC IOM: Ethics and PanFlu1 Pandemic Influenza and Ethics Healthy Carolinians Annual Conference 11 October 2007 Mark Holmes, PhD Vice President NC Institute of Medicine

2. NC IOM: Ethics and PanFlu2 Acknowledgements Task Force funded by Centers for Disease Control and Prevention through grant to NC Division of Public Health. The contents of this presentation are solely the responsibility of the authors and do not necessarily represent the official views of the CDC. Support for public presentations provided to the NC IOM by the Blue Cross and Blue Shield of North Carolina Foundation.

3. NC IOM: Ethics and PanFlu3 Overview Background on Pandemic Influenza (“PanFlu”) Task Force Composition and Process Task Force Findings and Recommendations Conclusions

4. NC IOM: Ethics and PanFlu4 Overview Background on Pandemic Influenza (“PanFlu”) Task Force Composition and Process Task Force Findings and Recommendations Conclusions

5. NC IOM: Ethics and PanFlu5 Three types of influenza Seasonal influenza: annual event (mostly during winter), about 1100 deaths per year in North Carolina, same general type of virus, vaccine available Pandemic influenza: rare event (occurring year round), higher death rate, new virus, vaccine may not be available Avian influenza: influenza occurring in birds, virus may mutate to become human influenza

6. NC IOM: Ethics and PanFlu6 Pandemic Influenza The world averages about three pandemic (worldwide epidemic) influenzas per century –1918-1919 (“Spanish Flu”) –1957-1958 (“Asian Flu”) –1968-1969 (“Hong Kong Flu”) In some sense, we are “overdue” for the next one Recent cases of H5N1 have led many experts (including the CDC) to say it is not a case of if but when the next pandemic will occur.

7. NC IOM: Ethics and PanFlu7 Likely healthcare impact of PanFlu A pandemic would involve multiple “waves” each lasting several weeks Predictions and simulations involve various assumptions regarding proportion of population infected and virulence of virus Estimated effect on North Carolina: 35,000 – 290,000 hospitalizations per wave (compared with 6,000 for seasonal flu)

8. NC IOM: Ethics and PanFlu8 Likely societal impact of PanFlu Best estimate during a pandemic influenza is a 40% employee absentee rate (due to either employees being sick or caring for loved ones) North Carolina has experience recovering from natural disasters, but the PanFlu experience will be different and will require a shift in thinking

9. NC IOM: Ethics and PanFlu9 Natural disaster vs. PanFlu Natural disaster: –Little effect on availability of workers –Can “borrow” resources from unaffected areas (e.g., electricity crews)

10. NC IOM: Ethics and PanFlu10 Natural disaster vs. PanFlu Challenges: Negotiating physical environment to get employees into work Capital may be unavailable (e.g., no utilities) Closed schools may keep some employees home to care for children Common solutions: Create barracks-type quartering for employees and day care capability for children of employees

11. NC IOM: Ethics and PanFlu11 Natural disaster vs. PanFlu Pandemic Influenza –Great effect on availability of employees –No ability to obtain resources from other areas (all areas are affected) http://www.history.navy.mil/photos/images/h41000/h41871.jpg

12. NC IOM: Ethics and PanFlu12 Natural disaster vs. PanFlu Challenges: Maintaining productivity with 40% employee absentee rate Closed schools may keep some employees home to care for children Note that a barracks-type solution is a mass gathering– exactly what should be avoided to limit infection! Lesson: may need to think “upside-down” about common approaches to crises

13. NC IOM: Ethics and PanFlu13 Ethics and PanFlu Planning There will not be time to consider these issues during a pandemic, so must consider them prior to event onset –Transparent process –Public input is critical

14. NC IOM: Ethics and PanFlu14 Overview Background on Pandemic Influenza Task Force Composition and Process Task Force Findings and Recommendations Conclusions

15. NC IOM: Ethics and PanFlu15 NC IOM/DPH Task Force on Ethics and Pandemic Influenza Planning In late 2005, DPH asked NC IOM to convene a Task Force on Ethics and Pandemic Influenza Planning to help inform the Division on ethical considerations during a pandemic Funded by NC Division of Public Health (Centers for Disease Control and Prevention) First such effort in the nation

16. NC IOM: Ethics and PanFlu16 Task Force Composition Co-chairs –Leah Devlin, DDS, MPH (State Health Director) –Rosemarie Tong, PhD (Professor of Ethics, UNC- Charlotte) –Honorary: NC DHHS Secretary Carmen Hooker Odom 34 other Task Force members –Public health and other government agencies, healthcare providers, business and industry, faith community, advocacy organizations, community leaders, ethicists, and representatives of underserved communities

17. NC IOM: Ethics and PanFlu17 Task Force Charge Increase awareness and understanding of PanFlu’s impact on NC, especially the public health response Identify and explore ethical issues Develop ethical template to guide leaders Involve citizens in exploring ethical issues Develop recommendations of next steps

18. NC IOM: Ethics and PanFlu18 Task Force Process Five Task Force meetings to learn more about key issues, build ethical framework, and develop, consider, and refine recommendations Four public meetings on Task Force recommendations –Charlotte, Greenville, Asheville, Raleigh –Collaborators: Old North State Medical Society, El Pueblo, PHRST Team Feedback from public meetings presented to Task Force at sixth meeting, refined recommendations before approving

19. NC IOM: Ethics and PanFlu19 Overview Background on Pandemic Influenza Task Force Composition and Process Task Force Findings and Recommendations Conclusions

20. NC IOM: Ethics and PanFlu20 Findings and Recommendations Culmination of Task Force work was the final report Stockpiling Solutions: North Carolina’s Ethical Guidelines for an Influenza Pandemic Electronic version available at http://www.nciom.org. Click on Task Forces > Ethics and Pandemic Influenza Planning

21. NC IOM: Ethics and PanFlu21 Other Resources Issue Brief http://www.nciom.org Article (Jan/Feb 2007 NC Med J) http://www.ncmedicaljournal.com

22. NC IOM: Ethics and PanFlu22 Previous Work Seminal work on ethical guidelines during a public health emergency Informed by SARS epidemic in Toronto Task Force heard from an author of report http://www.utoronto.ca/jcb/home/documents/pandemic.pdf

23. NC IOM: Ethics and PanFlu23 Ethical Template / Framework In order to guide the recommendations, Task Force adopted ethical principles to form an ethical blueprint: Accountability, Cooperation and Collaboration, Duty to Work, Equity, Honesty and Truth-telling, Inclusiveness, Proportionality, Protecting individual rights and privacy rights, Protecting the public, Reasonableness, Reciprocity, Responsiveness, Stewardship, Timeliness, Transparency, Trust

24. NC IOM: Ethics and PanFlu24 Four (three?) key issues Task Force identified four key issues –Responsibilities of healthcare workers to work –Responsibilities of critical workers to work –Rights of individuals versus protection of the public –Prioritization and utilization of limited resources First two can be conceptualized as one issue but are treated separately

25. NC IOM: Ethics and PanFlu25 1. Responsibility of healthcare workers to work During a pandemic, healthcare organizations will be facing unprecedented demand and likely operating at 60% staffing levels Meeting the needs of the population will be difficult; “voluntary” absenteeism will make this situation even worse What is the duty of healthcare workers to work during a pandemic influenza?

26. NC IOM: Ethics and PanFlu26 “Healthcare worker” defined “Healthcare workers” include –Licensed healthcare professionals –Unlicensed healthcare professionals –Healthcare workers not providing direct patient care (e.g., environmental services)

27. NC IOM: Ethics and PanFlu27 Duty to work The duty to work stems from three obligations: 1.Professional obligation: as a member of a health profession, the provider agrees to a duty to work 2.Employment obligation: contractual obligations require the worker to support the work of the organization 3.Human obligation: the welfare of everyone is enhanced when all of society’s members recognize their moral responsibility to assist each other in times of need

28. NC IOM: Ethics and PanFlu28 Professional Obligation Despite risks to themselves, licensed and nonlicensed healthcare professionals have an ethical obligation to provide care because: 1.Ability to provide care is greater than that of the public 2.Social contract resulting from the privilege of self-regulation and self-licensure 3.Free choice of a profession or job devoted to caring for the ill

29. NC IOM: Ethics and PanFlu29 Reciprocal Obligations Government and healthcare organizations have reciprocal duties: 1.Ensure that the work asked of healthcare personnel does not exceed their professional capabilities, and that the tasks assigned are targeted to addressing the existing emergency. May involve “Just in Time” training. 2.Ensure that healthcare workers are suitably protected, compensated, and supported. 3.Provide healthcare personnel and organizations with qualified immunity from liability from malpractice or other suits if they act in good faith to provide needed health services during the pandemic.

30. NC IOM: Ethics and PanFlu30 Recommendation 2.1 (a)All healthcare personnel in healthcare settings have an ethical responsibility to perform their regular employment duties during an influenza pandemic and to assume new responsibilities for which they are trained, as long as actions by the healthcare personnel will not lead to greater harm than the failure to act. (b) Government and healthcare organizations have a reciprocal responsibility to ensure that healthcare personnel are protected and supported to the extent possible. Frontline healthcare workers and others at increased risk of infection should have priority in receiving available personal protective equipment, vaccinations, antiviral drugs, and other nonmedical control measures. All critical healthcare personnel should receive behavioral health services and other goods or services needed to enable them to work. In addition, organizations have a responsibility to ensure that workers are appropriately trained to fulfill the tasks assigned to them during a crisis.

31. NC IOM: Ethics and PanFlu31 The SARS experience A librarian is suing Mount Sinai Hospital [Toronto] for $2.1 million, claiming she was forced to quit her job when she refused to continue screening staff and visitors for SARS symptoms. Kellee Kaulback, who worked in the hospital's library for two years, said she was made to work as a SARS screener during the outbreak but received no training in how to fit her mask or properly take temperatures. …Kaulback learned during her first shift that her mask had been fitted improperly, since she hadn't pinched the metal bar above her nose, nor tightened the elastic bands. While working her next shift, she was told that the way she and other screeners were opening boxes of probes - the plastic piece that fits over the thermometer and allows it to be reused - was actually contaminating them…. Palmer K. “Librarian sues over SARS duty”, The Toronto Star, July 10, 2003 Thursday, Ontario Edition, NEWS; Pg. B01.

32. NC IOM: Ethics and PanFlu32 Recommendation 2.2 Healthcare organizations should design business continuity plans to prepare for events such as a pandemic. Plans should identify the critical functions that must be continued and those positions that are critical to the continued operation of the healthcare organization. Workers who would be required to work should be made aware of the expectation to work during events such as a pandemic flu upon hiring or upon the adoption of the plan. The healthcare organization should specify the anticipated supports that will be available to the critical healthcare personnel to enable them to work, as well as the sanctions if critical healthcare personnel fail to show up for work when otherwise required to do so.

33. NC IOM: Ethics and PanFlu33 Recommendation 2.3 In order to ask healthcare providers and other healthcare personnel to assume greater risk and responsibilities, the North Carolina General Assembly should: (a) Modify existing laws to clarify that in the case of a declared disaster under the North Carolina Emergency Management Act (NCGS Ch. 166A, Art. 1): (i) The standard of care to be applied in any medical negligence action arising out of healthcare provided during an influenza pandemic is the standard of practice among members of the same healthcare profession with similar training and experience, practicing under the same circumstances including the unique circumstances presented by an influenza pandemic, and situated in the same or similar communities at the time the healthcare is rendered.

34. NC IOM: Ethics and PanFlu34 Recommendation 2.3, cont. (ii) Healthcare personnel and healthcare organizations have qualified immunity from liability. Individuals and organizations should not be liable for damages due to injury or death, unless there is clear and convincing evidence that the harm was caused by gross negligence, wanton conduct, or intentional wrongdoing. (iii) Healthcare personnel and healthcare organizations will be indemnified for the costs of defending the lawsuit, including attorneys’ fees, unless the injury or death is found to be a result of gross negligence, wanton conduct, or intentional wrongdoing. (b) Modify the workers’ compensation laws to provide benefits to individuals who are injured because they were required to obtain an influenza vaccination or other prophylaxis as part of their job responsibilities.

35. NC IOM: Ethics and PanFlu35 Recommendation 2.4 The North Carolina Healthcare Licensure Boards should develop formal guidelines on the duty to provide care during emergencies, including outbreaks of infectious diseases. The guidelines should specify healthcare professionals’ ethical duties, as well as the limits of such obligations.

36. NC IOM: Ethics and PanFlu36 2. Responsibilities of critical workers to work US Department of Homeland Security has identified seventeen critical industries that comprise the national infrastructure (e.g. public health and healthcare, water, food, energy, water, banking, transportation, telecommunications) Maintenance of social order (and public safety) depends on continued operation of these industries What is the duty of critical workers to work during a pandemic influenza?

37. NC IOM: Ethics and PanFlu37 Definition of critical workers When we say “critical workers”, we mean “critical workers in critical industries”. There are non-critical workers in critical industries; these recommendations would not apply to workers whose job function is not critical to the continued operation of the organization.

38. NC IOM: Ethics and PanFlu38 Scenario A manager at a local grocery store designates cashiers and shelf stockers as critical workers for an influenza pandemic. Although he has informed his cashiers and shelf stockers that they are critical workers, the manager is not sure that these low- wage employees will report to work during a pandemic. The store does not have enough income to pay employees more for their work during the pandemic, and the manager is worried that the threat of termination will not be well received. He believes several of his employees would rather quit than work during a pandemic.

39. NC IOM: Ethics and PanFlu39 Recommendation 3.1 (Similar to 2.1) (a) Workers in critical industries have an ethical responsibility to perform their regular employment duties during an influenza pandemic and to assume new responsibilities for which they are trained, as long as actions by personnel will not lead to greater harm than the failure to act. (b) Government and employers have a reciprocal responsibility to ensure that workers are protected to the extent possible. For example, workers in critical industries at increased risk of infection should receive priority for available personal protective equipment, vaccinations, antiviral drugs, and other nonmedical control measures. All critical workers should receive behavioral health services and other goods or services needed to enable them to work. In addition, employers have a responsibility to ensure that workers are appropriately trained to fulfill the tasks assigned to them during a crisis.

40. NC IOM: Ethics and PanFlu40 Recommendation 3.2 (Similar to 2.2) Employers and contractors should design business continuity plans to prepare for events such as a pandemic. Plans should identify those positions that are critical to the continued operation of the industry and whether the job needs to be performed on-site or can be adequately performed off-site. Workers who would be required to work should be made aware of the expectation to work during events such as a pandemic upon hiring or upon the adoption of the plan. Employers and contractors should specify the supports that will be available to the critical workers to enable them to work, as well as the sanctions that will be enforced if critical workers fail to show up for work during a time of crisis.

41. NC IOM: Ethics and PanFlu41 Recommendation 3.3 (a) Federal, state, and local governments have the primary responsibility to identify the types of businesses that are essential to meet society’s basic healthcare needs. Other businesses and organizations should also examine their services to determine if they provide essential goods and services for society. (b) During an influenza pandemic, organizations should prioritize the health of their employees and reduction of the spread of disease over the financial position of the organization. (c) Organizations have a duty to follow the recommendations, guidelines, and restrictions that public health and other government officials provide. For example, if social distancing measures are recommended, organizations not in critical industries should comply with these recommendations.

42. NC IOM: Ethics and PanFlu42 3. Individual Rights vs. Public Protection The Governor and State Health Director have considerable powers during an emergency. During a pandemic, one of the most effective tools in public health’s arsenal is implementation of social distancing. Limiting contact can slow the spread of the virus.

43. NC IOM: Ethics and PanFlu43 Photo #: NH 41730. U.S. Naval Historical Center Photograph. http://www.history.navy.mil/photos/events/ev-1910s/ev-1918/influenz.htm

44. NC IOM: Ethics and PanFlu44 From Hatchett RJ, Mecher CE, Lipsitch M. From the cover: Public health interventions and epidemic intensity during the 1918 influenza pandemic. Proceedings of the National Academy of Sciences. 2007. ;104:7582-7587.

45. NC IOM: Ethics and PanFlu45 Balancing rights and protection Public health officials should choose the least restrictive and least intrusive effective alternative that is necessary to protect the public. Public health interventions should be as just and fair as possible. Justice requires that affected individuals have due process rights to challenge the restrictions and that restrictions be applied equitably to similarly situated individuals. Public health should only seek the release of personal health information when needed to protect the public. Released information should be as limited as possible and the public should be aware of the safeguards in place to protect any information collected.

46. NC IOM: Ethics and PanFlu46 Social distancing Once the virus has entered society, quarantine and isolation will likely have little effect Although within their powers, most experts anticipate government officials will request locations to close and people to refrain from mass gathering, rather than compel it

47. NC IOM: Ethics and PanFlu47 Recommendation 4.1 Government leaders should implement restrictions on personal liberties deemed likely to be effective to limit illness and mortality in the context of a pandemic, but should limit these measures to the least restrictive alternative reasonably necessary to protect the public.

48. NC IOM: Ethics and PanFlu48 Recommendation 4.2 (a) Prior to and during the course of a pandemic, the North Carolina Department of Health and Human Services should partner with local health departments to develop a public outreach campaign to foster community awareness and understanding of pandemic influenza. The outreach campaign should: (i) Include other stakeholders, community groups, and the media; (ii) Ensure that the public is well informed of the potential need to use community mitigation efforts or to prioritize the use of limited resources; and (iii) Include mechanisms to obtain ongoing feedback from the community prior to and during the course of an influenza pandemic. (b) The North Carolina Department of Health and Human Services should continue to work with the North Carolina Justice Academy, Administrative Office of the Courts, local law enforcement, UNC School of Government, North Carolina National Guard, and North Carolina Department of Crime Control and Public Safety to create an understanding of the need to use social distancing measures and other community mitigation efforts to prevent the spread of disease in an influenza pandemic.

49. NC IOM: Ethics and PanFlu49 Recommendation 4.3 The Governor’s Office, in conjunction with the North Carolina Department of Health and Human Services and the Department of Crime Control and Public Safety, should develop a coordinated communications plan, to ensure that the public obtains timely, accurate and continuous information about the influenza pandemic. Special attention should be paid to assure that this information is communicated to special populations, including, but not limited to, low-income communities, non-English speakers, and people who have visual or hearing impairments.

50. NC IOM: Ethics and PanFlu50 Recommendation 4.4 (a) All levels of government should ensure that individuals who are affected by isolation or quarantine orders receive needed assistance in accessing resources to meet their basic needs while they are subject to restrictions. (b) Government, social relief agencies, and other community groups should coordinate efforts to address the basic subsistence needs of individuals who have been adversely affected by an influenza pandemic.

51. NC IOM: Ethics and PanFlu51 Recommendation 4.5 In developing business continuity plans, businesses should consider the impact that lost income and lost benefits will have on their employees. Businesses should strive, to the extent possible, to continue to provide financial and other assistance to their employees during an influenza pandemic.

52. NC IOM: Ethics and PanFlu52 Recommendation 4.6 Individuals have a responsibility to prepare for an influenza pandemic. They should have reserve supplies and have plans to care for family members during a pandemic. In the event of a pandemic, individuals who are capable of going without government assistance should do so. Individuals should be encouraged to help out fellow citizens during this time of crisis.

53. NC IOM: Ethics and PanFlu53 4. Allocating Limited Resources During a pandemic, many key healthcare resources will be scarce –Vaccines –Antivirals and other medicines –Hospital beds, including ICU beds –Mechanical ventilators –Healthcare practitioners

54. NC IOM: Ethics and PanFlu54 Key questions How should we distribute limited healthcare resources (such as vaccines or ventilators)? What criteria should not be used to distribute healthcare resources?

55. NC IOM: Ethics and PanFlu55 Possible allocation/distribution schema Could create priority groups… 1.Assure the functioning of society (e.g., healthcare workers, public safety at high risk of illness) 2.Reduce the number of people who get sick 3.Reduce individual deaths and hospitalizations due to influenza 4.Protect children – they have the most life ahead of them..or create no priority groups: 5.Lottery 6.First come-first serve

56. NC IOM: Ethics and PanFlu56 Conceptualizing interventions PharmaceuticalNon- Pharmaceutical Prevention / Primary VaccinesPersonal Protective Equipment (e.g., masks) Treatment / Secondary AntiviralsTreatment Services (e.g., vents, beds)

57. NC IOM: Ethics and PanFlu57 Recommendation 5.1 Limited healthcare resources should be allocated according to the following criteria: (a) Allocation of vaccines (pharmaceutical prevention resources) should be made with the primary goal of assuring the functioning of society and the secondary goal of minimizing the spread of the disease. (b) Allocation of nonpharmaceutical prevention resources (such as personal protective equipment) should be made with the goal of assuring the functioning of society and preventing the spread of the disease. (c) Allocation of antivirals (pharmaceutical treatment resources) should be made with the primary goal of minimizing illness, hospitalization, and death and the secondary goal of assuring the functioning of society. (d) Allocation of nonpharmaceutical treatment resources (e.g., ventilators and hospital beds) should be made with the goal of reducing illness, hospitalization, and death.

58. NC IOM: Ethics and PanFlu58 Recommendation 5.2 (a) During an influenza pandemic, disease control and medical decisions should be based on clinical factors, the epidemiology of the spread of disease, and assuring the functioning of society. Decisions about which people to treat and what services to provide during an influenza pandemic should not be made based on socioeconomic or other factors unrelated to these criteria. (b) Healthcare organizations need to create mechanisms in advance of a pandemic to ensure that clinical decisions are made according to the ethical principles set out in these guidelines.

59. NC IOM: Ethics and PanFlu59 Recommendation 5.3 State, local, and national law enforcement should provide appropriate protection, based on available resources, for individuals and organizations in custody of and responsible for distribution and administration of limited resources such as vaccines and antiviral medications.

60. NC IOM: Ethics and PanFlu60 Conclusions Ethical considerations during a PanFlu will be considerable; best to explore them (as much as possible) prior to the event. Healthcare organizations have a duty to prepare. This includes planning, but also informing and involving employees. Working together, we will be able to weather the storm. But every decision will be fraught with ethical challenges, and ensuring a fair transparent process will be critical.

61. NC IOM: Ethics and PanFlu61 For more information NC Institute of Medicine http://www.nciom.org 919-401-6599 Pam Silberman, JD, DrPH (extension 23) President and CEO pam_silberman@nciom.org Mark Holmes, PhD (extension 24) Vice President mark_holmes@nciom.org