interoperability
I recently attended the FDA public workshop on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format” for the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27th 2013. Over 120 people participated in the public workshop including Manufacturers, Repackagers, Distributors, Dispensers, Industry Consultants and Solution Providers. The purpose of the public workshop was:

  • To obtain information about current practices, research, and ideas on the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs.
  • To discuss the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.

We broke out into discussion groups to provide feedback on several topics, and here are overviews of a few:

1. A review of Transaction Information, Transaction History, and Transaction Statement as defined in the DSCSA to discover if there were any specific issues or challenges related to the information that will be exchanged or if there were any clarifications needed. There were many issues brought up by each group including:

  • More definition and clarification needed for some of the transaction information components such as:
    • NDC Code syntax
    • Container Size
    • Strength and dosage form of the product
    • Number of containers
    • Date of the transaction
    • Date of the shipment
  • How to handle special cases such as:
    • Format of how to report back information when requested by the FDA
    • Whether a shorthand version of the Transaction Statement (i.e. Yes – this product is compliant with the DSCSA) is acceptable to the FDA to satisfy the Transaction Statement requirement
    • How does one determine if a trading partner is “authorized?”
    • Drop shipments
    • Consignment of products to a third party which are only reported at the end of the month

One of the interesting notes from the meeting is how acronyms start to get used. Participants initially referenced the information that needed to be reported between transacting parties as “Transaction Information, Transaction History and Transaction Statement”. This was refined down to “TI – TH – TS” and then eventually most participants settled on using “T3” as a shorthand reference.

2. What mechanisms would be used to satisfy the requirements of reporting the “T3” information – “Transaction Information, Transaction History and Transaction Statement” (paper, electronically or a combination of both) that is required as of January 1st, 2015? The general consensus was that Advanced Shipping Notices (i.e. ASN’s) transmitted using EDI (Electronic Data Interchange) would be used by the larger manufacturers, distributers, and dispensers who have that ability; and that packing slips would be used by the small and mid-size trading partners that cannot support ASN’s. Some stakeholders mentioned that they would make Web Portals available to trading partners to facilitate keeping the information in electronic form. The group as a whole asked for flexibility on the interoperability of “HOW” data will be shared and more guidance on “WHAT” data in what format is compliant.

The Healthcare Distribution Management Association (HDMA) has just released a new implementation guideline that details how to augment the EDI ASN to support the reporting of the “T3” information. This guideline is available for free here. Many participants wanted to know if the FDA will accept implementation of this guideline as conforming to the DSCSA reporting requirements..

3. How would stakeholders transition to a fully electronic version of the “T3” information when that is required four years after enactment of the DSCSA law in 2017? Many participants mentioned that they would recommend use of ASN’s initially in years 1-4, and that EPCIS (Electronic Product Code Information Services) may be more appropriate in years 5-9 in order to start preparing for unit level reporting as required ten years after enactment of the DSCSA law in 2023. GS1 is currently working on updating the EPCIS standard to support lot level reporting of transactions at this time so that it can be used to support “T3” reporting.

All in all, the public workshop seemed to accomplish its goals of gathering information about the issues and questions that stakeholders have about meeting the reporting requirements of the DSCSA. Based on the text of the law, the FDA must release a draft guidance document that establishes standards for the interoperable exchange of the “T3” information not later than one year after the enactment of the law. This means that the draft guidance may not be available until Nov 27th, 2014 which is only a little more than one month before the “T3” reporting must start.