Obstetrical Patient Receives Ampule of Digoxin Instead of BUPivacaine for Spinal Anesthesia
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Obstetrical Patient Receives Ampule of Digoxin Instead of BUPivacaine for Spinal Anesthesia

Jul 16, 2023

Problem: A pregnant patient with no significant past 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. Anesthesia staff then recognized that the patient was not getting the anticipated BUPivacaine effects and thought that it had been injected into the wrong space. They called the covering anesthesiologist for assistance, and a second dose was administered. The cesarean team delivered a healthy baby. However, 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.

While the manufacturer names for the ampules were not reported to us, BUPIVACAINE SPINAL (preservative-free BUPivacaine for intrathecal use) and digoxin are both available in 2 mL ampules (Figure 1). Since medications are not often provided in ampules, this can heighten the risk of mix-ups between the two drugs. We have previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine or BUPivacaine with EPINEPHrine. One review (Patel S. Cardiovascular drug administration errors during neuraxial anesthesia or analgesia-a narrative review. J Cardiothorac Vasc Anesth. 2023;37[2]:291-8) analyzed inadvertent neuraxial cardiovascular medication administration errors reported between 1972 and 2022. Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight patients.

Safe Practice Recommendations: Given the repeated number of serious mix-ups between digoxin ampules and local anesthetics, the US Food and Drug Administration (FDA) should take steps to have manufacturers package digoxin in vials. In the meantime, organizations should consider the following recommendations:

Review which medications (with special attention to ampules) are available in each unit-specific ADC location, anesthesia tray, and medication kit. Remove those that are not needed (considering typical diagnoses).

Evaluate whether digoxin needs to be stocked in your OR and labor and delivery unit or if it can be requested from the pharmacy, as needed.

Employ individual locked pockets or segregated storage, especially for high-alert 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 one medication in an ampule in an open matrix drawer.

In the OR, order BUPivacaine for patients and scan the barcode prior to administration. Read labels aloud, as would typically occur at handoffs between the circulating and surgical nurse.

Establish policies and procedures for returning unused medications. Require staff to return unused, non-refrigerated medications with intact packaging into a secure one-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 non-controlled 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 (e.g., anesthesia personnel, nurses, pharmacists, pharmacy technicians) and conduct regular competency assessments about the safe use of ADCs during orientation and annually.

Share this 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.

For additional recommendations, review the following resources:

ISMP Guidelines for the Safe Use of Automated Dispensing Cabinets

ISMP Guidelines for Safe Medication Use in Perioperative and Procedural Settings

ECRI. Automated dispensing cabinet setup and use errors may cause medication mishaps [ECRI Exclusive Hazard Report]. ECRI Alerts. February 8, 2017. Accession No. H0365

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