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Regulatory Focus™ > News Articles > 2021 > 9 > Pharmaceutical trading partners lagging in exchanging electronic product information

Pharmaceutical trading partners lagging in exchanging electronic product information

Posted 24 September 2021 | By Joanne S. Eglovitch 

Pharmaceutical trading partners lagging in exchanging electronic product information

Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.
Roughly half of manufacturers and distributors say they are currently exchanging EPICIS Electronic Product Code Information Services (EPICIS) data with each other, while these data are not being exchanged at all between distributors and dispensers, according to a recent survey by the Healthcare Distribution Alliance (HDA) Research Foundation.
Justine Freisleben, vice president of industry relations with HDA, said the group is “concerned” about readiness. “2022 is going to be a really critical year for building out anything else that’s still being designed and implementing all of these connections and processes,” Friesleben told Focus. “Supply chain partners need to be mindful of the lessons learned previously and shouldn’t expect to simply ‘flip a switch’ and have data flowing with product perfectly on November 27, 2023.”
DSCSA is silent on which type of data system to use for tracking products, and in the absence of a mandate, most stakeholders are aligning around the use of EPCIS, a GS1 standard for their data exchange. GS1 is a neutral, nonprofit global organization that develops and maintains global supply chain standards.
The HDA foundation survey, conducted from April to June 2020, assessed the current readiness of trading partners to meet the DSCSA requirements. It was distributed to 52 manufacturers, 21 distributors and five third-party logistics providers (3PLs).
Manufacturer readiness
The survey found that 59% of manufacturers are not sending EPCIS data to distributors, while 29% are sending data to one to six distributors; the remainder are sending data to 20 to 40 distributors.
The top cited reason for not sending ECPIS data to distributors is that there are not enforcement consequences for not doing so. The US Food and Drug Administration (FDA) announced last year that it would not take enforcement actions against partners that do not have the necessary electronic systems to verify saleable returns until November 2023. (RELATED: FDA delays enforcement of some DSCSA provisions by three years, Regulatory Focus, 26 October 2020).
Such enforcement discretion was cited by 43% of respondents, followed by the following reasons:
  • Industry is moving too slowly to implement EPCIS
  • Company lacks resources to adopt the standards
  • Lack of standards or lack of adherence to the standards
  • Need for IT upgrades to implement the standards
  • Company is prioritizing internal error resolution
Yet the overwhelming majority of manufacturers, 84%, say they are preparing to implement these systems. “While those manufacturers have implemented this current version of the standard, this does not necessarily mean data are being exchanged, and the transition to EPCIS 1.2 should only be viewed as a necessary, preparatory step,” said the survey.
Similar results for distributors
The survey found similar results for distributors, with 50% reporting they have established EPCIS connections with manufacturers. The top obstacle, reported by 75% of distributors, was “lack of trading partner commitment” in getting these systems in place.
Distributors report having no connections with dispensers. Forty-three percent say there are no plans to have direct connections to dispensers once the law goes into effect. Respondents said that “many dispenser customers” plan to use a portal supplied by the wholesale distributors to exchange transaction data.
The survey concludes that trading partners have a “significant amount of work to do” to meet the 2023 deadline. "Overall, the industry is in an initial stage of achieving EPCIS interoperable connections and data exchange with each other in a production environment. While many manufacturers have prepared internally to send data downstream with the transition to EPCIS 1.2, very few are sending data in production today."

Panelists at a traceability forum earlier this year said that trading partners are behind in getting these data systems up and running, when asked to identify a key obstacle in implementing the last major part of DSCSA. (RELATED: Panelists: Sluggish pace of DSCSA testing is worrisome, Regulatory Focus 4 May 2021)
“There’s much work to be done and the industry needs to focus on setting up connections, identifying and correcting issues, and educating the segments of the supply chain who have not been engaged to date or are holding off for FDA or work groups to release additional information,” cautioned HDA’s Freisleben.
The survey was sponsored by distributor AmerisourceBergen and solution providers Antares Vision Group, LSPediA, and TwoLabs.
HDA survey


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