Take My Pain Away

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Take My Pain Away

A Physicians Perspective of Prescription Opioids and Pain Management

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Take My Pain Away

By Gerald Aronoff, MD, Medical Director, Carolina Pain Associates

Like the beating metronome in the music video, the title and refrain of Take My Pain
Away,
by rock band Moullinex, remind me of what I see each day in my pain
management practice. Take my pain away, patients have asked me for over 30 years
now. Most of them come to me because they are in debilitating pain that interferes with
every aspect of their
livesfamily, work, and communityand have been unable to find
help for their pain. Hearing Take my pain away is all
too familiar to me.

Even when physicians and patients find the right treatment, if that treatment includes an
opioid, getting prescriptions filled can be frustratingly difficult, as it has been for Emily.
Emily is a forty-year
old nurse who has suffered for years with progressive rheumatoid
arthritis. Her puffy, deformed joints make ordinary tasks like brushing her teeth or
walking to the kitchen to make breakfast each morning excruciating ordeals. Her story
isnt unique. Chronic pain is a major public health problem in the United States that
imposes an enormous burden on individuals, families, employers, and society as a
whole. It affects about 100 million adults every year and, according to the Medical
Expenditure Panel Survey (MEPS), costs the economy between $560 and $635 billion
annually in health care costs and lower worker productivity.1 Much of the productivity
loss is in the form of lowered performance while employees are at workbecause
theyre working in pain, unable to perform to their usual standard.2

Emily spent years struggling to manage as best she could with acetaminophen and
ibuprofen. Her referral to my practice came, like many
others, because self-care,
interventional care, or low-dose opioids provided by a primary care physician no longer
supported a functional life. The journey to the use of optimal opioid dosing must be
deliberate
and managed carefully; in fact, very rarely does a patient in my practice

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Take My Pain Away
receive an opioid prescription on the first visit. While opioids pose a serious risk for
addiction and overdosea fact no one challengeswe must ask: Despite the risks, do
these analgesic medicines provide important benefits for the right patient, and can the
benefits be balanced against the potential risks?

Taking these facts into account and after a thorough evaluation and review of old
records, we did, on a follow-up visit, prescribe a long-acting opioid and an
antidepressant for Emily. She left our office grateful and more hopeful.

A call from her later that day was disturbing.

She came from a small town a number of miles away, and the local pharmacy there
would not fill her prescription for the opioid. As a medical professional herself, Emily
was already familiar with the gossip
and murmurs of some health care professionals
that create shame and stigma around opioid use for chronic pain. Now she was
experiencing some
of that first-hand.

Millions of Americans like Emily struggle with severe, chronic, unremitting pain that is
potentially disabling, but with appropriate pain relief, they have an opportunity to stay
functional and productive.
Without that relief, many will become disabled unnecessarily.
How did we get to a place where a patient with significant pain cannot find an FDA-
approved medication at her local pharmacy?

Opioids come from poppies and play an important role in pain and mood
regulation.
They are classified as opioids because they act on the opioid receptor of the brains
reward system. This biochemical pathway has been conserved for millions of years
through evolutionary biology to support critical survival skills like eating, social
interaction, and reproduction. The body itself produces three opioidsenkephalins,
dynorphins, and beta-endorphinthat give us feelings of pleasure from specific

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Take My Pain Away
activities. These natural, or endogenous, opioids help block pain and negative
emotions, enabling us to act even when were injured or struggling with an extremely
stressful situation.3 Our bodies opioids can
reduce discomfort, but they are not
produced in large enough quantities
to block extreme painnor do they have the
potential to cause an overdose.4

Although opium and its derivative products that were classified as opioids have been
used for centuries, it was not until the
1980s that researchers at leading cancer
hospitals began to formulate an approach that used opioids to manage pain. For these
patients, the need was great, as described by Dr. Kathleen Foley. Dr. Foley, who holds
the chair of the Society of Memorial Sloan Kettering Cancer Center in Pain Research,
has developed scientific guidelines for the use of analgesic drug therapy through
clinical pharmacologic studies of opioid drugs. She was elected to the Institute of
Medicine of the National Academy of Sciences for her national and international work
on the treatment of patients with cancer pain.

In her paper, Building the Field of Cancer Pain, she wrote:

My first task at Memorial Sloan Kettering Cancer Center was to

try to understand and
to better define the clinical syndromes patients exhibited and develop strategies for
their management. Much of my own clinical research developed from the experience of
seeing patients with painful neurological complications ranging from tumor infiltration of
the brachial plexus to epidural spinal cord compression to a wide range of unique cases
with base of the skull metastases and cranial nerve involvement. The patients had
extraordinary neurologic signs and symptoms and provided the unique opportunity to
see first-hand how pain affected their lives often preventing them from receiving
adequate cancer treatment because they could not endure the treatment and forcing
them to wish to die rather than endure severe pain. 5

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Take My Pain Away
Then, Dr. Russell Portenoy, a neurologist who completed a fellowship in pain
management at Memorial Sloan Kettering Cancer Center, and other pioneers
eventually bridged the gap between the use of opioids by physicians to treat cancer
pain to encompass treating severe, unrelenting pain from sources other than cancer.
Dr. Portenoy founded the Department of Pain Medicine and Palliative Care at Beth
Israel Medical Center in 1997the first full department in a U.S. medical
center
devoted to either palliative care or to pain managementand serves as its chairman.

Today, all physicians who treat chronic pain with opioids have a significant number of
patients in our practices that are back at work as
full-time employees or back at school
as full-time students because their pain is tolerable and under control. I have a group
of patients who take opioids on a regular, sustained basis, and no one could pick them
out of any group of their friends, neighbors, or coworkers. They look and act like
anyone else. They have no cognitive impairment and no sign of sedation or drowsiness
because their treatment
is under control, they are appropriate patients for the treatment,
and they are monitored by their treating physician or healthcare professional.

Chronic
pain creates a vicious cycle. Pain makes
people less able to continue their normal
activities and, eventually, if untreated, pain can
ruin their lives. They get depressed, and the
more depressed they get, the more they focus on
their pain.

The Pain Management Puzzle

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Take My Pain Away
Each case coming to a pain medicine practice is a puzzle that requires understanding
pathophysiology, pain generators, factors that activate and perpetuate the pain,
possible complicating psychosocial and
environmental factors, risk factors for use of
controlled substances, and concurrent medical and psychological issues that may
complicate pain
treatment. Chronic pain creates a vicious cycle. Pain makes people
less
able to continue their normal activities and, eventually, if untreated,
pain can ruin
their lives. They get depressed, and the more depressed they get, the more they focus
on their pain. Many of these people were well-adjusted at home and at work, but their
chronic, untreated pain not
only affects them, it also affects their kids, their family, and
their whole support system. Today, we know that physical and psychological symptoms
make each other more potent. Pain can make a patient depressed,
and depression
leads to more physical pain.

Clinical research has built a knowledge base that allows us to manage

these pain
patients using opioids as part of their treatment, at the same time as we consider the
risks for patients, families, and communities in order to limit abuse, addiction, and
diversion. Not all patients with chronic pain need to be on opioids; some will respond to
medications such as muscle relaxers, topical drugs, and other non-opioid
analgesics, or
to other non-drug regimens. But for patients who dont respond to other
pharmacological agents, or to physical or complementary therapies, it is very good to
know that there is a class of potent medications that, when used carefully with the right
patients,
might allow them to live more comfortable, active, and normal lives. With the
right approach to pain management using opioids along with other treatments, we can
help patients and benefit society by reducing the disruptions associated with opioid
misuse.

Deciding on a Treatment Plan

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Take My Pain Away
Like many pain management practices, ours is hectic. We see many patients, all by
referral. Most referrals come from primary care providers who are concerned that what
they are doing is not adequately controlling pain, or theyre concerned that escalating
the dose of
medications they're prescribing may exacerbate side effects or fail to
provide relief, even at the higher dosage.

We also get many referrals from orthopedists, neurologists, neurosurgeons, and back
specialists because a large percentage of our patientsroughly 70 percent or more
have musculoskeletal pain. We especially see a lot of lumbar spine pain, cervical pain
syndromes, neuropathic pain syndrome, and soft tissue injuries.

To unravel this complexity, in our practice, we take a three-dimensional look at the

patient, using a bio-psychosocial approach
to evaluating chronic pain. A comprehensive
initial history is followed
by a good physical exam, which, in combination with lab
evaluations, clarifies not only the medical and structural problems but also the
psychosocial problems that pain is imposing on the patients daily
life. We do a urine
drug screen, and we look at current and past history of smoking, problems with alcohol
or drugs in the patient or family, and psychological stressors, all of which can be risk
factors for using controlled substances like opioids. Other factors that increase risk
include a history of childhood sexual abuse and major psychiatric disorders, especially
at times when they are not well controlled.6 So, we stratify for minimal, moderate, or
severe
risk, based upon the pioneering work of clinical psychologist Steven Passik and
doctors Douglas Gourlay and Howard Heitboth addiction medicine specialistsand
others who have examined and written on assessment, universal precautions,
substance abuse, diversion, and the interface of pain and addiction.

Pain management physicians are employing more precise tools to help identify a
patients risk factors to increase the likelihood that physicians might predict future

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Take My Pain Away
misuse based on past behavior or thoughts. One extensively validated tool, in fact,
demonstrates 90 percent sensitivity in identifying patients that may eventually go on to
misuse their prescription medications.7

It is also important to look beyond type, as its

not possible to tell by looking at
someone whether he or she is going to be an abuser. Even after years of working in
this business, I can't predict who is at high risk based on outward appearance. A patient
may come to our office with a ponytail down his back and tattoos from neck to feet
which could lead some to draw fast judgments about the likelihood of abuse yet he
may be the ideal patient and do everything we ask of him, while another patient who
looks like the guy next door may end up abusing his medication. All of us
who
prescribe opioids experience this in our practices. That is why effective pain
management practices have a system in place to verify and
document everything, both
to help patients and to be part of the force against the addiction, abuse, and diversion
that devastate some communities across America. We compare the very detailed
medication history we take at the initial appointment to our state-controlled substance
database and any other medical records that we can identify. Equally important to this
initial work up is the careful ongoing monitoring we provide our patients.

But even patients who are at-risk for abusing pain relievers should not be excluded
from optimal pain management. The National Institutes of
Health Clinical Center has
stated unequivocally that every patient has the right to appropriate assessment and
relief of pain.8 This issue is particularly concerning to pain physicians since four out of
every 10 pain patients have some risk factors for opioid dependence and abuse such
as depression or anxiety disorders.9

Scientific evidence supports that interdisciplinary pain managementwhich minimizes

risk through careful selection, dose adjustment, and structured patient monitoringis
10
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Take My Pain Away
able to substantially reduce the potential for abuse. At-risk patients, though, demand
a higher and more time-intensive level of care that may not be possible for every
physician to provide. Therapy includes frequent follow-up and refills, urine testing, and
comprehensive monitoring programs. It also requires non-pharmacologic support such
as psychotherapy, substance abuse counseling, and physical fitness programs to
maximize the probability of good outcomes.

There is no medication that acts on the central nervous system that does not have
some potential for abuse, and the problem of pharmaceutical abuse goes well beyond a
single class of medications. A 2013 list published in Genetic Engineering and
Biotechnology News
shows the magnitude of the challenges facing the United States.
Among the top 10 pharmaceuticals abused in the U.S., four are opioids. The remainder
includes drugs for depression, anxiety, ADHD, insomnia, and narcolepsy.11

Careful screening and management can effectively mitigate the risks of prescribing
opioids for chronic pain, andworking togetherphysicians, regulators, policy makers,
and law enforcement can keep these medications out of the hands of abusers without
curtailing treatment of legitimate pain patients. Educating physicians about the proper
ways to prescribe and limit abuse of opioid drugs is a critical part of the solution. In fact,
in 2012, the FDA strengthened federal efforts to address the growing problem of
prescription drug abuse and misuse. These programs, entitled Risk Evaluation and
Mitigation Strategies (REMS), introduce new safety measures to reduce risks and
improve safe use of longer acting opioids while continuing to provide access to these
medications for patients in pain. 12

Ideally,
efforts to help ensure improved physician
prescribing habits and reduce
opioid abuse
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Take My Pain Away

should be interdisciplinary ones that includes all

involved government agencies, regulators,
industry, elected officials, and physicians.
Along
with the educational efforts, earlier this year the FDA has proposed class-wide
safety labeling changes and new post-market testing requirements for all longer-acting
opioid pain medicines in response to increased policymaker and public scrutiny
following highly publicized opioid analgesic approvals in 2013.13 Manufacturers have
further responded by continuing prescriber education, creating patient guides, and
supporting prescription monitoring programs at the state level.

Ideally, efforts to help ensure improved physician prescribing habits

and reduce opioid
abuse should be interdisciplinary ones that includes all involved government agencies,
regulators, industry, elected officials, and physicians. Each year about 17,000 new
doctors graduate from medical schools, many without adequate exposure to curricula
on pain management -- a problem that can be solved by the medical education
system.
Key stakeholders -- including federal and state regulators, industry, professional
associations, and physicians -- can work together
to solve the rest. I also hope that
employers will review their policies to make sure that workers who are stable on long-
acting opioids
and have their pain well-controlled can return to their jobs.

There is also hope that technology will help address pharmaceutical abuse and
diversion. Opioids with abuse-deterrent properties are just coming into the market with
formulations that become inactivated or resist being powdered or liquefied. Most of
these new drugs cannot prevent abuse, but they will make certain forms of abuse much
more difficult.

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Take My Pain Away
Among other abuse-deterrent technologies are formulations that add aversive agents,
such as niacin, that cause undesirable side effects like burning or stinging when they
are snorted or injected, or opioid antagonists that block the opioid receptors in the
brain. Combining these advances with extended-release formulations holds the promise
for achieving a therapeutic effect at much lower doses over longer periods, preventing
the rush that addicts crave. Of course, none of these technologies comes without
challenges. Abuse resistant and deterrent drugs have a higher price tagan ongoing
challenge in an era focused on reducing costs. I hope that healthcare plans and
pharmacies will offer these newer, safer alternatives, and I hope that physicians will
embrace these additional choices, rather than decide to leave opioid prescribing to far
too few experts.

I believe with all my heart that patients with chronic pain deserve the same commitment
and diligence from healthcare providers as all other
patients. Every day, I see patients
in my practice wholike Emilyare successfully managing their chronic, debilitating
pain with a multidimensional treatment plan that includes opioids. Until the advent of
medications that are at least as effective as opioids with fewer risks, physicians must
apply what they know and enlist the help of the larger health and law enforcement
systems to support patients and manage these risks.

*Gerald Aronoff, MD, is a paid consultant of Purdue Pharma, LP

References

1. Gaskin, D, & Richard, P. The Economic Costs of Pain in the United States. The Journal of Pain.
2012; 13(8): 715-724.

2. Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to
common pain conditions in the US workforce. Journal of the American Medical Association. 2003;

290(18): 2443-2454.

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Take My Pain Away
3. Koneru A. Endogenous Opioids: Their Physiological Role and Receptors. Global Journal of
Pharmacology. 2009; 3(3): 149-153.

4. How do opioids work in the brain? The National Alliance of Advocates for Buprenorphine Treatment
(NAABT) Web site. http://www.naabt.org/faq_answers.cfm?ID=6. Accessed on September 30,

2014.

5. Foley, KM. Building the field of cancer pain. Journal of Palliative Medicine. 2008:11(2) 176-179.
6. Passik, SD. Issues in Long-term Opioid Therapy: Unmet Needs, Risks, and Solutions. Mayo Clinic
Proc. 2009;84(7):593-601

7. Jamison, RN, Serraillier, J, & Michna, E. Assessment and Treatment of Abuse Risk in Opioid
Prescribing for Chronic Pain. Pain Research and Treatment. 2011: 1-12.

8. Legal, Ethical, and Safety Issues. NIH Clinical Center Web site.
http://clinicalcenter.nih.gov/participate/patientinfo/legal.shtml. Accessed on September 30, 2014.

9. Jamison, RN, Russ, EL, Michna, E, Chen, LQ, Holcomb, C, Wasan, AD. Substance Misuse
Treatment for High Risk Chronic Pain Patients on Opioid Therapy: A Randomized Trial. Pain. 2010

September; 150(3): 390400.

10. Office of the Army Surgeon General. (2010). Pain Management Task Force final report. Retrieved
from www.armymedicine.army.mil/reports Pain_Management_Task_Force.pdf.

11. Top 17 Abused Prescription Drugs of 2013. Genetic

Engineering & Biotechnology News (GEN) web
site. www.genengnews.com/keywordsandtools/print/3/33184/. Published on November 25, 2013.

Accessed on September 30, 2014.

12. US Food and Drug Administration. (2014, October).

Risk Evaluation and Mitigation Strategy
(REMS) for Extended-Release and
Long-Acting Opioids. Retrieved from

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

13. US Food and Drug Administration. (2014, April 16). New Safety Measures Announced for
Extended-release and Long-acting Opioids. Retrieved from

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm363722.htm.

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Take My Pain Away

Sponsor Content
About the Author
Gerald Aronoff, MD, Medical Director, Carolina Pain Associates
Past president, American Academy of Pain Medicine

More from this sponsor

Treating Pain, Combating Abuse

Treating Chronic Pain in a Nation with Persistent Drug Abuse
J. DAVID HADDOX, DDS, MD, VICE PRESIDENT, HEALTH POLICY, PURDUE
PHARMA L.P.

Generation Rx
Reversing the Deadly Trend of Medicinal Abuse
STEVE PASIERB, PRESIDENT AND CEO, PARTNERSHIP FOR DRUG-FREE
KIDS

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Take My Pain Away

A Brief History of Opioids

Pain, Opioids and Medicinal Use

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