Contract Pharma magazine...June 2010
THE FDA’S PUBLICATION OF THE FINAL guidance on a standard
numerical identifier (SNI) for pharmaceutical packages
at the end of March awoke the drug industry from
its track and trace slumber. Manufacturers, distributors, pharmacies
and their vendors had been snoozing since September
2008, when California pushed back its e-Pedigree implementation
date, an action with significant national implications.
Instead of having to put unique serial numbers on packages
starting January 1, 2011, California, responding to pleas from
an ill-prepared drug industry, pushed back that e-Pedigree
deadline to January 1, 2015. One-half of all drug packages
arriving in the state on that date will have to have unique serial
numbers printed on them. The other half will have to follow
suit one year later.
“Everybody took a deep breath when the California Board of
Pharmacy delayed its e-Pedigree requirement,” agreed Ruby
Raley, director, healthcare solutions, Axway, a company that
provides the software to run the data repositories that hold
information about drug package pedigrees as an individual
package moves from the manufacturer to (perhaps) a repackager
to a wholesaler and on to the retail or hospital pharmacy.
Axway is involved in numerous track and trace pilots with comTHE FDA’S PUBLICATION OF THE FINAL guidance on a standard
numerical identifier (SNI) for pharmaceutical packages
at the end of March awoke the drug industry from
its track and trace slumber. Manufacturers, distributors, pharmacies
and their vendors had been snoozing since September
2008, when California pushed back its e-Pedigree implementation
date, an action with significant national implications.
Instead of having to put unique serial numbers on packages
starting January 1, 2011, California, responding to pleas from
an ill-prepared drug industry, pushed back that e-Pedigree
deadline to January 1, 2015. One-half of all drug packages
arriving in the state on that date will have to have unique serial
numbers printed on them. The other half will have to follow
suit one year later.
“Everybody took a deep breath when the California Board of
Pharmacy delayed its e-Pedigree requirement,” agreed Ruby
Raley, director, healthcare solutions, Axway, a company that
provides the software to run the data repositories that hold
information about drug package pedigrees as an individual
package moves from the manufacturer to (perhaps) a repackager
to a wholesaler and on to the retail or hospital pharmacy.
Axway is involved in numerous track and trace pilotswith companies
such as AstraZeneca, Johnson & Johnson, and Glaxo-
SmithKline. “Nothing happened last year,” she remarked.
Now, publication of an FDA-approved package serialization
scheme has given the pharmaceutical industry a reason to
restart its version of California Here I Come. Whereas the
California Board of Pharmacy provided no specifics on package
serialization, the FDAhas; manufacturers no longer have to
wait and guess what might be acceptable in the Golden State
come January 1, 2015, a date that, given the complexities of e-
Pedigree compliance, isn’t so far away.
James McCrory, vice president, products and technology at
rfXcel Corp., said, “The SNI guidance is a big deal in three
ways. It reflects new interest in federal government safety of
prescription drugs, provides endorsement of GS1, which is
pretty big since people have been hanging back waiting to see
what happens, and matches what leaders and distributors and
manufacturers are doing in their own pilots.” The SNI essentially
endorses the serialization standard adopted by the international
standards group GS1. GS1 has one serialization standard
for numbers printed in 2D barcodes (GT10) and a second
one for numbers printed on radio frequency identification
(RFID) tags (G10).
An agreed-upon format for an item-level SNI is only the first
step in a closed-loop e-Pedigree (often used synonymously
with track and trace) system such as the one adopted
by California, and likely to be endorsed by Congress. Other
follow-on elements include:• security framework for data exchange,
• record retention policies,
• SNIs at the pallet and case level,
• standardized chain-of-custody data to be tracked by
logistical units,
• standardized electronic data exchange format,
• data carriers with specific encoding formats identified,
• guidelines for reporting exceptions noted by supply chain
participants, and
• hierarchy of the SNIs expected in a shipment.
The FDA SNI provides a first-step level of certainty to manufacturers,
in terms of compliance with federal expectations,
and assures them that the U.S. is moving in the same basic
direction as other countries, many of whom are far more
advanced in their national track and trace requirements. That is
all true despite the limitations of the FDA guidance: it is a suggested
package identification formula. There is no federal
requirement that drug manufacturers follow it, much less put a
serial number on each item-level package. The limits of the FDA guidance, some of its nuances and its
failure to address the important issue of which technology
should be used to print the SNI have all combined, apparently,
to seal the lips of pharmaceutical manufacturers who just three
years ago were touting their track and trace efforts. Prominent
proselytizers such as Pfizer, Abbott and Purdue Pharma have
declined to comment on the FDA final guidance on an SNI. “I
ran this request up the flag pole and have learned that we are
unable to grant interviews on this topic,” explained Libby
Holman, spokeswoman for Purdue Pharma, which has been an
aggressive track and trace experimenter because of its manufacture
of OxyContin, a popular target of drug diverters.
Tom McPhillips, vice president, U.S. Trade Group, Pfizer
Inc., did not return an e-mail requesting comment. Mr.
McPhillips, in his comments to the FDA after the draft guidance
was published, asked the agency not to require manufacturers
to print the national drug code (NDC) as part of both the
machine readable and human readable SNI. The FDA rejected
that request.
Nonetheless, manufacturers support the specificity of the
SNI, and its agreement with GS1 standards, which gives them
more certainty than California’s prescription for a unique serial
number. The only guidance in the Golden State law, according
to Virginia Herold, executive officer of the California Board
of Pharmacy, is that the number be part of an “interoperable”prospective impact of counterfeit drugs on public health and
safety. The 2007 Heparin recall underlined the value of track
and trace (had it been deployed by the pharmaceutical chain)
with regard to drug recalls. Preventing thefts is an important
affiliate benefit, too. In March, thieves broke into an Eli Lilly
warehouse in Enfield, CT and stole $75 million worth of prescription
drugs. The crooks took pallets of the anti-cancer
drugs Gemzar and Alimta, the schizophrenia drug Zyprexa,
the antidepressant Cymbalta and other prescription medicines.
Theoretically, those stolen drugs could not come back into the
legal distribution chain if they had SNIs printed on 2D barcodes
or RFID tags on each package’s label.
It is clear that manufacturers are the big winners, relatively
speaking, from the final guidance. Scott Melville, senior vice
president for government affairs for the Healthcare
Distribution Management Association (HDMA), said, “The
FDA guidance provides manufacturers and the entire pharmaceutical
supply chain with needed. But while the HDMA has
welcomed the guidance, it clearly did not get everything it
wanted. For example, the HDMA had not wanted the FDA to
endorse an ‘alphanumeric’ as a serial number option.”
However, Anita Ducca, senior director, regulatory affairs at
HDMA, acknowledged the FDAwas responsive to her group’s
concerns. “We had a number of things we wanted the FDA to
change fromits draft guidance and for themost part the agency did that,” she states. “Our members are ready and willing to
work within the parameters of the guidance.”
Neither did hospitals and pharmacies get exactly what they
wanted. Some pharmacy groups had also pushed for a different
SNI. The American Society of Health System Pharmacists
(ASHP) had urged the FDAto modify the NDC number so that
its components included the RxNorm CUI as the drug/form/
dose component of the code. Justine Coffey, JD, LLM, director,
federal regulatory affairs, said, “Currently, ASHP members are
struggling with inconsistencies relating to the National Drug
Code (NDC) and its application to barcode point-of-care, clinical
information systems, and hospital financial systems.”
Axway’sMs. Raley noted that hospitals are particularly concerned
about avoiding medication errors, especially given the
passage of the health care reform bill, which mandates a number
of new payment methodologies based on the hospital
reducing errors of all kinds. She explained that many drugs
come in many formulations and doses, information which will
not be gleaned from the SNI endorsed by the FDA. Ms. Raley
pointed out that hospitals are particularly sensitive to this issue
given the publicity generated by the misadministration of
Heparin to twins born in November 2007 to the actor Dennis
Quaid and his wife.
Minor reservations aside, the HDMA’s Mr. Melville emphasized
that the final guidance allows his members and everyone
else to move forward. “The first step in an e-Pedigree system is
putting a number on the package,” he said. “The second step is
what you do with that number.”
For distributors a big issue is how the SNI is printed on the
item-level package label. The two options that have emerged
over the past half-decade are a 2D barcode or a radio frequency
identification (RFID) tag. Distributors have generally favored
RFID tagging, since they could check in packages to their warehouses
without a reader having to be “in the line of sight” with
the individual package. This saves them time, which is important
because any e-Pedigree requirement costs the distributor
money and earns the company no profit. But RFID tags are
expensive, and manufacturers have generally pushed for printing
serial numbers within 2D barcodes, not just because the
labels are cheaper, but because the packaging lines can run
faster than they could if RFID tags are printed on the package.
Moreover, RFID tags cannot be used on some products.
The final guidance on the SNI appears, however, to endorse
2D barcode serialization without actually saying so. “The FDA
landed on 2D,” stated Ms. Raley. “It is very clear they talked
about the total acceptability of 2D although they did not rule out RFID.” RFID does have some significant shortcomings when it
comes to package use, such as its deleterious effect on biologics.
Robert Celeste, director, healthcare, GS1 US, said that in fact
all the manufacturers who have done pilots, and are doing
them now, are putting serial numbers on packages via 2D barcodes.
Some are also putting RFID tags on the product label,
and on cartons and pallets. He believes it is possible that RFID
tags on item-level packages may have utility—if their per unit
price comes down — in certain applications, for example,
where products must be kept at certain temperatures.
The final guidance, however, is silent on serialization of cartons
and pallets, which the California Board of Pharmacy, just
to cite one interested party, had pushed for, and on which the
FDA had asked for comments.
While the pharmaceutical supply chain now knows that the
SNI is the baseline for complying with California’s e-Pedigree
requirement, everyone up and down the chain is pushing for
federal legislation that would make the California requirement,
or some close version of it, national law and might resolve outstanding
technology questions as well. The 2007 congressional
law that required the FDAto publish some sort of SNI within 30
months—it did not specify guidance versus more legal regulation
— also told the FDA to “develop standards and identify
and validate effective technologies for the purpose of securing
the drug supply chain against counterfeit, diverted, subpotent,
substandard, adulterated, misbranded, or expired drugs.” The
FDAreceived comments but has done nothing to impose a technology
solution, which various players in the drug distribution
chain would probably oppose, but which is clearly necessary.
In the 2007-2008 session of Congress, Reps. Steve Buyer (RIN)
and Jim Matheson (D-UT) introduced the Safeguarding
America’s Pharmaceuticals Act, which would have established
a federal e-Pedigree mandate. That law has not been reintroduced
in the current Congress, perhaps, suggested Ms. Herold
of California’s Board of Pharmacy, because members of the
House and Senate have been overwhelmed with healthcare
reform, financial reform and economic recovery. Also, the same
sense of urgency that disappeared in California in September
2008 disappeared from Congress at about the same time.
As the HDMA’sMr.Melville put it, “We want a uniformfederal
pedigree standard. We can’t have barriers to movement of
products.” He added that Reps. Buyer andMatheson, at a hearing
onMarch 10, stated they are working on a redrafted version
of their bill. “We are very hopeful it will be reintroduced soon,”
said Mr. Melville. “We expect it to look like the California
implementation schedule.”
