Contract Pharma: What are the key benefits of 2D barcodes on pharmaceutical products?
 
Gwen Volpe: 2D barcodes on pharmaceutical labels allow for lot numbers and expiration dates – data crucial to patient care – to be incorporated into a scannable format. The FDA requires a linear (1D) barcode which only includes the NDC (National Drug Code), so clinicians must manually enter the lot number and expiration date by visually locating it on the container and entering it into various systems that require it, such as IV Workflow Systems and Automated Dispensing Machines. By placing GS1 DataMatrix  barcodes on our pharmaceutical labels, clinicians can count on accurate data crucial to patient care to be input with a scan, which means greater efficiency for clinicians and better patient care. Imagine how many mistakes are made by visually looking at a small vial of medication, locating, and manually typing in the lot and expiration date when that can be solved with a simple scan. 

Contract Pharma: What were some of the challenges transitioning to 2D barcodes?  

Gwen Volpe: From a labeling perspective, a linear barcode is a must-have; you cannot remove it since it is an FDA requirement. So, one challenge is manufacturers must make room for a 2D barcode on labels and when doing so there must be sufficient white space between barcode types. 2D is an enhancement to the label and requires change control to implement and that is a large organizational task. Fresenius Kabi has more than 700 product SKUs and while we are adding a 2D barcodes to the labels, there may be unrelated changes needed.  From a process perspective, you must schedule and prioritize and that’s a significant sequencing activity; the more drugs you have, the longer it takes. We have packing engineers and labeling experts that have a role to play in mocking up the new labels from specification drawings. The entire labeling effort takes communication and planning.

Also from a production perspective, there are many things to consider that require time and effort, for example: assessment of current physical equipment capabilities, installing new printers capable of printing 2D DataMatrix barcodes on vial and syringe labels, new optical camera systems capable of inspecting these barcodes, and revising the design and even substrate of labels to support the printing process. There must be integration with our current inventory management system to automatically transfer the GS1 Global Trade Item Number (GTIN), lot, and expiry dates to the new printing and inspection systems, ensuring we are printing the correct data. SOPs and training documents have to be created and implemented to ensure operators and quality assurance personnel were trained appropriately. Finally, it’s important to communicate with our commercial team to let them know when individual codes are ready so they can communicate with our customers.  

Contract Pharma: What are some other advanced data initiatives that Fresenius Kabi and the industry is taking on?  
 
Gwen Volpe: Fresenius Kabi is always looking for ways to ensure our products meet the needs of clinicians and the patients they serve. One way we are doing this is through RFID technology. RFID is a wireless auto-identification technology that Fresenius Kabi has embraced to meet the needs of our customers who were purchasing our products and manually RFID tagging to identify and track medications. The process of manually tagging and encoding takes valuable time and resources for a hospital, so we embed an RFID tag identified with the NDC, lot number, expiration date, and serial number so hospitals don’t have to. This Fresenius Kabi portfolio featuring this technology is called +RFID.

When a hospital manually tags to read the data, proper placement of the tag is a consideration. Fresenius Kabi +RFID products take the manual placement of the RFID tag out of the decision-making process for hospital staff. I have been in facilities that have job aids just to ensure technicians and pharmacists know where to place the RFID tags for optimal performance on different products. Pharmaceutical formulations play a role too, as not all products will have the same read performance using identical RFID tags supplied by vendors. The one-size-fits-all approach does not always work. You can get close with most, but some may require a unique RFID tag that is more closely tuned to the product itself for the best performance. 

Additionally, we pre-test our +RFID inlays with ARC RFID lab of Auburn University and post-manufacture test finished products with the Axia Lab of Michigan State to complement our own rigorous manufacturing testing and validation to ensure high quality and read performance for our customers. The backbone of the data encoding of our +RFID product line follows GS1 Standards, so any vendor is able to decode our tag just like our GS1 barcodes. This makes data readily available for the system that needs it, interoperable, and consistent. This helps our clinicians with the data needed for accurate inventory control and identification, which contributes to better patient care.

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