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 Preparing for the Golden
Rule
If the electronic pedigree
rules from California’s State Board of Pharmacy stay
their course, the next year will be pretty busy.
California’s laws, which will require drug manufacturers
to generate electronic pedigrees down to the smallest
saleable package, are still slated to take effect
January 1, 2009. The mandate calls for unique
identifiers for each package, nonproprietary data
formats, and interoperability among trading partners.
Wholesalers may not sell products without pedigrees into
California, and California pharmacies may not purchase
them.
With the drug industry still in its
RFID-piloting phase and little item serializing taking
place throughout the industry, meeting California’s
epedigree laws will be tough for drug companies. Some
manufacturers, in fact, almost seem willing to pull
their products out of the California market before
investing time and money in item serialization. At the
board’s September 20 meeting on electronic pedigrees in
Los Angeles, a generic drug representative pulled me
aside and said that her company may have to withdraw its
1000-plus products from California because it cannot
comply by 2009. And other meeting attendees alluded
publicly to an even bigger threat to healthcare in
California—drug shortages of noncompliant products
should the rule take effect before most of the industry
is ready.
“Meeting California’s epedigree rules
will be a relatively large undertaking,” says David
DeJean, director of serialized products for Systech
International (Cranbury, NJ). “There is no
grandfathering of already distributed products allowed,
so wholesalers will be asking for drug manufacturers to
comply with California by next summer. So we are really
looking at a ten-month period.”
Drug
manufacturers do have a lot of work ahead of them. But
there are solutions that may help companies comply (or
get as close as possible to complying) in time to meet
California’s deadline.
Systech is part of a new
group formed to help drug manufacturers prepare for
epedigrees. The California Express Solution teams up
SupplyScape (Woburn, MA), Nosco (Gurnee, IL), Systech,
and HP to provide an integrated solution for complying
with California’s requirements for product serialization
and electronic pedigrees.
 “All of
industry may not be ready in time, but companies can
start by deploying electronic pedigrees,” said Graham
Clarke, vice president, business development, for
SupplyScape, during a September 18 Webinar on California
Express. “They can leverage lot and batch numbers and
add serialization later,” he explained after the
Webinar. “Regardless of whether manufacturers can get
there in time, they need to develop a plan on how to get
there and be proactive in discussing their plan with
California’s state board. Manufacturers should not
surprise the board with a lack of or partial
compliance.”
As part of the California Express
Solution, HP can facilitate development and integration
of necessary architecture and enterprise resource
planning/warehouse management systems (ERP/WMS); the
company also manufactures digital technology used to
print serialized labels and packages. Nosco can provide
preserialized packaging, while Systech can track and
manage packaging-line serialization data at every
packaging stage. SupplyScape can deliver the epedigree
data management system to enable manufacturers to send
epedigrees to wholesalers, pharmacies, and other trading
partners; to date, the company has delivered more than
200 million electronic pedigrees to more than 70
clients. HP’s Security Solutions Center in Puerto Rico
will be available to the team for project development,
reported Webinar speaker Janine Brown, principal
consultant for HP.
The team is gearing up to
help manufacturers meet a number of challenges. One
Webinar attendee asked how packaging lines may need to
be changed support compliance. Speaker DeJean explained
that the biggest challenge will be to get existing
packaging lines to perform serialization. “It could take
20-26 weeks,” said DeJean. The California Express
Solution team can “assess such work early on in the
blueprint phase.” California Express supports
preserialization and on-line serialization, said
DeJean.
Manufacturers may choose to approach
pedigrees and item serialization in steps. For companies
not yet equipped to serialize products on their
packaging lines, Nosco offers preserialized labels and
cartons. “It is easier to get started with
preserialization,” says Craig Curran, director of
strategic initiatives for Nosco. “It can speed things
up, and it can reduce capital costs. Companies can then
move to line serialization later on should the
application call for it.” The preserialized 2-D
Datamatrix bar codes or RFID tags can create a data
registry that can be provided to pharmaceutical
manufacturers for use in production.
 DeJean adds that companies may also
want to consider starting serialization with “local
databases” that can assemble pedigree data for
pick-pack-and-ship operations and feed the data into
pedigree messaging solutions like SupplyScape’s but do
not immediately link into enterprise resource planning
(ERP) software. “This way, you can ease into ERP
processes. Changes to ERP systems can take time. If you
can take a phased-in approach and limit the impact to
other systems, you can be successful in meeting
California’s timeline.”
Whether or not a company
chooses to receive preserialized packaging with a
certified file or produce 2-D codes or write RFID tags
in-line often depends on the number of packaging lines
and SKUs. The investment in retrofitting packaging lines
could be significant.
The California Express
Solution team is holding workshops around the country to
help manufacturers understand these and other options.
For instance, cost comparisons between line
serialization and preserialization and between RFID and
2-D bar codes are provided. For participants who want
details more specific to their own operations, two-day
on-site assessments are available. “We can give
companies a status report on their California readiness.
We formed the team just so manufacturers would not have
to spend a lot of time researching their options,”
explains Clarke.
Adds DeJean: “We are working
toward getting companies to market implementation. The
team is presenting a commercially scalable, available,
and sustainable infrastructure.”
The California
Express Solution team will be following EPCglobal’s
Pedigree Messaging Standard format. It can also support
EPCglobal’s EPCIS standard, and it will support
EPCglobal’s Track and Trace standards once they emerge.
Finally, the team offers certified integration with the
SAP platform.
At the L.A. epedigree meeting, the
California state board seemed very reluctant to delay
legislation until 2011. “Consumers must be protected
from counterfeit drugs,” said state board member Robert
Swart. “To continue to delay implementation is not on
our agenda—2009 is the date,” added board member Stanley
Goldenberg.
While Curran feels that it is unrealistic
to think that every company and every product can comply
by 2009, he says that companies should still get started
promptly. “Pick one commodity or brand and figure out
first how to comply with that product and packaging
line,” he advises.
“Manufacturers are accepting
what they have to do, and there are leadership
examples,” notes Clarke. He points to early adopters of
item serialization, such as Pfizer, whose Peggy Staver
spoke at this week’s California Express Solution
workshop in Chicago. “Manufacturers have the longest
road to hoe, and they would like their options to be
clearer. Our goal with California Express Solution is to
explain the requirements and clarify all
options.”
For details on upcoming workshops and
the solution, visit www.GetEpedigreeReady.com.
Daphne Allen
Editor
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