Sunday, January 26, 2014

Addressing the Twin Problems of Chronic Pain and Opioid Addiction

America is experiencing a remarkable resurgence in opioid addiction. New England, despite its reputation for Yankee toughness, currently seems to be the epicenter, and Vermont Governor Peter Shumlin devoted his recent State of the State message to Vermont's heroin problem.  How we got here is, alas, relatively simple, and starts with Purdue Pharma, the creators of OxyContin and the huge P.R. campaign claiming we are massively undertreating chronic, nonmalignant pain and that opioids are a safe and effective treatment for it. Perhaps my views are slightly skewed by practicing in a community health center, but I have become steadily less convinced that: a) chronic opioids are an appropriate treatment for many, if any, patients who are not suffering from painful, terminal conditions and b) the benefits to the few who are genuinely helped to be more functional and less miserable are far outweighed by the massive harm to society as a whole.  At this point, personally, I have perhaps 3 patients whom I think may be genuinely benefiting and a few others who I think are unwilling to go through the discomfort of getting off opioids but probably aren't otherwise being harmed or harming anyone else.  And I have probably terminated controlled substance contracts with over 90% of the patients I have had who have had them, many inherited from other providers but some started by me with the best of intentions or unintentionally as what I expected to be pain that should resolve in a month or two never did.  I am now a buprenorphine provider (required of all faculty in my clinic to precept residents) and, while I think buprenorphine is really important as a way to make opioid addiction treatment available to far more patients than limited facilities and funding allow for methadone, I am particularly bothered that so many of our buprenorphine patients have been created by our own actions. And, while far safer than most other opioids, it is certainly contributing to supply of opioids on the street that are leading to ever more addiction.

What should we do?  Well, below I am including one approach that I think should be considered.  Alas, I am clearly in a minority as it is showing up here because I can't get any journal to take it.  You can judge for yourself if it is just poorly-written, utterly stupid, or unpublishable for some other, obvious reason beyond being politically unpopular as it would require an acknowledgment of how bad current policies are and the devotion of new resources ("taxes") to carry out.  Are there other possible solutions? Certainly. But is continuing on our current course, nibbling at the edges (Massachusetts has just enacted dose limitations, analogous to Washington State) going to make a dent in the problem, or do anything to help us figure out how we might actually do a better job helping all the people with chronic, nonmalignant pain for which we currently have no good answers?

Addressing the Twin Problems of Chronic Pain and Opioid Addiction
            The United States health care system is simultaneously providing opioids to more and more people for chronic, nonmalignant pain, experiencing a growing crisis in rising rates of addiction to prescription opioids, and failing to make major advances in pain treatment.  A recent report from the Institute of Medicine (IOM) highlights the high costs of chronic pain and shortcomings in its assessment and treatment.  It cites estimates of at least 116 million Americans affected and annual economic costs of $560-635 billion and contains a “Blueprint for Transforming Pain Prevention, Care, Education, and Research.”  The blueprint starts with a call for a comprehensive, population-level strategy for chronic pain prevention, treatment, management, and research, and supporting collaboration between primary care clinicians and pain specialists.1 
            The difficulties in managing chronic, nonmalignant pain arise from several sources, including problems with measurement, efficacy of treatments, and use of opioids.  Pain is an inherently subjective phenomenon.  Pain assessment has become the Joint Commission-mandated “fifth vital sign,” but this measurement has not led to advances in treatment of chronic pain.  Furthermore, we have no magic bullets for treating chronic pain.  Many widely-used interventions have been found to be little or no better than placebo.2-7  Medications are typically mainstays of treatment for pain, but the evidence base here is also lacking.  A systematic review of medications used to treat sciatica judged the evidence to be limited and of low quality.8  Overuse of NSAIDs is discouraged due to risks including GI bleeding, perforated ulcers, kidney damage, and now cardiovascular events.  We are cautioned to limit use of acetaminophen, since it is the largest cause of acute liver failure in the United States, with about half of cases resulting from unintentional overuse.9
            In the last two decades, there has been a large increase in the use opioids for the treatment of chronic, nonmalignant pain, substantially due to new products and heavy promotion from the pharmaceutical industry.10  Treatment of chronic, nonmalignant pain has become intimately linked with issues of opioid dependence, misuse and addiction.  The CDC has reported a number of frightening and depressing statistics about opioid use in America – a near-doubling of emergency department visits for misuse or abuse of pharmaceuticals, mostly opioids, between 2004 and 2009, and a quadrupling of both opioid sales between 1999 and 2010 and opioid overdose deaths between 1999 and 2008.  Overdose deaths from prescription opioids now outnumber deaths from heroin and cocaine combined.11  The incidence and costs of neonatal abstinence syndrome have also jumped dramatically.12
            One might hope this national adventure in prescription opioid use was based on strong evidence for their efficacy in the management of chronic, nonmalignant pain, as opposed to pharmaceutical industry marketing.  However, the proliferation of short- and long-acting opioid formulations has failed to yield a commensurate reduction in chronic pain.  The extant, limited evidence suggests modest benefits, at best, with some side-effects and unclear effects on quality of life, employment status, and other outcomes.13  It has been suggested that successful long-term opioid treatment may not even be treating pain, per se.14  Withdrawal symptoms make it difficult to wean patients off these medications and to know whether discomfort with reducing or stopping really reflects efficacy for pain or physiologic dependence.  The proportion of patients treated with opioids who become addicted may be substantially higher than generally believed.15  The CDC report makes clear the societal consequences of the massive increase in the supply of prescription opioids.  Even if trends were to reverse now, the consequences our current practices will linger for many years, as highlighted by a recent RCT of treatment for prescription opioid abuse that found extremely high relapse rates after the cessation of buprenorphine-naloxone therapy.16
            A number of efforts have been implemented or proposed to reduce misuse and diversion of opioids.  Many states have prescription drug monitoring programs (PDMPs) but access may be cumbersome and not all even allow provider access.  In Massachusetts, we are not allowed to delegate access to a nurse or other clinic personnel, yet the state legislature has passed a law requiring checking the registry prior to seeing every new patient.  PDMPs may reduce abuse but have not so far been shown to reduce mortality.17  The state-based nature of PDMPs leads to issues that decrease any potential benefits, as demonstrated by this email I received from a colleague:
Does anyone have access to the Connecticut prescription monitoring program?  I need to look up a patient.  I contacted them and they said that I should have a CT license in order to get access.
            Washington State has instituted a guideline limiting maximum opioid dosing for non-cancer pain18 and New York City has issued guidelines to limit prescriptions of opioids by emergency departments.19  Mandatory continuing medical education requirements in pain management, including both state-based programs and the proposed opioid risk evaluation and mitigation strategies (REMS) from the FDA, are hypothesized to help, without much supporting evidence.  Becker and Fiellin discussed shortcomings of the current REMS proposal and made some suggestions for improvement, while discussing that these were still likely insufficient.20 
            Opioid prescription registries and mandatory provider education will not solve the interconnected issues of chronic pain and opioids, nor will guidelines.  I can see three possible options for the future:
1)      continue as we have been doing, nibbling at the edges without addressing the central issues;
2)      ban most or all prescribing of opioids outside of the settings of postoperative, trauma, and terminal disease care; or
3)      try a new, more controlled approach that might actually help patients with chronic, nonmalignant pain access safer, more effective treatment and provide better evidence about the benefits and harms of long-term opioid and other therapies.
            Option 1 is self-explanatory.  I had thought option 2 was both self-explanatory and unlikely, but Blue Cross Blue Shield of Massachusetts (BCBSMA) instituted a new policy for opioid prescriptions on July 1, 2012, demonstrating that insurers can and will create policies moving in that direction without any state or federal action.  It allows prescribing an initial 15 day supply of short-acting opioids and one additional 15 day supply within 60 days of the initial supply; any other short-acting prescriptions will require prior authorization.  Prior authorization is required for all new long-acting opioid prescriptions and for all buprenorphine prescriptions.21  This will almost certainly decrease opioids prescribed to BCBSMA patients, increase administrative burdens on providers, decrease BCBSMA costs for opioids, and shift some costs of opioids onto patients.  However, it is unlikely to lead to increased knowledge about the treatment of chronic, nonmalignant pain and the role of opioids therein.
            For option 3, I propose an approach with three key components: 1) development of regional, regulated, multidisciplinary pain treatment centers, whose providers could access a wide range of therapies and prescribe long-term opioids for chronic pain if deemed appropriate; 2) development of training programs and certification for primary care specialties in both chronic pain management and addiction medicine; and 3) strict annual limitations in how long an outpatient could be prescribed opioid medications by other providers outside of the setting of terminal disease – perhaps 2 months cumulatively by all providers.  Due to the nature of opiate addiction, there is a strong argument for time limitation.  Dose limitation, such as that enacted by Washington State, likely also has a role, particularly given the evidence suggesting its efficacy in reducing overdose deaths.18  Patients reaching their annual limits (with exceptions for clearly-identifiable situations like undergoing multiple surgical procedures) who felt they needed more opioids would be referred to one of the pain treatment centers, where they would receive a thorough assessment, state-of-the-art pain treatment (which might or might not include opioids), and the opportunity to participate in clinical trials of new approaches to pain management.
            This would accomplish several important goals simultaneously.  We will not cure everyone’s pain, but we will not be undertreating it.  I believe the vast majority of providers would gladly trade the right to prescribe unlimited opioids to their patients for a system that would let them treat acute pain and provide a resource for helping them manage patients whose chronic pain was not adequately controlled, irrespective of whether opioids were an issue.  Instead of saying to a patient, “No, I am not giving you any more opioids for your pain,” they could convey the much more positive message, “I cannot prescribe you any more opioids, but since your pain is still causing you such distress, I am referring you to a center that can provide you the best available care for your pain, which may or may not include opioids.”  These centers would be ideally positioned to enroll patients in high quality studies and advance the science of treatment for chronic pain, much as cancer centers of excellence do today.
            There are a number of reputable pain clinics in existence, but nowhere near enough to meet the demand, and most primarily focus on procedural interventions that are well-remunerated.  A key question is whether there are sufficient providers qualified and willing to work in the centers I am proposing.  Three specialties currently have subspecialty certification in Pain Medicine – Anesthesiology, Physical Medicine and Rehabilitation, and Psychiatry and Neurology.  This needs to be expanded to primary care specialties.  Training would need to include the range of options available for treating pain, including pharmacologic, behavioral, interventional, and physical approaches and a solid grounding in behavioral and addiction medicine.  I recognize that this approach could not be implemented nationwide with existing personnel, but there is no reason that one state, region, or even an integrated delivery system could not undertake a pilot program.
            While these centers would likely have close oversight of opioid prescribing, pain specialists and other clinicians who prescribe opioids currently have no protection from what might seem like capricious enforcement actions by the Drug Enforcement Administration.  Treatment protocols and internal oversight in these centers should lead to both safer prescribing and lower risk for enforcement actions.  Although the barriers to creating effective health care teams should not be underestimated,22 the opportunity to work in state-of-the-art, multidisciplinary pain centers at the forefront of clinical research should attract more providers into the field and facilitate formation of effective teams.  Such a system could increase fragmentation of care, so it would need to be carefully designed to include patients’ primary care providers as key members of the team, as called for by the IOM.1
            Who would oversee such centers and how this would occur would require creative thinking and novel collaborations, since different aspects would likely fall under the purviews of the Drug Enforcement Administration, state medical licensing boards, and the Substance Abuse and Mental Health Services Administration – but the model of office-based buprenorphine treatment for opioid addiction suggests this is not an insurmountable barrier.  At least initially, centers would likely need set-aside research funding pools, but over time they almost certainly would become highly competitive for more traditional grant funding.  We will need to accept a new social contract in which indefinite access to opioids for pain is not viewed as a “right” and the centers will need Institutional Review Boards willing to deal with the complex issues raised by the studies that will be proposed.  However, patients do not have an inherent right to receive unproven therapies and long-term opioid therapy for nonmalignant pain is clearly a risky, unproven therapy.
            The reorganization I am proposing would place us well on the way to addressing the IOM’s charge to transform the treatment of chronic pain.1  The failures and harms of our current approach are obvious.  Tinkering will fix neither treatment of chronic pain nor the epidemic of prescription opioid abuse.  Given the high costs to society of both, can we afford not to try a new model such as this?

References
1.     Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.
2.     Kirkley A, Birmingham TB, Litchfield RB, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2008;359(11):1097-107.
3.        Laupattarakasem W, Laopaiboon M, Laupattarakasem P, Sumananont C. Arthroscopic debridement for knee osteoarthritis. Cochrane Database Syst Rev 2008(1):CD005118.
4.     Eccleston C, Williams AC, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2009(2):CD007407.
5.     Rubinstein SM, van Middelkoop M, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for chronic low-back pain. Cochrane Database Syst Rev 2011(2):CD008112.
6.     Gross A, Miller J, D'Sylva J, et al. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev 2010(1):CD004249.
7.     Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976) 2009;34(10):1078-93.
8.     Pinto RZ, Maher CG, Ferreira ML, et al. Drugs for relief of pain in patients with sciatica: systematic review and meta-analysis. BMJ 2012;344:e497.
9.     Bower WA, Johns M, Margolis HS, Williams IT, Bell BP. Population-based surveillance for acute liver failure. Am J Gastroenterol 2007;102(11):2459-63.
10.   Ornstein C, Weber T. Patient advocacy group funded by success of painkiller drugs, probe finds. Washington Post 2011 December 23, 2011.
11.   Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep 2011;60:1487-92.
12.   Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA 2012;307(18):1934-40.
13.   Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010(1):CD006605.
14.   Sullivan MD, Ballantyne JC. What Are We Treating With Long-term Opioid Therapy? Arch Intern Med 2012;172(5):433-4.
15.   Juurlink DN, Dhalla IA. Dependence and addiction during chronic opioid therapy. J Med Toxicol 2012;8(4):393-9.
16.   Weiss RD, Potter JS, Fiellin DA, et al. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry 2011;68(12):1238-46.
17.    Gugelmann HM, Perrone J. Can prescription drug monitoring programs help limit opioid abuse? JAMA 2011;306(20):2258-9.
18.   Franklin GM, Mai J, Turner J, Sullivan M, Wickizer T, Fulton-Kehoe D. Bending the prescription opioid dosing and mortality curves: impact of the Washington State opioid dosing guideline. Am J Ind Med 2012;55(4):325-31.
19.   Juurlink DN, Dhalla IA, Nelson LS. Improving opioid prescribing: the New York City recommendations. JAMA 2013;309(9):879-80.
20.   Becker WC, Fiellin DA. Federal Plan for Prescriber Education on Opioids Misses Opportunities. Ann Intern Med 2012.
21.   Blue Cross Blue Shield of Massachusetts. New Quality and Safety Measures in Opioid Management, Effective July 1, 2012. (Accessed March 30, 2012, at http://www.bluecrossma.com/bluelinks-for-employers/whats-new/special-announcements/opioid-management.html)
22.   Grumbach K, Bodenheimer T. Can health care teams improve primary care practice? JAMA 2004;291(10):1246-51.


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