On September 12th the Office of Inspector General (OIG) released the first of a series of readiness examinations of the Life Science/Healthcare Industry for DSCSA.  The remaining readiness examination will involve Dispenser/Pharmacy readiness for DSCSA and an overall assessment of the whole industry’s ability to track and trace products through the entire HealthCare Supply Chain.  This post is written from our customer’s perspective (Providers/Dispensers) of the OIG’s report.

 

Overall this report is an industry reminder that all stakeholders (Manufacturers, Distributors, and Dispensers) have room to improve as DSCSA evolves in anticipation of full interoperability in 2023.  OIG’s report focuses on Distributor/Wholesaler readiness by using a sample of 31 wholesalers including the three largest drug wholesalers (McKesson, Amerisource Bergen, and Cardinal Health) within their sample methodology.  It is important to note that the three largest drug wholesalers in the US account for 80% of all wholesale drug transaction by dollar volume.  The remaining sample represents medium and smaller institutions.

 

Results

The good news is that every organization in the OIG’s findings has some system in place to track and trace drug product.  The not so great news is that 14 of the 31 (none of the large wholesalers) were missing at least one element of the required elements for DSCSA compliance including; NDC, form, strength, and package.  Overwhelmingly this track and trace data is being shared via all manner of mechanisms including highly automated EDI, vendor portal solutions, email attachments and even paper.   Specific issues that have been highlighted in this report are related to:

  • Complications with compliance when Intermediate wholesalers were involved in a transaction
  • 340B program compliance in the context of a covered entity and contract pharmacy responsibilities under the regulation
  • Definition of excluded products
  • Lack of data transmission standards

 

RXTransparent Guidance

For our customers and potential customers, each of these identified issues creates challenges for downstream Providers/Dispensers to remain compliant with DSCSA.

Missing Data Intermediate Wholesalers

If the upstream trading partner does not provide a complete record of all the necessary information especially the drug products NDC then downstream compliance will be difficult to achieve.  We specifically want to highlight the challenge related to loan/borrow/trade/sales transactions that occur between providers/dispensers.   Within the RXTransparent platform, we explicitly created our “Manual Pedigree” functionality to specifically address imperfections from what are essentially intermediate distributors/wholesalers in the drug supply chain.

340B Covered Entity/Contract Pharmacy

From a 340B perspective, we have collaborated with many of our customers to implement DSCSA Provider/Dispenser compliance for 340B by integrating the contract pharmacy data into the RXTransparent platform. We are also segregating access to our customers (Covered Entity) users who are singularly responsible for the 340B program effectively quarantining them from standard transactions.

Excluded Definitions

Generally, the manufacturer determines if a product is excluded from DSCSA but there are specific issues that have been raised by the wholesaler community.  The RXTransparent platform is built on top of our CorPharma™ drug database which includes the entire NIH national library of medicine, FDA Orange Book, and FDA purple book.  We define a prescription drug product in the platform as a product that FDA designates as a prescription drug without exception. It is interesting to note that individual products highlighted in the OIG’s report included products which are in critically short supply within the market, which is the exact environment that can motivate bad actors to attempt to subvert the legitimate drug supply chain.

Single Data Transmission Standard

The FDA will be working to address the interoperable data standard of the future in upcoming meetings. The OIG report did not mention the GS1 EPCIS standard or blockchain technologies that are growing in importance, especially in the context of serialized data requirements affecting Providers/Dispensers in 2020.  The RXTransparent team has engineered our platform for all of the above standards including our current Block Chain deployment, EPCIS, EDI, Portal Integration, Email, and even the original data standard paper.

 

Conclusion 

We are dedicated to keeping our Provider/Dispenser customers compliant by ensuring that they have the best system in the U.S. to deal with every unique complication in DSCSA.  The RXTransparent platform gives our customers an opportunity to make a reasonable effort to comply with DSCSA. To read the OIG report, click here.

 

What’s Next

We will be hosting an In-Depth Guide to DSCSA Webinar on Wednesday, September 27th at 2 PM Eastern time, where we will cover the OIG’s latest findings and all things DSCSA.  To register for the event visit us at our site:

http://www.rxtransparent.com/webinars