Grayson_edit_Cardiology_book_temp 12/10/2009 12:56 Page 6
Tracking and Tracing Standards
Serialization, Pedigree Tracking and Tracing, and Standards—State of the Industry
a report by
Michelle Grayson
1
and Steve Winkler
2
1. Managing Editor, Touch Medical Communications; 2. Standards Architect, Standards and Open Source Group, SAP
Serialization is the process of uniquely identifying an object so that not direct contribution and participation from a spectrum of interested
only are its product type, expiration date, best-before date, lot number, companies, including manufacturers, retailers, healthcare providers,
etc. associated with the item, but any one item can also be distinguished transportation and logistics providers, aerospace and defense companies,
from other items of the same type from the same batch. This can be done and the technology developers themselves. There are other organizations
with both true serialization—where objects are sequentially numbered— working on creating standards in healthcare, including Health Level 7
or with a randomized series of unique numbers. A product’s pedigree, on (HL7), the International Health Terminology Standards Development
the other hand, documents its chain of ownership or possession. Organisation (IHTSDO), developing and promoting Systematized
Combined with serialization, pedigree permits tracking of individual Nomenclature of Medicine—Clinical Terms (SNOMED CT), and the
items throughout the supply chain. International Council for Commonality in Blood Banking Automation,
Inc. (ICCBBA), which manages the International Society of Blood
Importance of Standards Transfusion (ISBT)’s 128 standards for transfusion medicine and
Introducing systems such as pedigree and serialization for international transplantation. All international standards must conform to those
goods requires careful planning, which is where standards can help. The developed by the International Organization for Standardization (ISO). As
total cost of ownership (TCO) and overall integration costs for new healthcare is a highly regulated industry—more so than consumer
hardware and software can be kept to a minimum if all elements of the products in general—it is the target of many new regulations concerning
supply chain have a commonality, provided by standards. Similarly, in a serializing or at least uniquely identifying each object in the supply
dynamic supply chain that regularly introduces new stakeholders—such as chain. A number of initiatives are currently under discussion. In the US,
new suppliers, partners, or customers—the exchange of information the Food and Drug Administration (FDA) is required by law to establish
across different systems will be facilitated by use of common standards. a system to govern unique numerical identifiers placed on either
The amount of data that modern systems have to cope with has grown packages or pallets of drugs by March 2010. This process will facilitate
exponentially. Pedigree laws demand that the unique identifiers for items the security of the supply chain against “counterfeit, diverted,
packaged together in a case or pallet are readable in order to be able to subpotent, substandard, adulterated, misbranded or expired drugs.”
1
associate the case with the items inside all the way through the supply The FDA took a step toward meeting that goal in January 2009 by
chain. As current practice is to identify only the batch, the onus falls on publishing a draft guidance on uniquely identifying pharmaceuticals at
wholesalers and pharmacies to cope with an additional order of the package level—what it considers to be the smallest saleable unit
magnitude difference in the data that have to be captured and managed. made available from a manufacturer. This guidance suggests that the
Again, standards will help ensure that the flow of data is fast and smooth. standard numerical identifiers for prescription drug packages should be a
serialized National Drug Code (sNDC), comprising an NDC plus an eight-
Standards Organizations digit numerical serial identifier.
1
In Europe, the European Commission
The largest standards organization working in this field is GS1, a global (EC) published a draft directive in December 2008 that aims to protect
federation of 108 member organizations representing companies the supply chain from “falsified medicinal products.” The proposed
interested in implementing standardized technology to address real amendments to the existing code covering medicinal products include
business problems. Established more than 30 years ago, GS1 welcomes establishing a legal basis whereby the EC can mandate safety features
such as a serialization number on the packaging of prescription
Steve Winkler is a standards architect in SAP’s Standards and
medicines. The draft directive includes a new point about safety features
Open Source group. He works on standards strategy for supply that will make it “possible to ascertain identification, authenticity and
chain and product life-cycle management, and for industry-
traceability of medicinal products.”
2
specific standards covering consumer products, life sciences,
wholesale, and retail. His current focus is radiofrequency
identification (RFID) and related business processes, for which he International Progress
helped develop the Electronic Product Code Information Services
Across the globe, each country has its own set of regulations regarding
(EPCIS) standard in the EPC global community. Prior to his focus
on business standards, he represented SAP in the development
serialization that may differ from the FDA’s, depending on their
of technology standards that support web services. Previous endeavors at SAP include architecting perspective and maturity level. Nevertheless, pharmaceutical supply chains
and developing a messaging system for SAP NetWeaver’s Process Integration (PI) product.
are global and any one chain will need to be able to comply with multiple
national standards. Therefore, it is important to have internationally
6 © TOUCH BRIEFINGS 2009
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19