With smallpox, don’t over- or underreact
Seven health care workers with a history of heart disease have died after being vaccinated for smallpox, leading the federal Centers for Disease Control and Prevention (CDC) in Atlanta to add heart disease to the list of reasons to exclude individuals. The CDC says it is just being cautious until it determines if there is a connection between the deaths and the vaccine, but risk managers should follow the same path in their own institutions.
The deaths should not necessarily deter any risk manager from recommending continued participation in the nationwide smallpox vaccination plan, says Jane McCaffrey, director of risk management at Oconee Memorial Hospital in Seneca, SC. Risk managers should take note of the possible correlation and act accordingly, but don’t overreact, she says.
"If you’re already participating in the vaccination program, this is no reason to stop it. We knew there were risks involved from the outset, so this is one more risk that we didn’t know about before, if it turns out to be a real risk," McCaffrey says. "It’s not as if we thought this was risk-free and suddenly we found out that it’s not."
The CDC took what it calls a "precautionary step" in adding a temporary medical deferral to the smallpox vaccination program for persons who have been diagnosed with heart disease. The CDC is investigating whether there is any association between smallpox vaccination and reports of heart problems in seven health care workers who have been vaccinated.
The CDC added the temporary measure to the existing list of deferral criteria based on information from its real-time monitoring system, which showed a small number of heart-related incidents among health care workers following smallpox vaccination.
"It is not clear whether this number is greater than would be expected normally in this population," according to a statement from the CDC.
CDC officials have received several reports of heart-related problems among the 25,645 people who have been vaccinated in the civilian program. The seven cases prompting the CDC’s precautionary action include three cases of myocardial infarction, one of which resulted in death; two cases of angina; and two cases of myopericarditis (inflammation of the heart muscle or sac surrounding the heart). In each case, the individual’s medical history — including risk factors for heart disease — is being studied.
Cases of heart inflammation following smallpox vaccination were reported in the 1960s and 1970s, the CDC reports. However, the information from these reports does not provide any information about the types of people who may be at higher risk for heart-related problems following smallpox vaccination.
"We promised to closely monitor this program and to put safety first, so we are exercising exceptional caution," according to a statement from Julie Gerberding, MD, CDC director. "If our investigation shows this precautionary measure should become permanent or the need for other changes or enhancements in the civilian smallpox vaccination program, we will take immediate action."
The smallpox plan was initiated in recent months as a response to increased threats of bioterrorism, with the goal of vaccinating a number of front-line health care workers across the country. Vaccination is voluntary for both institutions and individuals, and significant numbers of both have declined to participate because of the perceived risk of the vaccine. About 25,645 civilians have been vaccinated already, the CDC reports. The seven deaths occurred seven to 17 days after vaccination.
The CDC already had recommended that some individuals be excluded, such as those with some types of skin disease. Now the CDC is recommends that people with known cardiac disease — such as cardiomyopathy, previous heart attack, history of angina, or other evidence of coronary artery disease — be temporarily deferred from receiving smallpox vaccination.
This is a prudent step and not especially surprising, McCaffrey says. She compares the situation to clinical research, in which you must inform participants about the known risks at the outset, but then more risks may be revealed as the research continues. Your consent process and any exclusion criteria must be revised in the light of new information. She urges risk managers to remember that the CDC has not definitively said that the smallpox vaccination had anything to do with the seven deaths.
"The CDC has been extremely sensitive to the issue of risk, so I’m sure they’re being cautious," she says.
Cause and effect?
What about those health care workers who already have been vaccinated before the heart disease exclusion? McCaffrey wonders if those people may need some type of medical attention or monitoring, but the CDC so far says there is no answer to that question until it resolves whether the seven deaths actually were related to the smallpox vaccination.
It may turn out that there is no cause and effect between the vaccination and the deaths from heart disease, but in the meantime, risk managers must play it safe.
"This does mean that you want to be sure to exclude people with heart disease in a definitive way until we know more. That probably means you’re going to have to screen every person for a history of heart disease, and you may have to examine participants for heart disease risk factors even if they don’t know of any existing problems," she says. "If you’re doing vaccinations tomorrow, you should be scrambling to get as much information on this one risk as you can."
CDC officials said they will provide states with simple questions about heart problems to use in screening people volunteering for smallpox vaccination. The CDC also asked the Advisory Committee on Immunization Practices’ (ACIP) Smallpox Vaccine Safety Review Board to examine reports of heart-related adverse events occurring in connection with the smallpox vaccination program.
Seven health care workers with a history of heart disease have died after being vaccinated for smallpox, leading the federal Centers for Disease Control and Prevention (CDC) in Atlanta to add heart disease to the list of reasons to exclude individuals.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content. TESTING
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