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  1. Shastay, Ann MSN, RN, AOCN

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Farxiga and Fetzima mix-ups. The U.S. Food and Drug Administration (FDA) is aware of several reported mix-ups due to name confusion between two medications-FARXIGA (dapagliflozin) and FETZIMA (levomilnacipran). Farxiga was approved in January 2014 to lower blood glucose levels in adults with type 2 diabetes when used along with diet and exercise. It is available in 5 and 10 mg tablets. Fetzima was approved in July 2013. It is a selective norepinephrine and serotonin reuptake inhibitor for major depressive disorder. The drug is available in 20, 40, 80, and 120 mg extended-release capsules.


Upon review of the five medication error reports received by FDA, it is believed that the errors can largely be attributed to the drugs being approved and marketed within 6 months of one another. Both drug names begin with the letter F and end with the letter A, and are of the same length and number of syllables. Prescribers and pharmacists may choose the wrong item from computer screens. Furthermore, the container labels might appear similar since both display the proprietary name of the product in red font (Figure 1).

Figure 1 - Click to enlarge in new windowFigure 1. Drugs have been confused due to name similarity.

We added this name pair to the ISMP List of Confused Drug Names that is available on our Web site at http://www.ismp.org. Prescribers should include the indication with orders or prescriptions. Community pharmacists should counsel all patients before dispensing these drugs to confirm the indication. Home care nurses should review the medications their patients are taking. Hopefully, as practitioners become more familiar with the two products, name confusion errors will diminish.


Confusing dose pack labeling. We received complaints about the label on methylPREDNISolone dose packs by Greenstone. The drug is supplied in a blister pack containing twenty-one 4 mg tablets. The label on the blister pack is printed on a shiny foil surface that's hard to read. It also has arrows pointing in serpentine fashion intended to guide the patient to the correct dose, at the right time, and on the right day (Figure 2). However, the layout is potentially confusing and differs from other dose packs of methylPREDNISolone that have the tablets for a given day arranged in a line across the blister pack. When contacted, Greenstone told us that there was no specific rationale for the layout of the labeling. We also forwarded the report to the U.S. FDA. Community pharmacists who dispense this product should make sure to show the blister pack and labeling to the patient and discuss how to take the tablets. Home care nurses should also review the information with the patient to ensure the medication is being taken correctly.

Figure 2 - Click to enlarge in new windowFigure 2. Potentially confusing blister pack labeling on Greenstone's methylPREDNISolone dose pack.

Insulin pen error. Improper injection technique with an insulin pen led to elevated blood sugars in two patients (Shah et al., 2014). In both cases, patients injecting insulin dialed to the prescribed amount of insulin units using the LANTUS SOLOSTAR (insulin glargine) insulin pen. The patients then properly completed the next step and inserted the needle into the skin. However, instead of pushing the purple button at the end of the pen to inject the insulin, they twisted the dial back down to zero (Figure 3). By dialing back down to the zero, the patients thought the twisting mechanism was injecting the insulin. Both patients received no insulin. The Lantus SoloStar insulin pen (and others) is designed to be twisted "up or down" until the user has turned to the correct amount of insulin to inject. But the button must be pushed to inject the insulin. Healthcare providers who teach patients about pen use must adequately explain how the insulin dose is delivered and have the patient demonstrate how they'll be using the pen to confirm proper administration technique.

Figure 3 - Click to enlarge in new windowFigure 3. The correct way to administer a dose using the Lantus Solostar pen is to dial the correct dose (top) and then push the button once the needle is below the skin (bottom).

Don't open Pradaxa capsules. Nurses and others may not be aware that the dabigatran package insert states, "The oral bioavailability of dabigatran etexilate (PRADAXA) increases by 75% when the pellets are taken without the capsule shell compared to the intact capsule formulation. Dabigatran capsules should therefore not be broken, chewed, or opened before administration." Pharmacokinetic studies have shown that the absorption increases significantly if administered this way, increasing patients' risk for severe bleeding.


A hospital notified us recently that a patient brought to its emergency department from an outside care facility was admitted for hematemesis. It is believed that some nurses at the care facility may have been opening the dabigatran capsule and sprinkling the contents on the patient's food. The hospital wants to alert others to be aware of this situation so staff training and other measures can be provided to avoid adverse events with dabigatran. The medication administration record (MAR) listing for dabigatran at this hospital states "Do NOT break, chew, or open capsules." Other hospitals and healthcare facilities should consider adding this statement to their MARs as well. Pradaxa is also included on the DO NOT CRUSH list on our Web site (http://www.ismp.org/Tools/DoNotCrush.pdf).


Oral syringe scale not user friendly. When a hospital pharmacy ordered Baxa (now Baxter) oral syringes through its regular wholesaler, syringes arrived with the numbers on the syringe scale printed upside down (Figure 4). This presentation, of course, is unlike all other syringes, oral or parenteral. Although the associated volumes are accurate, with the scale printed this way, users are forced to engage their brain 180 degrees opposite to what they are accustomed. Also, the abbreviation mL precedes the number, "mL 0.5," although practitioners are used to reading "0.5 mL." Another concern is that the syringes do not carry the statement, "For Oral Use Only," as do other oral U.S. syringes.

Figure 4 - Click to enlarge in new windowFigure 4. Oral syringe on left has a measurement scale printed upside down.

We contacted Baxter, and the company is investigating how the syringes entered the supply chain, considering these syringes are not listed in its catalog. The syringes in question didn't have either Baxa's or Baxter's name on them, and they were marked as made in Denmark. Hospitals that receive these should return them to their wholesaler/source and replace them with oral syringes with a proper measurement scale and statement, "For Oral Use Only."




Shah A., Sullivan M. M., Rushakoff R. J. (2014). A new "twist" on insulin pen administration errors. Endocrine Practice, 20(6), 617. [Context Link]