The increasingly complicated business of sourcing and moving products is a pain point for many companies today. But when the products are essential for human health, supply chain visibility is crucial.
With stringent regulations, time-sensitive medications, and patient safety at stake, pharma stakeholders need comprehensive visibility into their supply chain to ensure the integrity, quality and availability of medicines.
The COVID pandemic exposed key weak points in pharma’s supply chain. Fortunately, these weaknesses can be strengthened and possibly eliminated by utilizing an aligned strategy that leverages data made available in advanced barcodes.
The importance of visibility
Supply chain visibility involves the collection, analysis and sharing of data throughout the supply chain network. This enables companies to track the movement of goods, monitor inventory levels, and identify bottlenecks or disruptions within the supply chain, allowing for timely decision-making and problem-solving.
Pharma supply chain visibility encompasses various aspects, including tracking and tracing the movement of products from the manufacturer all the way to point of use. It involves monitoring temperature-controlled environments to ensure proper storage and transportation conditions. Visibility also extends to regulatory compliance, where pharma manufacturers must uniquely identify products, enabling traceability and recall management. One pressing example is the Drug Supply Chain Security Act (DSCSA) which requires unit-level traceability in an electronic, interoperable manner by November 27, 2023. (The FDA recently announced an enforcement delay until November 27, 2024.)
By achieving supply chain visibility, pharma can optimize inventory management, improve recall management, reduce the risk of counterfeiting or tampering and prevent drug shortages.
Aligning on standards
Every trading partner in the supply chain needs to access, understand, utilize, add and share information about products’ identification, location and status as they move from point of origin to point of use. Critical product information is being encoded in traditional linear or two-dimensional (2D) barcodes like the GS1 DataMatrix so it can be easily captured.
This information’s usability lies in the use of global data standards to enable interoperability. Every product should be identified consistently across the supply chain, using a GS1 Global Trade Item Number (GTIN). DSCSA requires a “2D data matrix barcode” for packages and a “linear or 2D data matrix barcode” for homogenous cases. The use of 2D barcodes allows all four product identifiers — GTIN with embedded National Drug Code, serial number, lot number and expiration date — to be encoded, in addition to any information manufacturers need to include.
When all supply chain partners are using GS1 Standards and equipped with optical scanners, this data can be captured and automatically shared up- and downstream for effective collaboration. This becomes crucial in the event of a product recall or other safety issue where traceability and speed is paramount.
While recent surveys suggest that the majority of pharma stakeholders are developing capabilities around scanning, the consumption of enriched data elements is still in progress. It is recommended that pharma manufacturers discuss their 2D transition strategy with key trading partners including distributors, wholesalers, third-party logistics providers and end users as they create transition plans.
Perhaps the most important aspect of the entire operation is collaboration. Effective and timely communication enables faster, more targeted recalls, along with the reassurance that comes with knowing where a drug is at any point. Without standardization of homogenized information enabling a common language that all entities can understand, it would be virtually useless. With the DSCSA deadline approaching, the days of proprietary product identification schemes and databases are over. Interoperability is the only way forward.
In pharma’s complex and interconnected global marketplace, supply chain visibility empowers companies to enhance collaboration with suppliers, distributors and customers — fostering trust and transparency throughout the entire ecosystem.