Companies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment. Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes. It is a big deal and it affects a large number of companies.
With the FDA’s recent announcement that they will postpone enforcement of the transaction data exchange requirement until May 1 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”), everyone is hoping things start up and run smoothly from that point on. I do too, but I fear that companies—including solution providers—are not preparing for what is likely to turn out to be the most difficult part of the data exchange implementation. That is, handling exceptions.
An “exception” is an honest mistake in a shipment. They happen to everyone, and in fact, for large wholesale distributors, they happen every day at every distribution center.
A drug that appears on the packing list—and in the DSCSA Transaction Data—is not found in the physical shipment. Or, something is found in the physical shipment that is not listed in the DSCSA Transaction Data. Or, an entire shipment is delivered to the wrong destination, but the DSCSA Transaction Data was delivered to the right destination.
When these things happened in the past, companies had various ways of correcting them. These corrections were aimed at ensuring that the buyer was charged only for what was actually received by them. This could have included returning extra product, shipment of missing product, billing the buyer for extra product that they decided to keep, etc. All of these fixes were financial. Once the buyer and seller were satisfied that the financial transaction was whole between them, the exception was considered “handled”. How an exception was “handled” could vary from company to company and from transaction to transaction and even from day to day. The two parties simply had to agree on a fair and financially equitable resolution.
But once companies are engaging in transactions that require compliance with the DSCSA, these common errors could become much more costly headaches. Let’s take a closer look at one common occurrence and see what might be necessary to resolve it under the DSCSA.
Let’s assume a wholesale distributor mistakenly fills one SKU in a larger order with the wrong product in a shipment to a chain pharmacy. The TI and TH they sent to the chain pharmacy at the time of the shipment would not match the products received and so the pharmacy would end up with one drug it did not need and would be missing one it still needs—perhaps a little more critically now because of the lost time.
As I said above, there are multiple ways this error could get fixed. In the past, neither the buyer nor the seller cared about correcting the original Electronic Data Interchange (EDI) Advance Ship Notice (ASN) as long as their agreed upon resolution resulted in a correct invoice. The invoice was the important thing. That’s the part that ensures the trading partners are financially whole.
But now, under the DSCSA, the TI and TH will need to be corrected based on whatever the trading partners choose to do to fix the financial and inventory discrepancy. If the ASN is not corrected, then both the buyer and seller are out of compliance with the DSCSA. In my example, the DSCSA TI and TH were contained in the original ASN. What would be necessary to correct the original ASN?
The seller would need to be able to reopen the ASN, adjust the quantities and perhaps the drugs included in the shipment, depending on the specifics of the original error and the agreed resolution. And then they would need to retransmit the ASN to the buyer, in some cases, keeping the original shipment date and perhaps in other cases, using a new shipment date for the corrected shipment. Does your ASN-generating program have that capability today? Not sure? You might want to check. And you should also develop Standard Operating Procedures (SOPs) to document how to invoke the most common types of exceptions and the typical resolutions.
Fortunately, GS1 Healthcare US is working on a new version of their DSCSA guidance that will include a number of exception handling scenarios (for GS1 US’s current DSCSA guideline, see “The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1”). Only problem is, they will probably focus only on handling exceptions with EPCIS events rather than ASNs. That will not really help most companies until around 2021 or so (see “Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?”).
But most fortunately, the HDMA is right on top of this problem! Last month, while visions of sugar-plum fairies danced in our heads, the HDMA was still working hard and published their “HDMA ASN Exceptions Guidelines for the Drug Supply Chain Security Act”. It is another “must read” document from the HDMA for anyone using EDI ASNs for the exchange of TI, TH and TS to meet the DSCSA. Download it, read it, understand it and implement it. Until the FDA publishes new guidance that specifically addresses exception handling, the HDMA guideline is the best resource to follow.
The HDMA remains the undisputed best source for industry consensus guidance about meeting the DSCSA. Make sure you check out their other vital guidelines covering:
- Formatting ASNs to meet the DSCSA (see “Just Released – The HDMA EDI ASN Guidance For DSCSA” and “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”);
- Supply Chain Transaction Scenarios for DSCSA (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”);
- Use of Barcodes in the U.S. Pharma Supply Chain (not specific to DSCSA yet, see “Updated HDMA Bar Code Guidance: A Must Read”).
And subscribe to RxTrace to receive release notices and analysis of future HDMA guidelines.