Obstetrical Patient Dies After Inadvertent Administration of Digoxin for Spinal Anesthesia

A pregnant patient with no significant medical history was undergoing a scheduled cesarean delivery in an operating room (OR) and was to receive spinal anesthesia. An anesthetist typed in “bupivacaine” at an automated dispensing cabinet (ADC), and a drawer that provided access to several medications opened. The anesthetist inadvertently removed an ampule of digoxin rather than bupivacaine, prepared the dose, and administered it intrathecally. The anesthetist did not scan the barcode or read the label aloud to another staff member prior to administration.¹

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Anesthesia staff then recognized that the patient was not experiencing the anticipated bupivacaine effects and thought the drug had been injected in the wrong location. They called the covering anesthesiologist for assistance, and a second dose was administered.¹

The cesarean team delivered a healthy infant, but shortly after the birth the patient complained of dizziness, blurred vision, and a severe headache with left facial drooping and left-sided weakness. She began losing her ability to communicate and then experienced apnea and complete paralysis. She was intubated and transferred to the intensive care unit. During an OR ADC medication count, a nurse found that a digoxin ampule was missing. Inadvertent digoxin administration into the intrathecal space was suspected, and a digoxin level was ordered and detected. The team determined that the patient was brain dead, and she died shortly thereafter.¹

Although the manufacturer names for the ampules were not reported to the Institute for Safe Medication Practices (ISMP), bupivacaine spinal (preservative-free bupivacaine for intrathecal use) and digoxin are both available in 2-mL ampules (FIGURE). Because medications are not often provided in ampules, this can heighten the risk of mix-ups between the 2 drugs. The ISMP has previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (eg, epidural, intrathecal) instead of the intended bupivacaine or bupivacaine with epinephrine.¹

One review analyzed inadvertent neuraxial cardiovascular medication administration errors reported between 1972 and 2022^.1

Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in 8 patients.²

RECOMMENDATIONS

Given the repeated number of serious mixups between digoxin ampules and local anesthetics, the FDA should take steps to have manufacturers package digoxin in vials. In the meantime, organizations should consider the following recommendations:

• Review which medications are available in each unit-specific ADC location, anesthesia tray, and medication kit, with special attention to ampules. Remove any that are unnecessary, considering typical diagnoses.
• Evaluate whether digoxin needs to be stocked in the OR and labor and delivery unit or whether it can be requested from the pharmacy, as needed.
• Employ individual locked pockets or segregated storage, especially for highalert medications like digoxin or medications given via the spinal route, such as preservative-free bupivacaine.
• Use barcode scanning upon selection in the pharmacy and when stocking medications in the ADC to ensure it is placed in the correct drawer or pocket.
• Avoid stocking medications in ampules when possible or store them far apart, and never store more than 1 ampule medication in an open matrix drawer.
• In the OR, order bupivacaine and scan the barcode prior to administration. Read labels aloud, as would typically occur at handoffs between the circulating and surgical nurses.
• Establish policies and procedures for returning unused medications. Require staff to return unused, nonrefrigerated medications with intact packaging into a secure 1-way return bin in the ADC that is maintained by the pharmacy. Otherwise, return these items to the original secure locked-lidded pocket if it is a noncontrolled substance. This process should be guided by barcode verification. Practitioners should return unused refrigerated medications to the designated ADC refrigerated return bin, which should be checked regularly by pharmacy staff.
• Educate staff (eg, anesthesia personnel, nurses, pharmacists, pharmacy technicians) and conduct regular competency assessments about the safe use of ADCs during orientation and annually.
• Share the aforementioned event with staff and discuss lessons learned. In addition, conduct regular reviews and discussions of medication events and close calls reported in your organization and by outside organizations such as ISMP.

About the Author

Michael J. Gaunt, PharmD, is a senior director of error reporting programs and editor at the Institute for Safe Medication Practices (ISMP) in Horsham, Pennsylvania. He also serves as the editor of the monthly ISMP Medication Safety Alert! Community/Ambulatory Care newsletter.

References

1. Institute for Safe Medication Practices. Obstetrical patient receives ampule of digoxin instead of BUPivacaine for spinal anesthesia. ISMP Medication Safety Alert! Acute Care. 2023;28(17):1-2.
2. Patel S. Cardiovascular drug administration errors during neuraxial anesthesia or analgesia—a narrative review. J Cardiothorac Vasc Anesth. 2023;37(2):291-298. doi:10.1053/j.jvca.2022.10.016

The ISMP Guidelines for the Safe Use of Automated Dispensing Cabinets and ISMP Guidelines for Safe Medication Use in Perioperative and Procedural Settings can be reviewed for further information.