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US FDA Advises Against Dispensing Single Insulin Pens

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US FDA Advises Against Dispensing Single Insulin Pens 2

The US Food and Drug Administration (FDA) is advising clinicians to dispense insulin pens in their original sealed cartons to a single diabetes patient. 

FDA issued a notice last week aimed at clarifying the intent of revisions made to the labels of several different types of insulin pens, including Humalog KwikPen (Eli Lilly), Novolog FlexPen (Novo Nordisk), and Lantus Solostar (Sanofi Aventis) in November 2019.

The new notice states that these products should only be dispensed in their original sealed cartons and not separately.

Most insulin pens are supplied as five pens in a sealed carton and are not labeled to be dispensed as individual units. Each carton contains just one copy of the prescribing information and instructions for use, so dispensing individual pens to different patients would lead to some not receiving this information.

FDA says it has received safety reports related to opening the cartons to dispense individual pens, including wrong-drug errors, missed doses, failure to dispense the instructions for use, and complaints of possible tampering. “The carton labeling and sealed packaging are important for both health care professionals and patients,” the FDA notice states.

In addition, individual pens with different dosages and formulations may look similar, which could lead to confusion for patients who use more than one type. Storing them in their original cartons can reduce that risk.

“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 says.

This may be particularly important in situations such as long-term care facilities, hospitals, and other institutional settings, as well as homes in which more than one person takes insulin.

May Be Instances to Dispense Single Pens, Adjust Accordingly

However, FDA does acknowledge that there may be instances where clinicians might choose to dispense individual pens outside of the carton, not in accordance with the labeling, based on professional judgment.

In those situations, FDA advises taking additional mitigating actions, such as adding tamper-indicator tape, providing a photocopy of the prescribing instructions to the patient, and/or labeling the individual pen with the patient’s name.

The notice also says that the 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.”

And the agency recommends contacting the manufacturers regarding patient 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.”

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