Signed into law on November 27, 2013, the Drug Supply Chain Security Act (DSCSA) doesn’t just affect U.S. pharmaceutical manufacturers. It also will have an impact on wholesale distributors and third-party logistics providers. In particular, it will require the establishment of licensure standards and annual reporting of information to the FDA. By November 2019, distributors will be required to have implemented traceability at their operations.
In the first phase of the DSCSA, wholesale distributors were tasked to trade only with authorized partners; to send and receive transaction information, transaction history, and transaction statements; to quarantine and investigate suspect drugs; to notify the FDA and other stakeholders of any illegitimate drugs; and to meet the FDA licensing requirement.
AmerisourceBergen, one of the big three pharmaceutical wholesale distributors, has helped to shape the implementation of the DSCSA in the pharmaceutical supply chain.
According to ABC’s Heather Zenk, Vice President of Secure Supply Chain Operations, the company started by identifying which system changes and enhancements would be needed, which involved changes to business processes, and whether there were requirements that affected both.
She said that the company had a lot of the processes already in place.
“What we’ve put in place is that we are receiving our transactional information inbound from all of our manufacturing trading partners. We receive that, store it, and then we generate all of our transactional information statement and history to our pharmacy trading customers,” said Zenk. “All we needed to do was change terminology to align with the DSCSA requirements and retrain a few associates on appropriate handling of quarantined areas, etc.
“The accepting of the transactional data in a standardized format was a larger opportunity for us. That was probably our most difficult [regulation] to adhere to. That is solely due to the modern manufacturers we conduct business with.”
At present, the company conducts business with every U.S.-approved pharmaceutical manufacturer in the United States.
“If you break it all down, we probably work with about 500 manufacturers,” said Zenk.
Standardizing Data Exchange
“It’s really relevant for AmerisourceBergen to get the wholesaling industry to ask the manufacturing community for data to be exchanged in a standardized format,” said Zenk, explaining that ABC worked to update the ASN (Advanced Shipment Notice) data standards so that the wholesaling industry could request information to be sent to them using the same format from the manufacturers.
“We felt that that was important,” she continued. Therefore, one manufacturer wouldn’t receive different standards from different wholesalers. “We knew in order to keep down the cost of healthcare, we needed one standard to do the data exchange.”
ASN is an electronic data interchange standard. Usually a manufacturer sends the ASN to the entity receiving a product (so that the group receiving it knows what to expect).
“What we did with the ASN is we took the required data element and the transactional information statement and history and we enhanced the ASN so that all of the data elements and the transaction statements were included within that data transmission. So, we could use that tool as a mechanism to receive all of the compliant data,” said Zenk. “We used the current electronic data interchange (EDI) and enhanced that messaging to meet the requirements.
“In a sense, we took a supply chain tool and made it a compliance tool.”
Using ASNs for DSCSA Compliance
The DSCSA was signed in 2013, which left the wholesale community with approximately 13-14 months (until January 2015) to implement this first requirement: lot-level traceability.
“We knew we had to use an existing tool and couldn’t come up with a new standard or new tool. So, we used the ASN as that mechanism and that’s what the industry has used for this first phase of lot-level traceability and information being exchanged between trading partners,” said Zenk.
In order to standardize transactions between trading partners—specifically manufacturers and wholesalers—it was essential that companies exchange and receive information in the same manner. One manufacturer could be doing business with 20 retailers and 20 wholesale distributors in the U.S., which (in practical terms) meant that one manufacturer could have to meet up to 40 different requirements for EDI.
“We knew we had to standardize information at AmerisourceBergen, and we knew the manufacturers could only digest and handle (for ease of doing business with us) one mechanism to give data to the whole industry,” said Zenk.
How the Manufacturing Community Responded
“Everyone was receptive,” said Zenk. “The manufacturing community was thankful that the wholesaling community in the U.S. was coming to them with one set of requirements.
“As the wholesalers, we were all happy because we were then all going to be able to comply much easier (if we were all in the same standard and all requesting the information/data exchange in the same way).”
Despite this outwardly positive response, manufacturers still had one more hurdle to jump through: testing data transactions.
“There’s still that business-to-business testing that needed to go on,” Zenk said, explaining that, although one set of requirements for data exchange was helpful in terms of ease of business, manufacturers still had to run a series of tests to ensure all was working properly.
“The manufacturers were still forced to test with their 40 direct trading partners, but they were testing the same data transaction,” said Zenk.
Testing Serialized Barcodes
The deadline that is on most companies’ minds this year is November 2017—where manufacturers must have serialized product. Such a change will impact companies all along the supply chain as well as the industry going forward.
“We want to be a partner with our manufacturers,” said Zenk. “They’re spending significant capital: changing production lines, changing processes to place a serialized bar code on the product as the law requires. We want to be a resource for those manufacturers.”
ABC offers services to manufacturers to test the serialized barcode for:
- Data content
- Data outlay
“A lot of times manufacturers will go through the process, but we couldn’t read the product, or the data construction isn’t how the manufacturer thought it’d be read by someone else, or the data barcode quality is too low that we can’t read it,” Zenk explained.
At first, the company received artwork approvals as a PDF document from manufacturers. However, after further discussions, it was determined to be most advantageous for the manufacturer to send the finalized package in the form it would be going into the market.
“We’ve had a significant amount of manufacturers take us up on that. For them, they can also say internally they’ve checked with trading partners how this is going to perform in the market (and if the barcodes can be read),” said Zenk.
In these tests, ABC discovered things such as a package was too glossy and the 2D barcode couldn’t be read or the barcode string wasn’t properly broken up in the barcode data (though it was segregated appropriately on the human-readable component).
ABC, like many wholesalers, is eager to work with their trading partners to ensure a smooth transition.
“This is our requirement as an industry,” said Zenk. “This isn’t your requirement. It’s our requirement.
“This is new to all of us. We’re all learning as we go. And why don’t we try to use others in the marketplace as a sounding board or as a conversation/knowledge share? We’re all in this together.”
Misconceptions Surrounding the DSCSA
“I think we still have an opportunity for knowledge outreach to a lot of different parts of the supply chain. We have manufacturers who are very engaged and pharmacy customers who are very engaged, but from a way of doing business and an understanding about the requirement, I think we still have opportunities as a complete supply chain to help each other understand,” said Zenk.
ABC works closely with GS1 Global, as the company is part of the GS1 working group, and one of the things that the companies see is the misconception in the pharmaceutical industry that standardizing the supply chain is unique to the United States.
“We do a lot of work with GS1 Global and global expansion of serialization. Many countries already have serialization enacted and are using it in pharmacy practices and in distribution locations,” said Zenk. “I think sometimes through our U.S.-myopic lens, we think somehow this is something that’s just unique to the U.S., and by no means is it. And that’s exciting as a global participant, but it’s also exciting from the U.S. perspective that we can learn from other implementations throughout the globe of what worked and what didn’t necessarily work for them.”
Serialization: A Global Opportunity
The countries that have been successful in their serialization operations, according to Zenk, have had a few similarities, including a common:
- Communication language
- Sharing language
- Data capture language
“Once we can get through those commonalities, that affords the opportunity to change business process—to get more data that would make more sense so we can service patients better, have better exchanges of information (quicker, cleaner, faster),” said Zenk.
Furthermore, Zenk stresses the importance of understanding serialization requirements across the globe. By familiarizing ourselves with these requirements, the same standards can be implemented—instead of having different standards in each country.
All of these compliance requirements—whether in the U.S. or in another part of the world—come down to one thing: creating a more secure supply chain.
“As an industry, we want to make a more secure supply chain,” said Zenk. “I think we have a high level of security around the supply chain in the U.S., but how can we go even further? Serialization and DSCSA do that for us, but it also then increases patient safety.