Episode #54 Medication Safety and Look-alike VialsJuly 20, 2021
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.
To kick off the show, we discuss the APSF endorsement of the Institute for Safe Medication Practices or ISMP initiative called the “ISMP Medication Safety Self-Assessment for Perioperative Settings. The online data submission deadline is fast approaching on August 31, 2021. For more information check out the link here. https://www.apsf.org/news-updates/ismp-medication-safety-self-assessment-for-perioperative-settings/
Next, we hear from the APSF Social Media Manager to reveal why this medication safety topic is so important on social media.
Our featured article today is “Important Medication Errors and Hazards Reported to the ISMP National Medication Errors Reporting Program During 2021” written by the late Ron Litman, whose life and career had great impact in this area from the June 2021 APSF Newsletter. You can find the article here. https://www.apsf.org/article/important-medication-errors-and-hazards-reported-to-the-ismp-national-medication-errors-reporting-program-during-2020/
Important topics that we discuss today from the article include prescribing, dispensing, and administering extended-release opioids to opioid-naïve patients and not using smart infusion pumps with dose error-reduction systems in perioperative settings.
Join us next week to continue the conversation as we review errors with oxytocin administration, hazards associated with infusion pumps located outside of the room for patients with Covid-19, risks associated with combining or manipulating commercially available sterile products outside the pharmacy, and incorrect injection by intraspinal injection associated with tranexamic acid.
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© 2021, 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.
I want to highlight a recent publication on our website that is directly related to our show today. The APSF is endorsing the Institute for safe Medication Practices or ISMP initiative called the “ISMP Medication Safety Self-Assessment for Perioperative Settings. This initiative launched on May 18th of this year. It involves a new self-assessment that provides a way for healthcare professionals to document compliance with regulatory or accrediting requirements for proactive risk assessment and performance improvement. The result is the creation of organization-specific, safety-focused initiatives with the ability to compare experiences with that of other similar organizations. The online data submission deadline is fast approaching on August 31, 2021. I will include a link to the article and at the bottom of the article you can click over to the ISMP.org website for additional resources and information. I went ahead and clicked on the link for more information too. This tool may be used by hospitals, ambulatory surgery centers, and office-based surgery practices. The benefits include the following:
- Increased knowledge of best practices related to safe medication systems in the perioperative and surgical or procedural setting.
- Help with identifying and prioritizing gaps in the safe medication systems at your institution so that these gaps can be filled in to keep patients safe.
- Establishment of a baseline of the evaluation of the perioperative medication system that is coupled with measuring progress over time that is facility specific.
- And finally, helps to look at the current state of medication safety systems in different perioperative and procedural settings on a national level with the creation of a baseline measure for these efforts.
Before we dive further into today’s episode, we’d like to recognize Edwards Lifesciences, a major corporate supporter of APSF. Edwards Lifesciences has generously provided unrestricted support as well as research and educational grants 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!”
The focus for this show is medication safety which is very fitting after discussing the new ISMP initiative. This is a topic that is so important for anesthesia patient safety. In fact, it is the 7th Priority on the APSF patient safety priorities list for this year which includes drug effects, labeling issues, shortages, technology issues, and processes for avoiding and detecting errors. This was the topic for the 2018 Stoelting Conference and many APSF Newsletter articles. Plus, coming soon this year, the APSF will co-host a summit with the ISMP. Administration of medication to patients is something that anesthesia professionals frequently do while providing anesthesia care, but it is so much more than just administering the medications. It must be the correct medication by the correct route of administration in the correct dose at the appropriate time for the appropriate indication while monitoring for drug effects and be on the lookout for side effects or drug reactions. This is the time when anesthesia professionals need to stay vigilant. The #APSF crowd on twitter has brought up medication safety related to look-alike drug vials which are a big threat to patient safety. I reached out to the APSF Social Media Manager to help discuss this important issue. I am going to let her introduce herself now.
[Pearson] Hi, my name is Amy Pearson (@AmyPearsonMD), and I am a physician anesthesiologist and assistant professor at the University of Iowa. I’m also the Social Media Manager for the Anesthesia Patient Safety Foundation.]
[Bechtel] I asked Pearson, “Why do you think that this is such an important topic on social media?” Let’s take a listen to what she had to say.
[Pearson] I think this is such an important topic on social media because it is such high stakes and yet SO bewildering. The most classic example is the lookalike vials of phenylephrine and ondansetron. Phenylephrine is a potent vasoconstrictor meant to quickly raise the blood pressure by infusion or diluted injection ONLY. It comes in a 10 mg/ml tiny vial – and here’s the thing – the vial is ONLY meant for reconstituting to a more dilute dose. If one were to draw up that vial in a syringe and inject it directly into the patient, that could be a 100-fold overdose of the intended medication. Since the standardization of vials is so variable, many other vials look very similar to phenylephrine, especially ondansetron, an anti-nausea medication which is commonly drawn up and injected -you guessed it- directly into the patient. These mix-ups have caused serious harm and even death. I’m really proud of the anesthesia community, especially on Twitter, for calling attention to this concern and alerting each other to medication vials that can be easily mistaken for each other. Labels, sizes, and colors of vials can change at any time, so it’s important to take note when unexpected vials could turn up in your anesthesia cart. You can check out APSF’s hashtag #lookalikevials to see more examples. It’s really eye-opening.
[Bechtel] Thank you so much to Pearson for helping to highlight this important topic. We are going to keep the conversation going by turning to the June 2021 APSF Newsletter and the article, “Important Medication Errors and Hazards Reported to the ISMP National Medication Errors Reporting Program During 2021” written by the late Ron Litman, whose life and career had great impact in this area. To follow along with us, head over to APSF.org and click on the Newsletter heading. First one down is the current issue. Then scroll down looking in the left hand column and the 6th one down is our featured article today.
The article starts by highlighting that the ISMP has a voluntary practitioner online reporting system with thousands of reported medication errors. This system was used to create a list of important medication errors over the past year. Buckle up your medication safety belts and we are going to review these now.
First up, is the prescribing, dispensing, and administering extended-release opioids to opioid-naïve patients. This is a big threat to patient safety that has led to patient harm and death. Even though this has been a documented problem for decades, it continues to be a problem for 2 reasons: a knowledge deficit about the risk of administering extended-release opioids to opioid-naïve patients and not differentiating opioid-naïve and opioid-tolerant patients correctly. An example of this situation from the ISMP reporting system is the use of fentanyl patches for opioid-naïve elderly patients to treat acute pain or prescribed for patients with a reported codeine allergy that was really just a minor drug intolerance. This is not a safe practice since prescriptions for fentanyl patches should only be given to opioid-tolerant patients to treat pain that is so severe that it requires long acting and long term treatment. This was such a big problem in 2018 and the ISMP took action by issuing a statement in the Targeted Medication Safety Best Practices for Hospitals that fentanyl patches should never be prescribed for opioid-naïve patients or patients with acute pain. In the past year, this was updated into a new Best Practice which involves verifying and documenting the patient’s opioid status of either naïve or tolerant and category of pain either acute or chronic before prescribing and dispensing ER opioids. This new best practice can be accomplished by establishing clear definition for opioid-naïve and opioid-tolerant patients and then creating a standard process for gathering and documenting patient’s opioid status and type of pain. The default orders should start with the lowest initial dose and frequency when starting treatment with an extended-release opioid, and there needs to be programmed alerts to confirm opioid tolerance during the prescription and dispensing processes. Another vital step is to differentiate between true allergic reactions and drug intolerances or adverse effects for patient’s allergy history. The final recommendation involves removing fentanyl patches from any automatic dispensing cabinets or as part of unit stock in clinical locations where patient are treated for acute pain. Fentanyl patches do not need to be stored in emergency departments, operating rooms, the PACU, or any procedural areas. These are simple recommendations, but there is still work to do since a 2020 ISMP survey revealed low compliance with these important steps.
Let’s move on to the next important area for medication safety which includes Not Using Smart Infusion Pumps with Dose Error-Reduction Systems in Perioperative Settings. The ISMP released a 2020 Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps with the recommendation for smart pumps that have dose error-reduction systems anywhere infusion pumps are used and in all perioperative areas. Do you have this kind of smart pump at your institution? If we take a closer look at the perioperative patient care areas, there may be challenges with implementing this recommendation. First, this may not be a clearly defined expectation from leadership that anesthesia professionals need to use smart pumps with dose error-reduction systems. This is a type of advanced medical technology and without appropriate training, anesthesia professionals may not understand the functions including bolus dosing. In addition, the programmed dose and infusion limits may be unacceptable unless anesthesia professionals participate in the development of the anesthesia drug library. It is just as important that the infusion pump’s ”anesthesia mode” only be used by anesthesia professionals in the perioperative setting and may not be appropriate for the floor or ICU because of the risk for overriding dosing and concentration limits when the hard stops are converted to soft stops.
We can make the use of infusion pumps safer with the following steps:
- Clear direction from leadership for the expectation of the use of smart pumps with dose error-reduction systems.
- Anesthesia professional engagement during the creation of the smart pump library.
- Use of upper and lower hard limits for medication doses, concentrations, infusion rates, and loading and bolus doses.
- Use of the bolus features and set hard limits for catastrophic doses as well as no allowing the delivery of bolus doses by increasing the rate of the infusion.
- Providing adequate hands-on training prior to using the infusion pumps with documentation of competency assessments.
- And finally, analyzing pump data to gather information about any challenges associated with effective use of smart pumps in the perioperative patient care areas.
We are about halfway done with our featured article today, so you will have to join us again next week to learn more about errors with oxytocin administration, hazards associated with infusion pumps located outside of the room for patients with Covid-19, risks associated with combining or manipulating commercially available sterile products outside the pharmacy, and incorrect injection by intraspinal injection associated with tranexamic acid. These are all big threats to patient safety and the good news is that there are steps that we can take to address these situations.
Before we wrap up for today, we are going to hear from Pearson again. I asked her what does she envision for the future with regards to medication safety and look alike vials. Pearson provides some great insight:
[Pearson] In the future, I hope that there will be more standardization from manufacturers regarding medication vials. Many departments have installed drug labeling machines that scan and verbalize the medication before printing the label, which acts as a second check for the anesthesia professional, who is often the only person choosing, preparing, labeling, and injecting medications in the room. Also, while this is still a topic for debate, I personally believe that vials of medications in the same category (for example, opioids) should share the same color.
Theoretically, if you mix up one opioid for another, at least you are still giving the same intended class of medication, rather than, for example, giving a blood pressure medication when an opioid was intended. I’m actually very excited about the recent ASA Statement on Labeling of Pharmaceuticals for Use in Anesthesiology, which has recommendations for consistent medication labeling in line with ASTM International, the International Organization of Standards, the Institution for Safe Medication Practices, and the FDA. There are recommendations for colors, font, content, and label material that even consider color blindness. I do hope that these standards are adopted not only by the anesthesia professionals who label syringes but also the manufacturers who create the vials. Thanks for having me on the show, Dr Bechtel, and I look forward to interacting with you all on Social Media!
[Bechtel] And a big thank you goes to Pearson for her contributions to the show today. Before you join her on the APSF social media channels, remember if you have any questions or comments from today’s show, please email us at [email protected] and we hope that you will tune in next week when we will continue to this discussion.
Visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today. You can find us on twitter, Instagram, Facebook and LinkedIn! See the show notes for more details and we can’t wait for you to tag us in a patient safety related tweet or like our next post on Instagram, like us on Facebook, or connect with us on LinkedIn!! Follow along with us for the latest news and updates in perioperative and anesthesia patient safety.
Until next time, stay vigilant so that no one shall be harmed by anesthesia care.
© 2021, The Anesthesia Patient Safety Foundation