Isoflurane: Labeling Error

By Marlene Icenhower, BSN, JD, CPHRM
 

The Institute for Safe Medication Practices (ISMP) has issued an alert regarding reports of mislabeled isoflurane, a general anesthetic administered via inhalation. Several healthcare institutions have reported receiving cartons labeled “Isoflurane USP 100 mL” from the manufacturer, Piramal Critical Care, that contained isoflurane USP 100 mL labeled “for animal use only.” The drug manufacturer has advised that both products have the same chemical composition, that both products are pure, and that both products are manufactured under the same sterile conditions.

In the event that your organization stocks isoflurane, consider taking the following steps:

• Review the alert. The ISMP alert contains more details on this labeling error and National Drug Code (NDC) numbers for affected products. Notify all potentially affected departments within your organization.
• Inspect your inventory. Immediately inspect your drug inventory to ensure it does not contain isoflurane labeled “for animal use only” (NDC-11695-6777-1). Notify all providers who administer isoflurane about this labeling error.
• Remove mislabeled inventory from stock. Remove mislabeled isoflurane from inventory and keep it in a safe place that cannot be accessed for patient use. Notify the Food and Drug Administration, manufacturer, and wholesaler, and await further instructions for disposition of the mislabeled inventory. Ensure that correctly labeled isoflurane is available to avoid delays in care.
• Monitor. In the event that any patient received mislabeled isoflurane, notify risk management personnel and your professional liability carrier for further instructions.
• Review processes. Take this opportunity to review your policies and procedures regarding management of medication, device, and equipment recalls to ensure you are responding to these notices in a timely fashion in order to enhance patient safety.

 
 
Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.