Welcome to the NAVIPPRO Signal.
We are pleased to announce the addition of a new data stream to the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO): real-time, product-specific data from adolescents in treatment for substance abuse.
These data are collected through the Comprehensive Health Assessment for Teens (CHAT™), which is now being used by clinics in the Addiction Severity Index – Multimedia Version (ASI–MV©) Connect network of substance abuse treatment centers. The network currently comprises more than 500 clinics across the nation.
Below you’ll find a brief introduction to the new adolescent surveillance component of NAVIPPRO. You’ll also find an update on our latest research on methods for reducing the risks of opioid medications, including an examination of the issues surrounding the development of abuse-deterrent formulations. Finally, you’ll find links to a roundtable discussion on the respective responsibilities of the prescriber and the patient in managing opioid therapy.
We hope you find this issue of NAVIPPRO Signal useful. If you have any questions about NAVIPPRO or our research, please feel free to contact us.
Sincerely,
The NAVIPPRO team
NAVIPPRO now includes data from adolescents in treatment for substance abuse
The rise of prescription drug abuse is especially troubling in light of indicators that it is a growing trend among adolescents. A new report that synthesizes data from several government sources, the National Prescription Drug Threat Analysis 2009, reveals that non-medical use of prescription drugs is most prevalent among young adults (ages 18-25), and that “adolescents (12 to 17 years of age)… compose a significant user group for these drugs.” It also indicates that more people are initiating drug use with prescription drugs, with 1 in 5 initiating use with powerful pain medications, such as oxycodone, hydrocodone, and methadone.1
As part of our efforts to improve the risk/benefit balance of prescription medications, we have now added a new data stream to NAVIPPRO: real-time, product-specific data from adolescents in treatment for substance abuse. The Comprehensive Health Assessment for Teens (CHAT) is a web-enabled, multimedia assessment tool designed specifically for patients ages 13-18, and collects product-specific data on prescription opioids and stimulants. As of June 2009, these data are being collected from clinics in the ASI-MV Connect network that treat adolescent patients, as well as from therapeutic schools, treatment academies (non-residential), and other organizations specializing in treating adolescents for substance abuse.
Initial responses have been positive. Tim McShane, L.L.P.C., C.A.A.C., of Harbor Hall in Petoskey, Michigan, reported that a counselor administering CHAT for the first time found it to be “the most thorough adolescent assessment tool I have ever used.” In addition, “client feedback was very positive,” and the program “flows nicely” and makes it “very easy to gather the needed psychosocial information.”
The CHAT data-collection process is identical to that used for the adult ASI-MV Connect assessment. When a patient completes the CHAT assessment interview, aggregate, HIPPA-compliant data are automatically uploaded to a secure central server. These data include information on the specific product being abused, where the patient obtained the product, and the route of administration used.
“Gathering this kind of data about adolescent drug use has historically been challenging, given both practical and ethical concerns,” explains Theresa Cassidy, M.P.H., Director of Epidemiology at Inflexxion. “By integrating data collection about pharmaceuticals in the clinical workflow, in a way that is not an impediment but instead clinically beneficial, we can potentially build a more detailed, accurate picture of adolescent substance abuse than has previously been possible.”
The CHAT assessment interview, like the adult ASI-MV Connect interview, is designed to enhance accuracy. The program poses interview questions using a “voice over” and displays accurate pictures of all of the drug products. Use of tree logic enables the program to simulate an interviewer, guiding appropriate respondents to questions about the use of particular pharmaceuticals, showing the names (trade/brand, generic, and street/slang) and pictures of the products. The respondent clicks on the picture(s) of drugs he or she has used, which registers the product-specific data. A “fake” drug helps track the extent of error due to patient inattention, fabrication, or other misidentification issues. Of the 97,135 cases in the ASI-MV Connect database as of June 1st, 2009, .006% of respondents indicated any use of the “fake” drug drug and only .004% indicated having abused it.
For additional information about how treatment centers use CHAT, read our media release on the CHAT launch [PDF] or visit the ASI-MV Connect website. If you have specific questions about CHAT data, please feel free to contact us.
Research update: examining methods for reducing the risks of opioid medications
Every component of NAVIPPRO is scientifically developed and tested, and our research team regularly publishes the results in peer-reviewed journals.
Following are abstracts and links to our most recently published articles, examining issues of importance in developing strategies for mitigating the risks of opioid medications:
Can abuse-deterrent formulations make a difference? Expectation and speculation [Full PDF] – Budman, S.H., Grimes Serrano, J.M. & Butler, S.F. (2009). Harm Reduction Journal, 6(8).
Description: It is critical that issues surrounding the abuse and misuse of prescription opioids be balanced with the need for these medications for the treatment of pain. One way to decrease the abuse of prescription opioid medications is to develop abuse-deterrent formulations (or ADFs) that in some way prevent drug abusers from extracting the active ingredient in order to employ alternate routes of administration, such as injection, snorting, and smoking. Several factors, including the pharmacokinetic profile of the drug, the features of the drug formulation that make it attractive or unattractive for abuse, the type of drug abuser, the progression of one's addiction pathway, and one's social environment may all play a role in the abuse of prescription opioids and what methods are used to abuse these drugs. This paper will examine these factors in order to understand how they affect the abuse of prescription opioids and routes of administration, and how the development of ADFs may alter these patterns.
Women who abuse prescription opioids: Findings from the Addiction Severity Index-Multimedia Version Connect prescription opioid database – Green, T.C., Grimes Serrano, J.M., Licari, A., Budman, S.H. & Butler, S.F. (2009). Drug and Alcohol Dependence, 103(1-2).
Background: Evidence suggests gender differences in abuse of prescription opioids. This study aimed to describe characteristics of women who abuse prescription opioids in a treatment-seeking sample and to contrast gender differences among prescription opioid abusers. Methods: Data collected November 2005 to April 2008 derived from the Addiction Severity Index-Multimedia Version Connect (ASI-MV Connect) database. Bivariate and multivariable logistic regression examined correlates of prescription opioid abuse stratified by gender. Results: 29,906 assessments from 220 treatment centers were included, of which 12.8% (N = 3821) reported past month prescription opioid abuse. Women were more likely than men to report use of any prescription opioid (29.8% females vs. 21.1% males, p < 0.001) and abuse of any prescription opioid (15.4% females vs. 11.1% males, p < 0.001) in the past month. Route of administration and source of prescription opioids displayed gender-specific tendencies. Women-specific correlates of recent prescription opioid abuse were problem drinking, age <54, inhalant use, residence outside of West U.S. Census region, and history of drug overdose. Men-specific correlates were age <34, currently living with their children, residence in the South and Midwest, hallucinogen use, and recent depression. Women prescription opioid abusers were less likely to report a pain problem although they were more likely to report medical problems than women who abused other drugs. Conclusions: Gender-specific factors should be taken into account in efforts to screen and identify those at highest risk of prescription opioid abuse. Prevention and intervention efforts with a gender-specific approach are warranted.
Cross-validation of a screener to predict opioid misuse in chronic pain patients (SOAPP-R) – Butler, S.F., Budman, S.H., Fernandez, K.C., Fanciullo, G.J., Jamison, R.N. (2009). Journal of Addiction Medicine, 3(2).
Objectives: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a self-report questionnaire designed to predict aberrant medication-related behaviors among persons with chronic pain. This measure was developed to complement current risk assessment practices and to improve a clinician's ability to assess a patient's risk for opioid misuse. The aim of this study was to cross-validate the SOAPP-R with a new sample of chronic, noncancer pain patients. Methods: Three hundred two participants (N = 302) prescribed opioids for pain were recruited from 5 pain management centers in the U.S. Subjects completed a series of self-report measures and were followed for 5 months. Patients were rated by their treating physician, had a urine toxicology screen, and were classified on the Aberrant Drug Behavior index. Results: Seventy-three percent (73.2%) of the subjects (N= 221) were followed and 66 participants repeated the SOAPP-R after 1 week for test-retest reliability. The reliability and predictive validity, as measured by the area under the curve (AUC), were found to be highly significant (test-retest reliability = 0.91; coefficient α = 0.86; AUC = 0.74) and were sufficiently similar to values found with the initial sample. A cut-off score of 18 revealed a sensitivity of 0.80 and specificity of 0.52. Conclusions: Results of this cross-validation study suggest that the psychometric parameters of the SOAPP-R are not based solely on the unique characteristics of the initial validation sample. The SOAPP-R is found to be a reliable and valid screening tool for risk of aberrant drug-related behavior among chronic pain patients.
PainEDU roundtable: “Prescriber and Patient Opioid Responsibilities”
One of the most important tools in mitigating the risks of prescription pain medications is education. To support the prevention and intervention components of NAVIPPRO, we design, test, and implement empirically validated educational programs. These programs include PainEDU.org, a website that offers extensive educational resources to 20,000 registered health care professionals.
In a roundtable discussion recently featured in the PainEDU newsletter, we asked three experts in the pain management community to define the respective responsibilities of the prescriber and the patient in managing opioid therapy, an issue that has been highlighted in the ongoing discussions about the optimal design of opioid Risk Evaluation and Mitigation Strategies (REMS). Following are brief excerpts and links to the complete responses online:
Jennifer E. Bolen, J.D. – “One area that is especially critical [when prescribing opioids] relates to the evaluation of the patient and whether there is indeed a legitimate medical reason for the use of a controlled substance to treat the patient's pain. If there is, then the prescriber should engage in an informed consent discussion with the patient to ensure the patient understands the potential risks, expected benefits, available treatment alternatives, and special issues associated with the use of the recommended medication.”
Bill McCarberg, M.D. – “First of all, the patient needs to understand the treatment plan, and everything that goes along with that. This would include the amount of time that may be needed to achieve successful control of the painful condition. Secondly, the patient has to also clearly understand the mutually (patient and clinician) determined goals of treatment, and these need to be both achievable and realistic in nature. Lastly, and most importantly, adherence to the medical regimen as prescribed is critical to safe and responsible use of opioids for treating pain.”
Thomas E. Quinn, M.S.N., R.N., A.O.C.N. – “Because of the regulations associated with opioid use and the potential for abuse, the issue of trust can become a challenge in a clinician-patient relationship. For instance, a patient may feel insulted and mistrusted when subjected to a urine screening. During treatment planning, clinicians should prospectively explain that tests, such as a urine screen, are a common practice, as well as explain to their patients what the risks are for opioid therapy and why these regulations exist.”
References
1 Drug Enforcement Administration, National Drug Intelligence Center (2009). National Prescription Drug Threat Analysis 2009 (L0487-001). Johnston, PA.
About NAVIPPRO
The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a public health-oriented risk management solution that integrates the four key components of an effective Risk Evaluation and Mitigation Strategy (REMS): national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
NAVIPPRO began in 2001 with a series of grants from the National Institute on Drug Abuse (NIDA). In 2005, Endo Pharmaceuticals became the founding industry sponsor of NAVIPPRO and in 2006 Alpharma Pharmaceuticals LLC. (now King Pharmaceuticals, Inc.) became the second industry founder. Since that time, Shire Development, Inc. has joined in supporting the program, including providing founding sponsorship for the CHAT component. With NIDA’s continued support of ongoing research and product development, NAVIPPRO is constantly evolving to meet our goal of advancing public health.
- NAVIPPRO now includes data from adolescents in treatment for substance abuse
- Research update: examining methods for reducing the risks of opioid medications
- PainEDU roundtable: "Prescriber and Patient Opioid Responsibilities"
- References
- About NAVIPPRO
- NAVIPPRO
- Surveillance
- Signal detection
- Signal verification
- Prevention & intervention
- ASI-MV Connect
- About Inflexxion
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Support
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc.in the development of NAVIPPRO.
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc. in the development of NAVIPPRO.
The contents of this newsletter are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis or treatment. Reliance on any information provided in this newsletter is at your own risk.
You should consult your physician or other qualified health provider if you have questions about a medical condition. If you think you have a medical emergency, call your doctor or 911 immediately.
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