NOTICE: The HDMA has updated this guideline again only a few months after this essay was published. Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information. — Dirk.
The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA). HDMA members and non-members can download a copy of the new document here. Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“. (See the image to the right.)
The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who supply prescription drugs into the U.S. market should plan to implement these new guidelines as soon as possible because the major wholesale distributors will almost certainly require them in short order. Check with your customers to confirm.
The HDMA has done a great service to the industry here, providing a simple and logical way of meeting the DSCSA Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS) requirements with a minimum of changes to the ASN that many companies were already using. HDMA is the publisher of the guidance and all of the major wholesale distributors will align behind them (HDMA is their industry association after all), providing pharma manufacturers with a single approach to work toward. This is exactly what I felt needs to be done (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure” and “DQSA: Getting To Electronic Transaction Data Exchange“).
The new HDMA document includes two example scenarios and provides the full example ASNs for both, including a clear and concise explanation of the elements contained within each segment. The first example is for a direct purchase scenario where a manufacturer is selling a single drug to the first wholesale distributor. The second example is for an indirect purchase scenario where the first wholesale distributor ships a drug to a second wholesale distributor. Both examples are carefully designed to show how the shipment of a single drug would be depicted. By studying these examples, people familiar with EDI message structure and usage should be able to figure out how to extend them into more complex shipping scenarios, such as multiple products with multiple histories, etc.
Meeting the TI requirement is not difficult. HDMA simply added segments to include the full “ship to” and “ship from” street addresses to be used to represent the buyer and seller respectively. Meeting the TH requirement was slightly more complex–especially for products with complex histories–but equally logical.
In meeting the TS requirement, HDMA has chosen a very simple approach. They have included a YNQ segment (Yes/No Question) that allows companies to state that “Yes, this product and this statement are DSCSA compliant”. The YNQ segment is a little more terse than that, but that’s my interpretation of what it means.
Will the FDA agree that this approach fulfills the intent of the Transaction Statement, which has seven different parts and is very lengthy, or will they insist on something more? We probably won’t know until November when the FDA is due to publish their draft guidance on the exchange of transaction data, but in the meantime this approach provides a simple, low-overhead way of representing the user’s assertion that they believe the shipment complies with the DSCSA. If the FDA disagrees with the wording at that time, then it could be a straightforward edit to bring it into compliance. On the other hand, if the FDA disagrees with the entire approach, that could require the HDMA to go back to the drawing board to come up with an entirely new approach. Supporters of this simple approach should make their preference known to the FDA at their upcoming workshop and in their response to the workshop docket.
This is how this is supposed to work, as envisioned by Congress in the DSCSA. The industry and the FDA working together to come up with a commonly applied approach to securing the supply chain. The ultimate goal is interoperability that ends up protecting the supply chain and patients. Interoperability only comes from everyone adopting the same approach. The HDMA has taken a big step toward that goal today with the publication of this guidance.