Influenza Vaccine Mandates

I have been involved in infection control and in what is now called quality for my career. Since infection control issues can occur in any department, my job involves being on numerous quality related committees (Medical Executive, Pharmacy and Therapeutics, etc) where I have witnessed or participated in what seems to be innumerable quality initiatives.

It always gripes my cookies when someone says “Get your own house in order,” because that is a person who evidently is arguing from ignorance. Since To Err is Human was published at the turn of the century, the hospital systems in Portland and across the country have invested significant time and money into quality improvement. Do a Pubmed on ‘Hand Hygiene Compliance’ in the last decade; there are over 400 references. Or ‘deep venous thrombosis prophylaxis’ — over 5,000 references. Or ‘ventilator associated pneumonia prevention’ — over 750 references. Pick a topic related to safety and quality and search the literature, and you will find a remarkable amount of research into the best ways to decrease morbidity and mortality in the hospital.

Hospitals, at least those in my city, take safety and quality very seriously, and by applying the results of these studies, there has been a marked decrease in mortality and morbidity in my institutions. Compared to historical controls, we estimate we have, in the last 2 years, prevented about 600 hospital acquired infections and over 200 deaths. Those numbers are not fudged, but real progress. I make, or made, a large chunk of mortgage payment from hospital acquired infections. Not any more.

Not a single intervention we have implemented has required the use of a SCAM. We did not need to introduce reiki or homeopathy or acupuncture into the hospitals to get these benefits. Nope. Not a one. Just the application of science-based medicine. It did require an immense amount of time and energy, because human behavior and hospital systems are complex and making changes that are effective and can be incorporated into in the busy work environment of the hospital is not as easy as one would think.

Not only has the implementation of all our quality initiatives not required the input of any SCAMs, it is difficult to find a reference where the SCAM community is making any efforts to improve their quality. Take hand hygiene, probably the most important intervention you can do to decrease the spread of infectious diseases.

In the chiropractic literature there is one study. Acupuncture and naturopathy? None. These are the three fields that are often associated with Institutions of <sarcasm> Higher Learning </sarcasm> and they are not publishing in areas of quality. Of course, evaluating quality interventions requires a firm understanding of the scientific method, not, given their curricula, one of their strong points.

There is one quality indicator where we still lag: influenza vaccine compliance. Locally and nationally, it is rare to get influenza vaccine rates above 50%. It is a condition of employment in health care, or at least in hospitals, that all the workers are vaccinated, or immune from prior illness, to a number of infections including chicken pox, mumps, hepatitis B, and measles. Most of the infections are those that can be transmitted from the health care providers (HCP) to their vulnerable patients. All the employees are immune to these diseases and, if at the time of employment they refuse the vaccines, they get the opportunity to find employment elsewhere. No exceptions.

The influenza vaccine is different; at most institutions it is not mandated and compliance is low. In recent years I have gone on the wards with the flu cart and given influenza vaccinations to the staff. It is fun and you get the opportunity to talk with your colleagues about the importance of vaccination and answer their questions. There are always one or two who will not make eye contact and avoid me so they do not need to get the shot or to engage in conversation with me. But most people, even those who may refuse the vaccine, will talk to me and, even if I do not convince them on the spot, I will give them something to think about. Some websites trumpet the low compliance of health care workers (HCW) as evidence that the HCW’s know something that the rest of us do not, and that is why they are not vaccinated. I have yet to hear a compelling reason outside of Guillian Barre and anaphylaxis. Instead I hear a variety of myths or misunderstandings. I address those arguments with a slightly more snarky tone over on my Medscape blog, A Budget of Dumb Asses. It is worth the every penny of the free registration for the opportunity to read it.

There is a movement to make flu vaccine mandatory, a condition of employment, for health care providers as well. The Society for Healthcare Epidemiology of America (SHEA) released a position paper, supported by the Infectious Disease Society of America, that recommends the influenza vaccine be mandatory for HCP’s. To the surprise, I am sure, of no one, I would support such a move.

There are three reasons to make the vaccine mandatory: two evidence-based, one philosophical.

There are careers where you are expected to place the needs of others ahead of your own. The most extreme example is the military or the secret service, where it is expected that you might die as a result of your job. Less extreme examples include policemen, firemen, and, yes, health care providers.

Medicine is more than a job. It is a calling, which is a weird thing for me to say, because it is a calling to what? Or whom? Got me. But it is. In medicine the expectation is that I will care for anyone who comes my way and that I will place the patients needs before my own.

I remember the old days, standing at the bedside of AIDS patients, with no idea what caused the disease or how it was spread, hoping that the (it turned out excessive) gowns and gloves would prevent transmission of the disease to me. But I, and my colleagues, did the work. And should plagues, known and unknown, strike again, as they will, I expect that most of my colleagues will be at my side, tending to the ill, regardless of the personal risk. Society expects that we will be there.

HCP’s have an moral obligation to minimize the chance that will harm will occur to patients, many of whom are particularly vulnerable. This duty is summed up in the three laws of health care:

  1. A HCP may not injure a human being or, through inaction, allow a human being to come to harm.
  2. A HCP must obey any orders given to it by SBM, except where such orders would conflict with the First Law.
  3. A HCP must protect its own existence as long as such protection does not conflict with the First or Second Law.

SHEA summed it up:

Those in support of mandatory programs argue that influenza vaccination is an ethical responsibility of HCP, because HCP have a duty to act in the best interests of their patients (beneficence), to not place their patients at undue risk of harm (nonmaleficence), and to protect the vulnerable and those at high risk of infection. The duty to put patient interests first is outlined in nearly every professional code of ethics in medicine, nursing, and other healthcare fields.

The influenza vaccine is safe. Serious side effects are extremely rare and the risks from influenza are much greater. The vaccine is far safer than driving (30,000 deaths a year), taking a bath (450), or standing under a coconut tree (130). Of course people are not good at evaluating relative risks. I had a patient with a heart valve infection from heroin use who smoked 2 packs a day, drank a fifth a day, and rarely showered; but when he came in with new shortness of breath and I wanted to get a chest x-ray, he refused because he was worried about the radiation exposure. So it is with vaccine. Some people have a feeling, unsupported by the literature, that vaccines are unsafe, and if they were unsafe, I would not and could not recommend mandatory vaccination.

In adults

In placebo-controlled studies among adults, the most frequent side effect of vaccination was soreness at the vaccination site (affecting 10%–64% of patients) that lasted less than 2 days. These local reactions typically were mild and rarely interfered with the recipients’ ability to conduct usual daily activities. Placebo-controlled trials demonstrated that among older persons and healthy young adults, administration of TIV is not associated with higher rates for systemic symptoms (e.g., fever, malaise, myalgia, and headache) when compared with placebo injections. One prospective cohort study indicated that the rate of adverse events was similar among hospitalized persons who either were aged 65 years and older or were aged 18–64 years and had one or more chronic medical conditions compared with outpatients. Among adults vaccinated in consecutive years, reaction frequencies declined in the second year of vaccination. In clinical trials, serious adverse events were reported to occur after vaccination with TIV at a rate of less than 1%. Adverse events in adults aged 18 years and older reported to VAERS during 1990–2005 were analyzed. The most common adverse events reported to VAERS in adults included injection-site reactions, pain, fever, myalgia, and headache. The VAERS review identified no new safety concerns. Fourteen percent of the TIV VAERS reports in adults were classified as serious adverse events, similar to proportions seen overall in VAERS. The most common serious adverse event reported after receipt of TIV in VAERS in adults was GBS. The potential association between TIV and GBS has been an area of ongoing research (see Guillain-Barré Syndrome and TIV). No elevated risk for prespecified events after TIV was identified among 4,773,956 adults in a VSD analysis.

Then there is efficacy. I have discussed the efficacy of the flu vaccine before. In the hospital, there is no single intervention that will prevent the spread of infection. One of the hallmarks of anti-science/anti-vaxers is a binary approach: either the medical intervention is 100% effective or it is 100% useless. It is rare to see a nuanced discussion of the science behind the efficacy of the flu vaccine on the anti-vax web sites. Success in decreasing transmission of disease is always multifactorial: hand hygiene, cough etiquette, not coming to work when ill (an all-too-common problem), proper isolation for those who may have influenza, and more are part of a multifaceted approach to prevent the spread of infection in hospitals. Vaccines are like Captain Crunch: only part of a healthy breakfast.

The rationale for vaccinating HCW’s is also multifaceted.

We do not want health care providers to be disease vectors for our patients, most of whom are at high risk for bad outcomes from influenza.
Many of our patients may not be vaccinated or be unable to respond to the vaccine (the old and immunoincompetent) and are not protected from influenza.

There are 4 studies that demonstrate when HCW’s are vaccinated, mortality declines in residents of long term care facilities (the current phrase for nursing home). While similar studies have yet to be done in hospitals, there are multiple lines of data that converge on the same conclusion: the more people that are vaccinated against the flu, the fewer people who die.

The Cochrane review, as always with influenza, gets it wrong. While noting that “pooled data from three C-RCTs showed reduced all-cause mortality in individuals >/= 60.”, they go on to say “The key interest is preventing laboratory-proven influenza in individuals >/= 60, pneumonia and deaths from pneumonia, and we cannot draw such conclusions.” No, it is not the key interest. Most deaths from influenza are secondary deaths from exacerbation of underlying medical problems. All-cause mortality is an important endpoint, especially if you are the one dying.

The recent Skeptics Guide to the Universe podcast (#274) had an interview with Ben Goldacre, author of Bad Science and discussed big pharma malfeasance, of which there are endless examples. They noted that the makers of olsetamivir (Tamiflu) did not want to give the unpublished data from clinical trials to the Cochrane group for fear they would make a botch of the data. For once I am sympathetic to big pharma, given the bias and spin (i.e. they do not agree with me) of the Cochrane reviews on influenza treatment and prevention. I would not give my influenza data to the current crop of Cochran flu reviewers if I were a drug company, and I am no fan of the shenanigans that so often define the interactions of pharmaceutical companies and science.

I can, at some level, understand the opposition to mandatory vaccination as a philosophical position, although I see it on par with opposition to mandatory sterile technique in the OR. Many philosophical positions are at odds with reality. But you will excuse me if I neither let you operate in my hospital nor take care of my patients. I cannot see where your philosophy gets to triumph the material safety of patients.

Several institutions and health care systems have instituted mandatory vaccination with good results, achieving 96% and greater vaccination rates.

I get the sense that those who rail against the morbidity and mortality of modern medicine are the same who would decry mandatory vaccination, even though it would improve the safety in the hospital that they so fret about.

I completely support the SHEA/IDSA position. The vaccine is safe, effective, and HCP’s have a ethical and professional imperative to prevent the spread of infection to their patients.

SHEA views influenza vaccination of HCP as a core patient and HCP safety practice with which noncompliance should not be tolerated. It is the professional and ethical responsibility of HCP and the institutions within which they work to prevent the spread of infectious pathogens to their patients through evidence-based infection prevention practices, including influenza vaccination. Therefore, for the safety of both patients and HCP, SHEA endorses a policy in which annual influenza vaccination is a condition of both initial and continued HCP employment and/or professional privileges.

Sounds good to me.

Posted in: Science and Medicine

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