Mandate to Protect Patients from Health Care–Associated Influenza

Abstract

Advice is judged by results, not by intentions. —Cicero Hell isn't merely paved with good intentions, it is walled and roofed with them. —Aldous Huxley The admonishment to those in the healing arts to avoid harming patients dates back to the Hippocratic Corpus, >2300 years ago. In the past decade, the patient safety movement has gained momentum, precipitated by the Institute of Medicine Report “To Err is Human” [1]. Health care workers can and do transmit influenza to vulnerable patients, leading to illness, deaths, and nosocomial outbreaks [2, 3]. The risk is compounded by the high rate of asymptomatic infection among health care workers and their dedication to their patients and their coworkers, leading them to often work with mild to moderate symptoms [4, 5]. Influenza vaccine is, at best, modestly effective for some patients at the highest risk of influenza, including older persons, infants, and persons with severely compromised immune function [6]. In contrast, efficacy is highest among healthy younger adults, which includes many health care workers. Vaccinating health care workers against seasonal influenza is a simple, safe, and effective tool that has been shown to reduce absenteeism among staff, reduce health care associated influenza, and prevent mortality among patients [5, 7, 8]. An economic analysis in the United Kingdom found that campaigns to improve influenza vaccination of health care workers were highly cost effective [9]. Since 1981, the Advisory Committee on Immunization Practice of the Centers for Disease Control and Prevention has recommended influenza vaccine for all health care workers. Unfortunately, the rate of vaccination among health care workers in the United States remains unacceptably low. Only 42% and 44% of health care workers reported having received influenza during the 2005–2006 and 2006–2007 influenza seasons, respectively [6]. This represents a very modest increase after more than a decade of effort [10]. Three broad categories of interventions have been used to improve vaccine coverage: (1) education and provision of free vaccine, combined with measures to improve access and convenience, such as roving carts; (2) requiring that health care workers sign declination forms acknowledging that they have been educated about the benefits and risks to their patients; and (3) mandatory vaccination enforced by reassignment to non–patient care roles or by termination of employment. The last approach, mandatory vaccination, has generated the most controversy. The policy pits the ethical principal of nonmalfeasance against individual autonomy. Mandatory vaccination policies have been endorsed by several organizations, including the New York State Department of Health, the Infectious Diseases Society of America, the American College of Physicians, the Association for Professionals in Infection Control and Epidemiology, and the National Foundation for Patient Safety. Several large health care organizations have adopted mandatory vaccination policies, led by Virginia Mason Medical Center (Seattle, WA) in 2004. The list now includes some of the largest and most prestigious organizations in the United States, including Hospital Corporation of America, Johns Hopkins Health System, University of Iowa Hospitals, Hospital of the University of Pennsylvania, Children's Hospital of Philadelphia, and the Department of Defense [11]. Mandatory vaccination has also generated vigorous debate and opposition, including legal challenges [12]. This year, the New York state health commissioner issued a regulation requiring influenza vaccination for all health care workers. Justice Thomas J. McNamara of the New York Supreme Court issued a temporary restraining order until 3 lawsuits can be heard and the legal issues tested in court [13]. The implementation, efficacy, and consequences of mandatory vaccination policies for influenza among health care workers have not been reported in the peer-reviewed literature. In this issue of Clinical Infectious Diseases, Babcock et al [14] report on the experience at BJC HealthCare, a Midwestern health care organization that employs ∼26,000 people and includes 11 hospitals, ranging from rural and suburban hospitals to the teaching hospitals affiliated with Washington University School of Medicine (St. Louis, MO). Influenza vaccination was made a condition of employment for all employees, regardless of job description. However, the policy did not apply to physicians in private practice or employed by Washington University. The policy was accompanied by extensive communication efforts to communicate the policy and the rationale and to dispel the common myths. Medical and religious exemptions were granted on the basis of predetermined criteria. Employee health nurses and the medical director reviewed requests for exemptions. When employees were denied exemptions, they could meet with employee health nurses and the physician directing the program. The program was highly successful. Of 25,980 employees, 98.4% were vaccinated and 1.59% received exemptions (1.24% for medical reasons and 0.35% for religious reasons). Only 8 employees (0.03%) were terminated. All physicians employed by the organization, including >900 resident physicians, complied with the program. An online search did not find any evidence of legal challenges to the policy. Physicians not employed by the organization were not covered by the policy, and vaccine coverage rates for the medical staff were not reported. It is possible that private or university physicians pose a residual threat to patients. Of interest, BJC HealthCare allowed the employee's physician to request a medical exemption for pregnancy. Influenza vaccine is strongly recommended for pregnant women, and the increased toll of the 2009 H1N1 influenza virus on pregnant women has been well described [15]; therefore, this may reflect a concession to residual misconceptions held by some obstetrical providers. Are these results generalizable? The authors emphasize the strong support that they received from all levels of leadership, from the CEO to unit managers; the role of education and “myth busting;” and the possible impact of the recession in influencing choices made by employees. It is clear that significant resources were devoted to communication and education, as well as for logistical support. A standardized application form for medical exemptions will be used in subsequent years that should decrease the effort required for review. The authors do not comment on the level of trust and collaboration that existed between employees and administration—a factor that may prove critical. Thus, the impressive results, with few adverse or unanticipated consequences, may not be easy to replicate. Could other measures have achieved similar results? It is impossible to know. Few, if any, trials have been published that compare different approaches to improving vaccine coverage. As recently reviewed by Talbot [16], interventions are often bundled, making the contribution of individual policies difficult to determine. During the previous season, BJC Health-Care used a quality scorecard, education, incentives, and mandatory declination forms, and influenza vaccine coverage increased from 54% during 2006–2007 to 71% during 2007–2008. It is possi-ble that, with several more years of ef-forts, mandatory declination could have achieved adequate coverage. Some institutions have achieved coverage of ∼90% with comprehensive policies that include enforcement of strong declination statements, including the Clinical Center at the National Institutes of Health [17] and Intermountain Healthcare in Utah (unpublished data). However, although declination policies appear to increase coverage rates, experience to date has been mixed [16, 18]. In a survey of 22 hospitals, Polgreen [19] found that implementation of declination policies increased coverage by a mean of 11.6%. Other studies have shown an association between a hospital's use of declination forms and higher influenza vaccine coverage, but a causal relationship could not be demonstrated with the cross-sectional design [20]. Several conclusions can be drawn. First, the arguments favoring influenza vaccination of health care workers as a key patient safety tool are ethically, scientifically, and financially compelling [21]. Second, misconceptions and lack of knowledge about influenza and influenza vaccines are persistent barriers to improved coverage among health care workers, but education alone has not been effective [22]. Third, successful programs require the use of multiple tools, including education, incentives, accountability, and a strong commitment at all levels. Fourth, the experience of Babcock at al [14] reveals that mandatory influenza vaccination policies achieve extremely high coverage rates. In contrast, most health care systems have failed to achieve high coverage. Lastly, influenza vaccine coverage rates of 50%–75% are unlikely to provide adequate protection of patients. The debate has focused on the appropriate methods to improve coverage. This focus may be counterproductive. Instead, the debate should focus on results, not intentions or methods. Health care organizations should be expected to achieve influenza vaccine coverage that optimizes patient safety and to make data on coverage readily available to public health authorities and the public. I propose 90% coverage as an appropriate target. Organizations can then choose to achieve the target with less coercive methods if they can, or if necessary, choose to mandate vaccination. Intentions and principles do not protect patients; results are needed. Financial support. National Institute of Allergy and Infectious Diseases (1U01AI082184–01) and Centers for Disease Control and Prevention (1U181P000303). Potential conflicts of interest. A.T.P. has served as a consultant for NexBio.

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