In the United States, patterns of opioid use for the management of pain have drastically
changed over the past 30 years. In the 1980s, the American pain medicine landscape
was characterized by opiophobia, the fear to prescribe opioids. Around the turn of
the millennium, however, we witnessed a fairly rapid shift to opiophilia, or the “overprescribing”
of opioids. The ubiquitous undertreatment of pain was the catalyst for clinicians
and pain societies to successfully lobby for increased use of opioids for all pain
types, including non-cancer pain. The approval of new standards for pain management
incorporating pain as the “fifth vital sign” by the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO)1 seemingly fueled this increase in opioid prescription.
From 1991–2009, prescriptions for opioid analgesics tripled, with emergency department
visits related to non-medical use of prescription opioid overdoses doubling from 2005–2009.2
In 2010, accidental overdose deaths associated with opioids increased for the eleventh
consecutive year, highlighting the drastic shift in opioid use.3 The figurative pendulum
began to swing toward opiophobia following the publication of data that demonstrated
that the risk of addiction associated with chronic opioid use was likely underestimated.4
Guidelines for the use of controlled substances released by the Federation of State
Medical Boards of the US in 1998 reflected this change in attitude.5 At present, there
is a general consensus that opioids are over-prescribed and education among health
care providers is sorely lacking, with considerable debate on how to appropriately
address the issue not yet resulting in a balance between treating legitimate pain
patients, and mitigating abuse, overdoses, and related deaths. In this environment,
physicians and non-physician prescribers, health systems, regulatory agencies, and
insurers are seeking tangible targets for intervention.
The US Food and Drug Administration (FDA) has been criticized for its Risk Evaluation
and Mitigation Strategy (REMS) program, which some believe creates burdensome barriers
for appropriate opioid prescription.6 However, the agency’s recent response to a strongly
anti-opioid organization’s petition to further impede opioid prescription was encouraging.7
The petition requested three changes to the indications for opioid use: 1) striking
the term “moderate” from opioid labeling for chronic non-cancer pain, 2) adding a
maximum daily dose equivalent of 100 mg morphine for non-cancer pain, and 3) adding
a maximum duration of 90 days for continuous use for non-cancer pain. The FDA responded
by stating that, “When prescribed and used properly, opioids can effectively manage
pain and alleviate suffering – clearly a public health priority”, and “FDA knows of
no physiological or pharmacological basis upon which to differentiate the treatment
of chronic pain in a cancer setting or patient from the treatment of chronic pain
in the absence of cancer. FDA therefore declines to make a distinction between cancer
and non-cancer pain in opioid labeling.”7 The limitations for maximum daily dose or
duration of treatment were denied for lack of scientific evidence. The FDA agreed
to change the term “moderate” because it is moving away from severity classifications
(mild, moderate, severe) to focus prescribers’ attention on an individual’s needs,
accounting for the serious risks of opioid therapy and lack of alternative analgesic
options in certain clinical scenarios. The FDA received over 1,900 comments regarding
the petition, most of which opposed the petitioners’ recommendations; among them were
comments from chronic pain patients, clinicians, and professional societies, with
professional societies expressing concern for the lack of evidence supporting these
changes and the “one size fits all approach” instead of individualized care.7
Despite the petition being denied, the proposed changes have crept into policy and
practice within various health systems, prescriber networks, insurance plans, and
community pharmacy retail chains. For some, this reflects the desperation for potential
interventions to address the opioid problem, while for others it has provided the
justification to deny care to legitimate pain patients requiring time and valuable
health care resources to adequately treat and monitor. Meanwhile, third party payers
continue to deny or severely limit adjunctive non-medication options such as physical
therapy, acupuncture, chiropractic care, exercise programs, etc. The treatment for
most types of chronic pain with the highest evidence-basis and the lowest level of
iatrogeneses – interdisciplinary pain management programs – is facing extinction (outside
of the Veterans Administration system) in the US, as insurers refuse to pay for them
(despite strong empirical evidence of cost-effectiveness as well as clinical efficacy).8
Ironically, when pharmacotherapy becomes the complete therapeutic focus, those groups
at greatest risk of abuse and diversion are the very same cohort of patients denied
expensive extended release therapies that are more often available in abuse deterrent
formulations.9,10 Just as the risk of opioid treatment was underestimated previously,
today we see adverse outcomes or addiction being used to illegitimately deny access
to large groups of patients who struggle daily with chronic pain. The Institute of
Medicine’s 2011 report Relieving Pain in America, estimated that 100 million Americans
suffer from chronic pain.11 Treatment of pain costs the US approximately $635 billion
per year, which is more than heart disease, cancer, and diabetes combined.11 We suggest
that the increase in opioid prescribing may in fact be the result of concerned clinicians
attempting to treat a legitimate and widespread public health problem. Today, it is
widely accepted that opioid prescribing has become excessive, necessitating a paradigm
change resulting in an improved general approach to pain management.
A paradigm shift is critical to return individualized patient care to the central
focus and move toward a more balanced approach to pain management incorporating lessons
learned over the past 30 years. Any efforts toward equilibrium are currently being
compromised by media sensationalism, the antagonistic approach of regulatory agencies,
and third party payers’ refusal to cover safer pain medications. Recently, public
pressure in response to media sensationalism, neuromythology, and mischaracterization
of pain patients as drug addicts has even deterred some prescribers from treating
pain patients that they have successfully treated for years without problems of drug
aberrancy. Similarly, regulatory crackdown and fear of expensive lawsuits has resulted
in major retail pharmacy chains turning away pain patients, thereby forcing them to
“crawl” from pharmacy to pharmacy, hoping that their prescriptions will be filled.12
This enforcement-based approach to reduce inappropriate use of opioids makes no distinction
between pain patients and addicts. Unfortunately, this approach has been consistent
with the US drug enforcement policy since the Harrison Act of 1914 through to the
“war on opioids” today. Throughout US history, any effort to reduce the demand for
opioids by educating prescribers, increasing monitoring, and treating addicts has
received insufficient support.13,14 In addition, third party payers consider only
cost when considering confirmation or validity testing for urine drug screens, abuse
deterrent opioid formulations, or frequency of clinician monitoring and follow-up.15
These measures are critical to weeding out abusers from legitimate pain patients,
and are clearly cost-effective measures for reducing unnecessary long-term dispensing
of large supplies of opioids to individuals interested in diversion or abuse.
While estimates of opioid misuse, abuse, and addiction vary in patients with chronic
pain, they clearly represent only a small portion of this unfortunate population.16,17
Why should patients with chronic pain who are prescribed necessary opioids for legitimate
medical purposes endure the wrath of policy changes and resultant untreated pain due
to criminality of others, or because clinicians are undertrained in identifying risks
and addressing those risks? These questions certainly raise ethical concerns.
From practical and ethical perspectives, the keys to reducing abuse, diversion, overdoses,
and accidental deaths associated with prescription opioid use are neither state and
federal regulatory sanctions and intimidation, nor media histrionics aimed at selling
more press. Rather, the keys to reducing aberrancy while continuing to safeguard access
to these medications for the subpopulation of chronic pain sufferers that can benefit
from them involve better risk mitigation. Regulatory agencies and the media seem to
believe that risk mitigation is their responsibility, when, in order to protect patient
autonomy, it should rest primarily in the hands of the once sacred provider-patient
dyad. Very few physicians are “bad players” when it comes to opioid prescription,
ie, engaging in frank maleficent behavior (eg, running “pill mills”). Indeed, few
would disagree with the responsibility of regulatory agencies to intercede aggressively
in such cases. Given that some physicians can perhaps be accused of being remiss in
their opioid prescribing practices by not utilizing the tools that they have at their
disposal to mitigate risk, including taking detailed medical histories, utilizing
brief screening measures such as the Screener and Opioid Assessment for Patients with
Pain (SOAPP)18 or the Pain Medication Questionnaire (PMQ)19 prior to initiating opioid
therapy in order to stratify level of risk, and engaging in sound and ethical urine
drug testing practices with all patients receiving opioids. If the resources were
to be made available, it would be beneficial for each state’s medical society to periodically
review the risk mitigation platform of each prescribing provider and oversee any necessary
improvements. It would also likely be helpful if the myriad states that currently
have voluntary prescription monitoring programs changed their statuses to mandatory.
Clearly, state agencies have the potential to work with physicians and their patients
with pain as opposed to against them. While the FDA has been making an effort to deal
with the complex opioid conundrum in an objective and productive manner, the Drug
Enforcement Administration (DEA), on the other hand, seems to be dealing with the
American opioid crisis through sweeping actions and reactions that have been unmethodical
and lacking in forethought – and are accordingly indirectly resulting in considerable
suffering – to the practices of many well-intentioned physicians, and, more tragically,
to the well-being of patients.
Once the DEA begins to function as it is designed to function in regard to opioids
– ie, in the best interest of the people – steps toward the resolution of our opioid
crisis can potentially begin to be made. The media certainly appears to have a reciprocal
relationship with the DEA, as it appears to be fixated on the regulatory agency’s
war on opioids – and in doing so, may indirectly be fueling it. And finally, as mentioned
previously, the insurance industry’s obsession with cost-containment and profitability
is making it impossible for many Americans to gain access to the opioids that are
least likely to be abused and diverted. Physicians have more confidence in the safety
of abuse-deterrent formulations,20 and may very well be choosing not to prescribe
any opioids to their patients with pain when abuse-deterrent formulations are not
covered by their patients’ insurance.
We are certainly not advocating that all patients with pain should be utilizing opioids.
Their potentially deadly iatrogeneses as well as their potential for abuse and diversion
should not be underestimated. However, we will continue to posit that a carefully
selected subpopulation of patients with pain for whom no other viable treatment options
are available has the right to relief and enhanced quality of life – which opioids
may provide. We are not denying that opiophilia had been out of hand for too many
years in the US. However, the pendulum has indeed swung awry, which has benefited
neither patients with pain nor society as a whole. Until patient advocacy groups are
heard and clinicians of variable disciplines work in concert with regulatory agencies
in the absence of media hysteria, the critical state of American pain medicine is
not likely to improve. Undoubtedly, the media and the insurance industry are complicit
in this unfortunate turn of events. However, as a government agency entrusted with
safeguarding the well-being of Americans (as opposed to merely generating profits),
we hope that the DEA will begin to monitor its policies more closely and exercise
improved forethought in an effort to protect the fundamental human right to relief
of pain. Let the pendulum rest, as achieving rapprochement in regard to opioid analgesics
is more productive than is our recent climate of extremism.