DSCSA
From Data to Labor: Manufacturers Are Trying to Make Sense of Traceability Requirements KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. HDA surveys reveal much work is needed to meet 2023 DSCSA requirements.
2. Aggregation, a prerequisite to sending serialized transaction data, has slowed.
E
xperts continue to sound the alarm on DSCSA compliance progress in the pharmaceutical manufacturing industry, both on implementing GS1 Electronic Product Code Information Services (EPCIS) and trading partner plans for exchanging data. The upcoming November 27, 2023, DSCSA compliance date requires transaction data with product identifiers to be provided with physical product. As Jeff Falardeau, Manager, Pharmaceutical Information Technology at Cardinal Health, said at the Healthcare Distribution Alliance (HDA) 2021 Traceability Webinar Series in April, “…we’re just really concerned about the runway left and the number of manufacturers that still need to jump in the pool here and start testing with us before 2023.”
3. One company says outbound scanning may require a 12 to 15% increase in their headcount.
• 59% of manufacturers report they are not currently sending data to distributors—HDA says manufacturers cite “delays due to either past or potential future enforcement discretion” as the top obstacle to implementing EPCIS at 43%. • More than half (57%) of manufacturers have no successful connections in a production environment today. • Most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with distributors’ dispenser customers. • A typical 3PL currently is working to connect an average of 67 manufacturer clients.
Watch this video on exchanging master data via EPCIS files: hcpgo.to/dataexchange
EPCIS work continues In September, HDA’s Research Foundation released its inaugural report, EPCIS Implementation Benchmarking Survey, enlightening industry trading partners on the status of successful data connections, defined as “[connections that are] fully integrated and working in a production environment,” and highlighting perceived obstacles to implementation. The 16-page report reflects responses from 70 companies across the pharmaceutical supply chain, including manufacturers, distributors, and 3PLs. The results offered some startling statistics, including the following:
↑ Many companies already face labor shortages. Inbound and outbound scanning will add to distribution employee workloads.
22 | Healthcare Packaging • November/December 2021
GEO_0621_F4.indd 22
12/1/21 5:20 PM
