Clinolipid container label issue

Supply chain issues are impacting the availability of many products, including fat emulsion products for parenteral nutrition (PN). One hospital pharmacist reported that she had recently switched from the pharmacy’s usual supply of lipid injectable emulsion (ILE) to Baxter’s CLINOLIPID 20% product. Although the hospital has not experienced any errors, a potential safety issue was identified that prompted proactive education of the pharmacy team and reporting of the issue to ISMP. The total volume of the product is 250 mL, but the concentration that is most prominently displayed is 20 g/100 mL (Figure 1). The product is often prescribed in terms of percent concentration (20%) and volume. However, the way the total volume and concentration are presented could lead practitioners to incorrectly assume that the bag contains a total volume of 100 mL and 20 g. As a result, this could contribute to a dispensing or dosing error.

We believe that displaying the total amount per total volume (i.e., 50 g/250 mL) would minimize the risk for confusion and error. Incidentally, the label for the 1,000 mL Clinolipid container lists the amount per container volume (200 g/1,000 mL), not 20 g per 100 mL, so the concentration expression on the 250 mL bag is inconsistent. ISMP has contacted Baxter about the label on the 250 mL product. Baxter reports that its regulatory team has initiated a label change for the 250 mL bag with the US Food and Drug Administration (FDA).