To protect supply chains from the threat of counterfeit medicines and theft, firms in the pharmaceutical industry and government regulators are working together to improve the security of medical supply networks. Many countries are now pairing pharmaceutical serialization with track and trace systems to combat the risks faced in drug supply management today. They are using pharma serialization and traceability initiatives to prevent the circulation of counterfeit, stolen, and adulterated products in their nation's pharmaceutical supply.
Increased public health and safety are not the only benefits provided by pharmaceutical serialization and track and trace efforts, however. These same initiatives can help pharmaceutical manufacturers obtain greater visibility into the movement of their products across the supply chain—end-to-end visibility that they can use to improve demand forecasting and production planning.
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Pharmaceutical serialization and track and trace requirements
In the U.S., the Drug Supply Chain Security Act (DSCSA), which was enacted in 2013, established new regulations for enhancing pharmaceutical supply chain security. The legislation calls on manufacturers, distributors, and dispensers to build a digitalized and interoperable system for tracking and tracing prescription drug products as they move through the supply chain. It delineates a set of pharmaceutical serialization and track and trace requirements which are to be phased in over several years.
The first set of requirements which took effect in 2015 state that:
- All participants in the pharma supply chain must work exclusively with authorized (duly registered or licensed) trading partners.
- All companies must provide, obtain, and maintain certain information about each product transaction.
- All companies must carry out processes and procedures to respond to requests for that information from federal and state officials.
- All companies must have systems and processes in place to investigate, verify, and quarantine suspect or illegitimate drug products.
The first phase of DSCSA-mandated track and trace efforts ushered in lot-level traceability, requiring that dispensers only accept prescription drug products if accompanied by three forms of documentation: Transaction Information, Transaction History, and Transaction Statement(s). All supply chain participants are required to share chain-of-ownership data at each sale or transfer of ownership.
The second phase of DSCSA requirements introduced drug product serialization and enhanced verification of serialized products. It mandates that all companies selling prescription drug products in the US serialize each individual saleable drug unit. The third and final phase of the DSCSA pharmaceutical serialization and track and trace framework introduces unit-level traceability, requiring that all trading partners in the pharmacy supply chain share chain-of-ownership data in a manner that allows for serialized items to be traced back to the product origin.
Trading partners must exchange the required documentation, or the Transaction Information and Transaction Statement(s), in a secure, electronic, and interoperable manner. They must be able to verify the product identifier on the drug package and must maintain secure, electronic, and interoperable systems in order to store and provide such documentation in response to requests. They are required to maintain this documentation for at least 6 years.
Simplifying and automating pharmaceutical serialization and track and trace compliance processes
In order to comply with pharmaceutical serialization and track and trace regulations, players in the pharmaceutical industry supply chain are investing in new software, hardware, and processes to identify, track, share, and manage the required transaction information. They are investing in and adopting the use of 2D barcode scanning equipment, network design and planning tools, enterprise resource planning (ERP) systems, warehouse management software, supply chain control towers, and other types of tools that can be used to simplify and automate pharmaceutical serialization and track and trace compliance processes. These technologies can also be used to improve inventory management processes and enhance supply chain efficiency and visibility.
Pharmaceutical serialization and track and trace as business opportunity
While the investments firms are making into their pharmaceutical serialization and track and trace infrastructure are substantial, the returns on those investments will only increase as firms learn how to leverage the data created and shared as a result of serialization and traceability efforts. Sharing and analysis of serialization data enables firms to create a more efficient and integrated digital supply network. They can use serialization data to bridge information and process silos in the pharma supply chain, thereby enhancing cross-functional transparency and fostering collaboration.
In leveraging their pharmaceutical serialization and track and trace infrastructure and the data it provides, firms in the healthcare sector can achieve greater oversight of supply chain activities—detecting and resolving bottlenecks, potential disruption, and other issues early—and build a more efficient, responsive, and agile supply chain. By obtaining greater visibility into both supply chain operations and drug consumption patterns, they can improve demand forecast accuracy, enhance inventory optimization, and optimize sales and marketing campaigns.
Wholesalers and distributors can use serialization data to increase supply chain automation and optimization and improve order fulfillment and tracking. And healthcare providers and pharmacies can use data from serialization processes to enhance inventory management and supply chain efficiency. With the right technology, all organizations participating in the pharma supply chain can leverage serialization data to enhance supply chain integrity, efficiency, and agility while helping to protect public health and safety.
Building an intelligent supply network with pharmaceutical serialization data
Creator of the world's largest digital supply network for the pharmaceutical industry, TraceLink is helping its customers realize the transformative value of their investments in pharmaceutical serialization and track and trace initiatives. Getting their start by providing firms with software to generate and manage serialization data, automate global compliance reporting, and enable seamless information sharing across trading partners in the healthcare sector—TraceLink now offers its customers a powerful platform for mining the full potential of their data and data from more than 280,000 organizations in the global pharmaceutical supply chain.
TraceLink's technology helps organizations not just comply with pharmaceutical serialization and track and trace requirements but derive greater value from their serialization efforts. With Serialized Product Intelligence, a fully automated, self-service analytics application that is built on TraceLink's Digital Network Platform, firms can proactively aggregate and analyze serialization data to monitor serialized operations, avoid costly disruptions, detect and resolve compliance issues faster, and streamline supply chain operations. They get end-to-end visibility into serialization processes and automated reporting that helps save time and expense. TraceLink is helping firms create a more agile and intelligent supply network that is compliant, serialized, and designed for traceability.
Pharmaceutical Serialization and Track and Trace FAQs
What is serialization in pharmaceuticals?
It is the assignment of a unique, traceable serial number to individual items or saleable units in the pharmaceutical industry. Pharmaceutical serialization requirements vary depending upon the country in which the product is to be sold.
What are pharmaceutical serialization and track and trace systems?
Track and trace systems are used to follow the movement of pharmaceutical products along nodes in the supply chain from manufacturer to distributor to dispenser. Serialization, or the assignment of a unique serial number to individual items or saleable units, helps regulators and pharmaceutical companies identify the location of a drug product or retrospectively identify and verify the path traveled by a drug product in order to determine its authenticity. The main purpose of pharmaceutical serialization and track and trace regulations is to combat drug counterfeiting and theft and improve public health and safety.
Can the blockchain be used for pharmaceutical serialization and track and trace systems?
Because blockchain is essentially a digital distributed ledger, which can be used to record transactions chronologically and permanently, it could potentially be used for tracking and tracing products. It is highly resistant to corruption and tampering and provides a single source of truth that can be used to verify the authenticity of a product.