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Panelists: Sluggish pace of DSCSA testing is worrisome

Posted 04 May 2021 | By Joanne S. Eglovitch 

Panelists: Sluggish pace of DSCSA testing is worrisome

In a recent traceability forum, the pharmaceutical industry and other trading partners were told to start testing their data systems now to ensure that any glitches are ironed out before prescription drug products must be electronically tracked through the supply chain to ward off counterfeiting. The Drug Supply Chain Security Act (DSCSA) mandates that these systems go live in November 2023.
 
To ensure readiness, panelists participating in the 29 April Healthcare Distribution Alliance (HDA) forum also urged manufacturers to take a step-wise approach to implementing the data exchange requirements.
 
DSCSA requires that all supply chain partners track their products through the supply chain and share specific information on transactions, including transaction information and transaction statements, also called the “master data.” These data must be exchanged in a fully interoperable way with all trading partners, and data are to be kept for 6 years.
 
The law is silent on which type of data system to use for tracking products and exchanging information with trading partners. In the absence of a mandate, most stakeholders are aligning around the use of EPCIS (Electronic Product Code Information Services), a GS1 Standard for their data exchange. GS1 is a neutral, nonprofit global organization that develops and maintains global supply chain standards. (RELATED:  Companies collaborate on DSCSA guideline as deadlines approach, Regulatory Focus 26 November 2016)


Jeff Falardeau, the manager of pharmaceutical information technology for Cardinal Health, said that “For now, we are a little concerned about the number of manufacturers that still need to jump in the pool and start testing for 2023.”
 
Lack of readiness biggest challenge
 
When asked to identify a key obstacle to implementing the last major part of DSCSA, panelists agreed that trading partners are behind in getting these data systems up and running.
 
Brad Pine, the vice president of brand pharma and regulatory for Smith Drug Company, said that “our biggest challenge is getting manufacturers to send us EPCIS.” He added that while many of the larger manufacturers are going ahead and testing these systems, many of the smaller ones are not.

“The larger manufacturers will handle this, while the smaller manufacturers are relatively clueless. I was talking to one the other day and they said, ‘Yes, we have all the information.’ I said, ‘How are you going to get it to me? They said, ‘Oh, I have to send it to you?” recounted Pine.
 
Pine also projected that many manufacturers will also wait until the last minute to send their EPCIS data. His company is working to onboard “300-plus manufacturers” with exchanging this information. “What is going to happen is that manufactures are all going to have to come to us at the same time, so it will be a juggernaut.”
 
He further noted that the “big three” warehouse distributors are also “pushing the issue.” The big three wholesale distributors are AmerisourceBergen, McKesson and Cardinal Health.
 
Falardeau concurred that “we are seeing technical challenges, a lack of readiness. Some companies are very proficient, and others are less so.”
 
Manual data pulling

Currently, many trading partners are manually pulling transaction data and putting this information on spreadsheets.
 
Allison Sheldon, the senior manager of digital serialization at Pfizer, said that “right now we are pulling data from our internal systems and making spreadsheets and going back and forth with our trading partners to make sure we are exchanging all the data.”
 
Urges step-wise approach
 
Sheldon said that to ensure readiness, manufacturers need to take a step-wise, incremental approach in testing these systems manually and electronically well before the November 2023 deadline.
 
The first step, which should last about two weeks, is to exchange the required master data manually with trading partners. The next step is to establish a master data configuration to illustrate how these data would be exchanged electronically with partners; this process should last about a week. The next step is to test connections between systems, which should last about two weeks. The last step is to align this system with all trading partners, a process lasting about one week.
 
Sheldon said that this onboarding path should be done in the next year and a half as “process changes do not happen overnight.”
 
Exceptions management is key
 
Besides the data exchange component, another major area for manufacturers to address is “exceptions management,” or knowing how to handle the products that do not have identifiers and cannot move through the supply chain.
 
Michael Ventura, the vice president of solutions and innovations for LSPediA, asked, “Do you have the systems in place to manage this? Exception management will be critical.”
 
Ventura added that “everyone has a role to play in 2023; the window is two years. A lot of folks have not done anything to meet this goal. People must test like they mean it. We are all in this together.”
 
“Full adoption for the exchange with manufacturers is key,” emphasized Jeff Falardeau of Cardinal Health. “We can’t ship products if we don’t have the data.”
 
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Tags: DSCSA, EPCIS, FDA

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