Respondents: Pharmacies are still lagging in the compliance requirements that will be in effect in November 2023
The sixth annual Serialization Readiness Survey, a poll of manufacturers and distributors, is out from the Healthcare Distribution Alliance (HDA). As in past years, the main worries are how broadly manufacturers are readying their IT systems to convey required transaction data to their trading partners—specifically, wholesaler-distributors. The worries of early years, in getting readable barcodes on individual packages, have faded but not disappeared. All this is happening in the context (in the US) of the Drug Supply Chain Security Act (DSCSA), which has a November 2023 deadline for a fully interoperable, electronic data-sharing system that can track individual pharmaceutical packages from point of origin to point of dispensing.
Key findings of the 2021 survey, which involved a relatively small number of manufacturers (around 40) and distributors (25) responding last May:
- Forty percent of manufacturers are currently sending or plan to send, by the end of 2021, at least some serialized data to their wholesale distributor customers upon shipment. Forty-three percent plan to do so by November 2023. Another 16% are still unsure of when they plan to exchange data with wholesale distributors via EPCIS for all products.
- Over the past three years, the number of manufacturers planning to send serialized data with 100% of product has fallen to 12% from 35% (2020) and 21% (2019). Most manufacturers, 65%, anticipate sending 100% of data with shipped product by 2023, when it is legally required.
- “Aggregation”—the process of compiling all the individual package serial data when shipping in a case or pallets—is essential for distributors to maintain their workflows. The pace of adding this capability at manufacturers has slowed: While 45% are currently aggregating, 56% planned to aggregate by the end of 2019 in the 2019 and 2020 surveys. Now, nearly 40% will do so by 2023. This number is up from a quarter last year, indicating a shift in timelines.
- Distributors are still preparing for data exchange. Only 60% of distributors can accept serialized data today. However, approximately 48% are receiving serialized data for between 1% and 5% of transactions.
- Two-thirds of manufacturers anticipate using the verification router service (VRS) to support verification requests of non-direct purchasers. With the FDA granting enforcement discretion on the saleable returns requirement until 2023, 56% of distributors have no concerns with meeting this deadline, while 44% still have concerns. The key concerns cited are “challenges with VRS,” “accuracy” and “completeness of data exchange.”
- Dispenser knowledge of DSCSA requirements remains inconsistent and is generally low, especially among independent pharmacies, according to distributor respondents.
“The uneven state of readiness among supply chain partners has likely been exacerbated by operating under the pressures of the Covid-19 response,” notes Perry Fri, EVP, industry relations for HDA. “However, our findings also illustrate the range of interpretations and information gaps that must be overcome within the next two years. Educating trading partners, such as the dispenser community, and aligning on requirements will be crucial to getting implementation over the finish line.”
This year’s survey was sponsored by LSPediA and Movilitas, two solution providers.