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Insulin Pens: Technology Is Not without imPENding Risks

With the use of insulin pens growing in the U.S., it’s important to be alert to the increasing potential for errors as well, especially in hospitals….

Although the U.S. still lags well behind Europe and Japan in the use of pen injectors for medication delivery, the availability of an increasing number of medications packaged in pen injectors here has spurred recent growth. Interest in self-administration of medications in the home, particularly among older patients with chronic diseases such as diabetes, has propelled the use of this unique delivery method. Intended primarily to facilitate easy and accurate self-administration of subcutaneous drugs, pen injectors can now be found in hospitals and other settings for use by practitioners when administering medications to patients.

As with any new technology, ISMP has received numerous reports of medication errors that have occurred in both patients’ homes and healthcare facilities when using pen injectors. Since the use of these devices will likely continue to expand in the future, we are working to establish safe practice guidelines that can be employed in both settings to reduce the risk of serious errors. To accomplish this, we need to learn as much as possible about the types of risks occurring with pen injectors. Below we offer a glimpse of what we have gathered so far from reports submitted to the USP-ISMP Medication Errors Reporting Program.

Using pens like vials
  • In response to the rising costs of medications, some healthcare providers have replaced insulin vials on nursing units with insulin pen injectors (or just the pen cartridges) from which they routinely withdraw a patient’s prescribed dose using an insulin syringe and needle. In some cases, the pens or cartridges are used as multiple-dose vials for a single patient, and each dose is removed with a sterile needle and syringe; in other cases, the pens or cartridges are used as floor stock “vials” from which to obtain insulin doses for multiple patients using a new sterile needle and insulin syringe for each puncture into the cartridge membrane. The manufacturers do not recommend the withdrawal of medication from the pen, except in an emergency with a malfunctioning pen. In these instances, the pen should then be discarded, even if insulin remains in the pen. Similar to withdrawing medication from a vial, these practices may also result in unlabeled syringes of insulin.
  • Large pockets of “air” have been observed in cartridges of insulin pen injectors after aspirating some of the drug with a needle. If the pen injector or cartridge is not discarded, and the air is not eliminated before delivering a subsequent dose, the patient could receive less than the desired dose of insulin as well as a subcutaneous injection of air.
Dispensing errors
  • Insulin products with look- and sound-alike names have contributed to numerous errors in which the wrong pen injectors have been dispensed, resulting in poor glycemic control. For instance, a NOVOLOG MIX 70/30 (70% insulin aspart protamine suspension, 30% insulin aspart [rDNA]) FLEXPEN was dispensed instead of a NOVOLOG (human insulin aspart [rDNA]) FlexPen; the patient experienced unexpected fluctuations in blood sugar levels until the error was noticed.
Inadequate patient education
  • Patient education before discharge might not correspond with how the patient will be administering the medication at home. The patient’s insurance may not cover the cost of pen injectors, and the use of coupons and samples to help patients obtain these devices is often short lived. Thus, patients who are educated about using the device, but then cannot afford to purchase the medication in this fashion, will not be prepared to draw doses from a vial. Conversely, patient education before discharge might not be with the actual pen injector that will be used at home.
  • Many patients do not tip and roll their insulin suspension pen injectors adequately to assure proper mixing. This may result in large clumps of aggregated insulin flowing from the pen injector during the first injection, leading to hypoglycemic symptoms with new cartridges followed by subtherapeutic doses.
Additional concerns
  • If pens are dispensed for each inpatient, space may be limited, and labels with the patient’s name, location, and identification number could cover important information.
  • If patients find, after initial injection, that a multiple-dose pen injector contains less drug than needed for a single dose, they will be required to rearm the device, or use a new device, to inject the remaining amount. Memory of how much was already given may be inaccurate, leading to dosing errors.
  • The wide variety of pen injector designs makes it difficult for healthcare practitioners, particularly nurses, to learn how to use them properly and maintain competence.

We encourage healthcare practitioners to contribute to our pool of knowledge about pen injectors. If you experience problems with these devices or hear from patients about problems, please send a report to ISMP via ismpinfo@ismp.org. We are also interested in hearing about any safety guidelines you have employed when using pen injectors. We look forward to learning more about pen injectors and building safe practices around their use that we can share in a future newsletter.

CMS acts on reuse of insulin pens. CMS recently announced that hospitals will be issued a citation when incidents of insulin pen sharing are identified by surveyors. Regurgitation of blood into the insulin cartridge after injection will create a risk of blood borne pathogen transmission if the pen is used for more than one patient/resident, even when the needle is changed. ISMP has published several incidents of insulin pen sharing in hospitalized patients since we first wrote about this unsafe practice in our March 27, 2008 issue. (http://www.ismp.org/Newsletters/acutecare/articles/20080327_1.asp).

An FDA alert was issued on March 19th 2009 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149546.htm) and a CDC clinical reminder was published on January 5th this year (http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html). On May 18th the Centers for Medicare & Medicaid Services (CMS) became the latest federal agency to address the issue. The CMS announcement noted that some healthcare personnel may be unaware of the risks this unsafe practice poses to patients and that sharing of insulin pens is essentially the same as sharing needles or syringes. As such, CMS surveyors (e.g., state health department surveyors) and deemed accreditation agencies will cite providers in the same manner they will if they become aware of re-use of needles or syringes. The CMS announcement can be found at:

(https://www.cms.gov/Medicare/Provider-Enrollment-and-certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-12-30.pdf.

Cross contamination with insulin pens

From the March 27, 2008 issue

Facilities using insulin pens should bear in mind the possibility that an individual patient’s pen might be used for another patient. In one report, a nurse told us that, rather than wait for an individual patient’s pen to come from pharmacy, nurses at her hospital often borrowed a pen from another patient, put on a new disposable needle, and injected a dose of medication into the second patient using the first patient’s pen. Apparently, the nurses failed to recognize that it’s possible for biological contamination of the insulin solution to happen even if aspiration does not occur prior to injection. It is unclear whether these nurses felt pressured to engage in such an at-risk behavior because of system problems, such as lengthy turn-around time for delivery of new pen devices. Several studies suggest just how risky sharing pens among patients might be. 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 Care2001; 24:603-04, available at: http://care.diabetesjournals.org/cgi/content/ full/24/3/603).

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 Care1998; 21:1502-04, available at: http://care.diabetesjournals.org/ cgi/reprint/21/9/1502.pdf). The authors noted that air bubbles could enter the cartridges after injection unless the needle is removed, suggesting that biological materials could do the same while the needle is in place. Pen manufacturers caution users to remove the needle immediately after injection so as not to leave a channel for entry of air into the cartridge, and they also warn against sharing the device between patients. Obviously, this is something that requires ongoing education and oversight wherever insulin pens are used. Sharing of pens must be prohibited. While we are not aware of any cases of actual cross contamination, the risk remains. Many hospitals have employed pen technology successfully and safely, but it’s important to guard against possible failure points with these devices. For more information on potential problems with pen devices, see our November 30, 2006 newsletter article, PEN injectors: Technology is not without imPENding risks (www.ismp.org/ Newsletters/acutecare/articles/20061130.asp).

Courtesy of www.ismp.org

 

Report Medication Errors to ISMP:

Diabetes in Control is partnered with the Institute for Safe Medication Practices (ISMP) to help ensure errors and near-miss events get reported and shared with millions of health care practitioners. The ISMP is a Patient Safety Organization obligated by law to maintain the anonymity of anyone involved, as well as omitting or changing contextual details for that purpose. Help save lives and protect patients and colleagues by confidentially reporting errors to the ISMP.

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