New York mandates seasonal flu vaccinations for health care workers: Is H1N1 shot next?
One of many simmering issues as pandemic season approaches
In a likely prelude to a battle royal over mandating a swine flu vaccine, the New York State Health Department overrode nursing union protests recently in enacting an emergency regulation requiring seasonal flu shots for frontline health care workers.
The State Hospital Review and Planning Council approved the regulation Aug. 6, with the mandate applying to hospitals, diagnostic and treatment centers, home health care, AIDS home care agencies, and hospices. Nursing home employees are not covered under the regulation, but the state legislature is discussing amending a state law to include them. Health care workers with only peripheral contact with patients and direct caregivers are exempt, as are those with documented medical contraindications to vaccination. There is no exemption for religious or personal beliefs.
Mandating immunization for the H1N1 influenza A pandemic strain when the vaccine becomes available is "something that is being discussed" by public health officials, confirmed Jane Zucker, MD, assistant health commissioner for immunization in New York City (NYC). Hospitals have been gearing up for the mandate as discussions surfaced, with health officials saying poor compliance with seasonal flu shots can not be ignored in the face of a pandemic.
"Many hospitals have been actively promoting influenza vaccine every year for their staff, but those who work in the field know that the uptake of the flu vaccine has been low," she says. "This mandate will help to dramatically increase the vaccination rate and I think [hospitals] view that as very positive."
Indeed, infection preventionists and hospital epidemiologists who have been fighting to increase flu immunizations for years welcomed the move.
"It's been a long time coming," says Elaine Larson, RN, PhD, FAAN, CIC, associate dean for research at the Columbia School of Nursing in NYC. "I think it's a terrific idea. We have tried the opt-out programs where people have the choice of declinations. It really has not improved the rates sufficiently to protect during a year when we are likely to have a big outbreak."
Despite decades-old national public health recommendations to vaccinate health care workers against seasonal flu, the odds that any given health care worker has been immunized each year are about the same as a coin flip. For example, Cornell Medical Center in New York City conducted massive voluntary flu campaigns the last two years, but still had 43% of its work force unvaccinated, notes Louis Drusin, MD, hospital epidemiologist.
"That really isn't helpful in terms of herd immunity," he says. "If we did have a major outbreak, it would probably diminish the number of health care workers available to take care of patients in the hospital."
The 2009-2010 seasonal trivalent vaccine is not protective against swine flu, but includes the virus strains A/Brisbane/59/2007 (H1N1)-like; A/Brisbane/10/2007 (H3N2)-like; and B/Brisbane/60/2008-like.
"We know that we will have [sufficient] seasonal vaccine this year," Drusin says. "There won't be a shortage and we will have it early. It's going to be a lot easier to get a greater percentage immunized against seasonal flu. Then we might be able to better determine whether [subsequent flu-like illness] is more likely to be the swine flu."
Beginning of a mandatory era?
Other states will no doubt scrutinize the New York regulation, and even in the absence of state laws, individual hospitals may take up the mandate banner in a pandemic flu season.
"This will have reverberations in medical centers, hospitals and in other states across the country," says William Schaffner, MD, chairman of the department of preventive medicine at Vanderbilt University in Nashville, TN. "There will be variations on this theme of mandatory. I think [an H1N1 vaccine] would be voluntary, but there will be individual circumstances out there where individual medical centers will perhaps make it mandatory."
Regardless, don't expect occupational health and union groups that have long resisted a mandate to go gently into that good night. The New York State Nurses Association (NYSNA) fought the regulation, calling it a "scorched earth" approach that ignores risk assessment and alternative intervention measures. The NYSNA challenged the state's authority to enact such a regulation in hearings, and posted "talking points" detailing its opposition on its website after the state approved the regulation.
"The Nurses Association questions the authority of this body to impose such a sweeping mandate as an emergency rule, without the declaration of a public health emergency," Eileen Avery, MS, RN, associate director of the NYSNA said at a July 23 hearing on the regulation. ". . . [T]he state may mandate quarantine, vaccine, or other such measures for the public good. But the action must have a real and substantial relation to an immediate threat to the public health and safety."
One could argue that seasonal flu actually fits those criteria — with 36,000 annual deaths — though that would essentially mean declaring every flu season a public health emergency. The prevailing opinion has been that of groups like the American College of Occupational and Environmental Medicine, which argues in its position statement that patient safety data is not sufficient to justify a mandate that overrides the worker's autonomy to refuse vaccination. That argument is clearly under siege. But where are the mandates for infection control measures, Avery asks.
"Is it possible that the [state health department] and health care facilities see mandatory immunizations as an 'easy fix' that promises to prevent workers from contracting both seasonal flu and H1N1?," she asked at the hearing. "By providing flu shots, will hospitals be able to avoid establishing and implementing effective infection control policies and procedures? What strategy does [the state health department] have to ensure that federally mandated infection control procedures are being followed?
The mandatory flu vaccination movement joins a host of simmering issues as the pandemic season approaches. Nationwide, this could be a long contentious flu season between hospitals and frontline health care workers, particularly if serious H1N1 infections strike clinicians before a vaccine is available. The recent death of a 51-year-old nurse in California of H1N1 was followed by nurses taking to the streets and demanding transparency and accountability about infection control measures and pandemic preparedness. On the respiratory protection issue, it's the ghosts of SARS again. An Institute of Medicine committee was expected to weigh in by Sept. 1 on yet another iteration of the N95 respirator vs. surgical mask debate, with Centers for Disease Control and Prevention advisors recommending the latter.
The unfolding dynamic is subject to rapid change and raises some complex issues. For example, if health care workers demand protection (i.e., N95s) from patients with H1N1, how can they protest the mandatory seasonal vaccine initiatives in states like New York?
"The state currently requires that health care workers be immunized for measles and rubella, diseases that can be eradicated by one or two immunizations in a lifetime," Avery said. "We have seen the benefit to the public by the virtual elimination of measles, mumps, rubella, smallpox, and polio. Influenza, however, cannot be eradicated. It is a constantly mutating virus and the flu vaccine must be administered annually. If this proposal takes effect, nurses will have to submit to vaccinations every year for the remainder of their careers in order to continue working or to get jobs in direct patient care."
The battle lines are drawn, but for their part, infection preventionists in New York favor a conciliatory approach.
"Our emphasis over the last three years is that [worker immunizations] protect the patient," says Barbara Smith, BSN, MPA, CIC, an IP at St. Luke's Roosevelt Medical Center in Manhattan and president of the New York City chapter of the Association for Professionals in Infection Control and Epidemiology. "That's how we are going to appeal to them — that this is really to protect the patient. Of course, if we have to, we will invoke that state law."
In a sense, the law gives IPs "backup," but nobody is expecting those who traditionally refuse shots to be heading to the front of the line.
"It will be challenging," she says. "There have always been a group of people who will take it no matter what. They are convinced that it will benefit themselves and the patient. It's that other 30% or 40% that we will be working hard with. I think one of the things we will be focusing on is really getting people to the education sessions."
Enforcing the edict falls mainly to the individual health care institutions. All bets are off if unions call for resistance, but right now, hospitals are hoping to work with labor reps.
"Administratively, we are trying to reach out to the unions proactively so they will see this as a benefit and to get their buy-in in implementing this," Smith says.
Even with worker buy-in, the logistical challenges of mass vaccination campaigns are still going to be daunting. "We have been planning for the last several months thinking this may come through from the state," says David Calfee, MD, MS, an associate professor of medicine in the division of infectious diseases at Mount Sinai School of Medicine in New York City. "We will use our point-of-distribution emergency preparedness plan, where we have large tables set up and there will be multiple people there providing vaccine. It's quick so people don't have to wait or spend much time away from their actual patient care duties to come and get the vaccine."
The regulation requires documentation of vaccine receipt, which actually could be about as difficult to do as any other aspect of the requirement, he notes. Vaccine safety and other issues that are often cited by reluctant health care workers will have to be addressed.
"I'm sure there will be people who are unhappy," he says. "We can certainly focus on the fact that we gave 6,000 vaccine doses last year and didn't have any major side effects. It's not as if it's something we have never done before; it's just more people."
In terms of health care epidemiology, having a fully immunized work force for seasonal flu is a luxury few IPs have enjoyed. "It will definitely be a good thing for our health care workers and our patients in terms of exposures in the hospital," Calfee says. "It would certainly make me feel better going into a hospital if I knew all the health care workers had been vaccinated for flu."
The planning assumption is that H1N1 will eventually be mandated as well, he says. "That's a two-part vaccine series so it will really be everybody getting three vaccines [in total], so we are probably going to be administering six times as much vaccine as we normally do," Calfee says.
'The sooner, the better'
While some doubt that a vaccine that has been fast-tracked would be mandated, a pandemic vaccine researcher emphasizes that the benefit to both workers and patients will almost certainly outweigh the risk.
"I don't want to come to work and take care of an H1N1 patient if I am not vaccinated against H1N1," says Donald Kennedy, MD, a professor of infectious diseases at Saint Louis University. "I think there may be reluctance on the part of health care providers to [show up] if they perceive that the risk of taking care of these patients is too high."
There was a time when people could only wish they had a SARS vaccine, he recalls. "In Canada, health care workers were taking care of people, getting the disease and dying from it," he says.
Kennedy is one of the researchers conducting H1N1 vaccine trials in humans at the Center for Vaccine Development at the university. "If we have a safe and effective vaccine, health care workers — particularly those who provide care to patients who would do poorly should they get H1N1 — should be vaccinated," he says.
Vaccinating high-risk patients does not provide complete immunity, he adds. "Many of the high-risk patients are unable to respond to the vaccine as well as low risk patients because of underlying diseases," he says. "So, even if you vaccinate these populations, it is not going to work as well as it would in a healthy person."
While conceding that risks are a legitimate issue for discussion, Kennedy reminds that the H1N1 vaccine was made with the same techniques used for seasonal virus. "We have been doing this for years without testing each seasonal flu vaccine every year," he notes.
Still, the issue may become somewhat moot in the initial months if H1N1 resurges in a big way before the vaccine can be approved and distributed. Vaccine investigators are working as fast as they can.
"We're chasing our tails around here," Kennedy says. "This is not something we can sit around and debate for six months. If this is going to be done — the sooner, the better. Doing it two years from now probably won't help much. If we had a 1918 flu vaccine but gave it to everyone in 1920, it wouldn't have done much good."
In a likely prelude to a battle royal over mandating a swine flu vaccine, the New York State Health Department overrode nursing union protests recently in enacting an emergency regulation requiring seasonal flu shots for frontline health care workers.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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