Lot number/expiration date a must for immediate container labels
At the meeting of the American Society of Health-System Pharmacists (ASHP) House of Delegates in Baltimore, MD, on June 13, 2023, Kevin Marvin, RPh, MS, FASHP called upon the FDA to require that bar codes on immediate container labels, such as unit-dose packages, syringe labels, and individual drug vials, incorporate the medication's lot number and expiration date to enable automated collection and validation of this information during preparation, dispensing, and administration. The current FDA barcode rule (21 CFR 201.25) requires that the National Drug Code (NDC) be incorporated in a one-dimensional linear barcode. However, these do not include the lot number and expiration date. The FDA currently allows two-dimensional barcodes that can encode this information, but the linear barcode is still required.
Barcode scanning versus manual logging of lot numbers and expiration dates is critical for patient safety, with improved data visibility especially for medication recalls. Current linear bar codes require scanning to verify the NDC, along with multiple mouse clicks and several keystrokes to enter the lot number and expiration date. The need for this additional data entry in the middle of a complicated I.V. workflow can also result in a sterility breach, or transcription or omission errors.
Ryanodex demo carton and vial look too much like the real thing
A hospital that stocks RYANODEX (dantrolene sodium) for injectable suspension in areas where patients are at risk for malignant hyperthermia reported confusion between the actual medication cartons and demonstration (demo) cartons that look remarkably similar (see Actual vs. demo carton). RYANODEX is a skeletal muscle relaxant indicated for treatment of malignant hyperthermia in conjunction with appropriate supportive measures. When the demo product was received after a request to the manufacturer, Eagle Pharmaceuticals (Eagle), hospital supply staff shelved it with the actual product, possibly because of their similar appearance. The storage error was identified before the product was used for patient care.
Ryanodex is available as a 250 mg vial of lyophilized powder which is administered as a single dose after reconstitution with 5 mL of sterile water for injection without a bacteriostatic agent (reconstitution yields 50 mg/mL). The manufacturer reported that the demo vials contain actual (expired) medication and are given to the clinical staff during training sessions on preparing doses. Hospital educators may take these vials to patient-care areas where malignant hyperthermia must be treated emergently, which may contribute to the risk of a mix-up.
Ryanodex demo vials come in the same size carton and have the same shape and coloring as the actual Ryanodex product. Each demo carton and vial is labeled, "DEMO For Training Only Not For Human Use." The demo vial does not include a bar code, NDC number, or expiration date, and the lot number includes the word DEMO. Additionally, each demo vial features auxiliary overseal tape that must be broken in order to access the product that says, "DEMO VIAL - FOR TRAINING ONLY."
Clinicians may fail to read all the information on the label, especially in an emergency. Or, they may read the container label information in vertical order, stopping once they identify the drug and its strength. They may fail to read the rest of the label once they identify the information they think they need, missing warnings.
Even if the clinician noticed the warnings, if demo vials are inadvertently stocked instead of Ryanodex, time-sensitive treatment may be delayed.
The US FDA has been informed about this issue. Demo products not intended for human use should be packaged to appear distinctly different than the actual product. When ordering demo products, provide an alternative shipping location in a nonproduction or storage area of the pharmacy, such as pharmacy administrative offices. Educational products must be stored separately from medications in classroom and training areas, and not in patient-care areas. Consider adding auxiliary labeling to the package and storage areas to warn that they are for demo use only.