The latest news from academia, regulators
research labs and other things of interest
Posted: May 6, 2009
Importance of On-Dose Technologies in the Fight Against Illegal Diversion of Pain Medication
(Nanowerk News) 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.
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.