The Value of DSCSA Pilots—and 9 Ways to Get the Most from Yours

For many pharma companies that have chosen a DSCSA or compliance solution, pilot projects are already underway. But some with lingering uncertainty about pilot initiatives are taking a wait-and-see approach, seeking industry guidance on whether a pilot is right for them and finding best ways to launch a piloting strategy. 

If you wait to pilot, you are missing a valuable opportunity to leverage your investment. Regardless of your company’s size and resources, participating in pilots can answer key questions for you, including:

• Will I be ready for the November 2017 serialization deadline for manufacturers, as well as other compliance milestones? 
• How will I position myself with regulators and partners if I’m not ready? 
• What can I learn from pilots that will reveal value beyond compliance and assist to influence industry guidance?

Read on for 9 aspects of piloting worth examining—whether you’re building your own pilot or partnering with others.

1. Develop a pilot strategy.

In general terms, your piloting goal will be to test the successful receipt and shipping of co-mingled serialized, non-serialized, and exempt products. Beyond those basics, determine what else you hope to get out of your pilot (see Tip #3). Then, consider these best practices to ensure the greatest impact: 

• Create a dialog with others. Sync and share findings, test and iterate, and key in on your partnerships and your message. 
• Plan and execute using manageable and testable chunks. You probably won’t get to everything on your list, so learn how you can combine pilot areas. 
• Consider wholesaler-to-dispenser transactions. Manufacturers must widen their scope beyond 2017 by looking at the DSCSA verification mandate for distributors, which arrives in 2019. 
• Include a 3PL or CMO scenario. Doing so will test how you take the authorization title to the product, opening up process management and data exchange findings.

2. Expose hidden business pain points.

While most pharmas plan to serialize their entire impacted portfolio, few have systematic verification or traceability capabilities in place today. Until you are underway with full compliance, piloting will intentionally trigger business bottlenecks you can address now. You’ll be able to adapt ahead of the deadlines, and ensure that serialization and traceability won’t upset the movement of your drug product down the supply chain.

3. Leverage your serialization investment.

Once you’re serializing product and storing data in a repository for sharing, you’ve tackled the compliance requirement. But how else do you plan to benefit from this considerable expense and effort? A pilot strategy can help you determine ways to maximize your serialization solution investment.

4. Focus on partner integration during piloting.

Beyond serializing your product, how will you share this data with others? Will you employ a network approach that uses a single connection, or will you test the time and cost needed for business-to-business connections with each partner and customer?

5. Test your data exchange by connecting to an available system.

A strong pilot also focuses on testing data exchange, and connecting to the physical movement of your product across the supply chain. There’s no better way to test this than connecting to a serialization system that’s already up, running, and available.

6. Avoid going it alone.

It takes a village to ship serialized product, so companies looking to implement serialization on their own are missing the bigger picture. Working narrowly in introverted silos may jeopardize bigger wins—working with partners enables you to:

• Get help from others who are further down the road toward serialization. 

• Leverage resources that may not be available within your group, especially if you’re a small or virtual company without a core serialization team of experts. 

• Collaborate, and shape industry practice as regulatory guidance is under development. 

7. Seek out FDA pilot studies.

The FDA is made up of regulators—not supply chain experts—whose primary concern is the quality and safety of medicine. To support their objectives, the FDA is eager to learn about:

• ID and barcode issues 

• Interoperability 

• Data and system issues 

• Aggregation 

• Verification scenarios 

• Repackager, notification, and other special scenarios 

• Exception handling and errors

FDA requirements cover a broad spectrum, from master data management to packaging and manufacturing, from serialization repository to warehouse logistics. To help guide DSCSA compliance requirements, the FDA wants visibility into a uniform and wholly representative supply chain message. Piloting gives the FDA that visibility and can help guide and inform their decisions regarding requirements.

The best thing your company can do, no matter your size, is to participate in FDA-focused pilots so their guidance becomes something palatable and achievable for your business when issued. This requires you to be flexible and cooperative in your piloting and change-management processes. If there’s something about your operations or portfolio that’s painful to you, you have an important reason to share your findings.

8. Seek out HDA pilot studies.

As a trade group representing distributors, the Healthcare Distribution Alliance (HDA) is currently focused on the November 2019 verified saleable returns mandate, and has introduced pilots to understand the most efficient methods for verification.

The guidance that comes from the HDA pilot programs will speak directly to cost savings. With 2 to 3 percent of supply chain product in the U.S. coming back as saleable returns, wholesale distributors and pharmas don’t want to run the risk of impacting patient safety, or losing business when product is shipped back. Piloting helps manufacturers understand how to keep these saleable returns in the supply chain, and ensures that viable product is available for patients and customers.

The verification process can be cumbersome, such as when a wholesale distributor’s warehouse footprint is not big enough to store product and perform verification through manually capturing every number and calling the manufacturer. To avoid drug product gaps in the supply chain, the HDA pilot project is looking at several real-life scenarios, including:

• Manufacturers sending product identifiers to wholesale distributors for some or all units purchased. 

• Data being sent to a central repository for automatic verification through a discovery service or interface, through a router solution, or by manually verifying via phone, email, or portal. 

• Wholesale distributors scanning inbound and outbound product. 

9. Join the TraceLink Cloud Community.

Serialization pilots will require you to be interactive with others in the supply chain community. Joining the TraceLink Cloud Community provides that, giving its members the opportunity to collaborate with hundreds of active companies from across the entire supply chain.

Within the TraceLink Cloud Community, the DSCSA Pilot Workgroup is focused on exploring, testing, and analyzing capabilities for serialization, data exchange, and verification. Recent topics have included the newly released GS1 DSCSA implementation guidelines, EPCIS standards, HDA and FDA pilots, and TraceLink Network pilots.

Next steps

Your serialization efforts will be significant. If you focus only on compliance in the short term, you’ll find the use of your money and resources to be less than optimal. To increase your serialization investment, work with your partners to understand piloting dynamics, requirements, and dependencies. You’ll be better equipped to create a roadmap and timeline that will benefit your business well beyond 2017.