Insulin pen labels to warn against sharing devices

Hoping to reduce the spread of infection, FDA has ordered manufacturers of multi-dose insulin pens to display the warning “For single patient use only” on all such products.

According to FDA, more than 2,000 people with diabetes may have been exposed to diseases through shared use of an insulin pen in separate facilities in 2009 and 2011, and more than 700 patients of the Veterans Health Administration may have been exposed in 2013.

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“Insulin pens and pens for other injectable diabetes medicines should never be shared among patients, even if the needle is changed,” FDA’s announcement said. “Sharing pens can result in the spread of serious infections from one patient to another….Sharing pens can lead to transmission of infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.”

FDA officials said that no cases of infection resulting from shared use of insulin pens have been confirmed, but that cases may go unreported and it is difficult to identify sources of infection.

“In March 2008, the Institute of Safe Medication Practices first alerted healthcare facilities that an individual patient’s insulin pen may have been used on another patient,” the FDA announcement said. “Since that time, FDA has learned that thousands of patients have possibly been exposed to bloodborne pathogens through the sharing of multi-dose insulin pens intended for use by single patients.”

The warning will appear on the labels attached to the insulin pens, as well as on pen cartons, patient medication guides, patient package inserts, and use instructions.

FDA officials attribute the sharing of insulin pens to lack of awareness of the risks, poor training, missed medications, time constraints, and lack of appropriate warning labels.

Click here to see a complete list of diabetes medications supplied in multi-dose pen devices.