Medication errors have occurred due to confusion between NOVOLOG and FIASP, which are both marketed formulations of insulin aspart manufactured by Novo Nordisk. However, Fiasp and NovoLOG have different onsets of action after subcutaneous injection and are not substitutable. Fiasp contains niacinamide, which increases the speed of absorption and allows for administration at the start of a meal or within 20 minutes of starting a meal. NovoLOG should be administered within 5 to 10 minutes before a meal.
Both product container labels have the same generic name, insulin aspart. The Fiasp package insert lists niacinamide as an inactive ingredient, so the carton does not list this ingredient on the principal display panel. Rather, it appears only on the back of the package along with the list of other inactive ingredients. Also, because drug monographs may not list inactive ingredients, drug information systems that pull data from monographs may not list the niacinamide in Fiasp.
Prescribers and pharmacists may not be aware that Fiasp and NovoLOG are different. If insulin aspart is prescribed, it may result in dispensing either NovoLOG or Fiasp if the brand name is not included on the prescription. For example, a prescriber recently ordered Fiasp for a patient and submitted the prescription to the pharmacy electronically. Although he selected Fiasp, the electronic system communicated the selection as "insulin aspart injection 100 units/mL." The brand name was not included in the prescription, and NovoLOG was dispensed.
The company is aware of the potential for mix-ups and mentions this in company literature as something to watch for, saying that practitioners (particularly pharmacists) should confirm the brand name if it is not specified on the prescription or in the electronic prescribing system. If Fiasp is intended, prescribers should include the brand name on prescriptions, and electronic order systems should communicate the brand name if selected by the prescriber instead of only including the generic name. Also, patients should be made aware of the differences between the two insulins and the product intended for them, so they are prepared to check the drug they receive from the pharmacy.
Disposable Standard Pen Needles and Patient Education
Some patients who use insulin pens have not been educated about the proper use of disposable standard pen needles, as we have pointed out in a 2017 National Alert Network alert (http://www.ismp.org/node/44). It is such a problem that the U.S. Food and Drug Administration asked pen needle manufacturers to update the labeling and improve patient instructions for use (http://www.ismp.org/ext/155). The request was issued to inform patients that it is necessary to remove the inner needle cover on standard pen needles to administer the intended dose. Unlike safety needles used most often in inpatient settings, standard pen needles used in the home have outer and inner needle covers, both of which must be removed prior to injection.
We have learned of another patient who was not aware of the need to remove the inner needle cover for more than a year! The patient was admitted to a hospital with gait change, slurred speech, a blood glucose of 57 mg/dL, and a hemoglobin A1c of 13.9%. It was discovered that, until the day before admission, the patient had not been removing the inner needle cover when using LANTUS SOLOSTAR (insulin glargine) and NOVOLOG FLEXPEN (insulin aspart). He described administering an entire Lantus SoloStar pen per day and using a napkin to soak up the insulin that leaked onto his skin when injecting himself. The day before presenting to the hospital, the patient had attended a diabetes self-management educational course and learned that he had not been removing the inner cover of the pen needle. After this realization, he removed the inner cover and injected the prescribed amount of insulin, which his physician had continually increased over the course of the year (Lantus 150 units in the morning and 156 units at bedtime; NovoLOG 80 units before each meal) to control the patient's blood sugar. The patient developed hypoglycemia after injecting the prescribed amount, which was much higher than required had he been administering each dose correctly from the start of treatment. During admission, the patient required significantly less insulin (Lantus 15 units at bedtime and NovoLOG 4 to 6 units before each meal) than prescribed before his admission.
Although it may seem improbable that this misadministration happened for more than a year, it did! When dispensing an insulin pen and standard pen needles, educate the patient about proper use and employ the teach-back method to ensure patient understanding. Show patients which covers to remove from the pen needle prior to administration. If a patient's blood glucose level remains elevated after insulin administration, prescribers should suspect misuse of the device as a possible cause before increasing the dose. If suspecting improper use, ask the patient to demonstrate the administration process or to explain, step-by-step, how they are using the device.
Fatal Error due to Paxil-Trexall Sound-Alike Error
Another fatal methotrexate error has occurred, prompting ISMP to, once again, call upon healthcare providers to implement critical risk-reduction strategies to prevent these errors. In the most recent event, PAXIL (PARoxetine) was newly prescribed for an elderly woman with depression. A prescription for a 30-day supply of Paxil 10 mg daily was called into the pharmacy. Unfortunately, pharmacy staff likely misheard Paxil as TREXALL (methotrexate). Trexall 10 mg tablets were dispensed with directions to take 1 tablet daily. The dosing error was not detected prior to dispensing, and the woman was not counseled when she picked up the medication. The pharmacy label prominently displayed the brand name, Trexall, but the woman thought this was the newly prescribed antidepressant and began taking it daily. Seven days later, she became extremely ill. Her family took her to the hospital, where she was admitted to an intensive care unit. Sadly, she died within a week.
This is the first report we have received of a fatal daily methotrexate order linked to a Paxil-Trexall mix-up. However, this sound-alike name pair is particularly concerning. Unlike generic brands of methotrexate, which are available only as 2.5 mg tablets, Trexall is available in 5 mg, 7.5 mg, 10 mg, and 15 mg tablet strengths, some of which can overlap with doses of Paxil.
Daily doses of methotrexate are reserved for specific cancer diagnoses. Outpatient or discharge prescriptions should be electronically transmitted to pharmacies and should include the purpose of the drug. When taking verbal prescriptions, pharmacy staff should ask for the purpose of the drug. Also, pharmacies should not accept telephone orders for chemotherapeutic agents.
Patients should always be counseled when picking up prescriptions to verify the instructions and indication for taking methotrexate. A consumer learning guide for oral methotrexate from ISMP is available to provide to patients who take oral methotrexate to treat conditions other than cancer (http://www.ismp.org/ext/221).