- Hospitals, or those at the unit of use level, are not within the scope of DSCSA.
- To remove a tedious, manual tracking implementation process, Fresenius Kabi is implementing RFID tracking.
- RFID tagging is fairly invisible to packaging line operators through the use of antennas.
- RFID tagging is not a DSCSA replacement but an addition to 2D data matrix barcodes.
- Fresenius Kabi Goes Above and Beyond DSCSA Requirements
- Discover the Educational Opportunities Available at PACK EXPO Las Vegas 2021
- Read PMMI's report on the drive toward 4.0 connectivity in packaging and processing.
|Read the transcript below:|
Hi, I’m Melissa Griffen, contributing editor. The FDA’s Drug Supply Chain Security Act is high on the healthcare industry’s priority list as companies strive to create an interoperable track and trace system by 2023.
The DSCSA requires that manufacturers and repackagers affix or imprint to each package and homogenous case of product a product identifier in the form of a 2-dimensional data matrix barcode–or linear barcode for certain homogenous cases. This identifier must include:
- The product’s standardized numerical identifier–composed of the National Drug Code and a unique alphanumeric serial number
- The lot number
- And the expiration date
This allows the pharmaceuticals to be tracked and traced from manufacturer to receiving docks of healthcare providers at the unit of sale. However, hospitals, or those at the unit of use level, are not within the scope of DSCSA, resulting in a time-consuming, tedious manual track and trace implementation process.
Fresenius Kabi, a GS1 US member and healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition, has begun implementing RFID tracking on medication inventory at the request of its customers–mainly hospitals and pharmacies–removing that manual process.
RFID implementation was slowed by the pandemic, but in the Fall of 2020, Fresenius Kabi became the first pharmaceutical manufacturer to embed medication identification data into an RFID tag, relying on GS1 Standards to permit full interoperability and compatibility.
Each RFID tag is embedded into the existing label so it can run on the company’s existing packaging lines, making the process fairly invisible to packaging line operators, with no physical interaction at the packaging point. Antennas interact with the tags through radio frequency to embed the needed data. Tags that are unreadable or with incorrect information encoded are rejected from the line.
This RFID solution is not meant to be a DSCSA replacement but rather an addition to 2D data matrix barcodes. They work as an added layer of protection for pharmaceutical integrity for the sake of patients, while saving healthcare providers time and providing precise inventory control throughout hospitals.
Fresenius Kabi reports that its customers have responded positively to its RFID system called +RFID, and the company believes RFID to be gaining momentum in the United States with a current 11% of hospitals using the technology. The company further explains that using the GS1 Standards allows it to work with all of its customers’ RFID tracking system vendors, enabling the customers to choose the system that fits their needs.
For more on the pros and cons of Fresenius Kabi’s RFID implementation and GS1 US’s involvement in developing +RFID, read the full story at the URL on screen. Stay tuned as Keren Sookne recaps some educational opportunities in connected packaging at PACK EXPO Las Vegas. Thanks and see you next time on Take Five with Packaging World.
Keren Sookne: Thanks, Melissa. If you’re looking for more information on connected packaging and supply chain, I wanted to highlight a few upcoming educational sessions at PACK EXPO Las Vegas.
Also on Monday but at 4pm, Markem Imaje is offering an Innovation Stage session on optimizing packaging operations, and ensuring compliance and protecting your brand.
On Tuesday at 130pm at the PACK to the Future Stage, Specright will present The Transition of Packaging to a Digital World Through Data.
Thanks and see you at PACK EXPO Las Vegas!