Editorial
The evidence, ethics and politics of mandatory health care worker vaccination
Yearly epidemics of influenza are associated with 3–5 million cases of severe illness and about 250,000 to 500,000 deaths worldwide. Influenza symptoms such as cough, fever, headache and myalgia can last for about a week, and most people recover. However, particularly among high-risk groups including the elderly or chronically ill, influenza can lead to hospitalization and death, as well as complications including cardiovascular disease and exacerbations of chronic obstructive pulmonary disease.1 Vaccination programmes for residents of hospitals and seniors’ residences have been shown to reduce morbidity and mortality.2 Influenza vaccination is also recommended for health care workers in hospitals and in seniors’ residences (care homes) because of the risks of transmitting influenza to their patients.3 However, voluntary influenza vaccination uptake among health care workers remains low in most high-income countries.4 Because of this, one approach increasingly considered is mandatory vaccination as a condition of employment. A review of United States hospitals with mandatory vaccination policies found that such policies improved vaccination uptake from 64% to over 90%.5
Journal of Health Services Research & Policy 2015, Vol. 20(1) 1–3 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1355819614546960 jhsrp.rsmjournals.com
Cochrane meta-analysis) and four observational studies came to a different conclusion. They agreed that there is no evidence that vaccination of health care workers decreases the frequency of laboratory-confirmed influenza in patients.9 However, they found that vaccination decreased all-cause mortality among patients (a 29% relative risk reduction) and influenza-like-illness by 42%. They graded the quality of the evidence for the impact of health care worker vaccination on these two outcomes measures as moderate and low, respectively. The main reason for the different conclusions of these two systematic reviews was disagreement about the outcomes of interest. Thomas et al. focused on laboratory-confirmed influenza and hospitalization and argued that all-cause mortality and influenza-like-illness were insufficiently closely causally linked to be valid outcomes (they thus excluded one of the larger, higher quality randomized trials).10 On the other hand, Ahmed et al. argued that laboratory-confirmed influenza has major limitations as an outcome measure, and that all-cause mortality is a more appropriate outcome measure, given its obvious clinical importance and the broad clinical impact of influenza on sick, elderly hospitalized patients.
The evidence for and against health care worker vaccinations
Mandatory vaccination policies
While there is a consensus that research evidence supports voluntary vaccination programmes for health care workers, debate continues as to whether the evidence is sufficient to support mandatory vaccination policies.6,7 Despite two recently published meta-analyses of the effect of health care worker vaccination on patient outcomes reviewing many of the same studies, they emphasized different outcome measures and came to different conclusions. A Cochrane meta-analysis by Thomas et al.8 of three cluster randomized trials and one cohort study of influenza vaccination in seniors’ residences found no evidence that vaccinating health care workers can prevent laboratory-confirmed influenza or associated complications in patients. In contrast, a systematic review by Ahmed et al. of four cluster randomized trials (three of which were included in the
Despite debate about the evidence, some governments and health care organizations have judged that the evidence is sufficiently strong to justify mandatory vaccination policies for health care workers. Virginia Mason Medical Centre in Seattle, Washington, was one of the first organizations to implement such a policy in 2005, and many organizations and states in the United States have followed.11 In 2012, British Columbia was the first province in Canada to institute a policy requiring that health care workers receive the mandatory vaccine or wear a mask in patient care areas throughout the influenza season, as a condition of employment.12 The policy was implemented by the leadership council of the province’s Medical Officers of Health and came after several years of unsuccessful efforts to increase health care worker vaccination rates. In 2007, targets were set for
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
2
Journal of Health Services Research & Policy 20(1)
60% vaccination coverage for acute care workers, and 80% coverage for seniors’ residential care workers. From 2004 to 2011/2012, vaccination coverage for acute care staff ranged between 35% to 46% and 49% to 68% for seniors’ residential care staff.13,14
Why are voluntary vaccination rates so low? The side effects of the influenza vaccine are low, with the most common adverse effect being pain at the injection site. No differences between placebo and control groups were found in the most frequently described side effects of headache, malaise and myalgia. Guillain– Barre´ syndrome, a serious adverse effect, occurs in 0.70 per million vaccinations and is seen in a similar or greater frequency in individuals with influenza.15,16 There is a disconnection between the evidence supporting the low frequency of serious vaccine side effects and the perceptions of health care workers. Voluntary vaccination rates among health care workers remain low in spite of dedicating staff and resources to increase uptake through strategies such as education campaigns and mobile programmes, aimed at making the vaccine accessible and convenient. A survey of nurses at a University Hospital in London, UK, found respondents’ main reasons for non-uptake of the vaccine were concern about side effects (63%), lack of need to be vaccinated due to perceived high personal immunity (56%) and doubts about the vaccine’s effectiveness (36%).17
The ethics of mandatory vaccination In 2008, the European Scientific Working Group on Influenza conducted an analysis of the ethical arguments for and against mandatory vaccination programmes in health care workers. Mandatory vaccination policies have been justified by the professional obligation to do no harm to patients, as well as concern that if health care workers do not get vaccinated it will be harder to convince patients and the public to get vaccinated. Contrasted against the obligation to do no harm is the interference of mandatory vaccination with health care workers’ personal autonomy. Given the quality of the evidence about the impact of influenza vaccination of health care workers on influenza rates of their patients, the Working Group suggested that mandatory programmes should only be put in place if less than 50% of health care workers comply with vaccination.18
Union opposition to mandatory vaccination policies While most health care worker associations and unions across Canada strongly encourage members to be
vaccinated, they have generally taken a stance against mandatory programmes, arguing that they are an infringement of workers’ rights and personal autonomy. For example, the Canadian Federation of Nurses Unions released a statement that decried mandatory vaccination as not rooted in sound evidence, invasive and unethical, saying such policies deny ‘individuals the opportunity and right to make decisions about their own health and welfare’.19 However, some heath care worker associations have supported mandatory vaccination. The Canadian Nurses Association has stated that when voluntary programmes do not meet immunization levels protective to patients, and other strategies to increase uptake have failed, mandatory vaccination as a condition of employment is reasonable.20 These disagreements have gone to court. A grievance filed by a health workers’ union against the British Columbia mandatory policy was unsuccessful when it was taken to the province’s Labour Relations Board. The policy was found to be a reasonable exercise of an employer’s rights given its objective of improving patient safety, with the option for health care workers to wear a mask if they chose not to be vaccinated. The arbitrator pointed to many other organizations and jurisdictions implementing similar mandatory policies as further evidence for its reasonableness.21 The British Columbia policy and subsequent responses have been watched closely across Canada. Other health care organizations have moved towards mandatory policies, with a New Brunswick health authority and several Ontario hospitals recently instituting mandatory policies.22 There is speculation that with the British Columbia Labour Relations Board ruling in favour of employers’ mandatory vaccination policies, more will follow suit. It appears as if increasing numbers of hospitals and health authorities accept the evidence in favour of mandatory vaccination and that the obligations of health care workers to do no harm are felt to be sufficient to justify these policies. References 1. World Health Organization. Influenza (seasonal), www.who.int/mediacentre/factsheets/fs211/en/ (2014, accessed 3 June 2014). 2. Nichol KL, Nordin J, Mullooly J, et al. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med 2003; 348: 1322–1332. 3. van Essen GA, Palache AM, Forleo E, et al. Influenza vaccination in 2000: recommendations and vaccine use in 50 developed and rapidly developing countries. Vaccine 2003; 21: 1780–1785.
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
Editorial
3
4. Caban-Martinez AJ, Lee DJ, Davila EP, et al. Sustained low influenza vaccination rates in US healthcare workers. Prevent Med 2010; 50: 210–212. 5. Zimmerman RK, Lin CJ, Raymund M, et al. Hospital policies, state laws, and healthcare worker influenza vaccination rates. Infect Contr Hosp Epidemiol 2013; 34: 854–857. 6. Flegel K. Editorial: health care workers must protect patients from influenza by taking the annual vaccine. Can Med Assoc J 2012; 184: 1873. 7. Gardam M and Lemieux C. Mandatory influenza vaccination? First we need a better vaccine. Can Med Assoc J 2013; 185: 639–640. 8. Thomas RE, Jefferson T and Lasserson J. Influenza vaccination for healthcare workers who care for people aged 60 or older living in long-term care institutions. Cochrane Database Syst Rev 2013; 7: CD005187. 9. Ahmed F, Lindley MC, Weinbaum CM, et al. Effect of influenza vaccination of healthcare personnel on morbidity and mortality amongst patients: systematic review and grading of evidence. Clini Infect Dis 2014; 58: 50–57. 10. Griffin M. Editorial commentary: influenza vaccination for healthcare workers: making the grade for action. Clini Infect Dis 2014; 58: 58–60. 11. Rakita RM, Hagar BA, Crome P, et al. Mandatory influenza vaccination of healthcare workers: a 5-year study. Infect Contr Hosp Epidemiol 2010; 31: 881–888. 12. BC Centre for Disease Control. BC influenza prevention policy: a discussion of the evidence, www.bccdc.ca/NR/rdonlyres/C5263063-8A30-4866-A6D7-AF1381C1469A/0/ Influenza_prevention_policy_evidence_discussionFINAL. pdf (2013, accessed 3 June 2014). 13. BC Centre for Disease Control. Influenza vaccination coverage for staff of acute care facilities British Columbia, 2012/2013, www.bccdc.ca/NR/rdonlyres/ E438A008-6F24-4F0A-9685-5174A4D78CB9/0/ FlucoverageacuteHCWs2013_06_13.pdf (2012/2013, accessed 3 June 2014). 14. BC Centre for Disease Control. Influenza vaccination coverage for staff of residential care facilities British Columbia, 2012/2013, www.bccdc.ca/NR/rdonlyres/ AF1BE021-6259-4085-99FC-1F97CFF21DAA/0/ FlucoverageresidentialHCWs2013_06_13.pdf (2012/2013, accessed 3 June 2014). 15. Vellozzi C, Burwen DR, Dobardzic A, et al. Safety of trivalent inactivated influenza vaccines in adults:
16.
17.
18.
19.
20.
21.
22.
background for pandemic influenza vaccination safety monitoring. Vaccine 2009; 27: 2114–2120. Kwong JC, Vasa PP, Campitelli MA, et al. Risk of Guillain-Barre´ syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study. Lancet Infect Dis 2013; 13: 769–776. Zhang J, While AE and Norman IJ. Seasonal influenza vaccination knowledge, risk perception, health beliefs and vaccination behaviors of nurses. Epidemiol Infect 2012; 140: 1569–1577. van Delden JJM, Ashcroft R, Dawson A, et al. The ethics of mandatory vaccination against influenza for health care workers. Vaccine 2008; 26: 5562–5566. Canadian Federation of Nurses Union. CFNU position statement on mandatory influenza immunization of nurses, http://nursesunions.ca/sites/default/files/postition_statement_mandatory_immunization.pdf (2012, accessed 3 June 2014). Canadian Nurses Association. Position statement: influenza immunization of registered nurses, www.cna-aiic.ca/ /media/cna/page%20content/pdf%20fr/ps_influenza_immunization_for_rns_e.pdf (2012, accessed 4 June 2014). Influenza Control Policy Grievance. Between health employers association of British Columbia and health sciences association, http://www.cna-aiic.ca//media/ cna/page-content/pdf-fr/ps_influenza_immunization_ for_rns_e.pdf (accessed 30 July 2014). Gruben V, Siemieniuk RA and McGeer A. Health care workers, mandatory influenza vaccination policies and the law. Can Med Assoc J. Epub ahead of print 26 May 2014.
Karen Born1, Sophia Ikura2 and Andreas Laupacis3 1 Research Writer, Keenan Research Centre, University of Toronto, Canada Email: [email protected] 2 Senior Director of Community Engagement and Corporate Affairs, Toronto Central Local Health Integration Network and Faculty of Medicine, University of Toronto, Canada 3 Executive Director, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Faculty of Medicine, University of Toronto, Canada
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
The evidence, ethics and politics of mandatory health care worker vaccination
Yearly epidemics of influenza are associated with 3–5 million cases of severe illness and about 250,000 to 500,000 deaths worldwide. Influenza symptoms such as cough, fever, headache and myalgia can last for about a week, and most people recover. However, particularly among high-risk groups including the elderly or chronically ill, influenza can lead to hospitalization and death, as well as complications including cardiovascular disease and exacerbations of chronic obstructive pulmonary disease.1 Vaccination programmes for residents of hospitals and seniors’ residences have been shown to reduce morbidity and mortality.2 Influenza vaccination is also recommended for health care workers in hospitals and in seniors’ residences (care homes) because of the risks of transmitting influenza to their patients.3 However, voluntary influenza vaccination uptake among health care workers remains low in most high-income countries.4 Because of this, one approach increasingly considered is mandatory vaccination as a condition of employment. A review of United States hospitals with mandatory vaccination policies found that such policies improved vaccination uptake from 64% to over 90%.5
Journal of Health Services Research & Policy 2015, Vol. 20(1) 1–3 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1355819614546960 jhsrp.rsmjournals.com
Cochrane meta-analysis) and four observational studies came to a different conclusion. They agreed that there is no evidence that vaccination of health care workers decreases the frequency of laboratory-confirmed influenza in patients.9 However, they found that vaccination decreased all-cause mortality among patients (a 29% relative risk reduction) and influenza-like-illness by 42%. They graded the quality of the evidence for the impact of health care worker vaccination on these two outcomes measures as moderate and low, respectively. The main reason for the different conclusions of these two systematic reviews was disagreement about the outcomes of interest. Thomas et al. focused on laboratory-confirmed influenza and hospitalization and argued that all-cause mortality and influenza-like-illness were insufficiently closely causally linked to be valid outcomes (they thus excluded one of the larger, higher quality randomized trials).10 On the other hand, Ahmed et al. argued that laboratory-confirmed influenza has major limitations as an outcome measure, and that all-cause mortality is a more appropriate outcome measure, given its obvious clinical importance and the broad clinical impact of influenza on sick, elderly hospitalized patients.
The evidence for and against health care worker vaccinations
Mandatory vaccination policies
While there is a consensus that research evidence supports voluntary vaccination programmes for health care workers, debate continues as to whether the evidence is sufficient to support mandatory vaccination policies.6,7 Despite two recently published meta-analyses of the effect of health care worker vaccination on patient outcomes reviewing many of the same studies, they emphasized different outcome measures and came to different conclusions. A Cochrane meta-analysis by Thomas et al.8 of three cluster randomized trials and one cohort study of influenza vaccination in seniors’ residences found no evidence that vaccinating health care workers can prevent laboratory-confirmed influenza or associated complications in patients. In contrast, a systematic review by Ahmed et al. of four cluster randomized trials (three of which were included in the
Despite debate about the evidence, some governments and health care organizations have judged that the evidence is sufficiently strong to justify mandatory vaccination policies for health care workers. Virginia Mason Medical Centre in Seattle, Washington, was one of the first organizations to implement such a policy in 2005, and many organizations and states in the United States have followed.11 In 2012, British Columbia was the first province in Canada to institute a policy requiring that health care workers receive the mandatory vaccine or wear a mask in patient care areas throughout the influenza season, as a condition of employment.12 The policy was implemented by the leadership council of the province’s Medical Officers of Health and came after several years of unsuccessful efforts to increase health care worker vaccination rates. In 2007, targets were set for
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
2
Journal of Health Services Research & Policy 20(1)
60% vaccination coverage for acute care workers, and 80% coverage for seniors’ residential care workers. From 2004 to 2011/2012, vaccination coverage for acute care staff ranged between 35% to 46% and 49% to 68% for seniors’ residential care staff.13,14
Why are voluntary vaccination rates so low? The side effects of the influenza vaccine are low, with the most common adverse effect being pain at the injection site. No differences between placebo and control groups were found in the most frequently described side effects of headache, malaise and myalgia. Guillain– Barre´ syndrome, a serious adverse effect, occurs in 0.70 per million vaccinations and is seen in a similar or greater frequency in individuals with influenza.15,16 There is a disconnection between the evidence supporting the low frequency of serious vaccine side effects and the perceptions of health care workers. Voluntary vaccination rates among health care workers remain low in spite of dedicating staff and resources to increase uptake through strategies such as education campaigns and mobile programmes, aimed at making the vaccine accessible and convenient. A survey of nurses at a University Hospital in London, UK, found respondents’ main reasons for non-uptake of the vaccine were concern about side effects (63%), lack of need to be vaccinated due to perceived high personal immunity (56%) and doubts about the vaccine’s effectiveness (36%).17
The ethics of mandatory vaccination In 2008, the European Scientific Working Group on Influenza conducted an analysis of the ethical arguments for and against mandatory vaccination programmes in health care workers. Mandatory vaccination policies have been justified by the professional obligation to do no harm to patients, as well as concern that if health care workers do not get vaccinated it will be harder to convince patients and the public to get vaccinated. Contrasted against the obligation to do no harm is the interference of mandatory vaccination with health care workers’ personal autonomy. Given the quality of the evidence about the impact of influenza vaccination of health care workers on influenza rates of their patients, the Working Group suggested that mandatory programmes should only be put in place if less than 50% of health care workers comply with vaccination.18
Union opposition to mandatory vaccination policies While most health care worker associations and unions across Canada strongly encourage members to be
vaccinated, they have generally taken a stance against mandatory programmes, arguing that they are an infringement of workers’ rights and personal autonomy. For example, the Canadian Federation of Nurses Unions released a statement that decried mandatory vaccination as not rooted in sound evidence, invasive and unethical, saying such policies deny ‘individuals the opportunity and right to make decisions about their own health and welfare’.19 However, some heath care worker associations have supported mandatory vaccination. The Canadian Nurses Association has stated that when voluntary programmes do not meet immunization levels protective to patients, and other strategies to increase uptake have failed, mandatory vaccination as a condition of employment is reasonable.20 These disagreements have gone to court. A grievance filed by a health workers’ union against the British Columbia mandatory policy was unsuccessful when it was taken to the province’s Labour Relations Board. The policy was found to be a reasonable exercise of an employer’s rights given its objective of improving patient safety, with the option for health care workers to wear a mask if they chose not to be vaccinated. The arbitrator pointed to many other organizations and jurisdictions implementing similar mandatory policies as further evidence for its reasonableness.21 The British Columbia policy and subsequent responses have been watched closely across Canada. Other health care organizations have moved towards mandatory policies, with a New Brunswick health authority and several Ontario hospitals recently instituting mandatory policies.22 There is speculation that with the British Columbia Labour Relations Board ruling in favour of employers’ mandatory vaccination policies, more will follow suit. It appears as if increasing numbers of hospitals and health authorities accept the evidence in favour of mandatory vaccination and that the obligations of health care workers to do no harm are felt to be sufficient to justify these policies. References 1. World Health Organization. Influenza (seasonal), www.who.int/mediacentre/factsheets/fs211/en/ (2014, accessed 3 June 2014). 2. Nichol KL, Nordin J, Mullooly J, et al. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med 2003; 348: 1322–1332. 3. van Essen GA, Palache AM, Forleo E, et al. Influenza vaccination in 2000: recommendations and vaccine use in 50 developed and rapidly developing countries. Vaccine 2003; 21: 1780–1785.
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
Editorial
3
4. Caban-Martinez AJ, Lee DJ, Davila EP, et al. Sustained low influenza vaccination rates in US healthcare workers. Prevent Med 2010; 50: 210–212. 5. Zimmerman RK, Lin CJ, Raymund M, et al. Hospital policies, state laws, and healthcare worker influenza vaccination rates. Infect Contr Hosp Epidemiol 2013; 34: 854–857. 6. Flegel K. Editorial: health care workers must protect patients from influenza by taking the annual vaccine. Can Med Assoc J 2012; 184: 1873. 7. Gardam M and Lemieux C. Mandatory influenza vaccination? First we need a better vaccine. Can Med Assoc J 2013; 185: 639–640. 8. Thomas RE, Jefferson T and Lasserson J. Influenza vaccination for healthcare workers who care for people aged 60 or older living in long-term care institutions. Cochrane Database Syst Rev 2013; 7: CD005187. 9. Ahmed F, Lindley MC, Weinbaum CM, et al. Effect of influenza vaccination of healthcare personnel on morbidity and mortality amongst patients: systematic review and grading of evidence. Clini Infect Dis 2014; 58: 50–57. 10. Griffin M. Editorial commentary: influenza vaccination for healthcare workers: making the grade for action. Clini Infect Dis 2014; 58: 58–60. 11. Rakita RM, Hagar BA, Crome P, et al. Mandatory influenza vaccination of healthcare workers: a 5-year study. Infect Contr Hosp Epidemiol 2010; 31: 881–888. 12. BC Centre for Disease Control. BC influenza prevention policy: a discussion of the evidence, www.bccdc.ca/NR/rdonlyres/C5263063-8A30-4866-A6D7-AF1381C1469A/0/ Influenza_prevention_policy_evidence_discussionFINAL. pdf (2013, accessed 3 June 2014). 13. BC Centre for Disease Control. Influenza vaccination coverage for staff of acute care facilities British Columbia, 2012/2013, www.bccdc.ca/NR/rdonlyres/ E438A008-6F24-4F0A-9685-5174A4D78CB9/0/ FlucoverageacuteHCWs2013_06_13.pdf (2012/2013, accessed 3 June 2014). 14. BC Centre for Disease Control. Influenza vaccination coverage for staff of residential care facilities British Columbia, 2012/2013, www.bccdc.ca/NR/rdonlyres/ AF1BE021-6259-4085-99FC-1F97CFF21DAA/0/ FlucoverageresidentialHCWs2013_06_13.pdf (2012/2013, accessed 3 June 2014). 15. Vellozzi C, Burwen DR, Dobardzic A, et al. Safety of trivalent inactivated influenza vaccines in adults:
16.
17.
18.
19.
20.
21.
22.
background for pandemic influenza vaccination safety monitoring. Vaccine 2009; 27: 2114–2120. Kwong JC, Vasa PP, Campitelli MA, et al. Risk of Guillain-Barre´ syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study. Lancet Infect Dis 2013; 13: 769–776. Zhang J, While AE and Norman IJ. Seasonal influenza vaccination knowledge, risk perception, health beliefs and vaccination behaviors of nurses. Epidemiol Infect 2012; 140: 1569–1577. van Delden JJM, Ashcroft R, Dawson A, et al. The ethics of mandatory vaccination against influenza for health care workers. Vaccine 2008; 26: 5562–5566. Canadian Federation of Nurses Union. CFNU position statement on mandatory influenza immunization of nurses, http://nursesunions.ca/sites/default/files/postition_statement_mandatory_immunization.pdf (2012, accessed 3 June 2014). Canadian Nurses Association. Position statement: influenza immunization of registered nurses, www.cna-aiic.ca/ /media/cna/page%20content/pdf%20fr/ps_influenza_immunization_for_rns_e.pdf (2012, accessed 4 June 2014). Influenza Control Policy Grievance. Between health employers association of British Columbia and health sciences association, http://www.cna-aiic.ca//media/ cna/page-content/pdf-fr/ps_influenza_immunization_ for_rns_e.pdf (accessed 30 July 2014). Gruben V, Siemieniuk RA and McGeer A. Health care workers, mandatory influenza vaccination policies and the law. Can Med Assoc J. Epub ahead of print 26 May 2014.
Karen Born1, Sophia Ikura2 and Andreas Laupacis3 1 Research Writer, Keenan Research Centre, University of Toronto, Canada Email: [email protected] 2 Senior Director of Community Engagement and Corporate Affairs, Toronto Central Local Health Integration Network and Faculty of Medicine, University of Toronto, Canada 3 Executive Director, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Faculty of Medicine, University of Toronto, Canada
Downloaded from hsr.sagepub.com at University of St Andrews on March 16, 2015
