Wrong-Route Errors With Tranexamic Acid Can Be Serious

The Institute for Safe Medication Practices (ISMP) recently learned about 3 cases of accidental spinal injection of tranexamic acid instead of a local anesthetic intended for regional (spinal) anesthesia.

Container mix-ups were involved in each case. In 1 case, a patient scheduled for knee surgery received tranexamic acid instead of bupivacaine. The anesthesiologist immediately realized the error, but by then, the patient had begun to experience seizures. The patient recovered. In a second case, a patient undergoing hip replacement surgery received tranexamic acid instead of a local anesthetic for spinal anesthesia. The patient survived but experienced seizures and had extreme pain due to arachnoiditis. In a third case, a patient scheduled for bilateral knee replacement also inadvertently received tranexamic acid instead of bupivacaine for spinal anesthesia. The patient experienced seizures, which necessitated placing her into an induced coma for several days.

The ISMP has previously reviewed errors with tranexamic acid and noted that in the United States, bupivacaine, ropivacaine, and tranexamic acid are packaged in vials that may have the same blue color cap.¹ Although label colors and vial sizes may be different, when the vials are stored upright near each other, only the blue caps may be visible, making it more difficult to differentiate 1 drug from another. To make matters worse, these drugs are often found in areas where bar code scanning may not have been implemented or is not routinely used, such as the emergency department, labor and delivery, or perioperative areas, so mix-ups are less likely to be detected. Syringe labeling issues may also contribute to such errors. The literature has additional reports of serious patient harm because of wrong-route errors with tranexamic acid.^2-5

Tranexamic acid is an antifibrinolytic that prevents the breakdown of fibrin, thus promoting clotting. It is approved for short-term use (2 to 8 days) in patients with hemophilia to reduce the risk of hemorrhage during and following tooth extraction. It is also used off-label in a variety of hemorrhagic conditions to control bleeding, including postpartum hemorrhage. Although tranexamic acid is not indicated for joint surgeries, it is often used intravenously (IV) or topically during these procedures to decrease blood loss. Tranexamic acid is also available as an oral tablet for the treatment of cyclic heavy menstrual bleeding in women.

When given via the spinal route in error, tranexamic acid is a potent neurotoxin that is harmful to patients, with a mortality rate of about 50%. Survivors often experience permanent neurological injury, paraplegia, seizures, and ventricular fibrillation.⁶

SAFE PRACTICE RECOMMENDATIONS

Here are some tips for dealing with tranexamic acid:

• Consider NRFit syringes and connectors for local anesthetics used for regional anesthesia administered via the neuraxial route. NRFit connectors are incompatible with Luer connectors, thus preventing misconnections with drugs intended for IV use.
• Employ bar code scanning before dispensing and when accessing the drug in obstetrical and surgical areas.
• Minimize look-alike caps and vials by purchasing these products from different manufacturers.
• Purchase labels marked “Contains Tranexamic Acid” to place over the vial caps.
• Separate or sequester tranexamic acid in storage locations and avoid storing local anesthetics and tranexamic acid near each other.
• To prevent reliance on identifying the drug by viewing only the vial caps, never store injectable drug vials in an upright position, especially in a bin or drawer below eye level. Store them so that their labels are always visible.
• Use commercially available or pharmacy- prepared, premixed containers of tranexamic acid, which would be less likely to be confused with local anesthetic vials. Pharmacy preparation and labeling of infusions or syringes would help alleviate these errors. Also, local anesthetics may be available at some locations in premixed containers or prepared by a pharmacy for use in regional anesthesia.

MICHAEL J. GAUNT, PHARMD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care newsletter at the Institute for Safe Medication Practices in Horsham, Pennsylvania.

REFERENCES

• Dangerous wrong-route errors with tranexamic acid—a major cause for concern. Institute for Safe Medication Practices. May 23, 2019. Accessed November 10, 2020. www.ismp.org/resources/dangerous- wrong-route-errors-tranexamic-acid-majorcause- concern
• Veisi F, Salimi B, Mohseni G, Golfam P, Kolyaei A. Accidental intrathecal injection of tranexamic acid in cesarean section: a fatal medication error. APSF Newsletter. 2010. Accessed November 10, 2020. https:// www.apsf.org/article/accidental-intrathecal-injection- of-tranexamic-acid-in-cesarean-section-a-fatal- medication-error
• Srivastava U, Joshi K, Gupta V, et al. Accidental injection of tranexamic acid into subarachnoid space leading to fatal outcome: case report and review. The Internet Journal of Anesthesiology. 2012. Accessed November 10, 2020. http://ispub.com/IJA/30/2/14109
• Yeh HM, Lau HP, Lin PL, Sun WZ, Mok MS. Convulsions and refractory ventricular fibrillation after intrathecal injection of a massive dose of tranexamic acid. Anesthesiology. 2003;98(1):270-272. doi:10.1097/00000542-200301000-00042
• Garcha PS, Mohan CVR, Sharma RM. Death after an inadvertent intrathecal injection of tranexamic acid. Anesth Analg. 2007;104(1):241-242. doi:10.1213/01. ane.0000250436.17786.72
• Palanisamy A, Kinsella SM. Spinal tranexamic acid—a new killer in town. Anaesthesia. 2019;74(7):831-833. doi:10.1111/anae.14632