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Lawsuits, complications lower for febrile children
But vaccine doesn't prove that disease is not present
The introduction of vaccines that prevent bacteremia has significantly reduced the risk of serious bacterial infections associated with Haemophilus influenzae and Streptococcus pneumoniae. How does this impact liability risks when caring for febrile children?
"There will always be risk, but the risk is arguably lower. The prevalence of the disease and serious complications is lower today than it was," says Steven Krug, MD, chair of the American Academy of Pediatrics' Committee on Pediatric Emergency Medicine.
Vaccines dramatically lower risk
A recent study on vaccines and their benefits reported a 92% reduction in cases and a 99% reduction in mortality of diphtheria, mumps, pertussis, and tetanus.1 "Of course, endemic transmissions of polio, measles, and rubella have been eliminated in the U.S., and smallpox is no longer a threat worldwide," says Matthew Rice, MD, JD, FACEP, an ED physician with Northwest Emergency Physicians of TeamHealth in Federal Way, WA. "These are all due to vaccinations."
Vaccines have been the single most important method to prevent bacteremia, says Rakesh D. Mistry, MD, MS, an ED physician at Children's Hospital of Philadelphia. Before 1990, Haemophilus influenzae type b (Hib) produced countless numbers of patients with so called "occult" bacteremia in well-appearing febrile children, he notes. "Furthermore, the associated infectious complications from Hib bacteremia were significant," says Mistry. "Although the data is scant, it is believed that Hib vaccination reduced the incidence of occult bacteremia as much as tenfold."
Post-Hib vaccination, the leading cause of bacteremia is now S. pneumoniae, with studies from the 1990s estimating the rate of occult bacteremia at 1.5-2%, says Mistry. Less virulent than Hib, the invasive complication rate from S. pneumoniae has been estimated as low as 1 in 5000 cases of febrile young children under 36 months of age, he says.
"However, institution of pneumococcal vaccination since the turn of the century has cut these risks even further," says Mistry. Recent evidence has estimated current occult bacteremia rates at less than 0.5%, with complication rates over 1/10000, he notes.
Introduction of several vaccines have markedly reduced various bacterial infectious diseases, including meningitis. "Studies vary, but there is no doubt that some bacterial infections have been reduced at least 50% or more in those who have been appropriately vaccinated," says Rice. "If there is less likelihood of bacterial infections, there is less chance of that disease presenting and thus, all else being equal, less chance of the disease being 'missed.'"
However, Rice points to recent cases in Maryland in which parents were threatened with jail and fines for not vaccinating their school age children.2 "Thus, the risk of increasing outbreaks of previously unlikely diseases may reappear if society ignores vaccine requirements and diseases begin to emerge," he says.
Don't assume disease isn't present
It is possible to defend a malpractice lawsuit involving missed bacteremia and associated complications with the argument that it is a much more rare event, providing it is occult bacteremia, says Krug.
However, defending a medical malpractice case is complicated and dependent on the circumstances and facts, says Rice. "Of course it is possible to use the 'rare event' defense. But misdiagnosing a bacterial infection, especially ones with more devastating outcomes such as bacterial meningitis, is always difficult to defend because of the some of the severe damages," says Rice.
Emergency physicians are trained to think of the worst possible scenarios and sort out in the differential diagnosis those diseases that must be identified in the patient's best interest, says Rice. When administered to enough vulnerable patients, most vaccines provide a "herd" immunity, but vaccines are not all completely successful for eliminating the possibility of disease.
"The evaluation and treatment for each patient is contingent on the possibility of disease," he says. "If a severe disease like meningitis is a possibility, physicians must evaluate and treat the patient aggressively. You should not assume that administration of a vaccine is absolute proof that a disease is not present."
From a risk perspective, if a patient appears ill and part of the differential diagnosis is meningitis, then the best "risk adverse" practice is to rapidly progress with an evaluation and treatment with spinal tap and antibiotics, and readjust your strategy as more facts become clear, advises Rice.
Your clinical assessment is key
However, for cases of well-appearing febrile children age 3-36 months who present with fever, testing and treatment are not indicated based on the current evidence, says Mistry. "The most important aspect of this is 'well-appearing,'" he says. "The treating physician must be able to make this clinical assessment appropriately."
The ED is always subject to legal vulnerability, says Mistry. "We are in the unique position of evaluating a child for no more than one hour, and then having parents ask us to predict the future," he says. "The overwhelming majority of pediatric emergency physicians would defend a case of missed occult bacteremia, because, frankly, we would need to subject 10,000 children to antibiotics to potentially prevent just one complication."
Furthermore, there is no evidence to support the notion that antibiotics are 100% effective in preventing complications, adds Mistry. More and more febrile children will be discharged from EDs without testing and empiric treatment, since the rates of bacteremia are dropping, he says. "The overwhelming majority of physicians see this as a good thingthe less we subject children to unnecessary interventions the better," he says.
In these cases, however, two things are most important to protect EDs from legal complications, says Mistry. First, proper assessment of the clinical situation is critical, especially the appearance of the child, with good documentation. Second, and most important, remember proper anticipatory guidance and discharge instructions.
"ED physicians must counsel parents to monitor fever and control it appropriately, follow up for sequential evaluations with primary care physicians, and return for changes in the child's appearance," says Mistry.
1. Roush SW, Murphy TV, Vaccine-Preventable Disease Table Working Group. Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 2007;298:2155-2163.
2. Washington AT. Schools' 'last resort' needs a shot of sense. Opinion. The Washington Times. Nov. 20, 2007.
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