Patient Safety Tip of the Week Archive

What’s New in the Patient Safety World

February 2021

ISMP: 2 Alerts on NMBA’s

Fatal errors due to inadvertent administration of neuromuscular blocking agents (NMBA’s) have been problematic. There have been numerous interventions intended to prevent them and no single one is likely to ensure success. But each individual intervention contributes to the defenses.

“Look-alike” vials have been one factor contributing to such errors. So, one important intervention has been labeling of vials containing NMBA’s. Form several years, warnings on the vial caps stating “Paralyzing Agent” have been required. However, ISMP (Institute for Safe Medication Practices) has just published a warning that vials of NMBA’s lacking this warning have again appeared (ISMP 2021a). ISMP notes that, due to drug shortages during the COVID-19 pandemic, the FDA has allowed temporary manufacturing of these drugs without the vial cap (seal) warning statement. The ISMP article names specific products affected.

One important point in the ISMP alert is that the expiration date on several of the products affected is in mid-2022. That means that, even if the shortages are resolved, some of these vials are likely to be in hospital stock for over another year.

Therefore, it is critical that nurses and pharmacists and any others who handle or administer these drugs be made aware of this danger. ISMP recommends having pharmacy affix auxiliary “Warning: Paralyzing Agent” labels to vial caps prior to storage in critical care units, the perioperative setting, and emergency departments.

In our multiple prior columns on NMBA incidents (see full list below), we have also discussed other important interventions to prevent such accidents. Appropriate segregation of NMBA vials from other drugs, especially “look-alike” vials, is critical. NMBA vials should also not be part of “floor stock”. When NMBA’s are included in automated dispensing cabinets (ADC’s), you should require acknowledgement that the patient is mechanically ventilated (or the NMBA is to be used during intubation) before allowing retrieval of the vial from the ADC.

We’d also recommend that, as the drug shortage is resolved and new vials having the appropriate warning on the caps arrive, you remove any of the unlabeled vials from stock.

It’s important you heed this ISMP warning. You don’t want to put your patients in jeopardy. And you don’t want to put any of your staff in jeopardy of being at the sharp end of a tragic error cascade.

But, shortly after that first warning, ISMP issued another alert requiring immediate attention (ISMP 2021b): an extremely hazardous packaging error involving certain cisatracurium products from Meitheal Pharmaceuticals. While the outer carton identifies the vials inside as cisatracurium, the vials contained in the carton are labeled phenylephrine injection. The vials actually contain cisatracurium and have caps appropriate for a paralyzing agent. But, if you don’t notice this cap warning, you may think you are injecting phenylephrine. Results in a non-intubated, non-ventilated patient would be disastrous. ISMP urges facilities to immediately examine any and all cartons of cisatracurium from Meitheal Pharmaceuticals for this serious packaging error and make sure that none of these vials were actually distributed. ISMP has confirmed that both the FDA and the manufacturer are aware of this situation and that a recall is imminent.