Dreonna Breton, a pregnant registered nurse in Elizabethtown, Pennsylvania, believes that the vaccine for seasonal influenza poses more of a threat to herself and her unborn baby than influenza itself.
Breton believes this so strongly that she was willing to lose her job in December rather than comply with her employer's mandate to get the vaccine.
She isn't the first healthcare worker to get fired for declining vaccination, and she probably won't be the last. The yearly ritual of the needle in the arm, seemingly taken for granted in healthcare in years past, has become one more contested territory in the vaccine wars. The fight is even messier given that the healthcare field is divided on whether the shot should be mandatory.
Healthcare employers — notably hospitals — and professional societies for clinicians agree that healthcare workers should be vaccinated against influenza to protect patients. However, while the American Hospital Association (AHA) recommends that its members require vaccination for employees, the American Nurses Association (ANA) and the powerful National Nurses United (NNU) union both staunchly oppose such mandates even as they encourage their members to get the shot.
"Threatening termination is not a good way to cultivate a good trusting relationship," registered nurse Bonnie Castillo, the NNU's director of government relations, told Medscape Medical News.
Several major medical societies, such as the American College of Physicians and the American Academy of Family Physicians, side with the AHA. However, the American Medical Association has taken a neutral position, neither opposing nor supporting such a requirement except for long-term care workers, who ought to be immunized, it says.
Mandate supporters generally aren't draconian. They say employers should grant exemptions to employees who have valid medical or religious objections to vaccination, who then can be given masks to wear, or assignments that do not involve direct patient care. But not everyone agrees on what constitutes a valid exemption. There's also worry in public health circles that too many exceptions to any sort of vaccination requirement — for childhood diseases as well as influenza — could weaken society's herd immunity. Heightening that fear is an antivaccination movement based on bad science.
Meanwhile, healthcare workers like Breton, who view influenza vaccination as risky, are organizing. On its Web site, a group called Nurses Against Mandatory Vaccines (NAMV) offers sample letters for requesting an exemption, lists 2 attorneys who represent vaccine refusers, and sells T-shirts and water bottles emblazoned with its name.
The group's Facebook page has more than 14,000 likes. One certified nursing assistant recently posted a message saying, "They won't inject that poison into me."
NAMV states that the influenza vaccine is not "an effective way to eradicate a disease that is only estimated to cause approximately 30,000 deaths in the US per year." It claims that the federal government is pressuring hospitals to require vaccinations at the behest of vaccine manufacturers that in turn expect "to pad their own pockets."
At Odds With Medical Authorities
Into this morass enters Dreonna Breton, who used to work for a home infusion therapy company owned by 3 health systems and the Penn State Hershey academic medical center. Her employer, Horizon Healthcare Services, began requiring its employees in 2012 to get the seasonal flu vaccine.
Breton, a married mother of a toddler, viewed this mandate warily last fall. She had had 2 miscarriages in 2013: 1 in March and 1 in June. In October, Breton found out she was once again pregnant. She wondered if getting the flu vaccine would put yet another pregnancy at risk, however slight.
Some groups would consider that question already answered — in the negative. Those would be the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention (CDC), and the agency's Advisory Committee on Immunization Practices (ACIP). The CDC, for one, reported last September that "recent reviews of studies pertaining to seasonal and monovalent 2009 (H1N1) inactivated influenza vaccines in pregnancy concluded that no evidence exists to suggest harm to the fetus from maternal vaccination."
If anything, the CDC and other like-minded organizations have been more vocal than ever in urging pregnant women to get the flu vaccine.
"Pregnant women are at a higher risk of severe complications from influenza," said Joseph Bresee, MD, chief of epidemiology and prevention in the CDC's influenza division, in an interview with Medscape Medical News. The reason? Changes in their immune systems and lungs during pregnancy make these women more vulnerable. The A(H1N1) influenza strain in wide circulation now hits pregnant women especially hard, according to the CDC.
Recent research also shows that the seasonal flu vaccine administered during pregnancy confers immunity to infants under the age of 6 months, added Dr. Bresee. "So it protects the mom and the baby."
The case of Leslie Creekmore of Fort Smith, Arkansas, underlines the urgency in the CDC's recommendations. The 29-year librarian contracted influenza in January when she was 20 weeks pregnant. She had not been vaccinated. Creekmore went to a local hospital, ended up on a ventilator because of complications from severe double pneumonia, and was flown to Barnes-Jewish Hospital in St. Louis, Missouri, where she miscarried on January 16. Creekmore died February 10 shortly after she reportedly began experiencing liver failure.
Her sister-in-law Jamie Cook and others chronicled Creekmore's ordeal on a Facebook site called "Love for Leslie." To raise money for her medical bills, Creekmore's supporters have sold items such as a T-shirt bearing the words, "Get Your Damn Flu Shot."
"We will continue to use this horrible experience as a way to demonstrate the importance of flu shots for everyone," Cook told Medscape Medical News.
"No Ambiguity in National Policy"
Breton told Medscape Medical News that she came across the CDC's recommendation and rationales in her research.
"I looked at both sides with an unbiased perspective," she said. "I tried to figure out what was best for me and my baby."
One bit of evidence stirred up doubts in her mind. The label information on different flu vaccines, she discovered, states that no safety and effectiveness studies on pregnant women and nursing mothers were performed prior to approval by the US Food and Drug Administration (FDA). "It is also not known whether Fluvirin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity," the label for Fluvirin (Novartis) says, for example. The label language concerning pregnant women struck another cautious note by saying that the vaccine should be given only if "clearly needed."
Breton said that she has seen flu-vaccinated patients on rare occasions come down with Guillain-Barré syndrome and severe allergic reactions.
"Knowing what can happen, I decided it was more overwhelming to face the risks of flu vaccination than the risk of flu," she said.
The CDC's Dr. Bresee said Breton is correct when she notes the disclaimers on flu vaccine labels about the absence of safety data regarding pregnant women. However, the disclaimers are not as worrisome as Breton portrays them, he said. When drug makers design clinical trials for flu vaccines, they deliberately omit pregnant women for 2 reasons, he said. One, it saves them time and expense. Two, including pregnant women would muddy the safety analysis because they already are at a high risk of medical problems. In other words, are complications during the trial the result of the vaccine or pregnancy?
"That's difficult to tease out," said Dr. Bresee.
Because a vaccine label reflects the findings of clinical trials, drug companies play it safe and describe the health risk to pregnant women as unknown, he said. "Their lawyers tell them that."
However, "there's no ambiguity in national policy about using these vaccines in pregnant women," he said. That policy is buttressed by safety studies conducted after, not before, a vaccine gets approved.
These studies on the benefits of vaccinating pregnant women against influenza keep coming. Earlier last month, a study published online in the Canadian Medical Association Journal reported that women who get the vaccine during pregnancy may have a lower risk for a preterm delivery or a low-birthweight baby than pregnant women who aren't vaccinated.
A Doctor's Note, Rejected
Armed with the evidence she collected, Breton went to her superiors at Horizon Healthcare Services in October and said she did not want to receive the flu vaccine. She said she offered to wear a mask as a precaution. The company told her she needed a note from a physician citing a medical reason to exempt her from the vaccination policy. Breton produced one from a certified midwife only to learn that the note needed to come from a physician. Breton said she then went to a family physician employed by Lancaster General Health, a co-owner of the home infusion company.
The family physician gave Breton a letter recommending that she not be vaccinated.
"In my view, getting the flu shot would significantly and negatively impact her health," the physician wrote, "because of the increased fear and anxiety it would create as well as the emotional impact it could cause if she does miscarry again."
Two weeks later, Breton said, Horizon told her that her physician failed to cite a medical reason for an exemption. Her last day on the job was December 17.
Asked to comment on her termination, Horizon President Carolyn Carlson, RN, issued a statement saying that her organization "is committed to providing a safe environment for our employees and our patients."
"Our flu immunization policy mirrors similar policies at Johns Hopkins, the Hospital of the University of Pennsylvania, MD Anderson, University of California Irvine Medical Center, and a growing number of healthcare providers throughout the country," Carlson said. She noted that pregnant women are at a greater risk of experiencing influenza-related symptoms and pointed to declarations by the CDC and ACOG that the vaccine has proven safe for both mother and unborn child.
Requests for medical exemptions are reviewed by a committee of physicians appointed by Horizon, according to Carlson. This group reviews the request "against guidelines based on recommendations from the [CDC]."
As set forth by the CDC's ACIP, 1 contraindication for seasonal flu vaccine in all its forms is a history of severe allergic reaction to any component of the vaccine, including egg protein, or to a previous dose of any flu vaccine. A history of Guillain-Barré syndrome within 6 weeks of immunization is a precaution, but not a contraindication. A history of moderate to severe illness afterwards, with or without fever, is another precaution.
The ACIP recommends that pregnant women not take live attenuated influenza vaccine. That still leaves them, however, with inactivated and recombinant vaccines.
Vaccination Mandates Are All Over the Map
It's not clear how many hospitals require their employees to get vaccinated against influenza, but the number has been climbing, especially since the A(H1N1) pandemic of 2009-2010, according to a group called the Immunization Action Coalition (IAC). It maintains an "honor roll" of stand-alone hospitals, health systems, and state and local public health departments that mandate flu shots in one fashion or the other. L.J. Tan, MS, PhD, the IAC's chief strategy officer, told Medscape Medical News the number now tops 300.
The group's Web site lists the various policies of its honor roll institutions. Most of them state that employees must be vaccinated or face dismissal unless they qualify for a medical or religious exemption. In that case, they must wear a mask at work during influenza season.
Then there are the many variations on this basic policy. At Denver Health in Colorado, exempt employees must wear a mask when standing within 3 feet of patients, according to the IAC. Other institutions specify 6 feet. At McLaren Central Michigan, an acute care hospital in Mt. Pleasant, masks must be changed at least every 3 hours.
A sizable number of institutions also allow for personal or "other" exemptions, whereas others permit only medical exemptions. A handful, such as Bronson Methodist Hospital in Kalamazoo, Michigan, do not permit any kind of exemption or the mask option. In contrast, Frisbie Memorial Hospital in Rochester, New Hampshire, and several other organizations allow employees to wear a mask merely on the basis of declining vaccination; their policies do not mention the need for a special exemption, according to the IAC.
At some organizations, another option for exempt employees besides a mask is reassignment to non–patient care duties, or both. St. Jude Medical Center in Fullerton, California, says exempt employees must wear a mask or take a leave of absence during influenza season.
A few healthcare organizations put the thumbscrews on workers who qualify for an exemption. At Mercy Hospital Ardmore in Oklahoma, such employees receive a written warning and forego any merit increase in their salary, according to the IAC. Oroville Hospital in California sends its exempted employees to a mandatory infection control class. Waverly Health in Iowa goes one step further and requires such employees to score at least 80% on a class quiz.
Healthcare attorney Michael Smith told Medscape Medical News that he believes dismissals over influenza vaccination are "very rare." Breton's firing seems "kind of harsh," said Smith, who belongs to a law firm in Altamonte Springs, Florida, that specializes in representing healthcare providers.
However, Breton's employer, Horizon Health Services, may have considered that if it had given her an exemption and the mask option, monitoring use of the mask during home visits might have proved difficult, said Smith. In addition, her patients were probably immunosuppressed, putting them at greater risk if they had caught influenza from her, a point made by other commentators on the case.
"The nurse has a medical reason [for refusing vaccination], but does that mean you get to expose patients to an increased risk of infection?" he said. "There's no easy way to resolve it."
Where Organized Nursing Stands
Although out of step with the healthcare establishment on influenza vaccination, Deanne Breton still has the backing — in one respect— of organized nursing.
The ANA urges all RNs to get vaccinated but "upholds the right of nurses to make their own healthcare choices," said association spokesperson Jemarion Jones in a statement provided to Medscape Medical News. "ANA does not support making mandatory influenza vaccinations a condition of employment. Firing or disciplining RNs and other healthcare workers for declining is not an appropriate step or best strategy. There are other ways to protect patients and allow RNs...to decline."
Jones said the ANA would support mandatory vaccination only if the policy originates with a state government or some other high-level authority so that it was applied evenly and broadly, in contrast to the patchwork of employer mandates now in place. Other conditions the ANA would put on a "must vaccinate" policy include the following:
a prohibition against disciplinary or discriminatory actions against nurses who decline vaccination;
free vaccinations at convenient times and places; and
negotiating the mandate with collective bargaining representatives if an employer's nurses belong to a union.
That said, the ANA calls for aggressive programs to educate healthcare workers about the need for immunization. So does the NNU.
"Education and easy access to vaccination are critical," the NNU's Castillo said. "We don't see those strategies being fully implemented."
Compulsory vaccination only breeds resistance, she added. "It's ineffective and creates an atmosphere of distrust."
Can Stress Be a Medical Exemption?
Breton sought a medical exemption from her employer's vaccination policy, Her physician stated that a flu shot would make her anxious and fearful and thus harm her health. Horizon Health Services rejected this rationale, to Breton's dismay.
"There are studies linking miscarriages to stress," she said. "Why didn't that count as a medical reason? Mental health doesn't count?"
Whether anyone should be seriously stressed out by influenza vaccination is one question. Another is whether stress is a significant risk factor for miscarriage.
The healthcare world seems divided on that point. Illustrative of one side is a patient education page on the Web site of the Mayo Clinic stating that "stress has long been suspected as a possible cause of early miscarriage, but there's little evidence to support the theory." Miscarriages typically result from "a fetal chromosomal abnormality or another problem in the development of the embryo."
Still, research linking stress to miscarriage is out there, and it's growing. An article published in BJOG: An International Journal of Obstetrics and Gynaecology in 2007 stated that "feeling stressed," along with other factors, such as high maternal age and low prepregnancy body weight, was independently associated with a higher risk for miscarriage. Similarly, a study in the same journal published in 2008 reported that pregnant women with a high level of stress had an 80% greater risk for stillbirth compared with pregnant women with an intermediate level of stress, after adjusting for factors such as age, smoking, and body mass index, and excluding complications such as diabetes.
A study published last year in Psychosomatic Medicine compared pregnant Israeli women exposed to rocket attacks with pregnant women not living under this threat and found that the former group had a higher rate of miscarriage. Stress is associated with this higher risk, the study concluded.
These and other studies have not established any consensus, however, about a causal link. Obstetrician-gynecologist Linda Bradley, MD, who practices at the Cleveland Clinic in Ohio, told Medscape Medical News that she is not sure "about the stress argument" for pregnant women who want to avoid vaccination.
"Everybody has stress," said Dr. Bradley, a member of the Medscape' Obstetrics and Gynecology editorial board. "There's death and grieving, and we still have 4 million pregnancies a year. People are stressed when everything is right in their life."
Dr. Bradley said she sympathizes with Breton, but nevertheless urges all pregnant women to get vaccinated against influenza.
"The sequela [from influenza] is so horrible for the mother and baby," she said. "High fevers are not good for pregnancy."
For Dr. Tan at the IAC, mental health contraindications for flu vaccination as they relate to pregnancy "don't make a lot of sense."
"We have so much safety data," said Dr. Tan. "It is strongly in favor of pregnant women getting the vaccine."
"Sometimes We Are Pill Happy"
Dreonna Breton is due to deliver in the late June. So far, so good.
"Everything is going along smoothly," she said. "All the ultrasounds look good."
Although she is the odd nurse out when it comes to the positions taken by the CDC and ACOG on vaccination of healthcare workers, pregnant and otherwise, Breton said she has received "nothing but positive responses from her colleagues."
"People call from my old employer and say, 'We're outraged. We can't believe they've done this,' " said Breton. "Some say, 'I never wanted to get the flu shot, either, but I'm afraid of losing my job.' "
Some nurses who've been fired over refusing vaccination have taken their former employers to court. A case in point is Karen Good, who last month sued Coshocton County Memorial Hospital, Ohio, last month in a district federal court in that state. Good, a registered nurse supervisor, claims that the hospital wrongfully fired her in November 2013 after she declined influenza vaccination on religious grounds even though she had a letter from her minister as required for a religious exemption (the lawsuit does not describe the religious reason given). The hospital had granted her such an exemption in 2012 — and permission to wear a mask — based on a similar letter, but did not do so the following year.
Breton said other nurses have encouraged her to sue Horizon Health Services. However, she and her husband Jeremy are not interested in a court battle, at least not now.
"The only reason I would pursue litigation would be if the end result caused other hospitals to reexamine their policies and provide more leniency," she said. "But we're not looking to pursue...30 years of lost wages."
Breton doesn't want to give the impression she is a foot soldier in the antivaccine movement.
"I'm not against vaccination as a whole," she said. "But I'm skeptical as far as how many vaccines a baby gets. Vaccines have done wonders for us overall. But sometimes we are pill happy."
Breton said she hasn't given her toddler son all of the vaccines recommended by the ACIP — the varicella vaccine, for one. "[Chickenpox] is not something very serious," she said. "You get it at a young age and you're done with it."
She said she intends to remain in the nursing profession.
"There are still plenty of nursing jobs," Breton said, "where you are not required to receive the flu shot."
At least for the time being.
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Cite this: Pregnant RN Fired for Refusing Flu Vaccine: Not So Simple? - Medscape - Feb 05, 2014.