december 28, 2018 the honorable ron wyden 221 dirksen senate office bldg. washington, d.c., 20510...

December 28, 2018 The Honorable Ron Wyden 221 Dirksen Senate Office Bldg. Washington, D.C., 20510 Dear Senator Wyden,

The American Academy of Pain Medicine (AAPM) is deeply disappointed that your letter to Department of Health and Human Service (HHS) Secretary, Alex Azar, on December 18, 2018, seriously misrepresents the facts of AAPM’s relationship to pharmaceutical companies in an apparent effort to undermine the work and discredit the results of the HHS Pain Management Best Practice Inter‐Agency Task Force (PMTF), an important effort authorized by the Congress on a bipartisan basis. As the President of AAPM, I write to point out a number of misrepresentations in your letter.

First, you mischaracterized the relationship of AAPM with industry in your letter and implied that AAPM has been run by or influenced by industry because it has received industry payments. This is false. We all know that industries pay to advertise their products and services through TV, newspapers, journals, magazines, conferences, social media, as well as through other media channels. When pharmaceutical, medical device, or other companies exhibit their products at AAPM annual conferences, whether those products are books, needles, drugs, devices, or even a new antibody, these companies pay AAPM for the opportunity to use the conference venue. This in turn allows AAPM offset part of the cost of utilizing that venue for its conference. These transactions should never be interpreted as AAPM endorsing the products or services of these companies, nor is AAPM liable for any of their products or services. Paid advertising has been a common practice in the U.S. across different industries wanting to reach particular audiences, including members of professional societies. Indeed, it would have been genuinely problematic had AAPM offered industry the opportunity to advertise its products free of charge. That would constitute a true conflict of interest.

Another source of industry funding is through education or research grants. It has been AAPM’s guiding principle and practice that such funds are used exclusively at the discretion of AAPM to carry forward its mission of “advancing and promoting the full spectrum of multidisciplinary pain care, education, advocacy, and research to improve function and quality of life for people in pain.” AAPM has been consistently conducting its professional functions and fulfilling its

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societal obligations in total compliance with all relevant rules and regulations of the federal and state governing agencies and is independent of industry bias. For example, AAPM has been in total compliance with the requirements and rules set forth by the Accreditation Council of Continuing Medical Education (ACCME) in preparing its educational content, format, and materials used in the educational activities in its annual meetings, its website, and other channels. One of the requirements for ACCME accreditation is to be free of commercial bias in continuing medical education activities. AAPM has been continuously accredited by ACCME for more than two decades and was most recently awarded ACCME’s highest level accreditation – Accreditation with Commendation (Appendix A), which is awarded to providers that demonstrate compliance in all criteria and the accreditation policies. The ACCME states “We commend your organization for meeting the ACCME’s accreditation requirements and for demonstrating that yours is a learning organization and change agent for the physicians and patients you serve. You have demonstrated an engagement with your environment in support of physician learning and change that is a part of a system for quality improvement.” (Appendix A).

Second, you accused AAPM of “being deeply critical of opioid prescribing guidelines that were issued by the Centers for Disease Control and Prevention (CDC) in 2016.” Unfortunately, you failed to recognize the fact that AAPM actually commended and supported the efforts of CDC in its development of the guideline and made numerous recommendations to improve the guideline. We stated, in one of our correspondences to CDC, that “The AAPM appreciates this opportunity to provide further input to the revised CDC draft guideline regarding prescribing opioids for chronic noncancer pain. We acknowledge the many changes that have been made since the prior draft and we continue to support efforts to address persistent shortcomings in the current revised draft document. Towards that end, we now provide further general comments as well as specific recommendations regarding the language of the CDC guideline document.” We further stated that “In conclusion, we would like to reiterate our support for the CDC’s goal to reduce unnecessary morbidity and mortality associated with the misuse and diversion of opioid analgesics (Appendix B and C).” In contrast to your December 18th, 2018 letter, Appendices B and C accurately reflect the Academy’s response to the CDC guideline.

You also highlighted that “The organization’s criticism specifically targeted the CDC’s suggested daily dosing limits, the preference in the guidelines for use of non‐opioid therapies. The AAPM also questioned the evidence on which the guidelines were based.” You referred to an article (1) by Dr. Daniel Carr, then‐president of AAPM, for raising questions about the CDC guideline. It is well understood that no clinical guideline is perfect and all guidelines should and do evolve over time and improve as new challenges emerge and new evidence becomes available. The driving force for improving clinical guidelines and advancing patient care is to ask critical scientific and clinical questions to identify gaps and barriers and find new solutions through scientific and clinical inquiry and research. It is precisely the reason that the U.S. Congress asked the HHS PMTF to review the CDC guideline and make recommendations for update and refinement as one of its mandates.

I would further contend that it is not only a right but a duty of healthcare leaders to ask and address critical questions to advance patient care. Professionals fulfilling this obligation and

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exercising this right should not be denigrated or intimidated for doing so. To the contrary, these efforts should be encouraged and celebrated. In his article, Dr. Carr cautioned that “To ‘prefer’ nonopioids for chronic noncancer pain is logical in theory but will harm many (especially older) persons in whom heart attacks, kidney failure, bleeding, or strokes have led to worldwide warnings to limit NSAIDs or other drugs such as Celebrex. Still, an estimated 15,000 Americans die prematurely each year from these nonopioids.” Dr. Carr was emphasizing the complexity and nuance in providing individualized and patient‐centered care and cautioning that a one‐size‐fits‐all approach can be harmful to patients. The American Society of Anesthesiologists (ASA) has opposed Oregon’s Opioid Prescribing Proposal of a one‐size‐fits‐all approach to opioid therapy in a recent letter to Dana Hargunani, MD, MPH, Chief of Medical Officer, and Patrick Allen, Director of Oregon Health Authority of your great State (2). Dr. Carr’s remarks and the ASA’s position letter reflect an evidence‐based and common‐sense approach to patient care and should not be interpreted as “promoting opioid prescribing.”

It is well recognized in the medical community that some of the recommendations of the CDC guideline are not evidence‐based. For example, the daily dosing limits were not determined through a rigorous scientific process. Such limits have different effects on different individuals due to varying genetic factors, metabolic and body habitus factors, and past history of exposure. As Dr. Carr pointed out, “Setting rigid limits for daily opioid doses ignores well documented differences in individuals’ opioid requirements. Benchmarks may create a false sense of security when the daily opioid dosage is below a certain number. Yet, fatal postoperative opioid overdoses have occurred in individuals who showed no obvious risk factors and received low doses. For this reason, AAPM and other groups advocate close monitoring and follow up when prescribing any dose of opioids to patients with chronic pain.”

You have misrepresented Dr. Carr’s comments as President of AAPM regarding the CDC guideline, where he wrote, "The majority of CDC's recommendations are common sense, restating current guidelines of various professional groups." But he cautioned that "several CDC recommendations are not supported by evidence" and cited two earlier systematic reviews by the very same methodologic consultant that had reached very different conclusions on chronic opioid use for noncancer pain compared with the newest evidence synthesis for the CDC guideline. Your letter disparages AAPM's critique of the CDC guideline without mentioning the FDA's rejection of a 2012 Citizens' Petition, whose proposals were at the core of what became the 2016 CDC Guideline. The CDC guideline itself described most of its recommendations as being made on the basis of weak or very weak evidence.

It is clear that AAPM supported the development of the CDC opioid prescribing guideline, contributed to the improvement of the guideline, and identified areas for future improvement. As president of AAPM, I am proud of what our members and leaders have done to improve the safety, efficacy, and cost‐effectiveness of patient care. I am also proud of the fact that our dedication, expertise, and contributions to pain medicine are recognized by our patients and the HHS. It is not a coincidence that several members of AAPM were selected to serve in the HHS PMTF as well as other major national initiatives in pain management.

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Third, you questioned the eligibility for the Task Force of Dr. Rollin Gallagher, Editor‐in‐Chief of Pain Medicine and past president of AAPM. Your letter implied that industry support somehow benefited Dr. Gallagher personally or otherwise biased his work as Editor‐in‐Chief. This is simply not supported by the facts. His salary as Editor‐in‐Chief is, by contract, paid from an editorial allowance provided to AAPM by the publishers of Pain Medicine. This arrangement was made precisely because of the importance of assuring editorial independence of a medical journal from the societies involved (in this case AAPM, the Spine Intervention Society, and the Australia New Zealand Faculty of Pain Medicine of the College of Anaesthetists) in evaluating the merit of submitted research and review papers for publication.

The publishers of Pain Medicine, Blackwell/Wiley Press until 2016, and Oxford University Press since 2016, are leaders in the field of academic publishing in medicine and strictly follow these rules of editorial independence. The content and Editorial Board of Pain Medicine represent the focus of the journal on a rigorous, independent, peer‐review process that leads to the publication of scientific studies and reviews that reflect the Academy’s and the field’s core investment in a biopsychosocial, multi‐modal approach to pain management. Editorial leaders include academic clinicians and scientists from many health care fields including psychology, physical therapy, neuroscience, psychiatry, neurology, interventional pain medicine, addiction medicine, nursing, pharmacy, primary care, geriatrics, occupational therapy, integrative health, and rehabilitation. The resulting content of Pain Medicine reflects this broad approach to the clinical problem of pain.

Similarly, to avoid any perception of conflicts of interest, more than 10 years ago Dr. Gallagher as Editor‐in‐Chief voluntarily adopted the policy of having no consulting or advisory relationships with medical companies. These actions assured Pain Medicine’s readers and the field of editorial independence from industry influence. This was further reinforced by his career commitment in 2004 to helping the VA and DoD health systems develop their pain management programs manage the high volume of injured Veterans returning from the mid‐East wars with serious, complex injuries. Because of his background in academic family medicine, behavioral medicine and psychiatry, and epidemiology research, and his extensive clinical experience in pain rehabilitation following injury, he was invited to work with VA’s Central Office and the Department of Defense in leadership positions on clinical and research policy and development and with several other Federal agencies, such as NIH and HHS, on research and clinical policy initiatives (Appendix D). All these leadership posts required clearance for having no industry relationships. To imply that these efforts were tied to the pharmaceutical industry disparages the efforts of Dr. Gallagher and of thousands of healthcare workers in the VA and DoD who have contributed to improving the safe and effective care of pain for the tens of thousands of brave soldiers, marines, sailors, and airmen with painful injuries from their service for our country.

Finally, you questioned my eligibility for the HHS PMTF based on a consulting fee paid to me by Purdue on March 1, 2017. What your letter failed to recognize is the basis of the consulting fee. I was a member of an independent Scientific Steering Committee that reviewed investigator‐initiated research proposals to spare, taper, and discontinue opioids by investigating non‐opioid alternative treatments for chronic pain. All of the research proposals were submitted by

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investigators from academic institutions in the U.S. None of the proposals was submitted by Purdue employees or affiliates as specifically defined by the RFP (Appendix E). In this role, my sole involvement was to review, critique, and rate the scientific merit of the research proposals. At the end of 2016, when I was elected president‐elect of American Academy of Pain Medicine, I voluntarily divested myself from industry involvement in accordance with AAPM policy.

I appreciate that you acknowledged that “This payment appears to have been the only consulting fee that Dr. Cheng received since Open Payments was implemented in 2013.” I took part in this project because it was designed to spare, taper, and discontinue opioids by investigating alternative non‐opioid treatments. This has been consistent with my professional commitment and clinical practice of pain management, for which I was recognized by “Best Doctors in America,” “Top Doctors in America,” and “70 Best Pain Management Physicians in the U.S.” As a practicing physician, I prescribe opioids cautiously and sparingly in my practice. For example, according to the Ohio Prescription Drug Monitoring Program (PDMP) data, I wrote only an average of 4 opioid prescriptions/month compared to an average of 178 opioid prescriptions/month by physicians within my specialty (Appendix F). These facts clearly demonstrate that characterizing me as being beholden to industry is unsupported, and in fact, personally insulting. The selection of the HHS Task Force involved nominating, vetting, and onboarding processes. At that time and to this date, I have no financial relations with industry.

There are nationally accepted guidelines and recommendations related to controlling conflicts of interest through the Council of Medical Specialty Societies (CMSS) “Code for Interaction with Companies”: https://cmss.org/wp‐content/uploads/2016/02/CMSS‐Code‐for‐Interactions‐with‐Companies‐Approved‐Revised‐Version‐4.13.15‐with‐Annotations.pdf . These guidelines are more stringent than the Physician Payment Sunshine Act, which was incorporated into the Patient Protection and Affordable Care Act (PPACA). They include core principles and guidance suggestions related to: Conflicts of interest, financial disclosures, independent program development, and independent leadership. As announced in a 2014 AAPM President’s Message, AAPM has adopted and adheres to the CMSS Code https://academic.oup.com/painmedicine/article/15/5/730/1810464?searchresult=1 .

AAPM has never promoted any particular drugs or devices. What we are promoting and practicing is evidence‐informed, individualized, integrated, and patient‐centered pain care. This is why, in addition to my clinical practice and scientific research at the Cleveland Clinic, I serve on the HHS PMTF as one of the writing leaders, on the National Academy of Medicine Action Collaborative on Countering the U.S. Opioid Epidemic (as member of the Education and Training Working Group and member of the Research, Data, and Metrics Working Group), and on the HHS Centers for Medicare & Medicaid Services (CMS) Expert Work Group (EWG). The EWG serves to develop, specify, and maintain clinical quality measures used for reporting by eligible professionals using certified electronic health record systems, one of such measures has specifically been designed to evaluate potential opioid overuse. Similarly, other leaders of AAPM, such as Drs. Sean Mackey, Daniel Carr, Rollin Gallagher, Steve Cohen, Scott Fishman, Bill McCarberg, and Chester “Trip” Buckenmaier, have played critical leadership roles in the development of the National Pain Strategy, a collaborative effort recommended by the Institute of Medicine (now the National Academy of Medicine) and led by the HHS and the NIH.

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Unfortunately, your characterization of the HHS PMTF and members of the task force is deeply misguided. Your letter implies that the views of the Task Force on pain management promote the interests of pharmaceutical companies, not our patients. Nothing could be further from the truth. It is very unfortunate that the Task Force’s work on behalf of the many millions of Americans and their families affected by pain, and those in this group who also suffer from substance use disorder, is being characterized as run by or influenced by pharmaceutical companies. A more constructive approach would be for the Finance Committee to hold a full, unbiased, hearing on the Task Force’s recommendations after they are finalized. This would permit the HHS, professional experts, pain patients, and, perhaps, industry representatives to give a full account of the Task Force’s work and inform future policy choices of the Committee with respect to these very complicated issues. We are confident that with such full transparency, unbiased evidence will prevail, and the work of the HHS PMTF, mandated by the United States Congress and supported by patients and healthcare professionals and organizations, will help advance pain care for millions of Americans while simultaneously helping to curb the opioid epidemic in our nation.

Sincerely,

Jianguo Cheng, MD, PhD

AAPM President

CC All Members, Senate Committee on Finance

The Honorable Alex Azar, Secretary, Department of Health and Human Services

1. Carr DB. NPS Versus CDC: Scylla, Charybdis and the "Number Needed to [Under‐] Treat".

Pain medicine (Malden, Mass) 2016.

2. American Society of Anesthesiologist letter to Oregon CPTF, December 3, 2018.

http://www.lynnwebstermd.com/wp‐content/uploads/2018/12/ASA‐Letter‐to‐Oregon‐

CPTF‐1.jpg?F5CH=I

3. Gallagher, R and Mackey, M. President's Message. Pain Medicine, May 20, 2014.

https://academic.oup.com/painmedicine/article/15/5/730/1810464?searchresult=1

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Appendices:

A. ACCME Accreditation documents

B. AAPM letter to CDC

C. AAPM statement on CDC opioid guideline

D. The Anesth Clinics

E. RFP issued by Purdue Pharma.

F. PDMP reports.

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Appendix A

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January 12, 2016 Thomas Frieden, MD, MPH National Center for Injury Prevention and Control Centers for Disease Control and Prevention 4770 Buford Highway NE. Mailstop F-63 Atlanta, GA 30341 Re: Docket No. CDC-2015-0112; Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain Dear Dr. Frieden, The American Academy of Pain Medicine (AAPM) is an interdisciplinary society of pain medicine. AAPM is committed to ensuring the safety, efficacy, and cost-effectiveness of patient care through evidence-based care, patient-centered research, public and professional education, and science-based policy. AAPM appreciates this opportunity to provide further input to the revised CDC draft guidelines regarding prescribing opioids for chronic noncancer pain. We acknowledge the many changes that have been made since the prior draft, reflecting active debate about a variety of concerns raised during review of the initial and revised draft guidelines. We continue, however, to support ongoing efforts to address persistent shortcomings in the current revised draft document. Towards that end, we now provide further general comments as well as specific recommendations regarding the language of the CDC guideline document. General Comments: In AAPM’s initial correspondence regarding the guidelines (see italicized text below) we highlighted several areas of major concern. The first general concern is that in essence, the CDC guidelines appear to be focused upon societal risk mitigation in response to an epidemic of opioid misuse and abuse. They are not an evidence-based clinical practice guideline in the conventional sense, in which the clinical trial literature addressing a particular question is reviewed thoroughly and systematically to guide practice recommendations. Such an approach, relying upon the “best available evidence” was employed earlier by Dr. Chou, Dr. Ballantyne, and a distinguished group of clinicians and scientists in their 2009 systematic review of the same topic, sponsored by the American Academy of Pain Medicine and the American Pain Society.

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Appendix B

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Now, as a result of setting the threshold duration of clinical observations for efficacy and effectiveness so high that no studies met inclusion criteria for review in the current document, these same and other advisors have introduced negative bias that could lead to recommendations that adversely impact patient care. We are disappointed that despite our and others’ raising this fundamental concern, no substantive changes have been made in the methodology that remedies the biases of the current draft guideline. We emphasize that a number of unbiased authoritative entities (e.g., Cochrane Collaboration, US Food and Drug Administration, International Conference on Harmonization) as well as the peer-reviewed medical literature have accepted evidence addressing the efficacy and effectiveness of opioid therapy based upon clinical trials lasting one year or less. Obviously, the practical and ethical difficulties surrounding prospective randomized trials of greater than a year’s duration are such that none have been published. Our earlier comments (italicized below) remain relevant:

EVIDENCE REVIEW There are very significant concerns regarding the methodology of the evidence review. This is highlighted by the fact that, without major changes in available peer reviewed high quality studies, the conclusions of this review are far different than a major review published in 2009 (Chou et al). Indeed the literature has evolved some; however it is felt that the political climate and attitudes of the lay press and other interests have significantly changed and in part influenced the methodology of this work. Raising the bar for study inclusion to one year for outcome reporting excluded a significant number of scientific studies. As detailed on page 3 of the manuscript, the scope of the guidelines are for treatment of pain lasting longer than three months. Eliminating data regarding efficacy between 3 months and 1 year then creates a very significant bias and constitutes a methodological flaw. This could be addressed by including literature in the evidence review reporting outcomes at three months or more, or revising the guideline scope to address opioid prescribing in patients with chronic pain of one year duration or more. There are also significant concerns regarding the quality of evidence upon which the 12 specific recommendations are made. In 5 cases recommendations are made in the setting of low quality of evidence and the remaining 7 recommendations are made in the setting of very low quality of evidence. Thus the “contextual evidence” and expert opinion really form the basis of these entire guidelines rather than scientific data. This unfortunately is the status of the literature and our scientific knowledge and it is certainly not the CDC’s fault that this data is lacking. However, it should be recognized that interpretation of the “contextual evidence” is prone to bias as is the input of experts. This is an important point in that, with publication of these guidelines, a new prescribing standard will be set. It will be set based upon indirect evidence and opinion. In general, the opinions seem sensible and consistent with quality health care delivery, however proper evidence based outcome studies across the spectrum of chronic pain conditions need to be developed and the future direction of any guideline should support and facilitate such an endeavor.

The current draft guidelines seek to reduce the public health risks related to opioid overdose and abuse; they are prepared by the Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control. AAPM fully concurs with the vital importance of reducing

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public health risks related to opioid prescriptions; however, these guidelines must be appropriately balanced to ensure that the needs of patients in pain can be met. Chronic pain is a national healthcare crisis as well. Population-based epidemiologic investigations are not necessarily intended, nor are they sensitive, to detect subgroups for whom the benefit-to-harm ratio may differ from the population at large. In the current era of personalized, “precision” medicine, we should be mindful that some patients do well on chronic opioid therapy for noncancer pain, and conduct evidence reviews that seek to identify such subgroups. In order to be more transparent about the methodological limitations of the guidelines we strongly recommend changes be made to language in the first “Summary” paragraph of the document. The paragraph currently reads:

“CDC developed the guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, and recommendations are made on the basis of a systematic review of the scientific evidence while considering benefits and harms, values and preferences, and resource allocation.”

This sentence could be misleading, making it appear that recommendations were made on abundant good scientific information – which was not the case. Disappointingly, when multiple reviewers pointed out this discordance, the draft was revised such that its language became even more opaque, by substituting a numerical evidence rating scale for the previous clear wording. The present summary paragraph of the draft document does not reflect 1) that data from studies less than one year outcome were not considered, 2) that the recommendations are made on weak or no scientific evidence, and 3) that the majority of the recommendations are simply recommendations from the core panel of experts assessing indirect “contextual evidence”. For clarity and transparency we would suggest adding language to this effect:

It should be noted that the scientific evidence for this review, in contrast to the 2009 systematic review of the same topic, excluded the entire clinical trial literature on efficacy and effectiveness because no such study assessed such outcomes for over one year of treatment. Thus, the quality of evidence informing the present recommendations is generally low. Consequently, the CDC guidelines process relied heavily on clinical opinion and judgment of a small group of panelists whose remit was to address public health issues related to opioid overutilization.

We strongly recommend that, as is customary for other systematic reviews, a sensitivity analysis be conducted and reported as part of the literature review to assess how the findings on efficacy and effectiveness would be altered by including literature describing clinical trials of varied durations. Additional specific recommendations for revising the current draft guidelines follow.

Recommendation #5 currently reads

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When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/ day (recommendation category: A, evidence type: 3). Recommended change: When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, and should implement additional precautions and monitoring when considering dose increases (recommendation category: A, evidence type: 3). Then, in the nonbolded text following this specific recommendation, the draft guidelines could give examples (as it now does) of dosage thresholds proposed as demarcating lower from higher doses in this context, e.g., 90 MME/day. The current text in the draft guidelines in fact appropriately takes this approach to reviewing evidence for such thresholds and corresponding clinical decision-making. Rationale: We believe it is wrong to quote an arbitrary dose despite scientific evidence documenting individual genetic and environmental factors that produce variability of individual responses to opioid medications. This was the same conclusion reached by the US Food and Drug Administration (FDA) in its 2013 response to the Citizens’ Petition requesting limits on routine opioid daily dose and duration of treatment. The detailed literature review and scientific analysis underlying that refusal were provided in detail in that FDA document. Recommendation #6 currently reads Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days usually will be sufficient for most nontraumatic pain not related to major surgery (recommendation category: A, evidence type: 4). Recommended change: Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest generally effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. The duration of severe pain varies depending on the individual’s medical conditions but the need for

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opioids rarely exceeds one to two weeks for most nontraumatic or nonsurgical pain (recommendation category: A, evidence type: 4). Rationale: The relatively brief time when an acute pain episode may require opioids is not adequate to undertake an “N-of-1” dose response titration to determine the minimally effective dose, particularly if level of pain intensity is fluctuating. For those patients who require an opioid for longer than three days, the additional copays and cost of returning to a physician for a follow up prescription would be burdensome. Other practical difficulties for many seeking to return to a physician's office include scheduling logistics or continuing acute pain. In our initial correspondence we made the following recommendation (see italicized text below) but it does not appear to have been taken into consideration. We continue to strongly recommend removing the last sentence of the recommendation "Three or fewer days will usually be sufficient for non-traumatic pain not related to surgery".

In our initial response we noted the following: There is agreement that it is important not to over-prescribe opioids for acute pain. However there is substantial concern that the stated recommendation of “three or fewer days will usually be sufficient” is not accurate. This recommendation seems to be primarily drawn from emergency department prescribing guidelines for non-traumatic non-surgical pain. There are numerous painful conditions that are nontraumatic and nonsurgical that have more protracted courses (such as pancreatitis, renal colic, and sickle cell disease) that may often require longer duration treatment. Additionally, though specifically stated in the recommendation that the three day or less rule applies to non-traumatic and non-surgical pain, there is concern that physicians may misinterpret the guideline and inappropriately generalize the recommendation to all acute pain conditions. We recommend removing the last sentence of the recommendation ("Three or fewer days will usually be sufficient for non-traumatic pain not related to surgery"). In conclusion, we would like to reiterate our support for the CDC’s goal to reduce unnecessary morbidity and mortality associated with the misuse and diversion of opioid analgesics. We note that nonopioid prescription and over-the-counter analgesics such as NSAIDs likewise have a substantial associated morbidity and mortality. While the proposed guidelines may in theory have a positive impact on some of the public health issues regarding opioid abuse, addiction, and overdose, there is also an obligation to protect the ability of physicians to meet the legitimate needs of their patients. There are concerns that other Federal institutions such as the FDA are not aligned with the guiding principles of this draft document. As part of the Federal Partner Engagement Process we would urge the CDC to strengthen its communication with the FDA if these draft guidelines move forward. We sincerely hope that the information provided will be used constructively to inform additional necessary revisions to the CDC document.

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CDC Guideline for Prescribing Opioids for Chronic Pain A statement from the American Academy of Pain Medicine The American Academy of Pain Medicine cautiously supports the efforts of the CDC to address the challenges that often accompany prescribing opioids for chronic non-cancer pain. AAPM has long emphasized safety and effectiveness in pain treatment, and the CDC guideline echoes many of its recommendations. “We know that doctors – primary care and pain medicine specialists – are integral in treating pain wisely and carefully monitoring for signs of substance abuse. Abuse and diversion of prescription opioids must be addressed. Opioids are not the usual first choice for treating chronic non-cancer pain, but they are an important option—as part of a comprehensive multidisciplinary approach— that must remain available to physicians and appropriately selected patients,” said Dan Carr, MD, President of the American Academy of Pain Medicine and Professor of Public Health and Community Medicine at Tufts University. “We need to address both chronic pain and its treatment as public health challenges. This view is endorsed by the National Academy of Medicine and outlined in the draft National Pain Strategy from the NIH. Public health problems are typically complex; well-meaning, but narrowly targeted, interventions often provoke unanticipated consequences. We share concerns voiced by patient and professional groups, and other Federal agencies, that the CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence. It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately.” March 16, 2016

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Appendix C

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Appendix D

Advancing the PainAgenda in the Veteran
Population
Rollin M. Gallagher, MD, MPHa,b

KEYWORDS

� Pain � Chronification � Stepped care � Opioids � Veterans � Biopsychosocial� JPEP � Mini-residency

KEY POINTS

� Pain is more prevalent and more complex in Veterans whose wounds from severe injuries,including blasts, are also frequently complicated by posttraumatic stress disorder andtraumatic brain injury.

� Pain management should begin as soon as possible after injury to prevent the chronifica-tion of pain.

� Pain management should be continuous and multimodal, reflecting the influence of so-matic, psychological, and social factors on pain perception, psychological response,and treatment outcomes.

� The Stepped Care Model is an evidence-based approach to providing patient-centeredbiopsychosocial pain care at the level of the veteran’s needs based on complexity, comor-bidity, refractoriness, and risk.

� Methods to provide outcomes measurement to assist real-time clinical decision makingare needed.

INTRODUCTION: PAIN, A PUBLIC HEALTH PROBLEM

Pain leadership in the Veterans Health Administration (VHA) has outlined 6 essentialelements of effective pain management (Box 1). Its efforts to be successful in imple-menting these elements system-wide are outlined in this article. Transforming paincare in the VHA occurs in the context of a gradual, decades-old cultural shift in atti-tudes toward pain in the United States and globally. Although chronic pain hasbeen identified as a public health problem by our field for at least 2 decades,1–3

only recently has chronic pain been presented in more public-facing media as a na-tional and global health burden. The Economist’s recent article on global disability4

This paper does not reflect the official views of the Department of Veterans Affairs.a Pain Service, Michael Crescenz VA Medical Center, University and Woodland, Philadelphia, PA19035, USA; b Penn Pain Medicine, University of Pennsylvania, Philadelphia, PA, USAE-mail addresses: [email protected]; [email protected]

Anesthesiology Clin 34 (2016) 357–378http://dx.doi.org/10.1016/j.anclin.2016.01.003 anesthesiology.theclinics.com1932-2275/16/$ – see front matter Published by Elsevier Inc.

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mailto:[email protected]

mailto:[email protected]

http://crossmark.crossref.org/dialog/?doi=10.1016/j.anclin.2016.01.003&domain=pdf

http://dx.doi.org/10.1016/j.anclin.2016.01.003

http://anesthesiology.theclinics.com

Box 1

The 6 steps to good chronic pain care

Outlining the challenge: transforming VA pain care

1. Educate Veterans/families and promote self-efficacy

2. Educate/train all team members

3. Develop nonpharmacologic modalities

4. Institute safe medication prescribing, including safe opioid use (universal precautions)

5. Develop approaches to bringing the veteran’s expanded team together (virtual painconsulting and education as well as ongoing communication between team members)

6. Establish metrics to monitor pain care

From U.S. Department of Veterans Affairs. VHA Pain Management. 2015. Available at: http://www.va.gov/painmanagement/. Accessed December 21, 2015.

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discussed the economic implications of a study by the World Health Organization5

implicating low back pain as the most common cause of disability worldwide,including in North America, South America, Europe, Australia, Indonesia, and mostof Asia. Low back pain and other chronic pain syndromes, such as the most commondisabling disease in South Africa, human immunodeficiency virus/AIDS, are commonlycomorbid with and precede depression, which is the most common disabling condi-tion in several of the most populous African and South American countries and in Indiaand Pakistan.In the United States, the concept of pain as a major public health problem gained

traction in a wider sector of American society during the last decade, fueled by 3 inter-secting societal problems discussed in Congress and academic and health policy cir-cles and covered in the press.

First, hundreds of thousands of American troops were returning home with painfulconditions from the Middle East for care in military and the Department of Veter-ans Affairs (VA) facilities, many with comorbidities, such as posttraumatic stressdisorder (PTSD) and postconcussive syndrome; as substance abuse and suiciderates increased in this population, pain was discovered to be a driving factor.6–8

Second, economic studies suggested how chronic pain contributed to our nation’sincreasing health care costs and impacted the competiveness of America’s busi-nesses and overall economic health9 (Institute of Medicine [IOM] 2010).

Third, the increasing rates of prescription analgesic drug abuse and overdosedeaths and its impact on public health10–12 in the general population and in Vet-erans and service members raised national awareness of the importance of effec-tive and safe pain management.

Although organized medicine, beset with its increasing costs and inefficient sys-tems, had been unable to address the public health problem of pain, patients and theirfamilies spoke up and Congress listened, passing 3 pain bills: (1) the Veterans PainCare Act (2008)13; (2) the Military Pain Care Act (2009),14 both requiring yearly progressreports from these agencies; and (3) on the coattails of these first two bills, the require-ment in the 2010 Patient Protection and Affordable Care Act (2010)15 that the IOMcomplete a national study of pain. The IOM study documented that about 100 millionadults (approximately 30% of American adults) have some form of chronic pain andthat the cost of chronic pain, $565 to $635 billion yearly, exceeds the combined costs

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http://www.va.gov/painmanagement/

http://www.va.gov/painmanagement/

Pain Agenda in the Veteran Population 359

of cancer and heart disease.9 The IOM’s report cited myriad actions required to beginaddressing this enormous public health problem, including the following:

� Health care provider organizations should promote and enable self-managementof pain as the starting point of management.
� Develop educational approaches and culturally and linguistically appropriatematerials to promote and enable self-management.
� Population strategy should include developing strategies to overcome barriers tocare.� Strategies should focus on ways to improve care for populations dispropor-tionately affected by and undertreated for pain.

� Health professions’ education and training programs, professional associations,and other groups should provide educational opportunities in pain assessmentand treatment in primary care.� Education should improve knowledge and skills in pain assessment andtreatment.

� Pain specialty professional organizations and primary care professional associ-ations should support collaboration between pain specialists and primary careclinicians, including greater proficiency by primary care providers (PCPs) alongwith referral to pain centers when appropriate.

� Payers and health care organizations should revise reimbursement policies tofoster coordinated and evidence-based pain care.

� Health care providers should provide consistent and complete pain assessments.

PAIN IN MILITARY PERSONNEL AND IN VETERANS

Although about 30% of the US adult population experiences chronic pain, the rate inVeterans enrolled in the VHA is much higher. In older Veterans, the rate approaches50%16; their pain tends to be more complex, with higher rates of psychiatric and socialcomorbidities, such as substance abuse, depression, PTSD, and early work disability.This rate has grown steadily over the last 2 decades as aging warriors from earlier mil-itary service have retired and sought VA care for chronic illness management that theVA excels at providing relative to the general health sector. They bring with them painfrom service-related and battlefield injuries as well as pain from the diseases and theirtreatments associated with aging, such as cancer, arthritis, spinal conditions, andneuropathies. The survivors of war, such as those who served in Vietnam, also sufferits mental health consequences, with higher rates than the general population forPTSD and other mental scars of exposure to the battlefield.Rates of pain are even higher in VA enrollees from the recent Middle Eastern wars.

Almost 60% have musculoskeletal conditions, such as lower back pain.17 Moreserious injuries, such as penetrating wounds and mine blasts, that had low survivalin Vietnam (40%), now lead to 90% survival because of advances in personal battle-field armor and combat casualty care. These Veterans enter the VHA with permanentlydamaged, painful musculoskeletal tissues and peripheral nerves, including amputa-tions and spinal cord injuries, and often with several somatic and neuropathic sourcesof pain18–22 that affect longitudinal function.23 All Veterans with battlefield exposurerisk PTSD from their exposure to the dangers and horrors of war. Those exposed toblasts may have traumatic brain injury with high rates of pain and PTSD together(54%) and pain alone (70%).24,25 Collectively these conditions impact Veterans’longer-term physical, emotional and social well-being, as well as their successful rein-tegration to family and community life and lead to consequences, such as depression,substance use disorder (SUD), disability, overdose, and suicide.

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An additional problem related to pain management facing the nation and theDepartment of Defense (DoD) and VA, the greatly increased availability of opioids,has contributed to the opioid epidemic of increasing overdose rates.26 This epidemichas many causes.10 The VHA, which unlike the private sector has the capacity to studyits deidentified administrative database for a complete sample of all enrolled Veterans,has conducted some of the studies identifying factors that increase risks for overdose,such as higher daily doses, coprescription of benzodiazepines, and the comorbiditiesof SUD, depression, and PTSD.10–12,27 This database also provides the opportunity forstudying the impact of an intervention, such as the Opioid Safety Initiative (which isdiscussed later), to address such a public health problem.

THE PREVENTION AND REVERSAL OF PAIN CHRONIFICATION

Animal studies detailing the neurobiology of the development of chronic pain followinginjury, and human studies detailing the clinical course of pain after injury, have led to anew modeling of pain’s progression from acute to chronic pain, termed chronifica-tion.27–30 Fig. 1, the chronification cycle,31 simplistically diagrams the complicatedphenomenological process involved in the longitudinal course of pain and its conse-quences. Fig. 1 suggests that an effective health care system must have the capacityfor timely intervention at each stage to minimize the chances of progression to path-ologic structural and neurobehavioral changes and attendant social morbidities, aswell as to treat and, whenever possible, to reverse them.

Primary Prevention

The focus in primary prevention is that of actively shifting attitudes toward health,through engagement in healthy activities and lifestyles that prevent pain-causing

Fig. 1. Chronification of pain and the chronic pain cycle. OA-CVD, osteoarthritis, cardiovas-cular disease; SC, spinal cord. (From Gallagher RM. Management strategies for chronic pain.In: Krames ES, Peckham PH, Rezai AR, editors. Neuromodulation. New York: Academic Press;2009. p. 315; with permission.)

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disease and injury. The use of protective devices against injuries such as body armorand seat-belts, smoking avoidance and cessation, weight control, exercise, and formsof stress management (eg, yoga, meditation) are conceptualized. Establishing a plat-form of sound health practices provides a self-management foundation for longitudi-nally effective pain care.

Secondary Prevention

The focus in secondary prevention is on effective pain care after injury/disease onset.Care aims to

� Avoid unnecessary pain and secondary sensitization of the central nervous sys-tem (CNS) through peripheral pain control with timely application of neuromodu-lation (eg, ice, transcutaneous electrical nerve stimulation, neurostimulators),medications, and neural blockade with regional anesthesia.

� Reduce central pain perception and suffering through appropriate and safe useof medication and self-management techniques.

� Reduce structural and neurobehavioral damage from the injury itself and from itstreatment (eg, surgery, chemotherapy/radiotherapy, medication toxicities).

� Promote healing and disease modification to restore and maintain a person’sfunction and quality of life, including support from family and community.

Tertiary Prevention

The focus of tertiary prevention is functional restoration when a painful condition per-sists and becomes a chronic nociceptive or neuropathic stimulus leading to painchronification. Treatments target pathophysiologic neuroplastic changes to the spinalcord and brain affecting pain perception, emotions, cognition, and maladaptive be-haviors. Early recognition, prevention, and management of mood, sleep, and SUDsare key objectives.As suggested in Fig. 1, the course of chronification is determined by a person’s so-

matic pain condition interacting with their emotions and interpersonal and physical en-vironments, including their health care system. The behavioral neuroscience of thisinteraction underpins the principles of designing and assembling a health systemthat provides safe and effective pain care to a population.

� Once the pain-causing disease process or injury is effectively managed, and paintreatment commences, the salience of emotions and the social environment topain perception and behavior becomes apparent.

� Pain is powerfully conditioning, and its relief is highly rewarding; whoever andwhatever achieves that relief is greatly appreciated by the organism. Simplyput as follows:
� Actions that bring relief are highly reinforced. Thus, when a movement hurts,the brain automatically says do not move again or move in a way that doesnot hurt; and the pain does not occur or is relieved if it did occur. The painceases or is avoided when the organism does not move that way. Thissequence activates the reward centers in the brain and is remembered.Thus, patients need instruction in healthy movement and reinforcement forlearning to overcome the fear of healthy movement, even if it activates painno longer directly related to the ongoing tissue injury or disease.
� Similarly when a medication, such as an opioid, reliably relieves the pain, theeffect of that rewarding experience is the motivation to use it again when thestimulus recurs or the brain’s opioid level decrease, unmasking the painfulstimulus.

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� Patients with SUD, or a genetic predisposition, are vulnerable to therewarding characteristics of the opioid molecule on top of the reward ofpain relief. This characteristic may lead to continued and increased use,even when the pain stimulus is well controlled or is eliminated. Hence, aneffective care system must both identify such predisposition and providecloser monitoring.

� Other pathways may also promote the chronification process, such asneurogenesis-dependent, hippocampal-associative learning mechanismsthat are known to be associated with emergence of persistent pain from acutepain, and the interaction of depression with pain.32

� The clinical care system must be designed to account for the reality that not allchronic pain is the same. People differ in the peripheral stimulus, their CNS-mediated response to the activation of pain, the reward of pain relief, and thereward of opioids (particularly for those with SUD). There is also considerablevariability in how those within patients’ health care system understand andmanage those differences in each patient and their respective social network.33

All of these factors taken together will determine outcomes of treatment. Espe-cially identifying SUD or risk for SUD, and tailoring treatment accordingly, is para-mount for good population outcomes.

Knowledge of the framework outlined earlier is essential for developing competencyin pain assessment and biopsychosocial formulation and goal-oriented managementplanning, with an individualized array of choices for each patient and clinician toachieve safe and effective relief and to restore function and quality of life.34

The large proportion and sheer number of Veterans with complex pain conditionsrequires that the VHA and DoD make important structural and process changes inthe approach to pain care that assures effective and safe pain management. Forexample, data suggest that optimal acute pain care after battlefield or other injurymight include one or more of the following, each targeting a separate process in theacute pain experience:

� Regional anesthesia for neural blockade shortly after injury to prevent access ofthe pain stimulus to the CNS35

� Early use of ketamine to prevent wind-up and sensitization36

� Opioids when needed to reduce suffering and its activation of central stress path-ways contributing to chronification37

� Cognitive-behavioral/psychophysiologic stress control techniques38

� The development of goal-oriented management plans that include39

� Careful longitudinal monitoring to assure safe and appropriate use of medica-tions and other interventions

� The early integration of behavioral and integrative strategies such as cognitive-behavioral/psychophysiologic training, acupuncture, yoga and meditation

� Careful transition plans from hospital care to outpatient care� Effective communication about the plan of care and key information in the tran-sition of care to the VA and/or community clinicians following discharge fromthe DoD

STRUCTURAL CHALLENGES

The VA’s obligations to its Veterans required immediate and sustainable transforma-tive changes in pain management in a population-based, public health approach tothe management of pain; support for the health system’s research is needed to guide

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implementation. There are no easy solutions and many challenges in designing andimplementing an effective, population-based model of pain care in a health system.The VHA and the private health system are burdened by

� Inadequately trained workforces in pain management, including both primarycare and specialists9,40

� The lack of clinical practice guidelines/algorithms that are supported by good ev-idence, particularly combined treatments that can be used in primary care

� Poor fiscal support or credit for effective nonmedical pain managementinterventions

� Measuring quality by volume and number of procedures rather than clinicaloutcomes

� Interspecialty competition for lucrative procedures associated with specialtycare, impeding cooperation and collaboration

VHA’s challenges that differ from the private health care system include thefollowing:

� It has a capitated system with fixed budgets that precludes the following:
� Development of profit centers that in the private system generate revenue, withpersonnel recruitment affected by lower salaries
� A business model allowing for a quick response to rapid increases in demandsuch as occurred following 9/11 and the subsequent wars that created hun-dreds of thousands of new Veterans with pain and comorbidities

� It has an obligation to care for all Veterans (ie, no cherry picking of cases); clinicalteams must care for all cases, regardless of complexity. They cannot be dis-charged from care as they might be in private practice where insurance forbehavioral treatments of vexing comorbidities is limited. Thus, more complex pa-tients tend to selectively seek the VHA for their care and are a higher time andcost burden.

� Public scrutiny supports health systems research that finds flaws in care andgaps in the VA’s health delivery and publishes those findings in the lay pressand in medical journals.41 Although this level of transparency eventually mayspur system interventions to correct problems, these reports bring negativecongressional and constituent attention to the VA.

The VHA’s advantages over private health systems include the following:

� Administrative databases and the electronic medical record provide completesamples of its patient population to discover gaps in care and also provide base-line data for outcome studies of system interventions to correct gaps.42–44

� Decisions about system design and clinical processes are not pressured togenerate income to the degree they are in the private health sector, providinggreater opportunity for studying innovations and, if successful, their system-wide deployment.

� The National Pain Management Strategy Coordinating Committee (NPMSCC)(Box 2), with representatives from all relevant VHA national offices, supports aNational Pain Management Program (NPMP) office that advises the VHA onpain management policy and implementation.

� It has a workforce self-selected to be mission focused, not income focused. Inthe VHA many clinicians prefer the teamwork and support for good pain carethat is sometimes harder to achieve in a private or university setting where gener-ating revenue is paramount.

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Box 2

The NPMSCC (Field Advisory Committee)

National Pain Program office: director, deputy director, research advisor, program coordinator

� Primary care2

� Physical Medicine and Rehabilitation

� Pain medicine2

� Addictions

� Neurology

� Mental health integration

� Pain psychology

� Patient education

� Anesthesiology

� Geriatrics

� Postdeployment health2

� Pharmacy (Pharmacy Benefits Management)

� Nursing2

� Employee Education System2

� Women’s health

� Research

� Integrated health

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� There is no reinforcement of the models of pain care in the community thatperpetuate fragmented, ineffective care45,46:� The sequential specialty/subspecialty care model: Patients with pain arereferred among specialists seeking to find and eliminate the somatic painsource with more tests and procedures without formulating the dynamic inter-action of biopsychosocial factors, translated through behavioral neuroscience,that influence the course and outcomes of any one patient’s pain. Chronifica-tion occurs and costs accrue.

� The multidisciplinary pain center model: Patients fail traditional, sequentialcare, at high cost, including disability, facilitating chronification and its conse-quences and are then referred to a costly program to reverse chronificationand its morbidities.47

� The managed care model: Access to pain medicine specialty team care is notavailable or if available is limited to costly procedures, not expert bio-psychosocial care. They tend to be placed on escalating doses of medications,such as opioids, with their complications and, because of ineffective care, areoften unable to return to work or other role functioning.

� VHA has the ability to adopt new models of care delivery that promise to addressthese structural, socioeconomic, and clinical process issues in a community orhealth system caring for a defined population of patients. To this end, a newmodel of care is proposed: the Pain Medicine and Primary Care CommunityRehabilitation Model (PMPCCRM).45,46 This model is designed to emphasizethe critical role of clinical teams in a community, anchored by competent PCPswith access to pain medicine specialty teams in that community.

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� PCPs and their clinical teams add expert evidence-based pain managementclinical algorithms for pain management to their skills in longitudinal, compre-hensive chronic care.48–52 Combined with their more intimate knowledge ofgeneral health maintenance and management techniques, family and otherpsychosocial factors, and community resources that might importantly influ-ence the outcome of pain treatment, PCPs can tailor a biopsychosocial careplan that is individualized to their patients’ respective needs.34

� Pain medicine specialty teams, including integrative, behavioral, and physicaltherapies, actively collaborate with a community’s primary care network to beeasily accessible for consultation and specialty treatment to reduce chronifica-tion when PCP treatment is ineffective.

� Interdisciplinary pain rehabilitation centers, in the CARF model, are accessiblewhen, despite the collaboration of primary care and pain medicine teams,chronification progresses to disability and its related comorbidities.

THE STEPPED-CARE APPROACH

In response to these challenges and building on the principles of the PMPCCRM, theVHA has designed a population-based, stepped approach to pain management thatfocuses on primary, secondary, and tertiary prevention. A progression of activitiesled to the publication and dissemination in 2009 of a policy directive, written by thisauthor and Dr Robert Kerns, then the National Pain Director, with the support and inputof pain colleagues and the interprofessional NPMSCC representing various clinical of-fices in the VHA (see Box 1). The directive53 outlined a new standard of care for painfor the entire VA, Stepped Pain Care, which directed that a biopsychosocial model ofpatient-centered chronic pain care be provided seamlessly and collaboratively in pri-mary care, secondary care, and tertiary care with movement between sectorsdepending on complexity, treatment refractoriness, comorbidities, and risk as illus-trated in Fig. 2. This model is consistent with the medical home model in the Afford-able Care Act in that it requires the partnership of informed patients and a proactivehealth care system that is designed to engage patients in their health care planningand decisions. The model emphasizes the value of interdisciplinary teamwork inproviding biopsychosocial, patient-centered pain management in primary care witheasy access to consultation and collaborative models of care with necessary special-ists, particularly an interdisciplinary pain specialty team, and underpinned by a stronginstitutional culture of a shared mission and responsibility.To fully implement a public health model of pain management in its target popula-

tions, the VA must work closely with the DoD, within whose sphere (combat) pain usu-ally starts. In 2009 Lieutenant General Dr Eric Schoomaker, the Army SurgeonGeneral, chartered the Army Pain Task Force, including pain experts from the Army,Navy, and Air Force, with the author representing the VA. The Task Force completedan intensive, 6-month, in-depth study of pain management in the military, makingdozens of site visits to highly reputed practices as well as holding 3 retreats, and pub-lished a 163-page report,54 which thoroughly outlined the current deficiencies in care.From these activities and insights, the group made more than 100 recommendationsfor transforming pain care in the military. Key among these was the adoption of theVHA’s Stepped Care Model of pain management. Subsequently, the VA-DoD HealthExecutive Council (HEC), cochaired by their undersecretaries for health, chartered aPain Management Working Group (HEC-PMWG), cochaired by this author andDr Chester (Trip) Buckenmaier, which was charged with establishing a single systemof continuous, collaborative, and effective pain care, research, and education for the

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Fig. 2. Continuum of VHA stepped pain care. CBT, cognitive behavioral therapy; CIM, com-plementary and integrative medicine; PC, primary care. (From Gallagher RM. Pain medicineand primary care: the evolution of a population-based approach to chronic pain as a publichealth problem. In: Deer TR, Leong MS, Buvanendran A, et al, editors. Comprehensive treat-ment of chronic pain by medical, interventional, and behavioral approaches. The AmericanAcademy of Pain Medicine textbook on patient management. New York: Springer; 2013;with permission. “Comprehensive Treatment of Chronic Pain by Medical, Interventional,and Behavioral Approaches. The American Academy of Pain Medicine Textbook on PatientManagement” is a copyrighted work of the American Academy of Pain Medicine. � Amer-ican Academy of Pain Medicine 2013.)

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VA and DoD. The Defense and Veterans Center for Integrated Pain Management is anewly functional office chartered under the lead of the Army, and now under the Uni-form Services University of the Health Sciences, to help operationalize the work of theHEC-PMWG.55

Early descriptions of the VA’s Stepped Care Model56 have been updated with anincreased emphasis on teaching self-management57 as well as system support for pri-mary care by pharmacists through medication and opioid management.58,59 Alsoadded are behavioral health technicians for screening and management of aberrantillness behavior and mental health comorbidities60,61 and access to evidence-basedguidelines and clinical algorithms.48–52,62 The evidence base for this model isemerging from clinical trials and cohort studies in primary care systems. Notably, allof these have been conducted in the VHA, wherein specific primary care enhance-ments have been shown to improve outcomes in primary care practices managingpain. Examples of these stepped programs include the following:

� Dobcha and colleagues,42 in a blinded cluster-randomized controlled trial,compared the impact of an ‘assistance with pain treatments’ intervention with‘treatment as usual’ in 401 Veterans with musculoskeletal pain cared for by 42primary care physicians over a 12-month period. They found significant

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improvements in pain disability, patients’ ratings of global impression of change,and depression severity in those with depression.

� Kroenkeandcolleagues63completeda randomizedcontrolledstudy (SteppedCarefor Affective Disorders and Musculoskeletal Pain) of the impact of a 12-weekstepped program versus treatment as usual in Veterans with musculoskeletalpain anddepression. The steppedprogram, consisting of optimizedantidepressanttherapy and participation in a pain self-management program, substantiallyimproved depression and moderately reduce pain severity and disability.

� Wiedemer and colleagues58,59 studied the impact of creating a structuredpharmacist-run clinic for Veterans with aberrant behavior, when prescribed opi-oids in a primary care setting. Almost half of those referred with aberrant behaviorand all those with risk factors for abuse without aberrancy could be managedeffectively. The use of urine drug screens for patients on long-term opioids in pri-mary care increased significantly, and provider satisfaction was high.

� Bair and colleagues’s64 study Evaluation of Stepped Care for Chronic Pain in Vet-erans of the Iraq-Afghanistan war with musculoskeletal pain found that the com-bination of algorithm-guided analgesics, self-management training, and briefcognitive behavioral therapy provided by trained nurses resulted in significant im-provements in pain severity as well as in pain-related disability and interference.

To promote this transformation in all 142 VHA medical facilities and their relatedoutpatient clinics, the VHA established an NPMP office, which is responsible for policydevelopment, coordination, oversight, and monitoring of the VHA National Pain Man-agement Strategy in collaboration with other relevant VHA program offices, such asprimary care, mental health, pharmacy benefits management services, nursing, inte-grative health, and the other national offices and programs listed in Box 1.The NPMP is supported by and supports several task forces in addition to the

NPMSCC now cochaired by Drs. Friedhelm Sandbrink and Robert Sproul, and workgroups that enable VHA to achieve its goal of implementing a patient-aligned, SteppedCare Model of team-based pain care system-wide. Monthly meetings include thefollowing:

� NPMSCC (see Box 1) for advice and support from the other VA clinical and oper-ational offices monthly

� The National Pain Leadership Group consisting of 22 Veterans Integrated ServiceNetwork (VISN) (regional) and 142 facility Pain Points of Contact with whom newVA Central Office (VACO) programs and policies are shared and who providefeedback to VACO from the field

� The Primary Care Task Force that supports the Primary Care Pain Team (PACT)Pain Champions in the facilities across the system

� The interdisciplinary Pain Medicine Specialty Team Work Group that aims tostandardize accessible, effective, pain specialty consultation and collaborationand referrals to Step 2 across the system65

� The CARF Pain Rehabilitation Task Force that provides training and standardiza-tion of CARF functions across the system66,67

National, regional, and facility responsibilities within the VHA network are outlined inthe VHA Pain Management Directive 2009-053,53 which, besides outlining the Step-ped Care Model, requires the following:

� Standards for education and training that would generate a clinical workforcewith the competencies needed to provide good pain care

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� A system of monitoring care system-wide to assure safety and effectiveness� A system of identifying quality improvement and implementation research suc-cesses to develop evidence-based stepped care strong practices or bright spots

� A system of communicating about such practices and for implementing themsystem-wide

PROVIDING EDUCATION AND TRAINING

To inform the field of challenges, goals, and plans, late in the last decade VHA con-ducted national and regional workshops for pain champions and pain experts from re-gions (VISNs) and facilities across the country. Following recommendations9,40 thattraining improve both in postgraduate and graduate medical education, a VHA work-group identified core competencies for VHA PCPs in pain management, as listed inTable 1, now further developed by national workgroups.48–52,60,68–70 Programs toaddress these competencies encompass office-based procedures and interventions,such as taught by the VHA’s Pain Mini-Residency.71

The VHA and DoD have developed several national education and training pro-grams to improve the pain management competencies of its present and futurework force.

� VA-DoD Tiered Acupuncture Training Across Clinical Settings aims to train physi-cians in medical acupuncture and providers in battlefield (auricular) acupuncture(BFA) across both DoD and VA health systems, so that Veterans have access toacupuncture as a first-line treatment of pain.72,73 Already, training has occurredfor several thousand front-line clinicians in battlefield acupuncture and for almost100 medical acupuncturists in a 300-hour course, leading to them becoming BFAfaculty (instructors) who are distributed across the health system to sustain theexpansion of this workforce so all Veterans will eventually have access.

� VA-DoD Joint Pain Education Project (JPEP): JPEP74 convened subject matterexperts in the broad domains of pain management knowledge and skills to createa virtual textbook of 27 modules of evidence-based instruction in pain manage-ment. These modules are released for use in all VA-DoD educational programs,such as Specialty Care Access Network (SCAN) Extension for CommunityHealthcare Outcomes (ECHO), the Mini-Residency, and asynchronous onlinetrainings; integration into medical residency programs and other professionaltraining programs has begun. (The VA provides full or partial training to about70% of US-trained physicians.)

� Pain Mini-Residency for PCPs: This curriculum71 emphasizes the developmentof competencies in history, physical examination, and goal-oriented bio-psychosocial treatment planning for common regional pain syndromes. Impor-tant components of the development of PCPs’ skills include the following:
� Recognizing when and how to treat a given condition using an array of medical,behavioral, and integrated health treatment options, including training in spe-cific office-based procedures, such as BFA and trigger point injections
� Recognizing when and how to make appropriate referrals to a specialty carepain service

� Learning the communication skills to effectively discuss a biopsychosocialplan of care with Veterans

� The program uses instructional materials from an approved standardized na-tional curriculum (JPEP) and includes a virtual learning phase, a 3-day face-to-face component, and a follow-up preceptor phase using existing training

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Table 1Core competencies in primary care pain management

Primary Care Competency Educational Strategy Measurement of Achievement Strategies for Sustainability

� Conduct of comprehensive pain assessment� History including assessment of psychi-

atric/behavioral comorbidities, addic-tion, and aberrant behavior (diversion)

� Conduct of routine focused physical/neurologic examinations

� Judicious use of diagnostic tests/procedures

� Web-based training� In-person training sessions� Manuals from Pain.Edu

� Completion of training (mini-residency,SCAN ECHO, TMS) (asynchronous)

� Chart review

� Panel size adjustments andincreased visit time for painpatients

� Performance measures/monitors� PACT pain champions

� Optimal patient communication� How to encourage realistic evidence-

based expectations� How to provide reassurance and

discourage negative behavior� How to foster pain self-management� Negotiating behaviorally specific and

feasible goals

� Web-based training� In-person training sessions� Manuals from Pain.Edu� Motivational interview

training

� Completion of training� Patient feedback� Patient satisfaction surveys, but must

account for skew due to disgruntledpatients, secondary gain

� Ongoing reassessment of treatment plan� Appropriately soliciting patient

questions and concerns

� Availability of wellnessprograms

� Behavioral management/painpsychology

� Patient support groups� Templates for functionalevaluation and reevaluation

� PACT pain champions

� Pain management� Knowledge of accepted clinical practice

guidelines� Rational, algorithmic-based

polypharmacy and goal-orientedbiopsychosocial care plans

� Institute safe and effective opioidmanagement procedures

� Knowledge/use of common metrics formeasuring function

� Determining the need for stepped carewith behavioral, integrative health, andphysical therapies and integrating theminto care plans appropriately

� Determining the need for secondaryconsultation and creating functionalconsultation and collaborative careprocesses

� Web-based training� In-person training sessions� Manuals pain Web site� List of available services� Service agreements� Web-based info on local

arrangements� Links to practice guidelines� Use of Academic Detailing

Program

� Completion of training� Medication utilization monitoring

(long-acting vs short-acting opioids,nonopioid therapy)

� Utilization of adjuvant therapy, otherinterventions

� Chart review

� Separate problem patients fromregular PC pain population

� Identify and review outliers� Availability of wellness/integra-tive health programs

� Behavioral management/painpsychology

� Performance measures/monitors� PACT pain champions

Abbreviations: PACT, patient aligned care team; TMS, talent management system.

Pain

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programs, such as SCAN ECHO, academic detailing, and local preceptor in-struction and support.

� Pain SCAN-ECHO: The VHA’s pain management SCAN ECHO44 program derivesfrom theUniversity ofNewMexico’sECHOmodel of usingvideoconferencing tech-nology to teach providers chronic painmanagement skills beyond that of their pre-vious training.75 In themodel of a resident case conference, interdisciplinary teamsof clinicians (pain medicine specialists, pain psychologists, psychiatrists, socialworkers, pharmacists, integrative health clinicians, and physical therapists) simul-taneously supervise several providers whose patients have difficulty accessingspecialty pain care because of one or more factors, such as distance, transporta-tion,and illness severity.Usingchecklists for gatheringstandardclinical informationregarding thepatients’ condition, the pain specialty teamhelps providers completean assessment and develop an individualized treatment plan that, in turn, is thentracked at important milestones unless an urgent/emergent issue arises. Thespecialty team and PCP will modify the treatment plan as needed. A didactic pre-sentation (professional education credit included) related to the cases presentedaccompanies each session. Ultimately, the program aims to create a knowledgenetwork, with ECHO trainees in the primary care site having a forcemultiplier effectthat improves the pain management skills of other clinicians in their setting. SCANECHO, which is particularly beneficial in rural and underserved geographic areaswhere Veterans have low access to pain specialty care, has been adopted in 6different regions of the VHA. Benefits of this program include the following:� Reduced travel burden by delivering pain management closer to Veterans’homes

� Lower utilization of specialty care� Improved quality of care through PCPs’ development of clinical competenciesin pain management
- Early results, comparing 2 similar hub and spoke systems in the VHA, one
with SCAN-ECHO and the other without, demonstrated that providerswho participated in Pain SCAN-ECHO showed increased use of nonopioidpain medications and physical therapy.44

� Higher provider and veteran satisfaction� Opioid Safety Initiative (OSI): TheOSI76 projectmonitors targeted safety practicesin opioid pain management, such as reductions in prescribing high-dose opioidsand opioids and benzodiazepines together, and increases in use of urine drugscreens and evidence-based nonmedical therapies, such as cognitive behavioraltherapy and complementary and integrative health treatments, both which arenow required to be available in all facilities. Several projects support OSI.� OSI toolkit: An expert, interdisciplinary team provides detailed, evidence-based, and peer-reviewed education and guidance for both providers andpatients. The toolkit, with public-facing materials available on the VA’s PainManagement Internet site77 and clinician-facing materials on the VA’s PainManagement Intranet site, has been widely presented throughout the VHA inmultiple educational formats and communications. For example, the toolkithas detailed instructions about guiding safe medication tapers from opioidswhen clinically indicated. Besides clinical guidance, interested readers canfind many other public-facing assets in the toolkit.

� Signature informed consent for long-term opioid prescribing: VHA Directive1005, Informed Consent for Long-term Opioid Therapy for Pain, ensuresthat all Veterans on long-term opioids (more than 3 months and not for palli-ative or cancer care) have an informed discussion with their prescriber and

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health care team on the risks and benefits of chronic opioids for the man-agement of chronic pain and alternative therapies for pain. This discussionis guided by a detailed review of the document, “Taking Opioids Respon-sibly.”78 This approach standardizes the essentials of safe opioid prescrib-ing in VHA by normalizing provider-veteran discussions and the use ofroutine urine drug screens and by fostering shared decision making aboutpain management options and medication safety. Many Veterans find theprocess most helpful when presented in groups whereby discussion isencouraged in a supportive environment that tends to destigmatize theprocess.

� Opioid Therapy Risk Report: To further strengthen the OSI by supporting cli-nicians in clinical decision making, the VA recently accelerated the deploy-ment of a state-of-the-art dashboard tool, the Opioid Therapy Risk Report(OTRR) for Veterans prescribed long-term opioids.79 Dashboards appearingdirectly in the VHA electronic medical record provide clinicians with point-of-care (real-time) access to veteran-specific data and information. OTRRprovides clinician/team point-of-care access to a dashboard for data oneach individual veteran’s pain-related diagnoses, clinic visits, opioids pre-scribed, last urine drug screens, psychiatric comorbidities, and completionof the informed consent document. Thus, the OTRR supports providers’panel management and care coordination as well as supporting safe opioidprescribing.

� Academic detailing: One of the major benefits of clinical pain practice in theVHA is the important and growing role of pharmacists trained in pain manage-ment as active members of the clinical pain team in facilities. One such project,the Opioid Renewal Clinic,58 has been described and replicated as PharmacyPain Management Clinics across the VHA. Another project is the AcademicDetailing (AD) Service,80 established by the Pharmacy Benefits ManagementOffice to support the Opioid and Psychotropic Drug Safety Initiatives. AD cre-ates and provides patient- and provider-level tools that are designed to beused during AD visits to facilities where AD meets with pain teams and with in-dividual providers needing support to facilitate discussion and address ques-tions related to medications and other treatment modalities. AD is a proveninnovation of the academic and private sector to aid in post-training continuingeducation.81,82

� Stratification Tool for Opioid Risk Management (STORM): This project uses theVHA’s administrative database to generate data on the effectiveness of theOSI in achieving goals for safer opioid prescribing and by providing evidenceas to the impact of specific changes, such as increasing the use of urine drugscreens, on reducing risk of opioid overdose.83

� Overdose Education and Naloxone Distribution (OEND): This project hascreated and distributed trainings throughout the VHA promoting awarenessof the risks for overdose and training of families and others in the use ofnaloxone rescue kits to reverse opioid-related overdose. To date, more than100 potential overdose deaths have been averted.84

� Pain nursing: The Pain Management Nursing Work Group, in conjunction with theUniversity of Wisconsin, continues the Pain Resource Nurse (PRN) program,85

designed specifically to meet the needs of Veterans at all VA sites. Training ofnursing pain champions at Tampa VA Medical Center (VAMC) has resulted intrained representatives at 40 VHA facilities. These pain champions are nowbeginning to develop PRN programs within their local facilities.

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Gallagher372

VETERANS HEALTH ADMINISTRATION PAIN RESEARCH

The VA’s pain research enterprise86–88 ranges from studies of the neurobiology of dis-ease to implementation research. The nidus of the VA’s pain research effort lies in thePain Research Working Group (PRWG), led by Dr Robert Kerns of VA Connecticut andYale University in monthly phone meetings for many years and almost yearly in face-to-face meetings in various venues. These meetings facilitate dialogue among paininvestigators and the VHA’s Office of Research Development and introduce new in-vestigators to the VA pain research enterprise. They foster dialogue and collaborationsamong VHA investigators and research centers. Dr Kerns, as National Advisor for PainResearch, meets weekly with the National Pain Program office to coordinate discus-sions with PRWG members about national clinical priorities. The VHA’s pain researchenterprise addresses our society’s important need for implementation research, arecognized donut hole of the National Institutes of Health’s research portfolio. TheVA’s administrative database, built on the electronic health record, enables studiesof trends and gaps in care, the effects of larger-scale practice interventions and policychanges, and epidemiologic studies that inform hypotheses for prospective studies,clinical trials, and implementation research. Our research enterprise remains chal-lenged to develop a system of uniform longitudinal pain assessment that providesboth meaningful measurement yielding real-time decision support in the clinic aswell as building a robust data registry to support large scale studies, although severalefforts are presently underway.89,90

SUMMARY

Pain management, historically a footnote in the medical battle to cure disease and fixinjury, is now being recognized by society as addressing one of its most pressing,longstanding, and costly public health issues. The American people, through their rep-resentatives in Congress, now also demand attention to pain; the VA has respondedas outlined in this article. The VHA’s pain enterprise is vibrant and growing, fueled bythe compassion of a workforce dedicated to the mission of relieving the suffering ofthe men and women who have served our country. The structural problems perpetu-ating ineffective pain management that are so carefully delineated in the IOM Report9

have resulted in the Department of Health and Human Services’ National Health Strat-egy,91 which proposes specific steps in this enterprise, including training and struc-tural changes. Congress asks that we improve the competency of our clinicians andfacilities in providing compassionate, safe, and effective care. Working in collaborationwith the DoD, the VHA has taken up the challenge of developing effective training, bothat the graduate and postgraduate levels. We must now work with our academic part-ners to ensure the uniform effectiveness of that training system-wide. Similarly, whenwe demonstrate successful interventions through clinical trials, we must furtherdevelop our capacity to implement these interventions system-wide. To achieve ourgoals, we must support clinicians and their teams as they attempt to engage Veteransin the mission of achieving a health-oriented approach to pain management focusedon their function, sense of well-being, and overall quality of life.

ACKNOWLEDGMENTS

The author would like to thank the following VHA leaders, representing hundreds ofothers across the country, who have committed themselves to the care of pain in ourVeterans and to furthering pain management. Cochairs of the NPMSCC: FriedhelmSandbrink (Deputy National Director), Robert Sproul; Primary Care: Gordon

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Schectman, Lucille Burgo, Steven Eraker, Steven Hunt, Ilene Robeck, Peter Marshall,Matt Bair, Erin Krebs, Steve Mudra, Michael Saenger, Pat Dumas; Pain Medicine Spe-cialty Team Work Group: Friedhelm Sandbrink, Sanjog Pangarkar, Aram Mardian,Jack Rosenberg, Michael Craine, Ali Mchaourab, David Drake; Research: RobertKerns (National Research Advisor), Audrey Kusiak; Anesthesia: John Sum-Ping;DVCIPM/DoD: Chester (Trip) Buckenmaier, Kevin Galloway, Steven Hanling, ChrisSpevak, Eric Schoomaker, Richard Thomas; Pharmacy Benefits Management: MikeValentino, Virginia Torrise, Francine Goodman, Tom Emmendorfer, Michael Chaffman;Academic Detailing: Melissa Christopher, Sarah Popish, Elizabeth Oliva; MentalHealth: Dan Kivlahan, Andy Pomerantz, Karen Drexler, Steve Dobcha, Ilse Wiechers,Jodie Trafton; Nursing: Susan Hagen, Jan Elliot, Nancy Wiedemer; Ethics: Ken Berko-witz, Karen Rasmussen, Virginia Sharpe; EES: Anne Turner, Rosemary McIntyre, AnneSanford; VHA Pain Program office: Pamela Cremo, Merry Dziewit.

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91. The Interagency Pain Research Coordinating Committee. The National Pain Strat-egy: a comprehensive population health level strategy for pain. Available at:http://iprcc.nih.gov/National_Pain_Strategy/NPS_Main.htm. Accessed November17, 2015.

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http://www.dvcipm.org/clinical-resources/pain-assessment-screening-tool-and-outcomes-registry-pastor



http://iprcc.nih.gov/National_Pain_Strategy/NPS_Main.htm

©2016 Purdue Pharma L.P., Stamford, CT 06901-3431 MR-02057 A10636 8/16

Request for Research Proposals to Evaluate Strategies forOptimal Opioid Sparing, Tapering and Discontinuation

Chronic pain can be complex to treat, and patients with chronic pain are often medically complex. An important objective of appropriate pain management is utilizing pain medicines at the lowest dose for the shortest duration to achieve treatment goals. While opioid therapy can play an important role in chronic pain management, there is little data on use of opioid sparing and opioid tapering strategies. These represent important data gaps for optimizing medical treatment to adequately and safely control chronic pain.

Treatment guidelines for opioid use among patients with chronic pain generally indicate that opioids should be tapered slowly to reduce the risk and severity of withdrawal symptoms.1, 2 However, there are few studies substantiating strategies to taper opioids to lower doses, or to stop opioid therapy after long-term and/or high-dose use, and how this process can best be integrated with other pain management strategies to ensure patients maintain adequate pain control. By addressing these data gaps through research funding, Purdue Pharma L.P. hopes to advance our remit to be part of the solution to reduce misuse and abuse of prescription opioid medicines.

Description of Request for Proposals:

Proposals are requested to address the following research question: What is a safe and effective strategy to taper patients with chronic pain to lower opioid doses, or to stop opioid therapy altogether, while maintaining adequate pain control? Studies can be prospective or retrospective, and may incorporate single or multiple strategies. Specific strategies and outcomes of interest include, but are not limited to:

• Opioid sparing Evaluation of non-opioid and non-pharmacologic treatments that may complement tapering or discontinuation, for example: NSAIDs, nerve blocks, cognitive behavioral therapy, exercise programs, mindfulness training

• Cessation of opioid therapy:- Identification of predictors for difficulty in tapering or stopping chronic opioid therapy- Utilization of buprenorphine or methadone during down-titration/discontinuation- Assessment of patient acceptance of various tapering strategies

- Effectiveness of therapies to minimize patient withdrawal symptoms

Applicants should complete an information sheet and submit a 1 to 2 page letter of intent that outlines the study concept. The study concept must include:

The information sheet and additional information can be found at http://www.purduepharma.com/healthcare-professionals/clinical-trials/investigator-initiated-research/.

The letter of intent must be submitted via email to [email protected] by 5:00 PM EDT on September 30, 2016. Letters of intent will be reviewed by an independent Steering Committee, and a subset of applicants will be invited to a teleconference to present the study concept in greater detail and to ask and answer questions. The Steering Committee will invite a set of applicants to submit a 10 to 15 page study proposal and line-item budget, and will select final awardees. Funding will be issued based upon a fully executed milestone-based agreement. All accepted proposals are expected to result in publication of findings in a peer-reviewed journal. The primary study investigator must be based in the United States. Preference will be given to proposals that incorporate Purdue’s opioid products.

Potential applicants are strongly encouraged to contact Purdue at [email protected] for additional information prior to submitting a letter of intent

References: 1. Department of Veterans Affairs/Department of Defense. Tapering and discontinuing opioids factsheet. http://www.healthquality.va.gov/guidelines/Pain/cot/

OpioidTaperingFactSheet23May2013v1.pdf. Accessed July 14, 2016.

2. Centers for Disease Control and Prevention. Guideline for Prescribing Opioids for Chronic Pain. Pocket Guide: Tapering Opioids for Chronic Pain. Available at: http://www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf. Accessed August 25, 2016.

• Objective• Design• Target population• Key inclusion/exclusion criteria

• Methods• Primary/secondary endpoints• Intended analysis• Estimated study duration

Appendix E

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DATE:

NAME: DEA #:

ROLE: SPECIALTY:

PDMP REQUESTS BY YOUR DELEGATE(S)

ANXIOLYTIC / SEDATIVE / HYPNOTIC PRESCRIBING (MONTHLY AVERAGE)

Within your Specialty (WS)

4 164You Similar Prescriber (SP)

OHIO PRESCRIPTION MONITORING PROGRAM

OPIOID TREATMENT DURATION (% OF PATIENTS) (FULL REPORT PERIOD)

PRESCRIPTIONS BY DAILY MME (MORPHINE MILLIGRAM EQUIVALENT) (FULL REPORT PERIOD)

1783 125 142You Similar Prescriber (SP)

PDMP USAGE (MONTHLY AVERAGE)

NUMBER OF PRESCRIPTIONS YOU WROTE FOR OPIOIDS (MONTHLY AVERAGE)

SPECIALTY FIELD AVERAGE

SIMILAR PRESCRIBER (SP):

PMP Prescriber Report

DATE COVERED BY THIS REPORT:

NUMBER OF PERSONS FOR WHICH YOU PRESCRIBED OPIOIDS (MONTHLY AVERAGE)

PRESCRIPTION VOLUMES (TOTAL MME) (MONTHLY AVERAGE)

MEMBER NUMBERS IN YOUR PEER GROUPS: 227WITHIN YOUR SPECIALTY (WS):


GABAPENTIN PREGABALIN MORPHINE SULFATE

TOP MEDICATIONS PRESCRIBED ( FULL REPORT PERIOD)

BY YOU BY YOU + OTHER PRESCRIBERS BY YOU BY YOU + OTHER PRESCRIBERS

PRESCRIPTIONS FOR OPIOID + BENZO IN SAME MONTH

0 0 0

PRESCRIPTIONS

0PRESCRIPTIONS FOR OPIOID + BENZO + CARISOPRODOL IN SAME MONTH

251

DOSAGE UNITS

SIMILAR PRESCRIBER AVERAGE

0

PATIENTS EXCEEDING MULTIPLE PROVIDER THRESHOLDS (FULL REPORT PERIOD)

DANGEROUS COMBINATION THERAPY

PATIENTS EXCEEDING MULTIPLE PHARMACY THRESHOLD

0

190

0PATIENTS EXCEEDING MULTIPLE PRESCRIBER THRESHOLD

183PDMP REQUESTS BY YOU

5/10/2018

Jianguo Cheng

Physician (MD, DO) Pain Medicine

BC8999267

10/1/2017 - 3/31/2018

129

92.00%

0.00% 8.00% 0.00%

77.58%

16.75%4.45% 1.22%

77.62%

17.11%4.27% 0.99%

MME 0-50 MME 51-90 MME 91-200 MME >200You SP WS

0

32

You SP WS

0.00% 0.00%

77.78%

22.22%1.29% 8.40%

47.76% 42.56%

0.94% 5.94%

39.54%53.58%

< 7 Days 7-28 Days 29-90 Days > 90 DaysYou SP WS

575 113 2,350

71,991

20,84934,925

76,338

25,89440,176

Oxycodone Containing Products Hydrocodone Containing Products Other Opioids

You SP WS

0

3048

You SP WS

Appendix F

of 39

DATE:

NAME: DEA #:

ROLE:

2/20/2018

Jianguo Cheng

Physician (MD, DO) Anesthesiology

BC8999267

7/1/2017 - 12/31/2017

121

0

1

0PATIENTS EXCEEDING MULTIPLE PRESCRIBER THRESHOLD

0PDMP REQUESTS BY YOU

BY YOU BY YOU + OTHER PRESCRIBERS BY YOU BY YOU + OTHER PRESCRIBERS

PRESCRIPTIONS FOR OPIOID + BENZO IN SAME MONTH

0 0 0

PRESCRIPTIONS

0PRESCRIPTIONS FOR OPIOID + BENZO + CARISPORODOL IN SAME MONTH

0

DOSAGE UNITS

SIMILAR PRESCRIBER AVERAGE

0

PATIENTS EXCEEDING MULTIPLE PROVIDER THRESHOLDS (FULL REPORT PERIOD)

DANGEROUS COMBINATION THERAPY

PATIENTS EXCEEDING MULTIPLE PHARMACY THRESHOLD

NUMBER OF PERSONS FOR WHICH YOU PRESCRIBED OPIOIDS (MONTHLY AVERAGE)

PRESCRIPTION VOLUMES (TOTAL MME) (MONTHLY AVERAGE)

MEMBER NUMBERS IN YOUR PEER GROUPS: 137WITHIN YOUR SPECIALTY (WS):


GABAPENTIN PREGABALIN BUPIVACAINE HCL

TOP MEDICATIONS PRESCRIBED ( FULL REPORT PERIOD)

OHIO PRESCRIPTION MONITORING PROGRAM

OPIOID TREATMENT DURATION (% OF PATIENTS) (FULL REPORT PERIOD)

PRESCRIPTIONS BY DAILY MME (MORPHINE MILLIGRAM EQUIVALENT) (FULL REPORT PERIOD)

1003 88 73You Similar Prescriber (SP)

PDMP USAGE (MONTHLY AVERAGE)

NUMBER OF PRESCRIPTIONS YOU WROTE FOR OPIOIDS (MONTHLY AVERAGE)

SPECIALTY FIELD AVERAGE

SIMILAR PRESCRIBER (SP):

PMP Prescriber Report

DATE COVERED BY THIS REPORT:

SPECIALTY:

PDMP REQUESTS BY YOUR DELEGATE(S)

ANXIOLYTIC / SEDATIVE / HYPNOTIC PRESCRIBING (MONTHLY AVERAGE)


4 113You Similar Prescriber (SP)

95.83%

0.00% 4.17% 0.00%

70.39%15.75% 4.38% 9.49%

71.08%15.77% 4.32% 8.82%

MME 0-50 MME 51-90 MME 91-200 MME >200You SP WS

0

1 1

You SP WS

0.00% 0.00%

80.00%

20.00%1.36% 8.59%

51.04%39.01%

1.66% 8.62%

49.37% 40.35%

< 7 Days 7-28 Days 29-90 Days > 90 DaysYou SP WS

650 75 1,92515,145

8,554

45,220

14,8125,409

38,800

Oxycodone Containing Products Hydrocodone Containing Products Other Opioids

You SP WS

0

16 13

You SP WS

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