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Thrombolytic therapy performed within a
relatively narrow temporal window can significantly improve outcomes in
patients with acute ischemic stroke. For years, we struggled as only a tiny
fraction of patients potentially eligible for thrombolytic therapy were seen,
evaluated, and treated within that narrow window. Stroke centers, hub and spoke
stroke systems, community triage systems, and teleneurology
have significantly helped increase the number of stroke patients eligible for
thrombolytic therapy.
But thrombolytic therapy can have adverse
consequences, particularly conversion to hemorrhagic stroke. And the risks of
such complications increase when errors occur with thrombolytic therapy. A new
study (Dancsecs 2021)
assessed the occurrence and nature of errors during thrombolytic therapy with altepase in regional hospitals and a Comprehensive Stroke
Center (CSC).
Two-hundred-twenty-seven (34%) patients
received alteplase at the CSC and 448 (66%) patients received alteplase at
regional hospitals. Of the patients receiving alteplase at a regional hospital,
58 patients (12.9%) were at an acute stroke ready facility (ASR) while 55
(12.3%) were at a primary stroke center (PSC). The remaining 335 patients
(74.8%) received alteplase at a regional hospital with no stroke certification.
There were a total of five regional centers that were
ASR hospitals and three regional centers that had a PSC designation.
19.8% of patients had an error associated with
alteplase administration. 1.5% occurred at the CSC and 18.2% occurred at
regional hospitals. Errors occurred at all 3 levels of stroke care at regional
hospitals, though they were most frequent at undesignated centers. The most
common error identified was receiving an over-dosage of alteplase, all of which
occurred in patients receiving alteplase at a regional hospital. Under-dosing
and infusion errors were also very common, as was
administration of alteplase in patients with apparent contraindications. The most
common contributing factor leading to a medication error with alteplase was an incorrect
calculation (23%). Incorrect programming of infusion pumps was also
common (20%) and incorrect patient weight being used to calculate the dose
occurred in 16%.
There were patient impacts from the errors. Patients
who had errors associated with alteplase administration more commonly
experienced hemorrhagic conversion compared to those who did not have an error
with administration (12.7% vs 7.1%). Fortunately, this did not appear to lead
to a significant difference in neurologic outcome.
The authors stress
that the most common contributing factor leading to a medication error in
patients transferred from other facilities was a calculation error, primarily
due to the use of incorrect patient weights rather than faulty computations. We
discussed the problem of inaccurate weights in thrombolytic therapy in our
December 8, 2015 “Danger of Inaccurate Weights in Stroke Care”. Often, in the urgency to administer
thrombolytic therapy in a timely fashion, staff do not formally weigh the
patient on a scale. They either ask the patient how much they weigh or they estimate the patient’s weight themselves. It
turns out that estimating a patient’s weight frequently results in erroneous
weights being used in the dose calculation (Barrow
2016). Clinicians underestimated mean difference weight by 1.13 kg
between estimated and actual weight, but disparities were most likely at the
upper and lower extremes of weight. So, some patients will be underdosed,
others overdosed. Though 80% of patients received a tPA
dose within the acceptable range, 11.5% were underdosed and 8.1% overdosed. When
they looked at improvement in NIHSS scores, those patients who received a dose
in the acceptable range had the greatest improvement. But those in the “underdosed”
range (corresponding to the heaviest patients) had less improvement than those
in the “overdosed” range. That heavier, underdosed population accounted for
about a third of all their stroke patients. Barrow et al. conclude that beds
capable of weighing patients should be mandated in emergency rooms for patients
with acute stroke.
Dancsecs et al.
recommend that regional hospitals who administer alteplase should have a
pharmacist involved in some capacity to handle the complexity of dosing administering
alteplase. They also note that tenecteplase dosing (a
one-time dose of 0.4 mg/kg) may reduce the rate of non-weight and
non-calculation errors compared to alteplase. And they suggest use of a
standardized infusion pump library in regional hospitals should also be
considered in order to help standardize the rate at
which alteplase is infused.
Of course, patient weight issues and infusion
pump errors are not unique to thrombolytic therapy. We’ve
listed below our numerous columns on both issues.
While education and training of personnel in
regional hospitals on these issues makes sense, there are also important system
implications. In many (or most) cases where thrombolytic therapy is
administered in a non-stroke-certified hospital, a telemedicine consultation
with a stroke center neurologist is undertaken. So, it is important that the
stroke center neurologist be cognizant of the patient weight issue and the
infusion pump programming issues and advise the regional personnel accordingly at
the time of the consultation. Perhaps the stroke center pharmacist could even participate
in those telemedicine consultations.
Timely use of thrombolytic therapy can significantly
improve neurological outcomes in those patients with acute ischemic stroke who
present within the therapeutic window. But we must ensure that thrombolytic
therapy be administered safely. We’ve seen too many
cases where past experience with a bad outcome makes regional hospitals
hesitant to initiate thrombolytic therapy in patients who are good candidates
for it.
Some
of our other columns on errors related to patient weights:
March 23, 2010 “ISMP
Guidelines for Standard Order Sets”
September 2010 “NPSA
Alert on LMWH Dosing”
August 2, 2011 “Hazards
of ePrescribing”
January 2013 “More IT Unintended Consequences”
December 8, 2015 “Danger
of Inaccurate Weights in Stroke Care”
May 2016 “ECRI
Institute’s Top 10 Patient Safety Concerns for 2016”
September
2017 “Weight-Based
Dosing in Children”
January
2018 “Can
We Improve Barcoding?”
June
2018 “Incorrect
Weights in the EMR”
March 2021 “PPSA
Reminder: Weigh Your Patients and Do It In Kilograms”
Our prior columns related to infusion pump
issues:
· May 2010 “FDA's Infusion Pump Safety Initiative”
· April 27, 2010 “Infusion Pump Safety”
·
August 2016 “Home
Infusion Therapy Pitfalls”
·
March 2020 “ISMP
Smart Infusion Pump Guidelines”
·
August 4, 2020 “Intravenous Issues”
·
November 10, 2020 “More on Infusion Pump Errors”
References:
Dancsecs KA, Nestor
M, Bailey A, et al. Identifying errors and safety considerations in patients
undergoing thrombolysis for acute ischemic stroke. Am J Emerg
Med 2021; 47: 90-94
https://www.sciencedirect.com/science/article/abs/pii/S0735675721002291?via%3Dihub
Barrow T, Khan MS, Halse
O, et al. Estimating Weight of Patients With Acute
Stroke When Dosing for Thrombolysis. Stroke 2016; 47(1): 228-231; Published
ahead of print November 10, 2015
https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.115.011436
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