Mandated flu vaccines may be ‘new norm’ in health care

Hospitals and health care systems now often mandate influenza vaccinations for their employees that may apply to everyone in the system, from janitors to chief executive officers. And the mandates matter.

The Centers for Disease Control and Prevention (CDC) reported that vaccination coverage among health care personnel during the 2014-2015 season was 44.0% in settings where vaccine was not offered, promoted, or required and 73.6% or 83.9%, respectively, when vaccine was offered free on site for 1 day or multiple days. When vaccination was mandated, the rate was 96.0%.

“There are no direct data, but there are some indications that clearly show a trend toward more and more hospitals and health systems adopting policies that mandate their employees be immunized yearly against influenza,” said Paul Carson, MD, FACP, director of infection control and prevention at Sanford Medical Center in Fargo, N.D.

“Based upon self-reporting to the Immunization Action Coalition, it is probably safe to assume that, at a minimum, somewhere around 10% of hospitals have adopted these policies, and likely it is much higher than that,” he said.

For many health care organizations and infectious disease specialists, the reasons for mandating the yearly vaccine are compelling. About 35,000 deaths each year are attributed to influenza, with a mortality rate that equals that of breast cancer, Dr. Carson said. Influenza disproportionately affects elderly and very young people and those with chronic diseases, “the people we care for on a daily basis,” he said. “There are numerous nosocomial outbreaks of influenza traced back to an infected health care worker that have been documented in the literature.” In addition, a 2014 meta-analysis in Clinical Infectious Diseases reported that nearly all included studies showed a benefit in patients' all-cause mortality when facilities increased influenza vaccination rates among health care workers.

The Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA), the CDC, and other groups have long recommended yearly vaccination of health care workers to reduce health care-acquired influenza. The CDC has recommended the vaccine for health care workers since 1981. In 2011, ACIP recommended that acute care hospitals, long-term care, and other facilities employing health care personnel require annual immunization as a condition of employment unless there are compelling medical contraindications.

Patient safety issue

Many medical organizations and physicians argue that health care workers have an ethical obligation to protect themselves and their patients from influenza. “The fundamental concept is that influenza vaccination for health care workers is both an ethical and professional obligation because it is a patient safety issue,” said William Schaffner, MD, MACP, an infectious diseases specialist at Vanderbilt University School of Medicine in Nashville, Tenn.

“The logic of this is so compelling that 1 professional society after another supports not only the recommendation but also the mandate that all health care workers be vaccinated. It's become the new norm,” he said.

In 2010, the ACP Board of Regents formally agreed that all health care workers with direct patient care activities should be required to have the annual influenza vaccination, with exemptions allowed for medical contraindications or religious objections. On July 28 this year, the Board of Regents issued a new policy statement calling on states to pass legislation that would eliminate exemptions to existing vaccinations of all children, adolescents, and adults for any reasons other than medical contraindications.

Sandra Adamson Fryhofer, MD, MACP, a past ACP president, said she supports this new policy statement. “The ACP is saying that everyone should be vaccinated. For physicians, immunization is a duty ... The vaccine is not 100% effective, but it is our best bet for keeping us and those around us protected,” she said.

John O’Neill, DO, FACP, chair of the ACP Immunization Technical Advisory Committee, said the public health concern with influenza, a vaccine-preventable disease, is related to the large number of deaths each year that are attributed to the complications of the disease. “We are certainly interested in making an impact on that number, and we believe that vaccination is the best way to reduce the number of deaths,” he said. (For more on how physicians can increase vaccination rates in their practices, click here. )

How mandatory is ‘mandatory’?

Health care systems now moving to mandatory influenza vaccination have been motivated by calls for such action in recent years from ACP, the National Vaccine Advisory Committee, the American Hospital Association, the American Public Health Association, the National Business Group on Health, the Infectious Diseases Society of America, the National Patient Safety Foundation, and others. And the Immunization Action Coalition maintains on its website an “honor roll” of health care systems that mandate the vaccine. More than 500 hospitals are currently listed.

Another factor driving the move toward higher vaccination rates is a 2013 requirement by the Centers for Medicare and Medicaid Services that most acute care hospitals report seasonal influenza vaccination coverage among health care workers. Those hospitals that do not report are subject to a 2% reduction in the annual payment increase under the hospital Inpatient Prospective Payment System, and the data about vaccination rates are publicly available, according to Public Health Report.

Among health care facilities that mandate influenza vaccination, exemptions are often allowed for medical and religious reasons. In the BJC health care system, a large Midwestern organization with 25,000-plus employees, about 1.24% had a medical exemption and 0.35% had a religious exemption when the program was implemented in 2008, according to an article about the policy in Clinical Infectious Diseases in 2010. Hilary M. Babcock, MD, MPH, associate professor in the division of infectious diseases at Washington University School of Medicine in St. Louis, said that employees in the system who want a religious exemption must apply each year, explaining their reasons.

The number of employees seeking an exemption has remained fairly consistent, she said. By Dec. 15 each year, each employee must receive an influenza vaccine or have a medical, philosophical, or religious exemption that has been approved by Human Resources. An employee without an exemption then has 1 month to either gain exemption or comply with the policy. If neither occurs, the person's employment is terminated on Jan. 15.

Workers with an exemption must wear a mask during flu season every year. “We follow influenza data in our community very closely and when we start seeing cases, we declare the beginning of influenza season and that it is time to start wearing masks. We make a declaration when the risk is past that it is OK to stop wearing the masks,” Dr. Babcock said.

At Dr. Carson's hospital, employees who work in close proximity to patients also must wear a mask during flu season if they have a legitimate and approved exemption. Those refusing vaccination who do not have an exemption are furloughed without pay during the active flu season. Independent physicians in the community must show proof of vaccination if they want hospital privileges.

Johns Hopkins has a similar policy. According to information on the Johns Hopkins website, employees can receive a religious exemption and an exemption for certain medical reasons, such as a previous severe allergy to the vaccine or its components or a history of Guillain-Barré syndrome within 6 weeks of an influenza vaccine.

Employees who do not have an exemption and still choose not to be immunized are placed on unpaid administrative leave of 1 week or less. If the requirement is not met by the end of that leave, the employee will be considered to have voluntarily resigned. Medical staff who do not comply are placed on administrative suspension of privileges for the duration of the flu season and are denied access to patients in clinical care areas. Those with an exemption must wear a surgical mask within 6 feet of patients during flu season.

At Loyola University Medical Center in Illinois, the mandate for vaccination was extended in 2009 to not only employees but also to students, volunteers, and contractors. According to an article by Jorge Parada, MD, MPH, FACP, and colleagues in the June 2013 American Journal of Infection Control describing their multiyear experience with mandatory vaccination, only 15 clinicians or volunteers out of approximately 8,000 people quit their jobs because of the mandate.

“Most of these were volunteers or part-timers, and, in contrast, 99% of all people received vaccine,” Dr. Parada said. Loyola also allows exemptions for medical contraindications and religious objections, which were accorded to the remaining 1%.

Some resistance

Despite the successes, rolling out a mandatory program prompts many questions about why it is needed. Education programs, town hall-type meetings, letters to employees, articles in internal newspapers, and 1-on-1 conversations are used to spread the word about the reasons for mandating the vaccine. Employees typically raise concerns about the safety of the vaccine, how the program will work, and whether the mandate will be applied equally to all employees.

Employees also question why they are being required to get a vaccine that is not 100% effective. “We all wish we had a better vaccine,” Dr. Babcock said. “We totally support research and development on making a better vaccine. But in the interim, this is the only vaccine we have, and in most people it provides some protection against some strains of flu pretty much every year.”

The vaccine requirement is considered just part of a complete influenza control program needed in every health care facility, she added.

According to Dr. Carson, many workers also contend they are not at significant risk and that they never get the flu. “They lack understanding of the risk they pose to their patients, and so they object to being forced to do something they see as unnecessary,” he said.

Studies have shown that health care workers frequently come to work sick, and even if they don't feel sick, asymptomatic infection is common, Dr. Carson said.

“The virus can be spread even with that asymptomatic infection,” he stressed. “The argument that ‘I don't get sick and am not a risk to patients' just simply doesn't hold any water.”

Dr. Schaffner agreed. “Most will say that they will stay home when they are sick. First of all, they don't, but let's assume everyone ideally does that. They don't understand the basic biology of the virus, because the day before they get sick or 2 days before, they are already exhaling the influenza virus and there is no way to prevent that. They are putting their patients at risk.”

Tracking efficacy of mandatory immunization is difficult. “Patients can develop flu after leaving the hospital, so we wouldn't know about that, and there is a lot of variability every year in how bad the season is. It is very difficult to get real good data about hospital-acquired influenza,” Dr. Carson said.

Establishing a mandatory policy is not without precedent, Dr. Carson said, since courts have upheld the principle that government can mandate immunizations when in the public interest, as during the 1905 smallpox outbreaks. Private employers, such as hospitals, can set terms and conditions of employment and terminate “at will” for any reason except an illegal one, such as race or gender. The 1 exception, though, is when there are collective bargaining agreements, he said.

States can also mandate immunization of health care workers and the public. CDC spokesperson Ian Branam said in an e-mail that influenza vaccination requirements for health care workers may be established by state health departments, local/county health departments, or individual health care employers.

Last year, the Massachusetts Nurses Association (MNA) sued Brigham and Women's Hospital in Boston, where the worker vaccination rate was below 80%, over its mandatory vaccination policy. The union contended that the mandate violates a state regulation barring hospitals from requiring employees to be vaccinated if they do not want the vaccine, regardless of the reason. The Newsletter of MNA Region 5 reported in its spring 2015 issue that the lawsuit is still pending in Superior Court.

In 2010, SEIU Healthcare Employees Union District 1199 in Rhode Island opposed mandatory vaccinations, saying the requirement is in violation of due process and interferes with health care workers' right to bargain with their employer. The organization encourages its members to get the flu vaccine to protect themselves, their families, and their patients but states that workers should be able to decline the vaccination for religious, medical, or philosophical reasons. The organization filed a lawsuit in Rhode Island in 2012 against a Department of Health regulation requiring health care workers, including volunteers and nonmedical staff, to get a flu shot or wear a mask when in contact with a patient. The lawsuit was withdrawn in 2013, according to the Providence Journal.

Recent outbreaks of infectious diseases, including the measles outbreak at Disneyland in California, the mumps outbreak in the National Hockey League, and the recent pertussis outbreak have underlined the importance of herd immunity, Dr. Schaffner said.

“Vaccines have 2 functions: to protect the individual who receives it but also to lead to a healthier disease-free community. It's that second one that is at issue with health care workers,” he noted. “It's a patient safety issue. That has to be said time and time again.”