ISMP Warns of Medication Safety Issues with Critical Care Drug Products

The Institute for Safe Medication Practices (ISMP) has issued an alert about potential safety issues with critical care drug products being introduced in the United States to help ease shortages due to the coronavirus disease 2019 (COVID-19) pandemic.

The nonprofit organization urged practitioners to prepare for extra precautions with vials of neuromuscular blocking agents that do not have the “Warning: Paralyzing Agent” statement required on vial caps, and a propofol product that has double the concentration of what is available in the United States.

Neuromuscular blocking agents are considered high-alert medications because of their well-documented history of causing catastrophic injuries or death when used in error. According to ISMP, the FDA has allowed temporary manufacture of some neuromuscular blocking agents without the required vial cap warning, which may make them appear more like other medications in similar size vials and cap colors. In alerting the health care community, ISMP officials said the group believes awareness about the absence of the usual warning statement is critically important.

According to ISMP, neuromuscular blocking agents may be stocked in locations outside of the operating area and intensive care units, so it is important for hospitals and health systems to examine areas where they might be stored, determine the likelihood of product mix-ups, and educate clinical staff. ISMP also recommends that organizations immediately affix an auxiliary label noting “Warning: Paralyzing Agent” on the vial caps that do not have them.

In addition, ISMP alerted the health care community that marketing of an overseas propofol product is scheduled to begin this month in the United States under an emergency use authorization (EUA) that limits use to maintaining sedation in patients requiring ventilation in an intensive care unit during the COVID-19 pandemic. ISMP is recommending that this product, Propoven 2%, be carefully reviewed by an interdisciplinary committee that includes pharmacy, nursing, medical, anesthesia, critical care, and ambulatory care representatives, prior to use.

Propoven 2% contains the same active ingredient as FDA-approved propofol (Diprivan); however, Propoven 2% contains double the propofol concentration (20 mg/mL vs 10 mg/mL), a fact that may lead to overdoses if practitioners are unaware. All critical care prescribers, nurses working in critical care units, and anesthesia providers should be alerted to the double concentration. According to ISMP, warning stickers about the concentration should be applied immediately upon receipt of the product in the pharmacy so that each container is labeled prior to storage and distribution.

Updates to electronic drug databases, and smart infusion pump drug libraries will be necessary, according to ISMP, as typical infusion rates for propofol 1% will need to be halved with Propoven 2%.

REFERENCE

ISMP Warns about Medication Safety Issues with Drug Shortage Replacement Products [news release]. Horsham, PA; June 5, 2020: ISMP [email]. Accessed June 5, 2020