The Case

A 48-year-old man with colon cancer was booked for laparotomy and sigmoid colectomy. The patient was assigned an American Society of Anesthesiologists physical status classification of level III due to serious nature of his colon cancer.¹ An intravenous (IV) cannula was inserted for preoperative fluids while the patient was in his hospital room. In the preoperative treatment area, the Anesthesiology resident flushed the IV cannula to ensure that it was patent and functional. The Anesthesiology department had run out of bright red labels for rocuronium, a non-depolarizing muscle relaxant, so syringes containing rocuronium were labelled with handwritten labels. Immediately after the IV fluid flush using a syringe labeled as “0.9% saline”, the patient became unresponsive and immobile. The patient was speedily intubated in the Operating Room (OR) after being ventilated with sevoflurane, a halogenated inhalational anesthetic, and oxygen by the attending anesthesiologist. The operation was cancelled, and the patient was transferred from the OR to the ICU (Intensive Care Unit), mechanically ventilated and sedated.

In the ICU, the patient started moving after about one hour, once muscle relaxant reversal medication was given, and the patient was extubated soon afterwards. On inquiry, he said that he initially felt “paralyzed” after the IV flush and could hear everything that was being said prior to his intubation and sedation. The patient was found to be medically stable and was scheduled for close follow-up to assess for any complications, including psychological consequences.

The Commentary

By Robert Scott Kriss, DO

Background

This case is an excellent example of an adverse drug event due to mislabeling or “syringe swap.” Adverse drug events are the second most common type of error in healthcare.² It has long been known that education regarding medication safety is relatively lacking in medical education. This problem, combined with reliance on self-reported data, has led to under-reporting of medication errors and relatively little attention being paid to this critical issue.³

The perioperative setting holds unique challenges, as seen in this case, compared with other areas in the hospital. The high-stress, high-acuity nature of the perioperative setting requires that clinicians often bypass standard safety checks, such as electronic physician order entry with clinical decision support, pharmacy oversight before administration, and second provider checks at the time of medication administration. As a result, the perioperative setting may have higher rates of medication errors and adverse drug events than other hospital settings.⁴ For example, researchers at a major academic medical center recently observed 277 operations with 3,671 medication administrations and reported that 193 (5.3%) involved a medication error and/or an adverse drug event, of which 79% were judged to be preventable. About one-third of these errors led to an observed harm, and 24% represented labeling errors, the most common type of perioperative medication error.³ These labeling errors occurred when the provider did not use the labeling system, either because it was not installed in that location or because of a workaround to circumvent its use.

In the ICU setting, two studies reported an overall rate of 80.5 medication errors associated with harm per 1,000 patient-days and 745 parenteral medication errors per 1,000 patient-days.^5,6 A prospective, direct observational study of medications administered at the ICU bedside found one medical error for every five doses of medication administered, and among these medical errors, 23% were errors by omission.⁷ Wake Up Safe, a quality improvement initiative of the Society for Pediatric Anesthesia, reported 2,087 adverse events associated with 2,316,635 pediatric anesthetic administrations from 32 institutions. Of these events, 276 were medication errors, of which the most common type was accidental administration of the wrong dose (N = 84), followed by accidental administration of the wrong syringe (N = 49). Over 80% of reported medication errors reached the patient, more than half caused patient harm, and 15 (5%) required a life-sustaining intervention. Nearly all cases (97%) were judged to be either likely or certainly preventable⁸ through the use of prefilled medication syringes to avoid accidental ampule swap, bar-coding at the point of medication administration, and two-person checking of medication infusions for accuracy.

Concern about adverse drug events has led to the creation of organizations like the Institute for Safe Medical Practices (ISMP) to serve as a resource and clearinghouse for guidelines, tools, and recommendations. ISMP and other organizations have promoted important safety interventions, including removing concentrated potassium solutions from most clinical settings and relabeling medication with similar spellings.

As discussed in the landmark National Academy of Science Report To Err is Human, improving medication safety begins with professional education, implementation of consistent work flows, and a culture that admits that errors occur. Much progress has been made since the landmark report spotlighted the frequency of medical errors and how often they could be avoided, but there is no universally adopted strategy for perioperative medication administration.³

Recommendations

The risk of a medication labeling error of the type presented in this case could be minimized through strict adherence to use of pre-printed labels with the name of the medication, its form or concentration, and its expiration date. Color designation, or use of a pre-assigned color for each type of medication, can also facilitate prevention of medication administration errors in high-risk settings such as the operating room because the pre-assigned color of each medication can serve as a backup safety check to the text on the medication label.⁹

To provide an added level of safety, a bar code or QR code could be printed on the label for verification prior to patient administration. Technology alone cannot eliminate medication errors; technologic innovations must be combined with education, support, universal access, provider buy-in, and a culture that values its presence. Studies examining scanning technology have shown the potential to dramatically reduce medication labeling and dispensing errors in a pharmacy setting, but not necessarily in perioperative settings.¹⁰ The perioperative setting presents unique challenges and obstacles compared to other hospital settings due to its time-critical and high-stress environment. This unique situation often necessitates that the provider skip standard safety checks (i.e., electronic order entry, pharmacy approval, and multiple nursing checks) prior to administering medication. Nanji et al found very high rates of medication errors in the perioperative setting, compared with prior studies in other inpatient settings.³

Systems Change Needed/Quality Improvement Approach

At a minimum, the resident described in the case should have drawn the “0.9% saline” flush and fully labeled it, using either a pre-printed or handwritten label, when they prepared the syringe. The syringe should not leave the provider's hand without a complete label. Single or multiple syringes should never be combined prior to labeling, and no medication should be administered without a complete label, defined as listing the name of the medication, its form or concentration, and its expiration date.

Medication errors, specifically mislabeling, are not rare and are not caused by inattentive or inexperienced providers. They occur in all healthcare settings and by providers at all experience levels. Nanji et al noted no difference in error rates between residents, physician staff, and nurse anesthetists in the perioperative setting. Each institution must determine what safeguards (i.e., bar code technology with label printing, electronic order entry or second provider) are appropriate for their unique situation.³ However, every institution should begin by improving education about medication errors and by de-stigmatizing falsely-held beliefs so that identification and reporting can improve.

Take Home Points

• Medication errors are common and labeling errors are the single most common type of medication error in perioperative care.
• The first step to decreasing medication errors is to increase awareness and revise educational curricula to include discussion of medication errors.
• Consider medication safeguards that make institutional sense; for example, checking by multiple physicians or nurses or use of bar code technology before administering high-risk medications in the perioperative setting.
• No medication should be administered without a complete label, defined as listing its name, form and/or concentration, and expiration date.

Robert Scott Kriss, DO
Health Sciences Associate Clinical Professor
Department of Anesthesiology & Pain Medicine
UC Davis Health
Rskriss@ucdavis.edu

References

1. ASA physical status classification system. American Society of Anesthesiologists. Accessed March 31, 2022. [Available at]
2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-376. [Free full text]
3. Nanji KC, Patel A, Shaikh S, et al. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016;124(1):25-34. [Free full text]
4. Kaufmann J, Schieren M, Wappler F. Medication errors in paediatric anaesthesia-a cultural change is urgently needed!. Br J Anaesth. 2018;120(3):601-603. [Free full text]
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6. Valentin A, Capuzzo M, Guidet B, et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009;338:b814. [Free full text]
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8. Lobaugh LMY, Martin LD, Schleelein LE, et al. Medication errors in pediatric anesthesia: a report from the Wake Up Safe quality improvement initiative. Anesth Analg. 2017;125(3):936-942. [Available at]
9. Jelacic S, Bowdle A, Nair BG, e al. A system for anesthesia drug administration using barcode technology: The Codonics Safe Label System and Smart Anesthesia Manager. Anesth Analg. 2015;121(2):410-421. [Available at]
10. Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administration. N Engl J Med. 2010;362(18):1698-1707. [Free full text]