Alteplase- and Tenecteplase-Related Errors and Risk Mitigation Strategies in the Treatment of Acute Ischemic Stroke: A Study of Event Reports From 52 Hospitals

Background: Alteplase and tenecteplase are thrombolytic agents used to treat patients with acute ischemic stroke (AIS). Despite the convenient bolus dosing of tenecteplase, its off-label use for AIS creates new patient safety challenges that are understudied. Methods: The study was conducted in two parts. In Part I, we queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for event reports involving alteplase and tenecteplase that were submitted between 2017 and 2022. Based on results from Part I, in Part II we narrowed the query to reports submitted in 2021–2022 and applied inclusion criteria to identify reports that described a medication error involving the use of alteplase or tenecteplase to treat AIS. In Part II, all reports were reviewed and coded for stages of the medication-use process, associated factors, and event type. Results: Part I results (N=858) showed a decrease in reports of alteplase events and an increase in reports of tenecteplase events. In Part II (N=92), 52% of reports involved alteplase and 48% involved tenecteplase. Wrong dose was the most frequently coded event type for both medications at a combined 48%. Several tenecteplase-related events were attributed to unfamiliarity with the medication, confusion between indications, and incorrect use of the electronic health record (EHR) or failure to use the EHR, whereas many errors unique to alteplase occurred during the multistep calculation, preparation, and administration processes. Conclusions: Safety events involving alteplase and tenecteplase in the treatment of AIS are diverse. We present a list of potential strategies to prevent and mitigate errors involving these high-alert medications and encourage providers to adopt those that are meaningful to their workflow and practice setting.