October 13, 2020

The U.S. FDA has issued a safety communication in regard to proper dispensing of insulin pens. These products should typically be dispensed in their original, sealed carton to a single patient. Storing or dispensing insulin pens outside of their original cartons can increase the risk of dispensing errors and of patients using the wrong insulin product.

According to the FDA, “insulin pens dispensed individually outside of their cartons may have contributed to medication errors including wrong-drug and wrong-dose errors resulting in hyper- or hypoglycemia, missed doses, complaints of possible tampering, and dispensing without the instructions for use.”

Most insulin pens are dispensed in cartons that contain 2-5 pens intended for use by only one patient. Because insulin pens with different dosages and/or formulations often look similar, the cartons feature various colors, font styles, and other design elements that help distinguish one product from another and prevent medication errors. Individual pens within the carton do not have their own sealed packaging, and each carton contains only one copy of the drug’s prescribing information and instructions for use.

Although healthcare providers may choose, based on their professional judgment, to dispense individual pens outside of their cartons, this practice is not in accordance with FDA-approved labeling for these products. The FDA encourages healthcare providers to consider the known risks of dispensing individual pens outside of their cartons and incorporate additional safety measures to mitigate these risks. Such measures may include adding tamper-indicator tape to the pen, providing a copy of instructions for use to the patient, and labeling the individual pens for individual patient use.

The FDA is strongly encouraging manufacturers of insulin pens to develop smaller carton sizes that can better accommodate variable insulin doses and needs. The agency also suggests that organizations facing challenges with multiple-pen cartons contact the manufacturers to emphasize the need for smaller and single-pen carton sizes.

A full copy of the safety communication can be found on the FDA’s website.

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