Pharmaceutical trading partners are slow to exchange electronic product information

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Posted on September 24, 2021 | Through Joanne S. Eglovich

Pharmaceutical trading partners are behind schedule in exchanging electronic product information under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires such exchanges to be in place by the 27th. November 2023.

About half of manufacturers and distributors say they are currently exchanging EPICIS Electronic Product Code Information Services (EPICIS) data, while this data is not exchanged between distributors and distributors at all, according to a recent Healthcare survey. Distribution Alliance (HDA) Research Foundation.

Justine Freisleben, vice president of industrial relations with HDA, said the group was “concerned” about the preparation. “2022 is going to be a really critical year to build whatever is still being designed and implement all of these connections and processes,” said Friesleben. To concentrate. “Supply chain partners should be aware of the lessons learned previously and shouldn’t expect to just ‘flip a switch’ and data flow flawlessly with the product on November 27, 2023.”

The DSCSA is silent on what type of data system to use to track products, and in the absence of a mandate, most stakeholders are aligning themselves with using EPCIS, a GS1 standard for their exchange of information. data. GS1 is a global, neutral, non-profit organization that develops and maintains global supply chain standards.

The HDA Foundation survey, conducted from April to June 2020, assessed the current readiness of business partners to meet DSCSA requirements. It was distributed to 52 manufacturers, 21 distributors and five third-party logistics providers (3PL).

Manufacturer preparation

The survey found that 59% of manufacturers do not send EPCIS data to distributors, while 29% send data to one to six distributors; the others send data to 20 to 40 distributors.

The main reason given for not sending ECPIS data to distributors is that there are no application consequences for not doing so. The United States Food and Drug Administration (FDA) announced last year that it would not take any enforcement action against partners who do not have the electronic systems to verify salable returns until November 2023. (RELATED) : FDA delays implementation of certain DSCSA provisions by three years, Regulatory guidance, October 26, 2020).

This enforcement discretion was cited by 43% of respondents, followed by the following reasons:

  • Industry moving too slowly to implement EPCIS
  • The company lacks the resources to adopt the standards
  • Lack of standards or non-compliance with standards
  • Need IT upgrades to implement standards
  • The company prioritizes the resolution of internal errors

However, the overwhelming majority of manufacturers, 84%, say they are preparing to put these systems in place. “Although these manufacturers have implemented this current version of the standard, this does not necessarily mean that data is being exchanged, and the transition to EPCIS 1.2 should only be seen as a necessary preparatory step,” the survey said. .

Similar results for distributors

The survey found similar results for distributors, with 50% of them claiming to have established EPCIS links with manufacturers. The main obstacle, reported by 75% of distributors, was the “lack of engagement of business partners” in setting up these systems.

The distributors declare that they have no connection with the distributors. Forty-three percent say there are no plans to have direct connections with distributors once the law goes into effect. Respondents said that “many distributor customers” plan to use a portal provided by 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 phase of achieving EPCIS interoperable connections and exchanges. of data between them 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 into production today. “

Panelists at a traceability forum earlier this year said trading partners are behind in setting up and running these data systems, when asked to identify a key barrier to the implementation of the last major part of the DSCSA. (RELATED: Panelists: The slow pace of DSCSA tests is worrying, Regulatory guidance May 4, 2021)

“There is a lot of work to be done and the industry needs to focus on making connections, identifying and correcting problems, and educating segments of the supply chain that do not have been engaged to date or waiting for the FDA or task forces to release additional information, ”HDA’s Freisleben warned.

The survey was sponsored by distributor AmerisourceBergen and solution providers Antares Vision Group, LSPediA and TwoLabs.

HDA survey

© 2021 Society of Regulatory Affairs Professionals.



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