For two decades, the drug industry has debated how best to create a digital chain of custody for its products. Mandates, initiatives and deadlines have varied unpredictably, a case in point being legislation in the State of California for mass serialization of prescription drugs—whose deadline has been extended several times over the past seven years. (See, for example, “Pedigree Adopters Play the Waiting Game.”)
Today, however, the message is clear: the California State Board of Pharmacy has put a stake in the ground, and there are now firm deadlines for sequenced implementation of serialization of most prescription drugs intended for sale in California. Between 2015 and 2017, manufacturers, wholesalers, and pharmacies must define and implement a meaningful track-and-trace system, including serialization and network components.
Increased threats to the life sciences supply chain—counterfeiting, diversion and organized theft from storage and distribution networks—have increased the industry’s sense of urgency. While FDA has not provided its own mandate, it has actively sponsored e-pedigree education, hosting a Track and Trace Public Workshop this past February that encouraged manufacturers to develop and define:
- An electronic system for track, trace and authentication (using a unique identification number for each product)
- Participants—from point of manufacture to dispensing
- Product level information requirements
- Data format and architecture—“standardized and non-proprietary”
There are multiple drivers towards mass serialization outside the U.S. as well:
- Turkey: new pharmaceutical cartons must be serialized with a 14-digit GTIN as well as a 20-digit serial number with lot and expiration codes
- Italy, Belgium and Greece: require serial numbers at the single pack level
- France: requires a CIP 13-digit data matrix code for tracking pharmaceutical shipments from manufacturer to patient
- Brazil: requires security labels (tamper evident) as well as 2-D data matrix bar codes with a unique serial number (IUM) for all pharmaceuticals sold (effective 2012)
Taking the Necessary Steps
Manufacturers in the life sciences have taken varied approaches to create a safe and secure supply chain. There is one thing that none can dispute: This is not an easy task!
Fortunately, supply chain management has evolved over the past decade. Previously viewed as functional activities performed by vertical groups within procurement, manufacturing and distribution, effective supply chain management is now much more sophisticated and horizontal, and is viewed as a strategic advantage.
In common with other industries, in particular electronics and automotive, the pharmaceutical industry now includes a multitude of players, across an increasingly outsourced network of transformation and distribution partners. It is critical to take a holistic view when defining strategies and approaches for something as important as an information system to share data at the product and transaction level. Although current mandates and programs are initiated at the finished product manufacturing point, it is prudent to take into account future needs for a more granular perspective, to include visibility into product ingredients and components—and potentially final consumption and/or return and destruction (an important point, as FDA has emphasized the value of serialization for product recall).
Irrespective of the level of detail desired, however, manufacturers must follow several fundamental steps in defining their short-, medium- and longer-term strategies:
1. Identify and engage an executive sponsor, while ensuring that all key stakeholders are included in the review process. Taking into account the participants across the product lifecycle will enable a more holistic view of data sources, as well as users of data that could facilitate process transformation.
Internal participants should include (but are not limited to):
- Procurement and finance
- Product development/product management
- Marketing and sales
- Customer service and support
- Quality and industry compliance and validation
- Risk management
- Storage and distribution
- Information technology personnel and partners
- Legal entities (internal and external legal counsel need to understand implications of data sharing, confidentiality and intellectual property protection)
External supply chain participants include:
- Suppliers—direct and indirect suppliers of raw materials, components and packaging materials
- Outsource manufacturing partners, packaging and repackaging facilities
- Logistics service providers—carriers, freight forwarders, customs house brokers, trade and finance partners
- Customers—distributors as well as final consumers
2. Understand the business drivers—what policies and mandates should be taken into account? In the case of specific regulations and mandates, there are timeframes and information requirements that are not negotiable. For compliance with the California requirements, for example, expectations are well defined. Companies that wish to sell product in this market have little time to waste in order to ensure “business as usual.” Compliance with other regulations, such as those outside the U.S., should be driven by business strategies, current and future. The emphasis is on understanding, at the product level, the impact of consolidation, outsourcing and marketing strategies—taking into account local, regional and global requirements for product-level track and trace, as well as the potential benefits of supply process visibility.