Episode #209 Preventing Catastrophic Medication Errors: The Dangers of TXA and Bupivacaine Mix-ups

Hello and welcome back to the Anesthesia Patient Safety Podcast.  My name is Alli Bechtel, and I am your host. Thank you for joining us for another show. We have an exciting show today since we are opening up the June 2024 APSF Newsletter. Our first article today addresses a recurrent threat to anesthesia patient safety with important considerations to help address this issue.

Before we dive into the episode today, we’d like to recognize Edwards Lifesciences, a major corporate supporter of APSF. Edwards Lifesciences has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, Edwards Lifesciences – we wouldn’t be able to do all that we do without you!”

Our featured article today is from the June 2024 APSF Newsletter. It is “Unraveling a Recurrent Wrong Drug-Wrong Route Error—Tranexamic Acid in Place of Bupivacaine: A Multistakeholder Approach to Addressing this Important Patient Safety Issue” by Elizabeth Rebello and colleagues. To follow along with us, head over to APSF.org and click on the Newsletter heading. First one down is the current issue. From here, scroll down until you get to our featured article today. I will include a link in the show notes as well.

To help kick off the show today, we have one of the authors. I will let her introduce herself now.

[Rebello] “My name is Elizabeth Rebello and I’m an anesthesiologist at the University of Texas MD Anderson Cancer Center in Houston, Texas.”

[Bechtel] I asked Rebello why she wrote this article. Let’s take a listen to what she had to say.

[Rebello] “The topic of wrong drug, wrong route medication errors involving tranexamic acid inadvertently being injected intrathecally in place of bupivacaine has interested me as this medication error is often caused by a lookalike vial or ampule.  And a sequelae from this medication error is devastating, often resulting in paralysis or death.

The incidence of this medication error is increasing as the use of TXA is increased. There were 23 reports of this error occurring in the last four years.”

[Bechtel] Thank you so much to Rebello for introducing this article. Now, it’s time to get into the article.

The article starts with a review of the scope of the problem of medication safety during anesthesia care. Anaesthesia professionals must remain vigilant to help prevent medication errors in the face of significant challenges including lack of standardization, drug shortages, production pressures, high-stress work environments, and limited resources. This is a costly threat to patient safety as well that has been estimated at $42billion dollars by the World Health Organization. Medication errors may arise following a small lapse in concentration or due to systemic issues in workflow and the consequences of wrong drug or wrong administration route may be devastating for patients. This article features a wrong drug wrong route medication error that occurs when anesthesia professionals inadvertently administer tranexamic acid into the intrathecal space when performing a neuraxial block. This medication error is associated with a mortality rate of about 50%. Preferred Physicians Medical, an anesthesia-specific professional liability carrier, has received 6 reported events of tranexamic acid-bupivacaine drug errors in the past 10 years with most of the events occurring in the past 4 years. These 6 events all occurred during orthopaedic surgeries, but it has been reported during caesarean deliveries and other abdominal procedures as well. In the past 10 years, we have also started to use more tranexamic acid or TXA based on the reports of several studies including the POISE-3 trial which revealed decreased bleeding by up to 25% with TXA administration. With increased TXA administration, anesthesia professionals are tasked with working to help prevent medication administration errors going forward.

Did you know that we have talked about this medication error of TXA for Bupivacaine before on the podcast? Check out Episode #19 where we discussed a recent alert regarding tranexamic acid administration from the National Alert Network. This alert included 3 cases of accidental intrathecal administration of tranexamic acid instead of the intended local anesthetic medication leading to seizures. This podcast episode and alert are from 2020, so we still have work to do to help keep patients safe from this devastating medication error.

To help illustrate this event, let’s take a look at the case study in the article. I am going to read excerpts from it now.

“This is a case of a 67-year-old man who presented for left total knee arthroplasty. The patient’s medical history was significant for morbid obesity, hypertension, and coronary artery disease. The anesthestic plan was for a subarachnoid block with monitored anesthesia care. An anesthesia professional was also expected to administer TXA intraoperatively at the request of the surgeon. The hospital’s policies and procedures stated that TXA must be ordered from the pharmacy in prefilled infusion bags. However, this practice was seldom followed by the surgical team in the patient’s Operating Room (OR). Accustomed to the usual OR’s practice, the anesthesia professional removed 10 mL vials of TXA and bupivacaine from the automated dispensing cabinet in preparation for the case.

Once the patient arrived in the OR, the anesthesia professional drew up what he believed to be bupivacaine into a syringe labeled “Marcaine/Fentanyl.” The anesthesia professional had difficulty administering the block due to the patient’s body habitus, and he called the supervising anesthesiologist to assist. The anesthesiologist administered a 2.5 mL dose, but the block did not induce the intended effect. Within minutes, the patient reported pruritus in his perineum. The anesthesia team assumed the patient’s discomfort was the result of a failed block, and they elected to convert the case to a general anesthetic. After induction, the patient was noted to have minor leg twitching. Once the procedure progressed to the point TXA was needed, the anesthesia professional discovered the TXA vial was opened, while the bupivacaine vial remained sealed and unused on the anesthesia cart. Upon recognizing the patient had received a 250 mg dose of TXA intrathecally, the anesthesia professional alerted the anesthesiologist and surgeon, and they decided to complete the procedure and evaluate the patient in the PACU.

The patient remained intubated and on a propofol infusion upon transfer to the PACU, where he began experiencing seizures a short time later. The patient was transferred to the Neurological Intensive Care Unit (Neuro-ICU) for evaluation. There, the decision was made to take the patient back to the OR to undergo a cerebral spinal lavage. After the procedure, the neurology critical care physician elected to leave the patient on isoflurane until the seizures stopped or the inhalation agent was no longer tolerated. Isoflurane was subsequently discontinued in favor of propofol and ketamine, and the seizures were suppressed by postoperative day (POD) #3.

The patient had a lengthy and eventful stay in the neuro-ICU. He experienced delirium due to toxic and metabolic encephalopathy, and myoclonic status epilepticus requiring prolonged intubation. He was extubated on POD #14, and the nasogastric tube was removed on POD #17. The patient exhibited cognitive deficits, including both short- and long-term memory impairment.

He was discharged to a rehabilitation hospital on POD #23. During his 2-week admission, the patient’s cognition, memory, and motor function gradually improved. The patient was also treated for shoulder pain, which was attributed to a rotator cuff tear resulting from seizures. The patient required skilled nursing care for several weeks post-discharge. Fortunately, the patient went on to make a remarkable recovery, and his neurologist noted his executive and motor functions returned to baseline approximately 13 months after the event.

The patient and wife subsequently filed a lawsuit against the anesthesia professionals involved, the anesthesia group, the hospital, and the orthopedic surgeon. The anesthesia professional acknowledged liability at the outset of the case, and the parties conducted discovery to fully evaluate the plaintiffs’ damages. The parties mediated the case a year later, and the plaintiffs settled with the anesthesia professional and the anesthesia group within the policy limits.”

This case helps to highlight how this medication error may occur in any operating room and the significant morbidity associated with administering TXA in the intrathecal space. The first infographics in the article reveals two keys when it comes to this medication error. First, the risk of harm is high since over 50% of TXA-associated intrathecal injections resulted in death or harm. Second, the single most effective measure to reduce the incidence of wrong drug-wrong route TXA-Bupivacaine errors is pre-mixed bags.

It is alarming that unacceptably high accidental injections of TXA into the intrathecal space continue to occur. Let’s look at the literature. There is a 2023 article, “Tranexamic acid associated with intrathecal toxicity during spinal anesthesia: a narrative review of 22 recent reports” by Santosh Patel published in the European Journal of Anaesthesiology that reported on 22 events occurring between July 2018 and September 2022. The analysis revealed the following:

• Death occurred in 36% of patients
• Permanent harm occurred in 19% which included residual muscle weakness, chronic pain, T10 and L1 spine fractures from the convulsions, mild cognitive impairment, and multiple neurological deficits to extreme pain.
• The fatality rate was higher in female patients.
• Two-thirds of the events occurred during orthopaedic surgery and caesarean sections.
• Most patients who survived the first few hours developed refractory status epilepticus for 3 days up to 3 weeks requiring mechanical ventilation and intensive care
• Sympathetic stimulation leading to refractory ventricular arrhythmias and death occurred in the first few hours for some patients.
• There was a lack of knowledge about the clinical characteristics of intrathecal TXA toxicity leading to delayed diagnosis or confusion in some cases as well.
• There does not appear to be a dose-response relationship. Patients who received lower doses of 160-200mg have died, while patients who received 300-350mg have survived.

After wrong drugs are administered in the intrathecal space, that severity of patient injury depends on the toxicity of the drug. When TXA is given intravenously, it may be beneficial to help decrease blood loss during surgical procedures, but when TXA is given inadvertently in the intrathecal space, it is a strong neurotoxin that can cause neurological injury, seizures, paraplegia, ventricular fibrillation, and death.

The big question is, What causes this error? The Human Factors Analysis Classification System was used in the narrative review and found that mistaking look-alike TXA ampules or vials for local anesthetics was the predominant cause of all 22 events. The author suggests that these errors could have possibly been prevented by double checking the medication with another human or using technology such as a barcode scanner to verify the correct drug was drawn up.

We have so much more to talk about when it comes to TXA-bupivacaine medication errors. The APSF authors give a call to action that since the same error continues to occur multiple times with accidental administration of TXA into the intrathecal space, we must implement reliable prevention strategies in every perioperative space to help keep our patients safe. We are going to talk about these strategies next week when our show continues with part 2. In the meantime, head over to APSF.org and check out the Look-Alike Drug Vials Gallery. Here you can find examples of TXA and various local anaesthetics look alike vials. Check out your drug cart. Do your vials of bupivacaine and TXA look similar as well? Look alike vials contribute to medication errors and can impact patient safety. We cannot let down our guard.

If you have any questions or comments from today’s show, please email us at [email protected]. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.

The APSF has another great resource, the APSF Video Library. We talked about the all new fire safety video recently, but there are other videos that you can check out. The Medication Safety in the Operating Room: Time for a New Paradigm is an 18 minute long video that was released in January 2012 and is intended for everyone who works in the operating room during surgery. So, what are you waiting for? Head over to APSF.org and click on the Patient Safety Resources Heading. The fourth one down is the APSF video library and then scroll down until you get to the medication safety video. We hope that you will watch this video and  share it video with your anesthesia, surgery, and nursing colleagues or better yet watch it all together to help keep patients safe from medication error in the operating room.

Until next time, stay vigilant so that no one shall be harmed by anesthesia care.

© 2024, The Anesthesia Patient Safety Foundation