Expert Article: Ensure Drug Supply Chain Compliance by Getting Your Data in Order

The deadline looms. Packaging stakeholders have already done plenty to comply with foundational track-and-trace regulations set out by the Drug Supply Chain Security Act (DSCSA). On November 27, 2023, the interoperability requirements take effect. The responsibility to comply is in the hands of the packaging IT group. 

The Partnership for DSCSA Governance (PDG) recently released new guidelines that provide insight into how DSCSA regulations will be implemented, with specific information on compliance requirements, business requirements, and functional design. In addition, PDG has provided the industry a clear implementation structure for its sprint to the November deadline with the release of four new chapters of its Foundational Blueprint for 2023 Interoperability. 

Progress in Packaging and Serialization

A 2022 survey conducted by the Healthcare Distribution Alliance found that 75% of manufacturers plan to send all of their DSCSA-required serialized data with shipped products by the November 2023 deadline. This plan may sound like unfinished business, but it does represent progress. In contrast, the 2021 survey found that only 45% of manufacturers sent serialized data to wholesale manufacturers. 

There's been progress in packaging and serialization. By and large, product labels have been modified and redesigned. Packaging line systems are updated and upgraded. Physical printing of barcodes and human-readable information is aligned, and barcode grading of “C” or above has been tested with downstream trading partners.

The Devil is in the Data Details

Data integration efforts are off to a great start. Verification Router Service (VRS) has been generally established to automate the verification of serial numbers. Not everyone has a fully baked plan to handle verifications, but come November 27, it must be part of the plan.

While Transaction Information (TI) and Transaction Statements (TS), known as TI/TS, are now electronically exchanged at the lot level, the Blueprint describes how to enable a functional data stream aligned at the product level across each stage of pharmaceutical distribution. Electronic Product Code Information Services (EPCIS) Exchange will facilitate the transfer of interoperable TI/TS data by providing real-time visibility into the movement and location of products within the supply chain, identifying bottlenecks, tracking inventory levels and optimizing processes.

Packaging and repackaging teams are also adopting aggregation solutions to accurately track identification and familial relationships. DSCSA spells out serialization requirements for unit and case levels. However, before regulatory enforcement has even been triggered, wholesalers are demanding aggregation across all packaging hierarchies, ensuring serialized relationships between unique identifiers. Even with all these preparations, there are points in the data flow where misalignments are likely to occur.

Data Mismatch Risks

One of the major concerns in the packaging industry is the potential for a mismatch between barcode and human-readable data, causing significant problems throughout the supply chain, including mislabeled products, lost inventory and reduced efficiency. 

The drug supply chain is a complex network of various stakeholders, including manufacturers, distributors, wholesalers, contract manufacturing organizations (CMOs), third-party logistics providers (3PLs), and many others. As drugs move from one point to another in the supply chain, it is critical that the accompanying data is delivered successfully to the next trade partner. TI/TS enables sharing of essential data related to drug ownership, location, and movement in the supply chain.

Was the Message Delivered?

Data transport failures can occur due to something as simple as a misdirected email or a rejected data handshake. Even when data is received by the intended recipient, it may be unreadable or corrupted due to technical glitches or data entry errors. 

All stakeholders in the drug supply chain must adopt robust data management systems and processes to ensure the accurate and timely sharing of critical information and to minimize the risk of data transport failures or data corruption.

Packaged, Repackaged, Lost in the System

Pharmaceutical products are packaged and repackaged as they move through the supply chain, resulting in a parent/child relationship. For example, if the unit number is correct at the bottle level, but there is a mismatch between the carton and case levels, the product could end up in the wrong packaging, leading to inaccurate inventory data and potentially causing regulatory compliance issues. 

Manufacturers, distributors, and other stakeholders in the supply chain can implement robust systems to track the parent/child relationship of the product throughout the supply chain and ensure that the correct packaging is used at each level, minimizing the risk of mismatches.

Future Focused Data

Ensuring the accuracy and accessibility of data in the pharmaceutical supply chain is critical not just for today, but also for the future. DSCSA guidelines require all supply chain partners to maintain a complete electronic record of the transaction history for each drug product they handle, including the product's ownership and movement through the supply chain.

This data must be maintained and accessible for at least six years, during which data integrity must be maintained. This data integrity is especially important in the case of product and data mismatches, as it can have long-term implications on patient safety, regulatory compliance, and supply chain efficiency.

Avoid the Boomerang

Given the sheer volume of prescription medicines going through the U.S. supply chain, putting even one percent of products into quarantine would cripple the industry. Today, rework operations accommodate for unacceptable products or accidental packaging disconnects. 

Avoiding these pains requires total accuracy in matching the pallet and everything it carries to the electronic record sent to the wholesale distributor and accurately reconfiguring that data as the product is repackaged downstream and sent to dispensaries. If data exchange isn't pristine throughout, the entire system is rendered unstable. 

The Road Ahead

The big test is coming. Without forethought, preparation, and testing, companies and some aspects of the supply chain may fail, and failure is not an option.

In a matter of months, the pharmaceutical ecosystem needs to be ready to provide data on origin, destination, and movement through the supply chain. Suppose a product is found to be contaminated or otherwise unsafe. In that case, it is critical to be able to quickly identify all of the locations where the product was distributed so that affected products can be removed from the market. Failure to comply with product tracing regulations can result in fines, product recalls, and damage to a company's reputation. 

Proper handling of related data is essential to the future of the pharmaceutical supply chain. The goal of total alignment of data and product is in reach with the deployment of a configurable, scalable process built to meet the integration and compliance requirements of today and tomorrow.