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
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Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention,
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