BARCODING OF LOT NUMBER AND EXPIRATION DATE

To advocate that the Food and Drug Administration and organizations that develop barcode standards require barcodes contain lot number and expiration date on all immediate product packages to enable automated collection and validation of this information during medication preparation, dispensing, and administration processes; further,

To educate regulatory and safety organizations that barcode scanning versus manual logging of lot numbers and expirations is critical for patient safety and preparation sterility and improves data visibility for medication recalls; further,

To advocate that state boards of pharmacy, regulatory agencies, and accrediting bodies delay punitive action on rules requiring logging of lot number and expiration dates during sterile product preparation until this information is made available on immediate product barcodes.

Rationale

The current Food and Drug Administration (FDA) barcode rule requires the National Drug Code (NDC), lot number, and expiration date on all saleable medication packages. FDA created an exception for immediate packages, which include unit dose packages and individual vials sold as lots in boxes. More than 90% of products dispensed in a hospital are immediate packages. The FDA exception requires that the barcodes on these immediate packages be linear (1D) barcodes. Due to the technology of 1D barcodes, it is difficult to fit the larger barcode containing additional characters needed to code lot number, expiration date, and NDC on labels of inner packages. As a result, the 1D barcodes required on inner packages only contain the NDC. 2D barcodes require less label space than 1D barcodes, and 2D scanners can read 1D and 2D barcodes. Many products dispensed are saleable packages that only contain 2D barcodes, and 2D barcode readers are significantly less expensive and more reliable than the 1D laser scanners used in the past. Hospitals have responded by widely adopting use of 2D scanners.

A proposed FDA rule will allow but not require 2D barcodes and require only the inclusion of the NDC in the barcode. The FDA states that the reason for these requirements is that the expansion of the NDC to 12 digits will create issues for manufacturers that code a 10-digit NDC number in the barcode and don’t have the label space to expand the 1D barcode to 12 digits. The proposed rule will not guarantee that barcodes on inner products contain lot number and expiration date. FDA has stated that they are addressing the immediate package requirements in the revised rule, but this is only true for the NDC 12-character expansion and not for the encoding of lot and expiration date.

Multiple state boards of pharmacy, including California and Texas, require hospitals to log the NDC, lot number, and expiration dates on all intravenous (IV) products that are compounded or repackaged. United States Pharmcopeia (USP) Chapter 797 is adding the same requirements, effective November 1, 2023. The logging of lot numbers and expiration dates is not a second check but an attempt to track medications all the way to the patient in the case of recalls and event reporting. With IV workflow systems and barcodes with lot number and expiration dates, an IV product can be prepared and documented with only two barcode scans. Current linear barcodes require scans of the NDC, multiple mouse clicks, and many keystrokes on a keyboard to enter the data. For example, a two-component IV product with a base solution and one additive was reported to require 22 keystrokes and 2 mouse clicks at a minimum if lot number and expiration date are not in the barcode. In addition, putting a keyboard into the sterile environment or pulling hands in and out of the sterile field threatens sterility. Dispersing this data entry work in the middle of a complicated IV workflow will not only create data entry or transcription errors but will increase the potential for computation errors, as the preparer keys in or handwrites a long series of seemingly random numbers while computing, measuring, and verifying doses.

Software vendors have acknowledged that their systems already have the functionality to capture lot number and expiration dates, if available, through barcode scanning, replacing numerous keystrokes. This functionality has not only been added to IV preparation functions but also to dispensing and medication administration functions as well. In addition, many systems allow barcode scans to be initiated by foot switches, permitting users to avoid touching scanners, therefore minimizing potential impacts on sterility. One vender has reported that they are in the process of adding automatic checks for expired medications and recalled lot numbers during all medication barcode scanning functions throughout the medication-use process. Significant safety improvements and time savings can be realized through automated checking of expiration dates and recalls throughout the medication-use process, including automated dispensing cabinet restocking.

Although state boards of pharmacy and USP are considering and implementing rules to track medications to the patient and validate expiration dates, there is a general lack of understanding how these rules impact IV preparation workflows and corresponding medication safety and sterility of IV preparation. It is important that rulemakers understand these impacts and implement rules to require the inclusion of lot number and expiration date on immediate product barcodes. Healthcare organizations should communicate the need for NDC, lot number, and expiration date on all immediate products, including repackaged products and investigational medications, to the FDA and GS1, the barcode standards organization that defines medication barcode standards, to assure the resulting barcodes meet the needs of health systems.