The traceability mandate
as defined by the Drug Supply Chain Security Act (DSCSA) can be traced back at least as far as 2004. That is when the FDA outlined a program where drugs would be identified (possibly by RFID tags, a technology that later was dropped in favor of 2D barcodes) and a “pedigree” of the drug’s movement from place of manufacture to place of dispensing would be recorded. At the time, some industry leaders were reluctant advocates of this mandate, pointing out that the then-defined pedigree rules would be nearly impossible to implement.
Following the passage of DSCSA in 2013, AmerisourceBergen (ABC) has become one of the leaders in the traceability initiative. ABC is adding value as a distribution partner by taking a patient-centric approach as it supports its customers in implementing the DSCSA requirements.
“It’s been foundational to our approach that, as with any IT solution we would implement, patient safety would be clearly demonstrated and the performance of the overall supply chain improved,” says Jeff Denton, Senior Director, Global Secure Supply Chain, at ABC. “AmerisourceBergen designed its traceability solutions with future regulations in mind. This forward-thinking approach has not only allowed us to be DSCSA-compliant ahead of schedule, it also allowed us to prepare for any future regulations in the United States and across the globe.”
ABC offers a single enterprise solution for all its internal stakeholders impacted by the regulation: distribution, manufacturing, packaging, and pharmacy. The company uses a “scan service” approach with its business units where the company reduces as much impact as possible on the distribution center’s activities. The burden of processing and rules management as well as trading partner communications are held at the enterprise level instead of at the local level.
During the past two years, ABC became the only major global wholesale distributor to participate in a customer co-innovation project with SAP, in an effort to develop a new software solution from the ground up. In addition, the company has made public their intention to standardize on SAP’s newly announced product — Advanced Track and Trace for Pharmaceuticals (ATTP).
“In our process of adopting ATTP, we were guided by some basic principles,” Denton says. “One is that we wanted to standardize on one system that could be used throughout our diverse organization. The other is that our operations have become global, and we wanted a system that could be adapted to both the US requirements as well as those of other countries.” He notes, “AmerisourceBergen has its own packaging operations, so we have experienced some of the same complex issues that manufacturers have seen in adjusting the packaging lines for barcoding and tracking solutions.”
Embedded in the choice of ATTP is ABC’s commitment to the use of GS1 Standards, including the use of EPCIS messaging with Global Trade Identification Numbers (GTINs) and Global Location Numbers (GLNs). “As of today, no one is using EPCIS messaging in pharma distribution,” he says. “The industry is unclear on how well data will be stored and reported when all the traceability elements are in place with serial numbers. Our expectation is that we will be able to handle the data collection and reporting requirements with a combination of EPCIS messaging, ATTP, and a cloud solution. We recognize that data volume will be massive.”
As Denton sees it, the current industry requirement under DSCSA is taxing the systems that use EDI data with Advanced Shipping Notice (ASN) formats, and it won’t be feasible when item-level traceability becomes the requirement. “This is why we will also be migrating to a cloud solution to handle the new message traffic and size of data files being passed to and from our trading partners.”
Another of Denton’s expectations is that business value will be found in item-level traceability (most organizations are approaching it primarily as a compliance requirement). “We must be prepared for any needs and capture as much data as possible related to our secure supply chain. There are many business units in our organization that may find value in the data,” he says. “We have no idea where this may go, but I’m confident that business value will be found.”
AmerisourceBergen will be rolling out ATTP throughout its organization over the next year (some of this involves a conversion from an earlier SAP product, known by its acronym OER), and soon adding a new Cloud solution too. “More than 200 of the best minds in our industry and in our organization have been involved with the DSCSA effort and will continue to be involved as we transition to serial number management.”
The company is also working actively with the Healthcare Distribution Management Assn (HDMA), GS1 US, GS1 Global, the Pharmaceutical Distribution Security Alliance (PDSA) and others for pilot programs of traceability systems over the next few years.