Welcome to the World of EDI and Track & Trace
The night before last Christmas, the FDA did what it could to reduce the unrest in the drug industry by extending the enforcement of the DSCSA to 1stMay, 2015. Well, time flies … the revised due date is just four weeks away.
In an attempt to put out the fire, some companies that constitute the medical supply chain are passing the required transaction exchange data to their respective trading partners using Advanced Shipment Notices.
An ASN lies in the broad category of electronic data interchange documents, and is a notification of deliveries that are pending. In essence, an ASN is similar to packing list and is typically sent out in an electronic format. An ASN can be used for a variety of purposes from listing the goods in a shipment to additional information including order details, product description, packaging type, physical depiction, carrier particulars, and arrangement of goods within the transportation used.
“Companies that initially chose ASNs are finding it extremely difficult to continue with the same for carrying compliance data without hiccups. That’s because the DSCSA-specific solutions deployed by the companies to generate ASNs have been built with poor understanding of the underlying EDI standards. EDI itself is not the right way to pass information mandated by the DSCSA.”
A number of companies are thinking of opting in for ASNs to carry the core transaction exchange data mandated by the Drug Supply Chain Security Act – the Transaction Information (TI), the Transaction History (TH) and the Transaction Statements (TS) are to be sent out to trading partners as instances of Advanced Shipment Notices.
While ASNs might be good enough to temporarily serve the purpose of choreographing transaction data exchange, the question is that are ASNs an actual long-term solution to the fundamental problem of information exchange?
The initial guess was that once companies begin using ASNs to exchange lot-based transaction data, they will most likely continue with the same for at least five years down the road. But surprisingly, that has not been the case. Companies that initially chose ASNs are finding it extremely difficult to continue with the same for carrying compliance data without hiccups. That’s because the DSCSA-specific solutions deployed by the companies to generate ASNs have been built with poor understanding of the underlying EDI standards. EDI itself is not the right way to pass information mandated by the DSCSA.
I will give you an example. At TrackTraceRx we deal with our clients EDI/ASN integration on a daily basis. One of our clients upstream trading partner who happens to be a big deal in the industry was not passing lot numbers in their ASN. They were compliant, as they purchased directly from the manufacturer and was passing a direct purchase statement. However, this definitely posed a challenge as without the lot number, we were not accurately able to map the shipment order quantity with their appropriate lot number. With the DSCSA not requiring to pass the lot number electronically adds a manual process within the supply chain. Our client needed to receive the shipment and manually add a lot number. We reached out to their upstream trading partner and asked if they could add the lot number within the ASN. Their response:
“A note regarding lot number: As per the DQSA, title II DSCSA, wholesalers are not required to pass lot or original transaction date if the wholesaler purchases direct from the manufacturer, or a repackager that purchases direct from the manufacture, or an exclusive distributor. Upstream Trading Partner only purchases from these entities and is not required to pass the lot number or original transaction date.
You are correct about the exclusion of the Lot and Expiration on the ASNs by us. We do have plans to include these pieces of data into the ASNs in a future phase. Our DQSA project team is currently working through the inclusion of Lot and Expiration so that it complies with the FDA deadline and requirements. Any information regarding this will be passed onto business partners once said information is available for distribution.”
Interestingly enough, we received two answers. One that corresponds to the law, and the second is acknowledging that this could cause a problem and that they are working on adding this information to help their client and probably their other clients who have complained about the same issue.
At TrackTraceRx we were able to create a solution within our portal to handle missing lot numbers in EDI/ASNs. This is just one example of the challenges facing our supply chain by not having a standard defined.
Turbulent experience with ASNs should serve as an eye-opener for others. Whole sale distributors and pharmaceutical manufacturers who previously relied on ASN for conventional financial purposes cannot simply extend the same for transaction data exchange. With additional requirements such as saving pertinent data for six years, securing the relevant information, printing the documentation, and integration with ERP software, ASN clearly doesn’t cut it anymore.