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Unrecognized need to refrigerate etoposide capsules leads to wasted drug
Roger Selvage 399

Unrecognized need to refrigerate etoposide capsules leads to wasted drug

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Error Alert

Pharmacy technician inspecting a refrigerator

Institute for Safe Medication Practices, Horsham, PA

Etoposide capsules are a cold-chain medication used for small cell lung cancer that must be stored under refrigeration between 2°C and 8°C (36°F–46°F). A specialty pharmacy reported an error that resulted in a carton of etoposide 50 mg capsules being left out at room temperature overnight for about 12 hours.

This error happened during the packing phase of the pharmacy workflow, which comes after production and pharmacist verification. This was the first time the pharmacy had dispensed etoposide capsules, and the packing technician did not realize they needed to be stored at refrigerated temperatures. The technician packed it for shipment as a room-temperature medication without a cooler box or an appropriate number of cold packs.

When the pharmacist discovered the etoposide carton at room temperature the next morning, they researched temperature stability and excursion data to see if the medication was still stable. They called the manufacturer, but additional temperature stability data were not available at that time. The pharmacist then sequestered the medication for disposal since they could not confirm its stability.

Unfortunately, the product was on backorder, and the other pharmacies within the same company did not have this medication in stock. The pharmacy transferred the prescription to an outside pharmacy to prevent the patient from being late with their dose.

Standard process

Many oral capsules are stored at room temperature, but this specific medication should be stored in the refrigerator. Etoposide 50 mg capsules are packaged in cartons with 20 unit dose capsules.

While the name of the drug and strength are prominently displayed on the carton’s primary display panel, the storage information is printed on a narrower side panel, so it may not be immediately apparent that this product should always be stored in the refrigerator.

This pharmacy does have a process in which, when each cold-chain item is removed from the refrigerator, pharmacy staff place a blue laminated card in the medication tote that follows it through the entire filling and packing process until it is packed into a cooler box for shipping or returned to the refrigerator. The staff person then uses a dry-erase pen to write the time they removed the medication from the refrigerator on the blue card. This timestamp is visible during filling, product verification, and packing to help ensure that the medication is not out of the refrigerator for longer than designated in the pharmacy’s drug cold-chain protocol (e.g., 30 minutes).

The pharmacy has also employed technology to remind staff they are working with a cold-chain medication. For example, the packing station computer screen says “cold,” and the packing label prints automatically with an “R” (for refrigerate) as another reminder. It is unclear why all these indicators were missed in this case. ■

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