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COMPLIANCE
Author: Andre Caprio – director of business development, Covectra.
T
he Drug Supply Chain Security Act (DSCSA) has been an active topic of discussion amongst companies in the pharmaceutical supply chain for the past eight years. Enacted by Congress in November 2013, Title II of DQSA outlines the steps to achieve interoperability, electronic tracing of products at the package level, to identify and trace prescription drugs as they are distributed in the US territory. Since its inception, key industry associations, including the Healthcare Distribution Alliance (HDA), Pharmaceutical Development Group (PDG), and GS1 have dedicated exclusive panels to debate the impacts of DSCSA and to provide valuable resources in efforts to collaborate for this industry wide objective. Although considerable progress has been achieved during the previous years, much work is still required until the pharmaceutical industry can finally “flip the switch” for DSCSA. Supply chain disruptions caused by the Covid-19 pandemic, coupled with a shift in focus towards vaccine development and distribution, have contributed to creating delays in DSCSA compliance efforts. Nonetheless, per
What next for DSCSA? interoperable with approximately 1-5% of their trading partners. Furthermore, a major distributor, member of the Big Three family (the three largest distributors in the US), indicated concerns around data quality and failures caused by EPCIS/DSCSA syntax or semantics issues when receiving files from trading partners. These issues were present amongst third-party logistics providers (9% failure rate) and manufacturers (37% failure rate). Part of the challenge around data interoperability is because several serialisation solutions providers exist, each with their own proprietary software products, with thousands of trading partners in the pharmaceutical supply chain hosting their own data. Although some progress has been achieved in connecting these systems, the process has proven to be lengthy and labour intensive. DATA QUALITY CONCERNS AT THE MANUFACTURER LEVEL Throughout 2018 and 2019, the FDA ran a series of pilot studies that aimed to assess the impacts of having stakeholders verify the authenticity of a pharmaceutical product by scanning its unique data matrix barcode and authenticating it against the manufacturer hosted serialisation database. Simply put, once a product was scanned, the manufacturer’s system would provide a positive or negative result based on the unique information embedded on the product’s data matrix. Although the enforcement of this specific DSCSA milestone was later delayed in 2020, the results of the pilot studies were peculiar, with a high percentage of authentic products (upwards of 25%) returning a negative confirmation. Many manufacturers were puzzled as to the cause of these “false negative” results. Upon further investigation on the embedded data contained in the faulty barcodes, the most common issues included the wrong placement of comma separators, use of double zeroes for lot and expiry dates, amongst other technical issues. Furthermore, it was concluded that most of the data errors were because of
the FDA’s recent guidance during its public meeting in October of 2021, further enforcement discretions are highly unlikely to be granted. Therefore, the target date for full compliance and interoperability has been set for November 27th, 2023. INTEROPERABILITY REMAINS THE BIGGEST HURDLE As DSCSA legislation states, trading partners in the pharmaceutical supply chain must have systems in place which enable the capture, storage (up to six years), and transmission of data in EPCIS format amongst stakeholders. EPCIS is a GS1 standard that enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers. During the annual Traceability Seminar in November 2021, the HDA disclosed results of its recent supplier survey around data interoperability progress, which were far from encouraging considering the legislation was two years away from the ultimate deadline at that time. In this study, 54% of respondents were manufacturers and 46% were distributors. Amongst all participants, only 37% indicated they were actively
