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Medication Errors

Cohen, Michael R., ScD, MS, RPh

doi: 10.1097/01.NURSE.0000553288.64460.3e
Department: MEDICATION ERRORS
Free

Peel-off label conceals key information on a vial of rocuronium...don't confuse migalastat and miglustat

PRESIDENT OF THE INSTITUTE FOR SAFE MEDICATION PRACTICES

The reports described in Medication Errors were received through the ISMP Medication Errors Reporting Program. Report errors, close calls, or hazardous conditions to the Institute for Safe Medication Practices (ISMP) at www.ismp.org, 1-800-FAIL Safe, or ismpinfo@ismp.org. Michael R. Cohen is a member of the Nursing2019 editorial board.

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ROCURONIUM VIAL

Peel-off label conceals key information

During endotracheal intubation of a patient in the ED, a nurse obtained a vial of rocuronium and noticed that the label listed the concentration as 10 mg/mL. This led to confusion regarding the total amount of drug in the vial—until the nurse turned the vial and read that the total volume was 5 mL. Upon further inspection, she realized that the manufacturer, X-GEN Pharmaceuticals, had placed a peel-off overlay label on the vial that was intended to be used as a syringe label. Once the label was peeled off, the concentration on the underlying vial label is expressed as 50 mg/5 mL (see photo). Thankfully, no error was made during preparation of the dose.

This close call brings to light concerns about the labeling. The Institute for Safe Medication Practices (ISMP) does not want to discourage the use of peel-off labels but cannot support such labels when they are affixed in a way that creates safety concerns. Peel-off labels should be included on a separate card or attached in a way that does not cover the required product label, including the total amount of the drug per total volume. ISMP has notified both X-GEN and the FDA regarding the labeling concern. Other rocuronium manufacturers may have similar labeling, so clinicians should inspect their supply to see if that is the case.

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MIGALASTAT OR MIGLUSTAT

Look alike, sound alike

Migalastat (Galafold) was approved to treat certain adult patients with Fabry disease, an inherited disorder caused by a dysfunctional enzyme that leads to a buildup of globotriaosylceramide, a fat. Signs and symptoms include pain episodes, particularly in the hands and feet; clusters of small, dark red spots on the skin (angiokeratomas); a decreased ability to sweat (hypohidrosis); corneal opacity, tinnitus, and many other disorders. Some, such as stroke and kidney failure, are life-threatening. Migalastat acts by stabilizing the dysfunctional enzyme.1,2

Unfortunately, migalastat looks and sounds very much like miglustat (Zavesca), which is indicated to treat adults with mild or moderate type 1 Gaucher disease. Patients with Gaucher disease also have a defect in an enzyme that normally breaks down certain fatty substances that can build up in organs.3,4

Besides similarities in name and indications, migalastat and miglustat are similar in dosage form: Both are available only in oral capsules. Migalastat is provided in a 123 mg capsule and miglustat in a 100 mg capsule. Because only one strength is available for either medication, prescribers may omit specifying the strength in some circumstances. With similarities in names, single strengths, and oral capsule formulations, omitting the strength increases the risk of a wrong-drug error.

To prevent errors, neither medication should be prescribed, dispensed, or refilled without verifying the patient's diagnosis. If an organization has both medications in stock, adding an alert during order processing or requiring a hard stop to verify the patient's diagnosis would help prevent mix-ups. Clinicians should also refer to these medications using brand names when possible, and bar code scanning should be employed during product selection and administration.

ISMP recommends storing the medications apart from one another and is considering adding these drugs to its list of drugs that should be identified with tall man letters (for example, migALAstat and migLUstat) to help differentiate these drugs on computer screens and in other presentations.

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REFERENCES

1. Genetics Home Reference. Fabry disease. US National Library of Medicine. 2019. https://ghr.nlm.nih.gov/condition/fabry-disease.
2. Galafold (migalastat) capsules, for oral use. Prescribing Information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf.
3. Genetics Home Reference. Gaucher disease. US National Library of Medicine. 2019. https://ghr.nlm.nih.gov/condition/gaucher-disease.
4. Zavesca (miglustat) capsules, for oral use. Prescribing Information. http://www.zavesca.com/pdf/ZAVESCA-Full-Prescribing-Information.pdf.
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