Data Quality Issues At The Heart Of FDA's DSCSA Troubles

The Struggle for Seamless Pharmaceutical Traceability

The Food and Drug Administration (FDA) has recently announced a series of delays and guidelines for the implementation of the Drug Supply Chain Security Act (DSCSA). This move is aimed at addressing the critical issue of data quality, which has been a major hurdle in achieving seamless pharmaceutical traceability. In this article, we delve into the intricacies of the DSCSA, the challenges it poses, and how these issues are impacting the pharmaceutical supply chain.

What is the DSCSA?

Signed into law as part of the Drug Quality and Security Act (DQSA) in November 2013, the DSCSA is a comprehensive framework designed to enhance the security of the pharmaceutical supply chain. It aims to prevent counterfeit, contaminated, stolen, or otherwise harmful drugs from entering the U.S. market. The act mandates that manufacturers, wholesalers, healthcare providers, and pharmacies maintain and share certain prescription drug data in a secure format that can be transmitted between each of their systems.

The Role of Data in Pharmaceutical Traceability

Data plays a pivotal role in ensuring the integrity and safety of prescription drugs. The DSCSA requires the electronic exchange of data in an interoperable manner, which means that each product must have a digital twin represented by the data encoded in the barcode and transaction event data. This digital version must be aligned with the physical product, which includes product identifiers such as Global Trade Item Numbers (GTINs), National Drug Codes (NDCs), serial numbers, lot/batch numbers, and expiration dates.

The Challenges of Data Quality

Despite the clear requirements outlined in the DSCSA, many stakeholders in the pharmaceutical supply chain are struggling with data quality issues. These challenges include:

• Massive Data Quantities: The sheer volume of data required to be verified is overwhelming. Wholesale distributors must verify the product identifiers for each "sealed homogenous case" or individual package of a drug that was returned to the wholesaler and intended to be redistributed.

• Complex System Requirements: The DSCSA demands sophisticated systems capable of aggregating and inferring data effectively. However, the undefined terms "aggregation" and "inference" have left many stakeholders uncertain about how to implement these requirements.

• Data Integrity and Security: Ensuring the confidentiality of commercial information and trade secrets is crucial. Any breach in data security can lead to falsification and disrupt the entire supply chain.

• Supply Chain Disruptions: If the required data is not available, products may be left unloaded from trucks or sent back. Cold chain products, in particular, are vulnerable to these disruptions due to stringent temperature control requirements.

FDA's Response to Data Challenges

In response to these challenges, the FDA has released additional guidance documents aimed at providing clarity and aligning the requirements with the enforcement deadline extension of November 27, 2024. The first document addresses the verification requirements for wholesale distributors and dispensers concerning saleable returned drugs and suspect or illegitimate products.

The second document provides insight into the implementation specifics of the enhanced security requirements. It clarifies some of the undefined statutory language, particularly pertaining to the use of aggregation and inference. The FDA emphasizes that using such processes effectively depends on the quality of aggregated data, documentation, shipping/packing integrity, and the ability of trading partners to use this data effectively.

Stakeholder Concerns and Solutions

Many stakeholders, including manufacturers, wholesalers, and healthcare providers, have expressed concerns about their readiness to meet the DSCSA compliance deadlines. These concerns include:

• Collaboration with Trading Partners: Establishing effective communication and collaboration with trading partners is a significant challenge.

• Technical Challenges: Technical difficulties in implementing and maintaining the required systems and processes are widespread.

• Establishing Standards: Standardization of data exchange and system compatibility is another major concern.

To address these issues, experts suggest engaging with strong solution providers, getting educated on best practices, and leveraging proven solutions and DSCSA expertise. The FDA also recommends using the Electronic Product Code Information Services (EPCIS) standard for capturing and exchanging data, ensuring data and system security, and maintaining the confidentiality of commercial information.

Industry Progress and Remaining Challenges

While there has been significant progress in implementing the DSCSA requirements, much work remains before the November 2024 deadline. An HDA Serialization Readiness Survey found that only three-quarters of pharmaceutical manufacturers anticipated sending 100% of the required serialized data with shipped products by the next compliance deadline. This indicates that many companies still need to catch up and resolve data-related issues.

Conclusion

The FDA's extension of the DSCSA compliance deadline to November 27, 2024, is a testament to the complexity and challenges of achieving seamless pharmaceutical traceability. Data quality issues at the heart of these troubles highlight the need for continued efforts in standardization, technical proficiency, and collaboration among supply chain partners. As the industry moves closer to full traceability, it is crucial that all stakeholders prioritize data integrity and security to ensure patient safety and the integrity of the U.S. drug supply chain.

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References More Guidance Released from FDA for Drug Supply Chain Security Act Compliance.

Quarles & Brady LLP. https://www.quarles.com/newsroom/publications/more-guidance-released-from-fda-for-drug-supply-chain-security-act-compliance Are You Ready for Serialization/DSCSA Compliance? - Axway Blog. Axway. https://blog.axway.com/industry-insights/healthcare-life-sciences/ready-serialization-dscsa-compliance Drug Supply Chain Security Act (DSCSA) - GS1 US. GS1 US. https://www.gs1us.org/supply-chain/standards-and-regulations/drug-supply-chain-security-act DSCSA Exemptions from Section 582(g)(1) and Other Requirements. FDA. https://www.fda.gov/media/182584/download