One size may not fit all in the adoption of an electronic pedigree solution. Different companies may adopt different product
identity approaches. Bar-code, RFID, and varying approaches to serialization may be used. Furthermore, a manufacturer cannot
be guaranteed that a distributor or pharmacy will have the technology in place to electronically read the identity from an
RFID chip, so there may have to be redundant marking—bar coding, for instance—for some members of the supply chain.
Some believe that for the pedigree system to be truly comprehensive, the electronic system will need to interoperate with
paper processing, so entities that have not implemented an electronic process can both send and receive products. This would
require a means for printing, e-mailing, and scanning pedigrees.
Another practical detail: RFID tags can operate at several different frequencies: 13.56 megahertz, 915 megahertz, or 2.3-2.4
gigahertz. The different frequencies will have different prices, functions, and forms. More important, the physics of operating
at a given frequency offer certain advantages. For instance, 13.56 tags can be read through liquids and metals but are often
limited in range. The higher-frequency tags can have greater read ranges—feet rather than inches.
And then there is the issue of the stability of the pharmaceutical products under prolonged exposure to radio frequency waves.
Although the frequencies at which the tags and readers communicate are commonly used in home and industrial environments,
the power level is an order of magnitude higher. Fortunately, researchers at MIT have embarked on an industry-sponsored initiative
to verify the common belief that RF exposure will not affect the stability of drugs.
The full range of 60-plus issues identified by PSTF is well beyond the scope of this article. The point is that a great deal
of work remains to be done in a relatively short time. And the decisions companies must make involve significant investments.
An upcoming HDMA Healthcare Foundation study, based on case studies developed by AT Kearney, puts system integration costs
alone for a large manufacturer at $10-$16 million and at $3-$16 million for a large distributor, not including hardware, data-processing
software, and operating expenses.
The promise on the one hand and the uncertainties and investments required on the other appear to be prompting companies to
ask how they can shorten the implementation path, accelerate the benefits, and hedge the uncertainties.
How to Move Forward
It is not surprising that there are substantial uncertainties. The key question is not whether a system will be implemented,
but when? And what can be done in the meantime?
A recent AT Kearney presentation on the HDMA study called for the industry to agree on an overall rollout schedule. It outlined
an approach that would set a priority schedule for full EPC/RFID implementation with different categories of drugs, beginning
with products highly susceptible to counterfeiting (as defined by the NABP and Florida rules), controlled substances, and
high-priced/high-charge-back drugs. It also suggested an industry schedule for action. The first item on the list is for HDMA,
NACDS, and PhRMA to set a timetable. The presentation suggested that recommendations for technology standards, data standards,
and data sharing should all be completed before the end of 2004.
At a recent international conference on pharmaceutical counterfeiting, HDMA's new president, John Gray, reemphasized the organization's
commitment to driving adoption of the system. Other industry leaders reemphasized their commitment as well. Nonetheless, there
were also repeated references to the possibility that complete implementation will take longer than expected. The following
suggestions may help advance different parts of the effort:
Product identity standards. The pharma industry should adopt the EPC standard and extend it to address both privacy and cost concerns. Manufacturers should
be able to use either a serialization scheme that includes the NDC product code or omits it. Furthermore, a bar-code standard
for representing EPCs either as a redundant or sole marking should be defined.
Electronic pedigree document format. The industry should leverage the legal framework for paper documents established by Florida and the NABP to define the required
data fields that need to be shared among companies. It should also adopt the electronic data exchange standards developed
by UCC to create a global electronic pedigree document format.
Security infrastructure. The industry should establish a root digital certificate authority for securing electronic pedigree documents. A similar structure
was established by DEA for controlled-substance regulations. The root needs to be designed so that it can extend to secure