Track-and-Trace Implementation Update

It has now been more than eight years since the Track-and-Trace law, known as the Drug Supply Chain Security Act (DSCSA), was signed.  The Act outlines the steps that participants in the pharmaceutical supply chain and pharmacy industry must take to build a system that identifies and traces pharmaceuticals and facilitates the exchange of information at the individual package level by showing where a drug has been in the supply chain.  The deadline to implement all of this is the tenth anniversary of the Act being signed, November 27, 2023.

Recently, the HDA (Healthcare Distribution Alliance) Research Foundation published a survey[1] that assessed the industry’s progress.  The Foundation’s survey concluded that industry business partners are just now beginning to establish interoperable connections and work with data exchange in a production environment.

Even though over 80% of manufacturers have prepared to send data downstream, few are exchanging data in production today. Currently, almost 60% of manufacturers say they are not sharing data with distributors.  A little over 60% of manufacturers plan to connect directly with distributors, but nearly 40% of manufacturers will rely on third-party logistics providers, adding a layer of complexity to the process.  Only 16% of manufacturers are connected to dispensers.  Manufacturers stated they have run into obstacles like a lack of resources, slow movement in the industry as a whole, and delays caused by “either past or potential future enforcement discretion.”[2]

Around 50% of distributors are setting up connections currently, while approximately 40% are connected to manufacturers in a production environment; none have any connections with dispensers.  Even when implemented, 45% of distributors don’t plan to establish a direct connection with dispensers.  This indicates many distributors have a significant amount of work to do over the next two years to meet the November 2023 deadline.  Some survey respondents said COVID-19 has curtailed adoption of the standard.  There is also a question as to the number of business partners that prefer a direct connection versus a portal connection. The top distributor obstacle identified was a lack of trading partner understanding or commitment.

Currently, the only “widely recognized”[3] international standard developed to comply with the Track-and-Trace law is GS1’s Electronic Product Code Information Services (EPCIS), which allows trading partners to exchange the transaction data required to comply with the law.  Responses from the survey indicate that industry movement to implement EPCIS is slow possibly due to a lack of IT resources for testing and implementation, the obligation to make IT upgrades required before implementation, or the need to concentrate on error resolution stemming from this process.

Implementation of DSCSA processes has been difficult based on the survey responses.  If funding exists, the Foundation plans to conduct more surveys over the next two years to gauge progress.  Based on the progress still required for a November 2023 implementation, there is a possibility that this deadline, established in 2013, will be extended.  In the meanwhile, PHSL encourages organizations to talk with their software vendors or IT support to determine if the requisite steps are being taken to address this issue.

PHSL 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

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

http://phsirx.com/blog/track-and-trace-staggered-deadlines-may-lead-to-workflow-disruption

[1] https://www.hda.org/publications/epcis-implementation-benchmarking-survey/ EPCIS Implementation Benchmarking Survey (hda.org)

[2] https://www.hda.org/perspectives/2021/a-call-to-action-on-epcis-adoption-for-dscsa/

[3] https://www.hda.org/perspectives/2021/a-call-to-action-on-epcis-adoption-for-dscsa/

Posted January 5, 2022

Winter 2022 Newsletter:

National Drug Price Reduction Plan