Authors

  1. Cohen, Michael R. ScD, MS, RPh

Article Content

Accuracy of ENFit low-dose tip syringes

A recent US Food and Drug Administration (FDA) communication to patients and healthcare providers (http://www.ismp.org/ext/798) mentioned the potential for overdoses, under certain conditions, when using ENFit low-dose tip (LDT) syringes (between 0.5 mL and 6 mL). This can happen if the user does not clear the moat area around the syringe tip before administering a medication. The moat area is unique to the design of the ENFit LDT syringes (See Moat area of an ENFit LDT syringe). Liquid medications can enter the moat area when the syringe is dipped in liquid medication without using a syringe filling adapter such as an ENFit cap or medication straw. If fluid or air bubbles enter the moat area, the tip of the syringe should be tapped or flicked to eliminate the fluid or air bubbles before administering the medication. ISMP has recommended this practice when a straw or ENFit-compatible bottle cap is not used, which could happen if doses are prepared extemporaneously from a unit dose cup or bottle. The overdose risk is mainly with oral liquid medications that enter the moat area, especially with tiny doses used for pediatric patients.

 

While the FDA's analysis has identified a potential for overdose using ENFit LDT syringes, no patient injuries have been reported. In contrast, serious patient injuries and deaths have been reported due to misconnections (http://www.ismp.org/ext/799). Therefore, the FDA continues to recommend the use of enteral devices and syringes that reduce the risk of misconnections, including ENFit LDT syringes.

  
Figure. Moat area of... - Click to enlarge in new windowFigure.

Trulicity pen should never be primed

A health system received several reports about wasted TRULICITY (dulaglutide) pens because nurses tried to prime them prior to administration. Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, lowering A1C levels. It is available as a single-dose solution pen in 4 strengths that is administered subcutaneously once weekly. Nurses may not be familiar with Trulicity pens since weekly doses are designed for self-administration at home. While nurses are familiar with various types of pens that require priming, the Trulicity "pen" is more like an autoinjector with its own needle that does not require priming. Conversely, some of the other GLP-1 agonist medications, such as VICTOZA (liraglutide), OZEMPIC (semaglutide), and BYETTA (exenatide), require the attachment of a disposable needle and priming.

 

With the Trulicity pen, nurses should remove the base cap and dispose of it, place the clear base flat and firmly against the skin at the injection site (abdomen, thigh, or upper arm), turn the green bar to unlock the pen, then press and hold the green injection button. (See Trulicity pen.) After a click, continue to hold the clear base firmly against the skin for about 5-10 seconds until a second click, which happens as the needle starts retracting. Any attempt to "prime" a Trulicity pen by going through these steps and injecting contents into the air would empty its contents and waste the pen. Trulicity is packaged for patient use in cartons of 4 pens for a 1-month supply. Although the carton includes a fold-out pamphlet with easy-to-understand instructions and sketches, there is only one pamphlet per carton, so it cannot be given to nurses for reference with each dispensed dose. Instead, the health system that reported this problem has designed information leaflets to include when dispensing Trulicity. Instructions in the package insert or the accompanying pamphlet may also be copied (color copying is preferred since the instructions use color to make them easy to understand). The health system is also adding comments to the medication administration record (MAR) that states "Do Not Prime the Trulicity Pen." This note will appear when the nurse opens the MAR before administration.

  
Figure. Trulicity pe... - Click to enlarge in new windowFigure. Trulicity pen