Serialization and related track and trace regulations are now a strategic requirement. For pharmaceutical companies, the supply partners they work with to produce life-saving medicines, and the distribution trade partners that ensure these medicines get to the patients who need them worldwide, track and trace requirements are rapidly becoming a daily part of normal operations in the pharmaceutical supply chain. Propelled by a growing counterfeit drug threat that kills more than 100,000 people annually, regulations for drug serialization, supply chain traceability, and government reporting will affect almost 80 percent of the world’s drug supply by the end of 2018. From the United States and the European Union to China, Brazil, and more, over forty countries will have instituted serialization and other traceability regulations in four short years.
In the United States, the 2013 Drug Supply Chain Security Act (DSCSA) was designed to help combat these patient safety threats. Lot-level traceability, product and transaction verification, and unit-level serialization will be instituted in phases starting in 2015, and will converge into end-to-end unit-level traceability in 2023. The 2017 DSCSA serialization deadlines will mark the first time that many pharmaceutical companies and their supply chain partners will have to implement serialization and manage serialized product inventory.
What has been learned by those who have already started? What are the key issues to master in preparing for DSCSA serialization deadlines? And, why should you start now to understand your true readiness timelines and build your strategic plan, particularly in the context of the global regulatory environment?
DSCSA REGULATIONS & TIMELINE
The Drug Supply Chain Security Act’s ten year timetable outlines critical steps to build an electronic, interoperable system to identify and trace prescription drugs from manufacturer to dispenser across the supply chain serving the United States market. Implementation of the forty pages of complex DSCSA regulations can be broken down into three general phases:
• 2015: Lot-level traceability and verification of products and transactions
• 2017-2020: Serialization of drug products and enhanced verification of serialized product identity
• 2023: Unit-level traceability
On the surface, preparing for the 2017 DSCSA serialization deadlines doesn’t seem that challenging – at least in comparison to other global serialization regulations. Pharmaceutical companies and their CMO/CPO partners must generate serial numbers for each saleable unit and sealed homogeneous case of drug product produced. The serial numbers with associated National Drug Codes (NDCs), lot numbers, and expiration dates need to be encoded into 2D data matrix barcodes (for units) and either 2D data matrix or linear barcodes (for cases) following generally recognized industry standards. If you just look upon serialization as “putting numbers on bottles,” it can be very tempting to put off planning for DSCSA serialization. However, it’s more complex than that.
To understand the full complexity of serialization readiness, here are five key issues that pharmaceutical companies need to consider as they build their serialization programs and ask themselves: “When do I need to start?”.
1. Serialization is More than Putting a Number on a Bottle
Current and proposed serialization and barcoding regulations create a complex, strategic data management challenge. While U.S. DSCSA data requirements are fairly straightforward, globally there is a highly diverse serialization ecosystem to contend with:
- Coding: 2D data matrix or linear barcodes may be used incorporating global GTINs or country specific NTINs
- Formats: GS1 standards predominate while China’s EDMC and Brazil’s IUM differ significantly in length and format
- Sources: Manufacturers can create their own serial numbers except in China where they are requested from the government
- Attributes: Serial numbers may be randomized or sequential and uniqueness may be required within a product line or across all products
- Packaging hierarchies: Serialization may be required at the unit level (EU), unit and case level (US) or all levels below pallet (China)
- Aggregation: Aggregation may be a legal requirement or a potential trade mandate
- Master data: Company, partner and product data related to serialization requirements varies widely from country to country and across trade partner relationships
So, unless your company will only serve the U.S. market and none of your supply or trade partners does business in other markets, it is critical to understand the diversity of the serialization regulations and how they potentially impact your enterprise IT architecture, your operational processes or the readiness of your supply partners to serve you when you need them.
2. Serialization Forces Supply and Trade Partner Networks to Evolve
You have to understand all potential network connections (internal, supply, trade, governmental) over which serialization information needs to flow, not just internal packaging site or CMO/CPO links, to understand the regulatory and business data flows your infrastructure needs to support. The serialization infrastructure you develop will probably have to support a surprising diversity of data types, connection methods, business preferences and regulatory interpretations across your various network relationships.