"Every system is perfectly designed to produce the results it is producing" Rob Perez
On a daily basis, we draw up and administer very, very dangerous drugs without pharmacy oversight. Many of the drugs we administer during anesthesia have effective doses (ED50s) that are the same as their lethal doses (LD50s), in other words, drugs with very, very low therapeutic indices. Just think about it for a moment. If you make a 10-fold or even 100-fold dosing error with an antibiotic, probably nothing terrible will happen. On the other hand, if you accidentally or intentionally give a correct dose of a muscle relaxant, say succinylcholine, to your patient, and if you can’t ventilate, oxygenate, and rescue your patient, he or she will die. This concept of the very low therapeutic indices of anesthetic drugs was drilled into me during my residency and fellowship and was something I drilled into all my students. Interestingly, in the 1970s, the danger of succinylcholine and its accidental administration was so clear and so much at the forefront of our nascent safety culture in anesthesia at the time, that succinylcholine was manufactured and dispensed in hexagonal bottles in order to make it impossible to mix it up with other drugs. For some unknown reason (to me), this design feature, namely, using specific vial shapes for certain drugs or drug categories disappeared. Why? And as we will see, can we bring it back?
Today in our safety culture-driven profession, a glaring chink in our armor is how the drugs we use in our every day practices are packaged in lookalike bottles that often change month to month even from the same manufacturers. Today’s PAAD by Bitan et al.1 takes a deeper dive into this issue. Myron Yaster MD
Original article
Bitan Y, O’Connor MF, Nunnally ME. The vial can help: Standardizing vial design to reduce the risk of medication errors. Int Anesthesiol Clin. 2024 Apr 1;62(2):58-61. Doi: 10.1097/AIA.0000000000000431. Epub 2024 Jan 22. PMID: 38251720.
Safe administration of drugs is crucial to how we practice anesthesia. As anesthesiologists, we are unique in that we prepare, label, and administer medications without pharmacy oversight. Unfortunately, potential medication errors in the perioperative period resulting in patient harm is much more common than we’d like to acknowledge,2 is often under-reported, and many of the corrective “fixes” either don’t work or blame the victim (the nurse or doctor administering the medication) rather than the system that produced the problem. Indeed, the problem is so real and pervasive that a non-profit, the Institute for Safe Medication Practices (ISMP), is devoted entirely to preventing medication administration errors. The ISMP has a bi-weekly publication, the ISMP Medication Alert newsletter (https://www.ismp.org/newsletters/acute-care ), that we would highly recommend all of you to read on a regular basis. In fact, going forward we will regularly start to scan and review this publication for the PAAD readership.
The most common proposal to prevent medication errors and swaps is to “read the label.” Although this process works most of the time, being the humans that we are, it doesn’t work all the time. And we need a consistently reliable process that will prevent medication errors for all patients. Bitan et al. explained that people have “two ways of thinking, a fast and a slow way. Deliberate thinking is effortful and slow. Part of being capable of complex tasks involves offloading the limited capacity slow system to the fast one.3 Much of the acquisition of expertise in complex work is converting the product of deliberation into decisions based on familiar patterns. The more an expert can convert their work to “thinking fast,” the less tiresome and more efficient their work will be. However, “thinking fast” is also characterized by heuristic thinking and other cognitive biases that affect decision-making. An unintended consequence of this expert practice is that it reduces the ability to correctly process the meaning of the labels that clinicians read.”1
Let’s be honest. In the OR, we work in a rapidly changing and unpredictable environment which can be demanding and stressful, leading to cognitive overload, failure, and adverse events. Technologic solutions to the problem of medication administration error and drug swaps, such as using Integrated medication management systems that have built-in scanning and label printing functions, as well as interoperability with automated medication-dispensing cabinets have been shown to help but have not eliminated the problem.4,5 Some hospitals have pharmacy resources to provide pre-filled syringes with easily readable labels, which remove the steps of drawing up the medication and labeling the vial. Another solution, suggested by Bitan et al., borrows from the airline industry and is a back to the future solution. “Designing tools, procedures, and work environments that better match human capabilities and limitations improves quality and reduces failure. People use varied cues to understand and operate in their environment. They use size, shape, location, color, and texture to guide them through their tasks.”1 “Designers in other domains have successfully created designs that do not require the label to be read at all. Most people can identify the shape of a Coca-Cola bottle without reading the label. Why not design and package similar features into the bottles and ampules that contain our lowest therapeutic index medications? For example, just as we did in the past with succinylcholine, why not demand that ALL pharmaceutical companies use hexagonal bottles for all neuromuscular blocking agents with RED caps and keep the labeling the same color with a readable size font? Similarly, perhaps we can demand square or other shaped bottle packaging for heparin and anti-fibrinolytics like TXA and aprotinin?
What do you think and how can we get the power of the FDA to demand some of these changes? Can Wake Up Safe or our friend and colleague at the FDA, Dr. Adam Saperstein, be our voice? Send your thoughts and comments to Myron who will post in a Friday reader response.
References
1. Bitan Y, O'Connor MF, Nunnally ME. The vial can help: Standardizing vial design to reduce the risk of medication errors. International anesthesiology clinics 2024;62(2):58-61. (In eng). DOI: 10.1097/aia.0000000000000431.
2. Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology 2016;124(1):25-34. (In eng). DOI: 10.1097/aln.0000000000000904.
3. Kahneman D. A perspective on judgment and choice: mapping bounded rationality. Am Psychol 2003;58(9):697-720. (In eng). DOI: 10.1037/0003-066x.58.9.697.
4. Jelacic S, Bowdle A, Nair BG, Kusulos D, Bower L, Togashi K. A System for Anesthesia Drug Administration Using Barcode Technology: The Codonics Safe Label System and Smart Anesthesia Manager. Anesthesia and analgesia 2015;121(2):410-21. (In eng). DOI: 10.1213/ane.0000000000000256.
5. Thomas JJ, Bashqoy F, Brinton JT, Guffey P, Yaster M. Integration of the Codonics Safe Label System(®) and the Omnicell XT(®) Anesthesia Workstation into Pediatric Anesthesia Practice: Utilizing Technology to Increase Medication Labeling Compliance and Decrease Medication Discrepancies While Maintaining User Acceptability. Hospital pharmacy 2022;57(1):11-16. (In eng). DOI: 10.1177/0018578720970464.