Although the U.S. Food and Drug Administration (FDA)’s Drug Supply Chain Security Act (DSCSA) recently granted a reprieve for one year before sanctioning pharmaceutical companies, the November 27, 2023, deadline nevertheless remains.
Ten years in the making, the last DSCSA phase requires stakeholders in pharmaceutical supply chains to meet three interrelated statutory components: interoperable exchange, verification and tracing. In a nutshell, data exchange between value chain partners will be critical to easily track and trace products in real time—as the FDA will begin ramping up inspections for DSCSA compliance.
The reprieve does not mean that companies can wait an extra year before implementing the right technologies and workflows to comply. The nuance is that the FDA will wait until November 24 before enforcing the Act.
Even today, many pharma manufacturers still find themselves grappling with the intricacies of compliance, especially when it comes to getting all the technological moving pieces to work together seamlessly for end-to-end serialization, trading partner authorization, and data retention, verification, and reporting.
During a December 2022 FDA workshop on DSCSA implementation, manufacturers indicated that while they had robust traceability and record-keeping procedures, they “highlighted downstream connectivity challenges caused by data misalignment between trading partners.” They also considered “the ripple effect of things as minor as clerical errors or as major as incompatible web portals or electronic product code information services systems used to maintain data.”
Distributors, third-party logistics and dispensers are also struggling with achieving 100% interoperability and accurate, reliable unit-level data between their trading partners’ systems and procedures. Not all partners are in lockstep with one another in terms of technology choices, deployment timelines, and overall DSCSA compliance maturity.
Some lawmakers and members of Congress are concerned about the DSCSA readiness of organizations across the industry, demanding that the FDA evaluate the shortages and disruptions that are likely to occur due to DSCSA noncompliance and the lack of readiness by September 15, 2023.
Boosting DSCSA Readiness Through An Integrated Technology Ecosystem
While industry pundits and policymakers are asking for a more phased approach to support the industry in the transition and avoid supply chain disruptions, compliance regulations will still be imminent, regardless of an extended deadline, to safeguard the integrity of the U.S. drug supply chain.
Time is of the essence for the pharmaceutical industry players to adopt new technologies to get up to speed regarding DSCSA compliance. Above all, it takes an entire mindset shift in the pharmaceutical industry, which has traditionally been more conservative when it comes to adopting new technologies. Fostering a culture of innovation and continuous improvement that goes beyond the medications themselves—and toward operations—is paramount.
Pharma manufacturers are increasingly bogged down by a stark labor shortage, but it’s still important to ensure the production and delivery processes are not siloed. One way to accomplish this is to consider the utilization of collaborative robots, or “cobots.” This innovation used along the production line (including at the end of the line for palletization) is helping improve the industry from research to quality control. Many of these cobots can connect with upstream serialization software and an end-to-end traceability (track and trace) platform to track and trace units through to the hand-off to distributors and all the way to retail and even patients.
Pharma companies could also explore the use of shared record databases and the integration of blockchain technology to create an immutable and secure ledger for drug transactions, or, at the very least, DSCSA labeling software and modern inventory management systems to easily identify and trace prescription drugs. Data analytics and visualization tools, often incorporated into an entire technology solution, can help stakeholders better share data with trading partners and regulators.
The more integrated the approach to technology investments, the easier it will be to ensure true interoperability between suppliers and comply with the DSCSA. It can also contribute to staving off the devastating effects of supply chain disruptions, which, based on McKinsey & Company estimates, can cause a potential loss of 25% of a pharma business’ EBITA.
While planning and deploying a DSCSA readiness strategy may appear daunting, with multiple considerations and the right technology solutions, businesses in the pharmaceutical industry can not only ensure compliance but also strengthen supply chain resilience, no matter how the market evolves.
Source: Forbes
