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Proceedings of a Workshop
Pages 1-76

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From page 1...
... . In an effort to address this ongoing epidemic of opioid misuse, policy and regulatory changes have been enacted that have served to limit the availability of prescription opioids for pain management.
From page 2...
... Speakers in the fourth session discussed measures that have been developed and implemented to address the opioid use disorder epidemic and whether those measures have been sufficiently flexible to limit unintended consequences for those with serious illness. Policies to expand access to non-opioids for pain management were also examined, as were associated coverage and reimbursement policies.
From page 3...
... , the roundtable aims to foster ongoing dialogue about crucial policy and research issues to accelerate and sustain progress in care for people of all ages experiencing serious illness. In his introduction to the workshop, James Tulsky, chair of the Department of Psychosocial Oncology and Palliative Care at the Dana-Farber Cancer Institute, said that when he moved to Massachusetts in 2015, it became clear that clinicians and members of Dana-Farber's outpatient palliative care service were experiencing great angst over how to care for people suffering from pain related to their cancer in the context of the opioid use disorder epidemic.
From page 4...
... In addition to its commitment to combatting the opioid use disorder epidemic, the organization made a public commitment to focus on improving care for people with serious illness including offering more end-of-life benefits.4 Dreyfus noted that both of these health issues share many similarities: Patients with chronic pain and those with substance use disorder have suffered from being outside of the mainstream of medical treatment. Both illnesses are highly influenced by the social circumstances of patients and their families' dynamics, as well as the emotional and behavioral health issues of patients and their families.
From page 5...
... (Botticelli, Friedrichsdorf, Kertesz, Meghani) • Increase access to palliative care and pain specialists who are trained to screen for opioid use disorder and to treat opioid use disorder in the palliative care setting.
From page 6...
... • Address the societal stigma that patients with chronic pain are now sharing with those who have substance use dis orders by educating the nation that chronic pain and sub stance use disorder are both health conditions. (Nickel)
From page 7...
... • Increase communication between clinicians in the chronic pain and serious illness world and clinicians in the substance use disorders field. (Tulsky)
From page 8...
... • Include the technology industry in addressing the opioid use disorder epidemic. (Liebschutz)
From page 9...
... She also spoke about the multigenerational effect the opioid use disorder epidemic is having on families, as grandparents and even great-grandparents are left to care for their grandchildren and great-grandchildren. Following the video, Jane Liebschutz, professor of medicine and chief of the Division of General Internal Medicine at the University of Pittsburgh Medical Center, provided a historical perspective on opioid prescribing and substance use disorders.
From page 10...
... Based on the belief that patients in serious pain were undertreated and that opioids were not addictive, opioid prescribing soared in the early 1990s (see Figure 1)
From page 11...
... However, "the parallel rise in opioid prescription also went along with the parallel increase in addiction and overdose," Liebschutz explained (Paulozzi et al., 2011) (see Figure 2)
From page 12...
... Noting that the terms "substance abuse" and "opioid abuse" are no longer used, Liebschutz explained that the correct terminology is "mild,
From page 13...
... Liebschutz further pointed out that in 2002, an estimated 400,000 Americans had used heroin in the previous year, but by 2016, the number had risen to nearly 1 million. Liebschutz explained that the third wave of the opioid use disorder epidemic is currently sweeping the United States, driven by fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine.
From page 14...
... . As Liebschutz alluded to at the start of her presentation, the opioid use disorder epidemic is having a significant impact on families.
From page 15...
... FIGURE 5 U.S. mortality rates have risen because of the opioid use disorder epidemic.
From page 16...
... . Liebschutz noted there are a number of support groups for parents affected by the opioid use disorder epidemic, including Learn to Cope9 and Parents of Addicted Loved Ones.10 Liebschutz pointed out that neonatal abstinence syndrome, now called neonatal withdrawal syndrome (NOWS)
From page 17...
... PAIN MANAGEMENT FOR PEOPLE WITH SERIOUS ILLNESS: CHALLENGES AND OPPORTUNITIES IN THE CONTEXT OF THE OPIOID USE DISORDER EPIDEMIC Building on Liebschutz's introductory presentation, R Sean Morrison, the Ellen and Howard C
From page 18...
... More than a decade ago, Leipzig asked Morrison if he would serve as the palliative care physician for Chaikin, and he has cared for her since that time. Leipzig explained that she approached Morrison after consulting with multiple clinicians who were not only unable to provide a diagnosis for Chaikin's condition, but could not successfully address the extreme pain she was experiencing.
From page 19...
... "Somehow, we need to get the word out." With Chaikin and Leipzig providing a compelling real-life perspective of the challenges of treating patients with serious illness and chronic pain, Morrison then introduced the three panelists who would further address the issue: Stefan Kertesz, professor in the Division of Preventive Medicine at the University of Alabama at Birmingham School of Medicine; Cardinale Smith, associate professor of medicine and director of quality for cancer services at the Mount Sinai Health System and the Brookdale Department
From page 20...
... Opioid Correction Versus Opioid Trauma: Where Policy Meets Chronic Pain "This is a time of tragedy, and times of tragedy call for questions," said Kertesz, referring to the rising number of opioid overdose deaths in the United States. The questions he raised include • How do we know what we think is right is actually right?
From page 21...
... "That really gets to the heart of the matter," he said. "Where the metrics in play to reverse a very large and very serious crisis are neutral on the question of whether patients live or die." Kertesz noted that his patient had not gone through acute withdrawal, but rather experienced what is called prolonged abstinence syndrome.
From page 22...
... , or buprenorphine as replacements for opioids. 11 For more information on the CDC Guideline for Prescribing Opioids for Chronic Pain, see https://www.cdc.gov/drugoverdose/prescribing/guideline.html (accessed April 1, 2019)
From page 23...
... Nationally, high-dose opioid prescribing fell 48 percent over 8 years, yet "the overdose deaths involving potentially prescribed opioids (i.e., natural and semisynthetic, excluding methadone, fentanyl, or heroin) remain constant at approximately 10,000 per year since 2010, according to a query from the U.S.
From page 24...
... There is, however, another layer to the response to the opioid use disorder epidemic, and that has to do with how health systems respond to and support their clinicians who have been traumatized by the harm they have caused their patients by restricting their access to pain medications. In health care, said Kertesz, the normal response to a catastrophic event is root cause analysis, remediation, investigation, and the offer of support.
From page 25...
... To make corrections at the systems level, he emphasized two key issues: • A crucial step is to reverse metrics, policies, and legal threats that jeopardize protection of legacy patients; nearly all of these factors violate the CDC guideline while invoking its authority. • Any entity using metrics based on prescription numbers must collect and publicly report patient outcomes, including whether they are dead or alive, if their care has been continuous or if they have lost care, and whether they were hospitalized or not, and be held accountable for adverse outcomes.
From page 26...
... . Given the changing demographics of the nation, with minority populations, and particularly the Hispanic or Latino population, growing at a faster rate than the population as a whole, it is likely that there will be an increase in disparities when it comes to having access to pain medication, said Smith.
From page 27...
... Chronic pain, said Smith, affects more people in the United States than common diseases such as cardiovascular disease, diabetes, and cancer, and there is an unequal burden of pain across racial and ethnic populations. In general, said Smith, different races and ethnicities self-report about the same rates of illicit drug use, but the rate of drug-induced deaths is far higher in whites than in Hispanics or African Americans.
From page 28...
... FIGURE 7 Perceptions of disparities in health care. SOURCES: As presented by Cardinale Smith, November 29, 2018; Kaiser Family Foundation, 2002.
From page 29...
... In New York, for example, the law requires a new prescription for someone with acute pain to be limited to 7 days of medication.13 The law does exempt those with serious illness such as cancer or those in palliative care and hospice. Smith, who treats cancer patients, said that even when she writes a prescription in her health system's electronic health record and adds the correct diagnostic code, she still receives a call from the pharmacist making sure that she is prescribing the correct amount.
From page 30...
... Pain Management for Children with Serious Illness: Challenges and Opportunities in the Context of the Opioid Use Disorder Epidemic Shifting the focus to the pediatric perspective, Stefan Friedrichsdorf of the Children's Hospitals and Clinics of Minnesota opened his remarks by observing that, despite the fact that children ages 17 and younger make up more than 22 percent of the U.S. population (U.S.
From page 31...
... . The opioid use disorder epidemic in the United States has produced "many experts, pundits, and politicians who really offer simplistic blameworthy origins for the problem," and "simplistic soundbites and solutions," said Friedrichsdorf.
From page 32...
... Friedrichsdorf stressed that the question to ask is not whether it is appropriate to use opioids to treat pain in children, but rather, what amount of opioid prescribing is appropriate in children. Friedrichsdorf and his colleagues take a multimodal approach to analgesia in children and use several different medications that act synergistically to provide more effective pediatric pain control with fewer side effects than would be achieved with a single analgesic.
From page 33...
... In addition, he said, limiting access to pain clinics and appropriate pain medication risks driving adolescents in particular to illicit drugs that carry a much greater risk to their health and lives. Pediatric patients, he said, need access to interdisciplinary outpatient pediatric pain clinics, inpatient pediatric services, mental health services, and drug treatment programs covered by health insurance.
From page 34...
... Workshop participant Marian Grant, a policy consultant and palliative care nurse practitioner, noted that she has seen the pendulum swing to where clinicians are now reluctant to prescribe opioids for patients with appropriate need. Recently, she explained, she had two cancer patients who used heroin, and one went back to using street drugs.
From page 35...
... That said, it would not be practical to send every patient in need of an opioid prescription to the medical director of a hospice or palliative care program. "We are going to have to offer a degree of support and training that is beyond merely alluding to a guideline or a website," said Kertesz.
From page 36...
... Chronic pain, explained Merlin, is distinguished from acute pain by duration, with chronic pain lasting at least 3 months (Interagency Pain Research Coordinating Committee, 2016; IOM, 2011)
From page 37...
... In particular, there have been few studies on approaches for managing patients with serious illness, chronic pain, and a substance use disorder. The current literature focuses on patients with cancer in oncology and those in palliative care settings.
From page 38...
... . In an effort to address the question of what clinicians should do when they have a patient with serious illness, pain, and a substance use disorder, Merlin looked to see whether the general literature on chronic pain and substance use disorder might inform possible approaches.
From page 39...
... As a result, the idea that "organic pain" automatically merits treatment with opioids no longer holds true. "One needs to assess the risk versus benefits of prescribing opioids and not conflate opioids with good quality pain management," said Merlin.
From page 40...
... 40 PAIN MANAGEMENT FOR PEOPLE WITH SERIOUS ILLNESS FIGURE 8 An algorithm for deciding what actions to take with patients with serious illness who display behaviors suggestive of a substance use disorder. NOTE: For additional information, see http://mytopcare.org/dealing-with-aberrantbehaviors-in-patients (accessed April 1, 2019)
From page 41...
... . In conclusion, Merlin emphasized that managing chronic pain and substance use disorder in individuals with serious illness is challenging, but it is also important and rewarding.
From page 42...
... When she has a patient with chronic pain and an opioid use disorder, regardless of whether there is also a serious illness, she prescribes buprenorphine because she does not work in a licensed methadone clinic. Merlin pointed out that methadone for pain is dosed differently than methadone for opioid use disorder.
From page 43...
... She also mentioned that NIH, the U.S. Department of Defense, and the VA have an $81 million initiative looking at pain management and patient outcomes in real world, pragmatic settings using practical approaches.
From page 44...
... IMPACT OF POLICY AND REGULATORY RESPONSE TO THE OPIOID USE DISORDER EPIDEMIC ON THE CARE OF PEOPLE WITH SERIOUS ILLNESS The fourth session of the workshop featured three presentations on how regulations and policies developed in response to the opioid use disorder epidemic are affecting the ways in which health care providers treat their patients with serious illness. Hemi Tewarson, director of the Health Division of the National Governors Association (NGA)
From page 45...
... Tewarson explained that in an effort to better address the opioid use disorder epidemic, NGA released a roadmap in 2016 with strategies for both opioids and heroin. This roadmap urged state leaders to assess their current capacity to deal with the epidemic and to identify evidence-based and promising practices they can deploy and evaluate not just in terms of reducing the number of prescriptions filled or overdose deaths, but also patient outcomes.
From page 46...
... 46 FIGURE 9 Drug poisoning mortality: United States, 2016. SOURCES: As presented by Hemi Tewarson, November 29, 2018; Rossen et al., 2017.
From page 47...
... Fifteen states have set 7-day prescribing limits, for example, and four states have 3- to 4-day limits. Though all of these states have exceptions for people with chronic pain and cancer, as well as for those who are in palliative care, providers in these states are concerned about how to apply these exceptions.
From page 48...
... However, some states have laws that threaten to remove a child from a mother if she comes forward with a substance use disorder, so there is work that needs to be done to change those laws. With regard to increasing access to non-opioid pain management therapies, NGA convened a roundtable to identify possible solutions, particularly regarding coverage policies, that will generate a white paper for state leaders.
From page 49...
... In his opinion, accelerating the collection, analysis, and dissemination would help policy makers tremendously. Turning to the federal response to the opioid use disorder epidemic, Botticelli highlighted the role that the Patient Protection and Affordable Care Act and Medicaid expansion have played in increasing access to treatment.
From page 50...
... The plan, said Botticelli, tried to promote a balanced view -- one that did not just talk about reducing opioid prescribing, but also the individuals for whom it is appropriate to have access to opioid pain medications.
From page 51...
... The Office of National Drug Control Policy also worked to foster collaborative efforts between public health and public safety in high-intensity drug trafficking areas to increase information sharing. Botticelli explained that some members of Congress believed that Medicaid expansion actually caused the opioid use disorder epidemic because it enabled more people to get more prescriptions for opioids.
From page 52...
... Haywood shared that one thing he learned from this analysis was that the opioid use disorder epidemic in many areas resembles a communicable disease, which he called a shocking discovery until he considered it from a social practice standpoint. "That let us know that whatever solutions we bring to bear, it is not enough to look just inside the four walls of the hospital or clinic setting.
From page 53...
... In closing, Haywood stressed again the importance of creating a learning system to develop and disseminate the evidence to health care plans, patients, and society at large in an effort to address the opioid use disorder epidemic. Discussion Tulsky opened the discussion by asking the panelists to comment on what they think the greatest political pushbacks have been to enacting evidence-based policies in three areas of emphasis that Tewarson discussed: reducing prescriptions and access, increasing pain management, and expanding access for treatment for substance use disorder.
From page 54...
... Joanne Lynn of Altarum's Program to Improve Elder Care commented on Haywood's remark that the opioid use disorder epidemic resembles a communicable disease. Given that, she wondered if the conventional tools of public health, such as contact tracing and using public information, are being underused.
From page 55...
... Alford asked the panelists to comment on why insurers stopped paying for multimodal comprehensive pain management programs, which had the effect of eliminating them, whereas interventions of specialty pain programs are paid for even though they are not evidence based. He also commented on the possibility of moving decision making on reimbursement away from needing robust evidence of efficacy, which will take time to generate, and instead looking at risk.
From page 56...
... He pointed out that a value-based approach relies on patient outcomes, regardless of what treatment modality the physician decides to use. For the first panelist, Bob Twillman, executive director of the Academy of Integrative Pain Management and clinical associate professor at the University of Kansas School of Medicine, characterized that one of the most important things he heard was the need to address treatment of separate and co-occurring chronic pain and opioid use disorder.
From page 57...
... •  are deep systemic issues at the root of the tension There between addressing the opioid use disorder epidemic and ensuring access to opioids for people who rely on them to man age their pain. Stigma around addiction and behavioral health issues and •  limited availability of treatment programs have the effect of reducing access to effective treatment.
From page 58...
... She pointed out "what needs to happen is for there to be widespread acceptance among the public that substance use disorder is a health condition and it deserves a health care response." She further noted the need for a better understanding of the role that trauma, particularly adverse childhood events and exposure to inter­ generational substance use disorder, play in determining the risk of developing a substance use disorder. Moreover, greater understanding of the role of genetic predisposition is needed.
From page 59...
... "I believe that education has the potential benefit of reducing overprescribing while maintaining access to care for our patients," said Alford. Alford explained that he has given a great deal of thought to why health care professionals have not been educated about chronic pain and substance use disorders, both of which are common, and opioids, which have been around for years.
From page 60...
... Reacting to Alford's remarks, Dreyfus pointed out that everything Alford said about the need for training and education around substance use disorder and pain management also applies to the care of people with serious illness. Patrice Harris, president-elect of AMA and adjunct professor of psychology and behavioral sciences at Emory University, has chaired AMA's Opioid Task Force since 2014, and noted that the task force was convened to amplify what physicians were already doing in this area and to look at ways AMA could coordinate its efforts both within the profession and in partnership with other organizations.
From page 61...
... 4. The issue of stigma should be elevated as well as the ways in which it affects those who have chronic pain or a substance use disorder.
From page 62...
... "That is a place where we can cut back without hurting any chronic pain patient," said Humphreys, "and if that is your child getting that Vicodin, as a parent you are absolutely delighted at that reduction." Humphreys referred to work by one of his graduate students modeling the health benefits and harms of public policy responses to the opioid use disorder epidemic (Pitt et al., 2018)
From page 63...
... Alford, returning to his earlier comments, called for an investment in multidisciplinary faculty development across specialties given there is a limited number of board-certified pain specialists and substance use disorder specialists. He also proposed creating a clearinghouse for all of the educational materials that organizations such as CDC, FDA, AMA, the American College of Physicians, and many specialty societies have produced.
From page 64...
... She then recounted that when her physician of 9 years closed his pain management clinic, what followed was the worst experience of her life. While she has been able to find a physician who would prescribe high-dose opioid therapy, it requires her to travel from Alabama, where she lives, to California every 3 months, at great cost.
From page 65...
... Dreyfus commented that the Roundtable on Quality Care for People with Serious Illness is trying to address these issues through activities such as this public workshop. The idea for the workshop, he explained, grew out of the broad recognition that there are millions of patients struggling with chronic illness and chronic pain who are caught between the blunt responses to the opioid use disorder epidemic and the need to manage pain.
From page 66...
... Alford agreed that allowing for partial fills would help and added that preauthorization requirements can make it difficult to try different medications or to rotate medications to avoid escalating doses. Nickel then commented on the importance of addressing the societal stigma that patients with chronic pain are now sharing with those who have substance use disorders.
From page 67...
... At the same time, it is important to consider what this would mean for policy, particularly concerning how to address trauma in early childhood education. Alford pointed that part of the problem with pain is that physicians are worried about treating acute pain as if it is chronic pain, and that writing one prescription for an opioid is going to result in addiction or overdose.
From page 68...
... Twillman agreed, stating that often stakeholders "confuse quality with fewer opioid pills being prescribed." Nickel also noted that what struck her among the suggestions and priorities she heard is the need to collaborate for better patient outcomes for those individuals with chronic pain and those with substance use disorders. Alford commented on the experience of an English professor who is in chronic pain and is on long-term opioid therapy who wrote about his rather humiliating experiences every time he refills his prescription (Unger, 2017)
From page 69...
... 2016. Frequency, predictors, and outcomes of urine drug testing among patients with advanced cancer on chronic opioid therapy at an outpatient supportive care clinic.
From page 70...
... 2016. CDC guideline for prescribing opioids for chronic pain -- United States, 2016.
From page 71...
... 2015. Racial disparities in pain management of children with appendicitis in emergency departments.
From page 72...
... 2019. Managing chronic pain in cancer survivors prescribed long-term opioid therapy: A national survey of ambulatory palliative care providers.
From page 73...
... 2018. Navigating cancer pain management in the midst of the opioid epidemic.
From page 74...
... 2018. Noninvasive nonpharmacological treatment for chronic pain: A systematic review.
From page 75...
... 2017. States with prescription drug monitoring mandates saw a reduction in opioids prescribed to Medicaid enrollees.


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