Maintaining product integrity is a complex and multifaceted challenge, encompassing an array of risk management, supply chain, product design and packaging strategies. Baxter’s product integrity program takes into account the differing levels of complexity and risk associated with individual products and markets.
Baxter’s risk assessment is dynamic and informed by ongoing monitoring and information sharing among law enforcement and regulatory officials and industry players due to changing economics, shifting political climates, new technologies and other world events. Baxter also monitors for patterns or anomalies within its own pharmacovigilance, product complaint reporting and customer order systems.
Maintaining a secure supply chain, from Baxter to the end user of the product, is essential to ensure product integrity. Direct sales and sole source agreements are one way the company can retain control and/or visibility of the product. Baxter regularly monitors customer purchasing data and trends and has terminated or changed customer relationships after detecting actions that jeopardize supply chain integrity (e.g. resale of product, unexplained spikes or changes in ordering behavior that would suggest diversion). Baxter’s sales contracts include restrictions that support supply chain transparency and control, including the destruction of product packaging in some markets.
Additionally, the company was an early adopter of GS1 standards adopting the Global Trade Item Number (GTIN) in 2004. A GTIN is a unique identification number that provides the link between the product and the information pertaining to it. GS1 standards are used to uniquely distinguish all products, trade items, logistic units, locations, assets and relationships in the supply chain— from manufacturer to consumers. Baxter believes that global adoption of GS1 standards will facilitate greater use of technologies that can help ensure products are moved correctly and efficiently throughout the supply chain.
Industrywide, global adoption of GS1 standards are important building blocks in securing the supply chain. Baxter looks forward to expanding its implementation of the GS1 standards, furthering its product integrity efforts and driving greater security and efficiency in the delivery of Baxter’s products to healthcare providers and patients around the world.
Baxter collaborates with regulatory and public health officials and industry experts to share intelligence, insights and experience regarding product integrity. Groups such as GS1, Pharmaceutical Cargo Security Coalition, Parenteral Drug Association and Rx360 have facilitated exchange of industry expertise and collaboration with regulatory authorities to develop and raise standards, drive voluntary adoption of new processes and technologies, and implement new measures to advance product integrity and protect patients and clinicians.