As one of the Big 3 wholesale drug distributors in the US and the biggest employer in Ohio, Cardinal Health onboarding 450 manufacturer trading partners for EPCIS data exchange in 2022 is a mission critical project. This project will support Cardinal Health’s new supply chain operation in Nov. 2023 under the mandate for the FDA’s Drug Supply Chain Security Act.
To protect patient safety, the FDA is undertaking the biggest project in US drug supply chain history. It will transform the drug manufacturing and distribution from “how many” to “which one” using serialization. The single most important vehicle for tracing ”which one” is the EPCIS data that facilitates the exchange of serialized data between two trading partners.
Cardinal Health EPCIS Requirement
In order to help prepare trading partners for the transition, Cardinal Health and LSPediA are hosting a monthly virtual workshop on using Investigator for EPCIS data exchange. The first of these workshops took place on Nov. 17, 2021 with more to follow on the third Wednesday of each month.
Jeff Falardeau, Manager of Pharmaceutical Information Technology at Cardinal Health, gave a presentation on the timeline and operational process for his company. He also laid out potential pitfalls and proper practices, as well as a guide on where to start in the process of onboarding.
As of today, about 10 percent of Cardinal Health’s manufacturer trading partners are sending production EPCIS data. This number has to increase rapidly in 2022 to support Cardinal Health’s planning for 2023. That shifts resources to focus on outbound shipping and outbound EPCIS data exchange with their dispenser customers.
“Cardinal Health has articulated the EPCIS requirement to suppliers to have them sending us serialized aggregated data one year in advance, so that would be a year from November 27th,” Falardeau said. “So, it’s imperative that suppliers do work with us to have this data to us by the timeframe that we’re asking, because we really need that time to stabilize and provide our dispensers with the appropriate amount of focus, so that they can be successful as well.”
Trading Partner Readiness
A poll taken during the workshop indicated that 21% of Cardinal Health’s manufacturer suppliers that were participants in the workshop are currently exchanging EPCIS data in either the test environment or the production environment. Another 18% would begin to test EPCIS data with Cardinal Health the first quarter of 2022, and 22% in the second quarter of 2022. Perhaps cause for concern was that nearly 24 percent indicated they would not begin EPCIS exchange until the fourth quarter of 2022.
Participants had a lengthy question and answer session with Falardeau and LSPediA’s Andrew Meyer. One question asked if Cardinal Health would be able to receive EPCIS data without aggregation.
“Technically, we can receive it, but we don’t want it,” Falardeau said. “We can’t make much use of it in future state. Cardinal Health really can’t do anything with the non-aggregated data in terms of either using it in receiving or outbound shipping. So, we prefer not to get non-aggregated data.”
If you fail to plan, then you are planning to fail. A good plan is not complete without risk management. The workshop asked the manufacturer attendees what could cause the delays on their end for EPCIS data exchange. The audience overwhelmingly pointed that the readiness of their current solutions is in question. Other potential pitfalls are resource constrains and readiness of their own supply chain partners. That includes CMO and 3PL partners. Lastly, 15% of the audience did not rule out the possibility of another FDA enforcement discretion.
Collaboration between trading partners is essential for DSCSA implementation. Falardeau said he appreciated the level of engagement and the quality of questions asked and looked forward to future workshops. He encourages manufacturer trading partners to “work proactively with distributors to send and stabilize the data over the next 12 months.” The first step for manufacturers is to start onboarding with Cardinal Health today.
Taking The First Step
LSPediA and Cardinal Health will host the next workshop on Dec. 15, 2021. The topic will delve into the details of Cardinal Health’s EPCIS process flow using Investigator. To register for the next and future workshops, click here. You can get the workshop agenda here.
Enhanced Security Solution
For manufacturers who are concerned about their solution readiness, the Enhanced Drug Distribution Security requirement presents both technical and operational challenges. The solution must be in place to enable the operations. To that end, manufacturers are encouraged to take the forward-looking position to evaluate Investigator and LSPediA’s OneScan solution for their own adoption at the enterprise level.
Investigator is built with hundreds of GS1 data rules and complex business algorithms. It detects EPCIS errors in seconds and sends real-time alerts to CMOs. It also facilitates the outbound EPCIS data exchange by receiving outbound shipping data from 3PL, WMS, or any EPCIS system. Then it churns out the perfect EPCIS data file for your wholesale distributor customers.