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An easy way to understand DSCSA implementation for pharmaceutical wholesale distributors

April 28, 2023
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If you're confused about how a DSCSA implementation starts, what problems it can solve, and what its benefits are in the long term, check out this 1-minute video case study! It features Genetco, one of the largest privately owned generic distributors in the U.S.

Genetco buys from 120 manufacturers, and serves pharmacies, hospitals, and other facilities. Genetco prides itself on offering high-quality products at low prices, its same-day shipping capability, and the expertise of its team of customer service representatives.

The company recognized that DSCSA compliance was essential not only to FDA compliance, but to the profitable flow of day-to-day business. However, it faced persistent issues with erroneous data that hampered its operations.

Read on to learn more!

The Challenge

The Drug Supply Chain Security Act (DSCSA) represents a transformation of the U.S. drug supply chain. Its goal is to enable any trading partner to track, trace, and verify the status of prescription drugs at the package level, from initial production to final sale. Amid a phased 10-year rollout ending November 27, 2023, pharmaceutical trading partners must be authorized for product traceability and able to carry it out at the lot level, a requirement since 2015, and at the serial level, on the November 2023 deadline.

Since erroneous transaction data will stop product movement, Genetco sought to avert disruptive outcomes from data errors rooted in their DSCSA solution. However, its legacy provider couldn’t consistently provide complete shipment data, and – critically – didn’t integrate at all with Genetco’s ERP system. These issues resulted in recurring processing errors, which increasingly pulled personnel away from their jobs to deal with missing or incorrect 3Ts data. The legacy system also potentially posed a problem for future audits, adding unforeseeable business exposure.

“OUR PREVIOUS DSCSA SOLUTION PROVIDER WAS DIFFICULT TO WORK WITH. THEY WERE UNABLE TO CONFIGURE THE SYSTEMS THE WAY WE NEEDED OR INTEGRATE WITH OUR ERP FOR AUTOMATION, AND WE RECEIVED INCORRECT DATA.”

BILL CARNEY, VICE PRESIDENT OF OPERATIONS, GENETCO

Genetco’s Bill Carney, Vice President of Operations, began the search for a new provider rather than continue to divert time, attention, and resources away from the activities that support and grow Genetco’s business. In his search, Carney prioritized providers who could integrate with Genetco’s business operations, reduce or eliminate product quarantine time for inbound receipts, demonstrate versatility and cost effectiveness, and who shared Genetco’s commitment to customer service. Further, he sought to bypass complex manual processes that would require additional full-time hires, instead pressing for solutions that combined automation, flexibility, reliability, and system performance.

The Solution

Genetco selected LSPedia’s OneScan suite, including its EDI Track, EPCIS, VRS, Investigator, Portal, and API Connector modules. The implementation of OneScan enhanced transaction data integrity and removed duplicative manual entry, which streamlined distribution, prevented errors, and minimized product quarantine.  

To address exceptions (caused by recurring data quality issues), Genetco used LSPedia’s Investigator, which is built with hundreds of GS1 data rules and complex business algorithms. Investigator detects all errors in an inbound EPCIS file in seconds, and sends real-time alerts to the data sender as well as a live link where they can review issues and apply a resolution. 

The Investigator resolution process

During a 20-week implementation period, OneScan was integrated with Genetco’s ERP system for master data synchronization and order automation. This integration was a core success milestone, proving LSPedia’s unique capability to configure and integrate with any business systems, and agnostically bring automation, flexibility, reliability, and system performance to its customers. LSPedia technology went live in Genetco’s production environment in May 2020.

The Results

Genetco saw immediate improvements to its DSCSA operations and ASN quality, with operational problems declining 70%. Its Perfect Order Rating also jumped, as shipments consistently had correct tracing data at the lot and package level.

The improvement saved time for Genetco personnel, who could again fully focus on making on-time shipments to pharmacies and their customers. Additionally, the data visibility of EDI Tracking enabled them to sequence deliveries, time docking and unloading processes, and quickly receive shipments into inventory.

“INTEGRATION AND IMPLEMENTATION WERE VERY EASY AND SMOOTH. WE WERE QUITE IMPRESSED WITH HOW QUICKLY LSPEDIA’S SOLUTIONS FIT US.”

LSPedia’s flexibility proved beneficial in dealing with the effects of the Covid-19 pandemic, during which many pharmacies changed their ordering patterns to prevent supply shortages in their stores, while manufacturers dealt with limited on-hand inventory. LSPedia’s solution helped Genetco adapt quickly, making it easy to coordinate inbound supply changes and outbound shipping changes. In 2021, Genetco executed Phase II DSCSA implementation with LSPedia’s Investigator module, which automated VRS4 and EPCIS exceptions management.

The companies are now taking the vital step of jointly supporting Genetco customers for DSCSA compliance. Given that each trading partner must be compliant and receive correct data before a transaction, it’s in any company’s best interest to ensure that its partners have an efficient and compliant way to exchange data with them.

The Benefits

  • Turnkey DSCSA compliance: LSPedia ensured that Genetco is working with complete DSCSA data, and can quickly identify and resolve errors. Simplicity, flexibility, and user-friendliness make LSPedia’s solutions easy and time-efficient.
  • Trusted partnership: In addition to quick-turnaround support, LSPedia plans ongoing calls and collaborative visits to help Genetco spot dangers and improve its operations.
  • Low cost of ownership: Genetco achieved its goals while saving money, as LSPedia’s solutions freed up staff time, prevented quarantined product, and streamlined exceptions management.

“LSPEDIA HAS PROVEN TO BE ORGANIZED AND COMPETENT. WE HAD A DEDICATED LSPEDIA TEAM DURING BOTH IMPLEMENTATIONS. THEY KEPT OUR PROJECTS ON TRACK WITH WEEKLY IMPLEMENTATIONS MEETINGS, TIMED DELIVERABLES, AND UP-TO-DATE PROJECT PLANS. POST GO-LIVE, OUR ISSUES AND REQUESTS ARE HANDLED IMMEDIATELY.”

LSPedia is your most comprehensive option to achieve turnkey DSCSA compliance, improve logistics efficiency, and optimize exceptions management. Contact LSPedia online or by email for more information, or use this form to get a free DSCSA audit report.