No need to rush? Hospitals go slow with smallpox vaccination plan

Caution is a tool to avoid adverse reactions

Caution prevailed over urgency as hospitals slowly began implementing the smallpox vaccination program in February. By taking extra safeguards and strictly limiting the health care workers receiving the vaccine, they hoped to avoid the adverse effects associated with the vaccine.

Concerns about liability and compensation limited participation in the program, while federal authorities sought to allay those concerns. An increasing number of hospitals opted out, while many of those participating found fewer volunteers than expected.

"We’re looking for 150 volunteers at Baystate Medical Center [in Springfield, MA]. We’re probably only going to be at a third of that, 50 or 60," said James Garb, MD, director of occupational health and safety at Baystate Health System. "Hopefully, it will go well, and people will see it’s not so terrible."

The Chicago-based American Hospital Association asked for, and received, written assurances from Health and Human Services Secretary Tommy Thompson that the Homeland Security Act protects hospitals from liability due to adverse reactions and nosocomial transmissions. Thompson also told union representatives that he would work with Congress to develop a compensation plan for those harmed by the vaccine. An Institute of Medicine (IOM) panel had likewise underscored concerns about compensation, safety, education, and the timing of the vaccination program.

But Thompson told representatives of the Washington, DC-based Service Employees International Union (SEIU) that the program could not be delayed. "He told our president, We can’t delay this program because we’re going to war [with Iraq],’" recalls Bill Borwegen, MPH, SEIU health and safety director, who was at the meeting.

The SEIU and other unions advised health care workers to make sure sufficient safeguards were in place before volunteering for the vaccine.

The speed of the program was a major issue for hospitals, as well. "The program is moving too fast," said Roslyne Schulman, AHA’s senior associate director for policy development, in the days before the Centers for Disease Control and Prevention (CDC) released the vaccine. "They ought to slow down and reevaluate some of these issues that remain unresolved."

In fact, many hospitals and even state health departments have created a longer timeline. The CDC envisioned a program that would begin at the end of January and last 30 to 60 days.

Arizona public health officials chose to wait until they completed an educational program and received more clarification on compensation issues.

"We’re not going to rush into something until we know people are adequately educated and prepared," says Marte Keller, program manager for education and training in the office of bioterrorism preparedness and epidemic response at the Arizona Department of Health Services in Phoenix.

In Georgia, only three of seven trauma centers in metropolitan Atlanta decided to participate. The initial vaccinations in those hospitals will be limited to about 10 or 15 employees, and the program will eventually expand to about 45 employees per hospital, explains Patrick O’Neal, MD, EMS medical director for the Georgia Division of Public Health.

"We’re not going to move on until we’re comfortable that we’re not seeing a lot of complications in the early steps," he adds. "We feel that it’s imperative that we evaluate this very carefully, very slowly, and we not move aggressively on this in a pre-event scenario," O’Neal points out.

Elsewhere, the go-slow plan evolved from employee reluctance. In Connecticut, one of the first states to request vaccine and the first to administer it, only four employees received vaccinations on the first day of the program. Variations in vaccine programs in different states and individual hospitals ultimately may be enlightening. The IOM panel suggested that the CDC evaluate the differences and correlate them with safety data. The panel also advised CDC to carefully evaluate Phase 1 of the vaccination program — vaccinating as many as 500,000 health care workers — before moving on to other groups, such as emergency responders.

Two key concerns: Science and money

Continuing concerns about the smallpox vaccination revolve around two aspects: science and money.

Clinicians are accustomed to making evidence-based decisions. The smallpox vaccination program presents known risks of the vaccine and unknown risks of a smallpox attack.

Some hospitals have decided that the risks of smallpox are too low to justify exposing employees to potential adverse reactions. For example, Baystate Health System’s two smaller hospitals decided not to participate.

"One of the key factors is perceived risk. These two hospitals are in smaller communities," says Garb, who notes that employees reasoned, "What are the chances of the first case of smallpox showing up here? I’ll get vaccinated when the first case of smallpox shows up [somewhere].

"I can’t argue with that logic," he says. "There are some prominent physicians in this country who have said the same thing."

Vaccine a part of preparing for bioterrorism

Julie Gerberding, MD, MPH, director for the CDC stressed the importance of vaccination as a part of bioterrorism preparedness — a scenario far different from typical medical decision making.

"Sometimes, it is difficult for people who are thinking of this from a totally public health perspective to recognize that this decision is not just a public health decision," she said. "This is an issue of homeland security and an issue of national defense."

Cost is another harsh reality for hospitals. Hospitals have estimated their costs related to vaccination from $55 to $1,100 per vaccine, Schulman explains. For example, although a federal panel stated that furloughing employees is not necessary if the injection site is properly covered, some hospitals are choosing to furlough workers as an added protection against transmission of vaccinia to patients.

All participating hospitals have expenses related to training, monitoring, and absenteeism. Some hospitals are self-insured for workers’ compensation and have even higher potential costs.

"There’s no provision for any kind of compensation," Schulman adds. "Right now, this is sort of an unfunded mandate. We would like to see some sort of a program that would provide compensation to allow hospitals to protect their community," she explains.

(Editor’s note: A copy of the IOM report, Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, is available at www.nap.edu/catalog/10601.html.)