Track-and-Trace: Staggered Deadlines May Lead to Workflow Disruption

The Track-and-Trace law, also known as the Drug Supply Chain Security Act (DSCSA) was signed into law November 27, 2013.  The DSCSA outlines the steps and deadlines the pharmaceutical supply chain participants and pharmacy industry must take to build a system that identifies and traces pharmaceuticals.  By November 27, 2023, DSCSA expects the system to facilitate the exchange of information at the individual package level by showing where a drug has been in the supply chain.[1]

Other staggered deadlines occur throughout the ten-year implementation period with one occurring on November 27, 2017.  At that time, pharmaceutical manufacturers are required to place unique product identifiers on their packages.  This identifier is composed of the product’s NDC, a serial number, lot number, and the expiration date, all of which are recorded in a 2D bar code.  Repackagers are required to comply by November 27, 2018.  Wholesalers are required to use the 2D bar code by November 27, 2019, and pharmacies are required to do so by November 27, 2020.

As manufacturers prepare for their 2D bar code deadline, some are including the 2D bar code and the current linear UPC bar code.  Other manufacturers are replacing the linear UPC bar code with the 2D bar code. This is a cause for great concern for some pharmacies.

Although the law and its provisions have been public knowledge for almost 3½ years, those industry segments with later deadlines may not have completed upgrades to use 2D bar codes in their workflow processes.  It is unknown as to the extent how much of the current technology used in pharmacies cannot utilize a 2D barcode.  Packages with only a 2D bar code cannot be scanned by pharmacies without 2D scanning capability to verify the correct product has been selected for dispensing.  This situation may require manual system overrides and increase the potential for dispensing errors.

Entities downstream in the supply chain are evaluating steps needed to minimize disruption in workflow caused by the removal of a linear UPC bar code.  These steps may include installing new 2D bar code readers and associated software.  However, if this technology is not implemented in time, others may need to develop procedural “workarounds.”

In an effort to ensure a smooth transition and compliance with the law, NCPDP work groups proposed working with manufacturers to determine when their packages will be changing to comply with DSCSA requirements and which products will have their linear UPC bar codes replaced with 2D barcodes.

PHSI encourages pharmacies to talk with their software vendors or pharmacy IT support to determine how this issue may affect their organization.

Please read more about the enforcement delay of DSCSA:

http://phsirx.com/blog/update-track-and-trace-enforcement-delayed

PHSI has written about Track-and-Trace since President Obama signed this Act in 2013. Please see the below publications for more information:

http://phsirx.com/news-events/publications/computertalk-januaryfebruary-2015

http://phsirx.com/news-events/publications/computertalk-marchapril-2014

 

[1] https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ Accessed May 18, 2017

Leave a Reply