Ethical Issues in Pandemic Flu

1. Ethical Issues in Pandemic Flu Kathy Kinlaw Emory University Center for Ethics

2. Keeping allocation/prioritization in broader context • What can be done to increase vaccine production (vs. allocate scarce resource)? • Shorten time between recognition of new viral strains and intervention • Balance vaccines and antivirals utilization • How do we make sure vaccine gets to high risk groups once determined? Plan for public engagement, including involvement of state and local officials, that will improve “uptake” of vaccine by priority groups • Education of providers • Larger questions of personal freedom and choice – e.g. quarantine

3. Maximize Preparedness to Minimize Allocation Needs

4. Levels of Allocation • What budget and other resources are available for agencies dealing with influenza? (vs. other societal needs) • What resources are committed to prevention vs. crisis response? • Who receives scarce resources?

5. Underlying Values or Principles (Which May be Competing) • Respect for the rights of the individual (autonomy interests) • Equity - treat people equally (usually adds, a decent minimum level) local control re distribution of vaccine may lead to lack of equity • Utility - greatest good for the greatest number affected • Beneficence - Quality of Life/quality of benefit • Efficiency - maximize beneficent care, eliminate non-beneficial expenditure

6. Criteria for prioritization • Historically, ACIP priority is individuals at high risk • of hospitalization • Refine nature of hospitalization – length of stay, ICU stay, severity of illness • Risk of death • Beneficence-based commitment (promote good and remove harm) – likelihood of medical benefit • Even vaccination of HCP’s based on decreasing transmission to high risk groups • Herd immunity discussion based on impact on high risk groups (esp. elderly); working group called for need for impact data; would not lower priority of vaccination for older patients • Does raise questions of seeing children as means to an end

7. Current Position – Some guidance Much local Authority Local communities not satisfied with current guidance? Increased Guidance ? Role of community input and ethical transparency • Mandated categories • For vaccination; no local • control • Vaccine Orders and • distribution centralized • Incentives for vaccina- • tion and “penalties” • for failure to be • vaccinated • Equity? Consistency • Would this really help • local communities? Spectrum of Local/Central Control Total Local Control “Let the Market Work” No Guidance Local Autonomy Respect for individual choice Is this really what local Communities want? Access issues

8. Pandemic Flu moves us closer to: • Central control -> Collaboration • Mandated practices

9. Public Health Commitment • Long-term objective - Collective action by community to promote health of members • Movement away from free market, individual pursuit to a societal decision • Allocation as short term policy for crisis

10. Other ethical considerations • Procedural Ethics – who decides • Community involvement through process that has integrity • Cultural sensitivity – (e.g. sovereign nations) • Special consideration to those already marginalized in society already; potentially vulnerable populations

11. Equity - Egalitarian Approach • Fair distribution of resources across total population • Regardless of utility, benefit • Either random selection or % of all • Vaccinating significant % of population may not be possible • e.g., Meltzer et al ‘99 study - production, delivery and admin. of vaccine to 60% of U.S. population in short time as infeasible

12. A Look at Utility Maximization • Greatest Good for greatest # affected • Sum of the Benefit to each individual minus Cost to each individual • Overall utility maximization NOT = each individual’s utility maximized; ? of respect to individuals as ends in themselves, not merely means to overall utility • Indeed might violate fundamental rights of individuals or groups (low priority groups)

13. Triage cont. • Based on maximizing utility (greatest good for greatest #) • ? Greatest medical utility, eg. Saving lives • OR Greatest military good - return to the fight

14. E.G. Triage and Vaccine Prioritization • Are we vaccinating those most at risk of severe illness or life lost • OR • Preventing harm, maintaining “fighting strength” by vaccinating those most likely to spread disease?

15. Efficiency Criteria • Cost effective analysis – • Which alternative is most effective use of resources? • Effectiveness/health benefits of these alternatives can be measured in non-monetary units, such as years of life saved or quality adjusted life years (QALY’s) • difficulty of identifying objective measurement of benefit • not concerned with distribution of benefits

16. Objectives for Pandemic Vaccination Will Primary Goal be: • to prevent overall # of deaths? • to prevent deaths in high risk pts? • To decrease gross attack rates? • To decrease severe morbidity? • To decrease disruptions of essential services? See Meltzer, Cox, Fukuda 1999

17. Prioritization of Limited Vaccine • Varying Strategies • Those at High Risk for influenza-related complications, including death • determining who is at highest risk as dependent on epidemiology of pandemic • Those in essential community services • Those most likely to disseminate virus

18. Other ethical considerations • Procedural Ethics – who decides • Community involvement through process that has integrity • Cultural sensitivity – (e.g. sovereign nations) • Special consideration to those already marginalized in society already; potentially vulnerable populations

19. Increasing Prioritization for Decreasing Dissemination ? • Essential Services/Primary disseminators of disease • health care providers • long term care/chronic care workers (nursing homes, assisted living, mental health facilities, rehabilitation, home care) • Other essential services? • Pre-school and school children - high attack rates in early phases of epidemic; accessible

20. Prioritization cont. • High Risk Persons • Pts with chronic pulmonary or cardiovascular disorders • Others at high risk for complications from influenza (see ACIP recs) note age groups most at risk with viral stain • Residents of long term care facilities • Others age 65 and > • Disseminators • Family members of high risk persons • Other essential services • fire, police, mass transportation, sanitation morticians • Workers accessible through employers • College students

21. Timing • Combine values of: • Urgency/high risk • Likelihood of benefit • Decreasing dissemination • Efficiency – access to at risk groups and providers (LTC and chronic care facilities; preschools)

22. Phase 1 Phase 2 Phase 3 HC Wkrs; Pts with Respir and Cardiovasc disorders School & LTC Wkrs &Residts Other High Risk Family Of High Risk Pts Age 65 & > Groups Workers College Other Esst’l Svcs. Phasing of Prioritization?