Don't Share Insulin Pens, FDA Says

An FDA alert issued on March 19, 2009 reminds health care professionals that patients should not share insulin pens and insulin cartridges. Doing so creates a risk that blood-borne pathogens, such as human immunodeficiency virus (HIV) and hepatitis viruses may be transmitted.

In two hospitals, the cartridge component of insulin pens was used to administer the drug to multiple patients, although disposable needles were changed. According to the FDA, more than 2,000 people were involved. The incidents occurred between 2007 and 2009 in the United States.

Although the FDA did not report the name of the hospital, a separate report named the Army's William Beaumont Army Medical Center, in El Paso, TX, as one of the two hospitals. Some 2,114 patients were affected there. A second hospital may have been Fort Polk's Bayne-Jones Army Community Hospital in Louisiana. Less than 10 patients may have been affected there.

According to Amy Eagan, M.D., Deputy Director of Safety at the FDA's Division of Metabolism and Endocrinology Products at the Center for Drug Evaluation and Research (CDER), insulin pens are designed to be safe for one patient to use. A patient may use the pen multiple times with a new, fresh needle for each injection, but they are not designed to be used safely by more than one patient even if needles are changed.

The two hospitals involved are contacting patients and offering the affected individuals free testing for hepatitis and hepatitis C virus (HCV). Some patients have tested positive for HCV, but the FDA has not said whether pen sharing spread the virus. The FDA is working with the CDC to address infection control issues related to insulin pens. The El Paso Times reports that 16 patients at the El Paso Army hospital were found to have HCV.

Current instructions call for all insulin pens state that these devices should not be shared by patients. Insulin pens are pen-shaped devices that inject insulin. They have a pen reservoir, or insulin cardtride that usually contains enough insulin for several doses. Patients change the needle before each injection.

The FDA recommends that health care professionals identify each insulin pen with the patient's name and other identifiers to aid in verifying that each pen is used on the correct patient. The identifying information should not obstruct the dosing window or other product information. Not marking pens increases the likelihood of sharing. Hospitals should, says the FDA, review policies and educate staff regarding safe use.

Although the FDA issued this alert for insulin pens, the risk may be the same for other reusable injection devices.

Sources
FDA
Insulin pen precautions