Just a little over a year ago (see our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?”) we highlighted reports of the occurrence in Western New York of insulin pens being used on multiple patients, potentially causing cross-contamination of patients with blood-borne pathogens. The focus of our column was as much on how organizations are made aware of unsafe practices discovered elsewhere as it was on the insulin pens themselves. The above episodes occurred despite several warnings from ISMP, the FDA, and CDC as referenced in our column. We provided recommendations and referred readers to several articles by ISMP. Both ISMP and the VA Health System have discouraged use of insulin pens (or multi-dose pen injectors for other drugs) in hospitals.
Last month another hospital alerted more than 4,200 patients who may have received insulin from an insulin pen reservoir of possible exposure to hepatitis viruses and human immunodeficiency virus (HIV) due to possible blood contamination (Reuters 2014).
Shortly after the Western New York insulin pen incidents were reported ISMP issued a call for removal of insulin pens from use in inpatient settings (ISMP 2013). They cited similar incidents occurring at multiple hospitals since 2009. Many of those instances have occurred despite warnings from ISMP, the FDA, and CDC. And they cited evidence that blood and other materials have been found in such pens after use. They note that such pens were originally introduced for use in ambulatory care. They note that placing a label on the pen for a single patient has its difficulties and that other problems are seen, such as using the pens as multi-dose vials, risk of needlesticks, etc. They note that the VA National Center for Patient Safety has now prohibited use of multi-dose pen devices on patient care units in VA facilities with certain exceptions (VA 2013).
ISMP went on to note the ease with which such errors are likely to occur when providers not fully familiar with the safety issues around such pens are now confronted with such pens. They note that we cannot reasonably expect education and inservicing to reach all necessary parties and that punishment of those who never learned the correct use of such devices is not appropriate. Hence, they suggest the best solution is removal of such devices from the inpatient setting (with the exception of those circumstances identified by the VA NCPS and outlined in the ISMP article).
Please refer to our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?” and our April 2013 What’s New in the Patient Safety World column “More Tips on Insulin Pen Safety” for our recommendations for hospitals and for links to the important ISMP, VA, FDA and CDC communications on insulin pen safety.
If testing is done on the 4000+ patients in the current episode we can pretty much guarantee that several will test positive for some of the pathogens even if none were actually contaminated at that hospital through use of the insulin pens on multiple patients. Testing on about 500 of the 716 patients who could have been exposed to hepatitis or HIV because of the misuse of insulin pens on diabetic patients in the Western New York episode showed that at least fourteen tested positive for hepatitis B and at least six others tested positive for hepatitis C (Zremski 2013). And if the human toll and quality and patient safety issues are not enough to get you to ensure such episodes don’t occur at your facility, your CFO might let you know that the cost of one full course of hepatitis C with the newer drugs just on the market is about $84,000 (Pollack 2014).
Don’t you think you better act now?
Update: See our March 10, 2015 Patient Safety Tip of the Week “FDA Warning Label on Insulin Pens: Is It Enough?”
Reuters staff. New York hospital warns patients of possible HIV, hepatitis exposure. Reuters March 13, 2014
ISMP (Institute for Safe Medication Practices). Ongoing concern about insulin pen reuse shows hospitals need to consider transitioning away from them. ISMP Medication Safety Alert. Acute Care Edition. February 7, 2013
VA Patient Safety Alert. Multi-dose pen injectors. January 17, 2013
Zremski J. 20 Buffalo VA patients test positive for hepatitis. The Buffalo News. May 9, 2013
Pollack A. Lawmakers Attack Cost of New Hepatitis Drug. New York Times. March 21, 2014
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