Medication Errors

Maria G. Tanzi, PharmD

To address drug shortages with neuromuscular blocking agents used in the management of critically ill patients with COVID-19, FDA has allowed vials of rocuronium and vecuronium to be temporarily manufactured without the usual vial cap warnings. But the temporary absence of the statements “Paralyzing Agent” or “Warning: Paralyzing Agent” has numerous safety implications as medication errors can result in serious patient harm, including death. Both FDA and Institute for Safe Medication Practices (ISMP) have released guidance on steps to prevent medication errors. 

FDA alert   

In early June, FDA informed health professionals about the temporary change to the vial caps of rocuronium and vecuronium (see Figures 1 and 2). The affected products include rocuronium bromide injection 50 mg/5 mL and 100 mg/10 mL vials, and vecuronium bromide for injection 10 mg and 20 mg vials.

Historically, the warning statement on these vial caps has assisted clinicians in clearly identifying neuromuscular blocking agents from other medications stored in close proximity. If used incorrectly, these medications can cause significant patient harm, including death. Although the products will continue to have the same container and carton labels as before and only the vial caps will look different, strategies to prevent medication errors are important to implement.

Mitigation strategies      

“Health care practitioners should make sure that the new neuromuscular blocker vials are never stored standing up in a way that you can only see the caps,” said Michael Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, and president of ISMP.

The vials should be stored lying down so labels are visible in drawers, anesthesia trays, or in other storage containers or shelving. This is especially important when storing products on low shelves. “Store them apart from other drugs and place an auxiliary label (“Warning: Paralyzing Agent”) over the caps to warn that the vial contains a neuromuscular blocking agent,” Cohen added. These labels are available from several medical product suppliers.

All staff (pharmacy, nursing, anesthesia, emergency department (ED), etc.) should be aware of this temporary change for the rocuronium and vecuronium vials. Cohen recommended that safety committees review safe storage of these products since storage will vary, with these vials present not only in the pharmacy but also in other locations in the hospital such as crash carts, automated dispensing cabinets (ADCs), and anesthesia carts, kits, and trays. Staff should also be reminded about the need to use bar code scanning when dispensing and preparing doses, as well as to carefully check the container label to ensure the correct product is being administered.

Additional recommendations include limiting the availability of neuromuscular blocking agents like vecuronium in ADCs to perioperative, labor and delivery, critical care, and ED settings. In these settings, store the drugs in a rapid sequence intubation kit or in lock-lidded ADC pockets or drawers. Hospitals can also take additional precautions such as employing independent double checks, especially when the ability to remove these drugs via an override exists as an option. If these vials are stored in ADCs, FDA recommended that hospitals consider protocols to limit access and manage override removals.

Additional resource     

ISMP has released “Paralyzed by Mistakes—Reassess the Safety of Neuromuscular Blockers in Your Facility,” a comprehensive resource that discusses common errors that have occurred with neuromuscular blocking agents along with a list of safety recommendations.

The resource is available on ISMP’s website and discusses errors such as look-alike packaging and labeling; look-alike drug names; unsafe mnemonics; drug administration after extubation; unlabeled and mislabeled syringes; and unsafe storage. It also includes a list of primary and secondary recommendations to prevent these errors. The document can serve as an excellent reference to further enhance the safe use of neuromuscular blocking agents.