As a result of ongoing issues with the reuse of insulin pens on multiple patients, we believe that hospitals should closely reexamine the safe use of these pen devices, with strong consideration given to transitioning away from insulin pens for routine inpatient use.
In our January 24, 2013, issue we mentioned that more than 700 patients at a New York (NY) hospital may have been exposed inadvertently to human immunodeficiency virus (HIV), hepatitis B, or hepatitis C because of the reuse of insulin pens on multiple patients after changing the disposable needle (www.ismp.org/sc?id=144). Then, on the very same day that our newsletter was published, another NY hospital announced that it, too, had to notify patients about possible exposure to bloodborne pathogens due to improper sharing of insulin pens. In this latest case, 1,915 insulin-dependent patients were exposed between November 2009 and January 13, 2013 (www.ismp.org/sc?id=149).
These most recent cases are similar to other incidents of insulin pen reuse. At a Texas hospital in 2009, 2,114 insulin-dependent diabetic patients were exposed to disease transmission risk (www.ismp.org/sc?id=159). In 2011, more than 2,000 patients were exposed to this risk at a Wisconsin hospital and outpatient clinic. In addition, smaller numbers of patients have been involved in several other cases we have published in this newsletter over the years.
All it takes is one or two individuals who are not aware that it is unsafe to place a new disposable needle on a pen used for one patient and use it to deliver a dose of insulin to another patient. For example, a new graduate nurse or a temporary nurse may not have received proper training regarding the use of insulin pens, and thus a knowledge deficit may exist. Completely controlling for this is difficult, perhaps even impossible, given that unsafe pen use has persisted despite educational efforts and monitoring.
No cases have been reported in which bloodborne pathogens were transmitted from patient to patient when pens have been misused. Also, a study that was completed following the incident at the Texas hospital failed to demonstrate actual cross contamination (www.ismp.org/sc?id=150). However, other studies have shown that risk is certainly present when pens are reused for more than one patient since blood and tissue can travel back into the insulin pen cartridges.
Hemoglobin was detected in 6 out of 146 cartridges (4.1%) used by diabetic patients in one study (Sonoki K, et al. Regurgitation of blood into insulin cartridges in the pen-like injectors. Diabetes Care. 2001; 24(3):603-4; www.ismp.org/sc?id=151).
In another study of 120 patients, non-inert material, including squamous cells and other epithelial cells, was found in 58% of the cartridges (Le Floch JP, et al. Biological material in needles and cartridges after insulin injection with a pen in diabetic patients. Diabetes Care. 1998; 21(9):1502-4; www.ismp.org/sc?id=152). The authors noted that air bubbles could enter the cartridges after injection unless the needle is removed, thus suggesting that biological materials could do the same while the needle is in place.
The US Food and Drug Administration (FDA) (www.ismp.org/sc?id=153) and Centers for Disease Control and Prevention (CDC) (www.ismp.org/sc?id=154) direct users to remove the needle immediately after injection to decrease the risk of air entering the cartridge. They also warn against sharing the device between patients. Despite these warnings, reports of patients placed at risk of infection continue to surface.
Insulin pens offer convenience and may help to avoid certain types of medication errors; however, they were originally developed for use in ambulatory care, not hospitals. Placing a label on the pen for a single patient has its difficulties. Other problems such as using pen cartridges as multi-dose vials, the risk of needlestick injuries, and user technique errors have also been identified as serious safety concerns with pens used in hospitals (www.ismp.org/sc?id=155).
Based on the risks associated with reusing insulin pens on multiple patients, some hospitals have never transitioned to pens or reverted back to using vials (including 3 mL vials available from one insulin manufacturer). Most recently the Veterans Health Administration (VA) National Center for Patient Safety prohibited use of multi-dose pen devices on patient care units at VA facilities (www.ismp.org/sc?id=156). In doing so, the VA allowed for several exceptions, which we endorse (Table 1 below). Of course, we have no issues with the use of pens by patients at home as long as they are not shared with others. The VA further expects hospitals to review and update local facility policies for the use of all multi-dose pen devices or other types of pen devices that are used in patient care areas. Multi-dose pen devices must be stored in the pharmacy, and dispensed and labeled for an individual patient.
We hope that the ongoing issues with insulin pens will lead to recognition that a knowledge deficit regarding their safe use is more widespread than initially thought, and that the issue cannot be easily solved with education and monitoring alone or fairly dealt with by punishing those who have never learned the correct way to use these devices. We believe that the risk is best mitigated by removing insulin pens from use in inpatient settings.
Table 1. The VA’s Exceptions to the Use of Insulin Pens for Inpatients
Eligible patients participating in the VA medical center’s self-medication program
- Patients who are being educated prior to discharge to use a patient-specific, multi-dose pen device
- Inpatients requiring treatment with a medication delivered only in a multi-dose pen device, and no alternative formulation is available from the manufacturer for treating the patient while on a patient care unit
- Patients participating in a research protocol requiring the use of a multi-dose pen device while on a patient care unit
- Pen devices dispensed directly to the patient for use as an outpatient prescription