The intertwined public health issues of chronic pain management and the risks of opioid use and misuse continue to receive national attention. Family physicians find themselves at the crux of the issue, balancing care of people who have chronic pain with the challenges of managing opioid misuse and abuse. Pain is one of the oldest challenges for medicine. Despite advances in evidence and understanding of its pathophysiology, chronic pain continues to burden patients in a medical system that is not designed to care for them effectively. Opioids have been used in the treatment of pain for centuries, despite limited evidence and knowledge about their long-term benefits, but there is a growing body of clear evidence regarding their risks. As a result of limited science, external pressures, physician behavior, and pharmacologic development, we have seen the significant consequences of opioid overprescribing, misuse, diversion, and dependence.
In the face of this growing crisis, family physicians have a unique opportunity to be part of the solution. Both pain management and dependence therapy require patient-centered, compassionate care as the foundation of treatment. These are attributes that family physicians readily bring to their relationships with patients. While our currently fragmented health care system is not well-prepared to address these interrelated issues, the specialty of family medicine is suited for this task. The American Academy of Family Physicians (AAFP) is actively engaged in the national discussion on pain management and opioid misuse. Committed to ensuring that our specialty remains part of the solution to these public health crises, the AAFP challenges itself and its members at the physician, practice, community, education, and advocacy levels to address the needs of a population struggling with chronic pain and/or opioid dependence.
The AAFP is committed to addressing the dual public health crises of undertreated pain and opioid misuse/abuse at both the national and grassroots levels. To this end, the AAFP has formed a cross-commission advisory committee to address the multiple issues involved. Through its efforts with other physician and medical organizations, as well as governmental entities, the AAFP is committed to being a leader in promoting the advancement of safe pain management and opioid prescribing, and in addressing the growing burden of opioid dependence. The AAFP therefore challenges itself and its members to action in the following areas:
Chronic pain and opioid misuse are significant and interrelated health care issues that are important to our patients, the medical community, and society as a whole. A core tenet of the practice of medicine is to relieve suffering, yet the undertreatment of pain has been deemed a public health crisis by the National Academy of Medicine (NAM).1 The physician community struggles with uncertainties when managing a patient’s chronic pain in the face of an epidemic of opioid misuse, as well as the morbidity and mortality associated with overdose. When a family physician sits down with a patient who is seeking help, the fundamental goals of relieving suffering and avoiding harm can come into clear opposition.
Sadly, our current health care system is poorly equipped to address the needs of a patient who has chronic pain and/or opioid dependence. Patients can feel abandoned in their care, such as when they are marked with the stigma of addiction, labeled as “drug seekers” by health care providers, or “fired” from medical practices for opioid misuse. No one disputes that chronic pain should be managed with a multidisciplinary approach, yet family physicians often do not have the resources or personnel to provide that approach. They must work within a fragmented health care system in which patients can obtain prescriptions from multiple sources and multiple physicians. Since family physicians treat the whole patient and not just a subset of diseases, they face the challenge of working with patients who have multiple comorbidities, which complicates both managing chronic pain and balancing competing priorities during the office visit. Furthermore, the payment structure for the system at large (and for medications in particular) often rewards a fast-track approach instead of the comprehensive and time-consuming processes required to deliver the most appropriate care to patients struggling with chronic pain and/or opioid dependence and opioid use disorder.
Despite these challenges, family physicians must understand the history of managing chronic pain and opioid dependence, as well as the current science. They must also be prepared to be a key part of the solution. This position paper provides family physicians with critical information and calls them to action to address chronic pain and opioid dependence and opioid use disorder.
Pain and Opioids: How Did We Get Here?
Pain is one of the oldest medical problems, with a long history in medicine, religion, and social science. Recent history demonstrates that we still do not have a full understanding of chronic pain, leading us to ineffective and counterproductive pain management strategies.2 Opioid use for pain dates back to the 1800s. The use of opioids increased due to the need to treat devastating injuries sustained in warfare; opioid use was also affected by advancements in pain physiology, the discovery of endogenous endorphins and opioid receptors, and the development of synthetic opioids.3-5 Opioid pain relievers can effectively reduce pain, as demonstrated by multiple randomized trials.6 Unfortunately, almost all of these studies have lasted less than 16 weeks, and there are few data regarding the longer term effectiveness of opioids for chronic pain.7 On the basis of limited data, the U.S. Food and Drug Administration (FDA)—using varying degrees of scrutiny—approved many of the current extended-release opioids.8 The result was a false sense of security in the physician community about the efficacy and safety of these medications to address the growing issue of chronic pain.8
Chronic pain is common, with approximately 11% of the U.S. population reporting daily pain.9 In addition, pain is often more severe and more frequently undertreated in vulnerable subpopulations, including the elderly, racial/ethnic minorities, women, and socioeconomically challenged groups.1, 10 Efforts to address the significant morbidity of chronic pain led to an increased emphasis on the recognition and treatment of chronic pain. These efforts—which were highlighted by actions of the U.S. Congress, the National Academy of Medicine (NAM), and multiple professional organizations—focused on improving care, increasing research into pain and its management, and improving training of physicians who manage pain.1, 11, 12
Current Issues with Opioid Misuse and Abuse
Regular opioid use, including use in an appropriate therapeutic context, is associated with both tolerance and dependence. The presence of tolerance or dependence does not necessarily mean that an individual has an opioid use disorder. Tolerance is present when an individual needs to use more of a substance in order to achieve the same desired therapeutic effect. Dependence is characterized by specific signs or symptoms when a drug is stopped. “Opioid misuse” is a broad term that covers any situation in which opioid use is outside of prescribed parameters; this can range from a simple misunderstanding of instructions, to self-medication for other symptoms, to compulsive use driven by an opioid use disorder.13 “Abuse” is also a nonspecific term that refers to use of a drug without a prescription, for a reason other than that prescribed, or to elicit certain sensory responses.13
While cause and effect is unclear, the fact that rates of opioid use increased at the same time that physicians were being criticized for their undertreatment of pain is probably not a coincidence. Efforts to improve pain control led to pain becoming the “fifth vital sign,” and physicians were encouraged to address pain aggressively. In 2012, the number of opioid prescriptions written (259 million) equaled the adult population of the United States.14 Despite the increase in opioid prescribing, similar increases have not been observed with other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or other adjunctive nonopioid therapies, nor have we seen a concomitant change in the amount of pain that Americans report.15, 16
Increasing rates of opioid misuse and abuse have become a prominent topic in medical, public health, and mainstream media. The reality is that this growing trend is largely related to misuse of prescription medications. Prescription opioids are second only to marijuana as the first illicit substance people try, with approximately 1.9 million new initiates per year.14 Sales of prescriptions opioids quadrupled between 1999 and 2014.17 Not surprisingly, the prescribing practices of physicians have come under scrutiny. It is estimated that one out of five patients who have noncancer pain is prescribed opioids.15 Family physicians have played a role in this rising trend; primary care providers are responsible for about half of the opioid pain relievers dispensed.15
These increased prescribing practices have clearly contributed to the growing opioid epidemic. In 2014, almost 2 million Americans abused or were dependent on prescription opioids.18 In primary care settings, one in four people who receive prescription opioids chronically for noncancer pain struggles with opioid dependence.19 Every day, more than 1,000 people are treated in emergency departments for misusing prescription opioids.20 Concurrently, some of the challenges associated with obtaining prescription opioids, as well as cost issues, have led to a rise in heroin use.21, 22
Probably the most concerning consequence is the rise in intentional and unintentional opioid overdoses, which lead to substantial morbidity and mortality. While most people who abuse opioids get them for free from a friend or relative, those at highest risk of overdose (defined as individuals who use prescription opioids nonmedically for 200 or more days a year) obtain opioids using their own prescriptions (27%), get them from friends or relatives for free (26%), buy them from friends or relatives (23%), or buy them from a drug dealer (15%).23 The ultimate source remains prescribed medications. At least half of all U.S. opioid overdose deaths involve a prescription opioid.24 Based on data from 1999 to 2014, risk factors for death from prescription opioid overdose included being between ages 25 and 54, being a non-Hispanic white, and being male.24 Other risk factors include concomitant use of multiple prescribed and illicit substances (especially benzodiazepines),25, 26 nicotine use, higher prescribed dosages, inappropriate prescribing procedures, methadone use, and having a history of substance abuse.27
Opioids and the Management of Pain
There are key differences between acute and chronic pain. Acute pain is a warning symptom that has a functional role in the immune system and resolves with tissue recovery. It is mediated by intact neural pathways and it can be, when needed, controlled with opioids.28 Chronic pain arises from a complex web of heterogeneous illnesses and injuries, and affects a patient physically, psychologically, and emotionally. Frequently, it is associated with undue social and functional consequences, leading to lost productivity, reduced quality of life, and social stigma. Not surprisingly, addressing chronic pain requires a comprehensive approach, with an emphasis on safe and compassionate patient-centered care; chronic pain usually cannot be managed by prescription therapy alone.1,29
Recognizing this complexity, family physicians need guidance on how to best provide patient-centered, compassionate care. While guidelines and policy statements provide some assistance, the evidence available to support such recommendations and guidance is very limited. Previous guidelines have encouraged physicians to access and use specific resources, such as opioid risk assessment screeners,30 urine drug screening, standardized pain scales, and prescription drug monitoring databases.31, 32 Using these resources often adds time to already busy patient visits, so it is not surprising that many are not routinely used by physicians prescribing opioids for chronic pain.33 It is also worth noting that a report from the 2014 National Institutes of Health (NIH) Pathways to Prevention Workshop on the role of opioids in treatment of chronic pain stated that “evidence is insufficient for every clinical decision that a provider needs to make about the use of opioids for chronic pain.”8
The Federation of State Medical Boards (FSMB) developed a model policy to help state medical boards ensure the practice of both appropriate pain management and safe, appropriate opioid prescribing. This policy addresses key areas for medical boards, physicians, and patients with respect to the following: understanding of pain; patient evaluation and risk stratification; development of a treatment plan and goals; informed consent and treatment agreement; initiation of an opioid trial; ongoing monitoring and adaptation of the treatment plan; periodic drug testing; consultation and referral; discontinuation of opioid therapy; medical records; and compliance with controlled substance laws and regulations.34 Many states either have a medical board policy that is reflective of the FSMB’s model policy or are currently amending their medical board policy to reflect the model policy.
In 2016, the Centers for Disease Control and Prevention (CDC) published the CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016,35 which addresses many of the elements of the FSMB’s model policy. This CDC guideline was based on an evidence review that found no studies that evaluated the effectiveness of long-term (one year or greater) opioid therapy versus placebo or nonuse with regard to pain, function, and quality of life.35 Instead, the CDC based most of its recommendations on a review of contextual evidence using inconsistent inclusion and exclusion criteria for different pain management therapies. Because of these inconsistencies in methodology, and because strong recommendations were made on the basis of low-quality or insufficient evidence, the American Academy of Family Physicians (AAFP) did not endorse the guideline. However, the guideline does provide some useful information for family physicians; therefore, it was categorized as Affirmation of Value.36, 37
While guidelines and policies are available to physicians, there is a substantial deficit in the peer-reviewed research necessary to form a reliable evidence base. In order to fill this gap, it is imperative that family physicians actively advocate for and engage in research opportunities on appropriate pain management strategies.
Role of Family Medicine in Care of Patients with Opioid Use Disorders
Screening for Opioid Abuse and Misuse
Most guidelines recommend screening patients to determine risks of drug misuse and abuse and to mitigate those risks as much as possible. Screening is typically based on risk factors that can be identified through a thorough patient history, the use of prescription drug monitoring programs (PDMPs), and, on occasion, drug screening. Unfortunately, there are no risk assessment tools that have been validated in multiple settings and populations. Furthermore, cited risk factors, such as sociodemographic factors, psychological comorbidity, family history, and alcohol and substance use disorders,38 may lead to discriminatory practices that affect care for vulnerable populations. As a member of the American Medical Association (AMA) Task Force to Reduce Prescription Opioid Abuse, the American Academy of Family Physicians (AAFP) encourages physicians to use their state PDMP.39 These electronic databases are used to track prescribing and dispensing of controlled prescription drugs; they can be used to obtain information on suspected abuse or diversion and to help identify patients at risk so they can benefit from early intervention.40
Family physicians should be aware of the utility of naloxone in a harm-reduction strategy for combating opioid overdose. The use of naloxone as a reversal agent for opioid overdose is standard therapy for advanced emergency medical service (EMS) providers and in emergency departments. Increasingly over the last two decades, naloxone has been provided to lay people for use in an opioid overdose.41 While little high-quality data is available, naloxone consistently shows benefit in the studies that are available, whether used by nonmedical first responders42 or lay people.41, 43 The Centers for Disease Control and Prevention (CDC) reports more than 26,000 opioid reversals by lay people from 1996 to 2014.41 Often, these opioid reversals are part of an overdose education and naloxone distribution (OEND) program. The Substance Abuse and Mental Health Services Administration (SAMSHA)44 and the AMA Task Force to Reduce Prescription Opioid Abuse45 are encouraging physicians to identify patients at higher risk of overdose (e.g., use of higher opioid doses, concomitant benzodiazepine use, respiratory disease) and to provide them with naloxone. Most, but not all, states provide for increased layperson access to naloxone, and many have Good Samaritan provisions for prescribers and lay people.45
Medication-assisted treatment (MAT) of opioid and heroin dependence has existed for more than five decades46 and involves some form of opioid substitution treatment. Originally, only methadone (an opioid agonist) was available, but now clinicians have buprenorphine (a partial agonist used alone or in combination with naloxone) and naltrexone (an opioid antagonist with both oral and extended-release injectable formulations) as pharmacologic options for MAT. In addition, adjunctive medications such as clonidine, nonsteroidal anti-inflammatory medications (NSAIDs), and others are used in the treatment of specific opioid withdrawal symptoms.47 Prior to the Drug Addiction Treatment Act of 2000 (DATA 2000), medications for the treatment of substance abuse were available only via federally approved opioid treatment programs (OTPs). In these programs, personnel specifically trained in addiction medicine dispense certain Schedule II medications (methadone and levo-alpha-acetylmethadol [LAAM]) on a daily basis. With passage of DATA 2000, qualified physicians can now get a waiver to prescribe or dispense approved Schedule III, IV, or V medications for the treatment of opioid dependence outside of an OTP.48
With the increase in opioid misuse and the passage and implementation of DATA 2000, various federal and state authorities and professional organizations have produced guidelines to help providers treat opioid use disorders.47, 49-51 Since 2001, SAMHSA has provided the Federal Guidelines for Opioid Treatment Programs, which outlines specific recommendations for the administrative and organizational structure and function of an OTP.51 SAMHSA also published Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, which outlines the elements of office-based opioid treatment (OBOT) utilizing buprenorphine.49 The American Society of Addiction Medicine (ASAM) guideline for treatment of opioid use disorders describes a comprehensive strategy for management that encompasses elements of OTPs and OBOT.47 Similar to the SAMHSA guidelines, it details the initial assessment and evaluation of the patient who has opioid use disorder, offers recommendations for managing opioid withdrawal, and describes and contrasts all of the available pharmacologic options for treatment of opioid use disorder. It concludes with a discussion of psychosocial therapy to be used in conjunction with pharmacologic treatments, and provides guidance in the management of various special populations (e.g., pregnant women and adolescents).
Under the DATA 2000 legislation, qualified physicians—including primary care physicians—can apply to SAMHSA for a waiver that allows them to treat patients who have opioid use disorder with buprenorphine in the office setting.52 To get such a waiver, a physician needs to meet specific criteria (Table 1).
Table 1. Criteria For Physicians to Obtain DATA 2000 Waiver to Provide OBOT
The waiver process allows a resident in training to get a waiver as long as the resident holds an unrestricted medical license and the appropriate DEA registration. Once SAMHSA verifies that the information submitted by the candidate is complete and valid, the DEA issues a special identification number that must be included along with the regular DEA number on all buprenorphine prescriptions for opioid treatment. In the first year after successful completion of waiver certification, the physician can manage up to 30 patients with buprenorphine. After the first year, the physician can submit a request to treat up to 100 patients per year. Under a proposal submitted by President Barack Obama in March 2016, the maximum number of patients that a qualified buprenorphine provider can treat would increase to 200 per year.53
As of the most recent statistics, only about 2% of all U.S. physicians (4% of primary care physicians) have a valid DATA 2000 waiver, with even fewer actively prescribing MAT.54 Even if all of the waivered physicians prescribed MAT to the fullest extent possible, the workforce would only be able to treat 1.4 million of the patients who have a diagnosis of opioid dependence. Table 2 lists some barriers to obtaining and utilizing the waiver and providing OBOT.54
Table 2. Barriers to Providing OBOT
Despite these barriers, OBOT represents a critical opportunity for family physicians to address the opioid abuse epidemic. By working to reduce these barriers, the AAFP encourages family physicians to obtain a waiver and incorporate MAT into their practice.
AAFP Efforts to Tackle the Opioid Abuse Epidemic
The American Academy of Family Physicians (AAFP) recognizes the vital role that family physicians and other primary care clinicians play in the appropriate management of pain. To this end, the AAFP has developed policies, programs, and partnerships to advocate for and educate family physicians and the community. The AAFP’s policy55 on substance abuse outlines the organization’s support for training family physicians on the proper assessment, referral, and treatment of chronic pain. The AAFP also supports continued research into evidence-based guidelines for treatment of chronic pain. The AAFP supports implementation and use of prescription drug monitoring programs (PDMPs) and greater physician input into pain management regulation and legislation.55 In conjunction with the Association of Departments of Family Medicine (ADFM), the Association of Family Medicine Residency Directors (AFMRD), and the Society of Teachers of Family Medicine (STFM), the AAFP supports appropriate training for pain management and has developed guidance for teaching residents how to care for patients who have chronic pain.56 Through its maintenance of certification process, the American Board of Family Medicine (ABFM) offers a self-assessment module (SAM) in pain management, as well as a certificate of added qualifications (CAQ) in pain medicine and hospice and palliative medicine.57
Education and REMS
Since its inception in 1947, the AAFP has been committed to promoting and maintaining high standards in family medicine, and promoting the improvement of the health of the public. This is demonstrated by the dual role the AAFP plays in the continuing medical education (CME) community as an accredited CME provider, the first of three national standard-setting, credit-granting systems. While the AAFP opposes mandatory CME for physicians on opioid prescribing,58 it strongly supports educating its members on effective and evidence-based pain management through CME and non-CME activities. The AAFP has offered several courses in risk evaluation and mitigation strategies (REMS). Additionally, the AAFP develops and provides multiple certified CME activities to address the topic of pain for its members. These CME activities are available in live, online, and enduring formats, which allows for increased access by members. The AAFP will continue to support family physicians to enhance their knowledge, competence, and performance when treating patients who have pain; it will also continue to provide CME to address the abuse, misuse, and safety of opioid prescribing.
Resources and Commitment
The AAFP collaborates with numerous external organizations on issues pertaining to opioids; these organizations include the American Medical Association (AMA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the State Pain Policy Advocacy Network (SPPAN), and the American Academy of Pain Medicine (AAPM). The AAFP has a prominent role on the steering committee of the Providers’ Clinical Support System (PCSS), which is sponsored by the American Academy of Addiction Psychiatry (AAAP). The PCSS provides training modules on pain management and medication-assisted treatment (MAT). Additionally, the AAFP joined 26 other medical associations in the AMA Task Force to Reduce Prescription Opioid Abuse. This task force was formed in 2014 to identify best practices for combating opioid abuse and to implement these practices across the country. The goals of the task force are to increase registration and use of PDMPs by physicians; enhance education on effective, evidence-based prescribing of opioids; reduce the stigma of pain and substance use disorder; enhance comprehensive assessment and treatment of pain; increase access to treatment for substance use disorder; and expand access to naloxone in communities.39 With other members of the AMA Task Force and a number of other public- and private-sector partners, the AAFP joined the White House and President Obama to address the nation's epidemic of opioid abuse and heroin use by increasing education on opioid prescribing.
The U.S. Department of Health and Human Services (DHHS) has updated its National Pain Strategy, which makes recommendations for improving pain management in the United States by addressing six key areas: population research; prevention and care; disparities; service delivery and payment; professional education and training; and public education and communication. The report also highlights opportunities to reduce the overreliance on opioid prescribing. Importantly, the strategy calls for better evidence and more research on pain management.59 The AAFP supports the National Pain Strategy, which outlines the essential elements of a nationwide strategy and is in line with the AAFP’s own position.
The AAFP provides its members with tools and resources for education, advocacy, and patient care. These resources include a chronic pain management toolkit, continuing medical education, office-based tools, and resources for community engagement, advocacy, and science and education. The AAFP also has formed a member advisory panel that comprises commission members and subject matter experts. This panel will provide input on and support for the AAFP’s goals and initiatives related to opioids and pain management.
Effective pain management and care of patients with substance use disorders require patient centeredness and compassion, which are hallmarks of family medicine. The AAFP is committed to ensuring that the specialty of family medicine is a central component of the solutions to ongoing issues with the health care system and the growing public health crisis. The recommendations and resources outlined in this paper are provided to encourage family physicians to take action on all levels to address the needs of a population struggling with chronic pain and/or opioid dependence, and to facilitate family physicians’ efforts.
(July 2012 BOD) (2016 COD)