Sugammadex Peel-off Label Leads to Confusion
BRIDION (sugammadex), a neuromuscular blocking reversal agent, has a peel-off label that expresses the drug concentration in a different way than the vial label itself. The peel-off label states the concentration and volume as 100 mg/mL (Figure 1). However, the vial label underneath expresses the drug’s strength as 200 mg/ 2 mL for the 2 mL vial (Figure 2), or 500 mg/5 mL for the 5 mL vial. The labeling can lead providers to falsely believe the entire vial (2 mL or 5 mL) contains only 100 mg. Twice already, staff in one hospital used the contents from the 2 mL vial but confused the peel-off label 100 mg/mL strength as the total amount of drug in the vial. For a patient who was supposed to receive 150 mg, two vials were used to draw up a total of 3 mL, and 300 mg was administered in error.
ISMP supports the use of peel-off labels to facilitate syringe labeling in clinical areas such as with vaccines or in the operating room (OR) where providers prepare doses from vials. However, expressing the drug strength two different ways can lead to errors. It creates a situation where the amount per mL is what is read, not the total amount of drug per container volume, as required of manufacturers in USP <7>. ISMP contacted Merck, the drug manufacturer, to recommend either changing the way the concentration is expressed on the peel-off label so it is the same as the vial label, or eliminating the peel-off label all together. Other products may have similar issues.