By: BarbraKaryne Nchinda Fobi
Tranexamic acid is an antifibrinolytic that inhibits the breakdown of fibrin thus promoting clotting (NAN Alert, 2020). It is used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation (WHO, n.d.). It is available as an oral tablet and solution for intravenous injection.
Tranexamic acid is listed in the World Health Organization (WHO) Model List of Essential Medicines for hemorrhage not elsewhere classified and postpartum hemorrhage indications. Globally, about one-quarter of all maternal deaths are associated with postpartum hemorrhage, with postpartum hemorrhage being the main cause of maternal mortality in low-income countries. In 2017, after reviewing studies that show that early use of intravenous (IV) tranexamic acid reduces death due to bleeding in women with postpartum hemorrhage, WHO updated its treatment recommendations to include “early use of IV tranexamic acid (as early as possible after clinical diagnosis of postpartum hemorrhage, and only within 3 hours of birth) in addition to standard care for women with clinically diagnosed postpartum hemorrhage following vaginal birth or caesarean section” (WHO, 2017).
How Errors Occur With The Use Of Tranexamic Acid
While correct administration of intravenous tranexamic acid may cause side effects such as nausea, vomiting, diarrhea, allergic dermatitis, giddiness, and hypotension (Pfizer, 2011), improper administration of tranexamic acid can be detrimental. Several cases have been reported where tranexamic acid was inadvertently administered via the spinal route. In fact, on September 9, 2020, the National Alert Network (NAN) issued an alert notifying healthcare professionals about dangerous wrong-route errors with tranexamic acid (NAN, 2020). When inadvertently given via the spinal route, it can lead to life-threatening neurological and/or cardiac complications, requiring resuscitation and/or intensive care with about 50% mortality rate (Patel, Robertson & McConachie, 2019).
Container mix-ups between vials/ampules of tranexamic acid and local anesthesia (e.g., bupivacaine or ropivacaine) have been involved in most reported cases. Patel, Robertson & McConachie stated that 20 of the 21 cases of spinal tranexamic acid administration errors included in their study involved ampule errors (not checking or reading the label, similar size ampules, similar printing on the labels, similar appearance of ampules). The NAN alert noted that in U. S, vials of bupivacaine, ropivacaine and tranexamic acid have the same blue color caps which lead to wrong drug selection when vials are stored upright next to each other (NAN, 2020).
How It Can Go Wrong
A 21-year-old with a 37-week twin pregnancy visited the emergency room due to painless vaginal bleeding. Ultrasound revealed decreased amniotic fluid and incomplete placenta previa. The patient was scheduled for cesarean section. In the operating room, the anesthesiologist asked the technician for 1.5% bupivacaine but was inadvertently given tranexamic acid. The anesthesiologist administered the medication, the patient began tossing and turning and complained of sharp pain from her lower extremities. Her condition continued to deteriorate, and general anesthesia was administered. Children were delivered safely but the patient developed a tachyarrhythmia that was treated but later developed severe jerking motions in her extremities and nystagmus consistent with seizure. A neurologist was consulted which led to a suspicion of the spinal anesthesia. Drug containers used during surgery were examined and an empty tranexamic ampule was found instead of bupivacaine ampule (Veisi et al., 2010).
Preventing Wrong-route Administration Of Tranexamic Acid
As custodians of medicines, young pharmacists are in an ideal position to prevent these errors. They can start by implementing the following recommendations provided by the NAN alert:
- Separate or sequester tranexamic acid in storage locations and avoid storing local anesthetics and tranexamic acid near one another (NAN, 2020).
- To prevent reliance on identifying the drug by viewing only the vial caps [or ampule shape and size], never store injectable drug vials [ampules] in an upright position, especially when stored in a bin or drawer below eye level. Store them in a way that always makes their labels visible.
- Minimize look-alike vials [ampules] by purchasing these products from different manufacturers. Consider purchasing labels that state, “Contains Tranexamic Acid” to place over the vial caps [ampules]. Utilize barcode scanning prior to dispensing as well as when accessing the drug in surgical and obstetrical areas.
- 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, such as tranexamic acid.
- Consider the use of pharmacy-prepared or commercially available premixed containers of tranexamic acid, which would be less likely to be confused with local anesthetic vials.
Overall, young pharmacists play a vital role in preventing the inadvertent administration of tranexamic acid via the spinal route. They should not only follow the above recommendations but also educate other members of their team about the correct administration of tranexamic acid.
References
- National Alert Network. (2020, September 9). Dangerous Wrong-Route Errors with Tranexamic Acid. Retrieved from https://www.ismp.org/sites/default/files/attachments/2020-09/NAN%20Alert%2020200909.pdf
- Patel S., Robertson B., & McConachie I. (2019). Catastrophic drug errors involving tranexamic acid administered during spinal anesthesia. Anaesthesia. 74: 904–914. https://doi.org/10.1111/anae.14662
- Pfizer Injectables. (2011). Cyklokapron: Highlights of prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf
- Veisi F., Salimi B., Mohseni G., Golfam P., & Kolyaei A. (2010). Accidental Intrathecal Injection of Tranexamic Acid in Cesarean Section: A Fatal Medication Error. Anesthesia Patient Safety Foundation. Retrieved from https://www.apsf.org/article/accidental-intrathecal-injection-of-tranexamic-acid-in-cesarean-section-a-fatal-medication-error/
- World Health Organization. (2017). Updated WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Hemorrhage. Retrieved from https://www.who.int/reproductivehealth/publications/tranexamic-acid-pph-treatment/en/
- World Health Organization. (n.d.). Tranexamic acid: Model List of essential medicines. Retrieved from https://list.essentialmeds.org/medicines/127
