Fear of Suit Stops Some EPs From Giving tPA
Suits more likely if EP fails to offer treatment
Even if a patient with a suspected stroke meets the criteria for tissue plasminogen activator (tPA), emergency physicians (EPs) are sometimes reluctant to administer it without having a neurologist evaluate the patient, says Joseph Shiber, MD, FACEP, FACP, FCCM, associate professor of emergency medicine and critical care at University of Florida College of Medicine Jacksonville.
"The fact that some of those hemorrhages can be severe scared a lot of EPs," says Shiber. Although the mortality risk is the same, tPA increases the risk of cranial hemorrhage ten-fold from about 0.6% to about 6.4%.1
"Lawsuits are much more likely for omission than for commission," says Shiber. "That makes me think that EPs are still a little bit shying away from giving it to patients."
Of the cases brought to trial against EPs involving tPA, 80% involved failing to give thrombolytic therapy, as opposed to giving tPA with a resulting bad outcome.2
"Some of the cases that did go successfully against the EP is when the diagnosis was questionable but was made too late," says Shiber. "The family thought an opportunity was missed." Consider these documentation practices to reduce legal risks:
• Show that the EP truly informed the patient about risks and benefits of treatment.
Shiber says the best approach is to briefly present the risks and benefits of having the therapy versus not having it. Allow the patient and/or family to come to their own decision, as opposed to making a recommendation yourself.
"This is the one time that I don't recommend a therapy. I present the options and let them make the decision," says Shiber. "If the EP says, I want to give you this therapy' and there is a bad outcome, that is fraught with complications."
Meticulously document the discussion and the decision-making process for any patient with a cerebral vascular accident who may meet treatment criteria by any interventional standard, advises Robert Suter, DO, MHA, professor of emergency medicine at UT Southwestern Medical Center in Dallas, TX.
"EPs may otherwise feel that they can sometimes cut corners on documentation. You cannot do that in a stroke case," says Suter.
• Specify the patient or family's reasons for why they accepted or refused treatment with tPA.
For instance, the EP might document that the family decided they wanted to proceed with the therapy because they knew the patient would want a chance to speak or walk better even with a risk of bleeding. Conversely, the EP can specify that the patient decided against the therapy because his or her symptoms were not too severe and he or she greatly feared cranial surgery and the associated risks.
"To document why the treatment is being done, or not being done, is not only going to protect you legally. It is also the best way to perform care," Shiber says.
Reluctance Still Exists
"Regardless of what anybody's position or feelings are about what the best treatment is, or whether they should give tPA or not regardless of whether people want to accept the literature the fact is that you are more likely to be sued for not giving thrombolytics," says Suter.
One reason EPs fail to treat with tPA is tied to the controversy over the original trials, says Suter. "We are talking about a treatment where the differences between whether a patient does well or poorly can be so extreme," he adds. "A lot of EPs had a real reluctance to accept the recommendations, given that there were a fair amount of concerns expressed by some prominent EPs."
Because complications, when they do occur, can be so severe, EPs who didn't feel as though they could evaluate the literature themselves were afraid to do something that was being communicated as potentially dangerous, says Suter.
"The fact is, though, that even though there are risks to treatment and there are still skeptics, the data analysis exceeds the scientific standards for recommending the treatment as being more beneficial than harmful," Suter says.
"Drip and Ship" Approach
What if the EP is still ruling out non-stroke causes for the patient's symptoms and the clock is ticking for beginning therapy with tPA? Shiber says EPs should err on the side of treating.
"There appears to be not much legal risk of treating conditions that may not be stroke, but more risk of having patients and family pursue a suit if they thought you should have given the therapy," he says.
Shiber recommends obtaining a neurological consult any time the stroke diagnosis is uncertain, or if there are any factors putting the patient at increased risk for complications.
"The literature shows that when the neurologist is involved in making the diagnosis, as compared to the EP making it alone, there are less complications and less risk of litigation," says Shiber.3
If a neurologist isn't available, EPs should document their attempts to obtain the consult and get the patient transferred to a center but not without treating the patient first if the risks are determined to be less than the benefits, says Shiber.
This is similar to the approach for reperfusion of acute myocardial infarction at a community ED without a cardiac catheterization lab, he says. The EP quickly evaluates the patient and starts therapy in the ED while getting the patient transferred to a percutaneous coronary intervention (PCI) center.
"If the patient reperfuses by the time they arrive, that's great. If not, you can go ahead and do a rescue PCI," says Shiber.
For stroke, the situation is very similar. "If the patient has a good outcome by the time they arrive, that's wonderful," says Shiber. "If they haven't, they can do interventional vascular therapy, or if they have complications, that's where they would best tend to it."
Shiber says this "drip and ship" model ensures that the opportunity for tPA isn't missed. If problems occur after tPA is administered, whether from tPA or from the stroke itself, the patient will be in the best place.
"All the literature shows that for all of these issues, centers that do it much more regularly and have higher volumes have better outcomes," says Shiber.4
1. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995; 333:1581-1587.
2. Bruce NT, Neil WP, Zivin JA. Medico-legal aspects of using tissue plasminogen activator in acute ischemic stroke. Curr Treat Options Cardiovasc Med 2011; 13(3):233239.
3. Moeller JJ, Kurniawan J, Gubitz GJ, et al. Diagnostic accuracy of neurological problems in the emergency department. Can J Neurol Sci. 2008;35(3):335-341.
4. Xian Y, Holloway RG, Chan PS, et al. Association between stroke center hospitalization for acute ischemic stroke and mortality. JAMA 2011;305:373-80.