Manufacturers that are not testing DSCSA data systems now are in 'big trouble'

Regulatory NewsRegulatory News | 08 August 2022 | By

While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these systems go live next November, said experts who recently spoke to Regulatory Focus.
 
Trading partners, for example, need to start testing and piloting data exchanges now to iron out any glitches early on, and manufacturers in particular need to pay special attention to the accuracy of the data being exchanged to prevent rejections of good products that are not counterfeit.
 
For its part, the US Food and Drug Administration (FDA) needs to clarify whether web portals will be allowed for data exchanges, particularly for small companies that do not have the resources to build tracing systems. The agency also needs to finalize its proposed rule on licensing standards for third-party logistics providers (3PLs).
 
Experts also discussed what supply chain trading partners need to do to prepare for next November’s deadline when these systems go live, and efforts being made to ensure a smooth transition. Beginning on 27 November 2023, DSCSA requires manufacturers, wholesalers and distributors and dispensers to exchange serialized product information and culminates the last major stage of the law’s implementation.
 
Extraordinary amount of progress
 
Perry Fri, executive VP of industry relations for the Healthcare Distribution Alliance (HDA), said industry has made an “extraordinary amount of progress” in the past few years in implementing DSCSA.
 
“I can’t sit here and guarantee that 100% of everything is going to work on 27 November 2023, but I have confidence that the massive amount of industry will be there.”
 
Fri said FDA’s issuance of a draft guidance on standards recommending the use of GS1’s Electronic Product Code Information Services (EPCIS) standard to transmit information through the supply chain, was an important development in facilitating DSCSA development. The guidance was issued in July. (RELATED: FDA publishes two critical DSCSA draft guidances, Regulatory Focus 5 July 2022)
 
Fri said FDA’s endorsement was important as wholesalers and distributors are expecting to finish up EPICS data exchange pilots with manufacturers this year, and all of 2023 will be taken up in conducting data exchanges with pharmacists.
 
Eric Marshall, the executive director of the Partnership for DSCSA Governance (PDG), also applauded the endorsement of EPCIS in FDA’s guidance. “Industry has been encouraging that kind of endorsement [of EPICS] for a while.” PDG is a consortium of 70 trading partners and technical experts and is an FDA public-private partnership defining data architecture for tracking products.
 
PDG is developing four additional chapters of a blueprint to assist industry in setting up the electronic systems necessary to comply with DSCSA. Marshall said the group aims to have these chapters ready for publication this fall. They will join the first chapter of the blueprint, which was released last July 2021. (RELATED: Industry consortium releases blueprint for DSCSA tracking systems, Regulatory Focus 16 July 2021)
 
Big trouble if not testing
 
David Mason, regional serialization lead for Novartis, said it’s essential that manufacturers start testing their systems and exchanging data now with their trading partners to iron out any data glitches early on.
 
“From what I’m hearing, if you are a manufacturer or a wholesaler and you have not started” to test the data exchange “you are in big trouble, you have a risk of not making it.”
 
He added “you can’t just turn the switch on in November.”
 
Data management crucial
 
Mason stressed the importance of having a robust data management system to ensure all the data that moves down the supply chain and back is correct, and errors are caught early on. “I would tell you that [this issue] will create problems with products moving through the supply chain, if we do not put a high bar on it.”
 
If there are issues, or problems with the barcodes or the labels “you can’t scan the product and you can’t move the product.”
 
In recognition of the importance of data accuracy, Novartis hired a data analyst four years ago whose sole job is to manage the data and ensure there is 100% reconciliation with packages and serial numbers for products moving through the supply chain.
 
“A lot of companies don’t understand data integrity. They are not maintaining their data properly…and it’s creating a lot of problems downstream.”
 
Problems arise when there are aggregation errors, using the wrong GS-1 Global Location Number (GLN), or the bar codes don’t match with the EPCIS message.
 
Even Novartis, which has been exchanging data with a CMO for three years is “still seeing issues with data and data maintenance.”
 
FDA needs to allow portals for data exchange
 
One area of uncertainty is whether FDA will allow small companies, such as dispensers, to use secure web portals to access data instead of requiring them to build tracing systems, said Mason. The draft guidance on standards for data exchange, while recommending EPCIS as a data standard, was silent on whether trading partners can use portals for data exchanges.
 
“We need that portal solution. The last guidance did not clarify, it endorsed EPCIS, which I have to recognize that was a huge step and we appreciated that. But we need to go back and clarify that we need a portal solution too.”
 
The portal is a website provided by manufacturers, or the sellers of the drug, to its trading partners that buy the product, that enables access to the drug transaction information.
 
Mason said that many trading partners, in particular smaller dispensers, or companies that are not a large pharmacy chain, such as Walgreens, CVS or Krogers, are going to need these portals.
 
“You have 60,000 plus trading partners in the US supply chain and most of them are not sophisticated enough or have the capital or have the infrastructure to build systems to collect this data. They need us to develop portal solutions where they can pull the data,” he said.
 
FDA needs to finalize 3PL rule
 
Fri at HDA said FDA also needs to finalize its licensing rule on wholesalers and third-party logistics providers (3PLs). A proposed rule was issued in February (RELATED: FDA issues long-awaited licensing rules for drug distributors and 3PLs, Regulatory Focus 3 February 2022)
 
“The proposed rule on 3PLs has some good points but it would be good to get those finalized,” Fri said.
 
DSCSA mandates that pharmaceutical manufacturers only accept drug products from “authorized trading partners” or parties that are properly licensed or registered to receive or transfer products. Authorized trading partners include manufactures, repackagers, dispensers, wholesale distributors and 3PLs.
 
No On/Off switch
 
Marshall said that DSCSA implementation will be an iterative process, rather than an abrupt switch. “Given this is an interoperable system of systems, 2023 will be the beginning and not the end; it won’t be one switch that gets turned on in November,” he said.
 
Mason said it is unrealistic to expect that DSCSA implementation will be problem-free, and that all supply chain trading partners will have these systems up and running by next November. He said, for instance, that there are still implementation issues with the EU’s Falsified Medicines Act (FMD), which has been in effect since 2011.
 
“If you look at Europe ... they still have gaps, and they are still working on issues,” Mason said.

 

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Tags: DSCSA, FDA

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