In the pharma supply chain, investigation can be supported through serialized drug identity tied to a complete, verifiable and non-repudiated chain of custody. This provides legal authorities with extensive and integrated detail on the product, the affected organization and the related financial transactions that can be used to accelerate the investigations of security threats.
We can raise the bar one step by adding in mechanisms to speed the detection of the break-in. By putting in an alarm system at the house, we gain prompt notification when a security event occurs. This will allow investigators to get on the scene more quickly and start following leads before they get cold.
In the pharma supply chain, we can enhance detection of product security threats in several ways. For example, authentication of serialized product identity and status at point of product receipt can help detect counterfeit or stolen drugs before they are taken into inventory. In addition, mandating receipt of an electronic chain of custody, provided through electronic pedigree, enables the recipient to identify suspicious product movement patterns and detect products that were intended for other geographic regions or supply chain channels.
We can further raise the bar by publicly signaling to criminals that this particular house is protected. Publicizing security protections like placing signs on the lawn of the presence of an alarm system will cause thieves to think twice before trying to enter and result in them moving on to potentially easier targets.
In the pharma supply chain, this is accomplished by the public widespread adoption of product security mechanisms such as product serialization, serialized product authentication and electronic pedigree. The result is a security barrier that protects the legitimate ingredient and finished dose supply chain by deterring would-be criminals from seeking simple profits and significantly raising the investment these criminals need to make.
A complete systemic security program would include solutions for all three dimensions. While this is the ultimate goal, its pursuit has to be measured against both the current resources available and the potential business value available from these tools. In addition, a company must decide if it should wait until a regulatory mandate is in place or push forward for other business reasons.
Novis: Protecting Patient Safety with an Eye toward Business Value
One company that decided not to wait until the dust settled is Novis Pharmaceuticals. As discussed earlier in the article, if you want to prevent a Heparin-like incident and at the same time open the doors to new business value opportunities, the next step is to beat legislation and start securing your supply chain now. Novis Pharmaceuticals, a leading distributor of biotherapeutic products to healthcare providers, didn't wait for legislation to move forward with a Patient Safety Initiative Program. In September 2007, Novis launched the initial Program phase to strengthen product security using electronic pedigrees for all the products it handles, starting with high-risk drugs like Heparin and ones that provide its customers the most value.
Product serialization was also a key part of the equation for Novis, yet the industry wasn't ready to take this next step en masse. So, Novis has also taken the proactive step of blending the SupplyScape Nexus/E-Pedigree platform with an internal serialization solution based on SAP AG solutions to further product tracking throughout the supply chain. This newly launched inventory tracking system, NOVIS RxID, is set to protect product integrity through a systemic product security program incorporating both item-level serialization and electronic pedigree. Particular attention was also given on how these security elements would be extended to Novis' customers.
Underlying the design of their product security program was Novis' ability to leverage these investments for business value. All aspects of the business were examined for opportunities, including internal operational processes and external trade relationships. First, Novis is leveraging the data access and process visibility of the SaaS-based Nexus environment to drive internal operational efficiencies. Novis distributes pharmaceuticals from five regional distribution facilities based in the United States and Puerto Rico. Each of these facilities manages a variety of processes, including initial distribution, returns processing and recall management. The integrated Novis/SupplyScape system provides a new level of control and decision-making across the business.