Posted on March 21, 2022 | By
Pharmaceutical manufacturers are behind distributors in testing electronic connections with trading partners, the November 2023 deadline for setting up these systems under the Drug Supply Chain Security Act (DSCSA), according to a recent survey by the Healthcare Distributors Alliance (HDA).
DSCSA requires that by November 2023, prescription drugs must be electronically tracked throughout the supply chain to prevent counterfeiting. In November 2014, the FDA released draft standards guidance for this interoperable exchange of information that recommends the use of EPCIS, a global GS-1 standard, or the creation and sharing of movement transaction data. products in the supply chain. The guidelines are not yet finalized.
The HDA survey was conducted from October to December 2021 to assess the current readiness of trading partners to meet DSCSA requirements. It has been distributed to 40 manufacturers, 16 distributors and four third-party logistics providers (3PLs).
The survey results are similar to those of the previous update in indicating a lack of industry readiness for the exchange of electronic product information. (RELATED: Pharmaceutical business partners late in exchanging electronic product informationRegulatory guidance September 24, 2021)
The survey found that while 88% of manufacturers have moved to EPCIS, a smaller number are actively testing these systems with trading partners. The report states that the transition to EPCIS “should only be seen as a necessary preparatory step”.
Fifty-five percent of manufacturers say they “are not currently connecting with distributors.”
Some of the top reasons cited by manufacturers, both branded and generic, for not switching to EPICS include lack of human resources (12), lack of guidance (11), potential enforcement discretion (10), IT resources (10), business partner understanding (9), employee knowledge (5), third-party vendor availability (4), and financial resources (1). Fourteen cited other reasons.
On the other hand, the survey revealed that distributors are making more progress in setting up these connections. “More distributors (69% versus half in the last survey) are making connections today, and it will be important that the rest of the industry starts making those connections as well if we are to achieve the goal of interoperability by 2023.”
A recurring theme in past surveys is that “there is no connection between distributors and providers today. Respondents noted that this lack of direct connections may be because many of the retailer’s customers consider accessing a portal provided and maintained by the retailer; as reported at HDA’s recent distribution conference, distributors likely won’t tune in until Q1 2023.”
The survey concludes that “Overall, the industry continues to be in the early stages of realizing interoperable EPCIS connections and data exchange 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 in production today.
“Industry stakeholders will have a lot of work to do over the next six quarters to meet this deadline, and it will be essential to overcome identified obstacles, such as ‘lack of commitment from business partners’ and ‘ dedicated IT and human resources,'” he said. Noted.
Justine Freisleben, Vice President of Industry Relations at HDA, said that “supply chain partners have their work cut out over the next six quarters. While we recognize that many manufacturers have made progress in exchanging data via EPCIS, very few send it to production.”
The survey was sponsored by distributor AmerisourceBergen and solution providers Antares Vision Group, LSPediA and TwoLabs.
Pharmaceutical industry groups have claimed that they are not officially incorporating EPCIS until the FDA formally approves its use. (RELATED: FDA Invited to Approve EPCIS to Boost Manufacturers’ Adoption of DSCSARegulatory guidance November 17, 2021)
© 2022 Society of Regulatory Affairs Professionals.