When DSCSA was passed into law, certain requirements were laid on all the elements in the distribution chain for prescription drugs but, for the most part, the method of implementation was left to the individual parts of the chain to negotiate and agree amongst themselves. One area of uncertainty is the Saleable Returns verification method, which has to be in place by November 2019. The end of 2019 seemed a long way in the future when the Act was passed but seems so no longer. There is disagreement on what the supply chain should be doing now.
The Healthcare Distribution Management Association (HDMA) represents primary pharmaceutical distributors who take product from pharmaceutical manufacturers and deliver it to healthcare providers. HDMA members can be expected to have a view on what should be done; the emerging problems are arising because they have more than one. The HDMA’s “Big 3” – McKesson, Cardinal and AmerisourceBergen (ABC) – have taken different positions, with McKesson and Cardinal going down one route and Amerisource choosing another.
Information on shipments has to be passed electronically and there are two major ways to do this:
- EDI ASN
ASN stands for Advanced Shipping Notice and is exactly what it sounds like: a message sent by shipper to consignee advising:
- What is being shipped, including details of the number of items, the shipment date, number of boxes and weight of the shipment and a description of packaging
- Method by which the goods are being shipped
- Information about the carrier.
An ASN is normally sent by EDI (electronic data interchange and not, as is sometimes said, electronic data information) and this method is usually referred to as EDI ASN, or simply ASN.
Electronic Product Code Information Service (EPCIS) is a global GS1 standard for swapping Electronic Product Code (EPC) information. EPCIS allows EPC data to pass seamlessly and securely between companies.
The advantage of EPCIS is that it allows automatic communication and the exchange of authenticated data. Reading the tag as the goods leave the sender’s premises can cause an ASN to be transmitted without human intervention.
Adoption of EPCIS across an industry would enable computers to communicate automatically with one another and pass data back and forth—with the right authentication—automatically. So the process could be automated. Tag reads at dock doors could automatically trigger software to send an ASN in the right format to the retailer’s EPCIS. The question is not: should pharmaceuticals adopt EPCIS? They should. The question is: is this the right time?
During the last HDMA Expo, each of the “Big 3”, Amerisource Bergen, McKesson and Cardinal had their own sessions to talk about DSCSA data transmissions to their partners and what they would like to see in the next upcoming years.
Amerisource says that it is and wants to see EPCIS implemented as soon as possible for transmission of all types of data. McKesson and Cardinal say that it is not and their option is:
- EDI ASN for lot base
- EPCIS for serialization.
*This creates two parallel electronic data pathways.
The Amerisource argument is: why have two electronic data pathways running in parallel when one would be sufficient and it’s fairly clear that EPCIS will eventually handle all transmission? Against this has to be set the fact that a lot of work has already gone into building an EDI ASN network while EPCIS still needs development.
It might be possible, and indeed a number of people have said this, to wish that the HDMA would publish the definitive guidelines on how data is to be transferred but – presumably because of the difference of opinion between the Big 3 – HDMA has restricted itself to publishing EDI and barcode guidance. Manufacturers still need to ask each wholesaler how they want data presented.
At the moment, it seems that all wholesalers allow DSCSA Transaction Information, Transaction History and Transaction Statement (TI, TH and TS) by EDI ASN and it is certainly true that all of the Big 3 currently receive all of these documents through ASNs – paper transactions have all but ceased for the last 15 months.
HDMA has begun piloting nine different transmission methods to find which combine lowest cost with greatest efficiency. The results should be available in third or fourth quarter of this year. That has not prevented each of the Big 3 from saying that, by the beginning of 2018, all manufacturers should be providing aggregation data so that the wholesalers can build up an inventory of valid serial numbers. The object is to have, from November 2019, different ways to verify saleable returns without phone calls or emails.
So will manufacturers all be providing serialization data through EPCIS? Amerisource clearly expects manufacturers to time EPCIS transmission to coincide with compulsory serialization. McKesson and Cardinal, on the other hand, point out that until November 2023 lot-based transaction documentation will comply with DSCSA. Adding serial numbers is permitted but optional, and must not interfere with meeting the DSCSA requirements on lot-based documents.
McKesson says that suppliers have achieved stability in sending lot-based transaction documentation through ASNs and see no reason to disturb that with a switch to EPCIS that would still require a level of debugging. The ASN system we currently have will be DSCSA compliant to November 2023. McKesson does not want to see that go into the melting pot.
A manufacturer wishing to send aggregation data to McKesson and Cardinal will need to do so in a separate data exchange running in parallel with the ASN compliance data. Two different feeds each containing information about the same products.
The decision might be easier if we already knew the structure or method of exchange of information post-2023 – but we don’t. It may be that the data will still pass between trading partners as it does under ASN now but it is also possible that there will be a more centralized architecture, which may or may not be a central repository for information. That’s a decision the FDA is to make some time during the next 5 to 7 years. McKesson’s argument, which is also supported by Cardinal, is that there is no point in now going through the work needed to construct a working EPCIS system if the FDA then dictates that it has to be done differently. ASN works, so why not stay with it until the future is clearer?
If Amerisource insists that all suppliers switch to EPCIS, manufacturers will have no choice. If, though, they make it optional, the wise choice will be to wait and see – and stay with ASN in the meantime.
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