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Warning: Don’t confuse idarucizumab with IDArubicin
November 5, 2015

Last month the US Food and Drug Administration (FDA) granted accelerated approval to PRAXBIND (idarucizumab) for use in patients who take PRADAXA (dabigatran) and suffer a life-threatening bleeding event. Hospital pharmacies may stock Praxbind if dabigatran patients are treated in the hospital or seen in the emergency department. Unfortunately, the drug’s nonproprietary name, idarucizumab, shares its first five letters with the antineoplastic drug IDArubicin. This might lead to the selection of the wrong drug from a computer system dropdown menu or selection of the wrong container from its storage location, since both drugs are refrigerated solutions.

This past week we received a report of a close call at a hospital where idarucizumab was pulled from stock instead of IDArubicin. The hospital had just purchased the reversal agent when the close call incident occurred. The idarucizumab carton was in the refrigerator next to a bag containing IDArubicin, which was being readied for a patient. A vial of idarucizumab was spiked with a closed system transfer device, but fortunately, a pharmacist noticed the error before any drug was actually administered.

As noted, many hospitals may already stock or are planning to stock idarucizumab in case it is needed, although cancer hospitals may not see a need to stock the drug. (There is already a risk of bleeding in many oncology patients undergoing treatment.) Once an order is entered electronically, barcode scanning of the drug vials will prevent a mix-up if it’s done prior to sterile compounding. Computer alerts and the use of tall man letters for computer selection screens (idaruCIZUMAB and IDArubicin) should also be considered for these drugs. Of course, neither drug should be dispensed or administered without confirming patient need.

Vials of IDArubicin should not be stored near idaruCIZUMAB vials. In fact, the proposed US Pharmacopeial Convention (USP) chapter (<800>) states that refrigerated antineoplastic hazardous drugs must be stored in a dedicated refrigerator, so separate refrigerators will be needed for each drug. Also, consider adding auxiliary labels to idaruCIZUMAB containers to alert staff who may access the drug. Since the error could also happen the other way around, it’s not a bad idea to inform staff and use an auxiliary label for IDArubicin, too. Praxbind is a colorless to slightly yellow, and clear to slightly opalescent, solution. Once the drugs are removed from their vials, staff will notice an obvious color difference between idaruCIZUMAB solutions and orange-red, clear IDArubicin solutions. But as in the case just reported, this might not always act as a deterrent, especially when the drugs aren’t used very often.

ISMP has notified Boehringer-Ingelheim, the manufacturer of Praxbind, about the mix-up and has also contacted appropriate world authorities that impact the development and ultimate safety of nonproprietary names. Please report any other events like this to ISMP by going to: www.ismp.org/MERP, and we’ll automatically notify FDA.

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