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 lives—family, work, and community—and 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 isn’t 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 work—because they’re 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 receive an opioid prescription on the first visit. While opioids pose a serious risk for addiction and overdose—a fact no one challenges—we 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 brain’s 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 opioids—enkephalins, dynorphins, and beta-endorphin—that give us feelings of pleasure from specific activities. These natural, or endogenous, opioids help block pain and negative emotions, enabling us to act even when we’re 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 pain—nor 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
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 1997—the first full department in a U.S. medical center devoted to either palliative care or to pain management—and 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.
The Pain Management Puzzle
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 don’t 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
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 they’re 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 patients—roughly 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 patient’s 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 Heit—both addiction medicine specialists—and 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 patient’s risk factors to increase the likelihood that physicians might predict future 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 it’s 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 management—which minimizes risk through careful selection, dose adjustment, and structured patient monitoring—is able to substantially reduce the potential for abuse.10 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, and—working together—physicians, 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
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.
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 tag—an 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 who—like Emily—are 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
- Gaskin, D, & Richard, P. The Economic Costs of Pain in the United States. The Journal of Pain. 2012; 13(8): 715-724.
- 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.
- Koneru A. Endogenous Opioids: Their Physiological Role and Receptors. Global Journal of Pharmacology. 2009; 3(3): 149-153.
- 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.
- Foley, KM. Building the field of cancer pain. Journal of Palliative Medicine. 2008:11(2) 176-179.
- Passik, SD. Issues in Long-term Opioid Therapy: Unmet Needs, Risks, and Solutions. Mayo Clinic Proc. 2009;84(7):593-601
- 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.
- Legal, Ethical, and Safety Issues. NIH Clinical Center Web site. http://clinicalcenter.nih.gov/participate/patientinfo/legal.shtml. Accessed on September 30, 2014.
- 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): 390–400.
- 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.
- 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.
- 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.
- 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.