Episode #210 Preventing Deadly Errors: Unpacking Safe Practices for Medication Administration in the OR

July 10, 2024

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Welcome to the next installment of the Anesthesia Patient Safety podcast hosted by Alli Bechtel.  This podcast will be an exciting journey towards improved anesthesia patient safety.

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 Paul A. Lefebvre, Patricia Meyer, Angela Lindsey, Rita Jew, and Elizabeth Rebello.

Thank you so much to Elizabeth Rebello for contributing to the show today.

So, what can we do to prevent this devastating wrong drug wrong route medication error? We need to make sure that TXA is only available in a premixed bag rather than a vial form in the perioperative environment. Here are some additional recommendations from the 2024-2025 ISMP Targeted Medication Safety Best Practices:

  • Use barcode-assisted medication safety checks, if available, when preparing and prior to administering medications in surgical and obstetrical areas.
  • Develop protocols to use premixed intravenous (IV) bags of TXA or pharmacy-prepared infusion bags to prevent mix-ups.
  • Foster a culture of safety.
  • Maintain a high level of vigilance when these two medications are given during a case.
  • Meet with key stakeholders to review their workflow when ordering and administering TXA to ensure safe practices.
  • Evaluate workload to ensure workload pressures will not result in unsafe workarounds and practices.
  • Report near misses and unsafe medication practices.
  • Conduct regular reviews and discussions of medication events and close calls reported in your institution.

Head over to the APSF Video Library. We highly recommend the video, Medication Safety in the Operating Room: Time for a New Paradigm, which was released in January 2012. The intended audience is everyone who works in the OR during surgery.

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© 2024, The Anesthesia Patient Safety Foundation

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 hope you tuned in last week when we kicked off the conversation about the devastating recurrent wrong drug wrong route error of inadvertent intrathecal tranexamic acid administration. This is Part 2 today and we will be discussing a multistakeholder approach to address this devastating patient safety issue.

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

Our featured article again 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.

Last week, we reviewed a case of inadvertent TXA administration in the intrathecal space instead of Bupivacaine. Intrathecal TXA is a neurotoxin that can cause neurological injury, seizures, paraplegia, ventricular fibrillation, and death. Over 50% of TXA-associated intrathecal injections result in death or harm. We are going to talk about considerations to help prevent this error in more detail today. The single most effective measure to reduce this drug error is to supply tranexamic acid in pre-mixed bags. Human factors analysis of this wrong drug, wrong route event has revealed that mistaking look alike TXA ampules or vials for local anaesthetic ampules or vials was the main cause of these events. It is alarming that this event continues to occur, so let’s dive into prevention strategies so that we can help to keep our patients safe during neuraxial anaesthesia care.

The APSF Stoelting Conference in 2010 was dedicated to Medication Safety and resulted in recommendations for new strategies for “predictable prompt improvement” of medication use in the OR.  Many of these 2010 recommendations have not been widely implemented. One such recommendation was that routine provider-prepared medications should be discontinued whenever possible and that high-alert medications (like tranexamic acid) should be prepared by the pharmacy in ready-to-use bolus or infusion form that is appropriate for both adult and paediatric patients.

Check out figure 1 in the article to see the hierarchy of effectiveness for risk-reduction strategies when it comes to preventing drug errors from least effective to most effective created by the ISMP or Institute for Safe Medication Practices.

Starting at the bottom of the figure, we have the strategies that are least effective and the easiest to implement. These include suggestions to “Be More Careful,” Available information, Educational Programs, Rules and Policies. These four strategies are in the low leverage group and are related to human reliability. The next group is the medium leverage group which includes warnings, alerts, reminders, and checklist, redundancies, and standardizations and protocols. These are more effective and a little harder to implement and span from human reliability to system reliability. At the top of the Figure are the three strategies that are the most effective and the hardest to implement. These high leverage strategies are related to system reliability and include Automation and computerization, barriers and fail-safes, and forcing function. I will include this figure in the show notes as well. We know that the interventions at the bottom of the figure that rely on humans have some benefits but are less effective than system-focused, high-leverage options. Let’s look at an example of a forcing function and fail-safe option. In Japan, there has been adoption of the NRFit neuraxial connectors which are designed to prevent misconnections and prevent wrong delivery of medications in the neuraxial space. Using NRFit neuraxial connectors was possible with advocacy with the Japan Ministry of Health, Labor, and Welfare. In the United States, efforts to adopt these connectors has not been successful.

What if we apply the ISMP’s most effective risk-reduction strategies to the problem of TXA-associated intrathecal errors? We can use barriers and forcing functions to help prevent this error. The first step would be to eliminate or significantly restrict TXA vials and ampules and only allow manufacture-prepared ready-to-administer TXA 1,000mg per 100ml bags or pharmacy-prepared IV bags. This strategy creates a constraint to avoid the look-alike problem with local anaesthetics and TXA. This sounds like such an easy and simple solution to such a big problem. It is also not a new concept to remove vials of medications that cause significant patient arm from patient care areas. In the 1990s, vials of concentrated potassium chloride could be found in patient care units. Following patient deaths from administration of concentrated potassium chloride, a national movement resulted in removing the concentrated vials and making sure that only dilute potassium chloride would be allowed in patient care units.  We have an opportunity here to remove TXA vials and ampules from patient care areas to help keep patients safe.

Let’s take a look at the Medico-legal perspective when it comes to this medication error. The authors report that medical malpractice claims resulting from medication errors are indefensible from a standard-of-care perspective. The claims are made against the responsible clinicians as well as negligence claims against the facilities. This may occur when there is evidence or testimony that the medication error occurred due to the facility prioritizing labour efficiencies or other cost-saving measures over patient safety. Often, these measures taken by the facility can lead to decreased patient safety and increased facility cost. Patients and families may seek millions of dollars in damages for medication errors that result in brain damage or death, especially when patients require ongoing medical care or are unable to return to work.

Another important consideration is the clinicians involved in medication errors may undergo civil litigation as well as licensing board investigations, and criminal charges. The licensing board may initiate formal disciplinary action against the clinician following a medication error. The facility where the medication error occurred may undergo investigation from regulators and accrediting bodies which can have a significant financial cost as well as impact the reputation of the facility. We know that to tackle the problem of medication safety, clinicians must feel safe to report near misses and medication errors and to review systems issues in the department and hospital and institution in a nonpunitive way. This is a requirement for improved patient safety. It is also important to have a system for providing confidential peer support when an event occurs to help reduce the long-term negative impact with the clinician as the second victim. Peer review protections depend on state law, which means that for a hospital to engage in appropriate and necessary systems review following a medication error event, it depends on the hospital’s location. The authors offer a call to action for policy makers in states without these protections to work towards the adoption of laws that will allow facilities to perform appropriate, confidential peer-review practices with clinicians who are free to review and discuss clinical care without fear of litigation and disciplinary action. A system of reporting and reviewing medication errors is a crucial step for decreasing future adverse events, encouraging continued reporting, and improving patient safety.

Next up, we are going to talk about the Manufacturer’s Perspective. There may be many suppliers for a particular product which helps to ensure a strong supply of medication in the market, but it may lead to differences in the appearance of the product. As a result of these variable appearances, there is a higher potential for look-alike medications. Did you know that there are 13 companies that manufacture TXA for the US market? In the US, you can find TXA stored in vials, premixed bags, and ampules. Eight companies manufacture Bupivacaine which you can find in vials for the most part and a very small percentage of ampules. There is a responsibility for manufactures to understand how drugs are stored and use this when they make packaging and labelling decisions especially when products are stored together and are incredibly high risk such as in this case with TXA and Bupivacaine. Manufacturers can also help improve medication safety by offering ready to administer products. Now that there are ready-to-administer infusion bags of TXA 1,000mg per 100mL bag available, there is a realistic and achievable way to prevent future TXA-Bupivacaine drug errors. Ready to administer products are recommended by major scientific and regulatory organizations including the Joint Commission. This is an important step for improved medication safety since premixed bags and prefilled syringes do not require assembly at the patient’s bedside just prior to administration. Using ready to administer products eliminates the medication preparation steps where errors may occur. Another benefit of FDA-approved manufacturer-prepared ready to administer products is that the label contains all the required information and a barcode to help verify the proper drug and dose prior to administration to help ensure safe drug delivery. The FDA has a rigorous approval process for manufacturers who want to provide combination products and there are a select number of manufacturers who have this manufacturing capability. There is a growing number of read to administer products which is a pivotal advancement in medication delivery and an important step for improving medication safety going forward.

So, what can we do to prevent this devastating wrong drug wrong route medication error? We need to make sure that TXA is only available in a premixed bag rather than a vial form in the perioperative environment. This provides the necessary forcing function and barrier to ensure safe medication delivery and is the single most effective intervention.

Let’s take a look at some additional recommendations from the 2024-2025 ISMP Targeted Medication Safety Best Practices.

  • Use barcode-assisted medication safety checks, if available, when preparing and prior to administering medications in surgical and obstetrical areas.
  • Develop protocols to use premixed intravenous (IV) bags of TXA or pharmacy-prepared infusion bags to prevent mix-ups.
  • Foster a culture of safety.
  • Maintain a high level of vigilance when these two medications are given during a case.
  • Meet with key stakeholders to review their workflow when ordering and administering TXA to ensure safe practices.
  • Evaluate workload to ensure workload pressures will not result in unsafe workarounds and practices.
  • Report near misses and unsafe medication practices.
  • Conduct regular reviews and discussions of medication events and close calls reported in your institution.”

The authors conclude with the call to action for that changes must be made to help prevent wrong drug wrong route medication errors. While TXA needs to be available in perioperative areas, the vials or ampules should be removed completely and replaced with ready to administer 100mL bags from the manufacturer, a 503 B compounding facility or the institution’s pharmacy. The cost of these premixed bags is a small price to pay compared to the cost of a medication errors that has such a high morbidity and mortality. So, what are you waiting for? The time to act is now.

[Bechtel] Before we wrap up for today, we are going to hear from Rebello again. I also asked her what she hopes to see going forward. Here is her response.

[Rebello] “Going forward, it is important to employ strategies which force functions and create barriers to prevent this wrong drug, wrong route error.  Having TXA available only in a pre-mixed bag rather than a vial or ampule in the preoperative environment is the single most effective way to reduce this error.

There are three ways to accomplish this measure. 1.  Have the medication drawn into a bag by your hospital pharmacy from the vial.  Two, have this medication provided in a bag from a compounding pharmacy, a 503B compounding pharmacy.  Or three, have a manufacturer prepared bag of TXA.  It’s important to recognize the benefit of replacing the TXA vial with a premixed bag.

The single measure could save a patient’s life. and also eliminate the devastating impact a medication error has on an anesthesia professional who may carry the burden of guilt their entire career.”

[Bechtel] Thank you so much to Rebello for contributing to the show today. We are looking forward to a future where TXA can only be found in premixed ready to administer bags in the perioperative environment.

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 anaesthesia, 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