FDA DSCSA Pilot Workshop: What You Need to Know

Last week the FDA held the first in a series of required workshops on DSCSA pilot programs. At this two-day event, they gathered a cross-section of supply chain members and solution providers, organized them into cross-functional teams to address FDA-specified topics, and then gathered participant feedback.

Why FDA Pilots Matter to Your Business

Regardless of whether or not your company participates in one of the FDA pilots, you’ll want to understand their scope and outcomes: the learnings that come from these – along with the pilots run by HDMA and other industry groups – will strongly inform any guidance and additional standards that the FDA issues. How your manufacturing, wholesaler, or dispensing business implements serialization and interacts with trade partners will be largely determined by these projects.

What Was Discussed

The FDA focused last week’s discussions around all of the upcoming requirements—from 2017 through 2023—and four key topics:

• Serialization: the plans and challenges with respect to serialized product and exchanging serialization data across the supply chain; 
• Product Tracing: the integration of DSCSA product tracing requirements into daily operations; 
• Verification: the processes involved in suspect or illegitimate product verification; and 
• Interoperability: the ability for trade partners to exchange data accurately, efficiently, and consistently. 

What the Industry Said

What follows is a summary of industry feedback around those topics and pilot program objectives – how participants think pilots should work, who should be involved, what they want to see studied, and more. This recap stems from two sources: the FDA’s readout of discussions at the end of day one, and the intelligence gathered by TraceLink’s workshop attendee - Lucy Deus, VP of Product Management – through roundtable readouts and general discussion throughout both days. The FDA has not yet published their day two readout.

Supply Chain Roles in Pilots

• Ensure pilots have a broad and wide reach to manufacturers, distributors, and dispensers. 
• Define “large” and “small” for all of these segments to ensure correct comparison of results. 
• Include representative critical players, not just the major players; independent and smaller companies that will have challenges should be involved, also.

Pilot Project Structure

• Create User Requirement Specification (URS) for pilot participants to create a common structure that allows results to be compared in a meaningful way. 
• Consider how to use the results: can you share them with others so they can build upon the pilot use cases and reduce repetition? 
• Develop use cases for the different types of movements through the supply chain. 
• Prioritize the most important and least understood processes to date. 
• Pilot the process of tracing product across the supply chain when there is belief of suspect product. 
• Measure the ratio of false positives and negatives, which will be deliberately built into pilots. 
• Measure cost to implement. 
• Measure operational impacts: understand both the touch points and impacts along each touch point. 
• After data reaches a dispenser, can there be automation to verify expiration date tolerances allowed for dispensing, and other methods to improve patient safety and accuracy by the dispensing endpoint? 

Product Identifier Issues 

• How serial numbers are issued and managed, including a CMO’s role. 
• Compare different standards for the identifier (10 or 11 digit NDC used in SNI, 14-digit GTIN). 

Barcode Quality Issues

• Readability of barcode, along with environmental and human considerations. 
• Convergence of linear and 2D barcode: which to use and when. 
• Determine minimum acceptable barcode quality grade. 
• Test various reader/scanner capabilities and variability. 

Interoperability

• Process and technology challenges due to variety of solutions expected: 

1. Central database vs. peer-to-peer, decentralized option. 
2. Trading partners with systems vs. others with little to no systems, or using someone else’s system. 

• Maintaining visibility of the product throughout the distribution supply chain: 

1. What to do when a trading partner goes out of business. 
2. Evaluate use of EDI and EPCIS.

Aggregation and Disaggregation

• Evaluate processes for product flow and data flow. 
• Identify data gaps, errors, and inaccuracies, particularly downstream when searching or examining data; how can errors be corrected? 
• Trade partner impact when inference is used vs. not used, and when in the distribution inference is no longer needed. 
• Test multiple levels of adoption of inference by different trading partners (e.g., when manufacturers aggregate, when wholesale distributors aggregate). 
• Develop use cases for the different types of movements through supply chain: full case moving through supply chain, cases broken down and units shipped, etc. 
• Time required to receive shipment, aggregate/disaggregate, create shipment. 

Exception Handling, Errors, and Inconsistencies

• Focus on “honest mistakes and errors”, including aggregation error. 
• What triggers a suspect product investigation or makes it non-saleable, vs. the “honest errors”. 
• Scenarios with “mixed product”, such as product subject to grandfathering or waiver/exemptions. 
• Fixing over/under shipments when more data or more product is needed. 
• Measure impact to product movement and incurred delays with exception processes in place. 
• Measure how many times something is unnecessarily quarantined. 
• When there is mixed serialized and non-serialized product, how is it known what is supposed to have a serial number? How can we avoid reporting of grandfathered or exempt product as a suspect product. 

Verification and Notification

• Measure time for a dispenser to check product against supplier and manufacturer prior to dispensing. 
• When there is a change of status, measure how quickly notification moves through the system to dispensers. 
• Measure overall effectiveness for compromised product or attacker in system: how long does it take to trace a transaction all the way back to the manufacturer? 
• How is communication to brand owner handled when a suspect or illegitimate product is found and reported to the FDA? 
• If 2D barcodes are used at the dispenser level for verification or other purposes, what kind of equipment or personnel training will be needed? 
• Process for investigation of suspect or illegitimate product, including all applicable trading partners and testing boundaries of the system. 
• How to support forensic or lab analysis throughout the supply chain) when illegitimate product is confirmed. 
• How to link or leverage notifications to patient. 
• Capabilities of the supply chain and data exchange mechanisms to achieve the statutory reporting timelines due to security, access to data, personnel availability. 
• How do we ensure the current authorized partners’ processes are in place and actually help to prevent illegitimate product from entering the supply chain? 

Data or Database Issues

• Use of technical data standards and attributes to enable interoperable data transfers. 
• Test different methods to handle the master data vs. transaction data separately, including the feasibility of sending master data only once per shipment and master data controls to minimize redundancy. 
• Integration into individual company data systems. 
• Develop performance measures, such as how to evaluate data throughout the product life cycle, including the maintaining data integrity throughout distribution. 
• Measure response time for resolution of data issues and cost implications when product movement is stalled due to a data issue. 
• EPCIS use and how this impacts dispensers – what happens if they don’t have connectivity? 
• Database performance issues when fully or partially loaded. 
• Data governance, and controlling access to data by trading partners, FDA or other officials. 
• Process for redaction of data (may not need to provide all data downstream).

Metrics for Testing Centralized vs. Decentralized Approach

• Test timing for decentralized model vs. centralized model, response times and how this impacts supply chain in verification and suspect product investigations. 
• Measure scalability and data protection methods. 
• Leverage PDSA Group efforts on criteria for centralized vs. decentralized models. 
• Decide on centralized vs. decentralized approach early so that pilots are focused on what is desired for the end state architecture; otherwise, the industry could incur significant costs in building out technical capabilities for both models in order to pilot both. 

Repackaging and Special Scenarios

How to effectively and reliably link newly issued product identifier back to the original manufacturer product identifier. 

• Process when data and product don’t move together, which changes data governance and where the data goes (drop shipments, 340B, investigational drugs.)

TraceLink will continue to report on FDA workshops and developments.