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Supplements Combating the Opioid Epidemic
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Introduction to the Opioid Epidemic: The Economic Burden on the Healthcare System and Impact on Quality of Life
Nicholas E. Hagemeier, PharmD, PhD
The Role of Managed Care Professionals and Pharmacists in Combating Opioid Abuse
Kirk Moberg, MD, PhD
Participating Faculty

Introduction to the Opioid Epidemic: The Economic Burden on the Healthcare System and Impact on Quality of Life

Nicholas E. Hagemeier, PharmD, PhD
Opioid analgesics are commonly used to treat acute and chronic pain; in 2016 alone, more than 60 million patients had at least 1 prescription for opioid analgesics filled or refilled. Despite the ubiquitous use of these agents, the effectiveness of long-term use of opioids for chronic noncancer pain management is questionable, yet links among long-term use, addiction, and overdose deaths are well established. Because of overprescribing and misuse, an opioid epidemic has developed in the United States. The health and economic burdens of opioid abuse on individuals, their families, and society are substantial. Part 1 of this supplement will provide a background on the burden of pain and the impact of opioid abuse on individuals, their families, and society; the attempts to remedy this burden through prescription opioid use; and the eventual downward spiral into the current opioid epidemic, including an overview of opioid analgesics and opioid use disorder and the rise in opioid-related deaths.
Am J Manag Care. 2018;24:-S0
Understanding Pain

Pain affects more Americans than diabetes, heart disease, and cancer combined.1 There are several approaches to classifying pain, including by duration, which is the most common (eg, acute, subacute, or chronic); by type (eg, nociceptive, neuropathic, inflammatory); and by intensity (eg, mild, moderate, or severe).2 Data from 2012 estimated that 126.1 million adults in the United States suffer from pain.3 This pain originates from a variety of conditions, diseases, and events. For example, 80% of patients undergoing surgery will experience postoperative pain, with fewer than half reporting adequate pain relief.4 Sixty percent of women experiencing their first childbirth rate their pain as severe, with up to 18% reporting persistent pain 1 year after delivery.4 According to 2016 survey data from the National Center for Health Statistics, 15.3%, 14.9%, and 28.4% of Americans older than 18 years experienced severe headache or migraine, neck pain, or lower back pain, respectively, within the past 3 months.5 Frequent back pain affects more than 26 million Americans between 20 and 64 years, and is the leading cause of disability in those under 45 years; acute headache accounts for 2.1 million emergency department (ED) visits every year.4,6 Of individuals seeking help from the ED for pain, 74% are discharged in moderate to severe pain.4

Acute pain is short in duration, self-limiting, and typically the result of identifiable causes, such as surgery, acute illness, trauma, labor and childbirth, medical procedures, and cancer or cancer treatment.2,7 Although short lived, acute pain stimulates the sympathetic nervous system and causes clinical symptoms of hypertension, tachycardia, diaphoresis, shallow respiration, restlessness, facial grimacing, guarding behavior, pallor, or pupil dilation.7 Although acute pain is a normal and necessary response to tissue damage, it may be associated with significant physical, psychological, and emotional distress.7 Furthermore, inadequate control of acute pain is a risk factor for developing chronic pain.7

Compared with acute pain, chronic pain—defined as pain lasting 3 months or beyond the time of normal tissue healing—is much more complex and challenging to treat.2,8 Although acute pain resolves as the body heals, chronic pain may persist for months to years and is often a result of changes to nerve function and transmission.2 Chronic pain does not resolve on its own, and, over time, the pain may become more sensitive; hyperresponsive; and able to produce intense, spreading, and unremitting pain, which may be affected by physical, environmental, and psychological factors.7 Therefore, chronic pain is often regarded as a disease in and of itself, and has been associated with reduced patient quality of life, well-being, and ability to function over the long term.7

Chronic pain affects many aspects of a patient’s life, including daily activities, physical and mental health, family and social relationships, and interactions in the workplace, as shown in Figure 1.9 For example, a study by Toblin et al found that 44% of US Army infantry soldiers reported chronic pain after a combat deployment; this pain was significantly associated with positive screens for major depressive disorder (odds ratio [OR], 2.3; 95% CI, 1.4-3.6) and posttraumatic stress disorder (OR, 1.7; 95% CI, 1.2.0-2.5).10

Despite the availability of opioid analgesics and other pharmacotherapies, many patients remain in pain. A 2006 survey in which 303 patients with chronic pain were currently using an opioid for treatment found that 51% of respondents felt as though they had no or little control over their pain.6 Additionally, 77% reported feeling depressed, 70% had trouble concentrating, and 86% were unable to sleep well due to pain.6

Data from the American Productivity Audit of 28,902 working adults from August 2001 to July 2002 revealed that 53% of the workforce reported headache, back pain, arthritis, or other musculoskeletal pain in the previous 2 weeks, with 13% reporting lost productivity time due to pain during that timeframe.6 Additionally, 77% of lost productivity occurred due to reduced work performance rather than absenteeism.6 This lost productivity has been estimated to cost several hundred billion dollars annually, including days of work missed ($11.6 billion to $12.7 billion), hours of work lost ($95.2 billion to $96.5 billion), and lost wages ($190.6 billion to $226.3 billion).4 Collectively, combining healthcare cost estimates and lost productivity, the total annual economic burden of pain on society ranges from $560 billion to $635 billion.4

In summary, pain contributes to substantial morbidity, mortality, and disability for millions of Americans. When inadequately or inappropriately treated or managed, the consequences extend beyond the individuals experiencing pain, impacting families, healthcare systems, work performance, and society.4

Prescription Opioids for Pain

Two decades ago, the burden of pain on American society reached a boiling point in the medical community, and there was a shift toward more compassionate treatment for all patients suffering with chronic pain.11 Following the publication of an observational study of 38 patients touting the use of opioid analgesics for chronic noncancer pain and the 1995 FDA approval of a time-released oxycodone formulation (OxyContin), the prescription opioid market exploded.11-13 Healthcare providers unwilling to prescribe opioids were considered “opiophobic,” and initiatives promoting stricter controls on opioid prescribing were described as “careless, naïve, and unsympathetic.”11

Opioids, including opiates, such as morphine and heroin, and synthetic opioids, such as fentanyl, are derivatives of opium and synthetic surrogates that work on µ-opioid receptors in the body to relieve pain.14 Additional opioid receptor subtypes include δ and κ nociception/opioid-receptor-like subtype 1 (ORL-1) receptors.14 Pharmaceutical agents may exhibit varying levels of agonism, antagonism, or mixed agonist-antagonist activity at different opioid receptors, depending on their chemical structure, which leads to different adverse effects and analgesic properties.14 Opioid analgesics are commercially available in oral, intravenous, transdermal, intranasal, epidural, and intrathecal preparations, which contributes to their clinical utility.8 Additional formulations, such as oral transmucosal, rectal, inhaled, and topical, may be compounded to meet individual patient needs.15

In 1998, the Federation of State Medical Boards (FSMB) of the United States released guidelines for the use of controlled substances for the treatment of pain.16 Although the initial purpose was to curtail controlled substance abuse by outlining the appropriate use of opioids and other pain medications, the guidelines had the opposite effect of “absolving prescribers from the responsibility of their actions and even promoted more prescriptions under the guise of appropriate medical treatment.”11 Direct statements from the guidelines declare: “…the Board will judge the validity of prescribing based on the physician’s treatment of the patient…rather than on the quantity and chronicity of prescribing;” continuing with “…physicians should not fear disciplinary action from the Board…for prescribing, dispensing, or administering controlled substances, including opioid analgesics;” and “…fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients;” and, finally, “…these guidelines have been developed to…alleviate physician uncertainty and to encourage better pain management.”16

In addition to these US FSMB guidelines, a review of medical records from 1990 to 1996 concluded that the increased use of opioids to treat pain did not contribute to increased rates of abuse.17 In late 1996, the American Pain Society initially promoted the phrase “pain as the 5th vital sign,” and by the year 2000, the Department of Veterans Affairs published a document recognizing “pain as the 5th vital sign.”18 In 2001, the Joint Commission on Accreditation of Healthcare Organizations, now known simply as the Joint Commission, released standards for inpatient and outpatient pain management that emphasized the patient’s right to pain relief as a key shift in the pain management paradigm.18,19

Following these initiatives and others that came after, opioid sales skyrocketed, as demonstrated in Figure 2.13 In 1991, prescriptions written in the United States for opioids were around 76 million.13 At peak in 2011, there were 219 million prescriptions written, an increase of nearly 300%, or 143 million from 1991, making the United States the largest consumer globally of opioid analgesics.20

Approximately 1 of 5 patients with noncancer pain or pain-related diagnoses are prescribed opioid analgesics; of 164 million pain visits in 2010, 20% of patients were treated with an opioid.21 In 2016, approximately 66.5 opioid prescriptions were written for every 100 Americans.22 As shown in Figure 3, the wide geographic variation in prescribing practices, with overprescribing predominantly occurring in Appalachian and midwestern regions, does not reflect discrepancies in injuries, surgeries, or conditions requiring analgesics.23,24 Results of a national county-level analysis by McDonald et al found significant correlations between amounts of prescribed opioids in 2008 and higher population size, lower education level, higher percentage of white non-Hispanic and African American, higher poverty, higher percentage without insurance and younger than 65 years, higher physicians per capita, and higher percentages among all surgeons, psychiatrists, and pediatricians.24 Although US prescription trends vary considerably from state to state, the dispensing of prescription opioids remains high across the United States.23

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