Phased-in approach gains favor as vaccines begin
As hospitals prepare to vaccinate hundreds of health care workers, they face a host of opposing pressures: Some health care workers may request the smallpox vaccine, but those designated for smallpox response may not want it. Vaccinations may lead to increased absenteeism in the midst of a nursing shortage and the flu season. And concerns about serious adverse events may spur some hospitals to restrict or even opt out of vaccination.
The burden of the logistics for vaccinating those workers falls largely on the shoulders of hospital employee health professionals.
Meanwhile, different approaches by state health departments create disparities in who will be vaccinated and how the vaccinations will occur. For example, Georgia announced a phased-in plan to limit vaccination to emergency department (ED) staff in the state’s 15 trauma centers and regional response teams in 19 public health districts — for a total of about 500 vaccinees. Then the state amended its plan to accelerate vaccination of health care workers at other acute-care hospitals. New York City announced plans to vaccinate about 15,000, with response teams at each hospital, and California’s plan would lead to about 50,000 vaccinations of health care workers.
The vaccination patterns will vary based on population and the nature of the health care delivery system. "We anticipated that states would have very variable plans for many good reasons, and whatever immunization occurs, we are certainly going to be more prepared than we are right now," Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention (CDC), said in a recent teleconference.
In fact, the estimates are likely to change many times as the plans evolve. "The big question mark is how many people are going to want it and be eligible for it," says James Garb, MD, director of occupational health and safety at Baystate Health System in Springfield, MA, who plans to conduct his vaccinations over a 10- to 12-week period. "We might not reach our quota."
The vaccinations were scheduled to begin late in January, after the provisions of the Homeland Security Act providing immunity from liability became effective Jan. 24. While the CDC recommends vaccination in centralized public health clinics for the most effective use of the 100-dose vials, many hospitals are planning to create vaccination clinics within their employee health service. Where the vaccination occurs may have an impact on the hospital’s potential legal liability for adverse events.
The CDC asked for vaccination to occur within a 30-day time frame, but acknowledged that more time would be needed. The agency approved state plans that allowed for a longer time span. "We want people to do it as safely as they need to — to gear up and get the job done right," Gerberding said.
Hospitals also must plan for mild reactions. Many employees will feel ill seven to 10 days after vaccination with symptoms that include fever, malaise, and swelling at the injection site or a lymph node.
One study found that about one-third of vaccinees felt ill enough to miss school, work, recreational activities, or to have trouble sleeping.1 Hospitals are factoring that into their planning, while union leaders are advising health care workers to obtain assurances about sick leave, medical costs, and workers’ compensation before receiving the vaccine.
"We need to make sure that safeguards are in place for the public and workers before this [vaccination] plan is released," says Bill Borwegen, MPH, occupational safety and health director for the Service Employees International Union (SEIU) in Washington, DC. "These are incredibly important issues that have not been addressed. [Congress and the administration] go out of their way to protect vaccine manufacturers. We need to do what we can to protect frontline health care workers."
The SEIU is advising health care workers to gain protections for possible lost work time and medical costs for themselves and family members who may be affected before agreeing to the vaccine. "There are very serious gaps in this program," he says. "We’re advising our members, if they want to be vaccinated, make sure these serious gaps are dealt with first."
Only eligible HCWs to receive first vaccines
In selecting the health care workers who receive the first vaccinations, hospitals consider the positions of highest need to treat a case of smallpox 24/7 for a period of seven to 10 days. Anyone who receives the vaccine must be willing to treat smallpox patients. Those who are not designated as high need will not be entitled to the vaccine in this first round of vaccinations.
But hospitals and public health departments may make their own assessment of the benefits and risks of the vaccine in deciding who receives it. "It’s clear that individual hospitals and public health departments may modify the [CDC] recommendations in order to meet their needs," said Jane D. Siegel, MD, professor of pediatrics at Southwestern Medical School of the University of Texas in Dallas and chair of the bioterrorism working group for the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC). "The goal is not to vaccinate the entire emergency department staff."
That assessment of "need" may vary dramatically. Hospitals may set stricter screening guidelines for contraindications, or may choose to initially vaccinate only those who had been previously vaccinated as children. Those who were previously vaccinated are expected to have milder effects.
Patrick O’Neal, MD, EMS medical director for the Georgia division of public health, says hospitals are reluctant to participate without strong protections from liability. Hospitals that treat a large number of AIDS patients are particularly concerned about the risk of transmission of vaccinia to vulnerable patients. Restricting employees from contact with such patients may be impossible, O’Neal says. "We’ve got major staffing issues in hospitals across the state of Georgia. To furlough active employees is just almost unthinkable," he says.
Concerns about the risk of the vaccine prompted the state’s largest hospital, Grady Memorial Hospital in Atlanta, to opt out of the vaccination plan.
Children’s Hospital of Philadelphia likewise chose not to vaccination health care workers at this time. Paul Offit, MD, chief of the division of infectious diseases, says he would identify the smallpox response team, screen and educate the employees — and then wait. He would activate the plan only if a case of smallpox is reported somewhere in the world.
Offit, who was the only member of the Advisory Committee on Immunization Practices (ACIP) to vote against the recommendation for vaccinating health care workers at most acute care hospitals, says not enough is known about the likelihood of a smallpox case.
In announcing the smallpox vaccination program, President Bush said, "Our government has no information that a smallpox attack is imminent." While the potential for a bioterrorism event involving smallpox is undetermined, the risks of the vaccine are well-documented.
"The question is, Is it right to use that vaccine now?’ No one knows the answer to that question," Offit says. "Right now we don’t have all the information we need to make the decision. We have to make the best decision we can." Offit concedes that some employees may want the vaccine even if he recommends waiting. He had not decided how to handle those requests.
Ironically, Offit actually is one of the few infectious disease specialists who has experience with the vaccine, which he administered to about 100 employees at the Wistar Institute, a research facility in Philadelphia. Moderate effects caused many employees to miss a day or more of work, he says. "It’s not at all uncommon for one to have fever, malaise, aching, significant swelling at the site, swelling of the lymph gland under the armpit. That’s all part of the vaccine," he says.
If he eventually administers the vaccine, Offit says he would consider a post-vaccination furlough for employees who work with immunosuppressed patients.
EH depts become smallpox vaccine clinics
Many hospitals are planning to conduct the vaccination in phases to minimize the impact. Employee health must offer confidential HIV and pregnancy testing, and make sure health care workers understand the contraindications. Employee health professionals also may need to recruit other nurses to help with the daily injection site monitoring.
At Baystate Health System, senior leaders are appealing to designated employees for cooperation with the vaccination program. Garb and the chief of infectious diseases will be among the first vaccinated.
Garb says he plans to transform the employee health clinic into a smallpox vaccination clinic one morning per week until the hospital vaccinates staff who are willing and eligible. He adapted the CDC screening and consent form, including questions about whether the health care workers have itchy or inflamed eyes, whether they have received the varicella vaccine within the last four weeks, and whether child care takes place in their home. (See form.) Infants 1 year or younger should not be in contact with vaccinated individuals.
"I’m hoping most of the people who aren’t eligible or don’t want it will screen themselves out," he says. Skin conditions may cause the greatest concern. The contraindication relates to eczema and atopic dermatitis, but even contact dermatitis — a common condition during New England winters — could eliminate some employees from the vaccination list.
Garb says he plans to ask any health care workers with raw, chapped hands to consult a dermatologist or wait until spring for the vaccination.
At Pitt County Memorial Hospital in Greenville, NC, Patricia Dalton, RN, COHN-S, occupational health administrator, also plans to phase in the vaccinations. "I remember when this was not a big deal. In 1966, I was administering smallpox vaccine all day long for school kids," she says. Out of 6,000 employees, Dalton says she expects to immunize 80 to 100. "I don’t even know if we’re going to get that much [vaccine]," she says. "One of the physicians had heard we might get 40 to 50 doses. We are strategizing about who would get it first." Dalton expects that occupational health nurses will provide the vaccinations at the hospital, so they will be the first immunized.
The hospital’s response plan calls for suspected smallpox cases to be triaged at an urgent care center, and for suspected smallpox patients to be treated in a care center set up in a surgicenter facility. "As much as possible, we would like to keep any potential for a smallpox case from coming into the hospital," she says.
For employee health departments with minimal staffing for even routine duties, the new responsibilities of monitoring smallpox vaccination can be overwhelming. MaryAnn Gruden, MSN, CRNP, NP-C, COHN-S/CM, executive president of the Association of Occupational Health Professionals in Healthcare in Reston, VA, an employee health nurse practitioner at Western Pennsylvania Hospital in Pittsburgh, notes that her hospital conducts annual TB skin testing every January. "In some offices that have good staffing, it may not be as much of an impact. For those of us working on a shoestring," she says, it will be a challenging process.
1. Frey SE, Couch RB, Tacket CO, et al. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med 2002; 346:1,265-1,274.
Maybe the vaccine won’t be as bad as we think
No serious reactions at biotech firm
Smallpox vaccination of selected health care workers may actually occur smoothly with relatively few severe adverse events, if recent experiences are a guide.
At Acambis, a Cambridge, MA-based company that won a Centers for Disease Control and Pre-vention contract to restock the nation’s supply of smallpox vaccine, occupational health physician Reid Boswell, MD, MPH, has vaccinated about 300 to 400 employees, after conducting careful screening for contraindications. "I’ve had very few complications with the vaccine and nothing that has required hospitalization or Vaccinia Immune Globulin (VIG)," says Boswell, who is medical director of the Mount Auburn Hospital Occupational Medicine Clinic in Cambridge, MA. "If you carefully screen people, we’re probably not going to have a lot of major problems."
One woman had a whole body urticarial rash, probably as an allergic reaction to trace amounts of antibiotics in the vaccine, Boswell says. She was treated with Benadryl. "I have no case where anyone has had an accidental inoculation of another person," he says. Boswell uses a six-page consent form, and employees are well-informed before they get the vaccine, he says.
He notes the common, mild effects of fever, pain, headaches, and malaise. But even those are not as bad among people who were previously vaccinated, he says. "It turns out that people vaccinated as children have fewer minor side effects. They still have a major take response, which shows they don’t have a lot of circulating antibodies, but they seem to have fewer of the side effects," he says.
What if emergency vaccination suddenly became necessary? The federal government is not recommending vaccination of the general public at this time. But if a smallpox case occurred, those exposed could still gain protection from vaccines administered within four days of exposure.
Public health officials in Tucson, AZ, recently tested the distribution of National Pharmaceutical Stockpile medicines to the general public as part of a bioterrorism drill. Although the scenario didn’t involve vaccination, the logistics would be similar, says Bryn Bailer, spokesman for the Bioterrorism Preparedness Program of the Pima County Health Department in Tucson.
"The public health department’s goal was to process 1,000 people during the six-hour clinic," Bailer says. "That includes registration, where people would fill out [forms listing] their health conditions. We had different scenarios set up for them. You might be a 12-year-old boy with asthma and epilepsy."
Public health staff and volunteer pharmacists determined what would be the best response for people with various medical conditions. In the drill, the ad hoc clinic was able to process 1,854 people and could easily have processed more, Bailer says.