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USP Quality Review

No. 72, Issued February 2000

Click here for printable version  (129KB).

Neuromuscular Blocking Agents - Proposed Labeling and Packaging Standards for Medication Error Prevention

Serious Consequences
The USP Advisory Panel on Medication Errors, a practitioner-based committee, is charged with reviewing and analyzing medication errors reported to the USP Medication Errors Reporting (MER) Program and making recommendations to USP and the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). More than 50 reports, including accounts of serious injuries and fatalities, concerning the misuse of neuromuscular blocking agents have been received through the USP MER Program. Because the USP MER Program is a voluntary reporting program, the true incidence of actual errors resulting from misuse of neuromuscular blocking agents is not known. The serious outcomes reported to result from medication errors with neuromuscular blocking agents prompted the USP Advisory Panel on Medication Errors to develop recommendations for labeling and packaging standards to be published in the United States Pharmacopeia-National Formulary, potentially alleviating this serious health concern.

Safe Use Recommendations
The USP Advisory Panel on Medication Errors has proposed several recommendations for the safe use of neuromuscular blocking agents. It is hoped that by implementing one or more of these as standards for the packaging and labeling of neuromuscular blocking agents, the products will be readily identifiable and therefore less likely to be misadministered. Several of the recommendations being considered include requirement of a standardized warning on the cap and closure of products packaged in vials; development of a standardized container (a unique design, shape, or texture of the container would be used in order to provide tactile clues to those handling the products); and development of a standard auxiliary label that must be affixed to all neuromuscular blocking agent products and admixtures prior to dispensing.

Medication Errors Case Studies
The following cases are abstracted medication errors reported to the USP MER Program. They illustrate the severe nature of the injuries that may result from accidental misuse of neuromuscular blocking agents.

• In the reporting facility's emergency department, commercially prepared prefilled saline flush syringes were not available. The nurses prepared saline flush supplies by drawing up syringes from multi-dose vials and labeling them by hand. A patient's vecuronium dose was not used, but the syringe was not discarded. The unused vecuronium, also labeled by hand, was inadvertently returned into the saline flush supply. The syringe looked similar to the saline syringes and accidentally was used to flush the IV line of an alert, nonventilator-supported, three-year-old child. The child became frightened, flaccid, and respiratory efforts ceased. He was quickly intubated and ventilated. Fortuitously, the child sustained no serious harm.

• An anesthesiologist needed to give a patient potassium chloride during a procedure. He chose to give a bolus through a central line rather than order a diluted peripheral infusion from the pharmacy. Concentrated potassium chloride had been removed from all areas of the hospital except the pharmacy IV room and a locked drawer in the open-heart operating room perfusionist cart. An open-heart procedure was in progress, so the anesthesiologist removed a vial from the perfusionist's cart. The anesthesiologist picked a vial he believed to be potassium chloride, based upon the vial's blue label color, size, and shape, but the vial was vecuronium. The anesthesiologist proceeded to withdraw the drug into an unlabeled syringe, and administer it to the patient. At the procedure's conclusion, muscle paralysis delayed patient recovery. At this point, the anesthesiologist investigated the contents of his cart and discovered the error. It was several hours before the patient fully recovered. Fortunately, permanent adverse sequela did not occur.

• Mivacurium, stocked next to metronidazole, was picked up and labeled by a technician as metronidazole. Four patients scheduled to receive the antibiotic instead received mislabeled mivacurium. All four patients experienced respiratory arrest. One patient died, one was in critical condition, and two recovered. A technician who noticed that a bag returned from the nursing unit was incorrectly labeled discovered the error.

• Pancuronium, which should have been stored in the refrigerator, was misplaced in the heparin flush stock. A nurse inadvertently administered 5mL of the neuromuscular blocking agent instead of heparin. The nurse looked at the vial and knew the wrong medication had been given. The patient, who was in the Intensive Care Unit, experienced the effects of the pancuronium administration, but recovered after ten hours on a respirator.

• A patient in the Critical Care Unit receiving a vecuronium drip for ventilator control was also receiving potassium chloride by IV piggyback. The patient was to be extubated, and an order was written to discontinue the vecuronium. The drug, however, was not removed from the patient's room. A nurse misread the label and hung the vecuronium instead of the intended potassium chloride. The patient remained on the ventilator six hours longer than anticipated and the critical care stay was prolonged.

• A physician wanted to sedate a combative emergency room patient. A neuromuscular blocking agent was ordered and then subsequently administered by a nurse. The patient, who had not been intubated, coded and suffered an anoxic insult. He was transferred to another hospital.

• Nimbex®, a neuromuscular blocking agent, was administered to a patient instead of Revex®, a narcotic antagonist. An anesthesiologist called the pharmacy and asked for "the new anesthesia drug that ends in an 'X'." The anesthesiologist meant Revex, but the pharmacy thought he meant Nimbex. Dosing instructions for Nimbex were given, and Nimbex was sent to the floor.

• A patient was lethargic after receiving morphine, midazolam, promethazine, and other medications that could contribute to lethargy. A physician wrote an order for "Narcan® 1 amp I.V." An Intensive Care Unit nurse tried to obtain the drug from the automated dispensing unit but could not find it because she was unfamiliar with Narcan, and the drugs are listed by generic name on the automated dispensing unit's screen. She asked a co-worker what was the generic name. However, she had already confused Narcan with Norcuron® and asked, "What is the generic name for Norcuron?" The co-worker told her that it was vecuronium. The nurse then removed vecuronium and administered an unknown quantity from a 10-mg vial to the patient. Subsequently, the patient experienced respiratory and cardiac arrest. The patient was resuscitated after several minutes of CPR and placed on a mechanical ventilator. The patient remained on the ventilator for several days, had a prolonged stay in the Intensive Care Unit, and was then transferred to the medical unit. The patient was critically ill before the event so it is difficult to determine what outcomes were directly due to the error.