Drug
wholesaler ahead of curve
July 06, 2006
It may be a few more years
before federal regulators catch up to drug wholesaler
H.D. Smith's efforts to prevent counterfeit
drugs from reaching consumers.
But the chase is on.
Last month, the U.S. Food and Drug Administration
said pharmaceutical wholesalers will need to
monitor more closely the massive quantities
of prescription drugs they sell.
The new rules, which will go into effect Dec.
2, will require a so-called pedigree, or paperwork
that proves authenticity as the drugs make their
way from manufacturer to distributor to patient.
H.D. Smith, the nation's fourth largest drug
wholesaler, is well out in front of the new
regulations.
The Springfield, Ill.-based company, which
is opening a giant new distribution center in
Kearny, has already installed an electronic
pedigree system at its Pompano Beach, Fla.,
distribution facility. The so-called e-pedigree
system allows for oversight well beyond the
new federal requirements and will put H.D. Smith
in compliance with tough new Florida regulations
that went into place July 1.
"This is where we've been ahead of everyone,
and we feel very strongly about our supply chain,"
said Robert Kashmer, H.D. Smith's vice president
for information technology.
The World Health Organization has quoted projections
that worldwide counterfeit drug sales will reach
$75 billion by 2010, a 90 percent increase from
2005.
In announcing the stricter requirements, the
FDA said it is focusing its attention primarily
on a handful of drugs most susceptible to counterfeiting,
including the erectile dysfunction pills Viagra
and Cialis,
the antiviral Tamiflu used to treat early flu
symptoms, the anemia treatment Procrit, and
the nail infection fighter Lamisil.
The FDA's announcement was likely prompted
by the actions of states such as Florida and
California, which have moved independently to
crack down on drug counterfeiting by requiring
the paper pedigrees on drugs shipped within
their state borders.
While the FDA has expressed support for stronger
preventive measures, the agency has yet to set
a timetable for when it might require electronic
tracking systems.
When that occurs, privately held H.D. Smith
will be ready.
Kashmer said H.D. Smith's electronic pedigree
software, designed by Massachusetts-based SupplyScape
Corp., is compatible with all major electronic
scanning systems, whether they are based on
bar codes or so called radio-frequency identification
technology.
That flexibility will enable H.D. Smith to
follow drugs through the distribution chain
regardless of the tracking technology employed
by the manufacturer.
Tracking technology similar to use in Florida
will be installed on a smaller scale at H.D.
Smith's new 217,000-square-foot distribution
site in Kearny, Kashmer added.
Located in a marshy, industrial area just west
of the New Jersey Turnpike, the facility will
replace H.D. Smith's existing distribution center
in Carlstadt, which is being shut down.
With miles of conveyor belts, the new facility
will use state of the art technology to protect
drugs from both the environment and potential
thieves. The new facility is at least the size
of an airport hangar.
The technology installed in New Jersey will
not initially be as comprehensive as that in
Florida because New Jersey lawmakers have yet
to approve Florida's stringent requirements,
Kashmer explained.
Counterfeiting, he said, is "an industrywide
problem and the entire supply chain needs to
be involved." H.D. Smith plans to move
the 200 employees located at the Carlstadt plant
to the new one in Kearny. The new site is expected
to be up and running in September.
Ken Johnson, a senior vice president with the
Pharmaceutical Research and Manufacturers of
America, the industry's trade organization,
said drug makers support calls for improved
technology to track counterfeit drugs.
"There is no single magic bullet to prevent
counterfeit drugs from entering the nation's
pharmaceutical supply chain," Johnson said.
"But there are many effective tools. And
we will continue to work with the FDA, pharmacists,
physicians and supply chain partners to implement
the mechanisms necessary to protect patients."
Source : http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjczN2Y3d
nFlZUVFeXkyOCZmZ2JlbDdmN3ZxZWVFRXl5Njk1NzUzOCZ5cmlyeTdmNzE3Zjd2cWVlRUV5eTI= |
