Pharma's DSCSA readiness "uneven", finds HDA poll

The pharma industry and its trading partners are making "uneven" progress in implementing the requirements of the Drug Supply Chain Security Act (DSCSA), two years ahead of its most critical deadline.

That is according to the latest readiness report by the Healthcare Distribution Alliance (HDA), which suggests that trading partners are deferring the investments needed to meet the DSCSA requirements, aimed at providing a 'plant to patient' traceability scheme for medicinal products.

Delaying these investments to 2022 or even 2023 "could hinder overall supply chain compliance with the federal traceability law," although the HDA acknowledges a factor may be the disruption and changing priorities caused by the COVID-19 pandemic.

One of the facets of the DSCSA is aggregation – linking each medicine pack to the case or pallet in which it is shipped – and the latest survey suggests that implementation has slowed.

While 45 per cent of manufacturers are currently aggregating, the latest results suggest timelines are shifting.

The findings reveal that while 56 per cent planned to aggregate by the end of 2019 in the 2019 and 2020 surveys. Now, nearly 40 per cent will do so by 2023, up from a quarter last year, indicating a shift in timelines.

All told, 40 per cent of manufacturers are currently sending or plan to send, by the end of 2021, at least some serialised data to their wholesale distributor customers upon shipment. 43 per cent plan to do so by November 2023, but another 16 per cent are still unsure of when they plan to exchange data with wholesalers for all products.

40 per cent of distributors meanwhile are still not prepared to accept serialised data and – of the 60 per cent that are doing so – 48 per cent are receiving serialized data for only between 1 and 5 per cent of transactions.

There are also lingering worries about complying with the FDA's deferred requirements on saleable returns, which requires wholesalers and distributors to verify the serialised unique identifiers of returned products before they can be placed into inventory for resale.

More than half (56 per cent) of distributors said they had no concerns with meeting the 2023 deadline, but 44 per cent still have concerns despite the delay from 2019, citing challenges with the verification router service (VRS) developed by supply chain stakeholders, as well as issues with accuracy and completeness of data exchange.

Meanwhile, dispenser knowledge of DSCSA requirements remains inconsistent and is generally low, especially among independent pharmacies, according to distributor respondents.

"The healthcare supply chain is entering a critical work period over the next two years," said Perry Fri, of the HDA and HDA Research Foundation.

"Our findings also illustrate the range of interpretations and information gaps that must be overcome within the next two years," he added.

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