Employee health smallpox role: Safeguard HCWs from vaccine risks

Hospitals begin preparing for vaccination of teams

Employee health professionals will not be administering the smallpox vaccine to health care workers, but they may be among the first to receive it under a recommendation approved by two federal advisory panels. About 500,000 health care workers — around 100 per hospital — may be vaccinated under the latest plan to prepare for bioterrorism. There have been no cases of smallpox worldwide since 1977, so even a single confirmed case of smallpox would be considered a bioterrorism event.

"We are not focusing on a target number of individuals to be immunized, but rather the objective is to identify . . . a sufficient number of health care workers in different categories to provide care in many, if not most, of the acute-care hospitals in this country," says John Modlin, MD, chair of the Advisory Committee on Immunization Practices (ACIP) and professor of pediatrics and medicine at Dartmouth Medical School in Lebanon, NH.

In the case of an actual outbreak, other health care personnel would be immunized, notes Walter Orenstein, MD, director of the Centers for Disease Control and Prevention’s (CDC) National Immunization Program. "The goal [of the immunization plan] is a cadre of people who could care for the first several patients in the first seven to 10 days on a 24-hour basis," he says.

ACIP and the Healthcare Infection Control Practices Advisory Committee (HICPAC), which also approved the recommendations, provide guidance to the CDC and the Department of Health and Human Services. The Bush administration is expected to make a decision on smallpox vaccination shortly. While many questions remain unanswered about how the vaccination process would proceed, the panels agreed on some basics:

• Vaccination with live vaccinia vaccine would be voluntary and would be offered to employees of the intensive care unit, the emergency department, infection control personnel, and selected other staff, including dermatologists, pediatricians, respiratory therapists, radiology technicians, engineers, and some employees from the security and housekeeping departments. Lab workers are not included in this recommended group because the viral load in clinical samples is expected to be low and to present a low risk.

• The vaccines would be administered by local and state health departments, but a team including infection control and employee health professionals would monitor and report adverse events daily.

• Employees would report to work after vacci-nation. However, their injection sites must be covered by gauze and a bandage. In daily inspections, infection control/employee health staff would ensure that the site is properly covered and the skin reaction doesn’t pose any risk to patients.

• Employees would undergo pre-screening before the vaccination day, and they would be asked about HIV risk factors, skin diseases, and the likelihood of pregnancy. Rapid HIV tests would be used for those who want to know their HIV status.

• Vaccination would occur in phases, with small groups of health care workers at a facility. Those previously immunized as children should be the first ones vaccinated.

• At this time, ACIP and HICPAC do not recommend immunization of emergency medical technicians or other first responders. However, hospitals could choose to include some of their emergency transport staff in the vaccinated care team.

Exactly who should be vaccinated ultimately will be decided by individual hospitals, panel members said. Hospitals with negative-pressure rooms would designate larger teams, while hospitals without negative-pressure rooms might focus on emergency department capability, they said.

"This is a care team. This is not protection of everybody who could possibly be inadvertently exposed," says Jane D. Siegel, MD, professor of pediatrics at Southwestern Medical School of the University of Texas in Dallas and chair of the HICPAC bioterrorism working group.

While hospitals await direction from the Bush administration on when and whom to vaccinate, employee health professionals should begin gathering key players to discuss immunization issues, says MaryAnn Gruden, MSN, CRNP, NP-C, COHN-S/CM, employee health nurse practitioner at Western Pennsylvania Hospital in Pittsburgh and executive president of the Association of Occupational Health Professionals in Healthcare. That would include medical directors of the intensive care unit and the emergency department, nursing administration, and managers of human resources and workers’ compensation, she says. "We have got to mobilize our resources and come up with a plan for how to monitor [vaccine reactions] before we administer vaccine."

Amid concerns over a possible war with Iraq and suspicions that Iraq may use smallpox as a biological weapon, vaccination plans have taken on a new urgency. Yet no one knows how many health care workers are likely to agree to take the vaccine, due to the risk of adverse events.

"I know some of the nurses at our hospital have said, I’ll take it, but only if my whole family gets it,’" says William Scheckler, MD, hospital epidemiologist at St. Mary’s Hospital Medical Center in Madison, WI, and professor at the University of Wisconsin Medical School. "Others said, I’ll never get it. It’s too dangerous.’"

Family members will not be offered the vaccine as a part of this program, he notes. However, if health care workers have household contacts with contraindications, such as compromised immunity, they will not receive the vaccine.

"I’m not sure you can get 100 people in our hospital to go through with it," says Lucy Tompkins, MD, PhD, medical director of hospital epidemiology at Stanford (CA) University Medical Center and an ACIP member. She will receive the vaccine as part of the team monitoring vaccine reactions at her hospital. "My personal feeling is that in my lifetime, I will probably never see smallpox."

While the actual risk of a smallpox event can’t be calculated, the risk of adverse events related to the live vaccinia (cowpox) vaccine is the focus of study and debate.

Pre-screening health care workers for contraindications to the vaccine could reduce potential adverse events by at least 50%, Modlin says. Yet in that process, as many as 20% of health care workers may be eliminated from vaccination due to skin conditions alone. For those with a history of atopic dermatitis, the vaccine can lead to generalized eczema vaccinatum, in which a large section of the body becomes infected with vaccinia. Because it’s difficult to screen for atopic dermatitis — many people may not have an accurate diagnosis — ACIP recommends excluding people with eczema or exfoliative conditions. Contact dermatitis is not a contraindication. Anyone with a household contact who has a contraindication to the vaccine, such as eczema, also would not receive the vaccine.

Before vaccination, all health care workers would receive an advice packet containing information about contraindications and a medical screening checklist. They would be offered an opportunity for HIV testing and pregnancy testing, but the testing would not be mandatory, according to the recommendations. Women also would be advised to use effective contraception until one month after vaccination.

The most severe reactions to the vaccine include postvaccinal encephalitis and progressive vaccinia, which involves progressive necrosis in the area of vaccination, often with metastatic lesions.

Based on past experience with the vaccine, the CDC estimates that there could be one death per million people among those receiving the vaccine for the first time and 0.25 deaths per million among those who have been previously vaccinated. Public health authorities hope to reduce that risk by eliminating those who have HIV or other disorders that affect immune sufficiency, or who have household contacts with an immune disorder.

The ACIP/HICPAC plan involves using a diluted formula of the existing Dryvax vaccine supply, with 15 quick sticks using a two-pronged needle. (The needles do not contain a safety feature.) Until the injection site heals completely, with the scab separating from the skin, vaccinated health care workers could accidentally inoculate other people or themselves. Yet advisory panel members emphasized that the risk of transmission of vaccinia from injection sites to patients is low.

Who will assume liability for the effects?

Each hospital would be responsible for monitoring the injection sites to make sure they’re covered properly. "It is also important to note that the very close contact required for transmission of vaccinia to household contacts is unlikely to occur in the health care setting," Modlin says.

No matter how careful the screening process, some adverse events will occur, public health authorities acknowledge. That leaves a lingering question: Who will assume the risk for those adverse events? ACIP did not address the liability issue, noting that the Department of Health and Human Services will consider those concerns. Smallpox is not a part of the National Childhood Vaccine Injury Act, which provides compensation for people who have adverse effects from vaccines.

For now, hospitals are assuming that workers will be covered by workers’ compensation. "If employees have adverse effects to other vaccines, then that is work-related," Gruden notes. "I don’t see why smallpox would be any different."

Although ACIP doesn’t recommend furlough for vaccinated health care workers, some will miss work due to even mild or moderate effects, including rash and fever. The vaccination plan should take into account the possibility of such absences, employee health experts note.

While hospitals prepare for vaccination, those in employee health should gather educational material on smallpox and the vaccinia vaccine, Gruden advises. After all, employees with concerns or questions will turn to employee health. "They’re going to call us. They’re not going to call the health department," she says.

(Editor’s note: More information on smallpox and the vaccinia vaccine is available at http://www.bt.cdc.gov/agent/smallpox/index.asp.)