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NAVIPPRO™: a complete risk management approach |
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With prescription drug misuse and abuse on the rise, the National Addictions Vigilance Intervention and Prevention Program, NAVIPPRO™, is a complete and sophisticated risk management solution. NAVIPPRO gives pharmaceutical and biotechnological companies an effective, in-depth way to monitor post-marketing, drug-specific abuse nationwide. Currently tracking opioid analgesics, with data on stimulants coming soon, NAVIPPRO helps you minimize drug safety concerns and continually investigate the extent of potential abuse and misuse.
NAVIPPRO's complete approach starts with accurate and sensitive surveillance. NAVIPPRO provides access to timely, reliable, drug-specific data from both urban and non-urban areas throughout the United States.
NAVIPPRO combines sophisticated proprietary, public, and patient-reported data to create a complete geo-spatial map of what's happening, right now. With over 165 treatment facilities supplying proprietary data, NAVIPPRO experts use scientifically developed methodologies and signal detection procedures to examine the extent of abuse and offer possible conclusions for individual events and specific areas of concern.
Finally, the NAVIPPRO system incorporates proven educational prevention and intervention programs that target clinicians, at-risk populations, and current drug users with online resources and tools. NAVIPPRO lets you leverage the successful, award-winning behavioral health solutions created and tested by Inflexxion (most with support, in part, from the National Institutes of Health) and fills in any existing gaps to give you complete, responsible, and effective risk management.
From surveillance to intervention and prevention, learn more about NAVIPPRO's complete risk management solution by contacting Andrea Licari at alicari@inflexxion.com.
NAVIPPRO was developed in part with support from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA). NAVIPPRO's founding sponsors include Alpharma Pharmaceuticals LLC., and Endo Pharmaceuticals.
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Interview with Inflexxion's Senior Consulting Advisor to NAVIPPRO™ John Brownstein, PhD |
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Assistant Professor of Pediatrics at Harvard Medical School
John S. Brownstein PhD has joint appointments in the Children's Hospital Boston Informatics Program at the Harvard-MIT Division of Health Sciences and Technology, and the Division of Emergency Medicine. Dr. Brownstein works on novel statistical modeling and medical informatics approaches for accelerating the translation of public health surveillance research into practice.
Q: What is biosurveillance?
Biosurveillance refers to automatic monitoring of public health trends and unusual occurrences. It's a supplement to traditional public health surveillance and relies on preexisting, real-time health data: data that is already out there and doesn't require a lot of manpower to obtain. Biosurveillance is a systematic monitoring of what's happening in public health right now.
Biosurveillance involves a series of methods of detecting and verifying signals before an outcome is confirmed. For opioid biosurveillance, the goal is to look for signals of abuse and misuse before official confirmation takes place; like a type of 'early warning.'
Q: A lot of your research has been focused on outbreaks of influenza and how to help epidemiologists monitor and learn from the study of these outbreaks. How is the tracking of prescription opioid abuse similar or different than monitoring influenza and infectious diseases?
There is an interesting commonality between opioid and infectious disease surveillance. In both cases there was a reaction to a signal event that led to a lot of public interest, for example; surveillance of bioterrorism (and in fact all infectious disease outbreaks) garnered attention after the highly publicized Anthrax outbreak. Concerns about OxyContin and the prescription pain abuse epidemic that developed also brought the need for opioid biosurveillance to the forefront of the public mind.
My work with influenza tries to understand how flu spreads in space and how epidemics take place in time. In terms of opioid abuse, we also look at geographic patterns and how use, misuse, and abuse patterns spread. Just like influenza, social networks play an important role and define high-risk areas. We look for signals of increased opioid abuse in particular areas and use classic sentinels to gather information. We are especially interested in data sources that provide early indications, such as treatment centers and media monitoring.
Q: Prescription opioid abuse is quite prevalent around the country, how can you tell the difference between the low level of abuse that is always there and a true outbreak?
It's important to understand how to scientifically validate the signals that we get. You want a system of data collection that's sensitive to change, but highly sensitive systems can be very 'noisy.' Too much noise leads to false positives and makes the system useless. Good biosurveillance always tries to reduce noise and respond to verified signals. Comparing data sources and collecting from multiple sources is a good way to provide cross validation.
Q: In your work on the NAVIPPRO™ program, how are you applying epidemiological methods to examining the data?
I work on validating signals and filtering 'noise.' I've helped the NAVIPPRO team develop advanced statistical methods for looking at patterns in data that are being collected from a variety of sources. We are looking for increased rates of abuse over time and across geography. In particular, I'm interested in the thresholds that define what particular rate in an area determines if there is an actionable issue occurring. The benefit of this type of biosurveillance is that you're looking for trends that are occurring in an area right now, in real-time with high geographic specificity.
Q: What are some of the biggest epidemiological questions in prescription opioid biosurveillance?
Again, there are a lot of similarities between opioid and infectious disease surveillance; the biggest epidemiological concerns are the same. It's important to find the compromise between sensitivity and specificity: finding a system that provides the earliest indications, while determining what is noise and what is a reliable signal. You have to have a system that doesn't set off many false alarms or people will stop listening. At the same time when there truly is a problem in a given area, you want to be sure to know it.
Also, knowing the needs of the audience you are reporting to is key. It's important to identify signals that are worth reporting and are actionable. If we identify problems and there is nothing that can be done, it's almost a worthless detection. If there is a onetime spike and then the situation goes back to normal, what can be done with that information? Successful biosurveillance comes from understanding what meaningful data is to your audience, screening the noise, and delivering useful information.
Dr. Brownstein was trained as an epidemiologist at Yale University where he received his PhD., and can be contacted at john_brownstein@harvard.edu.
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Explore NAVIPPRO™ data:
Abused routes of administration for various prescription opioids |
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Managing the risks associated with opioid analgesic abuse and misuse is essential to ensuring that these drugs remain available to the patients who need them. Understanding the different ways abusers make use of prescription opioids may be helpful in eventually developing abuse deterrent forms of these drugs. This data may also lead to more understanding regarding the natural history of prescription opioid abuse. Recently, NAVIPPRO™ data were used to examine preferred routes of administration among drug abusers for different classes of prescription opioids.
In a new analysis of NAVIPPRO data, 15.1% (2,404) of interviewees reported illicit use of opioids in the preceding 30 days. Analyses of prescription opioid abusers' interviews found striking differences regarding routes of administration for each of the following analgesics: Oxycodone, Hydrocodone, Morphine, and Fentanyl. Examination of opioid abusers' self-report assessments on admission to treatment centers found that they are:
· More likely to orally take Hydrocodone (89%) than other prescription opioids
· More likely to snort Oxycodone (51%) than other prescription opioids
· More likely to smoke Fentanyl (31%) than other prescription opioids
· More likely to inject Morphine (58%) than other prescription opioids
These data were obtained through Inflexxion's ASI-MV® Connect database, a continually growing collection of 18,000 self-reported, computer-administered interviews. New opioid-related interviews are uploaded daily to the ASI-MV Connect database, keeping information specific, accurate, and current.
In addition to research on generic drugs by analgesic category, NAVIPPRO gives you product-specific data for the following prescription opioids:
Actiq®
Avinza®
Combunox®
Darvocet®
Darvon®
Demerol®
Dilaudid®
Dolophine®
Duragesic®
Fentora®
Kadian®
Lorcet®
Lortab®
MS Contin®
MS IR®
Norco®
Opana IR®
Opana ER®
OxyContin®
Palladone®
Percocet®
Percodan®
Stadol®
Subutex®
Suboxone®
Talcen®
Talwin®
Talwin Nx®
Tylenol® with codeine
Tylox®
Ultram®
Ultracet®
Vicodin®
Vicoprofen®
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Prevention program targeting at-risk groups: educating college and university students |
According to a March 2007 report from The National Center of Addiction and Substance Abuse at Columbia University (CASA), "between 1993 and 2005, there has been a 342.9% increase in the proportion of students abusing prescription opioids like Percocet, Vicodin and OxyContin in the past month (0.7% to 3.1%, approximately 240,000 students)." With students dividing time between recreational activities and stressful studies, the college environment for many full-time, 18-22 year old students promotes (rather than restricts) substance use and abuse. The CASA study, Wasting the Best and the Brightest: Substance Abuse at America's Colleges and Universities, reports increases in prescription opioid abuse among college students as well as prescription stimulants, tranquilizers, and sedatives between 1993 and 2005.
College students nationwide are targeted by NAVIPPRO's™ proactive intervention and prevention education program: myStudentBody® Drugs. The online, interactive program addresses the real needs of at-risk college students who are already immersed in an epidemic of prescription drug misuse. Used on more than 100 college campuses across the country, myStudentBody Drugs is a module within Inflexxion's suite of behavioral health resources for college students and has an entire section devoted to prescription drug (stimulant and opioid) awareness.
As part of NAVIPPRO's educational tools and resources, myStudentBody Drugs educates and empowers at-risk college students to prevent misuse and abuse before it starts and offers intervention strategies for students already facing more severe prescription drug use problems. As a 24 hour educational resource that students use, myStudentBody Drugs offers:
· comprehensive coping strategies
· student submitted personal experiences (peer stories)
· the truth behind widespread myths about drugs
· medication side effects and interaction information
· basic and advanced prescription drug information
· self assessments and quizzes
In addition, myStudentBody Drugs contains current, relevant articles on topics that include legal repercussions, healthy activities to reduce stress, and the dangers of mixing substances and self-medicating.
A complete risk management solution, NAVIPPRO incorporates the myStudentBody Drugs tool as a proven educational resource for a known at-risk population. Pharmaceutical companies can support and use myStudentBody Drugs as part of their risk management program without a full subscription to NAVIPPRO. For more information, contact Andrea Licari. |
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Founding sponsors
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| The NAVIPPRO team would like to recognize the continued support of founding sponsors; Alpharma Pharmaceuticals LLC., and Endo Pharmaceuticals.
We would also like to acknowledge the support of multiple National Institute on Drug Abuse (NIDA) grants.
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Engel Conferences Drug Development Summit 2008 February 12-15, 2008 Amelia Island, FL
American Academy of Pain Medicine 24th Annual Meeting February 13-16, 2008 Orlando, FL
American Society of Addiction Medicine, ASAM
39th Annual Medical-Scientific Conference
April 10-13, 2008
Toronto, ON, Canada |
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Did you know? |
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Sponsored by NIDA, the results from the University of Michigan's Monitoring the Future survey found:1
*Most illicit drugs have shown considerable decline over the past decade
*Most perscription sedatives, tranquilzers, and pain killers have shown steady increases in non-medical use over the same decade
*Annual prevalence rates in 2007 for Oxycontin use are 1.8 percent, 3.9 percent, and 5.3 percent in 8th, 10th, and 12th graders, respectively
*One in every twenty high school seniors has at least tried OxyContin in the past year
1National Institute on Drug Abuse. (2007) Monitoring the Future 2007 Full Press Release on Drug Use from the University of Michigan citation format. (20 Dec. 2007). |
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| Next issue |
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NAVIPPRO Signal interviews Dr. Albert Villapiano, Vice President of Clinical Development, Substance Abuse, here at Inflexxion.
Dr. Villapiano will answer questions about the ASI-MV Connect system and how it supplies the NAVIPPRO™ system with valuable, patient-reported data from treatment centers around the country.
Submit your questions for Dr. Albert Villapiano now and be sure to read his answers in the upcoming issue!
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