|
|
| |
Purdue Pharma L.P.
Implements Radio Frequency ID System
for Drug Packaging to Deter Counterfeiting and Diversion
PRNewswire
November 15, 2004
Company Leads Industry in Complying with FDA Counterfeit Drug Task
Force
Recommendations Issued Today
STAMFORD, Conn., -- Purdue Pharma L.P. today
announced a pilot program to integrate unique radio frequency
identification
(RFID) tags on labels for 100-tablet bottles of OxyContin(R) (oxycodone
HCl
controlled-release) Tablets shipped to two of its largest customers.
Purdue
is one of the first pharmaceutical companies to provide fully
integrated,
anti-counterfeiting packaging designed to protect pharmaceutical
products
against counterfeiting and diversion through individual electronic
"license
plates." It is also the first to comply with the multi-layered
approach,
including RFID, to combat counterfeit drugs recommended today by the
FDA's
Counterfeit Drug Task Force. The initial shipments of the RFID-tagged
bottles
will be sent this week to Wal-Mart and H.D. Smith, the seventh-largest
drug
wholesaler in the U.S.
RFID involves the placement of small electromagnetic chips on cartons,
pallets, and individual product labels. This allows manufacturers and
wholesalers to track products more closely than ever before as they
move
throughout the distribution process.
|
|
|
"Our objective in implementing these security features is to deter
counterfeiting, reduce diversion, and help ensure the authenticity,
safety,
and integrity of our products," said Aaron Graham, Vice President and
Chief
Security Officer for Purdue Pharma. "RFID technology provides the
pharmaceutical industry with the ability to create an electronic drug
pedigree, or tracking mechanism, that will lead to greater supply
chain
security and patient protection against counterfeit drugs."
A drug "pedigree" is the paperwork that follows products from the
manufacturer, to wholesaler, to pharmacy. It is more difficult to
track the
authenticity of drugs with incomplete pedigrees. Purdue's initiative
addresses a number of consumer safety issues, including the
redistribution of
counterfeit, adulterated, re-labeled, and diverted prescription drugs
of
unknown authenticity, efficacy, and safety. Based on the availability
of RFID
tags, which are assembled in Maryland and Germany, Purdue plans to
expand the
implementation of RFID labels for all bottles of OxyContin Tablets.
"This is an outstanding collaboration between a manufacturer and
distributor which will help protect the nation's supply of medicines
and help
ensure that patients receive only authentic, efficacious, and safe
products,"
said John Burke, Vice President, National Association of Drug
Diversion
Investigators and Coordinator, Southern Ohio Prescription Drug HIDTA
(High
Intensity Drug Trafficking Area).
"RFID technology is an important new tool that will help our community
pharmacists ensure the safety and authenticity of the products they
dispense
to patients," said Bruce Roberts, Executive Vice President and CEO of
the
National Community Pharmacists Association (NCPA), which represents
70,000
independent pharmacists.
There are no privacy issues associated with RFID tags attached to the
labels of commercial OxyContin bottles. The RFID tag is passive (as
opposed to
emitting a signal) and can only be read with a special scanner held
within
inches of the label. Purdue intends to donate 100 hand-held scanners,
which
can be used to read all packages utilizing similar RFID technology, to
major
law enforcement and cargo theft investigative groups throughout the
country.
The FBI Law Enforcement Executive Development Association (FBI-LEEDA)
praised this donation. "The ability to track right down to the
individual
bottle level is a huge advancement for law enforcement," said Tom
Stone,
Executive Director of FBI-LEEDA. "This will provide police with a new
tool to
combat pharmacy crime and cargo theft."
Another level of security announced by Purdue today was the use of
variable-effect, color-shifting ink in the label for OxyContin.
Similar to
the technology used to deter counterfeiting of U.S. currency,
multi-layered
visible and invisible solutions are also included in the
recommendations
issued today by the FDA task force. The new labels are another
component of
Purdue's fully integrated, anti-counterfeiting, track-and-trace
initiative
designed to protect patients from counterfeit, diverted, and
potentially
unsafe prescription medications.
The professional product labeling for OxyContin(R) Tablets contains
the
following boxed warning:
WARNING:
OxyContin is an opioid agonist and a Schedule II controlled substance
with
an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists,
legal or illicit. This should be considered when prescribing or
dispensing
OxyContin in situations where the physician or pharmacist is concerned
about
an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of
oxycodone
hydrochloride indicated for the management of moderate to severe pain
when a
continuous, around-the-clock analgesic is needed for an extended
period of
time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT
PATIENTS
ONLY. These tablet strengths may cause fatal respiratory depression
when
administered to patients not previously exposed to opioids.
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,
CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin
TABLETS LEADS
TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF
OXYCODONE.
Full prescribing information for OxyContin is available at
http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately
held
pharmaceutical companies known for pioneering research on persistent
pain.
Headquartered in Stamford, CT, Purdue is engaged in the research,
development,
production, and distribution of both prescription and over-the-counter
medicines and hospital products. Additional information about Purdue
can be
found at http://www.purduepharma.com. |
| |
|
|
