Advertisement
Research Article| Volume 25, ISSUE 3, P565-571, March 2016

Tissue Plasminogen Activator Prescription and Administration Errors within a Regional Stroke System

      Background

      Intravenous (IV) tissue plasminogen activator (tPA) utilization in acute ischemic stroke (AIS) requires weight-based dosing and a standardized infusion rate. In our regional network, we have tried to minimize tPA dosing errors. We describe the frequency and types of tPA administration errors made in our comprehensive stroke center (CSC) and at community hospitals (CHs) prior to transfer.

      Methods

      Using our stroke quality database, we extracted clinical and pharmacy information on all patients who received IV tPA from 2010-11 at the CSC or CH prior to transfer. All records were analyzed for the presence of inclusion/exclusion criteria deviations or tPA errors in prescription, reconstitution, dispensing, or administration, and for association with outcomes.

      Results

      We identified 131 AIS cases treated with IV tPA: 51% female; mean age 68; 32% treated at the CSC, and 68% at CHs (including 26% by telestroke) from 22 CHs. tPA prescription and administration errors were present in 64% of all patients (41% CSC, 75% CH, P < .001), the most common being incorrect dosage for body weight (19% CSC, 55% CH, P < .001). Of the 27 overdoses, there were 3 deaths due to systemic hemorrhage or ICH. Nonetheless, outcomes (parenchymal hematoma, mortality, modified Rankin Scale score) did not differ between CSC and CH patients nor between those with and without errors.

      Conclusion

      Despite focus on minimization of tPA administration errors in AIS patients, such errors were very common in our regional stroke system. Although an association between tPA errors and stroke outcomes was not demonstrated, quality assurance mechanisms are still necessary to reduce potentially dangerous, avoidable errors.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Stroke and Cerebrovascular Diseases
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • 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: 1581-1588
        • Genentech web site
        Activase (Alteplase) package insert.
        (Available at:) (Accessed December 2, 2014)
        • Adams H.P.
        • Zoppo G.
        • del Alberts M.J.
        • et al.
        Guidelines for the early management of adults with ischemic stroke a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists.
        Stroke. 2007; 38: 1655-1711
        • Williams L.S.
        • Yilmaz E.Y.
        • Lopez-Yunez A.M.
        Retrospective assessment of initial stroke severity with the NIH Stroke Scale.
        Stroke. 2000; 31: 858-862
        • Madan A.
        • Borckardt D.
        • Borckardt J.J.
        • et al.
        A new approach to tracking the harmfulness of medical errors in health care systems.
        Qual Manag Health Care. 2010; 19: 298-303
        • Hacke W.
        • Kaste M.
        • Fieschi C.
        • et al.
        Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS).
        JAMA. 1995; 274: 1017-1025
        • Jauch E.C.
        • Saver J.L.
        • Adams H.P.
        • et al.
        Guidelines for the early management of patients with acute ischemic stroke a guideline for healthcare professionals from the American Heart Association/American Stroke Association.
        Stroke. 2013; 44: 870-947
        • Yamaguchi T.
        • Mori E.
        • Minematsu K.
        • et al.
        Alteplase at .6 mg/kg for acute ischemic stroke within 3 hours of onset Japan Alteplase Clinical Trial (J-ACT).
        Stroke. 2006; 37: 1810-1815
        • Majersik J.J.
        Stroke Receiving Facility Toolkit. Stroke System. Utah Bureau of Emergency Medical Services.
        (Available at:) (Accessed Dec 5, 2014)
        • Hacke W.
        • Kaste M.
        • Bluhmki E.
        • et al.
        Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke.
        N Engl J Med. 2008; 359: 1317-1329
        • Meurer W.J.
        • Caveney A.F.
        • Lo A.
        • et al.
        Lack of association between pre-treatment neurology consultation and subsequent protocol deviation in tPA-treated stroke patients.
        Stroke J Cereb Circ. 2010; 41: 2098-2101
        • Akins P.T.
        • Delemos C.
        • Wentworth D.
        • et al.
        Can emergency department physicians safely and effectively initiate thrombolysis for acute ischemic stroke?.
        Neurology. 2000; 55: 1801-1805
        • Uchino K.
        • Massaro L.
        • Jovin T.G.
        • et al.
        Protocol adherence and safety of intravenous thrombolysis after telephone consultation with a stroke center.
        J Stroke Cerebrovasc Dis. 2010; 19: 417-423
        • Lopez-Yunez A.M.
        • Bruno A.
        • Williams L.S.
        • et al.
        Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage.
        Stroke. 2001; 32: 12-16
        • Graham G.D.
        Tissue plasminogen activator for acute ischemic stroke in clinical practice a meta-analysis of safety data.
        Stroke. 2003; 34: 2847-2850
        • Tsivgoulis G.
        • Alexandrov A.V.
        • Chang J.
        • et al.
        Safety and outcomes of intravenous thrombolysis in stroke mimics a 6-year, single-care center study and a pooled analysis of reported series.
        Stroke. 2011; 42: 1771-1774
        • Zinkstok S.M.
        • Engelter S.T.
        • Gensicke H.
        • et al.
        Safety of thrombolysis in stroke mimics results from a multicenter cohort study.
        Stroke. 2013; 44: 1080-1084
        • Chernyshev O.Y.
        • Martin-Schild S.
        • Albright K.C.
        • et al.
        Safety of tPA in stroke mimics and neuroimaging-negative cerebral ischemia.
        Neurology. 2010; 74: 1340-1345
        • Guerrero W.R.
        • Savitz S.I.
        Tissue-type plasminogen activator for stroke mimics continuing to be swift rather than delaying treatment to be sure.
        Stroke. 2013; 44: 1213-1214
        • Goyal N.
        • Male S.
        • Al Wafai A.
        • et al.
        Cost burden of stroke mimics and transient ischemic attack after intravenous tissue plasminogen activator treatment.
        J Stroke Cerebrovasc Dis. 2015; 24: 828-833
        • Breuer L.
        • Blinzler C.
        • Huttner H.B.
        • et al.
        Off-label thrombolysis for acute ischemic stroke: rate, clinical outcome and safety are influenced by the definition of “minor stroke.”.
        Cerebrovasc Dis. 2011; 32: 177-185
        • Selim M.
        • Kumar S.
        • Fink J.
        • et al.
        Seizure at stroke onset: should it be an absolute contraindication to thrombolysis?.
        Cerebrovasc Dis Basel Switz. 2002; 14: 54-57
        • De Silva D.A.
        • Manzano J.J.F.
        • Chang H.M.
        • et al.
        Reconsidering recent myocardial infarction as a contraindication for IV stroke thrombolysis.
        Neurology. 2011; 76: 1838-1840
        • Aleu A.
        • Mellado P.
        • Lichy C.
        • et al.
        Hemorrhagic complications after off-label thrombolysis for ischemic.
        Stroke. 2007; 38: 417-422
        • Rubiera M.
        • Ribo M.
        • Santamarina E.
        • et al.
        Is it time to reassess the SITS-MOST criteria for thrombolysis? A comparison of patients with and without SITS-MOST exclusion criteria.
        Stroke J Cereb Circ. 2009; 40: 2568-2571
        • Guillan M.
        • Alonso-Canovas A.
        • Garcia-Caldentey J.
        • et al.
        Off-label intravenous thrombolysis in acute stroke.
        Eur J Neurol Off J Eur Fed Neurol Soc. 2012; 19: 390-394