Study Finds Non-Medical Prescription Opioid Users Have Multiple and Distinct Profiles
Inflexxion’s findings may help focus prevention efforts and intervention strategies for prescription opioid abuse reduction
• Aim of this study was to derive and describe typologies of prescription opioid use in a large and diverse population of adults being assessed for substance abuse treatment
• Researchers obtained data from substance abuse treatment, criminal justice, DWI and public assistance programs
• Results identified four subgroups of opioid users: use as prescribed, prescribed misusers, medically healthy abusers, and illicit users
November 7, 2011 - Newton, MA - This study is the first analysis of prescription opioid use typologies in a population of individuals being assessed for substance use problems from a large and diverse sample of such respondents in the U.S. The study detected multiple and distinct profiles of prescription opioid users, suggesting a range of typologies rather than a simple dichotomy of those who do or do not report non-medical use of prescription opioids. For most patterns, non-medical prescription opioid use did not occur in isolation of abuse of other substances. The prominence of comorbid psychiatric and medical problems suggest the need for better integration of and access to mental health, primary care and substance abuse treatment. A comprehensive public health approach that incorporates supply and demand reduction, adequately extends and supports harm reduction and treatment, and recognizes the need for effective intervention at the individual and structural levels is recommended.
More information on this study can be found in article, “Typologies of Prescription Opioid Use in a Large Sample of Adults Assessed for Substance Abuse Treatment” published November 2, 2011 in PLoS ONE, an international, peer-reviewed, open-access, online publication.
“As a population, non-medical prescription opioid users are not well-defined. We wanted to better understand who is using prescription opioids and whether we could detect subgroups of non-medical use,” says lead researcher Traci C. Green, MSc , PhD, Assistant Professor of Medicine and Epidemiology at The Warren Alpert School of Medicine of Brown University and Rhode Island Hospital. “Previous studies have focused on various demographic groups of non-medical prescription opioid users. These populations may differ drastically in important ways, including route(s) of administration of the prescription opioid, concurrent drug and alcohol use, treatment experience, and history of substance abuse dependence, among others. Such variability makes it difficult for public health statistics to make general statements about non-medical prescription opioid users. But this is an even bigger challenge for clinicians and policy makers, who are faced with the challenge of focusing prevention, screening, intervention, and treatment strategies to address non-medical prescription opioid use in a way that prioritizes individuals at high risk of harm and poor health outcomes, without a clear sense of the nature of the disparate populations that may be involved.”
Data were obtained from November 2005 through December 2009 from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid. Data were collected by Inflexxion’s proprietary NAVIPPRO™ (National Addictions Vigilance Intervention and Prevention Program) system. NAVIPPRO provides timely and accurate information about the misuse and abuse of prescription opioids and stimulants nationwide. With its real-time national monitoring system that includes data from hundreds of substance abuse treatment centers across the country, NAVIPPRO detects changes in prescription opioid and stimulant drug abuse patterns and estimates the relative rates of abuse.
Researchers detected four clinically interpretable and relevant subgroups including: use as prescribed (18.9%), prescribed misusers (26.9%), medically healthy abusers (35.8%), and illicit users (18.4%). Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose and 18.4% exhibited risk factors for blood-borne infections. According to the National Center for Health Statistics, drug-related deaths like overdose now outrank car accidents as the leading cause of accidental adult death.
“This is the first study ever to differentiate the underlying subgroups of prescription opioid abusers. Finding these subgroups can help us better formulate prevention and treatment strategies that can improve public health and intervention approaches,” says co-author Simon Budman, PhD, founder and CEO of Inflexxion and co-founder of NAVIPPRO. “Our findings may help clinicians and policymakers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction.”
“Due to the high degree of specificity of data that NAVIPPRO gathers and the large numbers of cases in our sample, we were able to explore patterns of prescription opioid use that incorporated route of administration, source of drug, and product-level indicators of non-medical use for short and long-acting opioid medications,” says co-author Stephen F. Butler, PhD, Senior Vice President and Chief Science Officer at Inflexxion. “The four unique groups of prescription opioid users we identified differed in key ways relevant to public health and clinical intervention, including: age, race/ethnicity, concurrent drug use, onset and duration of their drug use, routes of administration, and comorbid psychiatric and medical problems.”
“Our results add to a growing body of research indicating that prescription opioid products are being misused and abused in ways that call for more nuanced and public health-oriented post-marketing surveillance and risk management responses than have been proposed heretofore,” says Dr. Green. “The main thrusts of the current Prescription Opioid Abuse National Strategy and the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) components rely heavily upon provider and patient education and expansion of prescription monitoring programs. Based on our findings, such efforts will have limited effect on the largest subpopulations of non-medical prescription opioid users who are at greatest risk of adverse health events. These subpopulations are sizeable, exist primarily outside of the regular care of medical professionals, and would likely require other, very different intervention techniques, such as targeted overdose prevention counseling and response and health or social service venue-based preventive interventions.”
This study was supported by a National Research Service Award grant from the National Institute on Drug Abuse (NIDA) and by a 2009 Developmental grant from Lifespan/Tufts/Brown Center for AIDS Research. The writing of “Typologies of Prescription Opioid Use in a Large Sample of Adults Assessed for Substance Abuse Treatment” was funded in part by an unrestricted grant from Pfizer Pharmaceuticals, Inc.
Inflexxion Partners with Los Angeles County Department of Public Health
LA County implementing Inflexxion’s ASI-MV, the most advanced online behavioral health assessment program
October 17, 2011 - Newton, MA - Inflexxion, the leader in creating scientifically validated solutions for critical areas of health care, announces that Los Angeles County, the largest county in the United States, is using Inflexxion’s Addiction Severity Index-Multimedia Version (ASI-MV®), an online behavioral health assessment program, in its Community Assessment Service Centers (CASC) which will process over 9,000 newly released prison inmates over the next year and nearly 30,000 over the next three years.
With many of the newly released prison inmates in need of assistance as they re-enter into the LA community, the LA County Substance Abuse Prevention and Control (SAPC) division of the LA Department of Public Health, is implementing the ASI-MV to streamline assessment procedures, expedite treatment planning and simplify data gathering and analysis. LA County SAPC joins the growing number of organizations using the ASI-MV which currently includes over 700 adult and 120 adolescent behavioral health treatment centers in 39 states across the country.
“We are very excited to partner with LA County SAPC and equip the CASC assessors with the ASI-MV and the Analytics Data Center, providing the County with powerful tools and resources, which will enable them to effectively analyze behavioral health data within the community,” says Mike Waldron, Vice President of Sales and Marketing at Inflexxion. “ASI-MV provides LA County SAPC with the most advanced tools for behavioral health assessment processes and we look forward to working closely with them and providing continued support, clinical consultation and customization.”
ASI-MV is easily accessible from any Internet-connected computer and offers easy implementation and no software installation is required. ASI-MV expedites and enhances treatment planning with clinical reports and data easily accessible at any time, from any computer. To learn more about ASI-MV, view a demo at www.asi-mvconnect.com or request a free trial by emailing us at asimvinfo@asimv.com or call 1-800-848-3895 and select option 4.
Educational Pain Management Website PainEDU.org Collaborates with PAINWeek® 2011 on New Conference Activities
Events include PainEDU Manual book launch, educational sessions and PainEDU.org scholarship awards ceremony
August 29, 2011 - Newton, MA - PainEDU.org, an educational website for primary care clinicians and health educators looking to enhance their understanding of pain management, is collaborating with PAINWeek, the nation’s largest conference on pain for frontline practitioners, to bring new initiatives and activities to this year’s conference. During PAINWeek 2011, taking place September 7-10 at The Cosmopolitan of Las Vegas, PainEDU.org will launch its latest guide the PainEDU Manual, 4th edition, participate in three educational sessions and honor recipients of the PainEDU.org scholarship to PAINWeek during an awards ceremony.
The PainEDU Manual, 4th edition, A Pocket Guide to Pain Management is the latest book in the Inflexxion Health Series. This edition offers health care providers a comprehensive pain resource with new expanded up-to-date content not offered in previous editions. New topics include an overview of epidemiology and pathophysiology of chronic pain, basic principles of pain management, pain assessment and treatment of common types of chronic pain, pain management in special patient populations, patient-level opioid risk management and opioid REMS background and history.
Kevin L. Zacharoff, M.D., Vice President of Medical Affairs for Inflexxion and lead author of the PainEDU Manual, 4th edition, will sign complimentary copies on Friday, September 9 from 4:30-6:30 p.m. in the Chelsea Commons at The Cosmopolitan of Las Vegas. “We are excited about our collaborations with PAINWeek and officially launching the 4th edition of the PainEDU Manual at this year’s conference. This will be a great week and we are proud to be part of it,” says Dr. Zacharoff.
In addition to the book signing, Dr. Zacharoff will present three sessions at PAINWeek including:
Maximizing Treatment with the Chronic Pain Patient: Filling in the Gaps between Visits
Wednesday, September 7
7:30-8:25 a.m.
Clinical Implications of the Opioid REMS
Thursday, September 8
7:30-8:25 a.m.
Safe and Effective Treatment of Chronic Pain in Older Adults: Considerations and Educational Needs
Thursday, September 8
11:05 a.m.-12:00 p.m.
New this year, PainEDU.org awarded ten health care professionals who submitted essays about the importance of education in pain management with scholarships covering the cost of PAINWeek’s registration. One grand prize winner received an additional stipend towards travel and accommodations. Scholarship recipients were chosen for their writing detailing outstanding contribution to pain management and passionate work as patient advocates. Recipients had their winning application essays published on PainEDU.org, will be interviewed for an upcoming PainEDU.org article and will be recognized at an awards ceremony during PAINWeek. For details on how to apply for next year’s PainEDU.org scholarship to PAINWeek please email scholarship@painedu.org.
Recipients of the PainEDU.org scholarship to PAINWeek 2011:
•Karel Schram, PA-C: Hackley Community Care Center, Muskegon, MI (grand prize winner)
•James Adam Dailey, MD, Intern: Pitt Country Memorial Hospital, Greenville, NC
•Cathy Haberle, RN, BS, CHPN: Grand View Hospital, Sellersville, PA
•Reginald Hall, MD: Federal Medical Center, Butner, NC
•Kelly Lynn Kluesner, RN: Greenwood Ambulatory Surgery Center, Greenwood Village, CO
•Noel S. Lee, 3rd year medical student: UCSD Medical Center and VA San Diego Healthcare System, San Diego, CA
•Karen Marlowe, Pharm D, BCPS, CPE: Auburn University Harrison School of Pharmacy, Mobile, AL
•Vineeta Risbood, Pharm D, BCPS: Kaiser Permanente of Ohio, Cleveland, OH
•Pamela Ronning, MPA, BSN, RN: Hackley Community Care Center, Muskegon, MI
•Julie Rossow, RN: Madrid Home Communities, Madrid, IA
Inflexxion Partners with FEI Systems Streamlining Electronic Health Record Integration for Behavioral Health Organizations
Clinical data integration between online addiction assessment tool and electronic health record system
August 25, 2011 - Newton, MA - Inflexxion, a leader in creating scientifically validated solutions for critical areas of health care, announces the integration between its online version of the ASI-MV® and FEI Systems’ electronic health record system, the Web Infrastructure for Treatment Services (WITS).
The online ASI-MV is the most advanced tool for behavioral health assessment processes. ASI-MV streamlines assessment procedures, expedites treatment planning, simplifies data gathering and analysis of client needs and outcomes, and is now easily accessible from any Internet-connected computer. “ASI-MV in combination with WITS offers clinicians a fast and efficient way to move data from the intake assessment program to an EHR. The integration of these two systems offers behavioral health care providers a new comprehensive tool that organizes information and saves time, allowing clinicians to focus on client care,” explains Deborah Hillin, Senior Vice President at Buffalo Valley Inc., Hohenwald, TN, which has provided affordable alcohol and substance abuse treatment to patients in need for more than 30 years.
The integration between ASI-MV and WITS saves organizations time and allows clinicians to use the time saved to apply their skills and expertise to enhance quality of treatment. "We're very excited to have the ASI-MV online version integrated into our WITS EHR,” says Chris White, Vice President of Sales for FEI. “This will dramatically decrease the administrative time our shared customers will need to spend operating two separate clinical software programs to treat the same patient.”
Clients self-administer the ASI-MV interview by following audio and video prompts on a computer. When they are finished, clinicians can immediately generate a narrative report, client placement worksheet, and domestic violence risk summary, populated with client-specific data for treatment planning. The ASI-MV integration with WITS helps providers streamline data collection by eliminating the cost of collecting, cleaning, organizing and analyzing data from multiple sources. ASI-MV is easily accessible from any Internet-connected computer, offers easy implementation and no software installation.
Although originally designed as a substance abuse treatment services data collection and management system, WITS has evolved as an advanced behavioral health EHR system to meet the growing needs of organizations and government agencies. As an EHR system, WITS has over 40,000 users and manages almost 2 million patient records. With a feature-rich set of tools, WITS is used for case management, treatment planning, billing multiple payers, and managing the workflow for many different social services while protecting patient privacy using a fully HIPAA-compliant software platform.
To learn more about ASI-MV, view a demo at www.asi-mvconnect.com or request a free trial by emailing us at asimvinfo@asimv.com or call 1-800-848-3895 and select option 4.
Inflexxion Launches Online Version of the ASI-MV
A powerful online solution for behavioral health assessment, treatment planning, and data management
August 16, 2011 - Newton, MA - Inflexxion, the leader in creating scientifically validated solutions for critical areas of health care, launches the online version of the ASI-MV®. The new online version is a powerful tool that streamlines assessment procedures, expedites treatment planning, simplifies data gathering and analysis of client needs and outcomes, and is now easily accessible from any Internet-connected computer. The new online ASI-MV offers easy implementation and no software installation.
The ASI-MV online version provides a rapid, secure, client self-administered interview that is standardized, research-tested and available in both English and Spanish. From the dashboard, clinicians can start a client’s self-administered assessment interview, run clinical reports to assist with treatment planning, and generate analytics to gain insight into their client population. Brad Rikel, Deputy Executive Director of Mental Health Resources, Inc. in Clovis, New Mexico, where the online version was tested says, "Mental Health Resources, Inc. believes the online version of the ASI-MV provides greater access, availability and ease in use with our clients.”
The new online version saves organizations time and money associated with clinician administration of the ASI, which allows clinicians to use the time saved to apply their skills and expertise to enhance quality of treatment. “The online ASI-MV is now the most advanced tool for behavioral health assessment processes,” says Albert Villapiano, Ed.D., Vice President of Clinical Development at Inflexxion. “Our new online program expedites and enhances treatment planning with clinical reports and data easily accessible any time, from any computer. Data storage procedures meet the highest standards for the protection of PHI and staff members now have secure, password-protected access to their data from any location in which they are working.”
ASI-MV saves time and allows organizations to focus on the client, not the software. Adriatik Likcani, Program Director for Recovery Lighthouse, Inc. in Warrensburg, Missouri finds the new online ASI-MV “simple, easy, no more computer glitches to resolve, and very user friendly.” The new online version provides consistent, systematic data collection across multiple agencies or locations giving clinicians a powerful analytical tool to:
• Monitor progress and outcomes by viewing changes in the composite scores of their client population – in real-time
• Compare data across sites within an organization, as well as with national data
• Gather accurate information about their population for strategic planning, program development, and grant submissions
To learn more about the new online ASI-MV, view a demo at www.asi-mvconnect.com or request a free trial by emailing us at asimvinfo@asimv.com or call 1-800-848-3895 and select option 4.
Inflexxion, Inc. Receives Grant to Study Community College Efforts Dedicated to Student Substance Use Prevention
Journal of American College Health Published Inflexxion’s Study, “A Survey of 100 Community Colleges on Student Substance Use, Programming, and Collaborations”
July 14, 2011 - Newton, MA - Inflexxion, Inc. creator of MyStudentBody, the most comprehensive online alcohol and drug education program for college students, announces the publication of its study, “A Survey of 100 Community Colleges on Student Substance Use, Programming, and Collaborations” in the Journal of American College Health, Vol. 59, No. 6. In a study funded by the National Institute on Drug Abuse, researchers at Inflexxion surveyed 100 community college administrators, faculty and health services staff to understand the type of programs, collaborations and staffing and funding infrastructures community colleges are dedicating to student substance use prevention.
Survey participants reported a number of alcohol and other drug (AOD) related concerns on their campuses and reported that despite limited staff and funding, their institutions are implementing a number of prevention programs and collaborating with on- and off-campus groups. “There are excellent reasons for community colleges to attend to alcohol and drug issues in their students. Not only do many community college students experience many of the same negative alcohol and drug consequences seen in traditional four-year college students, but these issues may potentially detract from their engagement in and retention at college. For a population that is especially at risk of dropping out, all risk factors should be addressed,” says Inflexxion’s Emil Chiauzzi, Ph.D., Vice President of Product Strategy and the primary author of the study.
“Results from the survey also suggest community college health efforts geared at alcohol and drug prevention should receive more attention from key stakeholders,” says Elizabeth Donovan, Ph.D., Research Scientist at Inflexxion and a co-author on the study. “We learned there is much need for increased collaboration among researchers, clinicians, state authorities and institutions of higher education.”
With funding from the National Institute on Drug Abuse, Inflexxion is now developing an online community college student health program that can be used as part of student orientation or integrated into student academic classes. By implementing evidence-based substance abuse prevention strategies at community colleges, a growing public health concern can be more effectively addressed. However, more research is needed to understand how AOD prevention strategies can be most effectively targeted at the needs of community college students, who often struggle to balance academic, financial, and family responsibilities.
Comprehensive Health Assessment for Teens (CHAT®) a Scientifically Validated Tool with Strong Psychometrics
Substance Use & Misuse Journal Published Study Results in “CHAT: Development and Validation of a Computer-Delivered, Self-Report, Substance Use Assessment for Adolescents”
May 11, 2011 - Newton, MA - Inflexxion, Inc. announces the publication of its study, “CHAT: Development and Validation of a Computer-Delivered, Self-Report, Substance Use Assessment for Adolescents.” The results of this study indicate that CHAT, a computer-delivered, multidimensional, self-administered, substance use assessment for adolescents, is psychometrically sound.
CHAT follows a developmental approach that emphasizes the varying needs of young people, uses engaging multimedia to facilitate adolescents' self-administration, and assesses strengths as well as problem areas, providing a more comprehensive portrait for guiding treatment. “Use of a computer-delivered format aligns well with adolescent culture and their familiarity with computers as sources of information and entertainment. The self-directed nature of CHAT meets the adolescent’s developmental need for autonomy,” says Kimberlee Trudeau, Ph.D., Research Scientist.
CHAT was developed with input from adolescents and adolescent addiction experts. It generates scores in six different domains, which enables providers to review adolescents’ severity in alcohol use, drug use, tobacco use, psychological health, family relationships and peer relationships. When a CHAT assessment is administered a second time, scores can be compared with the first administration to determine outcome or progress in all six domains.
“Reliability and validity of CHAT’s six problem dimensions were evaluated in two studies we conducted from 2003 to 2008,” says Albert Villapiano, Ed.D., Vice President of Clinical Development at Inflexxion. “Study 1 included 192 adolescents and involved instrument development and initial test–retest reliability and construct validation. Study 2 included 356 adolescents and involved development of the multimedia format of the instrument and final test–retest reliability and construct validation.”
Results from the study published in Substance Use & Misuse indicate CHAT has reliability and validity for these six targeted problem severity dimensions. In addition to these scores, CHAT collects clinical data about other important domains: physical health, romantic relationships, school issues, work issues, legal issues, and recreational activities, as well as ratings about adolescents’ concern and motivation about each problem area.
This tool can be used to guide treatment planning for adolescents who are in treatment or in the juvenile justice system. CHAT is unique and successful because it is not labor-intensive to administer nor does it require clinical training to administer like many other assessment programs. CHAT allows for real-time data capturing and provision of reports for clinicians and administrators, while reducing the resources needed for the assessment process (e.g., clinician time). Such a technology-based infrastructure supports the current emphasis on continuity of care across service systems to improve client outcomes as well as build efficiencies to reduce health care costs.
This study was published in the journal Substance Use & Misuse, April 2011, Volume 46, Number 6. For reprints, please contact chatinfo@inflexxion.com.
College Health Program MyStudentBody Launches Newly Redesigned Student Conduct Course
Judicial Course encourages student self-awareness, learning from mistakes and taking responsibility
May 9, 2011 - Newton, MA - Inflexxion, Inc., creator of MyStudentBody, the most comprehensive online alcohol and drug education program for college students, is pleased to announce the launch of the newly redesigned Judicial Course. Created for students who violate their college or university alcohol policy, the Judicial Course encourages students to reflect on their behavior, increase self-awareness, learn from their mistakes, and take responsibility for their actions.
The Judicial Course is designed for use in conjunction with a college or university’s conduct sanctioning program or is qualified as a stand-alone educational program in conduct situations. Education and reflection are key components in reducing recidivism making the Judicial Course an ideal tool to serve as a sanction program. The education component includes review of basic alcohol education, strategies on dealing with difficult situations, real life scenarios and realistic, relatable messages. The reflection component encourages students to reflect on their situation and how to change future behaviors. The Judicial Course includes streamlined assessment questions, with new videos and visual feedback making the course more interactive and engaging for students.
When a college student commits an alcohol-related offense on campus, conduct officers can mandate the student to complete the course, an educational intervention for the student which can also facilitate discussions with counselors about the student’s behavior. “We believe that the MyStudentBody Judicial Course offers an effective combination of intervention components, including brief motivational feedback, interactive content and practical risk reduction strategies,” says Inflexxion’s Emil Chiauzzi, Ph.D., Vice President of Product Strategy. “In addition, rather than just focusing the student on the judicial offense, the student is encouraged to reflect on problematic behavior as it pertains to success at the college level.”
The course includes relevant articles as well as brand-new, specialized tools such as the “Sobering Up Timeline,” “Busted: Do you know your policy?,” and a video about alcohol poisoning. The course features assessments (including the AUDIT, a validated screening tool for alcohol use disorders and risky drinking), knowledge pre- and post-tests and a course survey. College administrators have the option of using follow-up assessments to track students’ ongoing behaviors and attitudes.
Through distinct programs for students, parents and college administrators, MyStudentBody can help reduce student health risks on the individual and campus community level, empower parents with tools for supporting student health and help administrators discover strategies and apply data to strengthen their prevention initiatives. MyStudentBody was developed with over $8 million in grant funding from the NIH and delivers effective prevention programs to hundreds of colleges and universities.
If you have any additional questions about the Judicial Course, please contact our account executives at 800-848-3895 x3.
Inflexxion, Inc. Offers Solutions to Meet the Needs of U.S. Government’s Action Plan to Reduce Prescription Drug Abuse
Strategies for Decreasing Prescription Opioid Abuse Can Support Action Plan and New FDA Requirements
May 3, 2011 - Newton, MA - Inflexxion®, the leader in the creation of scientifically validated solutions for critical areas of health care, announces three of its key products, PainEDU.org®, painACTION.com® and NAVIPPRO® align with the Obama Administration’s plan to reduce prescription opioid abuse outlined in “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” [PDF] The plan outlines the administration’s strategies to reduce the growing epidemic the Nation faces as prescription opioid abuse soars to record levels. “Inflexxion is proud to offer educational programs that can help the government meet the goals of the action plan for reducing our Nation’s fastest-growing drug problem, prescription opioid abuse” says Simon Budman, PhD, CEO, and founder of Inflexxion.
A key element of the action plan calls for increased education about safe and appropriate use of opioids for clinicians and patients. In support of the action plan, the Food and Drug Administration (FDA) is requiring an Opioids Risk Evaluation and Mitigation Strategy (REMS) making it mandatory for manufacturers of long-acting and extended-release opioids to provide funding for educational programs to healthcare providers, as well as materials healthcare providers can use when consulting with patients about the risks and benefits associated with opioid use. Inflexxion meets the FDA’s need for opioid education with PainEDU.org and painACTION.com; both are non-promotional, free online educational programs that cover every area which the FDA requires of an educational program.
“For the past several years, PainEDU and painACTION have been providing medication safety education to healthcare professionals and the public, so these programs are uniquely positioned to help meet the FDA’s Opioid REMS educational recommendations,” states Kevin Zacharoff, MD, VP of Medical Affairs at Inflexxion. “Our educational offerings have been developed and tested with support from the National Institutes of Health and are being used by pharmaceutical companies as part of their risk management and REMS plans.”
painACTION offers the public a variety of educational articles and tools on using opioids safely including information on the appropriate use, secure storage and disposal of opioids. PainEDU.org, which currently has over 35,000 subscribers and is adding over 1,100 new subscribers each month, offers healthcare providers education about pain assessment, safe and appropriate use of opioids, and opioid risk management tools.
“As a healthcare provider and educator, I find PainEDU.org invaluable for my education as well as the education of the primary care providers that I work with. Combined with the companion website for patients, painACTION.com, it is the first thing that I suggest to healthcare providers who want to know more about safe and effective pain management,” commented Ilene Robeck, MD, a pain and addiction specialist who works at the Veterans Administration Medical Center in Bay Pines, Florida.
Inflexxion’s opioid risk management tools include the Screener and Opioid Assessment for Patients with Pain (SOAPP®) which helps predict which patients, being considered for long-term opioid therapy, may exhibit aberrant behaviors in the future. SOAPP is part of the clinical guidelines for the American Pain Society/American Academy of Pain Medicine, Utah Department of Health, and the Berkshire Health System Pain Care Resource Manual. Inflexxion’s Current Opioid Misuse Measure (COMM)® helps identify whether a patient, currently on long-term opioid therapy, may be exhibiting aberrant behaviors associated with misuse of opioid medications. The SOAPP and COMM are both part of the Canadian National Regulatory Guidelines for Safe and Effective Use of Opioids. PainEDU.org also offers a variety of case-based pain management accredited Continuing Education (CE/CME) courses to healthcare providers, including physicians, nurses, psychologists, and pharmacists.
A second component of the Obama administration’s action plan to reduce prescription opioid abuse involves assessment and metrics. Inflexxion’s proprietary NAVIPPRO (National Addictions Vigilance Intervention and Prevention Program) data streams can provide this much needed assessment and metrics through its tracking and monitoring. NAVIPPRO is a turnkey solution developed with support from the National Institutes of Health and pharmaceutical sponsors that provides timely and accurate information about the misuse and abuse of prescription opioids nationwide. With its real-time national monitoring system that includes data from hundreds of substance abuse treatment centers across the country, NAVIPPRO detects changes in prescription opioid drug abuse patterns and estimates the relative rates of abuse. These data offer government agencies and pharmaceutical companies a powerful tool for prescription drug abuse surveillance and related public health efforts such as the ones outlined in the government’s action plan.
Educational Pain Management Website PainEDU.org Offers Scholarships to PAINWeek®
Receive a PainEDU.org scholarship to PAINWeek, the largest national pain conference in the country
February 22, 2011 - Newton, MA - PainEDU.org, an educational website for primary care clinicians and health educators looking to enhance their understanding of pain management, announces it will award 10 health care professionals scholarships covering the cost of registration for PAINWeek, the nation’s largest conference on pain for frontline practitioners. One grand prize winner will also receive a stipend towards travel and accommodations. Taking place September 7-10, 2011 at The Cosmopolitan of Las Vegas, PAINWeek is the only national pain conference developed to meet the educational needs of physicians, nursing professionals, physician assistants, dentists, pharmacists, psychologists, and podiatrists.
PAINWeek offers a diverse curriculum and multidisciplinary faculty who will present courses on a variety of pain management topics. PAINWeek provides health care professionals with 100+ hours of continuing medical education (CME) activities. “We are thrilled to be partnering with PainEDU.org which is such a valuable resource for pain management education,” said Debra Weiner, Managing Partner at Aventine Co. and Director of Program Development for PAINWeek. “Working with PainEDU.org to offer scholarships to PAINWeek helps advance our organizations’ shared goal of disseminating knowledge and tools to frontline clinicians who are faced with treating the majority of patients in pain.”
Apply today to receive one of PainEDU.org’s scholarships to PAINWeek. Scholarship recipients will have their winning application essay published on PainEDU.org, be interviewed at PAINWeek for an upcoming PainEDU.org article and be presented with a certificate at an awards ceremony during PAINWeek. For details on how to apply and more information on scholarship rules and regulations, please visit http://www.painedu.org or email scholarship@painedu.org.
About PainEDU.org
PainEDU.org was developed and is maintained by Inflexxion, Inc., founded in 1989 with the goal of leveraging technology to improve public health. Inflexxion creates clinically validated tools and programs for critical areas of health care, including prevention and wellness education, addiction and pain treatment, and pharmaceutical risk management. Key offerings include: NAVIPPRO, PainEDU.org, painACTION.com, SOAPP, and COMM. These innovative solutions help reduce health-related risks, enhance clinical outcomes, and positively impact the quality of care.
About PAINWeek
PAINWeek is the largest national conference on pain for frontline practitioners. Held during Pain Awareness Month, PAINWeek will convene September 7-10, 2011 at The Cosmopolitan of Las Vegas. The 2011 conference will offer over 100 hours of continuing medical education activities sponsored by Global Education Group. For more information visit www.painweek.org. PAINWeek is managed by Aventine Co.
College Health Program MyStudentBody Launches Comprehensive Essentials Course
New course features enhanced alcohol and drug components and a brand-new sexual violence component
January 10, 2011 - Newton, MA - Inflexxion, Inc., creator of MyStudentBody, the most comprehensive online alcohol and drug education program for college students, is pleased to announce the launch of the new Essentials Course featuring enhanced alcohol and drug components and a brand-new sexual violence component. The Essentials Course includes streamlined assessment questions, with videos and visual feedback making the course more interactive and engaging for students. The new course is designed to provide a comprehensive approach to helping college students prevent and understand the risks associated with student health and campus life.
The MyStudentBody Essentials Course will officially launch at the NASPA Alcohol and Other Drug Abuse Prevention & Intervention Conference January 13-15 at the Miami Marriott Biscayne Bay. Inflexxion’s Emil Chiauzzi, Ph.D., Vice President of Product Strategy and Elizabeth Donovan, Ph.D., Research Scientist will present research poster, “A parent-based alcohol and other drug intervention for college students: Randomized controlled trial results” on January 13, 6:00-7:45 p.m. in the Bayview Junior Ballroom. January 14 from 1:30-2:45 p.m. Dr. Chiauzzi will participate in an afternoon plenary panel, “Choosing an online alcohol education program,” and from 5:30-6:30 p.m. Dr. Chiauzzi and Dr. Donovan will host program session, “Health prevention programming at community colleges: results of two health studies” in Salon F.
As most conference attendees and college administrators know, many high-risk college students are prone to abusing alcohol or drugs, and in some cases, both. “We based the development of the Essentials Course on our own National Institutes of Health (NIH) grant research, customer feedback, and the latest evidence-based college health findings,” says Dr. Chiauzzi. “Because of the widespread use of marijuana and prescription drugs on many college campuses, we believe it is critical to offer students motivational interventions for both alcohol and drug use. In addition, we heard from many colleges and universities that they wanted to expand their sexual assault prevention programming, so we developed course material that aligns with the Department of Justice grant requirements for such programs.”
Statistics from the Department of Justice indicate that 1 in 4 college-aged women will experience an act of sexual violence before they graduate. Many students are unsure what constitutes an act of sexual violence, and what to do if they happen to witness or be a victim of one. To address these issues, the sexual violence component was developed in consultation with Joan Tabachnick, author of Engaging Bystanders in Sexual Violence Prevention (National Sexual Violence Resource Center, 2008). Schools that choose to implement the sexual violence component will help students learn how to identify an act of sexual violence, enhance bystander intervention, and provide resources for seeking help.
“I am so excited sexual violence is part of the new course,” said Beth Grampetro, Director of Wellness Services at The Boston Conservatory where MyStudentBody is used as part of the student health program. “This new Essentials Course is great and presents the information from a good perspective that will resonate with students.” Another current MyStudentBody customer, Patrick Carpenter, Director of Residence Life at Elms College said, “The new Essentials Course is exactly what I want to be teaching. I’m thrilled with all it offers.”
Through distinct programs for students, parents and college administrators, MyStudentBody can help reduce student health risks on the individual and campus community level, empower parents with tools for supporting student health and help administrators discover strategies and apply data to strengthen their prevention initiatives. MyStudentBody was developed with over $8 million in grant funding from the NIH and delivers effective prevention programs to hundreds of colleges and universities.
To learn more about the new MyStudentBody Essentials Course, please contact Holly Lyng at 617-614-0415 or at hlyng@mystudentbody.com.
Inflexxion, Inc. to Highlight NAVIPPRO™ at FDA Advisory Committee Meeting
Pharmaceutical risk management solution provides real-time view into prescription drug abuse
October 18, 2010 – Newton, MA - Inflexxion, a leader in the creation of scientifically validated solutions for critical areas of health care, announces its research scientists will be participating in the FDA’s “Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee” on October 21 and 22 in Washington, DC, highlighting prescription drug abuse data captured within Inflexxion’s proprietary NAVIPPRO™ data streams. NAVIPPRO provides timely and accurate information about the misuse and abuse of prescription opioids and stimulants nationwide. The Inflexxion research team pairs their data with best-in-class consulting services, partnering with pharmaceutical industry leaders to develop and implement Risk Evaluation and Mitigation Strategies (REMS) as well as a variety of other epidemiological, educational and scientific efforts on behalf of client companies.
The FDA meeting comes during a time of growing concern about prescription drug abuse and the need to reduce these risks. The Inflexxion research team has the unique expertise to examine tamper resistance in prescription opioids. With its real-time national monitoring system that includes data from hundreds of substance abuse treatment centers across the country, NAVIPPRO detects changes in prescription opioid and stimulant drug abuse patterns and estimates the relative rates of abuse. These data offer pharmaceutical companies and government agencies a powerful tool for prescription drug abuse surveillance and related public health efforts.
Simon Budman, PhD, CEO, and founder of Inflexxion, will be attending the FDA Advisory Committee meeting and is available for interviews and speaking engagements about NAVIPPRO and the implementation of opioid REMS. If you are interested in scheduling an interview with Dr. Budman, please contact Elsbeth McSorley at 617-614-0369 or emcsorley@inflexxion.com.
About NAVIPPRO
NAVIPPRO (National Addictions Vigilance Intervention and Prevention Program) is a proprietary turnkey solution developed with support from the National Institutes of Health (NIH) and industry that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs. A list of peer-reviewed publications is available at www.navippro.com, where you can also sign up to receive the NAVIPPRO Signal e-newsletter.
Inflexxion, Inc. Announces New Vice President of Sales and Marketing
October 14, 2010 - Newton, MA – Inflexxion, a leader in the creation of scientifically validated solutions for critical areas of health care, announces the appointment of Mike Waldron as Vice President of Sales and Marketing. Inflexxion integrates rigorous science with innovative technology to develop tools and resources that educate and empower health care providers, patients, and diverse populations in ways that lead to more effective treatment and prevention. Key offerings include: NAVIPPRO™, ASI-MV® Connect, PainEDU.org, painACTION.com and MyStudentBody.com. These innovative solutions help reduce health-related risks, enhance clinical outcomes, and positively impact the quality of care.
Waldron brings more than 25 years of successful sales, sales management and marketing experience to Inflexxion. He previously held positions as Director of National Accounts at Silverlink Communications and as Vice President of North American Operations at X.HLP, Inc. “I am thrilled to join the Inflexxion team and use my healthcare experience to help the company maximize its enormous potential,” said Waldron. “With so many unique products that provide solutions for many of today’s health care problems, Inflexxion stands to have a profound impact on health care and health education.”
“We are fortunate to have Mike join our team,” said Simon Budman, PhD, CEO, and founder of Inflexxion. “His impressive sales track record, enthusiasm for business challenges, sales management and team-based success will be a valuable asset to Inflexxion.”
Waldron received a Bachelor of Arts in psychology from Salem State College, a Bachelor of Science in business administration from University of New Hampshire and completed a Masters of Business Administration from University of Southern New Hampshire.
Inflexxion Announces Launch of Redesigned InsideADHD.org
InsideADHD.org now offers enhanced interactive resources, new design and more tools for families and children with ADHD
September 16, 2010 - Newton, MA – Inflexxion, Inc., creator of InsideADHD.org, an educational website for families and children with ADHD, is pleased to announce the launch of the newly redesigned InsideADHD.org. The new website is easier to navigate, better organized and more interactive with a fresh design that makes finding information faster and easier. InsideADHD.org offers more tools and features including a live Twitter feed, Expert Advice videos on a variety of helpful topics and convenient access to the InsideADHD Toolkit.
“The newly re-launched website focuses on all aspects of parenting children with ADHD and information on adult ADHD including treatment, family life, and succeeding at school and work. InsideADHD.org provides an educational experience that incorporates a wide array of resources and information including an educational video series,” says Clinical Psychologist Jonas Bromberg, PsyD. “Visitors can easily access the information most appropriate for them and their children, including courses about ADHD medication management, an “Ask the Experts” section and the popular InsideADHD Toolkit.”
The InsideADHD Toolkit contains useful tips and suggestions to help parents guide their children with ADHD through the school year. The online toolkit is designed for families of elementary, middle-school, and high-school students and includes practical tips to help parents manage the risks of ADHD medications. Examples include a Medication Contract for parents to use with their children, a Medication Log for tracking the use of ADHD medications, and Sample Letters for communicating with health care providers and teachers about a child’s condition and treatment.
This month’s re-launch is the first major change to the site design since InsideADHD.org was first introduced in May 2008. “From day one, our goal with InsideADHD.org was to be an informative, convenient source for everything someone would want to know about living with and treating ADHD. By enhancing the site, we are continuing that mission making our most valuable tools and resources more accessible to visitors of the site,” explains Dr. Bromberg.
Apart from the new features, InsideADHD.org will continue to provide popular existing resources, such as a course on ADHD medication management and the monthly InsideADHD e-newsletter. To learn more about InsideADHD.org and signup for the monthly newsletter, visit the website at www.InsideADHD.org.
PainACTION.com Proves to be Useful Tool for People with Chronic Back Pain
Pain Medicine publishes study results outlined in “painACTION-Back Pain: A Self-Management Website for People with Chronic Back Pain”
July 7, 2010 - Newton, MA -Inflexxion, a leader in the creation of scientifically validated solutions for critical areas of health care, announces the publication of “painACTION-Back Pain: A Self-Management Website for People with Chronic Back Pain” in Pain Medicine, the official journal of the American Academy of Pain Medicine (AAPM). The article, published in the July 2010 edition of Pain Medicine, Volume 11, Issue 7, reports findings from a recent study indicating chronic back pain sufferers, who used the online resource painACTION.com, reported a reduction in pain and stress, and improved coping abilities.
The painACTION-Back Pain study examined the usefulness of interactive self-management website painACTION.com, when used by people with chronic back pain. The study explored the website’s ability to help people improve their emotional management, coping, self-efficiency to manage pain and pain levels, and physical functioning compared with standard text-based materials. Results showed that compared with controls, painACTION-Back Pain participants reported significantly lower stress, increased coping skills and greater use of social support. Comparisons between the two groups further showed clinically significant differences in current pain intensity, depression, anxiety, stress and global ratings of improvement.
“We are very excited to have the results of our painACTION-Back Pain study published in Pain Medicine,” says primary investigator Emil Chiauzzi, Ph.D., Vice President of Product Strategy at Inflexxion. “PainACTION.com is unique in offering online self-management methods for people with chronic pain conditions and now we have evidence it can specifically help those with chronic back pain. We believe that the use of brief skill-based lessons and motivational self-assessments can empower people to take steps in managing the psychosocial challenges that are experienced by every pain sufferer. PainACTION.com offers an excellent complement to one’s visits with health providers, particularly in managing pain medications and tracking pain levels.”
Skill-based lessons are available to help people manage cancer pain, back pain, migraine pain, and neuropathic pain. PainACTION also offers multimedia tools, personal stories, a pain tracker, and articles on taking pain medications appropriately and safely, with an entire risk management curriculum devoted specifically to opioids.
Developed with grant support from the National Institutes of Health (NIH), painACTION is a non-promotional website that provides unbiased information on self-managing pain. The painACTION website is designed to serve as a daily resource for patients with chronic pain conditions, while at the same time providing clinicians with a useful tool for increasing quality of care – including ensuring that their patients understand how to take prescription pain medications safely.
The ongoing dissemination of painACTION is supported by Endo Pharmaceuticals, Inc. and King Pharmaceuticals, Inc.
To learn more about painACTION, visit the website at www.painACTION.com.
Canada's national guidelines for safe use of opioids recommends addiction risk screening and continuous monitoring
Guidelines incorporate Inflexxion's evidence-based practice tools
June 17, 2010 - Newton, MA - Canada's National Opioid Use Guideline Group (NOUGG) has released a new national set of guidelines, the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, to provide Canada's health care providers with clear, evidence-based guidance regarding the use of opioids to safely manage patients with chronic non-cancer pain.
The NOUGG guidelines have 24 practice recommendations to assist clinicians who are initiating opioid therapy, conducting an opioid trial, and/or monitoring long-term opioid therapy. In addition, the guidelines incorporate practice tools and other resources to support opioid prescribing practices for this specific patient group. These include the Screener and Opioid Assessment for Patients with Pain-Revised Version (SOAPP®-R) and the Current Opioid Misuse Measure (COMM)®.Developed by Inflexxion, the SOAPP is a brief, paper-and-pencil self-report tool that enables health care providers to assess the risk of addiction in patients being considered for opioid therapy. The COMM is a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.
“Canada has taken an important step towards standardizing practices among clinicians with regard to the process of safely and effectively managing pain when opioids are indicated as a therapeutic component,” says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion.
The SOAPP has been shown to be a highly sensitive instrument. In a recent study comparing the sensitivity of a semi-structured clinical interview and three screening tools, researchers found the highest sensitivity for the clinical interview and the SOAPP, followed by the Opioid Risk Tool (ORT) and the Diagnosis, Intractability, Risk, and Efficacy inventory (DIRE) (Pain Medicine, Volume 10, Issue 8, pages 1426-1433).
The release of the Canadian guidelines follows publication last year of ground-breaking evidence-based guidelines for use of chronic opioid therapy in noncancer pain patients in the U.S., developed jointly by the American Pain Society and the American Academy of Pain Medicine. These guidelines also highlight the utility of the SOAPP and COMM tools.
An article introducing Canada's new guidelines is published in the Canadian Medical Association Journal.
Inflexxion Captures Patient Insights Using Vovici’s Secure Feedback Platform
Health Care Innovator Recruits and Analyzes Target Populations for New Programs with Vovici
February 16, 2010 - Dulles, VA - Vovici, the leading provider of enterprise feedback management (EFM) solutions, today announced that Inflexxion, a pioneer in developing scientifically validated solutions for critical areas of health care, has deployed Vovici as its EFM platform for capturing insights from its target population.
Inflexxion has two research goals: validate program outcomes to justify funding and improve the programs’ ability to positively influence quality of care. Vovici is a critical partner in achieving both of these in a timely and cost-effective manner.
"We are a scientific organization, and much of the funding for our programs comes from the National Institutes of Health (NIH). We adhere to a rigorous grant application and approval process that requires proving that our programs work," explains Deborah Trottier, data manager at Inflexxion. "Using Vovici, I am able to anonymize the survey, randomize questions, and utilize branching logic all in a secure environment. This sophistication enables us to efficiently develop analysis that stands up to the scrutiny of the medical research community." In addition, the company uses Vovici to capture patient insights and reactions to Inflexxion programs. "Vovici delivers the timely, actionable insights from our target market that drives our program innovation," says Trottier.
Inflexxion was founded in 1989 by Dr. Simon Budman, internationally renowned researcher, innovator and entrepreneur, and former director of mental health research at Harvard Community Health Plan. Over the years, the company evolved into a leading developer of tools and programs to improve the quality of care and prevention, which are used nationally at substance abuse treatment centers, pain clinics, and universities. The programs that Inflexxion offers include Pharmaceutical Risk Management, Student Health, Consumer Health, and Substance Abuse.
"We constantly strive for new and better ways to make it easier for people to stay healthy," says Trottier. "We do this by defining target outcomes for our health and prevention programs, and then we generate measures that can be validated in the field." Inflexxion leverages Vovici to recruit communities in target populations and execute baseline and follow-up assessments. "Vovici gives us the power to execute on large, sophisticated research projects, and the flexibility to launch smaller surveys important to validating and updating our research."
Prior to adopting Vovici, Inflexxion used scanned forms mailed to research participants. "We used to get swamped with mailed responses. One of our surveys was 90 pages long and in Chinese. It took hundreds of man hours to scan the responses, not to mention having to reenter data samples to test for accuracy," recalls Trottier. "With Vovici, we start to review the data as soon as we deploy a survey. Vovici reduces 90 percent of the effort and greatly increases accuracy — one survey like that and Vovici pays for itself."
"The Vovici solution can be uniquely tailored for organizations like Inflexxion that have requirements for sophisticated scientific research and agile, timely market research," says Roderick Morris, vice president of marketing for Vovici. "It is rewarding to partner with Inflexxion and make a real difference in today’s health care."
About Vovici
Vovici is the pioneer of Enterprise Feedback Management (EFM), providing comprehensive survey software, panel management systems and online community solutions. Our survey tools enable organizations to centralize feedback data collection, build and manage proprietary panels, leverage corporate social networking, and utilize robust survey analytics and reporting. Our solutions increase customer loyalty, facilitate collaboration and innovation, influence critical business decisions and provide voice to online communities. Organizations worldwide, including more than half of the Fortune 500, rely on Vovici to gather feedback on customer satisfaction, perform market research and gauge employee satisfaction. Visit www.vovici.com for more information.
New findings may help clinicians ensure the safe and effective use of opioid medications
Study finds that the SOAPP® is a highly sensitive instrument for predicting aberrant drug-related behavior
December 21, 2009 - Newton, MA - At a time when prescription opioid abuse and misuse has become a major public health concern, new research may help clinicians and health care organizations determine the best approach for assessing the risk of aberrant drug-related behavior prior to initiating opioid therapy.
In a study to assess the sensitivity of common screening tools for predicting aberrant drug-related behavior, researchers found that the Screener and Opioid Assessment for Patients with Pain (SOAPP), a brief, pen-and-paper self-report tool, is a highly sensitive instrument.
The study, conducted by researchers including leading pain specialist Steven D. Passik, Ph.D., compared the sensitivity of a semi-structured clinical interview and three screening tools: the SOAPP, the Diagnosis, Intractability, Risk, and Efficacy inventory (DIRE), and the Opioid Risk Tool (ORT). Results showed the highest sensitivity for the clinical interview (0.77) and the SOAPP (0.72), followed by the ORT (0.45) and the DIRE (0.17). In addition, the researchers found that combining the clinical interview with the SOAPP increased sensitivity to 0.90.
The findings appear in the current issue of Pain Medicine (Volume 10, Issue 8, pages 1426-1433).
"Given the relative infancy of research in predicting aberrant drug-related behavior, comparing the predictive validity of these measures may provide insight about the relative importance of particular risk factors," write the authors. "By comparing recently developed risk measures, this study may be able to give pain centers and specialists valuable information about risk measurement to utilize their resources efficiently, increase their ability to detect risk, and add safeguards to reduce risk when indicated."
"This study is important because it provides new evidence that opioid risk assessment screening tools such as the SOAPP can increase the predictive power of the clinical interview, which is the foundation of the process," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "As we look ahead to the increased awareness of assessing opioid risk, and likely implementation of federally required Risk Evaluation and Mitigation Strategies (REMS) for opioid medications, we may begin to see more health care organizations and clinicians evaluating and incorporating these tools into the clinical workflow, so they can take an evidence-based approach to ensuring that opioid medications are used safely and effectively."
Developed by researchers at Inflexxion, the SOAPP is formally licensed for use at more than 50 health care organizations across the nation, including Kaiser Permanente. It is also available directly for individual clinical use at no cost to clinicians who register at PainEDU.org, Inflexxion’s award-winning educational website for health care professionals who prescribe pain medications.
On 40th anniversary, Harvard Vanguard Medical Associates honors visionaries in advancing patient care
Inflexxion Founder & CEO Simon H. Budman recognized as "Vanguard Visionary"
December 17, 2009 - Newton, MA - This year marks the 40th anniversary of the creation of Harvard Community Health Plan (HCHP), now known as Harvard Vanguard Medical Associates. To celebrate, Harvard Vanguard Medical Associates has published Transforming Patient Care: Quality, Innovation, Social Responsibility, a brief history of the organization that highlights the contributions of its founders and others who have made a significant impact advancing the delivery of patient care. Among those recognized as a "Vanguard Visionary" is Simon H. Budman, Ph.D., the founder and CEO of Inflexxion, Inc.
Dr. Budman joined the Harvard Community Health Plan as a staff psychologist in 1975, and went on to serve as director of Mental Health Research for HCHP (1981-89), associate director of the Insititute for Health Research (HCHP and the Harvard School of Public Health 1986-88), director of Mental Health Research, Training and Development (HCHP 1989-93), and director of Mental Health Training (HCHP 1993-96). Dr. Budman is widely known for the innovative mental health programs that he helped to develop at HCHP, particularly the model of short-term, intermittent psychotherapy. In 2000, he was recognized for that work with an award from the American Psychological Association.
Dr. Budman founded Inflexxion in 1989. Serving as President and CEO of the company, Dr. Budman has continued to pursue his vision of revolutionizing behavioral health care, leading the development of innovative tools and programs that are clinically tested for validity and efficacy. Inflexxion’s tools and programs are used nationally at substance abuse treatment centers, pain clinics, and universities to improve the quality of care and prevention in all of these settings. In recognition of Inflexxion’s work with the National Institutes of Health (NIH) in the Small Business Innovation Research (SBIR) program, it has been designated a "Model of Excellence" company.
"The history of our organization has always been about the future -- about the search for better ways to care for all patients. Those visionaries who led the way by revolutionizing the delivery of medical care four decades ago bequeathed to us a legacy of social responsibility in the practice of medicine," writes Gene Lindsey, M.D., President and CEO of Atrius Health and Harvard Medical Vanguard Associates. "We have honored their boldness and courage with our own continual belief in the centrality of the patient, and in our relentless quest to find new and better ways to make it easier for our patients to be healthy."
"My professional career started at HCHP. The opportunities that I had there inspired me to begin Inflexxion. My experience at HCHP also helped me to develop an organization which can improve health care and has a positive impact on people’s lives," says Dr. Budman. “I will forever be grateful to have been part of such a wonderful, pioneering system, and I hope that we at Inflexxion can emulate Vanguard Medical, continuing to increase the quality of health care through innovation.”
New guide helps clinicians improve pain management for Hispanic patients
Practitioner manual focuses on enhancing cross-cultural pain management
October 19, 2009 –Newton, MA – Inflexxion, a company that develops scientifically validated solutions for critical areas of health care, is pleased to announce the publication of Cross-Cultural Pain Management: Effective Treatment of Pain in the Hispanic Population. The manual, available at no charge to health care practitioners who register at the PainEDU.org website, provides guidance for practitioners seeking to improve pain management for their Hispanic patients.
"There is a cultural transformation taking place in the United States, and a disparity in treatment exists at many levels as a result of this growing diversity. This manual is aimed at helping practitioners develop the skills needed to provide the highest quality of care for all of their patients," says co-author Kevin Zacharoff, M.D. "While this book offers details about some of the issues that may separate Hispanic patients from others, its primary purpose is to minimize these differences to reach common ground. We hope to help enhance mutual understanding and communication between health care providers and Hispanic patients, which is critical to quality care."
Cross-Cultural Pain Management covers a broad range of topics that are important for meeting the needs of Hispanic patients. These include federal guidelines for providing culturally and linguistically appropriate services, a discussion of beliefs about the nature of pain in the Hispanic culture, how Hispanic patients may express pain, and non-pharmacologic and pharmacologic approaches to pain management for Hispanic patients. The manual includes appendices with practical tools and resources for clinicians, such as the Spanish version of the Wong-Baker Faces pain scale, translations of common pain words, and references to relevant websites for clinicians and patients.
In addition, the manual introduces Inflexxion's new painACTION Dolor de Cáncer website. Developed through a grant from the National Institute on Drug Abuse (NIDA), Dolor de Cáncer is a Spanish-language, free, non-commercial site designed to help Hispanic patients learn about the management of cancer pain.
"To help improve doctor-patient communication and the treatment of pain, we need to address the challenge from both perspectives," explains Dr. Zacharoff. "We developed the Dolor de Cáncer website to serve as a complement to doctor's visits, and we hope it will be effective in helping clinicians increase the quality of care for their Hispanic patients who suffer from cancer pain."
Cross-Cultural Pain Management is the latest addition to the popular Inflexxion Health Series, a collection of practitioner guides by leading experts in pain management. Other publications in the series include The PainEDU Manual: A Pocket Guide to Pain Management 3rd Ed., authored by Lynette A. Menefee Pujol, Ph.D., Nathaniel P. Katz, M.D., and Kevin L. Zacharoff, M.D., and Managing Chronic Pain with Opioids in Primary Care, authored by Nathaniel P. Katz, M.D., M.S., Bill H. McCarberg, M.D., and Lori Reisner, Pharm.D., F.C.S.H.P.
All of the books in the series are complimentary and can be obtained by visiting PainEDU.org and becoming a registered user. Practitioners may download an electronic copy or request that a print copy be delivered free of charge.
In addition, Inflexxion will have a booth at the Alliance of State Pain Initiatives (ASPI) annual conference, which will be held this year on October 23-25 at the Hyatt Regency in San Francisco, California. Conference attendees are encouraged to visit the booth, register for PainEDU, and pick up a free copy of Cross-Cultural Pain Management and other publications in the Inflexxion Health Series.
Study shows that adolescent ADHD prescription drug abuse is increasing
New InsideADHD.org Toolkit is available to help families ensure medication safety
September 21, 2009 – Newton, MA - A new study published in the journal Pediatrics has revealed a sharp increase in the number of calls to poison control centers regarding teen abuse of prescription medication for Attention Deficit/Hyperactivity Disorder (ADHD). Researchers at Cincinnati Children’s Hospital Medical Center analyzed data from the American Association of Poison Control Center’s National Poison Data System from 1998-2005, and discovered a 76% increase in the number of calls related to the abuse of prescription ADHD medication by adolescents.
To assist families of children with ADHD who may be concerned about this trend, Inflexxion, a behavioral health research company in Newton, MA., has published a free parent toolkit. The online toolkit, designed for families of elementary, middle-school, and high-school students with ADHD, contains practical tools to help parents manage the risks of ADHD medications. Examples include a Medication Contract for parents to use with their children, a Medication Log for tracking the use of ADHD medications, and Sample Letters for communicating with health care providers and teachers about a child’s condition and treatment.
“With the increase in the number of teens misusing or abusing prescription ADHD medications, there is an even greater need for parents, physicians, and teachers to be on the ‘same page’ and to closely monitor adolescents who are being treated for ADHD,” remarks Mary Robertson, RN, co-founder of the Lexington, Kentucky Bluegrass Chapter of Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) and a former National President of CHADD. “Inflexxion’s ADHD Toolkit can help families get organized whenever a change in dosage is required or when a new medication is started. As a new school year begins, it is important for parents to communicate any changes in treatment and performance with their child’s teachers and doctors; the toolkit is an excellent resource for tracking."
The toolkit was created by Inflexxion researchers with guidance from the nationally recognized experts on the Advisory Board for Inflexxion’s InsideADHD.org website. Developed to serve as a comprehensive resource, the website has articles, lessons, and tools to assist with the day-to-day challenges of life with ADHD. Visitors are invited to sign up to receive InsideADHD’s free monthly e-newsletter.
Berkshire Health Systems uses screening tools to better assess and respond to patient complaints of chronic pain and identify those occasional patients who may abuse or divert opioid medications
Clinician resource manual includes Inflexxion’s Screener and Opioid Assessment for Patients with Pain (SOAPP®)
June 25, 2009 –Newton, MA – Inflexxion, Inc. is pleased to announce that Berkshire Health Systems has chosen to include Inflexxion’s clinical practice tools in a Pain Care Resource Manual designed to help practitioners in Berkshire County, Massachusetts increase the quality of pain care services while combating pain medication misuse and diversion.
Berkshire Health Systems developed the manual as part of the Berkshire Community Pain Management Project, a pioneering initiative that has drawn recognition for its efforts to improve pain care management and address potential abusers or diverters of pain medication.
"This project has a number of components, including the publication of a toolkit for all Berkshire County prescribers, whether or not they are associated with Berkshire Health Systems," explains Alex N. Sabo, M.D., co-chair of the project and Chairman of the Department of Psychiatry and Behavioral Health. "The Pain Care Resource Manual is designed to serve as a clinical toolbox, providing best practices guidelines for the assessment and treatment of the chronic pain patient, resources to assist in the proper management of those patients, and guidance for responding to situations of suspected misuse or diversion of pain medication."
The Pain Care Resource Manual is distributed to clinicians through the Berkshire Health Systems intranet, with hard copies available to outside providers, and offers advice, comprehensive information, and tools for navigating along the continuum of treatment for patients with chronic pain.
These tools include the Screener and Opioid Assessment for Patients with Pain (SOAPP), developed by Inflexxion. The SOAPP is a brief paper-and-pencil self-report tool that enables clinicians to assess the risk of addiction in patients prior to initiating opioid therapy. The Pain Care Resource Manual includes both the SOAPP Version 1 and the SOAPP Version 1-Short Form.
The utility of the SOAPP was recently highlighted in a set of evidence-based clinical guidelines for the use of opioids in treating chronic non-cancer pain, developed jointly by the American Pain Society and the American Academy of Pain Medicine and published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2).
The SOAPP is also included in Clinical Guidelines on Prescribing Opioids for the Treatment of Pain developed by the State of Utah Department of Health, which recently announced a 12.6 percent drop in accidental prescription pain medication deaths following the launch of a multifaceted, state-wide initiative to reduce such deaths.
"Clinicians can play a vital role in preventing misuse or diversion of opioid medications, but they need ready access the right tools and resources," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "Inflexxion’s mission is to leverage technology to improve public health, and we applaud Berkshire Health Systems for making these tools available to clinicians throughout Berkshire County, empowering them to make a difference on a broad scale."
In addition to the SOAPP, Berkshire Health Systems has included the complementary Current Opioid Misuse Measure (COMM)® in the Pain Care Resource Manual. Also developed by Inflexxion, the COMM is a tool for identifying whether a patient, currently on long-term opioid therapy, may be exhibiting aberrant behaviors associated with misuse or abuse of opioid medications. Since the COMM examines concurrent misuse, it is ideal for helping clinicians monitor patients' aberrant medication-related behaviors over the course of treatment.
Both the SOAPP and COMM are also available directly to clinicians who visit and register at PainEDU.org, Inflexxion’s award-winning educational website for health care professionals who prescribe pain medications.
Novel approaches to drug safety surveillance presented at 2009 College on Problems on Drug Dependence (CPDD) conference
Inflexxion details research on new models for the detection, assessment, analysis, and prevention of prescription drug abuse
June 18, 2009 –Newton, MA – On June 20-25, The College on Problems of Drug Dependence (CPDD) will hold its 71st Annual Meeting, bringing together research scientists and clinical investigators from diverse sectors to explore the biochemical, behavioral, and public health aspects of drug dependence. Inflexxion, a company that develops clinically validated solutions for critical areas of health care, will present research on new models and tools for monitoring the abuse of prescription pain medications, verifying the potential efficacy of new "abuse-deterrent" opioid formulations, and assessing and tracking behavioral health in adolescents.
"Prescription pain medication abuse is a national public health crisis that demands innovation," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "The CPDD conference provides an excellent forum for examining the science behind proposed solutions."
Inflexxion, which has been recognized with a Tibbetts Award for its exemplary use of the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grants, has integrated a number of its NIH-funded programs to create the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™). NAVIPPRO provides pharmaceutical companies with data and tools for implementing science-based, measurable Risk Evaluation and Mitigation Strategies (REMS) for opioid and stimulant medications. The program combines national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
In late May, Inflexxion gave a presentation on NAVIPPRO at the FDA's public meeting on developing REMS for certain extended-release opioid medications. At the forthcoming CPDD meeting, the company's research scientists will provide details on findings from a series of investigations to test and refine components of the program, which is constantly evolving to meet public health goals.
"We’re examining critical questions in the development of systems for reducing prescription drug misuse, abuse, overdose, and deaths, while keeping valuable medications available to the patients who need them," explains Dr. Zacharoff. "Can we use data collected from substance abuse treatment centers to link empirical patterns of drug abuse with such factors as geographic location and drug availability, so we can design targeted interventions? How does this data compare with data from other sources, and what are the implications for its utility in improving drug safety? What is the best way to gather timely, accurate information about how adolescents are abusing prescription drugs? And looking ahead, what are the appropriate models for measuring the potential efficacy of new 'abuse-deterrent' opioid formulations?"
Inflexxion has developed a scientific approach to establishing the abuse-deterrence profile of a particular prescription opioid medication, and recently published peer-reviewed commentary on the issues surrounding the development of abuse-deterrent formulations, entitled, “Can abuse-deterrent formulations make a difference? Expectation and speculation” (Harm Reduction Journal, Volume 8, Article 6).
Inflexxion’s research scientists will give four presentations on the company’s research at the CPDD conference, including a presentation on a model for evaluating an abuse-deterrent formulation’s potential public-health impact. They are:
• "Geographic and contextual factors of prescription opioid abuse: Results from ASI-MV® Connect," presented Monday, June 22, 8:45 a.m. (Oral Communications 3: “Prediction of Addiction")
• "Abuse Deterrent Adjusted Measurement Model: ADAMM™," presented Monday, June 22, 9:15 a.m. (Oral Communications 3: “Prediction of Addiction")
• "Relative rates of prescription opioid abuse: Comparison of public health databases," presented Monday, June 22, 10:00 a.m. (Oral Communications 7: “A Royal Flush of Prescription Opioid Epidemiology")
• "Validation of CHAT™: An interactive, multimedia scale to assess alcohol and substance addiction severity among adolescents," Thursday, June 25, 8:00 a.m. – 9:00 a.m. (Poster Session IV: “Diagnosis and Assessment")
In addition, Emil Chiauzzi, Ph.D., Vice President of Product Strategy at Inflexxion, will participate in a workshop entitled "Communicating the Risks of Opioid Analgesics: How Can We Do Better?" on Tuesday, June 23, from 8:00-9:00 p.m. Dr. Chiauzzi, the principal investigator of 25 SBIR grants, will discuss the Internet as a communication tool for conveying risk information concerning opioid analgesics, and examine how online tools might be best used and evaluated.
To learn more about Inflexxion, or to request a copy of a poster, please visit www.inflexxion.com and click on "Contact."
To learn more about NAVIPPRO, please visit the website at www.navippro.com. Those interested in following developments in pharmaceutical risk management are welcome to sign up for "NAVIPPRO Signal," a free monthly e-newsletter, at www.navippro.com/newsletter.
About Inflexxion
Founded in 1989, Inflexxion leverages technology to improve public health. We create clinically validated tools and programs for critical areas of health care, including prevention and wellness education, addiction and pain treatment, and pharmaceutical risk management. These innovative solutions help reduce health-related risks, enhance clinical outcomes, and positively impact the quality of care.
Inflexxion announces the release of the Comprehensive Health
Assessment for Teens (CHATTM)
Web-enabled, clinically validated assessment tool helps organizations
increase the quality of care for adolescents
June 17, 2009 - Newton, MA - Inflexxion, Inc. today announced the release of the Comprehensive Health Assessment for Teens (CHAT), a behavioral health assessment tool for clients ages 13-18. CHAT was developed and research-tested with funding from the National Institute on Drug Abuse (NIDA), and has been found to be both valid and reliable. The tool is offered as part of Inflexxion's Addiction Severity Index - Multimedia Version (ASI-MV) Connect product suite, a behavioral health solution that helps organizations streamline their assessment procedures, expedite treatment planning, and simplify data gathering and analysis.
The ASI-MV Connect system is web-enabled, and has three main components: the client self-administered ASI-MV interview; clinical reports populated with client-specific data; and a powerful Internet-based data analysis tool, the ASI-MV Connect Data Center. With the addition of CHAT, organizations have access to a developmentally appropriate instrument for assessing their adolescent population.
“Adolescents are often users of multiple drugs, and many don't believe that taking drugs is a serious problem – a fact that is especially alarming given the rise of prescription drug abuse, which can be deadly,” explains Dr. Al Villapiano, Vice President of Clinical Development at Inflexxion. “Adolescents often enter treatment through diverse social services, such as child welfare or the juvenile justice system. But individual facilities may not be equipped to provide comprehensive assessment or coordinated care, leaving young people at risk for under-treatment of problems that can have a devastating impact on their lives. We developed CHAT to help organizations of all kinds implement standardized assessment procedures and ensure that adolescents receive the highest quality care.”
CHAT is designed to assist with treatment planning for adolescents who are beginning or are already in treatment for substance abuse or mental health problems, entering a juvenile justice facility, or presenting at any health care organization. Through a 45-60 minute "virtual" interview that clients self-administer on a computer, CHAT provides organizations with scores for a client in six problem areas: Alcohol Use; Drug Use; Tobacco Use; Psychological Health; Family Relationships; and Peer Relationships. In addition, important clinical information is provided about the client’s physical health and school, work, and legal issues.
“The CHAT format is based on the adult ASI-MV interview, which has been used by behavioral health treatment centers for nearly a decade, enabling the implementation of standardized, time- and cost-effective addiction assessment procedures,” says Villapiano. “Our hope is that CHAT will provide the same value for every organization that treats adolescents.”
CHAT has three important features lacking in other adolescent assessment instruments: it uses engaging multimedia that is geared to the adolescent population; it follows a developmental approach suited to the needs of young people; and it assesses strengths as well as problem areas, providing a more comprehensive portrait for guiding treatment. In addition, Inflexxion’s clinical research has shown that CHAT’s computer-mediated environment may increase the honesty and accuracy of client responses.
To learn more about CHAT and the ASI-MV Connect system, currently in use at nearly 500 facilities across the U.S., Canada, and Puerto Rico, visit the website at www.asi-mvconnect.com.
American Pain Society conference sheds light on critical challenges in pain management
Inflexxion introduces painACTION, a pain self-management website for people with chronic pain
May 6, 2009 – Newton, MA – On May 7-9, the American Pain Society (APS) will hold its 28th Annual Scientific Meeting in San Diego, California. The meeting brings together pain scientists and health care professionals to discuss the latest findings related to the diagnosis, treatment, and management of acute pain, chronic cancer and non-cancer pain, and recurrent pain. Inflexxion, a company that creates scientifically validated solutions for critical areas of health care, is presenting a poster to introduce painACTION.com, an online resource to help patients self-manage chronic pain.
"The APS conference is especially relevant right now, when we're starting to see important innovations in pain treatment and management emerging in response to critical challenges, such as the rise of prescription pain medication misuse, abuse, and overdose," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "The painACTION website is designed to serve as a daily resource for patients with chronic pain conditions, while at the same time providing clinicians with a useful tool for increasing the quality of care – including ensuring that their patients understand how to take prescription pain medications safely."
Developed with grant support from the National Institutes of Health (NIH), painACTION is a non-promotional website that provides unbiased information on self-managing pain. It leverages innovative technology, including a "smart" recommendation engine that delivers customized content to individuals, based on a user's pain profile, the information the individual has viewed, and psychosocial assessments.
To complement the guidance that clinicians provide during office visits, painACTION also offers multimedia lessons, tools, and articles on taking pain medications appropriately and safely, with an entire risk management curriculum devoted specifically to opioids.
Finally, painACTION provides specialized tools to empower patients in self-managing pain. Users can track their pain with an online Daily Pain Tracker, and print out charts to share with their health care provider. They can also complete skill-based lessons for self-managing their specific pain condition, with learning modules for managing cancer pain, back pain, and migraine pain.
"We view resources such as painACTION to be a critical piece of the pain self-management puzzle," says Emil Chiauzzi, Ph.D., a Principal Investigator in the project and Vice President of Product Strategy at Inflexxion. "It is important that people in pain build the daily coping skills to complement formal medical treatment, and utilizing the Internet affords consistent and reliable access to such information."
The ongoing dissemination of painACTION is supported by Endo Pharmaceuticals, Inc. and King Pharmaceuticals, Inc.
MyStudentBody-Parent: A New Way to Reach Students
May 4, 2009 – Newton, MA – Inflexxion announced today the release of MyStudentBody-Parent, a new component of the company’s MyStudentBody comprehensive student health suite. MyStudentBody offers college health administrators a wide range of tools for implementing evidence-based prevention and intervention strategies. With MyStudentBody-Parent, administrators can reach out to parents and families and help them communicate effectively with students about alcohol, drugs, and other health challenges on campus.
“Recent research has bolstered the support for engaging parents in campus prevention efforts, and we developed this program to help make it easier for college administrators to do that,” says Elizabeth Donovan, Ph.D., one of the research scientists at Inflexxion who led the development of MyStudentBody-Parent. “We hope that families will find the program both easy to use and engaging, so that it can be effective in helping administrators work with parents to reduce health risks for students throughout their college years.”
By offering this resource to families, administrators can:
Help parents encourage healthy behavior – To help families learn about good conversational strategies, the program offers online videos that explore a variety of ways to approach sensitive topics. These videos feature real parents and students, and are integrated in seven learning modules that cover key issues. The learning modules include Prevention Strategies, which has a "Key Conversation" that encourages parents create a plan with students for dealing with an alcohol poisoning emergency, and Share the Facts, which has articles on specific alcohol and drugs-related topics that families may wish to address with students.
Support a healthy transition to college -- To help administrators prepare families for the unique health challenges of the transition to college, the program includes user-friendly resources, such as a succinct, downloadable Parent Guide suitable for use in freshmen orientation, and an Orientation Checklist Tool, designed to help families successfully navigate orientation and learn about an institution's health-related policies and resources.
Strengthen health and safety initiatives -- Opening the lines of communication with families can help administrators garner additional support for their initiatives. Administrators can use MyStudentBody-Parent’s customizable interface to keep families informed about health-related events, programs, and resources. They can also help families learn about campus safety with Campus Perspectives, a series of audio stories that share insights from the campus professionals who work to keep students safe and healthy.
Every subscriber to MyStudentBody has full, free access to every component, including MyStudentBody-Parent.
Utah launches state-wide clinical guidelines for prescription pain medicationsto combat prescription drug-related deaths
Inflexxion's clinician tools are recommended to help health care providerssafely prescribe and monitor opioid medication use
April 16, 2009 – Newton, MA – Inflexxion, a company that creates scientifically validated tools for critical areas of health care, is pleased to announce that the State of Utah has included Inflexxion’s opioid risk management tools in state-wide clinical guidelines for prescribing pain medications. The guidelines were developed by the Utah Department of Health as part of an ongoing campaign to fight the rise of prescription drug overdose deaths in the state. They include both a set of evidence-based recommendations to guide clinicians in the appropriate use of opioid medications, and clinical tools to help doctors carry out the recommendations.
"For the past 17 years, prescription drug-related deaths have increased and now exceed deaths resulting from automobile crashes in our state. In fact, it is now the number one cause of unintentional death," writes David Sundwall, M.D., Executive Director of the Utah Department of Health, in the introduction to the guidelines. "It is our hope that the guidance in this document...will, if followed, significantly reduce deaths from misuse and abuse, but at the same time allow for the control of chronic pain with the proper use of opioid medications."
To develop the guidelines, the Utah Department of Health convened two multidisciplinary panels of experts: one to develop the recommendations, and another to select the accompanying clinician tools. The experts on the tools panel reviewed and graded 47 tools for usefulness and suitability for inclusion in the guidelines, and ultimately selected 21 tools from those with the highest ratings.
"This has been a tremendous amount of work, involving both experts and researchers to help us gather the best relevant knowledge and educational material that is available," says Erin Johnson, M.P.H., who serves as Prescription Pain Medication Program Manager for the Utah Department of Health's Prescription Pain Medication Management & Education Program. “We want to spread the word about the guidelines as widely as we can, so doctors in Utah and across the nation can benefit from them.”
Among the tools included in the guidelines is Inflexxion's Screener and Opioid Assessment for Patients with Pain Version-Revised (SOAPP-R®).
The SOAPP-R is a brief paper-and-pencil self-report tool that enables clinicians to assess the potential risk of addiction in patients prior to initiating opioid therapy. Its utility was recently highlighted in a set of clinical guidelines for the use of opioids in treating chronic non-cancer pain, which were developed jointly by the American Pain Society and the American Academy of Pain Medicine and published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2). Another version of the SOAPP, the 5-item SOAPP-SF, is recommended by Kaiser Permanente's Pain Management Advisory Group.
In addition to the SOAPP-R, the panel chose to include Inflexxion's Current Opioid Misuse Measure (COMM)®. The COMM is a tool for identifying whether a patient, currently on long-term opioid therapy, may be exhibiting aberrant behaviors associated with misuse or abuse of opioid medications.
These tools are also available directly to clinicians who visit and register at the PainEDU.org website (www.PainEDU.org). Published by Inflexxion, the PainEDU site offers extensive educational resources free of charge to clinicians who are interested in learning more about pain management, including online tutorials and scoring guides for the SOAPP-R and COMM tools.
"We’re very excited that SOAPP-R and COMM are included in the guidelines. Utah is a leader in this area, only the second state in the nation to develop guidelines for health care professionals to follow when prescribing pain medications for chronic pain," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "At Inflexxion, our mission is to improve public health, and we have developed tools like the SOAPP and the COMM for just this kind of purpose. We're proud to be part of a growing movement to ensure that doctors have the education and tools they need to prescribe opioid medications safely and appropriately – so we can protect patients and save lives."
FDA meeting on opioid REMS highlights the need for comprehensive, integrated risk management
Inflexxion is uniquely positioned to assist companies with risk evaluation and mitigation strategy plans
March 2, 2009 - Newton, MA - On Tuesday, March 3rd, the FDA will meet with manufacturers of extended-release (ER) opioid medications for what’s expected to be the beginning of a process to develop a new Risk Evaluation and Mitigation Strategy (REMS) program. According to the Agency, strategies for minimizing the risks of opioid medications -- which have included FDA-required risk minimization and action plans, or RiskMAPs -- need to be strengthened.
“Despite [the efforts of the FDA, drug manufacturers, and other stakeholders], the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade,” states the Agency in a media release announcing the meeting. Crafting a new REMS program, the Agency says, will entail “discussions with other federal agencies and non-government institutions, including patient and consumer advocates, representatives of the pain and addiction treatment communities, other health care professionals, and other interested parties.”
Inflexxion, a company that is deeply engaged with the pain and addiction treatment communities, is uniquely prepared to assist manufacturers, federal agencies, and other stakeholders with creating a comprehensive REMS. In 2001, the company’s pharmaceutical risk-management division launched development of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) with support from the National Institutes of Health (NIH). Now a nationally recognized public health-oriented substance risk management solution, NAVIPPRO integrates the four key components of an effective REMS: national, “real-time,” product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
“One of the key elements distinguishing REMS from RiskMAPs is the requirement for ongoing evaluation of the efficacy of a program, both by the FDA and the sponsor of the drug, so adjustments can be made to ensure that risk-mitigation goals are being met,” says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. “NAVIPPRO is designed to assist with this type of long-term, continuous evaluation.”
In a recent study of NAVIPPRO data published in Pharmacoepidemiology and Drug Safety (December 2008, Volume 17, Issue 12), the authors evaluated the surveillance component of the program. Analyzing NAVIPPRO’s “real-time” data stream, de-identified client assessment data continuously collected from the ASI-MV® Connect network of substance abuse clinics across the U.S., they examined the representativeness, geographic coverage, and timeliness of report of the data. They found that the data allow for the characterization of product-specific and geo-spatial differences for drug abuse, and can serve as a tool for monitoring the responses of the treatment center population to particular drug formulations.
According to Zacharoff, the findings show that NAVIPPRO data can be useful for measuring, in “real time,” the relative rate of abuse of a particular drug in a vulnerable population, and in a specific geographic area of the country. "These data can help detect early signals of an emerging trend of abuse, which in turn allows for targeted prevention and intervention efforts, and for gauging the impact of those initiatives," he says.
To address the need for prevention and intervention, Inflexxion has incorporated into NAVIPPRO its award-winning, empirically validated educational programs. These programs include PainEDU.org, a comprehensive pain education website for health care professionals with nearly 20,000 subscribed clinicians of varying disciplines. As part of its educational offerings, PainEDU provides clinicians with access to clinically tested practice tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP®).
Developed by Inflexxion, SOAPP is a brief, pen-and-paper self-report tool that enables health care providers to assess a patient's risk of addiction before initiating opioid therapy. It can be used in concert with the Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.
The utility of SOAPP and COMM were recently highlighted in new guidelines by the American Pain Society and the American Academy of Pain Medicine on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.
"In the past, drug sponsors and consultants worked individually on programs designed to minimize risk in a hit-or-miss fashion, with very little modification of the initiatives based on outcomes. I believe that the FDA hopes that this new REMS development process will provide an opportunity for these groups to come together, working more closely to ensure that patients are treated appropriately, based on collected data, with the best medications available, and the highest level of safety and vigilance," says Zacharoff. "We at Inflexxion are committed to assisting all stakeholders – including the manufacturers, the FDA, and health care providers – in successfully navigating these issues and together improving the risk-benefit balance of opioid medications."
To learn more about NAVIPPRO, visit the website (www.navippro.com).
Clinical guidelines for treating chronic pain highlight opioid addiction risk assessment
Expert panel finds that SOAPP® is likely to be helpful for risk assessment and stratification
February 25, 2009 – Newton, MA – Inflexxion, Inc., a company that creates scientifically validated and cost-effective solutions for critical areas of health care, is pleased to announce that its Screener and Opioid Assessment for Patients with Pain (SOAPP) has been identified by an expert panel as likely to be helpful for assessing the risk of opioid addiction in patients with chronic non-cancer pain.
SOAPP is a brief paper-and-pencil self report tool that allows clinicians to assess a patient’s risk of addiction before initiating opioid therapy.
The multi-disciplinary panel of experts, convened by the American Pain Society and the American Academy of Pain Medicine, conducted a comprehensive review of the evidence to develop a set of authoritative clinical guidelines on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.
“Proper patient selection is critical and requires a comprehensive benefit-to-harm evaluation that weighs the potential positive effects of opioids on pain and function against potential risks,” write the authors. “Thorough risk assessment and stratification is appropriate in every case.”
According to the authors, screening tools that assess the potential risks associated with continuous opioid therapy (COT) based on patient characteristics are likely to be helpful for risk stratification. The authors identify SOAPP Version 1 and the revised version, SOAPP-R, as among the tools that appear to have “good content, face, and construct validity.”
In addition to SOAPP, the guidelines highlight the utility of Inflexxion’s Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.
"We at Inflexxion are very pleased to see both SOAPP and COMM included in these recommendations," says Kevin L. Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "These guidelines underscore the importance of risk assessment and reassessment in this patient population. The inclusion of the SOAPP and COMM in these recommendations helps to validate Inflexxion’s mission, which is to help to reduce health-related risks, enhance clinical outcomes, and positively influence quality of care."
The SOAPP and COMM tools are available for download at no cost through Inflexxion's PainEDU website (www.PainEDU.org), along with a clinician tutorial that includes video case examples.
SOAPP was developed by Inflexxion with support from the National Institutes of Health (NIH) and an unrestricted educational grant from Endo Pharmaceuticals.