California’s Electronic Pedigree
Law Delayed to 2011: Now What?
Whether or not legislation will alter the implementation path, we should take a
deep breath and get back to work.
Joe Tenhagen, Vice President of Marketing
Nosco Inc. (Gurnee, IL)
Editor’s Note: The California State Board of
Pharmacy has delayed the implementation
date of the state’s electronic pedigree laws
from January 1, 2009, to January 1, 2011.
“The board concurs that the additional two
years to January 1, 2011, is, in the language
of Business and Professions Code section
4163.5, ‘require[d]’ in order to effectively
implement electronic technologies to track the
distribution of dangerous drugs within the
state,” wrote William Powers, president, California State Board of Pharmacy, in a March
25 statement.
The next two years will be busy, which
means that companies cannot slow down their
programs. “The additional time will simply
allow for greater development and refinement
of existing technical standards and greater
maturity of technologies. It will also allow
some time for the board to continue its partnership work with FDA on the development of
federal unique identifier standards, to ensure
that California and federal standards remain
consistent.”
Joe Tenhagen attended the March 25 California State Board of Pharmacy meeting.
Below, he shares Nosco’s advice for moving
forward.
The California State Board of
Pharmacy’s decision to delay the
implementation of California’s
electronic pedigree law to 2011 seems to
have limited impact on the pharmaceutical industry’s drive to continue preparations. In fact, many of the drug
producers I’ve talked with view the delay
as an opportunity to put the right system
in place rather than any shorter-term
solution that might need to be replaced
later. Long-term solutions range from
complete retrofits of packaging lines
with full data integration within enterprise resource planning (ERP) systems,
to obtaining preserialized packaging and
using off-line RFID tag and 2-D bar
A delay for the e-pedigree deadline means
more time to prepare. Develop a technology
roadmap for pharmaceuticals and biologicals.
code verification with limited ERP integration—enough to satisfy e-pedigree
processes. Each producer must decide
the best option for its firm.
Many producers believe the correct
approach is to invest in RFID as the preferred data carrier and utilize 2-D bar
codes for redundancy and as an exception for biologics and other unique situations. The two-year delay provides the
time to accomplish these goals and
potentially avoid additional capital later.
Wholesalers also want to remain efficient in their operations. Although they
will accept item-level 2-D bar coding,
Nosco has found that they strongly prefer RFID in order to remove bar coding’s line-of-sight constraint. RFID’s
efficiency is promising—for example,
one wholesaler handles up to 50,000
case-shipping events per day from its
largest distribution points. A fully electronic system seems like a necessary
endgame.
In the California State Board of
Pharmacy’s motion to delay, the board
cited among the main reasons the level
of industry preparedness, the state of
proven electronic pedigree and serialization implementation, and the potential
impact on patient safety should drugs
became unavailable to California
patients. Despite the delay, the board
commended manufacturers and wholesalers for their significant progress. The
board feels the delay will enable a more
“measured scale-up” by producers and
trading partners. Board members
strongly urged continued preparation to
meet the 2011 date to continue gaining
knowledge of the impact of electronic
pedigree and serialization on organizations through pilots and scale-up.
MAKING IT HAPPEN
Needless to say, the industry must
band together to ensure interoperability.
Manufacturers must understand stan-
Originally published in the May 2008 issue of
Pharmaceutical & Medical Packaging News.
