Viewpoint: An industry blueprint for DSCSA interoperability

Eric Marshall, Alissa McCaffrey , 14-Jul-2021

This week, the Partnership for DSCSA Governance (PDG) released the initial chapter of its Foundational Blueprint for 2023 Interoperability (the Blueprint) as part of its continued efforts to advance supply chain security.

PDG is a collaborative industry forum and FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the US.

The Blueprint is the first step to establishing such a model and is the result of the tireless efforts of dozens of stakeholders from each sector of the supply chain. The initial chapter of the Blueprint establishes detailed consensus business requirements to support each element of the Drug Supply Chain Security Act (DSCSA) interoperability requirements that will take effect on November 27, 2023.

The DSCSA’s 2023 interoperability requirements have three major components: interoperable transaction information (TI) exchange, interoperable verification, and interoperable tracing. The initial chapter of the Blueprint defines consensus business requirements to support these three key activities and the systems and processes to credential the authorized trading partners (ATPs) that will carry out these activities. Future chapters of the Blueprint will detail possible technical and structural components needed to meet the business requirements.

In other words, chapter one defines what the various DSCSA systems and process should include and achieve, and PDG work groups are actively engaged in continued disucssion of how systems and processes can be designed and structured to meet the requirements and recommendations in this initial chapter.

For example, the Blueprint clearly defines who can make use of systems and processes for interoperable drug tracing, the preconditions for executing the tracing process, and the outputs of the tracing process.

Future chapters of the Blueprint, however, will define more precisely the detailed process for interoperable drug tracing such as who performs the gathering of information to support drug tracing and the steps that are taken to do so.

The Blueprint strives to provide significant flexibility to trading partners to implement the DSCSA in a manner that best meets their business needs and seeks to leave the development and adoption of technology and solutions to the commercial marketplace. It is also important to recognize that a diverse multitude of approaches can impede interoperability, and the Blueprint seeks to balance those considerations.

Major components of the Blueprint

With regard to the interoperable exchange of serialized TI, the Blueprint addresses two major components: formatting of TI values and data reliability.

First, it defines or recommends specific standardized formats for each TI value to enable interoperability, while referencing and leveraging existing standards whenever possible. Recognizing the broad industry movement toward GS1’s Electronic Product Code Information Services (EPCIS) as the preferred standard for how TI is exchanged, PDG is hopeful that the Blueprint requirements will complement EPCIS in a way that enhances interoperability.

Second, the Blueprint establishes specific requirements to support the accuracy and reliability of TI designed to ensure that TI accurately and reliably represents the associated product moving through the supply chain, thereby enabling accurate and reliable verification and tracing practices that leverage that data.

Regarding interoperable verification, the Blueprint recognizes that verification systems and processes have advanced significantly in recent years as part of the Verification Router Service (VRS) developed by supply chain stakeholders convened by the Healthcare Distribution Alliance (HDA). The VRS was developed primarily for use in the verification of saleable returns, and the Blueprint suggests minor enhancements to accommodate additional use cases. More importantly, the Blueprint defines a framework for verification using manufacturer-provided TI data without use of a VRS, referred to in the Blueprint as “direct-to-replicate” verification.

Achieving interoperable tracing, and establishing the baseline systems and processes to do so, has been perhaps the most complex endeavor for industry stakeholders given a number of competing factors such as the complexity of tracing, uncertainty as to the anticipated frequency or volume of tracing, the sensitivities associated with suspect and illegitimate product investigations, and important confidentiality considerations.

As noted above, chapter one of the Blueprint defines who can use the tracing process, the preconditions for tracing, and the outputs of the tracing process; future chapters will provide more detail on how tracing is performed.

Perhaps the most debated question related to tracing is whether industry will develop a single shared system that automates the process for requesting and providing information related to tracing or whether industry will rely more heavily on individual trading partners’ systems and processes. While more of this detail is forthcoming, the Blueprint does emphasize that any trading partner can, ultimately, only be responsible for its own data and emphasizes the importance of configurability to enable each trading partner to design its own individual systems to meet its own individual business needs, automated or not.

One of the more significant implications of verification and tracing in 2023 and beyond is that it will greatly increase the interaction and communication among trading partners that do not have preexisting business relationships. For example, a manufacturer may receive an electronic verification request from a dispenser with which it does not have a direct business relationship. Similarly, a secondary wholesaler may receive a tracing information from a manufacturer with which it does not have a direct business relationship. This will require trading partners to have efficient mechanisms for establishing the identity and authorized status of other trading partners.

The final section of the Blueprint establishes requirements and recommendations to enable the use of digital credentials to meet that need.

Ultimately, the Blueprint is intended to be utilized by pharmaceutical supply chain trading partners, solutions providers, and other stakeholders, beyond the PDG membership. PDG is not a governmental entity or agency, and the requirements in the Blueprint are not legal requirements; the DSCSA expressly permits trading partners to adopt “alternate methods of compliance,” and the Blueprint is not intended to foreclose that option.

It is, however, PDG’s goal that the Blueprint—developed through months of collaboration among dozens of diverse stakeholders—will serve as an optimal approach to DSCSA implementation that trading partners will find presents the most efficient pathway to compliance.

Continued stakeholder engagement, dialogue, and feedback is essential to that goal.

To support continued discussion and feedback, PDG is hosting a series of workshops, free and open to the public, to further explore the Blueprint and the ways in which it can support the development of secure, electronic, interoperable systems and process for DSCSA implementation. Stakeholders can register for those workshops at www.DSCSAgovernance.org/blueprint.