Contact Information: Contacts: Joshua Taustein Dresner Corporate Services for NanoGuardian 312-780-7219 jtaustein@dresnerco.com Sara DeNio Dresner Corporate Services for NanoGuardian 312-780-7223 sdenio@dresnerco.com
White Paper Examines the Importance of On-Dose Technologies in the Fight Against Illegal Diversion of Opioid Medications
Pharmaceutical Security Expert Dr. John Glover Argues for On-Dose Brand Protection in the Fight Against Illegal Diversion of Opioid Medications to Prevent Misuse and Abuse
| Quelle: NanoGuardian
SKOKIE, IL--(Marketwire - May 6, 2009) - NanoGuardian™, a division of NanoInk® that
delivers brand protection solutions to fight illegal diversion and
counterfeiting, announced today that pharmaceutical security expert and
co-founder of the Pharmaceutical Security Institute, Dr. John Glover,
published a white paper extolling necessary requirements of the Food and
Drug Administration (FDA)-proposed Risk Evaluation and Mitigation
Strategies (REMS) for opioid products, commonly referred to as pain
medications.
The white paper, entitled "The Importance of On-Dose Technologies in the
Fight Against Misuse, Abuse and Illegal Diversion of Opioids," addresses
the pressing need for on-dose technologies in the battle against illicit
diversion and the intentional misuse and abuse of opioid medications. A
copy of the white paper is available on the NanoGuardian Web site at
www.nanoguardian.net/White Paper - On Dose Technology in the Fight Against Illegal Diversion of Opioid Meds.pdf.
In 2007, the FDA Amendments Act was signed into law, giving the FDA new
authority to require REMS for certain drugs and biological products. REMS
are required to manage a known or potential serious risk associated with a
product, which can include risks associated with drug abuse, overdose and
withdrawal. To date, REMS programs have focused on patient and prescriber
education. However, according to Dr. Glover, opioid products require a
more specialized mitigation approach, such as on-dose technologies.
"This paper underscores the importance of going beyond traditional
education-based aspects of the opioid-specific REMS," said Dr. John Glover.
"Opioid products already have established RiskMAP programs with education
and outreach programs as the cornerstones to battle misuse and diversion,
but these programs have failed to stem the growing tide of illicit
diversion, misuse and abuse. More is needed and on-dose technologies, such
as NanoGuardian's NanoEncryption™ technology, can greatly assist
manufacturers, law enforcement, and government agencies in mitigating
illicit diversion and the resulting misuse and abuse, by providing
distribution tracing information on each and every dose of a medication."
"With his extensive experience, including serving as the executive
assistant director for administration of the FBI and vice president of
security for a top tier pharma company, Dr. Glover is uniquely qualified to
share his perspectives on the important elements required for a successful
REMS program, with goals to address illegal diversion, misuse and abuse of
opioid medications," said Dean Hart, executive vice president of
NanoGuardian. "As Dr. Glover concluded in his white paper, on-dose
technologies should play a vital role in the prevention of illegal
diversion of opioids and other medications. NanoGuardian's NanoEncryption
technology can provide a significant resource to manufacturers and law
enforcement in addressing the illegal diversion of opioids. For this
reason, we felt it important to include this white paper on our Web site."
NanoGuardian's NanoEncryption technology is an on-dose, multi-layered,
brand protection technology that enables manufacturers to trace and
authenticate each and every dose from plant to patient. NanoGuardian's
technology can be applied directly to tablets, capsules and vial caps.
NanoGuardian's multi-layered security features enable NanoGuardian to
provide a dual-protective benefit with a single technology. The overt and
covert security features enable authentication at any point in the supply
chain, while the forensic NanoCodes provide for an unlimited amount of
manufacturing and distribution-related information on every dose and does
so without adding any particles or chemical markers to the current product.
In 2008, a NanoGuardian client received approval of its Supplemental New
Drug Application (SNDA) for implementing NanoEncryption technology as a
brand protection initiative.
Dr. John Glover is a pharmaceutical security expert with a distinguished
career spanning more than 35 years with the FBI, Bristol-Myers Squibb
Company (NYSE : BMY ), the Pharmaceutical Security Institute and the U.S.
State Department. Today, Dr. Glover serves as president of John Glover
Consulting, Inc., which provides consulting services to a very select
number of prominent corporate and non-governmental entities. Dr. Glover is
also the chair of NanoGuardian's Security Advisory Board.
About NanoGuardian
NanoGuardian™, a division of NanoInk®, focuses exclusively on
delivering brand protection solutions to fight illegal diversion and
counterfeiting. NanoGuardian's cutting-edge NanoEncryption™ technology
enables manufacturers to authenticate and trace the integrity of their
products across the supply chain. More information about NanoGuardian is
available at www.nanoguardian.net.