Mandating influenza vaccination for healthcare workers

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Mandating influenza vaccination for healthcare workers Expert Rev. Vaccines 8(11), 1469–1474 (2009)

Seth J Sullivan, MD, MPH Mayo Clinic Vaccine Research Group, Mayo Clinic, Rochester, MN 55905, USA Tel.: +1 507 255 7763 [email protected]

Robert Jacobson, MD Mayo Clinic Vaccine Research Group and the Program in Translational Immunovirology and Biodefense, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN 55905, USA Tel.: +1 507 266 4598 jacobson.robert @mayo.edu

Gregory A Poland, MD Author for correspondence

Mayo Clinic Vaccine Research Group and the Program in Translational Immunovirology and Biodefense, Department of Internal Medicine, Mayo Clinic, 611C Guggenheim Building, 200 First Street SW, Rochester, MN 55905, USA Tel.: +1 507 284 4968 Fax: +1 507 266 4716 poland.gregory @mayo.edu

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“...vaccination of healthcare workers reduces influenza infection, presenteeism … and absenteeism among vaccinees, reduces transmission to other staff and, most importantly, prevents morbidity and mortality among the patients they care for.” “The truth of the matter is that you always know the right thing to do. The hard part is doing it.” Norman Schwarzkopf Despite considerable influenza-related morbidity and mortality, the recent introduction of a novel influenza  A/H1N1 virus, and transmission of oseltamivirresistant seasonal and (rarely) pandemic influenza  A viruses, unacceptably few healthcare workers (HCWs) receive influenza vaccination [1,2] . Although evidencebased recommendations have been made to remedy this important problem, data from a recent survey by the CDC indicate that in 2007 only 44% of USA HCWs were vaccinated against influenza  [3,101] . This is despite CDC recommendations since 1981 that all HCWs be vaccinated annually against influenza  [4] , and the significant visibility given to this issue by numerous recent calls by federal bodies and professional societies for HCWs to receive annual influenza vaccination [102] . These recommendations are derived from evidence that influenza vaccination of HCWs reduces influenza infection, presenteeism (reporting to work ill) and absenteeism among the vaccinees, reduces transmission to other staff and, most importantly, prevents morbidity and mortality among the patients they care for  [5–8] . In addition, influenza immunization is cost effective  [9] . Here, we brief ly review the problem, report proposed solutions, and provide recommendations which we believe best achieve the goals of patient safety and HCW protection. 10.1586/ERV.09.118

The problem

Seasonal influenza epidemics result in an average of more than 200,000 hospitalizations and 36,000 deaths in the USA every year [10,11] . The total economic burden of annual influenza epidemics in the USA has been estimated at US$87.1 billion [12] . Influenza-related morbidity and mortality are significantly increased in populations served by HCWs, including the elderly, infants and young children, immuno­ compromised and pregnant patients, as well as those with chronic medical conditions [13] .

“Seasonal influenza epidemics result in an average of more than 200,000 hospitalizations and 36,000 deaths in the USA every year.” Significant morbidity and mortality has been documented by nosocomial influenza infection of these vulnerable patient groups [14–16] . Nosocomial influenza transmission is complicated by the fact that HCWs shed the virus while asymptomatic and routinely report to work with symptomatic influenza illness [17] . An additional consideration is that influenza immunization of some vulnerable patient groups may result in suboptimal immune responses, making immunization of those in contact with them critical [18–22] . Median patient mortality rates during nosocomial influenza outbreaks have been reported to be 16% in acute care and geriatric facilities, and as high as 33–60% in transplant or intensive care units [23] .

© 2009 Expert Reviews Ltd

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The trivalent inactivated influenza vaccine has been demonstrated to be safe and effective in preventing influenza transmission in healthcare facilities and care homes [24] . Likewise, increased vaccination rates among HCWs have been associated with significant decreases in nosocomial influenza among hospitalized patients and mortality among healthcare facility residents [5,25] . An important mathematical model has demonstrated a robust and linear relationship between increased HCW influenza vaccine uptake and decreased influenza attack rates among nursing home patients [26] . This model predicts that if all HCWs in a facility were vaccinated, approximately 60% of influenza infections among patients would be prevented. Furthermore, only seven HCWs would need to be immunized to protect one patient from an influenza infection. Nosocomial influenza outbreaks cost more than lives. As early as 1993 it was estimated that each episode of nosocomial influenza cost over US$7500 [27] . Investigations of these outbreaks are also costly; the expenses incurred to investigate just three outbreaks in Thailand were tenfold higher than the estimated costs of universally vaccinating its healthcare workforce [28] . Furthermore, both absenteeism and presenteeism among HCWs afflicted with influenza illness can adversely impact the ability of an institution to deliver high-quality and safe healthcare to the patients it serves [29] .

“This level of healthcare workers vaccine uptake has failed to significantly increase over the last decade, despite tremendous visibility and both programmatic and educational efforts.” Despite this convincing evidence, vaccination rates among HCWs remain unacceptably low. Data from the 1989–2005 National Health Interview Surveys indicate that only 43.2% (range: 39.9–46.6%) of HCWs had been vaccinated [1] . This level of HCW vaccine uptake has failed to significantly increase over the last decade, despite tremendous visibility and both programmatic and educational efforts [2] . Reported barriers to influenza vaccination among healthcare workers are numerous and well documented [30] . Misperceptions regarding the severity of influenza, the risk of transmitting the infection to patients, and the safety and efficacy of influenza vaccination are both fixed and persistent despite decades of education to the contrary. Our work among registered nurses suggests that standard education approaches are ineffective in changing nurses’ perceptions of, and practice of, influenza immunization [31] . By contrast, data do suggest that previous vaccination increases the likelihood of vaccination in subsequent years. For example, a recent cross-sectional survey of all full-time emergency department staff at an urban academic medical center in Boston (MA, USA) demonstrated that respondents were more likely to get an influenza vaccine if they had been vaccinated the year before, if they believed the vaccine was effective and if they believed the side effects of the vaccine were rare [32] . Solutions

The CDC and numerous other professional societies and publichealth bodies have outlined strategies to improve HCW vaccination rates [4,33,103–105] . These include educational programs 1470

that emphasize the importance of HCW vaccination for staff and patients, organized campaigns that promote and make the vaccines available, vaccination of senior medical staff or opinion leaders as role models, removing administrative barriers and providing easily accessible vaccines. However, despite their face validity and the use of these and other enhanced methods to increase vaccination rates, little or no progress has been made in improving HCW influenza immunization rates. Analysis of surveys conducted between 1989 and 2002 demonstrated that influenza vaccination rates among HCWs only improved from 10% in 1989 to 38% in 2002, without any significant change between 1997 and 2002 [2] . The CDC also recommends that HCW vaccination rates be regularly measured and reported, and that institutions give consideration to the use of signed declination statements for those refusing vaccines, although the latter has not been supported by evidence [34] . Signed declination policies have been utilized in multiple settings with variable levels of success. A survey that reported responses from 45 infectious disease consultants who worked at institutions with influenza vaccination declination policies revealed that the use of declination policies was associated with only an 11.6% mean increase in HCW vaccination rates [35] . Although declination programs were considered mandatory at 13 of the institutions represented, there were no punitive consequences for those who refused to sign the forms. Others have reported modest success with mandatory declination forms [36] , and a recent California (USA) state law mandates that declination forms be signed by all HCWs who refuse the vaccine [106] . Despite this, overall HCW influenza immunization coverage rates remain low.

“...mandatory childhood vaccination policies in the USA have been enormously successful.” Professional societies, including the Infectious Diseases Society of America and the American College of Physicians, recommend that influenza vaccination of HCWs be made mandatory [107,108] . They point out that even with interventions that promote and provide free and accessible vaccine, healthcare facilities regularly only achieve 40–60% coverage [37,38] . A total of 15 states in the USA already regulate HCW vaccination in long-term care facilities and four require that HCWs be vaccinated, unless ­religious, philosophical or medical contraindications exist [109] . To our knowledge, no organized religion has doctrinal conflict with influenza vaccination of HCWs. Other institutions have taken a lead in patient safety by implementing mandatory HCW influenza vaccination policies. The Department of Defense requires that both military and contract civilian HCWs be annually vaccinated unless medically exempt  [110] . Civilian institutions have also adopted this measure, achieving near 100% immunization rates. For example, in response to unsuccessful voluntary immunization programs, the Virginia Mason Medical Center (Seattle, WA, USA) instituted a mandatory influenza vaccination program for all of its approximate 5000 employees in 2005 [111] . Those who refused Expert Rev. Vaccines 8(11), (2009)

Mandating influenza vaccination for healthcare workers

vaccination due to medical or religious reasons were required to wear a mask for the duration of the flu season while working. In the year of implementation, a 98% immunization rate was achieved, up from 29.5% the year prior. In 2006 and 2007, the rates were 98.5 and 99%, respectively [112] . A hospital in Kalamazoo (MI, USA) achieved a 100% success rate by making influenza immunization a minimum work requirement for personnel involved in direct patient care, allowing for medical exceptions and religious objections [113] . And, even though previously well above the national average for HCW immunization rates, beginning with the 2008 influenza season the Barnes Jewish Hospital system required annual influenza vaccinations for all of its employees as a condition of employment [114] . Their vice president of quality, Clay Dunagan, stated that such a policy is a “matter of patient safety … a very simple step we can take to reduce the transmission of influenza within our hospitals and workplaces”. They have nearly achieved 100% compliance [115] . In August 2009, the state of New York (USA) legislated mandatory annual influenza vaccination of HCWs, recognizing that such a policy “will promote the health and safety of the patients they serve and support efficient provision of services” [116] .

“Although the CDC has recommended for nearly 30 years that healthcare workers be annually immunized, we still allow trusting, unknowing and vulnerable patients to be cared for in healthcare facilities that employ unvaccinated healthcare personnel.” It has been proposed that a public health intervention should be made mandatory when it fulfills three criteria: there is clear medical value of the intervention to the individual, the public health benefit of the intervention has been made clear, and when a mandate is the only way to consistently obtain benefit [39] . Using these criteria, mandated influenza vaccination of HCWs is “sorely needed” [39] . Arguments predicated on comprehensive ethical analyses articulate that patients expect HCWs and healthcare institutions to take all reasonable measures to ensure their safety [40,41] . These analyses have thoroughly explored the biomedical ethical principles of beneficence, non-malfeasance, respect for autonomy and justice [117] . Tilburt et al. argue in favor of mandatory influenza vaccination for HCWs by pointing out that ethical healthcare organizations must “create structures in which noble ends are more likely to be achieved”, despite fear of potential push-back from employees [41] . Substantial legal precedent for mandatory vaccination exists. Every state in the USA has regulations or laws mandating vaccination for children before they enroll in public or private school [42] . All states allow for medical exemptions; all but West Virginia and Mississippi allow religious exemptions; and 20 states allow philosophical exemptions [118] . These laws have precedent with the historic Jacobson versus Massachusetts case [119] . This decision essentially established the state’s authority to implement mandatory vaccination programs in exercise of its police powers www.expert-reviews.com

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to preserve the public health. The court ruled that “the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person, to be, at all times and in all circumstances wholly free from restraint” [120] . Indeed, mandatory childhood vaccination policies in the USA have been enormously successful [43,44] . Smallpox is eradicated, polio is nearly eradicated, and rates of diphtheria, measles, mumps, rubella, congenital rubella and Haemophilus influenzae type b have decreased by over 99% from the prevaccine licensure era [43] . However, mandatory vaccination policies are not without controversy [45,46] . Opponents purport that psychosocial harm from mandatory vaccination policies may alienate staff and damage morale; however, no evidence supports this concern. Opponents have also argued that mandatory immunization would only be justifiable if comprehensive voluntary immunizations were unsuccessful [46] . Such a condition now seems clear. HCWs, as part of their professional ethos, accept a variety of maneuvers designed to protect the patients they care for, including required vaccinations (measles, mumps, rubella, varicella, hepatitis B and pertussis), other protective maneuvers (masks, handwashing, and so on) and annual TB skin testing. Paradoxically, while proof of immunity to measles, mumps, rubella and hepatitis B are requirements for healthcare employment, all of these diseases combined do not parallel even a fraction of the morbidity and mortality of a typical annual influenza season. Recommendations

Given the overwhelming evidence supporting the benefits of influenza immunization of HCWs to themselves, their patients, other staff members, the community, and the institutions within which they work, we recommend the following: • All states should adopt mandates requiring that HCWs be annually vaccinated against influenza, with specific exemptions to this requirement determined by each state. It is an unfortunate reality that the majority of HCWs do not sufficiently value patient safety or the mission to deliver quality healthcare to annually accept a safe and effective influenza vaccine. Complicit in this has been the lack of support among many healthcare institutions and systems for mandating HCW influenza immunization due to fears of employee pushback. This leadership void has left us with unacceptable vaccination rates and placed employees and patients in unnecessary peril. It has long been clear that voluntary programs do not consistently result in acceptable rates of coverage over a sustainable time period. Although the CDC has recommended for nearly 30 years that HCWs be annually immunized, we still allow trusting, unknowing and vulnerable patients to be cared for in healthcare facilities that employ unvaccinated healthcare personnel; • Healthcare facilities should measure and report rates of influenza vaccination among its HCWs to state health departments. In pursuit of patient safety, and in keeping with the aforementioned evidence, a Joint Commission standard requires 1471

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healthcare organizations to implement staff influenza vaccination programs and track immunization rates [121] . Understanding the importance of this requirement, Melia and colleagues have successfully developed a computerized database that both tracks and reports rates of influenza vaccination among HCWs [47] . States should implement and enforce these reporting mechanisms in order to hold healthcare facilities accountable on this vital issue;

available. As our patients continue to suffer from this identifiable void in leadership, we have been left with no other viable alternative than for state legislative leaders to act. Indeed, several US states, notably New York and California, have enacted such legislation.

• Healthcare worker influenza vaccination rates should be a recognized quality care metric. In accordance with evidence that HCW influenza vaccination is a safe and effective way to prevent harm to patients, a healthcare institution’s ability to immunize its workforce directly reflects the quality of care it can provide. As a recognized quality care metric, HCW vaccination rates would provide patients a standard upon which to appraise a facility. Accordingly, facilities currently with suboptimal HCW vaccination rates, historically uninspired by the benefits of vaccination to its employees and patients, will find yet another motivator.

Although sound scientific evidence and ethical principals have clearly shown us the right thing to do, we have left the hard part to our legislative leaders. Now is their time to take the lead. Although knowing the right thing to do is easier than doing it, for our patient’s sake, we hope that state legislators will follow the lead of the State of New York (USA) and take active steps to ensure patient safety.

Conclusion

At the dawn of another influenza season and amidst the first influenza pandemic of the 21st Century, we will again experience nosocomial transmission, increased rates of medical errors, diminished quality of care due to staff absenteeism and present­eeism, and significant patient morbidity and mortality due to suboptimal HCW influenza vaccination. It is impossible to understand how or why this is acceptable in 21st Century healthcare given that a safe, inexpensive and effective tool to prevent such outcomes is readily References 1

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Financial & competing interests disclosure

The views in this article are the personal views of the authors and do not necessarily represent the views of the professional organizations or institutions within which we are members. Gregory Poland is the chair of a Safety Evaluation Committee for an investigational influenza peptide vaccine trial being conducted by Merck Research Laboratories. Gregory Poland offers consultative advice on new vaccine development to Novartis Vaccines, Merck & Co., Inc., Avianax, GlaxoSmithKline, Theraclone Sciences, Liquidia Technologies, Inc., Emergent BioSolutions and Novavax. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

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