HDA study rings alarm bells over DSCSA preparedness

A survey of pharma manufacturers, distributors and third-party logistics (3PL) companies has found there is still a long way to go before industry is ready to meet the FDA's timeline for medicines traceability.

Under the Drug Supply Chain Security Act (DSCSA), transaction data with unique product identifiers needs to be provided alongside physical drug products on November 27, 2023, and shareable with trading partners.

The survey focuses on transfer of information to partners using GS1's Electronic Product Code Information Services (EPCIS) - the format standard recommended in FDA guidance – and overall finds that the industry is still in the "initial stage" of implementation.

According to the results of the study, 59 per cent of manufacturers said they were not yet sending EPCIS data to medicine distributors for example.

The top reason for not doing so – cited by 43 per cent of respondents – was "delays due to either past or potential future enforcement discretion," according to Healthcare Distribution Alliance (HDA), an industry group which represents pharma distributors.

At the same time, most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with distributors' dispenser customers. Only half of distributors are setting up connections today, says the report, 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.

Three quarters of distributors identified a "lack of trading partner commitment" as the top obstacle to implementing EPCIS, according to the HDA.

A sizeable proportion of manufacturers (38 per cent) are planning to use a 3PL to manage connections downstream. But while 3PLs estimate they will need on average to connect with around 67 manufacturer clients, so far the average is around 10, with another five 'in process'.

"Though the deadline for sharing transaction data is two years away, many healthcare supply chain trading partners are realising there is work to be done to establish proper business-to-business connections," said Perry Fri, chief operating officer of the HDA Research Foundation.

That workload includes ensuring data are formatted, transmitted and received successfully, processes for troubleshooting are created, and that products in inventory have the right data attached to them for shipping after November 27.

"FDA's expectations around reaching the 2023 milestone on time are clear," commented Justine Freisleben, the HDA's vice president of industry relations.

"Knowing this, HDA urges trading partners to plan ahead, commit to implementing a solution as soon as possible, and work with their peers to achieve compliance — and for the continued safety and reliability of the US healthcare supply chain," she added.