Is this purely an academic discussion? No. As a risk manager, I will attest to the fact that “Lytic Gation” (litigation from tPA in stroke) is a real issue, and a lack of administration is a common allegation. It has been reported that physicians are more likely to be sued for not giving tPA than for the complications associated with giving it.

But according to Dr. David Newman’s analysis, the raw numbers for lawsuits don’t equate to likelihood. When the number of patients receiving the drug who experience complications and the large number of those eligible who do not get the drug are considered, the likelihood is probably the same.

With this policy in place, a physician whose best judgment suggests that giving tPA is not the right approach will be in direct conflict with the policy, which will then be used as evidence of negligence. It is therefore likely that more patients will receive tPA. Considering the possibility that the benefit of the drug is actually marginal or just due to chance, additional patients will thus be subject to unnecessary harm. This Level A recommendation places the TPA skeptic in the untenable position of being in conflict with the policy for not giving the drug to an eligible patient or giving it in spite of reservations about modest benefit and significant risk of harm. A well-crafted policy should reflect the science in such a way as to support, or at least not undermine, the clinician who favors either approach.

The work of the College is important, with far-reaching implications. With the authority to guide clinicians and shape the practice of our specialty comes an immense responsibility to advocate for our patients and members when the evidence is clear, seek diversity of opinion and recommend further investigation when it’s not, and have the wisdom to recognize the difference between the two.

Dr. Klauer is ACEP Council Vice Speaker and Director, Center for Emergency Medicine Education and Assistant Clinical Professor, Mich-igan State University College of Osteopathic Medicine, East Lansing.

Joint clinical policy based on current evidence

ACEP and the American Academy of Neurology (AAN) developed a joint clinical policy about the use of Intravenous tPA for managing emergency patients with acute ischemic stroke. The policy, approved by the ACEP Board of Directors and endorsed by the AAN Board of Directors, and published in the February issue of Annals of Emergency Medicine:

• Is evidence-based and designed to help clinicians answer questions when considering the use of tPA.
• Was developed using the ACEP clinical policy development process with the methodology being jointly agreed upon by ACEP and AAN.
• Is based on a thorough review of the medical literature. Evidence was graded using a weighted grading scheme defined in the clinical policy.
• Involved extensive reviews by emergency physicians, including those known to be in opposition to tPA and external reviewers from the Society for Academic Emergency Medicine, Emergency Nurses Association, American College of Physicians, Neurocritical Care Society, American Academy of Fam- ily Physicians, National Stroke Association, and the American Stroke Association.

This clinical policy is supported by the Emergency Nurses’ Association and endorsed by the Neurocritical Care Society. It was funded solely by ACEP and AAN. Companies were not allowed to participate in the development of or in funding the development or initial publication of the clinical policy. This clinical policy was not developed by “consensus” but by using a well-defined and well-established methodology. The recommendations are evidence-based. The clinical policy clearly states that the recommendations “are not intended to represent the only diagnostic and management options,” nor does it state that every acute ischemic stroke patient should receive intravenous tPA. It does say IV tPA should be offered to acute ischemic stroke patients who meet NINDS inclusion/exclusion criteria and can be treated within 3 hours after symptom onset; however, the effectiveness of tPA is less well established in institutions without the systems in place to safely administer the medication (Level A recommendation). Clearly, clinicians opting not to provide an acute ischemic stroke patient IV tPA should document their clinical decision making.