No expiration date on COVID-19 vaccine label

A hospital reported that clinicians had administered expired Moderna COVID-19 vaccines to 120 patients, who then needed to be revaccinated. A pharmacist working in a vaccine clinic identified the problem after he scanned the quick response (QR) code on a Moderna COVID-19 vaccine and found that it had expired. He called the pharmacy buyer to check on additional supplies and discovered that the entire hospital vaccine supply had expired. The buyer did not know that the QR code needed to be scanned to identify the expiration date. Instead, she assumed the vaccines had longer expiration dates and labeled the vaccines with a 30-day expiration date after removing them from the pharmacy freezer before dispensing them to clinics for refrigeration.

While staff should discard a vaccine vial after 24 hours since it is taken out of refrigeration or 12 hours after the first puncture, the actual manufacturer's expiration date, which was never identified on the label, always takes precedence. The clinic staff used the 30-day expiration date after removal from the freezer and did not check the QR code for the actual product expiration date before administration.

Once the FDA approved the vaccines for emergency use authorization (EUA), manufacturers made them available for the national stockpile before it was possible to complete the extensive testing necessary to determine the long-term expiration date. To expedite availability, some companies listed the date of manufacture on the label and asked practitioners to visit their website for the expiration date; others asked practitioners to use the QR code to view the actual expiration date based on the latest testing results, which companies could quickly change as they collected more data. When EUA COVID-19 vaccines are sent to the pharmacy or clinic, staff should scan the QR code and label the vaccines to reflect the current actual expiration date.

During distribution, when the vaccine storage location changes, such as a freezer, refrigerator, or in room temperature, plan how to express the expiration date by incorporating the manufacturer's recommended beyond-use date based on the storage location as well as the current expiration date provided by the QR code.

Another concern is that using a QR code to check expiration dates can adversely affect underserved communities without access to smart devices, internet, or cellular services. Teach clinicians about how companies generate expiration dates and that they must scan the QR code again prior to preparation. The FDA-approved COVID-19 vaccines, such as COMIRNATY (Pfizer-BioNTech) and SPIKEVAX (Moderna), have been fully tested and do have an expiration date on the label.

STS abbreviation results in a close call

A surgeon entered an order in the electronic health record (EHR) for sodium tetradecyl sulfate, a sclerosing agent used to treat varicose veins. A nurse then called the OR pharmacy and requested it using the abbreviation "STS." The pharmacist did not clarify the abbreviation and dispensed a vial of sodium thiosulfate injection.

Sodium thiosulfate is used to lessen the risk of ototoxicity associated with CISplatin. It is also used in combination with sodium nitrite to treat acute cyanide poisoning. Based on previous experience with sodium tetradecyl sulfate, the surgeon expected the medication to foam when drawn into the syringe. Before injection, he visually inspected the liquid in the syringe, which did not foam, and questioned if it was the correct medication. After reviewing the medication label, the error was identified, and the medication was not administered.

For clarity and safety, never abbreviate the names of medications or other substances used for treatment. If a colleague refers to a medication using an abbreviation, ask for the full name of the medication, and coach them to avoid using abbreviations as they are too often misinterpreted. In this case, the nurse should not have used the abbreviation "STS" to communicate the drug name when calling the pharmacist. In turn, the OR pharmacist should have verified the meaning of "STS" with the nurse and verified the order the surgeon had entered in the EHR. Lastly, the prescriber should have provided the indication with the medication order, which would have helped prevent this close call.