The US Food and Drug Administration (FDA) is overseeing around 20 pilot projects designed to inform the enhanced requirements that are due to come into effect in 2023. The requirements cover the “interoperable, electronic tracing of product at the package level.”
Kit Check, a provider of radio-frequency identification (RFID) tags, recently got its Drug Supply Chain Security Act (DSCSA) pilot accepted onto the FDA program.
“The goal of this pilot is to demonstrate how an RFID data carrier for electronic data exchanges can bring interoperability and tracking improvements while lowering the costs associated with DSCSA compliance,” Kit Check’s CEO, Kevin MacDonald, told in-PharmaTechnologist.
Novartis’ Sandoz unit and fellow generic drug manufacturer Nephron Pharmaceuticals are involved in the pilot, as are two healthcare providers.
The collaborators will use RFID tags to exchange product tracing information across the supply chain. Companies, including Pfizer, have used RFID to track products at the package level but 2D barcodes are the dominant technology.
DSCSA lists a “2-dimensional data matrix barcode” as the default means for communicating product identification information on drug packaging, although the law enables the FDA to create guidance permitting the use of other technologies.
MacDonald, who thinks existing technologies “have become dated”, sees the FDA pilot as a chance to generate evidence of why RFID should play a role in the implementation of DSCSA.
“By implementing RFID, hospital pharmacies are able to know with 100% certainty the right drug is in the right place at the right time for the right patient, as well as where that drug originated. RFID scanning technology is quicker, more powerful and dependable then the current 2D barcode scanning methods being used today,” MacDonald said.
Cutting costs
Kit Check already provides RFID-based tracking technology, in the form of its automated medication tray management system. When a used medication tray is placed on a scanning station, the system identifies medicines that are missing, expiring or incorrect.
The technician uses this information to restock the tray. Kit Check claims the entire process takes about three minutes, compared to up to 30 minutes when performed manually.
Applied to the DSCSA requirements, Kit Check thinks the technology can cut the cost of compliance and improve tracking.
However, there is currently a lack of quantitative evidence to support that position, with a 2016 review finding most of the information on the implementation of RFID is “not peer-reviewed and could contain biased or inaccurate data.”