Advocacy

Prescription Monitoring Programs: A Federal Perspective

Robert Saner, Esq., Washington Council, Pain Care Coalition

2011 has produced much heightened rhetoric in Washington about the abuse and diversion of prescription medications, particularly opioids. The White House "Drug Czar" has labeled the problem an epidemic, and called on agencies of the Executive Branch to help address it. The U.S Food and Drug Administration (FDA) continues to work on its opioid risk evaluation and mitigation strategies (REMS) as one strategy to address the problem. The Centers for Disease Control and Prevention is working on the problem from other angles, including consumer and professional education. Members of Congress in both the House and the Senate have bills in the hopper to, among other things, (1) require professional education as a condition of the Drug Enforcement Administration (DEA) registrations, (2) turn up the enforcement heat on rogue pill mills, (3) restrict the use of opioids to severe pain only, and (4) regulate access by Medicare and Medicaid patients to both prescribers and pharmacies to curtail "doctor shopping."

All of these efforts appear well intended, but important concerns remain with respect to the details of each. Most, at least in their current forms, would likely have unintended negative consequences for patient access to necessary care and professional discretion in delivering care best suited to an individual patient's needs. None has generated widespread support from industry, patient groups, or practitioners—with one possible exception.

That exception is legislation to reauthorize the National All Schedules Prescription Electronic Reporting (NASPER) Act passed by Congress in 2005. Administered as a public health program by the Substance Abuse and Mental Health Services Administration, NASPER provides a federal framework for state-based prescription monitoring programs (PMPs). It also authorized federal funding for state grants to promote PMP development, but the funding level for NASPER grants envisioned in 2005 was never fully forthcoming. PMPs now exist in most states, at least on paper, but differ from state to state and are in various stages of implementation. Funding remains a serious problem. States are in a fiscal bind, and there is currently no federal appropriation for NASPER grants in FY 2012, although $2 million was appropriated to support PMPs through the competing Hal Rogers PMP grant program at the Department of Justice.

To compound the funding problem, the NASPER authorization from 2005 has technically expired, making the program's future highly uncertain. A bill to renew the program passed the House last year, but no action was taken in the Senate. Rep. Ed Whitfield (R-KY) has introduced the reauthorization bill again this year as HR 866, and it has bipartisan support. A number of patient, professional, and industry groups have indicated likely support for the bill. The Pain Care Coalition (PCC), of which APS is a founding member, has indicated its likely support if certain drafting issues can be clarified.

The bill now sits in the House Energy and Commerce Committee, chaired by Rep. Fred Upton (R-MI). No current schedule for committee "mark-up" of the bill exists; however because the same committee and the full House approved a similar measure last year, favorable action by the House in this Congress seems likely to occur, though not during the remaining time in this first session. Assuming the House takes action in 2012, the focus will shift to the Senate HELP Committee, chaired by Senator Tom Harkin (D-IA).

PMPs are not a magic bullet. If well designed and funded, however, they are increasingly viewed as an important clinical tool to improve patient care while simultaneously reducing abuse and diversion. NASPER's public health approach to PMPs, as opposed to alternatives focus more on law enforcement, appears highly preferable. APS and its allies in the PCC will continue working proactively with legislators in support of responsible legislation to secure the program's future.

Treatment

NIDA Study on Painkiller Abuse Treated by Sustained Buprenorphine/Naloxone

According to a study conducted by the National Institute on Drug Abuse (NIDA), treating people addicted to prescription painkillers with buprenorphine plus naxolone (Suboxone) can reduce their opioid abuse. Study findings also suggest that intensive opioid dependence counseling does not effectively reduce misuse and abuse. In addition, study researchers advised that opioid abuse can be treated in a primary care setting; however after the medication is discontinued, there was a strong rate of relapse among participants.

Further research is needed to build on the results of the NIDA study, which is the first randomized large-scale clinical trial using a medication to treat prescription opioid abuse. Past studies focusing on the treatment of opioid dependence observed heroine-addicted patients at methadone clinics. In the large-scale clinical trial, 600 outpatient participants addicted to prescription opioids were treated with Suboxone and given standard medical management. To find out more about the results of the study, visit NIH News.

Clinical

APS President Seddon Savage Responds to CDC Report

Policy Impact: Prescription Painkiller Overdoses

APS President Seddon Savage, MD MS, spoke with Medscape Medical News to respond to the recently released Centers for Disease Control and Prevention (CDC) report regarding the increasing number of prescription opioid–related deaths in the United States. The CDC report stated that one in every 20 U.S. adults has a history of narcotic use and the U.S. Food and Drug Administration has drafted a blueprint to "guide prescriber training modules for long-acting and extended-release opioid drugs" (Shelley, 2011).

APS issued a statement in support of bringing attention to prescription drug misuse. In the interview, Savage explained that changes to the prescription drug system are needed because opioids are often used because they are effective and easy to administer. Better education and coordination among interdisciplinary team members can help find the right balance in opioid prescribing. Savage addressed the high-profile pill mill issues, misconceptions about prescribers, and next steps in Medscape News. To read the rest of the interview, visit Medscape. (A log in is required, but sign up is free!)

Reference
Shelley, A. (2011, November 14). Plans to curb prescription misus only scratch surface. Medscape News.

Research

Call for Rita Allen Applications

The call for Rita Allen Foundation (RAF) applications is open. The RAF and APS may award two grants in the amount of $50,000 annually for a period of as many as 3 years to those research proposals demonstrating the greatest merit and potential for success. Applications for the award are due January 17. Please visit the APS website for more information about the award and to apply.

Education

2012 Resident's Course Applications Now Open

Applications are now being accepted for the 2012 Resident's Course in Honolulu

Please visit Fundamentals in Pain Management: A Primer for Residents and Fellows for information about the 2012 course, eligibility requirements, important deadlines, and a link to the application forms. Applications are due by December 31.

Apply for a Young Investigator Travel Award

Young Investigator Travel Awards are available for the Honolulu meeting

APS is once again inviting young investigators to apply for travel support through the Young Investigator Travel Award Program. Applications are due by January 20 and should be submitted online. Please visit Young Investigator to access more information about the program and an application.

Scientific Meeting

Meeting Registration Opens December 15

Come to the APS 31st Annual Scientific Meeting in Hawaii for current information about the diagnosis, treatment, and management of acute pain, chronic cancer and noncancer pain, and recurrent pain. Register early to save $100.

Great Room Rates Available in Hawaii

Will you be attending the APS 31st Annual Scientific Meeting in beautiful Honolulu? APS has negotiated room rates that are the lowest in years for the Hilton Hawaiian Village—$199–$239 single/double plus applicable taxes. These discounted room rates will be recognized 3 days before and after the meeting (based on availability) if you are looking to add vacation time to the conference. The Hilton Hawaiian Village is located on Waikiki's widest stretch of beach on 22 oceanfront acres. With 20 restaurants and lounges and extensive activities including luaus, Friday Night fireworks shows, and more, you will definitely not be searching for something to do. Room rates are only available until April 16, so be sure to book your room and flight now! Check out APS Travel for more information about Honolulu, travel, and housing.

Explore Hawaii

Aloha! We are really looking forward to having the APS 31st Annual Scientific Meeting in beautiful Hawaii. We hope you take advantage of the vast array of activities Hawaii has to offer.

Downtown Honolulu and Chinatown
Explore downtown Honolulu by stopping at Aloha Tower Marketplace, situated right along the waterfront. Explore the various shops and restaurants and check out Chinatown where you will find art galleries, markets, and delicious food.

Waikiki Beach
The sandy beaches of Waikiki Beach offer chances to relax by the water or be adventurous by kayaking, snorkeling, or swimming with dolphins. No matter what you choose, Waikiki Beach is a site not to be missed and one that is hopping with life.

For more information, visit the Hawaii Convention and Visitors Bureau website.

Society

Update from the APS Mid-Year Board Meeting

In November, the APS Board of Directors assembled at the national APS office in Glenview, IL, to continue the process of implementing the strategic plan and how it relates to the Institute of Medicine report. The board reviewed goals and 2012 priorities in the areas of research, education, treatment, and advocacy.

During these challenging economic times, the APS Board is focusing on being financially conservative. Based on feedback from the recent member survey, the board voted to eliminate the APS Member Community for 2012. APS will be transitioning special interest group communication tools to a Listserv. Stay tuned in the coming weeks for communication on this transition.

In addition, Bob Saner summarized the efforts of the Pain Care Coalition in Washington, DC, and talked about the future of legislative initiatives, particularly amidst the upcoming elections. Another exciting year for APS is just around the corner. Be sure to stay tuned to future issues of APS E-News for more information and forthcoming initiatives.

2011 Annual Report Now Available

The APS 2011 Annual Report is now available.

• Get an update on APS's advocacy efforts.
• Hear about the successful Annual Scientific Meeting in Austin, TX.
• Learn about the APS annual award winners and funding recipients.
• Review APS financials and member demographics.

Members

APS Transitioning to Listservs

The APS board greatly values your feedback and we heard you in the recent APS member survey. Although a couple of APS member groups were actively using the APS online member community, many of our members weren't using the resource. In January 2012, the APS special interest groups (SIGs) will transition to Listservs to communicate and share information. Through the Listserv you will be able to

• connect and interact with colleagues
• disseminate information and news about the field of pain
• share documents and search archived documents online
• be an active member in the APS pain community.

If your SIG chair chose to use a Listserv for a communications tool, all SIG members previously subscribed to a discussion group in the member community have been transitioned to the appropriate Listserv. You will receive further instructions on how to use the Listserv in the coming weeks.

You are invited to join one of the 16 APS SIGs. If you currently are not involved in an APS SIG, we encourage you to look at the areas for involvement. If you are interested in joining an APS SIG, visit the SIGs page for more information.

Member Spotlight

What is your area of specialty?
I have an interest in several areas related to pain medicine. Clinically, a large part of my practice revolves around the diagnosis and management of patients with pain related to spine disorders. I also have an interest in treating patients with severe pain who are on high-dose opioid therapy but who have had less than satisfactory results.

What initially sparked your interest in working in your field? Briefly describe your career path.
After graduating from the Penn State–Jefferson 5-year premed/medicine program, I began a residency in general surgery. After 2 years, I transitioned into anesthesiology and then completed a fellowship in pain medicine at the Harvard Coordinated Pain Medicine program based at Brigham and Women's Hospital (BWH) in Boston. Since then, I have been a staff anesthesiologist and pain medicine physician at BWH and have been fellowship program director since 1995. My interest in pain medicine was sparked by the opportunity this practice has offered in terms of acute and chronic patient management, evaluative services and interventional approaches, and academics and clinical practice.

What has been a highlight of your work?
I run a large academic pain medicine fellowship program and am interested in identifying methods that promote teaching excellence and preparing new pain medicine physicians for practice. Also, I teach a graduate level class on public policy and medicolegal issues as they relate to pain medicine. Lately, I've been involved in a large outcomes-related study on the effectiveness of epidural injections for elderly patients with spinal stenosis. I have been fortunate to have mentored a number of my pain medicine fellows who have been awarded grants for pain research from organizations such as the American Society of Regional Anesthesia and Pfizer. Winning the Clinical Centers of Excellence award from APS in 2007 and 2011 has certainly been a major accomplishment of which our entire team at BWH can be proud.

Is there a particular challenge that you've either overcome or hope to address soon?
There are many challenges. How do we stay innovative without sacrificing good existing methods of practice? How do we stimulate curiosity and scientific interest in new generations of pain medicine practitioners? How do we continue to foster collaborations both within and outside of our specialty that will help us move our field forward? How do we establish and prove to our patients, our referral sources, and the healthcare system in general that our services are valuable?

Who is your favorite role model and why?
I have been fortunate to have had many role models. Two of my uncles (Relja and Srecko Nedeljkovic) were physicians who taught me the philosophy that physicians need to have a sense of humanity. My first anesthesia chairman, Paul Levesque, helped all of his trainees understand the importance and value of our specialty. Dan Carr at Tufts, similarly, has inspired many to think of pain medicine in a more universal and global sense. And many of my colleagues at BWH, both in the Pain Center and in the anesthesia department, have been models of how to work in an environment that promotes teamwork and collaboration to achieve the best goals for our patients, department, and institution.

How has membership in APS been of value to you and your professional development?
APS is an organization whose goals and mission are to optimize the prevention, diagnosis, and treatment of pain. The advocacy efforts of APS to promote excellence in pain medicine by recognizing centers of pain medicine excellence have been recognized as an important aspect of the overall strategy of the organization. Through this program, APS has helped our pain center focus, define, and streamline our overall mission. Like APS, our pain medicine center strives to achieve excellence in innovation, clinical care, research and expanding scientific knowledge, teaching and education, and advocacy and promoting the public good when in comes to pain medicine.

Reviews

Chronic Pain: An Integrated Biobehavioral Approach

Herta Flor and Dennis C. Turk. Seattle, IASP Press, 2011. 547 pages, soft cover. ISBN 978-0-931092-90-9. $75 members, $95 nonmembers.

The book is focused primarily on standard-of-care psychosocial interventions for which efficacy has been convincingly demonstrated. However, it provides overviews of several promising new behavioral treatment approaches, including sensory discrimination training, mirror therapy, neurofeedback, and virtual reality. Other emerging behavioral approaches such as acceptance and commitment therapy are not described. Inclusion of a chapter addressing the possibility of matching pain patients to specific treatments based on patient characteristics is heuristically valuable, even if it is not yet standard practice because of the still-evolving nature of the supporting research. Readers are presented with a detailed multiaxial assessment protocol demonstrating how standardized medical assessment data can be combined with psychological, behavioral, and psychophysiological data to classify patients into one of four empirically derived patient subgroups that have been shown in initial research to be useful for tailoring treatments.

In summary, this book by Flor and Turk provides a readable and comprehensive summary of the most widely accepted psychosocial approaches to chronic pain assessment and management. Inclusion of a CD containing key psychometric instruments as well as treatment protocol and patient materials makes this book a unique single resource for clinicians interested in proven psychosocial approaches to chronic pain management.

Reviewed by Stephen Bruehl, PhD. Dr. Breuhl is a professor of anesthesiology at Vanderbilt University School of Medicine.

Summaries

Even though pain is by far the leading reason people seek medical care, pain education at North-American medical schools is limited, variable and often fragmented, according to a Johns Hopkins University study published in The Journal of Pain.

The study examined the curricula at 117 medical schools in the United States and Canada and went beyond a simple analysis of historical presence-or-absence criteria in assessing pain education for medical students. This measurement does not distinguish the number of classroom hours devoted to pain education or coverage of various pain topics. The authors performed a systematic review analyzing curricular emphasis on topics such as pediatric and geriatric pain, neuropathic pain, cancer pain, pain neurobiology, and pharmacological pain management.

Results showed that a majority of medical schools are teaching one or more core topics in pain, but many schools are not reporting any pain teaching and most others devote less than 5 hours to pain education. Further, the authors found that cancer pain, pediatric pain, and geriatric pain are essentially unaddressed by the vast majority of medical schools.

They concluded: "Taken as a whole, these data bring to light glaring discrepancies between the prevalence of pain in society and the time dedicated to educating future physicians about pain in medical school. Given that the twin dangers of pain undertreatment and the abuse of pain-active medications are among our society's deepest health concerns, pain medicine does not receive the attention that it deserves in medical education."

Postoperative Pain Trajectories in Chronic Pain Patients Undergoing Surgery: The Effects of Chronic Opioid Pharmacology on Acute Pain
C. Richard Chapman, Jennifer Davis, Gary W. Donaldson, Justin Naylor, and Daniel Winchester; University of Utah School of Medicine

Some 100 million inpatient and outpatient surgeries are performed in the United States every year, and 80% of surgical patients experience postoperative pain, according to surveys. A large majority have moderate-to-severe pain. The risks for severe postoperative pain vary among patient groups based on age, overall health, anxiety, and other factors. For some patients, preexisting chronic pain conditions might place them at higher risk for severe postoperative pain.

In this study, researchers from the University of Utah sought to compare postoperative pain intensity and pain resolution duration in patients with chronic pain who take opioid analgesics with those who were not taking opioids before surgery. Based on research linking opioid use with perioperative hyperalgesia, the investigators hypothesized that patients with chronic pain on opioid pharmacotherapy would report more intense postoperative pain and a significantly slower rate of postoperative pain resolutions.

Results showed that patients with chronic pain who did not take an opioid before surgery reported the same initial postoperative pain intensity as normal surgical patients but their surgical pain resolved more slowly. Patients with chronic pain taking opioids, however, reported higher initial pain levels following surgery but resolved their pain at the same slow rate as other patients with chronic pain.

Individual Differences in the Effects of Music Engagement on Responses to Painful Stimulation
David H. Bradshaw, Gary W. Donaldson, Robert C. Jacobson, Yoshio Nakamura, and C. Richard Chapman; University of Utah Pain Research Center

Distraction is a proven pain reliever. It is hypothesized to be effective because it may divert cognitive focus from pain stimuli. If true, the key to successful pain control from this method would be the degree of engagement by the patient in a diversion task. Researchers from the University of Utah Pain Research Center evaluated the potential benefits of music for diverting psychological responses to experimental pain stimuli.

One hundred forty-three subjects were evaluated for the study. They were instructed to listen to music tracks, follow the melodies, and identify deviant tones. During the music tasks, they were given safe, experimental pain shocks with fingertip electrodes.

The findings showed that central arousal from the pain stimuli reliably decreased with the increasing music-task demand. Music helps reduce pain by activating sensory pathways that compete with pain pathways, stimulating emotional responses, and engaging cognitive attention. Music, therefore, provided meaningful intellectual and emotional engagement to help reduce pain.

Among the study subjects, those with high levels of anxiety about pain had the greatest net engagement, which contradicted the authors' initial hypothesis that anxiety would interfere with a subject's ability to become absorbed in the music listening task. They noted that low anxiety actually may have diminished the ability to engage in the task.

The findings suggest that engaging in activities like music listening can be effective for reducing pain in high-anxiety persons who can easily become absorbed in activities. They noted that interaction of anxiety and absorption is a new finding and implies that these personality characteristics should be considered when recommending engagement strategies for pain relief.

Fibromyalgia affects 1%–3% of the general population and has high comorbidity with depression. Transcranial magnetic stimulation (TMS) of the prefrontal cortex can cause changes in acute pain perception. Several weeks of daily left prefrontal TMS previously has been shown to treat depression. Researchers recruited 20 patients with fibromyalgia and randomized them to receive 4,000 pulses at 10 Hz TMS (n = 10), or sham TMS (n = 10) treatment for 10 sessions over 2 weeks in addition to receiving their standard medications, which were fixed and stable for at least 4 weeks before starting sessions. Subjects recorded daily pain, mood, and activity.

Questionnaires to assess fibromyalgia pain, fatigue, and depression were completed at baseline, at day 5 and day 10 of treatment versus sham treatment, and once a week for 2 weeks after treatment or sham treatment over the course of 1 month. In a group of TMS-naïve outpatients with fibromyalgia researchers found that 10 sessions of high-frequency left prefrontal TMS resulted in statistically significant reductions in daily pain over time in comparison to baseline mean pain in the treatment group. There were no significant reductions in pain over time in the sham-treated group. However, there were no statistically significant reductions in mean pain between treatment versus sham-treated groups in this pilot trial. There also was no statistical difference in depression at the end of 10 days of rTMS versus sham treatment.

It is premature to conclude that fibromyalgia pain is reduced as a result of TMS treatment until studies with larger sample sizes show differences between groups, not just pain reduction over time from baseline measures.

Impact of Biomedical and Biopsychosocial Training Sessions on the Attitudes, Beliefs, and Recommendations of Health Care Providers About Low Back Pain: A Randomised Clinical Trial
J. Domenech, D. Sánchez-Zuriaga, E. Segura-Ortí, B. Espejo-Tort, and J. F. Lisón; University of Valencia and University CEU

The beliefs and attitudes of healthcare providers may contribute to chronic low back pain (LBP) disability and influence the recommendations they provide to their patients. An excessively biomedical style of undergraduate training can increase negative beliefs and attitudes about LBP, but instruction following a biopsychosocial model possibly can lessen these negative beliefs among professionals.

The objectives of this study were to determine the effectiveness of two brief educational modules with different orientations (biomedical or biopsychosocial) on changing the beliefs and attitudes of students and to verify whether there also were changes in recommendations given to patients.

The study found that there was a divergent change in students' beliefs and attitudes about LBP after they completed educational sessions based on different viewpoints. These results confirm the previous belief that a strictly biomedical education exacerbates maladaptive beliefs and results in recommendations for work and activity levels that differ from those indicated by evidence. It is possible that changing the beliefs and attitudes about back pain in the early stages of training can lead to changes in the most enduring beliefs that students can apply when they start their professional practice.

This study's objective was to determine the differences in widespread pressure pain and thermal hypersensitivity in women with minimal, moderate, and severe carpal tunnel syndrome (CTS) and healthy controls. CTS is considered the most common neuropathy of the arm. Symptoms mainly are located over median nerve distribution, but extramedian sensory symptoms resulting in whole-hand involvement and proximal arm and shoulder pain experienced by 50% of patients with CTS suggest involvement of central nociception.

In this study, pressure pain thresholds were bilaterally assessed over the median, ulnar, and radial nerves; the C5 to C6 zygapophyseal joint; the carpal tunnel; and the tibialis anterior muscle. Warm and cold detection thresholds and heat and cold pain thresholds were bilaterally assessed over the carpal tunnel and the thenar eminence.

This study found that women presenting with CTS exhibited bilateral and widespread pressure and heat and cold hyperalgesia, but not heat and cold hypoesthesia, as compared with controls, suggesting the presence of central sensitization. The magnitude of hypersensitivity was not significantly different between women with minimal, moderate, or severe CTS, which suggests no differences in magnitude of pain sensitivity based on electrodiagnostic findings. In addition, the magnitude of pain sensitivity was related to the intensity of clinical pain but not to the presence of unilateral or bilateral symptoms. These findings support the hypothesis that widespread hyperalgesia is a common feature of the central sensitization seen in CTS.

Altered Central Sensitization in Subgroups of Women with Vulvodynia
Zheng Zhang, Denniz A. Zolnoun, Eric M. Francisco, Jameson K. Holden, Robert G. Dennis, and Mark Tommerdahl; University of North Carolina

Vulvodynia is a heterogeneous family of idiopathic pain disorders affecting more than 16% of women of reproductive age in the United States. It is characterized by both provoked and unprovoked pain in and surrounding vulvar skin, mucosa, and underlying musculature. This study's authors hypothesized that women who had experienced a longer time course with pain or had unprovoked symptoms are more likely to have measures consistent with altered central sensitization when compared with healthy controls or participants who had experienced a shorter duration of provoked pain.

This study compared 10 women with vulvodynia and matched 10 healthy controls in a series of sensory perceptual measures that assessed vibrotactile detection threshold on the fingertip, amplitude discrimination capacity, and the impact of conditioning stimuli on amplitude discrimination capacity.

The results suggest that women with vulvodynia have—although not statistically significantly—lower tactile thresholds on the fingertips than do control participants. Amplitude discrimination capacity was not significantly different between the controls and patients with vulvodynia; the impact of single-site conditioning (or adaptation) on performance of the dual-site task showed a remarkable difference.

These data suggest that women who have vulvar pain for long durations or those with unprovoked pain have more CNS involvement. These findings are consistent with the idea that chronic pain caused by vulvodynia alters central sensitization that leads to changes in sensory information processing.

In the Media

Talk Therapy by Phone May Ease Fibromyalgia: Study (Reuters)

Many Oncologists Not on Top of Managing Pain: Study (Reuters)

Sleep Problems Triple Women's Risk of Developing Fibromyalgia (CNN)

Chronic Pain Patients Report Difficulty Reaching Primary Pain Care Provider (Pain Medicine News)

Rewiring the Brain to Ease Pain (Wall Street Journal)

Doctors See Surge in Newborns Hooked on Mothers' Pain Pills (USA Today)