The US Food and Drug Administration is clarifying the intent of the November 2019 revisions to labelling for insulin pens, which state that health care professionals should dispense the pens to a single patient in the original sealed carton.
While the 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 labelling, based on their professional judgment, it advises that 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; labelling 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.
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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 organisations 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 Programme.
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