Preventing Wrong Drug-Wrong Route Errors Involving Tranexamic Acid and Local Anesthetics

Joint Announcement from the Anesthesia Patient Safety Foundation (APSF) and the Institute for Safe Medication Practices (ISMP)

Medication administration errors remain one of the most common and serious threats to patient safety in perioperative care. Recent reports have highlighted a disturbing trend of catastrophic wrong drug-wrong route errors, where intravenous (IV) tranexamic acid injection has been inadvertently administered intrathecally in place of local anesthetics such as BUPivacaine and ROPivacaine. Mortality in such cases may reach 50%, with survivors often sustaining permanent neurological harm.

As leading patient safety organizations, the Anesthesia Patient Safety Foundation (APSF) and the Institute for Safe Medication Practices (ISMP) are united in applauding the US Food and Drug Administration (FDA) for increasing awareness regarding this potentially fatal patient safety issue by requiring the following changes to the tranexamic acid injection prescribing information (https://www.fda.gov/drugs/drug-safety-and-availability/fda-provides-update-health-care-professionals-about-risk-inadvertent-intrathecal-spinal):

• Added a Boxed Warning to communicate the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection
• Added a statement to indicate that tranexamic acid injection is contraindicated as a neuraxial injection
• Updated the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution

Additionally, FDA is recommending that the container labels for tranexamic acid injection prominently display the product name and IV route of administration.

Key Safety Concerns

• Tranexamic acid and local anesthetics are frequently stocked in similar packaging (vials/ampules) and storage locations, creating a high risk for look-alike drug mix-ups.
• Both of these medications are commonly used during the same types of surgery, with the majority of catastrophic wrong drug-wrong route errors occurring during orthopedic arthroplasty and other procedures.
• These drugs are often stocked in areas where barcode scanning is not routinely utilized (e.g., perioperative areas, labor and delivery, emergency department), thus mix-ups are less likely to be detected.
• Intrathecal administration of tranexamic acid is a “never event” that has caused seizures, paraplegia, cardiovascular collapse, and death.
• Traditional safeguards such as education and double checks are insufficient on their own; higher-leverage system strategies and safeguards must be adopted.

Joint Recommendations

Assume this may be a risk within your organization and do not wait until an event occurs to take action. To prevent tranexamic acid and local anesthetics mix-ups, APSF and ISMP strongly recommend:

1. Removal of Tranexamic acid Vials/Ampules from Perioperative Areas

• Only ready-to-administer tranexamic acid premixed IV bags (1,000 mg per 100 mL) from manufacturers, compounding pharmacies, or institutional pharmacies should be stocked and available in the perioperative environment.
• Healthcare organizations should meet with key stakeholders (e.g., anesthesiologists, certified registered nurse anesthetists [CRNAs], certified anesthesiologist assistants [CAAs], surgeons, surgical staff, pharmacists) to review their workflow when ordering and administering tranexamic acid injection to understand usage (e.g., indication, dose, concentration, route). Seek agreement with stakeholders to eliminate the availability of multiple concentrations and work toward a standard concentration.
• Some off-label uses may occur in specific circumstances that require a vial, such as preparing soaked gauze. In these cases, appropriate alternative safety measures should be identified and implemented. When the 100 mg/mL tranexamic acid injection vial or ampule is being used in an off-label manner, consider completing a failure mode and effects analysis (FMEA) to identify potential failure modes and mitigation strategies, such as restricting access.

2. Implementation of High-Leverage System Safeguards

• Use barcode scanning or other technology-assisted machine-readable code at the point of care for verification before administration.
• Employ forcing functions and fail-safes, such as NRFit™ connectors for use with medications appropriate for neuraxial administration, to prevent wrong route delivery of medications.
• Standardize workflows to minimize the need for practitioner-prepared syringes.

3. Institutional and Regulatory Support

• Hospital and health system leaders must support medication safety by prioritizing the elimination of unsafe drug presentations and ensuring access to commercially available premixed infusion bags or standardized pharmacy-prepared alternatives.
• Regulatory agencies, accrediting bodies, and manufacturers should align to require safer packaging and distribution practices for tranexamic acid.

4. Fostering a Culture of Safety

• Gather feedback from practitioners and establish non-punitive reporting systems for near-miss and error events. Report incidents internally, to FDA MedWatch, and ISMP.
• Provide peer support for practitioners involved in adverse events.
• Regularly review system vulnerabilities and medication safety data with key stakeholders.

Conclusion

Tranexamic acid is a highly effective medication that improves outcomes in surgical and obstetric patients when used correctly. However, its continued availability in vials and ampules in perioperative settings presents an unacceptably high risk of catastrophic wrong drug-wrong route errors.

The time to act is now. APSF and ISMP urge hospitals, professional societies, regulators, and manufacturers to collaborate in eliminating tranexamic acid vials and ampules from the perioperative environment and to transition exclusively to ready-to-administer products supported by robust system safeguards.

Together, we can prevent needless harm and uphold the highest standards of patient safety.

CONTACT
Renee Brehio, PR & Communications Specialist, rbrehio@ismp.org

About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 30 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP was acquired by ECRI, a global organization advancing safe, evidence-based healthcare. The ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As a watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its lifesaving work. Visit www.ismp.org and follow @ismp_org to learn more.

The Anesthesia Patient Safety Foundation

Founded in 1985, The Anesthesia Patient Safety Foundation (APSF) promotes research of perioperative patient safety issues, supports the development of careers in patient safety, provides patient safety educational materials and communications to all anesthesia providers, and advocates for changes in clinical practices that improve patient safety. The APSF’s goal is that no one shall be harmed by anesthesia care.    

The Anesthesia Patient Safety Foundation (APSF) is a related organization of the American Society of Anesthesiologists. APSF provides support for research and education in perioperative patient safety. Its past initiatives have resulted in significant contributions to the field of anesthesia patient safety. APSF has distributed over $15 million in funding for anesthesia patient safety research projects over its 40 year history. For more information on APSF or to donate, please visit www.apsf.org.