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Serialization, Pedigree Tracking and Tracing, and Standards—State of the Industry
accepted standards mandated by an international, independent body. Radiofrequency Identification Issues
GS1 has developed a basic identifier, the Global Trade Item Number There is some concern that using RFID technology around biological products
(GTIN), which is known as the sGTIN when serialized. Sixty-five countries could inadvertently cause damage, particularly with active tags that operate
already accept the base GTIN for pharmaceuticals, but only a few of them at a high frequency.
3
However, the evidence is equivocal. The University of
are in the process of actually having the items serialized. GS1 interacts Wisconsin-Madison RFID Laboratory has been conducting a three-year
with most of the major governments around the world. The FDA is very project in partnership with three national blood centers concerning RFID
active in the standards development groups worldwide. The FDA has (passive 13.56MHz technology) and delivery of blood products. So far, they
already stated that its sNDC is compatible with sGTIN.
1
Global standards, have found no evidence of electromagnetic interference, even with zero
distance between RFID emitter and medical device.
4,5
Nevertheless, the FDA
has urged caution regarding use of RFID tags with biological products, and
noted that there is some evidence that this technology may interfere with
pacemakers and implantable cardioverter defibrillators.
6
There are political
aspects of the RFID technology as well: namely, there must be spare RF
Pharmaceutical supply chains are global
bandwidth in each country for it to work. Some countries, particularly in
and any one chain will need to be able to
Europe, already have a lot of RF bands allocated. National governments
understandably feel strongly about allocation of RFs for various purposes,
comply with multiple national standards.
and gaining agreement for bandwidth in each country is no easy task. There
are also practical issues to consider: many production lines run more or less
continuously, or at least at full capacity with all down-time accounted for—
often a year or two in advance. Finding time to shut them down in order to
particularly in the healthcare industry, are a major challenge as all test or implement a new system is hugely problematic. Furthermore, no two
countries are concerned about ensuring the health of their own citizens production lines are the same; they frequently have unique configurations
through their own regulated healthcare systems. and are bounded by particular space limitations, thus adding RFID equipment
is a challenge for manufacturers. However, such business challenges can be
Serialization Technology overcome with enough will. If manufacturers see the return on investment,
Linear barcodes are not suitable for serialization processes owing to the these issues will prove only short-term obstacles.
limited amount of data they can contain; the nearest technology is 2D
barcoding. Some countries are mandating serialization in 2D barcodes on Future Perspectives
pharmaceuticals; for example, Italy and Belgium already require Electronic pedigrees and serialization, whether using 2D barcodes or
serialization for pharmaceuticals at a country-specific level. Turkey is RFID, both offer increased visibility across the supply chain—visibility that
preparing to implement true serialization laws by taking a global to a degree is available today, but only at a price. Certain companies exist
approach. Other countries require identification only at the lot level; for that track items as they are traded and shipped around, process that
example, France will require a vignette in the form of a 2D barcode information, and sell it back to manufacturers. In this way, by
including lot number and expiration date by the end of December 2010. implementing serialization technologies, there will be an adjustment to
An alternative to barcode technology is radiofrequency identification the business mechanisms in the supply chain, which will be resisted by
(RFID). RFID tags are programmable and can be validated and read certain stakeholders. However, on the other hand, this could enable a
without line of sight. One of the main advantages of RFID technology is release of resources. Other returns on investment are possible: these
that when the tag is commissioned, the product is identified and read in
a matter of seconds. This is a much more complex procedure than with
a 2D barcode. When it was first introduced there was a great deal of
Electronic pedigrees and serialization,
interest in RFID, particularly in the US. However, at that point the
technology was still at an early stage; the cost of the tags was fairly high,
whether using 2D barcodes or
as was the infrastructure investment required. Although this has changed
radiofrequency identification, both
and prices have come down, the common view of RFID as added cost
remains—yet there are many advantages over barcodes. For example,
offer increased visibility across the
unlike 2D barcodes, RFID-labeled items can be associated with a pallet in
supply chain.
realtime (a process of inference) and checked in situ. It is not possible to
verify a barcoded item once it has been put into the case without
unpacking it. Another challenge is simply concerning the quantity of data technologies offer more security against counterfeits and diversions and
and the size of the barcode or tag. Many medical products offer only a better ability to respond to fluctuations in demand. Of course, the
very small amount of real estate, which is a challenge in terms of both benefits are different for each stakeholder in the supply chain. For the
ability to mark and speed. RFID technology is continually improving; FDA there is the benefit to public health offered by the ability to spot
these days it is possible to buy a larger-capacity RFID tag for not much fakes and to perform product recalls. Manufacturers gain visibility over
more than the smaller one, and the larger tag can easily contain an entire where their products end up and can verify genuine items—also
serial number. At the same time as technology costs are coming down, benefiting public health. Wholesalers can speed up business processes
the reliability of the technology is increasing. and ensure shipments are received and are genuine. Pharmacies can
PHARMACEUTICAL SERIALIZATION & AUTHENTICATION
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