Ethics Influenza vaccines Healthcare workers

EthicsInfluenza vaccines Healthcare workersJohan Bester (MBChB, Mphil Applied Ethics)Department of Family Medicine, University of Calgary

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

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

Los Angeles County• “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.”

British Columbia• Recently passed similar requirement

Pushback• Not accepted by all staff

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

Objectives• Ethical basis for such requirements

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

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

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

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

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

patients• Duty to do no harm, vaccination prevents harm

patients• Duty to do no harm, vaccination prevents harm• Protect the vulnerable, vaccination prevents spread to the

vulnerable

vulnerable• Obligation to set an example for the public

vulnerable• Obligation to set an example for the public• Voluntary measures failed to ensure adequate vaccination

vulnerable• Obligation to set an example for the public• Voluntary measures failed to ensure adequate vaccination• Mandatory vaccination policies increase vacc rates

vulnerable• Obligation to set an example for the public• Voluntary measures failed to ensure adequate vaccination• Mandatory vaccination policies increase vacc ratesTHUS: Ethical to have a mandatory vaccination policy

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

low risk of harm• Beneficence and non-maleficence trump personal autonomy

for HCW in this case

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)

may not be feasible (eg work absence or neg press ventilation)• Mandatory programs with infect control measures for non-

compliance ensures best vaccination coverage

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

The Argument • Significant illness/burden of disease

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

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

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

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

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

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/rightsThus: Justified to impose program of mandatedInfluenza vaccination on HCWOpt-out: wear a mask during flu season

An Argument:• Premise 1• Premise 2 Conclusion: Follows from premise 1 and 2

Examining an argument:Are the premises true?Is the logic sound?

Important premises in The Argument• Influenza is an important public health problem with

significant mortality and morbidity

significant mortality and morbidity• Vaccination is very successful in limiting spread and impact

significant mortality and morbidity• Vaccination is very successful in limiting spread and impact• Vaccinating HCW provides protection to patients

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

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)

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

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

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”

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

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

deaths in their report 2-8 March 2014• Mathematical models say 2000-8000 deaths each year

deaths in their report 2-8 March 2014• Mathematical models say 2000-8000 deaths each year• May be more, may be less.

Influenza is important• Can accept this, with proviso – morbidity and mortality not

exactly known

Vaccine is very effective • “Vaccine is very successful in limiting the spread and impact of

influenza.”

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

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.

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

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

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

influenza.”

influenza.”• Would have to dispute this premise. Evidence of moderate

efficacy with modest benefit.

Vaccinating HCW protects pt’s

“Vaccinating healthcare workers provides protection to patients”or “Vaccinating healthcare workers prevents harm to patients”

Possibly the key premise.

Question 1: What is a healthcare worker?

Question 2: What is the evidence for this?

Many ethical writers employ “The Argument”

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 randomisedcontrolled trial. BMJ 2006;333(7581):1241

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

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

- No evidence of this

- No evidence of this- Not clear how to define HCW

- No evidence of this- Not clear how to define HCW - Vaccine moderately effective, many HCW stillsusceptible despite vaccine

Low risk of harm• Minor side-effects• Only serious ones: AnaphylaxisGuillain-Barre (possible link, less than 1 in a million)

THUS: very low risk of harm from getting vaccine

Masks are effective• “Using masks is effective to prevent spread in the

unvaccinated”

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

Masks are effective• Conundrum:

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

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

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?

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 effectivepunitive measures?

unvaccinated”

unvaccinated”• Masks are not effective

unvaccinated”• Masks are not effective• Unreasonable to use as punitive measure. No place in

contemporary healthcare.

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

The Argument • Burden of disease uncertain, but significant

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

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

vaccinating HCW

vaccinating HCW• Low risk of harm - acceptable

vaccinating HCW• Low risk of harm – acceptable• Masks don’t work. If they did everyonewould have to use them. Unreasonable to usepunitive measures.

vaccinating HCW• Low risk of harm – acceptable• Masks don’t work. If they did everyonewould have to use them. Unreasonable to usepunitive measures.THUS:The Argument is not successful.

Other ethical considerations• Unjustified use of power; Freedom a cherished value, need

strong ethical reason to overrule

strong ethical reason to overrule• Money/time spent on mandatory vaccination could be spent

elsewhere – justice in distribution of finite resources

elsewhere – justice in distribution of finite resources• Industry’s influence. Studies and some ethics writers.

elsewhere – justice in distribution of finite resources• Industry’s influence. Studies and some ethics writers.• Industry: urgently need better vaccine

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 invery effective vaccines

Conclusion• Mandated HCW influenza vaccinations seem unjustified

Conclusion• Mandated HCW influenza vaccinations seem unjustified• Can recommend influenza vaccine to HCW and pt’s –

moderate efficacy and very low risk of harm

moderate efficacy and very low risk of harm• Should focus efforts on “super-spreaders”

moderate efficacy and very low risk of harm• Should focus efforts on “super-spreaders”• Review the influence of industry

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

Ethics Influenza vaccines Healthcare workers

Documents

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