Pharma trading partners have ‘significant’ work ahead of 2023 DSCSA deadline
Pharmaceutical manufacturers are lagging behind distributors in testing electronic connections with trading partners as the November 2023 deadline for having these systems in place under the Drug Supply Chain Security Act (DSCSA) approaches, according to a recent survey by the Healthcare Distributors Alliance (HDA).DSCSA mandates that by November 2023, prescription drug product must be electronically tracked through the supply chain to ward off counterfeiting. In November 2014, FDA issued draft guidance on standards for this interoperable exchange of information which recommends the use of EPCIS, a global GS-1 standard or creating and sharing transaction data about the movement of products through the supply chain. The guidance has not yet been finalized.
The HDA survey was conducted from October to December 2021 to assess the current readiness of trading partners to meet DSCSA requirements. It was distributed to 40 manufacturers, 16 distributors, and four third-party logistics providers (3PLs).
The survey results are similar to the previous update in pointing to a lack of readiness in industry in exchanging electronic product information. (RELATED: Pharmaceutical trading partners lagging in exchanging electronic product information, Regulatory Focus 24 September 2021)
The survey found that while 88% of manufacturers have transitioned to using EPCIS, a smaller number are actively testing these systems with trading partners. The report said that transitioning to EPCIS “should only be viewed as a necessary preparatory step.”
Fifty-five percent of manufacturers report they are “not currently in the process of connecting with distributors.”
Some of the top reasons by manufacturers, both brand and generic drugmakers, for not transitioning to EPICS include lack of employee resources (12), lack of guidance (11), potential enforcement discretion (10), IT resources (10), trading partner understanding (9), employee knowledge (5), third-party provider availability (4) and financial resources (1). Fourteen cited other reasons.
On the flip side, the survey found that distributors are making more progress in setting up these connections. “More distributors (69% as compared to half in the last survey) are setting up connections today, and it will be important that the rest of the sector also begins to make those connections to be able to meet the goal of interoperability by 2023.”
One lingering theme carried over from past surveys is that “no connections exist between distributors and dispensers today. Respondents noted that this lack of direct connections may be because many dispenser customers are planning to access a portal provided and maintained by the distributor; as indicated at HDA’s recent Distribution Conference, dispensers likely will not connect until Q1 2023.”
The survey concludes that “overall, the industry continues to be in the initial stages 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.”
“Industry stakeholders will have a significant amount of work to do over the next six quarters to meet this deadline, and addressing obstacles identified, such as “lack of trading partner commitment” and “dedicated IT and employee resources” will be critical,” it noted.
Justine Freisleben, vice president of industry relations with HDA, said “supply chain partners have their work cut out for them over the next six quarters. While we acknowledge that many manufacturers have made progress to exchange data via EPCIS, very few are sending it in production.”
The survey was sponsored by distributor AmerisourceBergen and solution providers Antares Vision Group, LSPediA, and TwoLabs.
Pharmaceutical industry groups have asserted they are not formally incorporating EPCIS until FDA formally endorses its use the use. (RELATED: FDA urged to endorse EPCIS to spur manufacturers’ uptake of DSCSA, Regulatory Focus 17 November 2021)
Benchmarking survey
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