In November 2019, the Agency approved revisions to the labeling for insulin pens recommending that the products be dispensed in the original sealed carton. As insulin pens often have similar appearances and are not labeled for dispensing as individual units, the carton helps both healthcare professionals and patients distinguish between the products, which are available in a variety of formulations and dosages.
The FDA noted in a recent safety communication that while there may be times when healthcare professionals may choose to dispense an individual pen, based on their professional judgement, the approved labeling states that these pens should remain in the original packaging. Insulin pens are generally supplied in cartons containing 2 to 5 pens; recently, the first single-pen carton size for an insulin product was approved.
To avoid potential errors if an individual insulin pen needs to be dispensed, the FDA recommends that health care professionals apply additional safety measures including adding tamper-indicator tape, providing a copy of the instructions for use, and labeling the pens for individual patient use. The Agency is also strongly encouraging manufacturers to develop smaller carton sizes.
Adverse events or medication errors related to the use of these products should be reported to the FDA’s MedWatch program.
