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January 2003 Last month, the President and the Secretary of Health and Human Services announced the government’s decision on smallpox vaccine. The announcement itself was somewhat anticlimactic, since the shape and content of the plan had been leaking out for the last four months. It is a considerably expanded plan over what the Advisory Committee on Immunization Practices had originally recommended in June 2002. For those few readers who may not yet be familiar with the details, the plan calls for broad immunization of health care personnel, followed later — perhaps next year — by allowing immunization of civilians by request. Important however, is the fact that there is no plan to broadly immunize the civilian population. Immunization of health care personnel is to be done in two steps: phase 1 will consist of immunizing a small number of “smallpox care teams” in each hospital: phase 2 will consist of the immunization of health care personnel more broadly. By the end of this process, it is expected that the number of health care personnel immunized will reach approximately 1 million.
The first phase of the plan, immunization of smallpox care teams, has already begun in some places and should be well underway within the next several months. The composition of these teams is determined by each hospital, but the CDC has a prioritized list that seems rational and includes some, but certainly not all, members of the following groups: emergency department staff, intensive care unit staff, general medical unit staff medical house staff, medical/surgical subspecialists, infection control staff, respiratory therapists, radiology technicians, security and housekeeping staff. These immunized personnel could, if a modest number of cases of smallpox occurred and were admitted, be organized in such a fashion as to provide competent and continuous patient care without broader immunization of other hospital personnel. Infectious disease physicians and hospital epidemiologists involved in the planning and implementation of these activities would do well to read the series of articles published electronically by The New England Journal of Medicine on Dec. 19, 2002 (the print edition will be published on Jan. 30, 2003). Included is a modeling study carried out by Samuel Bozzette, MD, PhD, and his colleagues at the RAND Institute, a survey of knowledge and attitudes about smallpox and smallpox vaccine carried out by Robert Blendon, PhD, and colleagues at the Harvard School of Public Health, a review by Kent Sepkowitz, MD, of the contagiousness of vaccinia virus and a review by a former CDC colleague of mine, Tom Mack, MD, MPH, who personally studied smallpox transmission in Pakistan 30-plus years ago. These articles will inform the discussion about the pros and cons of the Bush Administration program, but with the possible exception of Tom Mack’s comments, will not likely shape any hospital or individual decisions. The IDSA, through a letter from its president, W. Michael Scheld, MD, has generally endorsed the President’s program, being particularly supportive of the absence of a plan for mass immunization of civilians and also pointing out a number of critical but as yet unresolved issues. These include professional liability, compensation and leave, and prevaccine screening issues. The Society for Healthcare Epidemiology of America has not yet weighed in on this issue. It is clear that there are a large number of as yet unanswered questions and some answers to questions may not be known until the program is well underway. The following is my list of the most pressing issues and questions — and even this is incomplete.
And on and on… As hospitals actually get into the immunization program, many more questions will arise. It must be clearly understood by all that participation in a smallpox vaccination program is wholly voluntary. Just as it is voluntary for individuals, so it is voluntary for individual hospitals as well. Several hospitals have already decided against participation. These include both academic institutions and community hospitals. Notable among these institutions which have opted out are: Grady Memorial Hospital in Atlanta (right in the CDC’s back yard) and the Medical College of Virginia Hospital in Richmond, VA. The two common themes in reasons for opting out are no surprise, it is either, “we don’t believe the risk to our staff is justified,” or “we don’t believe the risk to our patients is justified.” The common thread in opting out is that the federal government may indeed know more than they have told us, but they have not yet made a convincing case for the vaccination program, even among health care personnel. Clearly, each hospital will need to go through its own decision process regarding the issue. Infection control personnel and employee health staff will need to develop their own plans for vaccination and follow-up, estimate the costs that will be incurred and present them to the administration and the medical staff. The costs of the program in individual hospitals will be significant, when one considers the planning and staff education time, the actual vaccination time and the extensive follow-up time required. The intrinsic bias of hospital administrators, nevertheless, will likely be to comply — assuming liability and compensation issues can be addressed satisfactorily. I anticipate most of the concerns will come from the medical staff, yet, the medical staff must be given the opportunity to consider the issues. Ultimately it is their patients who may be placed at risk (low though it may be). At this writing, I am not at all confident what the decision will be in my own hospital. It will likely be clear within the next several months, and certainly by the end of March. In informal discussion with colleagues about this issue, one of them observed that the smallpox immunization issue is the knottiest problem to come along since the HIV-infected health care worker problem of a decade ago; I agree with that assessment. Stay tuned! |
