After Heparin: - The Pew Charitable Trusts

—Chapter 3—
Sidebar 5
What is “track-and-trace”?
Any system to allow automated drug tracking requires two distinct, but related, technological
components. First, each individual unit to be tracked must have a unique identification—or serialization—number.
Second, the system requires an efficient means of embedding and reading these
numbers as products move through the distribution supply chain.
Serializing drug products at the unit, or package, level would permit tracking of drugs at a much
more granular level than the current lot level. In 2010, the FDA released a final guidance on a
standard form for serial numbers, suggesting that the number be an alphanumeric code of up to 20
digits following the product’s national drug code. 545 The FDA states in its guidance that this “serialized
national drug code” is compatible with existing serialization systems such as the Global Trade
Item Numbers system put forward by the GS1, a nonprofit standards-setting organization. 546
For a functioning track-and-trace system, serial numbers would be embedded in an electronically
readable tag, allowing wholesalers and pharmacies to scan serialized products as they move
through their facilities. Most track-and-trace requirements, such as those included in California’s
pedigree law, are technology-neutral, meaning they do not specify how the serial number will be
applied or recorded. However, there are two principal technologies in use: 2-D bar codes and
RFID. * The latter approach offers an advantage over bar codes in that the tags can be read through
packaging. Drug units are often packaged together for bulk shipping, and entities authenticating
units serialized by bar code must either rely solely on an overall shipment tag (and infer the validity
of the product within, which is a lower measure of confidence), or must open the shipping case to
scan individual units. One limitation to RFID is the potential for interference between frequencies
to affect read rates, according to a 2006 pilot of the technology by Cardinal Health, a national drug
distributor. 547 RFID is also a costlier tagging system than 2-D bar codes, although its price continues
to decrease. 548
In addition to serialization and electronic tagging, a third critical parameter to track-and-trace is an
effective data management system (or systems) that will house transaction information, and which
wholesalers and pharmacies may query to check a product’s transaction history.
* Radio Frequency Identification (RFID) Technology uses electronic tags and readers to pass data through radio waves.
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Pew Health Group