NAVIPPRO Signal e-newsletter: Developing and validating the SOAPP�


	September 1, 2009 \| ISSUE 12

	Welcome to the NAVIPPRO Signal. A number of recent developments have underscored the need for opioid risk management approaches that can ensure access to effective pain treatment while minimizing risk. Notably, newly published guidelines from the American Geriatrics Society (AGS) highlight the need to consider risks associated with the chronic use of non–steroidal anti–inflammatory drugs, or NSAIDs, to treat elderly patients with chronic pain. The guidelines recommend that “all patients with moderate–severe pain, pain–related functional impairment, or diminished quality of life due to pain should be considered for opioid therapy.”¹ “Here, we have a growing population for which opioid therapy may, in many cases, have a better risk–to–benefit profile,” says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. “In light of the rise of opioid medication–related deaths from misuse, abuse, and overdose, it′s critical that clinicians have access to, and understand the role of, tools for performing and documenting opioid risk assessment on a routine basis, as well as for continuously monitoring a patient′s therapy so that any necessary adjustments can be made.” Below you′ll find an article detailing the development, validation, and use of the Screener and Opioid Assessment for Patients with Pain (SOAPP^®), one of the clinical practice tools available through PainEDU.org. The PainEDU program is a leading online educational resource for health care providers seeking to improve their pain management skills, and a component of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO). As such, it has been integrated into Risk Minimization Action Plans (RiskMAPs) and proposed Risk Evaluation and Mitigation Strategies (REMS) for many leading prescription opioid medications. In addition to the article on the SOAPP, you′ll find a brief round–up of relevant news, including FDA′s recent approval of EMBEDA^™ (morphine sulfate and naltrexone hydrochloride) Extended–Release Capsules, a long–acting Schedule II opioid analgesic for the management of moderate to severe pain that is designed to reduce drug liking and euphoria when tampered with by chewing or crushing.² 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 Back to top Development and use of the Screener and Opioid Assessment for Patients with Pain (SOAPP) for opioid risk management Six years ago, researchers at Inflexxion, with grant support from the National Institutes of Health (NIH) and an unrestricted grant from Endo Pharmaceuticals, Inc., launched a study to develop a practice tool that would help clinicians assess the risk of aberrant drug–related behavior prior to initiating opioid therapy. At the time, there was no widely accepted or broadly used assessment tool to identify those patients at heightened risk of abusing opioid medication before beginning treatment. Today, that tool, the Screener and Opioid Assessment for Patients with Pain, or SOAPP, is a widely used instrument, and has become a standard tool for identifying patients who may abuse opioid medications. Identified by leading pain specialists as among “the most promising tools to date”³ for determining the level of risk prior to initiating opioid therapy, the SOAPP is formally licensed for use at more than 50 health care institutions across the nation. As of July 2009, there have been more than 11,300 downloads of the tool directly to individual health care practitioners through the PainEDU website. Notably, the SOAPP has also increasingly been adopted for use as part of integrated risk management plans in large–scale health care organizations and systems. These include Kaiser Permanente, Berkshire Health Systems, and the State of Utah Department of Health, among others. Following is a brief overview of the development and validation of the SOAPP, as well as a look at how it is being used by health care organizations to improve the risk/benefit balance of opioid medications. Development and validation of the SOAPP The development and scientific validation of the SOAPP has been documented in four peer–reviewed journal articles, with the first article published in 2004.⁴ In the initial field trial conducted with 175 chronic, non–cancer pain patients, the original 24–item version of the SOAPP was shown to be valid, and to predict aberrant drug-related behavior. Three measures were used to establish aberrant drug–related behavior: 1.) self–report via a structured interview; 2.) staff assessment; and 3.) urine toxicology reports. In 2005, a longer, larger field trial of a 14–item version of the SOAPP was conducted with 396 non–cancer pain patients, and showed comparable results.⁵ Continuing to test and refine the SOAPP, Inflexxion researchers developed a revised version, the SOAPP–R, to improve the predictive value of a low SOAPP score and give clinicians a higher level of confidence in the results. This version of the SOAPP was also shown to be valid, and the results of the study were published in 2008.⁶ Most recently, the SOAPP–R was cross–validated with a new sample of 302 non–cancer pain patients.⁷ The researchers concluded that SOAPP-R can help clinicians identify patients at high risk, who may need extra monitoring when prescribed opioids, as well as those who are at low risk, who may require fewer monitoring resources. This represents a significant advance, since providing clinicians with more sensitive information for decision–making may help to avoid the unintended consequence of under-prescribing opioid medications for patients who are in fact appropriate candidates for such therapy. *Implementation of the SOAPP in large–scale organizations and systems* In September 2008, the SOAPP became the first practice tool to be recommended by the Kaiser Permanente’s National Pain Management Advisory Group. The Kaiser Permanente network covers eight regions, including 13,000 physicians at 320 hospitals, and reaches nearly nine million members nationwide. “Chronic non–cancer pain treatment requires a multidisciplinary and multimodal approach, which may include the judicious use of opioid analgesics,” said Dr. Karen Pantazis, Clinical Lead of the National Pain Management Advisory Group. “Use of the SOAPP tool will assist Kaiser Permanente providers in balancing their goal of improved pain management with the concerns of abuse and diversion of these substances.”⁸ Since that time, the SOAPP has been integrated in risk management plans for the State of Utah Department of Health and Berkshire Health Systems. Berkshire Health Systems makes the SOAPP broadly available as part of a clinician toolkit for all practitioners in Berkshire County, regardless of whether they are associated with the organization.⁹ In Utah, the Department of Health has included the SOAPP in a set of groundbreaking clinical guidelines for prescribing pain medications, as part of a multi–faceted, state–wide initiative to reduce the number of accidental opioid medication–related deaths. Since the launch of the initiative, Utah health officials have reported a 12.6% decrease in the number of such deaths.¹⁰ For additional information on the SOAPP, visit the PainEDU website. If you would like to include the use of these tools in your risk management plans, please contact us. Back to top In the news: Opioid medications and Risk Evaluation and Mitigation Strategy (REMS) King Pharmaceuticals, Inc. announces FDA approval of EMBEDA^™: On August 13^th, King Pharmaceuticals, Inc. announced that the FDA has approved EMBEDA^™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use. EMBEDA^™ is indicated for the management of moderate to severe pain when a continuous, around–the–clock opioid analgesic is needed for an extended period of time. It is designed to reduce drug liking and euphoria when tampered with by crushing or chewing. “The development of formulations like EMBEDA^™ that employ technologies designed to reduce drug liking and euphoria associated with non-medical uses could potentially change how chronic pain is treated. Prescribers and patients have been hoping and waiting for safer medicines to treat chronic pain,” said Nathaniel Katz, M.D., M.S., President of Analgesic Research and Adjunct Assistant Professor, Tufts University, in the King press release. Follow the links below to learn more: FDA: Approved REMS: EMBEDA^™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules [PDF] King: FDA Approves EMBEDA^™ for Management of Moderate to Severe Chronic Pain EMBEDA^™ website FDA announces approval of Onsolis^™: On July 16th, FDA announced approval of Onsolis^™ with a REMS. Onsolis^™ (fentanyl soluble buccal film) is an opioid analgesic indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. “The REMS for Onsolis^™ was specifically tailored to that drug and should not be viewed as a model REMS for long–acting and extended–release opioid products,” said Douglas Throckmorton, M.D., deputy director of FDA′s Center for Drug Evaluation and Research (CDER), in the FDA announcement. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.”¹¹ Follow the links below to learn more: FDA: FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan FDA: Questions and Answers about Onsolis^™ (fentanyl buccal soluble film) Onsolis^™ website FDA posts public comments on opioid REMS development: On May 27–28^th, FDA held a public meeting to gather input on developing a class–wide REMS program for certain extended–release opioid drugs, with the aim of ensuring that the benefits of these drugs continue to outweigh their risks. Five hundred people reportedly attended the packed two–day workshop, representing a wide spectrum of perspectives.¹² The Agency has now published the comments that were filed in the docket, which include supporting documents from many of the people and organizations who gave presentations at the meeting. Inflexxion′s presentations and docket submissions underscored a number of key points, based on our experience with the NAVIPPRO program: Product–specific surveillance data is an important measure to gauge the value of any risk mitigation strategy The ASI–MV^® Connect data stream is a valuable source of such information, and can help identify geographical “hot spots” of abuse, as well as help to establish whether a REMS has been effective in mitigating abuse in these areas Education of health care providers and patients will be a key component of the opioid REMS Inflexxion is well positioned to tailor NAVIPPRO′s nationally known prevention and intervention programs, PainEDU.org and painACTION.com, to achieve that aim To review the public comments, follow the link below: Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs, Docket ID: FDA-2009-N-0143 Back to top References ¹American Geriatrics Society, AGS Panel on Persistent Pain in Older Persons. (2009). Pharmacological management of persistent pain in older persons. Journal of the American Geriatrics Society, 57(8):1331-1346. ²King Pharmaceuticals, Inc. (2009, August 13). FDA Approves EMBEDA^™ for Management of Moderate to Severe Chronic Pain, [Press release]. Retrieved August 19, 2009 from http://www.kingpharm.com/Investors/News_Details.cfm?news_item_id=527 ³Kirsh, K. & Passik, S. (2008). The Changing Paradigm of Pain Policy: Effects on Clinical Care. Medscape Neurology & Neurosurgery. Retrieved August 28, 2009 from http://www.medscape.com/viewarticle/576289 ⁴Butler, S., Budman, S., Fernandez, K. & Jamison, R. (2004). Validation of a screener and opioid assessment measure for patients with chronic pain. Pain, 112(1): 65-75. ⁵Akbik, H., Butler, S., Budman, S., Fernandez, K., Katz, N. & Jamison, R. (2006). Validation and clinical application of the screener and opioid assessment for patients with pain (SOAPP). Journal of Pain and Symptom Management, 32(3): 287-293. ⁶Butler, S., Fernandez, K., Benoit, C., Budman, S. & Jamison, R. (2008). Validation of the revised screener and opioid assessment for patients with pain (SOAPP-R). Pain, 9(4): 360-372. ⁷Butler, S., Budman, S., Fernandez, K., Fanciullo, G. & Jamison, R. (2009). Cross-validation of a screener to predict opioid misuse in chronic pain patients (SOAPP-R). Journal of Addiction Medicine, 3(2): 66-73. ⁸Inflexxion, Inc. (2008, September 22). Kaiser Permanente Recommends Brief Screening Tool to Mitigate Risk of Opioid Abuse, [Press release]. Retrieved August 28, 2009 from http://www.inflexxion.com/about.aspx?id=106 ⁹Inflexxion, Inc. (2009, April 16). Utah launches state-wide clinical guidelines for prescription pain medications to combat prescription drug–related deaths, [Press release]. Retrieved August 28, 2009 from http://www.inflexxion.com/about.aspx?id=106 ¹⁰Utah Department of Health. (2009, June 2). State Sees Dip in Rx Drug Deaths in 2008:Overdose remains the most frequent category of cases for Medical Examiner, [Press release]. Retrieved August 12, 2009 from http://hlunix.ex.state.ut.us/uthealthnews/2009/20090602-RxDeathStats.html#http://hlunix.ex.state.ut.us/uthealthnews/2009/20090602-RxDeathStats.html ¹¹U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2009, July 16). FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan, [Press release]. Retrieved August 20, 2009 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172366.htm ¹²McCaughan, M. (2009, June 1). Waking up to REMS (Part 1): Don’t believe the lack of hype. The RPM Report 6/2009. Back to top 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. Learn more. Back to top		Development and use of the SOAPP for opioid risk management In the news: Opioid medications and REMS References About NAVIPPRO NAVIPPRO Surveillance Signal detection Signal verification Prevention & intervention PainEDU About Inflexxion Contact Contact us to find out how we can assist you with your risk evaluation and mitigation strategy planning. Subscribe Join the NAVIPPRO Signal mailing list. 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. ©2009 Inflexxion, Inc. All rights reserved.