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Medication Errors

Cohen, Michael R. ScD, MS, RPh

doi: 10.1097/01.NURSE.0000559917.69319.c4
Department: MEDICATION ERRORS
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Avoid delegating vaccine preparation...vancomycin powder: do not confuse the diluent with the drug...new FDA naming convention for biological medications

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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VACCINE PREPARATION

This task should not be delegated

A medical assistant was helping a busy nurse in a pediatric office by ushering patients into treatment rooms and checking their vital signs. A pediatrician had prescribed both a hepatitis B and an influenza vaccine for one of the patients. The medical assistant brought both of the required vaccine information sheets into the treatment room to give to the child's mother and told the nurse that she had also prepared the prescribed vaccines. Grateful for the help, the nurse administered the vaccines to the child, assuming that the assistant had completed the necessary verifications before drawing up the vaccines. Unfortunately, she had not. When documenting medication administration, the nurse realized that, while she had correctly given the child a hepatitis B vaccine, she had incorrectly administered a hepatitis A vaccine instead of the prescribed influenza vaccine.

This error illustrates why nurses should never administer anything they have not prepared themselves, with a few exceptions; for example, during an emergency or when administering medication in a prefilled syringe, a premixed or pharmacy-prepared I.V. solution, or another unit-dose medication prepared in the pharmacy with the benefit of quality control mechanisms.

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VANCOMYCIN POWDER

Don't confuse the diluent with the drug

Firvanq (oral vancomycin) is available from CutisPharma in an oral solution kit containing bottles of vancomycin powder for oral solution and a grape-flavored diluent. Before use, the vancomycin powder must be reconstituted with the diluent. As shown in the photo, the containers are hard to tell apart because the Firvanq diluent label includes the brand name and concentration, and the powder label does not highlight “Powder.”

Figure

Figure

In a recent incident, a patient received 3 doses of the Firvanq diluent alone. It was thought that the technician preparing the doses may have seen only the drug name and concentration on the diluent label.

The Institute for Safe Medication Practices (ISMP) has contacted CutisPharma and hopes the company will modify the diluent label to emphasize “Diluent” in large bold font and de-emphasize the brand name and concentration. If your facility stocks and/or dispenses this kit, keep the bottles together in their carton until the product is reconstituted.

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NEW NAMING CONVENTION

What's with the random letters?

Nurses have noticed that newly approved biological medications have puzzling four-letter suffixes; for example, ibalizumab-uiyk, and trastuzumab and hyaluronidase-oysk. This new naming convention was mandated in 2017 by the FDA in the guidance, Nonproprietary Naming of Biological Products: Update Guidance for Industry. In it, the FDA clarified the need for identifying specific biological products with these suffixes to facilitate pharmacovigilance and safe use. The nonproprietary name for newly approved biological products is now a combination of the core name and a distinguishing suffix attached with a hyphen. Composed of four lowercase letters, this suffix has no specific meaning beyond identifying the drug as a biologic. The suffix applies to the entire drug name. In trastuzumab and hyaluronidase-oysk, for example, the “-oysk” suffix applies to the full name, not just the hyaluronidase component.

The placement of the identifier as a suffix rather than a prefix should result in biological products with the same core name being grouped together in electronic databases to help healthcare providers locate and identify these products. The suffix will also help differentiate various versions of the same biological medication.

When a biological nonproprietary drug name is used, ISMP highly recommends expressing the full name, including the suffix. ISMP also recommends using the brand and nonproprietary names together to provide redundancy and avoid name confusion; for example, Herceptin Hylecta (trastuzumab and hyaluronidase-oysk).

The FDA does not plan to require adding a four-letter suffix to biologic drugs that were approved before this new naming convention took effect.

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