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FDA requires warning to prohibit sharing of multi-dose diabetes pens
The FDA is requiring additional label warnings on multi-dose diabetes pen devices prohibiting the sharing of the injectable medicines to reduce the risk of infections being spread, according to a safety announcement from the agency.
A warning label stating “For single patient use only” will appear on the labels affixed to pens and on pen cartons based on the new requirement, according to the announcement.
Additional warnings against sharing pens will appear in the prescribing information along with Medication Guides, Patient Package Inserts and Instructions for Use.
Insulin pens and pens for other injectable diabetes medicines, designed to be safe for one patient to use multiple times with a fresh needle for each injection, can contain blood following use and should never be shared.
Sharing pens can lead to transmission of blood borne pathogens including the human immunodeficiency virus (HIV) and hepatitis viruses. In an attached data summary, the FDA lists examples of potential infection exposures related to the sharing of multi-dose pen devices dating back to 2008.
The agency notes that no confirmed cases of actual infection transmission have been reported but underscores sources of infection are often difficult to identify and could go unreported.
The FDA has issued safety alerts, including a 2009 FDA Health Care Professional Sheet, and launched campaigns cautioning against the sharing of insulin pens.
In the announcement, the agency suggests health care professionals and hospitals can help minimize errors by labeling pens with patient names or identifying information, verifying pens with patients, reviewing policies and educating staff members, and counseling patients.