Although manufacturers and distributors continue to make progress on DSCSA connections, the pharma supply chain still may not be on pace for a smooth November 2023, according to new data from the Healthcare Distribution Alliance's Research Foundation.
Toward the end of 2022, HDA published its annual Serialization Readiness Survey (reflecting responses in June 2022). At that point, the authors expressed concern that progress on DSCSA requirements was "uneven," with particular challenges in interoperability and collaboration.
The report noted that forming interoperable connections to support DSCSA data transactions can require weeks or even months. As this must be done for each pair of trading partners (e.g. a company with 50 partners must form 50 connections), it's a dangerous aspect to put off. Under the law, product cannot move through the supply chain if the transaction data accompanying (or preceding) it is missing, lacks the product identifier, or is otherwise incomplete. (Consequently, trading partners are also called upon to have means of investigating suspect transactions.)
Further, distributor respondents said that DSCSA was not well understood across their dispenser customers, fueling worries that many would be unable to easily roll out DSCSA-compliant solutions in the time remaining to the enforcement deadline.
HDA's recent Implementation Benchmarking Survey, reflecting the end of Q3 2022, indicates that the industry is showing further progress on forming connections between trading partners, with manufacturers reporting that 51 percent of their connections to distributors were either "in progress" or "completed."
Distributors' results showed an increase in "in progress" or "completed" connections to their suppliers, with the number among small and mid-sized suppliers reaching 22 percent, and the number among large suppliers climbing to 56 percent. There were also a higher number of distributors' connections to dispensers, with “in process” and “completed” connections growing to 46 percent.
Separately, the report shows continued momentum on EPCIS, with 88 percent of manufacturers and 75 percent of distributors having already adopted EPCIS 1.2. (The authors note that a decline from 92 percent in its previous benchmarking survey, due to an overall increase in respondents.)
Also measured were the perceived benefits of adopting EPCIS. Thirty-one percent of manufacturer respondents said they were seeing benefits from DSCSA compliance, while 37 percent said it was too early for them to benefit. The leading benefits cited were satisfying DSCSA compliance via the use of GS1 standards and the US EPCIS 1.2 Implementation Guideline; standardization and interoperability; and efficient data capture and transfer.
HDA asked manufacturer respondents to rank their obstacles to EPCIS implementation from 1 (greatest impact) to 12 (least impact). The top answers reflected challenges in access to employee resources; lack of understanding among trading partners; and the time to onboard trading partners. This is broadly in line with the previous fears in the Serialization Readiness Survey, bringing into sharper focus the need for organizations to prepare their workforces.
The authors express optimism on the pharmaceutical supply chain's progress toward "sharing transaction data in an efficient and interoperable manner," but the results aren't enough to dismiss the challenges and "lingering obstacles" that remain, including "a perceived lack of trading partner understanding, commitment and engagement in the process of exchanging transaction data."
Further, the report highlights issues regarding the staffing needed for DSCSA implementation, citing a "problematic" lack of IT workforce and employee resources.
The importance of training can't be emphasized enough -- many organizations may be planning for DSCSA without ensuring that they have staff with a deep understanding of how the new requirements apply to their business. For this reason, LSPedia offers DSCSA training classes aimed at creating subject experts, including detailed, practical exercises.
Also, check out this LSPedia post from January to learn more about DSCSA interoperable connections -- and how you might be able to make them easier.