[10/13/2020] The U.S. Food and Drug Administration is clarifying the intent of the November 2019 revisions to labeling for insulin pens, which state that health care professionals should dispense the pens to a single patient in the original sealed carton.
There is an increased risk of dispensing errors and patients using the wrong product if individual insulin pens are stored or dispensed outside of their carton. 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.
In November 2019, FDA approved revisions to the labeling for insulin pens to emphasize the agency’s recommendation for dispensing insulin pens to a single patient in their original sealed carton.
Insulin pens are approved to be dispensed in their original sealed cartons. Although FDA approved the first single-pen carton size for an insulin product on June 11, 2020, insulin pens are generally marketed in cartons containing two to five pens. Insulin pens are not labeled for dispensing as individual units. Because sealed cartons of insulin pens are intended to be dispensed to a single patient, each carton contains a single copy of the drug’s prescribing information and instructions for use. Although each carton is sealed, with the intent to alert health care professionals and patients when it has been opened, individual insulin pens within the cartons do not have their own sealed packaging. The carton labeling and sealed packaging are important for both health care professionals and patients. Health care professionals prescribe, dispense, and/or administer insulin pens, and may store different types of pens together. Patients may fill prescriptions for more than one type of insulin pen (e.g., both short and long-acting insulin) and may store different types of pens together. Individual insulin pens with different dosages and/or formulations often have similar appearances that can be difficult to distinguish. The cartons help health care professionals and patients differentiate between the insulin pens using various colors, font size, style, etc. displayed on the cartons.
FDA understands that there are situations where health care professionals may choose to dispense individual pens (outside of the carton), not in accordance with FDA-approved labeling, based on their professional judgment. In these situations, health care professionals should consider the known risks of dispensing individual pens and incorporate additional safety measures (e.g., adding tamper-indicator tape; providing a copy of the instructions for use to the patient; labeling individual pens for individual patient use) to mitigate those risks. FDA will continue to monitor the safety risks associated with dispensing individual insulin pens outside of the original sealed carton and will consider further steps as warranted. FDA has also strongly encouraged the manufacturers of insulin pens to consider developing smaller carton sizes to better accommodate variable insulin doses and needs. FDA suggests that organizations facing challenges with large carton sizes (multiple-pen cartons) contact the manufacturers to express the need for smaller (and single-pen) carton sizes.
FDA encourages health care professionals and patients to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program: