1. Ethics Influenza vaccines Healthcare workers Johan Bester (MBChB, Mphil Applied Ethics) Department of Family Medicine, University of Calgary

2. Is there a shift? Many hospitals and states in the US have mandatory policies

3. Is there a shift? Many hospitals and states in the US have mandatory policies Los Angeles County

4. “Every healthcare worker in an acute care hospital, nursing facility or intermediate care facility to either receive the influenza vaccination annually, or wear a mask during flu season when in contact with patients.”

5. British Columbia Recently passed similar requirement

6. Pushback Not accepted by all staff

7. Pushback Not accepted by all staff This differs from other required vaccinations – MMR, Hep B

8. Objectives Ethical basis for such requirements

9. Objectives Ethical basis for such requirements – THUS: The usual ethical argument for these requirements

10. Objectives Ethical basis for such requirements – THUS: The usual ethical argument for these requirements Analyze the argument in light of current evidence

11. Objectives Ethical basis for such requirements – THUS: The usual ethical argument for these requirements Analyze the argument in light of current evidence Conclude whether argument is successful

12. Objectives Ethical basis for such requirements – THUS: The usual ethical argument for these requirements Analyze the argument in light of current evidence Conclude whether argument is successful Implications

13. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

14. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

15. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Protect the vulnerable, vaccination prevents spread to the vulnerable Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

16. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Protect the vulnerable, vaccination prevents spread to the vulnerable Obligation to set an example for the public Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

17. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Protect the vulnerable, vaccination prevents spread to the vulnerable Obligation to set an example for the public Voluntary measures failed to ensure adequate vaccination Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

18. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Protect the vulnerable, vaccination prevents spread to the vulnerable Obligation to set an example for the public Voluntary measures failed to ensure adequate vaccination Mandatory vaccination policies increase vacc rates Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

19. Caplan’s argument Professional duty to place patients first, vaccination benefits patients Duty to do no harm, vaccination prevents harm Protect the vulnerable, vaccination prevents spread to the vulnerable Obligation to set an example for the public Voluntary measures failed to ensure adequate vaccination Mandatory vaccination policies increase vacc rates THUS: Ethical to have a mandatory vaccination policy Caplan AL. Morality of influenza Vaccine Mandates. Clinical Therapeutics Volume 35, Number 2, 2013

20. Zimmerman’s argument Vaccinating HCW benefits patients, prevents harm, and has low risk of harm Zimmerman RK. Ethical analyses of institutional measures to increase health care worker influenza vaccination rates. Vaccine 31 (2013) 6172-6176

21. Zimmerman’s argument Vaccinating HCW benefits patients, prevents harm, and has low risk of harm Beneficence and non-maleficence trump personal autonomy for HCW in this case Zimmerman RK. Ethical analyses of institutional measures to increase health care worker influenza vaccination rates. Vaccine 31 (2013) 6172-6176

22. Zimmerman’s argument Vaccinating HCW benefits patients, prevents harm, and has low risk of harm Beneficence and non-maleficence trump personal autonomy for HCW in this case Best way to prevent harm is vaccinating HCW; other measures may not be feasible (eg work absence or neg press ventilation) Zimmerman RK. Ethical analyses of institutional measures to increase health care worker influenza vaccination rates. Vaccine 31 (2013) 6172-6176

23. Zimmerman’s argument Vaccinating HCW benefits patients, prevents harm, and has low risk of harm Beneficence and non-maleficence trump personal autonomy for HCW in this case Best way to prevent harm is vaccinating HCW; other measures may not be feasible (eg work absence or neg press ventilation) Mandatory programs with infect control measures for non- compliance ensures best vaccination coverage Zimmerman RK. Ethical analyses of institutional measures to increase health care worker influenza vaccination rates. Vaccine 31 (2013) 6172-6176

24. Zimmerman’s argument Vaccinating HCW benefits patients, prevents harm, and has low risk of harm Beneficence and non-maleficence trump personal autonomy for HCW in this case Best way to prevent harm is vaccinating HCW; other measures may not be feasible (eg work absence or neg press ventilation) Mandatory programs with infect control measures for non- compliance ensures best vaccination coverage This also provides a way to opt-out for those with objections – wear a mask the whole flu season Zimmerman RK. Ethical analyses of institutional measures to increase health care worker influenza vaccination rates. Vaccine 31 (2013) 6172-6176

25. The Argument Significant illness/burden of disease

26. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients

27. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients High rate HCW vaccination lowers M&M in patients

28. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients High rate HCW vaccination lowers M&M in patients Voluntary programs – low rate HCW vaccination

29. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients High rate HCW vaccination lowers M&M in patients Voluntary programs – low rate HCW vaccination Duty to benefit and to do no harm

30. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients High rate HCW vaccination lowers M&M in patients Voluntary programs – low rate HCW vaccination Duty to benefit and to do no harm Professional duty limits HCW autonomy/rights

31. The Argument Significant illness/burden of disease HCW vaccination prevents spread to patients High rate HCW vaccination lowers M&M in patients Voluntary programs – low rate HCW vaccination Duty to benefit and to do no harm Professional duty limits HCW autonomy/rights Thus: Justified to impose program of mandated Influenza vaccination on HCW Opt-out: wear a mask during flu season

32. An Argument: Premise 1 Premise 2 Conclusion: Follows from premise 1 and 2

33. An Argument: Premise 1 Premise 2 Conclusion: Follows from premise 1 and 2 Examining an argument: Are the premises true? Is the logic sound?

34. Important premises in The Argument Influenza is an important public health problem with significant mortality and morbidity

35. Important premises in The Argument Influenza is an important public health problem with significant mortality and morbidity Vaccination is very successful in limiting spread and impact

36. Important premises in The Argument Influenza is an important public health problem with significant mortality and morbidity Vaccination is very successful in limiting spread and impact Vaccinating HCW provides protection to patients

37. Important premises in The Argument Influenza is an important public health problem with significant mortality and morbidity Vaccination is very successful in limiting spread and impact Vaccinating HCW provides protection to patients Vaccination has an acceptable risk of harm

38. Important premises in The Argument Influenza is an important public health problem with significant mortality and morbidity Vaccination is very successful in limiting spread and impact Vaccinating HCW provides protection to patients Vaccination has an acceptable risk of harm Masks are effective (preventing spread in unvaccinated)

39. Influenza is important Seems to be true; does seem to have significant M&M

40. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known

41. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known Part of larger problem “Influenza-like-illness”

42. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known Part of larger problem “Influenza-like-illness” Don’t routinely test those with ILI for influenza

43. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known Part of larger problem “Influenza-like-illness” Don’t routinely test those with ILI for influenza Pub Health Canada reported 3,450 hospitalizations and 189 deaths in their report 2-8 March 2014

44. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known Part of larger problem “Influenza-like-illness” Don’t routinely test those with ILI for influenza Pub Health Canada reported 3,450 hospitalizations and 189 deaths in their report 2-8 March 2014 Mathematical models say 2000-8000 deaths each year

45. Influenza is important Seems to be true; does seem to have significant M&M Exact burden of disease not known Part of larger problem “Influenza-like-illness” Don’t routinely test those with ILI for influenza Pub Health Canada reported 3,450 hospitalizations and 189 deaths in their report 2-8 March 2014 Mathematical models say 2000-8000 deaths each year May be more, may be less.

46. Influenza is important Can accept this, with proviso – morbidity and mortality not exactly known

47. Vaccine is very effective “Vaccine is very successful in limiting the spread and impact of influenza.”

48. Vaccine is very effective Bad year = 44% effective (95% CI 23% to 59%) Good year = 73% effective (95% CI 54% to 84%) Jefferson T et al. Vaccines for preventing influenza in healthy adults (Review). Cochrane Database of Systematic Reviews, Issue 6, 2013

49. Vaccine is very effective Bad year = 44% effective (95% CI 23% to 59%) Good year = 73% effective (95% CI 54% to 84%) Results of review: Influenza vaccination had modest effect in time off work and limiting influenza duration. Jefferson T et al. Vaccines for preventing influenza in healthy adults (Review). Cochrane Database of Systematic Reviews, Issue 6, 2013

50. Vaccine is very effective Bad year = 44% effective (95% CI 23% to 59%) Good year = 73% effective (95% CI 54% to 84%) Results of review: Influenza vaccination had modest effect in time off work and limiting influenza duration. No evidence for reducing complications of ILI or transmission Jefferson T et al. Vaccines for preventing influenza in healthy adults (Review). Cochrane Database of Systematic Reviews, Issue 6, 2013

51. Vaccine is very effective No impact on influenza mortality by raising vaccine coverage rates Even rates up to 65% made no difference Observational studies have substantially overestimated benefit of influenza vaccination Simonsen et al. Impact of the Influenza Vaccination on the Seasonal Mortality in the US Elderly Population. Arch Intern Med 2005;165:265-272

52. Vaccine is very effective Vaccine “modest” in over 65’s Some data that vaccinating children prevents spread to household members Thus, focusing on “super-spreaders” World Health Organization. Vaccines against influenza WHO position paper - November 2012. Weekly epidemiological record. No. 47,2012,87,461-476

53. Vaccine is very effective “Vaccine is very successful in limiting the spread and impact of influenza.”

54. Vaccine is very effective “Vaccine is very successful in limiting the spread and impact of influenza.” Would have to dispute this premise. Evidence of moderate efficacy with modest benefit.

55. Vaccinating HCW protects pt’s “Vaccinating healthcare workers provides protection to patients” or “Vaccinating healthcare workers prevents harm to patients” Possibly the key premise.

56. Vaccinating HCW protects pt’s Question 1: What is a healthcare worker?

57. Vaccinating HCW protects pt’s Question 1: What is a healthcare worker? Question 2: What is the evidence for this?

58. Vaccinating HCW protects pt’s Many ethical writers employ “The Argument”

59. Vaccinating HCW protects pt’s Many ethical writers employ “The Argument” Refer to 1 or more of 3 studies: 1) Potter et al. Influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. Journal of Infectious Diseases 1997;175(1):1–6. 2) Carman et al. Effects of influenza vaccination of health-care workers on mortality of elderly people in longterm care: a randomised controlled trial. Lancet 2000;355(9198):93–7. 3) Hayward et al. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ 2006;333(7581):1241

60. Vaccinating HCW protects pt’s Two interesting facts about these 3 articles:

61. Vaccinating HCW protects pt’s Two interesting facts about these 3 articles: 1) All done in nursing home/care home setting

62. Vaccinating HCW protects pt’s Two interesting facts about these 3 articles: 1) All done in nursing home/care home setting 2) All 3 have been included in a meta-analysis Thomas RE, Jefferson T, Lasserson TJ. Influenza vaccination for healthcare workers who care for people aged 60 or older living in long-term care institutions (Review). The Cochrane Database of Systematic Reviews, Issue 7, 2013

63. Vaccinating HCW protects pt’s Cochrane review found: -No evidence that vaccinating HCW prevents laboratory-proven influenza of its complications in LTC -No evidence that supports mandatory vaccination of HCW -These three studies were at some risk of bias, and none showed positive protection to patients -High quality RCT is needed Thomas RE, Jefferson T, Lasserson TJ. Influenza vaccination for healthcare workers who care for people aged 60 or older living in long-term care institutions (Review). The Cochrane Database of Systematic Reviews, Issue 7, 2013

64. Vaccinating HCW protects pt’s “Vaccinating healthcare workers provides protection to patients” or “Vaccinating healthcare workers prevents harm to patients”

65. Vaccinating HCW protects pt’s “Vaccinating healthcare workers provides protection to patients” or “Vaccinating healthcare workers prevents harm to patients” - No evidence of this

66. Vaccinating HCW protects pt’s “Vaccinating healthcare workers provides protection to patients” or “Vaccinating healthcare workers prevents harm to patients” -No evidence of this -Not clear how to define HCW

67. Vaccinating HCW protects pt’s “Vaccinating healthcare workers provides protection to patients” or “Vaccinating healthcare workers prevents harm to patients” -No evidence of this -Not clear how to define HCW -Vaccine moderately effective, many HCW still susceptible despite vaccine

68. Low risk of harm Minor side-effects Only serious ones: Anaphylaxis Guillain-Barre (possible link, less than 1 in a million) THUS: very low risk of harm from getting vaccine

69. Masks are effective “Using masks is effective to prevent spread in the unvaccinated”

70. Masks are effective Is there evidence? Study shows that masks do not stop influenza droplets. (Neither does cough etiquette) Zayas G, Chiang MC, Wong E, MacDonald F et al. Effectiveness of cough etiquette maneuvers in disrupting the chain of transmission of infectious respiratory diseases. BMC Public Health 2013, 13:811

71. Masks are effective Conundrum:

72. Masks are effective Conundrum: If masks work – we should all use them!

73. Masks are effective Conundrum: If masks work – we should all use them! Same justification as The Argument.

74. Masks are effective Conundrum: If masks work – we should all use them! Same justification as The Argument. Vaccine only provides protection to some; thus ALL should mask

75. Masks are effective Conundrum: If masks work – we should all use them! Same justification as The Argument. Vaccine only provides protection to some; thus ALL should mask If masks don’t work – why use them as alternative to vaccination?

76. Masks are effective Conundrum: If masks work – we should all use them! Same justification as The Argument. Vaccine only provides protection to some; thus ALL should mask If masks don’t work – why use them as alternative to vaccination? Is this punitive? Surely there are more effective punitive measures?

77. Masks are effective “Using masks is effective to prevent spread in the unvaccinated”

78. Masks are effective “Using masks is effective to prevent spread in the unvaccinated” Masks are not effective

79. Masks are effective “Using masks is effective to prevent spread in the unvaccinated” Masks are not effective Unreasonable to use as punitive measure. No place in contemporary healthcare.

80. Masks are effective “Using masks is effective to prevent spread in the unvaccinated” Masks are not effective Unreasonable to use as punitive measure. No place in contemporary healthcare. If it was effective, everyone would have to use masks, vaccinated or not

81. The Argument Burden of disease uncertain, but significant

82. The Argument Burden of disease uncertain, but significant Vaccine only moderately effective.

83. The Argument Burden of disease uncertain, but significant Vaccine only moderately effective. No evidence of benefit to patients or preventing harm by vaccinating HCW

84. The Argument Burden of disease uncertain, but significant Vaccine only moderately effective. No evidence of benefit to patients or preventing harm by vaccinating HCW Low risk of harm - acceptable

85. The Argument Burden of disease uncertain, but significant Vaccine only moderately effective. No evidence of benefit to patients or preventing harm by vaccinating HCW Low risk of harm – acceptable Masks don’t work. If they did everyone would have to use them. Unreasonable to use punitive measures.

86. The Argument Burden of disease uncertain, but significant Vaccine only moderately effective. No evidence of benefit to patients or preventing harm by vaccinating HCW Low risk of harm – acceptable Masks don’t work. If they did everyone would have to use them. Unreasonable to use punitive measures. THUS: The Argument is not successful.

87. Other ethical considerations Unjustified use of power; Freedom a cherished value, need strong ethical reason to overrule

88. Other ethical considerations Unjustified use of power; Freedom a cherished value, need strong ethical reason to overrule Money/time spent on mandatory vaccination could be spent elsewhere – justice in distribution of finite resources

89. Other ethical considerations Unjustified use of power; Freedom a cherished value, need strong ethical reason to overrule Money/time spent on mandatory vaccination could be spent elsewhere – justice in distribution of finite resources Industry’s influence. Studies and some ethics writers.

90. Other ethical considerations Unjustified use of power; Freedom a cherished value, need strong ethical reason to overrule Money/time spent on mandatory vaccination could be spent elsewhere – justice in distribution of finite resources Industry’s influence. Studies and some ethics writers. Industry: urgently need better vaccine

91. Other ethical considerations Unjustified use of power; Freedom a cherished value, need strong ethical reason to overrule Money/time spent on mandatory vaccination could be spent elsewhere – justice in distribution of finite resources Industry’s influence. Studies and some ethics writers. Industry: urgently need better vaccine Too much focus on moderate efficacy vaccine may dilute public confidence in very effective vaccines

92. Conclusion Mandated HCW influenza vaccinations seem unjustified

93. Conclusion Mandated HCW influenza vaccinations seem unjustified Can recommend influenza vaccine to HCW and pt’s – moderate efficacy and very low risk of harm

94. Conclusion Mandated HCW influenza vaccinations seem unjustified Can recommend influenza vaccine to HCW and pt’s – moderate efficacy and very low risk of harm Should focus efforts on “super-spreaders”

95. Conclusion Mandated HCW influenza vaccinations seem unjustified Can recommend influenza vaccine to HCW and pt’s – moderate efficacy and very low risk of harm Should focus efforts on “super-spreaders” Review the influence of industry

96. Conclusion Mandated HCW influenza vaccinations seem unjustified Can recommend influenza vaccine to HCW and pt’s – moderate efficacy and very low risk of harm Should focus efforts on “super-spreaders” Review the influence of industry We need a better vaccine. Is this perhaps where moral weight lies?