Pain Management

"Between 2019 and 2021, the prevalence of chronic pain among U.S. adults ranged from 20.5% to 21.8%, and the prevalence of high-impact chronic pain ranged from 6.9% to 7.8% (Figure). During 2021, an estimated 51.6 million U.S. adults (20.9%) experienced chronic pain, and 17.1 million (6.9%) experienced high-impact chronic pain (Table). The age-adjusted prevalence of both chronic pain and high-impact chronic pain was notably higher among certain demographic population groups including AI/AN adults, adults identifying as bisexual, and adults who were divorced or separated. The age-adjusted prevalence of high-impact chronic pain among AI/AN adults (12.8%) was six times as high as among nonHispanic Asian adults (2.1%) and nearly twice as high as among non-Hispanic White adults (6.5%). The age-adjusted prevalence of chronic pain among adults identifying as bisexual was 32.9%, compared with 19.3% among adults identifying as straight and 20.7% among those identifying as gay or lesbian. The age-adjusted prevalence of chronic pain and high-impact chronic pain among adults who were divorced or separated (29.6% and 10.1%, respectively) was nearly twice as high as among those who were married (18.2% and 5.2%, respectively). The age-adjusted prevalence of chronic pain and high-impact chronic pain among those born in the United States (21.6% and 7.0%, respectively) was nearly twice as high as among those born outside the United States (11.9% and 4.1%, respectively)."

"In this cohort study, nearly two-thirds (61.4%) of adults with chronic pain in 2019 continued to have chronic pain in 2020. While 14.9% of those with nonchronic pain reported chronic pain 1 year later, only 6.3% of those pain free in 2019 developed incident chronic pain and only 1.4% exhibited an onset of HICP. Lower educational attainment and older age were associated with higher rates of chronic pain in 2020 regardless of pain status in 2019. Of note, the incidence of chronic pain (52.4 cases per 1000 PY) was high compared with other chronic diseases and conditions for which the incidence in the US adult population is known, including diabetes (7.1 cases per 1000 PY),27 depression (15.9 cases per 1000 PY),28 and hypertension (45.3 cases per 1000 PY).29

"Although chronic pain is sometimes assumed to persist indefinitely, our finding that 10.4% of adults with chronic pain experienced improvement over time is consistent with previous evidence from studies in Denmark,30 Norway,31 Sweden,32 and the UK,33 which revealed rates ranging from 5.4% to 8.7% (eTable 2 in Supplement 1). Also similar across our study and these 4 studies30-33 were the rates of 1-year cumulative incidence for chronic pain at baseline, which ranged from 1.8%30 to 8.3%32 (eTable 2 in Supplement 1). The observed differences likely reflect variability in study methods, including how chronic pain was defined, the populations studied, and the length of follow-up. The rates for persistent chronic pain varied from 47.9%30 in the youngest cohort (aged ≥16 years at entry) to 93.5%32 in the oldest cohort (aged ≥65 years at entry). These rates suggest an age effect consistent with our finding that participants 50 years or older had a 29% higher adjusted RR of persistent pain than younger participants. Our ongoing research examines the underlying factors that may explain the observed differences in chronic pain incidence, persistence, and recovery rates in our study."

"In a large cohort of patients in the US prescribed stable, longterm, higher-dose opioids, undergoing opioid dose tapering was associated with statistically significant risk of subsequent overdose and mental health crisis, including suicidality."

"There has been a significant increase in cancer patients and survivors being unable to access their opioid prescriptions since 2016, when the Centers for Disease Control and Prevention (CDC) finalized opioid prescribing guidelines."

Percent of cancer patients and survivors who report being unable to get opioid prescription pain medication because the pharmacy did not have the particular drug in stock:
December 2016: 16%
May 2018: 41%

Percent of cancer patients and survivors who report being questioned by a pharmacist about why they needed their opioid pain medication:
December 2016: 16%
May 2018: 35%

Percent of cancer patients and survivors who report being unable to get their prescription pain medication because the pharmacist would not fill it for whatever reason even though the pharmacist had it in stock?
December 2016: 12%
May 2018: 27%

Percent of cancer patients and survivors who report being unable to get their opioid prescription pain medication because their insurance would not cover it:
December 2016: 11%
May 2018: 30%

Percent of cancer patients and survivors who report that their insurance company has limited them to just one pharmacy to go to for filling their opioid prescription pain medication.
December 2016: 14%
May 2018: 32%

Percent of cancer patients and survivors who report that their insurance company has reduced the number of times their opioid prescription can be refilled:
December 2016: 21%
May 2018: 36%

Percent of cancer patients and survivors who report that their insurance company has reduced the number of pills in their opioid prescription pain medication:
December 2016: 19%
May 2018: 25%

"According to the Medical Expenditure Panel Survey, the annual share of US adults who were prescribed opioids decreased from 12.9 percent in 2014 to 10.3 percent in 2016, and the decrease was concentrated among adults with shorter-term rather than longer-term prescriptions. The decrease was also larger for adults who reported moderate or more severe pain (from 32.8 percent to 25.5 percent) than for those who reported lessthan-moderate pain (from 8.0 percent to 6.6 percent). In the same period opioids were prescribed to 3.75 million fewer adults reporting moderate or more severe pain and 2.20 million fewer adults reporting less-thanmoderate pain. Because the decline in prescribing primarily involved adults who reported moderate or more severe pain, these trends raise questions about whether efforts to decrease opioid prescribing have successfully focused on adults who report less severe pain."

"In the current study, tapering was associated with absolute differences in rates of overdose or mental health crisis events of approximately 3 to 4 events per 100 person-years compared with nontapering. These findings suggest that adverse events associated with tapering may be relatively common and support HHS recommendations for more gradual dose reductions when feasible and careful monitoring for withdrawal, substance use, and psychological distress.⁹

"Previous research has examined adverse outcomes associated with discontinuing long-term opioids.^10-14 This analysis demonstrated associations between adverse outcomes and a more sensitive indicator of opioid dose reduction (≥15% from baseline). The associations persisted in sensitivity analyses that excluded patients who discontinued opioids during follow-up, suggesting that the observed associations between tapering and overdose and mental health crisis are not entirely explained by events occurring in patients discontinuing opioids. Additionally, all categories of maximum dose reduction velocity demonstrated higher relative rates of outcomes compared with the lowest (<10% per month), suggesting that risks were not confined to patients undergoing rapid tapering.

"Patients undergoing tapering from higher baseline opioid doses had higher associated risk for the study outcomes compared with patients undergoing tapering from lower baseline doses. Due to physiologic opioid tolerance,²⁷ patients receiving higher doses may have heightened intolerance of opioid dose disruption, potentially warranting additional caution in patients tapering from higher doses."

"Currently, large numbers of Americans receive inadequate pain prevention, assessment, and treatment, in part because of financial incentives that work against the provision of the best, most individualized care; unrealistic patient expectations; and a lack of valid and objective pain assessment measures. Clinicians’ role in chronic pain care is often a matter of guiding, coaching, and assist­ing patients with day-to-day self-management, but many health professionals lack training in how to perform this support role, and there is little reimbursement for their doing so. Primary care is often the first stop for patients with pain, but primary care is organized in ways that rarely allow clinicians time to perform comprehensive patient assessments. Sometimes patients turn to, or are referred to, pain specialists or pain clinics, although both of these are few in number. Unfortunately, patients often are not told, or do not understand, that their journey to find the best combination of treatments for them may be long and full of uncertainty."

"A growing number of restrictions on opioid prescribing are already impacting these patient populations."

According to a survey conducted for the American Cancer Society Cancer Action Network and the Patient Quality of Life Coalition:

Patients answering yes to "Has your doctor indicated his or her treatment options for your pain were limited by laws, guidelines, or your insurance coverage?"
Patients Being Treated For Cancer: 48%
Patients Being Treated For Chronic Pain: 40%
Patients Being Treated For Other Serious Illnesses: 56%

Patients answering yes to "Has your insurance company or pharmacy required you to only have opioid prescriptions from one doctor?"
Patients Being Treated For Cancer: 36%
Patients Being Treated For Chronic Pain: 25%
Patients Being Treated For Other Serious Illnesses: 26%

Patients answering yes to "Has your doctor refused to give you a prescription for an opioid plan medication?"
Patients Being Treated For Cancer: 35%
Patients Being Treated For Chronic Pain: 25%
Patients Being Treated For Other Serious Illnesses: 36%

Patients answering yes to "Has the pharmacist give you only part of your opioid prescription (for example: for 7 days instead of 30 days the prescription was written), and told you to call your doctor for a new prescription if you need more?"
Patients Being Treated For Cancer: 31%
Patients Being Treated For Chronic Pain: 18%
Patients Being Treated For Other Serious Illnesses: 21%

Patients answering yes to "Have you been unable to get your opioid prescription pain medication because the pharmacist or pharmacy sent you home without your prescription because they had to contact your doctor before filling the prescription?"
Patients Being Treated For Cancer: 26%
Patients Being Treated For Chronic Pain: 30%
Patients Being Treated For Other Serious Illnesses: 22%

Patients answering yes to "Has the pharmacist given you only part of your opioid prescription (for example: for 7 days instead of 30 days the prescription had been written), and told you to come back if you need more?"
Patients Being Treated For Cancer: 25%
Patients Being Treated For Chronic Pain: 26%
Patients Being Treated For Other Serious Illnesses: 26%

Patients answering yes to "Has your doctor or pharmacist told you that you have been flagged in their system as a potential opioid abuser?"
Patients Being Treated For Cancer: 21%
Patients Being Treated For Chronic Pain: 14%
Patients Being Treated For Other Serious Illnesses: 11%

"Approximately 100 million American adults experience pain from common chronic conditions, and additional millions experience short-term acute pain (Chapter 2). Many people could have better outcomes if they received incrementally better care as part of the treatment of the chronic diseases that are causing their pain. A nationwide health system straining to contain costs will be hard pressed to address the problem, however, unless early savings can be clearly demonstrated through reduced health care utilization and disability and fewer dollars wasted on ineffective treatments. The high prevalence of pain suggests that it is not being adequately treated, and undertreatment generates enormous costs to the system and to the nation’s economy (see Chapter 2)."

"It is well-documented that unrelieved pain continues to be a serious public health problem for the general population in the United States.^1-8 This issue is particularly salient for children,^9-14 the elderly,^15-19 people of racial and ethnic subgroups,^20-24 people with developmental disabilities,^25;26 people in the military or military veterans^27-30 as well as for those with diseases such as cancer,^31-36 HIV/AIDS,^37-40 or sickle-cell disease.^41-43 Clinical experience has demonstrated that adequate pain management leads to enhanced functioning and quality of life, while uncontrolled severe pain contributes to disability and despair.^4;44"

"Multiple studies that have examined why some persons who abuse prescription opioids initiate heroin use indicate that the cost and availability of heroin were primary factors in this process. These reasons were generally consistent across time periods from the late 1990s through 2013.^34-41 Some interviewees made reference to doctors generally being less willing to prescribe opioids as well as to increased attention to the issue by law enforcement, which may have affected the available supply of opioids locally.^38,40"

"'Opioid' is a generic term for natural or synthetic substances that bind to specific opioid receptors in the central nervous system (CNS), producing an agonist action. Opioids are also called narcotics—a term originally used to refer to any psychoactive substance that induces sleep. Opioids have both analgesic and sleep-inducing effects, but the two effects are distinct from each other.

"Some opioids used for analgesia have both agonist and antagonist actions. Potential for abuse among those with a known history of abuse or addiction may be lower with agonist-antagonists than with pure agonists, but agonist-antagonist drugs have a ceiling effect for analgesia and induce a withdrawal syndrome in patients already physically dependent on opioids.

"In general, acute pain is best treated with short-acting (immediate-release) pure agonist drugs at the lowest effective dosage possible and for a short time; Centers for Disease Control and Prevention (CDC) guidelines recommend 3 to 7 days (1 ). Clinicians should reevaluate patients before re-prescribing opioids for acute pain syndromes. For acute pain, using opioids at higher doses and/or for a longer time increases the risk of needing long-term opioid therapy and of having opioid adverse effects.

"Chronic pain, when treated with opioids, may be treated with long-acting formulations (see tables Opioid Analgesics and Equianalgesic Doses of Opioid Analgesics ). Because of the higher doses in many long-acting formulations, these drugs have a higher risk of serious adverse effects (eg, death due to respiratory depression) in opioid-naive patients.

"Opioid analgesics have proven efficacy in the treatment of acute pain, cancer pain , and pain at the end of life and as part of palliative care . They are sometimes underused in patients with severe acute pain or in patients with pain and a terminal disorder such as cancer, resulting in needless pain and suffering. Reasons for undertreatment include
"Underestimation of the effective dose
"Overestimation of the risk of adverse effects

"Generally, opioids should not be withheld when treating acute, severe pain; however, simultaneous treatment of the condition causing the pain usually limits the duration of severe pain and the need for opioids to a few days or less. Also, opioids should generally not be withheld when treating cancer pain; in such cases, adverse effects can be prevented or managed, and addiction is less of a concern.

"Duration of opioid trials for chronic pain due to disorders other than terminal disorders (eg, cancer) has been short. Thus, there is little evidence to support opioid therapy for long-term management of chronic pain due to nonterminal disorders. Also, serious adverse effects of long-term opioid therapy (eg, opioid use disorder [addiction], overdose, respiratory depression, death) are being increasingly recognized. Thus, in patients with chronic pain due to nonterminal disorders, lower-risk nonopioid therapies should be tried before opioids; these therapies include
"Nonopioid drugs
"Complementary (integrative) medicine techniques (eg, acupuncture, massage, superficial electrical stimulation)
"Cognitive-behavioral techniques
"Interventional therapies (epidural injections, joint injections, nerve blocks, nerve ablation, spinal or peripheral nerve stimulation)

"In patients with chronic pain due to nonterminal disorders, opioid therapy may be considered, but usually only if nonopioid therapy has been unsuccessful. In such cases, opioids are used (often in combination with nonopioid therapies) only when the benefit of pain reduction and functional improvement outweighs the risks of opioid adverse effects and misuse. Obtaining informed consent may help clarify the goals, expectations, and risks of treatment and facilitate education and counseling about misuse.

"Patients receiving long-term (> 3 months) opioid therapy should be regularly assessed for pain control, functional improvement, adverse effects, and signs of misuse. Opioid therapy should be considered a failed treatment and should be tapered and stopped if the following occur:
"Patients have persistent severe pain despite increasing opioid doses.
"Patients do not adhere to the terms of treatment.
"Physical or mental function do not improve.

"Physical dependence (development of withdrawal symptoms when a drug is stopped) should be assumed to exist in all patients treated with opioids for more than a few days. Thus, opioids should be used as briefly as possible, and in dependent patients, the dose should be tapered to control withdrawal symptoms when opioids are no longer necessary. Patients with pain due to an acute, transient disorder (eg, fracture, burn, surgical procedure) should be switched to a nonopioid drug as soon as possible. Dependence is distinct from opioid use disorder (addiction), which, although it does not have a universally accepted definition, typically involves compulsive use and overwhelming involvement with the drug, including craving, loss of control over use, and use despite harm."

"The under-treatment of pain is due in part to a kind of undesirable 'chilling effect.' The concept of a chilling effect, generally, is a useful law enforcement tool. When publicity surrounding a righteous prosecution 'chills' related criminal conduct, that chilling effect is intended, appropriate, and a public good. A chilling effect on the appropriate use of pain medicine, however, is not a public good. Recent research by members of the Law Enforcement Roundtable confirms that prosecutions of doctors for diversion of prescription drugs are rare.² But, on occasion, overly-sensationalized stories of investigation of doctors have hit the nightly news. When that happens, the resulting chilling effect reaches far beyond a 'good' chilling effect on bad actors, and directly affects appropriate medical practice. The consequence is extreme, and not what law enforcement would ever seek – our parents and other loved ones who are in pain simply cannot get the medicines they need."

"Persons with substance use disorders are less likely than others to receive effective pain treatment (Rupp and Delaney, 2004). The primary reason is clinicians' concern that they may misuse opioids. Although mild to moderate pain can often be treated effectively with a combination of physical modalities (e.g., ice, rest, and splints) and nonopioid analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen, or other adjuvant medications), management of severe pain, especially when cancer-related, often requires opioids. Moreover, physicians are increasingly using opioids to treat chronic non-cancer-related pain, and an emerging body of evidence suggests that, for some patients, this approach both reduces pain and may foster modest improvements in function and quality of life (Devulder, Richarz, and Nataraja, 2005; Haythornthwaite et al., 1998; Kalso et al., 2004; Martell et al., 2007; Noble et al., 2008; Passik et al., 2005; Portenoy et al., 2007; Portenoy and Foley, 1986)."

"Mild to moderate acute pain is often relieved by physical interventions—such as the application of ice, transcutaneous electrical nerve stimulation (TENS), massage or stretching, and/or bracing—along with a mild analgesic such as an NSAID or acetaminophen. More severe pain often requires opioid therapy, which will be discussed in depth below. When appropriately skilled clinicians are available in a system that is comfortable supporting such treatments, nerve blocks or spinal infusions can sometimes control more severe acute pain. Examples of common acute pain procedures are rib blocks for rib fractures or thoracic incisions; epidural infusions for thoracic, abdominal, or lower body surgery or trauma; and brachial plexus infusions for upper extremity postsurgical or trauma-related pain.
"Clinicians should generally not let concerns about addiction deter them from using opioids that are needed for severe acute pain. Carefully supervised short-term use of opioids in the context of time-limited treatment of such pain has not been documented to affect the long-term course of addictive disorders. Rather, inadequate pain control and treatment that frustrates, stresses, or confuses patients may lead to relapse (Wasan et al., 2006)."

"The US Drug Enforcement Administration introduced a schedule change for hydrocodone combination products in October 2014. During the period of our study, October 2013 to July 2016, the percentage of total drug sales represented by prescription opioids in the US doubled from 6.7% to 13.7%, which corresponds to a yearly increase of 4 percentage points in market share. It is not possible to determine the location of buyers from cryptomarket data. We cannot know, for example, if a drug shipped from a vendor in Europe was purchased by a US customer. Nevertheless, cryptomarket users often prefer buying and selling from vendors in the same country; international shipments carry risks of loss, interception by officials, and increased delivery times. A study of cryptomarkets in Australia found that local vendors were often preferred over international counterparts, despite substantially higher prices.²⁴ Another study³⁶ also noted the downward trends of international sales and therefore an increase in domestic sales, and yet another study⁴⁷ found that drug trading through cryptomarket is heavily constrained by offline geography. This preference for domestic trading, combined with the relatively large numbers of US drug vendors trading in cryptomarkets, leads us to presume that most sales of prescription drugs by US vendors will be sold to customers based in the US. Conversely, most transactions generated by non-US vendors will not be sold to US customers.

"The results of our interrupted time series suggest the possibility of a causal relation between the schedule change and the percentage of sales represented by prescription opioids on cryptomarkets. Our analysis cannot rule out other possible causal explanatory factors, but our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids. This possibility is reinforced by the fact that the increased availability and sales of prescription opioids on cryptomarkets in the US after the schedule change was not replicated for cryptomarkets elsewhere.

"Our results are consistent with the possibility of demand led increases. The first increase observed for prescription opioids was for actual sales (fig 1); with increases for active listings, and then all listings, following. One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply. Our results are also consistent with the iron law of prohibition³⁴ insofar as we identified the largest sales increases for more potent prescription opioids—specifically, oxycodone and fentanyl. Cryptomarkets may function as a supply gateway⁴⁸: customers who initially sought out illicit hydrocodone on cryptomarkets after the schedule change might then have favoured more potent opioids available on the marketplace."

"A number of barriers to effective pain care involve the attitudes and training of the providers of care. First, health professionals may hold negative attitudes toward people reporting pain and may regard pain as not worth their serious attention. As discussed in detail in Chapter 2, patients can be at a particular disadvantage if they are members of racial or ethnic minorities, female, children, or infirm elderly. They also may have less access to care if they are perceived as drug seeking or if they have, or are perceived to have, mental health problems. A literature review showed that people with pain, especially women, often have attitudes and goals that are different from, and sometimes opposed to, the attitudes and goals of their practitioners; patients seek to have their pain legitimized, while practitioners focus on diagnosis and therapy (Frantsve and Kerns, 2007). Consumers testified before the committee that patients often believe practitioners trivialize pain, which makes them feel even worse. Researchers working with patient focus groups have noted the 'perceived failures of providers to fully respect, trust, and accept the patient, to offer positive feedback and support, and to believe the participants’ reports of the severity and adverse effects of their pain' (Upshur et al., 2010, p. 1793)."

"Opioid medications also have a potential for abuse (a discussion of this important issue is in the Executive Summary and Section III of the Evaluation Guide 2013). Consequently, opioid analgesics and the healthcare professionals who prescribe, administer, or dispense them are regulated pursuant to federal and state controlled substances laws, as well as under state laws and regulations that govern professional practice.^70;71 Such policies are intended to prevent illicit trafficking, drug abuse, and substandard practice related to prescribing and patient care. However, in some states these policies go well beyond the usual framework of controlled substances and professional practice policy, and can negatively affect legitimate healthcare practices and create undue burdens for practitioners and patients,^72-76 resulting in interference with appropriate pain management.

"Examples of such policy language include:
  "• Limiting medication amounts that can be prescribed and dispensed for every patient;
  "• Unduly restricting the period for which prescriptions are valid;
  "• Unconditionally denying treatment access to patients with pain who also have a history of substance abuse;
  "• Requiring special government-issued prescription forms only for a certain class of medications;
  "• Requiring opioids to be a treatment of last resort regardless of the clinical situation;
  "• Using outdated definitions that confuse physical dependence with addiction; and
  "• Defining 'unprofessional conduct' to include 'excessive' prescribing, without defining the standard or criteria under which such a determination is made."

"During long-term treatment, the effective opioid dose can remain constant for prolonged periods. Some patients need intermittent dose escalation, typically in the setting of physical changes that suggest an increase in the pain (eg, progressive neoplasm). Fear of tolerance should not inhibit appropriate early, aggressive use of an opioid. If a previously adequate dose becomes inadequate, that dose must usually be increased by 30 to 100% to control pain."

"The research findings noted above need to be set against the testimony of people with pain, many of whom derive substantial relief from opioid drugs. This tension perhaps reflects the complex nature of pain as a lived experience, as well as the need for biopsychosocial assessments and treatment strategies that can maximize patients’ comfort and minimize risks to them and society. Regardless, the majority of people with pain use their prescription drugs properly, are not a source of misuse, and should not be stigmatized or denied access because of the misdeeds or carelessness of others."

"In our study, there was greater evidence for an association between substance use and chronic pain among inpatients than among MMTP [Methadone Maintenance Treatment Program] patients. Among inpatients, there were significant bivariate relationships between chronic pain and pain as a reason for first using drugs, multiple drug use, and drug craving. In the multivariate analysis, only drug craving remained significantly associated with chronic pain. Not surprisingly, inpatients with pain were significantly more likely than those without pain to attribute the use of alcohol and other illicit drugs, such as cocaine and marijuana, to a need for pain control. These results suggest that chronic pain contributes to illicit drug use behavior among persons who were recently using alcohol and/or cocaine. Inpatients with chronic pain visited physicians and received legitimate pain medications no more frequently than those without pain, raising the possibility that undertreatment or inability to access appropriate medical care may be a factor in the decision to use illicit drugs for pain."

"In the United States, many pain experts agree that physicians should prescribe opioids when necessary regardless of outside pressures as an exercise of their 'moral and ethical obligations to treat pain' (Payne et al., 2010, p. 11). For some time, observers have attributed U.S. patients’ difficulty in obtaining opioids to pressures on physicians from law enforcement and risk-averse state medical boards. Federal and state drug abuse prevention laws, regulations, and enforcement practices have been considered impediments to effective pain management since 1994, when the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality [AHRQ]) adopted clinical practice guidelines on cancer pain (Jacox et al., 1994a,b).
"Like AHRQ, the American Medical Directors Association (nursing home physicians) and American Geriatrics Society cite delays in access to prescribed opioids for nursing home patients, including those who are terminally ill, and the American Cancer Society has recognized the frequent inaccessibility of ­opioids necessary for treating some pain. The American Pain Society has developed evidence-based guidelines for controlling cancer pain, including the use of opioids when other treatments fail or when severe pain relief needs must be met immediately (Gordon et al., 2005). Fourteen years ago, the Institute of Medicine Committee on Care at the End of Life called for efforts to reduce regulatory barriers to pain relief at the end of life and termed some regulatory restrictions 'outdated and flawed' (IOM, 1997, p. 56)."

"Opioid medications present some risk of abuse by patients as well. A structured review of 67 studies found that 3 percent of chronic noncancer pain patients regularly taking opioids developed opioid abuse or addiction, while 12 percent developed aberrant drug-related behavior (Fishbain et al., 2008). A recent analysis revealed that half of patients who received a prescription for opioids in 2009 had filled another opioid prescription within the previous 30 days, indicating that they were seeking and obtaining more opioids than prescribed by any single physician (NIH and NIDA, 2011)."

"Undertreatment of pain among African Americans has been well documented. For example, children with sickle-cell anemia (a painful disease that occurs most often among African Americans) who presented to hospital emergency departments (EDs) with pain were far less likely to have their pain assessed than were children with long-bone fractures (Zempsky et al., 2011).
"In general, moreover, a number of studies have shown that physicians tend to prescribe less analgesic medication for African Americans than for whites (Bernabei et al., 1998; Edwards et al., 2001; Green and Hart-Johnson, 2010). A study that used a pain management index to evaluate pain control found that blacks were less likely than whites to obtain prescriptions for adequate pain relief, based on reported pain severity and the strength of analgesics provided. Because such an index is a way to quantify a person’s response to pain medication alone, it is likely that people in this study did not receive other types of treatment for pain either."

"Prescribers wrote 82.5 OPR [Opioid Pain Reliever] prescriptions and 37.6 benzodiazepine prescriptions per 100 persons in the United States in 2012 (Table). LA/ER [Long-Acting or Extended Release] OPR accounted for 12.5%, and high-dose OPR accounted for 5.1% of the estimated 258.9 million OPR prescriptions written nationwide. Prescribing rates varied widely by state for all drug types. For all OPR combined, the prescribing rate in Alabama was 2.7 times the rate in Hawaii."

"We identified a total of 986 cases over the 1998–2006 study time frame in which physicians had been criminally charged and/or administratively reviewed with offenses involving the prescribing of opioid analgesics. 335 were criminal cases (178 state, 157 federal) and 651 were administrative cases (525 state medical board cases, 126 DEA administrative actions regarding CS registrations).

"Numbers and Specialties of Study Physicians

"The 725 individual physicians involved in these cases over the study time period represent 0.1% of the total 691,873 patient-care physicians active in 2003, or one out of 954 physicians.

"As shown in Table 1, General Practice/Family Medicine physicians comprised the largest proportion of physicians involved in the criminal and administrative cases (39.3%). Pain Medicine specialists, both self-identified and board certified, comprised 3.5% of the physicians involved in these cases."

"PWUD demonstrated a predominantly protective approach to xylazine emergence by modifying their drug consumption routes and reducing injection drug use, aiming to mitigate potential harms associated with xylazine adulteration. While often discussed in the context of xylazine here, this echoes a broader literature that reveals an elevated prevalence of smoking among people who previously injected opioids on the West Coast of North America [30–32].

"Xylazine use has been associated with severely necrotizing skin infections that produce wounds even distal to the injection site or when individuals are smoking [10, 12, 33]. While more research is needed on the health implications of transitioning away from injection drug use towards other routes of administration (e.g., smoking) and its consequences, it is possible that transitioning away from injecting could reduce the likelihood of tissue necrosis or subsequent SSTIs [34]. However, it is still unclear if transitioning from injecting to smoking opioids (especially those adulterated with xylazine) decreases one’s risk for overdose and what the impacts are on cardiovascular health [35].

"While clients’ reliance on alternative consumption routes and peer networks for safety highlights the importance of peer-based harm reduction approaches, increased stimulant use and ‘human testing’ practices, intended to counteract xylazine’s sedative effects and verify drug safety, raises concerns about heightened susceptibility to overdose and other adverse outcomes [3, 36]. Increased polysubstance use with stimulants may increase clients’ overall drug consumption, thereby increasing their risk for additional adverse events (e.g., cardiac arrest, overdose, and SSTIs) [37–39]. Also, reports of using drugs alone underscore the need for additional interventions to address social isolation and enhance safety while people consume unregulated substances. One such intervention that may overcome these challenges could be implementing a phone-based overdose response service, as seen in Canada [40].

"The phenomenon of clients seeking out xylazine for its unique effects challenges existing literature on individuals’ preferences for xylazine and has implications for addiction treatment in the context of an evolving drug supply [41–43]. For example, more research is needed to develop guidelines for managing buprenorphine initiation while individuals are using xylazine-adulterated opioids to help mitigate anxiety and xylazine-related withdrawal symptoms [44]. On the other hand, despite efforts to reduce exposure to xylazine, some clients reported increasing their consumption of opioids, driven by the need to counteract diminished opioid availability and withdrawal symptoms associated with xylazine’s short half-life [45]. This finding contradicts previous hypotheses suggesting xylazine’s role in extending the duration of opioids’ effects [12, 46], indicating a nuanced interplay between substance availability, dependence, and desired effects."

"Migraine headaches are a major public health problem affecting more than 28 million persons in this country.¹ Nearly 25 percent of women and 9 percent of men experience disabling migraines.^2,3 The impact of these headaches on patients and their families is tremendous, with many patients reporting frequent and significant disability.⁴ The economic burden of migraine headaches in the United States is also tremendous. Persons with migraines lose an average of four to six work days each year, with an annual total loss nationwide of 64 to 150 million work days. The estimated direct and indirect costs of migraine approach $17 billion.^5,6 Despite the prevalence of migraines and the availability of multiple treatment options, this condition is often undiagnosed and untreated.⁷ About one half of patients stop seeking medical care for their migraines, in part because of dissatisfaction with the therapy they have received.⁴"

"In the future, the global need for pain medicine will increase rapidly. In developed and developing countries, the world’s population is aging, resulting in an increase of the prevalence of chronic, painful conditions and cancer. By 2025, there will be 1.2 billion people over the age of 60, which is double the current estimate of 600 million.¹⁴ Future demand for such care is also expected to rise due to the dramatically expanding prevalence of HIV/AIDS in several parts of the world. Tragically, the greatest need for pain relief is increasingly concentrated in developing countries, where access to morphine and other opioid analgesics is inadequate or non-existent. For example, WHO estimates that the burden of cancer will increasingly shift from industrialized countries to developing states, so that by the year 2020, 70 percent of the estimated 20 million new cancer cases will occur in developing states.¹⁵"

"Approximately 19.0% of adults in the United States reported persistent pain in 2010, but prevalence rates vary significantly by subgroup (Table 1). Older adults are much more likely to report persistent pain than younger adults, with adults aged 60 to 69 at highest risk (AOR = 4.0, 95% CI = 2.7–5.8). Women are at slightly higher risk than men (AOR = 1.4, 95% CI = 1.2–1.7), as are adults who did not graduate from high school (AOR = 1.3, 95% CI = 1.1–1.7). Approximately half of adults who rated their health as fair or poor say they suffer from persistent pain (AOR = 4.7, 95% CI = 3.7–6.0). Recent hospitalization (AOR = 1.6, 95% CI = 1.3–2.1) and obesity (AOR = 1.6, 95% CI = 1.3–2.0) are also linked to higher rates of persistent pain. In contrast, Latino (AOR = .5, 95% CI = .4–.6) and African American (AOR = .6, 95% CI = .4–.7) adults are less likely to report persistent pain than their white counterparts."

"Costly team care, expensive medications, and procedural interventions—all common types of treatment for pain—are not readily obtained by the 19 percent of Americans under age 65 who lack health insurance coverage (Holahan, 2011) or by the additional 14 percent of under-65 adults who are underinsured (Schoen et al., 2008). Together, these groups make up one-third of the nation’s population. Lack of insurance coverage also may contribute to disparities in care. An inability to pay for pain care is especially prevalent among minorities and women (Green et al., 2011). As discussed above, even for people with insurance coverage, third-party reimbursement systems tend not to cover or to cover well psychosocial services and team approaches that represent the best care for people with the most difficult pain problems. Surmounting this barrier may require coordinated action by advocates for improvement."

"Adequate pain treatment and follow-up may be thwarted by a mix of uncertain diagnosis and the societal stigma that is applied, consciously or unconsciously, to people reporting pain, particularly if they do not respond readily to treatment. Questions and reservations may cloud perceptions of clinicians, family, employers, and others: Is he really in pain? Is she drug seeking? Is he just malingering? Is she just trying to get disability payments? Certainly, there is some number of patients who attempt to 'game the system' to obtain drugs or disability payments, but data and studies to back up these suspicions are few. The committee members are not naïve about this possibility, but believe it is far smaller than the likelihood that someone with pain will receive inadequate care. Religious or moral judgments may come into play: Mankind is destined to suffer; giving in to pain is a sign of weakness. Popular culture, too, is full of dismissive memes regarding pain: Suck it up; No pain, no gain."

"The potential impact of the growing prevalence of pain on the health care system is substantial. Although not all people with chronic low back pain are treated within the health care system, many are, and 'back problems' are one of the nation’s 15 most expensive medical conditions. In 1987, some 3,400 Americans with back problems were treated for every 100,000 people; by 2000, that number had grown to 5,092 per 100,000. At the same time, health care spending for these treatments had grown from $7.9 billion to $17.5 billion. Thorpe and colleagues (2004) estimate that low back pain alone contributed almost 3 percent to the total national increase in health care spending from 1987 to 2000. While about a quarter of the $9.5 billion increase could be attributable to increased population size, and close to a quarter was attributable to increased costs of treatment, more than half of the total (53 percent) was attributable to a rise in the prevalence of back problems."

"Pain is a significant public health problem. Chronic pain alone affects approximately 100 million U.S. adults. Pain reduces quality of life, affects specific population groups disparately, costs society at least $560-635 billion annually (an amount equal to about $2,000 for everyone living in the United States), and can be appropriately addressed through population health-level interventions."

"In this emulated trial including more than 400 000 episodes of stable long-term opioid therapy, opioid tapering was associated with a small (0.15%) absolute increase in the risk of overdose or suicide events compared with a stable dosage during 11 months of follow-up. We did not identify a difference in the risk of overdose or suicide events between abrupt discontinuation and stable dosage, although the smaller number of episodes categorized as abrupt discontinuation may have reduced precision. The findings were robust to secondary and sensitivity analyses.

"The risk ratio of 1.15 for opioid overdose or suicide events associated with opioid tapering was smaller than in past studies conducted in other populations. This study examined commercially insured individuals receiving a stable long-term opioid dosage without evidence of opioid misuse. A large study of Veterans Health Administration patients estimated adjusted hazard ratios between 1.7 and 6.8 for the association of treatment discontinuation with suicide or overdose among patient subgroups defined by length of prior treatment.¹⁷ A study of Oregon Medicaid recipients found adjusted hazard ratios for suicide of 3.6 for discontinuation and 4.5 for tapering.¹⁸ A study using the same claims data set and similar definition of long-term opioid therapy as our study identified effect estimates between those in our study and those in prior studies, with an estimated adjusted incidence rate ratio of 1.3 for the association of dose tapering with overdose and 2.4 for the association of dose tapering with suicide attempts.³²"

"Despite reassurances brought by the 2022 Supreme Court ruling in Ruan v. US,¹³ many clinicians have abruptly reduced or discontinued prescription opioids,¹⁴ restricting access to primary care for patients^{15, 16} and potentially facilitating a transition to the illicit market where overdose and death are frighteningly common.^{17, 18} It is at this unique and dynamic intersection between the domains of public health and public safety that proprietary technologies marketed as clinical decision support (CDS) tools have entered clinical care without rigorous external validation, public data sharing, or regulatory approval.

"Bamboo Health’s NarxCare is one such technology: a PDMP-based analytics platform marketed as a CDS tool for physicians, pharmacists, and policymakers.¹⁹ Its patented algorithm, embedded into clinic workflows, generates multiple “Narx Scores” purporting to represent a patient’s risk of non-medical use of prescription “narcotics” (opioids), sedatives, and stimulants, and a composite score quantifying the overall risk of overdose death.²⁰ Clinicians view Narx Scores prominently displayed—such as next to a patient’s height, weight, and allergies²¹—in electronic medical record (EMR) systems across over 45 states, and in national pharmacies such as Sam’s Club and Walmart. Although it is unclear exactly how Narx Scores are used clinically, Bamboo Health’s promotional materials suggest NarxCare’s rapid implementation—amplified by near-universal state PDMP mandates—has positioned it to impact over one billion patient encounters annually across the US.^21"

"Even though opioids have been controlled in the United States with regulations and restrictions, opioid utilization has been increasing at an unprecedented pace (1-10). Manchikanti et al (1), in an evaluation of opioid usage over a period of 10 years, showed an overall increase of 149% in retail sales of opioids from 1997 to 2007 in the United States, with an increase of 1,293% for methadone, 866% for oxycodone, and 525% for fentanyl. Similarly, the increase in therapeutic opioid use in the United States in milligrams per person from 1997 to 2007 increased 402% overall, with the highest increase in methadone of 1,124% mg/person and oxycodone of 899% mg/person."

"While we do not know exactly which data elements are included in NarxCare, evidence suggests the algorithm differentially identifies individuals on the basis of work status, disability, and insurance, among other characteristics.⁴² Cochran et al.³⁴ found patients with higher pain severity or interference, those who were widowed, on leave, retired, or disabled, were most likely to have artificially elevated Narx Scores (“false positives”). As the authors hypothesize, it is possible that patients with unmanaged pain related to work status or disability now also experience challenges accessing care due to having an artificially elevated Narx Score. Furthermore, individual proxy measures likely used in NarxCare’s algorithm target patients with complex medical histories. For example, one study found that 20% of patients identified as “doctor-and-pharmacy shopping” according to a commonly accepted definition using prescription-level data—a factor likely included in NarxCare’s algorithm—were in fact diagnosed with cancer, thus necessitating visits with multiple providers to adhere to complex treatment regimens.⁴³ Patients without a primary care clinician, and/or those who see multiple different clinicians to manage pain associated with a complex medical condition (such as cancer), may be incorrectly flagged as high risk by NarxCare’s algorithm and create barriers to getting the care they need.

"Perhaps most concerning is that proprietary CDS tools carry the potential to incorporate additional data sources that reflect systemic inequalities in society, yet are unrelated to clinical care. Any company with access to various types of data (ex., credit history, zip code, educational attainment, or criminal justice history, among others) has the capacity to include these data elements in their proprietary algorithms without announcing it publicly. In the case of predictive modeling formulaic algorithms such as NarxCare, the harms of doing so may be amplified. By using retrospective data elements as proxy measures, predictive modeling algorithms predict future patterns of behavior by modeling past patterns of behavior. They are not designed to identify or address the root causes of the patterns predicted, and in this sense, they can perpetuate, rather than address, the disparities in place when the algorithm was created.

"This context is alarming as the medical community grapples with an increased awareness that clinical algorithms have the potential to discriminate—exemplified by the race adjustment embedded in the formula calculating glomerular filtration rate (GFR) that was used in clinical care and accepted by clinicians for decades without question, despite causing racial inequities in access to life-saving treatment.^{44, 45} Although Bamboo Health’s current promotional materials state only data from PDMP registries are included in NarxCare’s algorithm,¹⁹ state PDMP user manuals as recently as May 2020 stated that the platform could and will incorporate non-PDMP data sources in the future.²⁰ It is already known that several states incorporate criminal justice histories into their PDMPs.^{10, 42} Furthermore, as recently as 2021 Bamboo Health belonged to an umbrella organization—Appriss—responsible for designing software leveraging outstanding warrants and incarceration status to predict patterns of criminal activity for law enforcement.^{44, 46} Regardless of whether criminal justice information—or other types of data unrelated to clinical care—are included in NarxCare, Bamboo Health has not sufficiently reassured clinicians that its algorithm is free from potentially discriminating sources of data. Furthermore, its opaque nature does not allow us to determine for ourselves whether this is the case."

"The government is waging an aggressive, intemperate, unjustified war on pain doctors. This war bears a remarkable resemblance to the campaign against doctors under the Harrison Act of 1914, which made it a criminal felony for physicians to prescribe narcotics to addicts. In the early 20th century, the prosecutions of doctors were highly publicized by the media and turned public opinion against physicians, painting them not as healers of the sick but as suppliers of narcotics to degenerate addicts and threats to the health and security of the nation."

"DEA has increased enforcement efforts to prevent abuse and diversion of OxyContin. From fiscal year 1996 through fiscal year 2002, DEA initiated 313 investigations involving OxyContin, resulting in 401 arrests. Most of the investigations and arrests occurred after the initiation of the action plan. Since the plan was enacted, DEA initiated 257 investigations and made 302 arrests in fiscal years 2001 and 2002. Among those arrested were several physicians and pharmacists. Fifteen health care professionals either voluntarily surrendered their controlled substance registrations or were immediately suspended from registration by DEA. In addition, DEA reported that $1,077,500 in fines was assessed and $742,678 in cash was seized by law enforcement agencies in OxyContin-related cases in 2001 and 2002."

"Neuropathic pain (NP) is defined as pain caused by a lesion or disease of the central or peripheral somatosensory nervous system.[1] NP affects between 5% and 10% of the US population [2] and examples include diabetic neuropathy, complex regional pain syndrome, radiculopathy, phantom limb pain, HIV sensory neuropathy, multiple sclerosis-related pain, and poststroke pain.[3]"

Researchers used data from the American Productivity Audit to measure lost productivity in the US due to common pain conditions. In an article published in the Journal of the American Medical Association in 2003, they reported that "Overall, the estimated $61.2 billion per year in pain-related lost productive time in our study accounts for 27% of the total estimated work-related cost of pain conditions in the US workforce."

"National survey data that provide detailed data on use of treatments are limited. Of the common pain conditions, sufficient details have only been reported on migraine headaches. Recent data indicate that only 41% of individuals who have migraine headaches in the US population ever receive any prescription drug for migraine. Only 29% report that satisfaction with treatment is moderate, especially among those who are often disabled by their episodes. Randomized trials demonstrate that optimal therapy for migraine dramatically reduces headache-related disability time in comparison with usual care."

"Our estimate of $61.2 billion per year in pain-related lost productive time does not include costs from⁴ other causes. First, we did not include lost productive time costs associated with dental pain, cancer pain, gastrointestinal pain, neuropathy, or pain associated with menstruation. Second, we do not account for pain-induced disability that leads to continuous absence of 1 week or more. Third, we did not consider secondary costs from other factors such as the hiring and training of replacement workers or the institutional effect among coworkers. Taking these other factors into consideration could increase, decrease, or have no net effect on health-related lost productive time cost estimates. Fourth, we may be prone to underestimating current lost productive time among those with persistent pain problems (eg, chronic daily headache). To the extent that these workers remain employed,they may adjust both their performance and perception of their performance over time. The latter, a form of perceptual accommodation, makes it difficult to accurately ascertain the impact of a chronic pain condition on work in the recent past through self-report."

"An important message from epidemiologic studies cited by Blyth and colleagues (2010) is 'the universal presence across populations of characteristic subgroups of people with an underlying propensity or increased risk for chronic pain, in the context of a wide range of different precipitating or underlying diseases and injuries' (p. 282). These vulnerable subgroups are most often those of concern to public health.⁵ Increased vulnerability to pain is associated with the following:
"• having English as a second language,
"• race and ethnicity,
"• income and education,
"• sex and gender,
"• age group,
"• geographic location,
"• military veterans,
"• cognitive impairments,
"• surgical patients,
"• cancer patients, and
"• the end of life.
"Many of these same groups also are at risk of inadequate treatment."

"Dunn et al⁴ found that risk of drug-related adverse events among individuals treated for chronic noncancer pain with opioids was increased at opioid doses equivalent to 50 mg/d or more of morphine. Our analyses similarly found that the risk of opioid overdose increased when opioid dose was equivalent to 50 mg/d or more of morphine.

"The present study also extended prior research in several important ways. We used a large, national sample of individuals and focused exclusively on opioid overdose deaths. Because the circumstances that lead to overdose death may vary by the condition for which the opioid is prescribed and substance use disorder status, we conducted analyses for subgroups of patients, including those with cancer, acute pain, and substance use disorders.

"The present study also extended the prior research by exploring a novel risk factor, ie, concurrent prescriptions of regularly scheduled and as-needed opioids. We found that those patients who were simultaneously treated with as-needed and regularly scheduled opioids, a strategy for treating pain exacerbations,^7,8 did not have a statistically significant increased risk of opioid overdose in adjusted models. Recent treatment guidelines have indicated that the long-term safety of this strategy for pain exacerbation has not been established,^5,9 and in the present study we did not find evidence of greater overdose risk associated with this treatment practice after accounting for maximum daily dose and patient characteristics."

"The undertreatment of pain is a significant concern in populations with chemical dependency. In painful disorders for which there is a broad consensus about the role of opioid therapy, specifically cancer and AIDS-related pain, studies have documented that this treatment commonly diverges from accepted guidelines. Undertreatment is far more challenging to assess when a broad consensus concerning optimal treatment approaches does not exist. It would be difficult, therefore, to determine the extent to which the pain and functional impairments experienced by patients in this study relate to inadequate pain management. However, given the number of barriers identified as potential reasons for inadequate pain management, it is appropriate to raise concerns about undertreatment and to investigate it further."

"The most common reason cited as a barrier to opioid availability was low demand (93.1%). However, this did not vary by opioid analgesic sufficiency, pharmacy racial composition, pharmacy type, level of zip code urbanization, level of opioid analgesic supply, median age, household income, or proportion of residents ?65 years old. The fear that patients might use opioid analgesics for illicit purposes was the second most prevalent barrier identified (8.5%). Concern with illicit opioid analgesic use was more likely to be reported as a barrier by pharmacies with insufficient opioid analgesic supplies when compared with those with sufficient supplies (30.3% vs 4.3%; P ? .01). Again, this did not vary by pharmacy racial composition, pharmacy type, level of zip code urbanization, median age, household income, or proportion of residents ?65 years old. Too much paperwork (1%) and fear of robbery (1%) were rarely identified as potential reasons for opioid analgesic unavailability. Measures of association between covariates and barriers were not computed for the least common barriers (ie, too much paperwork, fear of robbery, and drug disposal regulations) because of empty cells. Other responses cited for failing to supply opioid analgesics (eg, pharmacy was located in a small community, pharmacy was near a major medical center, and community residents do not have adequate health insurance coverage) were of low frequency and were not analyzed further."

"Factors affecting the severity of pain in the elderly include

"• complex manifestations of pain;

"• underreporting of pain;

"• concurrent problems and multiple diseases (comorbidities), which complicate diagnosis and treatment;

"• higher rates of medication side effects; and

"• higher rates of treatment complications (American Geriatrics Society, 2009).

"In general, these same factors also contribute to the documented undertreatment of pain in the elderly, along with the lack of an evidence base concerning the pharmacokinetic and pharmacodynamic changes that occur with aging (Barber and Gibson, 2009). Similar to the situation with children in the past, elderly people rarely are included in clinical trials of medications, so clinicians have inadequate information about appropriate dosages and potential interactions with medications being taken for other chronic diseases (Barber and Gibson, 2009).

"A study of more than 13,000 people with cancer aged 65 and older discharged from the hospital to nursing homes found that, among the 4,000 who were in daily pain, those aged 85 and older were more than 1.5 times as likely to receive no analgesia than those aged 65-74; only 13 percent of those aged 85 and older received opioid medications, compared with 38 percent of those aged 65-74 (Bernabei et al., 1998). (A similar excess risk of receiving no analgesia was found among African Americans, Hispanics, and Asians compared with whites.)"

"Disparities in pain assessment and treatment on the basis of race and ethnicity are well documented.²⁹ Diminished ability to obtain access to opioid analgesics in local pharmacies is a significant barrier to quality pain care. The present investigation provides evidence that Michigan pharmacies in predominantly minority areas were significantly less likely to have sufficient prescription opioid analgesic supplies when compared with predominantly white areas. Regardless of median income and median age, significant differences were found in opioid analgesic availability on the basis of ethnic composition. These results support the findings of Morrison et al³⁸ that pharmacies in predominantly minority neighborhoods stock insufficient opioid analgesic supplies more so than those in predominantly white neighborhoods. However, these results also extend their findings by demonstrating the role of both social class and income on opioid analgesic availability. More specifically, the odds for not having sufficient opioid analgesic supplies are significantly higher among pharmacies in low income areas when compared with higher income areas, regardless of race. More importantly, we identified that the odds of having insufficient supplies in minority neighborhoods changed significantly on the basis of income (ie, high or low) (OR, 13.36 vs 54.42). Thus, social class and poverty seem to play a role for whites more so than minorities. Noncorporate pharmacies were also more likely to have sufficient opioid analgesic supplies than corporate pharmacies. These results suggest that if an opioid analgesic is prescribed for pain management, persons living in minority zip codes (even in higher income areas) or those living in low income zip codes (regardless of minority status) face additional barriers to quality pain care. Thus, vulnerable populations (eg, minorities and low income individuals) are at increased risk for inefficient and lesser quality pain care."

"Current estimates suggest that upward of 80% of the world’s population lacks access to basic pain relief [6]. Paradoxically, those 80% are mostly in poorer countries, and their need for pain relief is heightened by a relative absence of curative care such as surgery, or treatment for both communicable and non-communicable diseases causing pain (e.g., HIV/AIDS, cancer)[7]."

"We determined per capita need of strong opioids for pain related to three important pain causes for 188 countries. These needs were extrapolated to the needs for all the various types of pain by using an adequacy level derived from the top 20 countries in the Human Development Index. By comparing with the actual consumption levels for relevant strong opioid analgesics, we were able to estimate the level of adequacy of opioid consumption for each country. Good access to pain management is rather the exception than the rule: 5.5 billion people (83% of the world’s population) live in countries with low to nonexistent access, 250 million (4%) have moderate access, and only 460 million people (7%) have adequate access. Insufficient data are available for 430 million (7%). The consumption of opioid analgesics is inadequate to provide sufficient pain relief around the world. Only the populations of some industrialized countries have good access."

"Opioid medications are essential not only for drug dependence treatment but also for pain management. WHO estimates that 5 billion people live in countries with little or no access to controlled medicines that are used to treat moderate to severe pain.⁹⁰ Up to 80% of the estimated 1 million patients in the end stages of AIDS are in great pain, but very few have access to pain relieving drugs⁹¹ because of insufficient knowledge among physicians, inadequate health systems, fears of addiction, antiquated laws, and unduly strict regulations.⁹²"

"Mean treatment results demonstrated in the present study obscure variations at the individual patient level. Some older patients with chronic pain may receive substantial benefit through psychological therapy, while others may not benefit. There is no evidence that the beneficial results identified at the completion of treatment persisted up to 6 months for outcomes other than pain reduction. There were too few studies reporting long-term outcomes to determine completely whether this finding was due to decreased power or to a tapering of treatment benefits over time.

"The observed benefits were strongest when delivered using group-based approaches. Potential mechanisms that could account for this finding include access to peer support, social facilitation of target behaviors, and public commitment to therapy goals.⁵² No other results of participant, intervention, or study characteristics were found. Treatment benefits were equally likely to occur in older men and women irrespective of age and duration of chronic pain."

"Pain was very prevalent in representative samples of 2 distinct populations with chemical dependency, and chronic severe pain was experienced by a substantial minority of both groups. Methadone patients differed from patients recently admitted to a residential treatment center in numerous ways and had a significantly higher prevalence of chronic pain (37% vs. 24%). Although comparisons with other studies of pain epidemiology are difficult to make because of methodological differences, the prevalence of chronic pain in these samples is in the upper range reported in surveys of the general population. The prevalence of chronic pain in these chemically dependent patients also compares with that in surveys of cancer patients undergoing active therapy, approximately a third of whom have pain severe enough to warrant opioid therapy."

"Pain remains one of the most common physical complaints upon a person’s admission into the healthcare system (Burton, Fanciullo, Beasley, & Fisch, 2007; Foley et al., 2005; Freburger et al., 2009; McCarberg, 2010; Peterlin, Rosso, Rapoport, & Scher, 2009; Schug & Chong, 2009; Weiss, Emanuel, Fairclough, & Emanuel, 2001). Pain is prevalent in cancer, especially near the end of life (Paice, 2010; Smith et al., 2010), and in other diseases and conditions such as HIV/AIDS (Breitbart & Cortes?Ladino, 2010; Tsao, Stein, & Dobalian, 2010) and sickle?cell anemia (American Pain Society, 1999; Ballas, 2010); indeed, persistent pain itself is increasingly being recognized as a disease (Institute of Medicine Committee on Advancing Pain Research, 2011). However, insufficient treatment attention often is given to appropriate pain relief, especially when pain is severe or prolonged. In extreme circumstances, pain can impair all aspects of life and sometimes contribute to a person’s wish for death (Fishman & Rathmell, 2010; Ilgen et al., 2013; Institute of Medicine Committee on Advancing Pain Research, 2011; Institute of Medicine National Cancer Policy Board, 2001; Wasan, Sullivan, & Clark, 2010). When pain relief is achieved, it can result in improved quality of living for people with prolonged pain and can decrease suffering for people at the end of life (Higginson & Evans, 2010)."

"Because opioid analgesics have both a medical indication and an abuse liability, their prescribing, dispensing, and administration, indeed their very availability in commerce, is governed by a combination of policies, including international treaties and U.S. federal and state laws and regulations. The main purpose of these policies is drug control: to prevent diversion and abuse of prescription medications. However, international and federal policies also express clearly a second purpose of drug control, that being availability: recognizing that many opioids (referred to in law as narcotic drugs or controlled substances) are necessary for pain relief and that governments must ensure their adequate availability for medical and scientific purposes. When both control and availability are appropriately recognized in public policy, and implemented in everyday practice, this is referred to as a balanced approach (American Medical Association?Department of Substance Abuse, 1990; Cooper, Czechowicz, Petersen, & Molinari, 1992; Drug Enforcement Administration et al., 2001; Fishman, 2012; Gilson, 2010a; Gilson, Joranson, Maurer, Ryan, & Garthwaite, 2005; Joranson & Dahl, 1989; Office of National Drug Control Policy, 2011; Woodcock, 2009; World Health Organization, 2011a)."

"Approximately 12.3% of the respondents -- high school seniors in the United States -- reported lifetime nonmedical use of prescription opioids and 8.0% reported past-year nonmedical use. Table 1 shows the prevalence of motives for nonmedical use of prescription opioids among high school seniors in the United States. The leading motives included 'to relax or relieve tension' (56.4%), 'to feel good or get high' (53.5%), 'to experiment-see what it's like' (52.4%), 'to relieve physical pain' (44.8%), and 'to have a good time with friends' (29.5%).

According to a survey conducted by Roper Starch Worldwide for the American Pain Society in 1999, "Chronic pain as defined by this study is a severe and ever present problem. It can be as much of a problem to middle age adults as seniors and is one women are more likely to face than men. The majority of chronic pain sufferers have been living with their pain for over 5 years. Although the more common type is pain that flares up frequently versus being constant, it is still present on average almost 6 days in a typical week.
"About one third of all chronic sufferers describe their pain as being almost the worst pain one can possibly imagine. Their pain is more likely to be constant than flaring up frequently and two-thirds of them have been living with it for over 5 years."

According to a public opinion poll released in 1999, "It is estimated that 9% of the U.S. adult population suffer from moderate to severe non-cancer related chronic pain."

"The lifetime medical use of prescription opioids was reported by approximately 14.0% of those who did not engage in past-year nonmedical use of prescription opioids, 76.1% of nonmedical users of prescription opioids motivated only by pain relief, 71.4% of those motivated by pain relief and other motives, and 46.7% of those who reported non-pain relief motives only (p < 0.001). Among past-year nonmedical users of prescription opioids, approximately 56.5% of those motivated only by pain relief as compared to 23.1% of those who reported pain relief and other motives, and 14.2% of those who reported only non-pain relief motives had initiated medical use of prescription opioids before nonmedical use of prescription opioids. In contrast, approximately 19.6% of those motivated only by pain relief as compared to 48.3% of those who reported pain relief and other motives, and 32.5% of those who reported only non-pain relief motives initiated nonmedical use of prescription opioids before medical use of prescription opioids."

"There is some evidence that higher prescribed doses increase the risk of drug overdose among individuals treated with opioids for chronic non-cancer pain.⁴ Specifically, the risk of drug-related adverse events is higher among individuals prescribed opioids at doses equal to 50 mg/d or more of morphine. The association of opioid prescribing patterns with risk of over-dose may vary across groups of patients; opioid treatment recommendations for pain are typically specific to particular subgroups such as those with chronic noncancer pain,⁵ cancer-related pain, and substance use disorders.⁶ However, potential subgroup differences in opioid prescribing have not been examined."

"Overall estimates of current nonmedical use of prescription psychotherapeutic drugs among the population aged 12 or older that were described previously have largely been driven by the nonmedical use of prescription pain relievers. In 2014, about two thirds of the current nonmedical users of psychotherapeutic drugs who were aged 12 or older reported current nonmedical use of pain relievers (Figure 5).
"The estimated 4.3 million people aged 12 or older in 2014 who were current nonmedical users of pain relievers represent 1.6 percent of the population aged 12 or older (Figures 5 and 6). The percentage of people aged 12 or older who were current nonmedical users of pain relievers in 2014 was lower than the percentages in most years from 2002 to 2012, but it was similar to the percentage in 2013."

"Among persons aged 12 or older in 2010-2011 who used pain relievers nonmedically in the past year, 54.2 percent got the pain relievers they most recently used from a friend or relative for free (Figure 2.14). Another 12.2 percent bought them from a friend of relative (which was higher than the 9.9 percent in 2008-2009). In addition, 4.4 percent of these nonmedical users in 2010-2011 took pain relievers from a friend or relative without asking. More than one in six (18.1 percent) indicated that they got the drugs they most recently used through a prescription from one doctor. Less than 1 in 20 users (3.9 percent) got pain relievers from a drug dealer or other stranger, 1.9 percent got pain relievers from more than one doctor, and 0.3 percent bought them on the Internet. These other percentages were similar to those reported in 2008-2009."

"Among persons aged 12 or older in 2010-2011 who used pain relievers nonmedically in the past year and indicated that they most recently obtained the drugs from a friend or relative for free in the past year, 81.6 percent of the friends or relatives obtained the drugs from just one doctor (Figure 2.14). About 1 in 20 of these past year nonmedical users of pain relievers (5.5 percent) reported that the friend or relative got the pain relievers from another friend or relative for free, 3.9 percent reported that the friend or relative bought the drugs from a friend or relative, 1.9 percent reported that the friend or relative bought the drugs from a drug dealer or other stranger, and 1.8 percent reported that the friend or relative took the drugs from another friend or relative without asking."

"Conventional wisdom suggests that the abuse potential of opioid analgesics is such that increases in medical use of these drugs will lead inevitably to increases in their abuse. The data from this study with respect to the opioids in the class of morphine provide no support for this hypothesis. The present trend of increasing medical use of opioid analgesics to treat pain does not appear to be contributing to increases in the health consequences of opioid analgesic abuse."

"Among patients who are prescribed opioids, an estimated 80% are prescribed low doses (<100 mg morphine equivalent dose per day) by a single practitioner (7,8), and these patients account for an estimated 20% of all prescription drug overdoses (Figure 3). Another 10% of patients are prescribed high doses (?100 mg morphine equivalent dose per day) of opioids by single prescribers and account for an estimated 40% of prescription opioid overdoses (9,10). The remaining 10% of patients are of greatest concern. These are patients who seek care from multiple doctors and are prescribed high daily doses, and account for another 40% of opioid overdoses (11). Persons in this third group not only are at high risk for overdose themselves but are likely diverting or providing drugs to others who are using them without prescriptions. In fact, 76% of nonmedical users report getting drugs that had been prescribed to someone else, and only 20% report that they acquired the drug from their own doctor (4). Furthermore, among persons who died of opioid overdoses, a significant proportion did not have a prescription in their records for the opioid that killed them; in West Virginia, Utah, and Ohio, 25%–66% of those who died of pharmaceutical overdoses used opioids originally prescribed to someone else (11–13). These data suggest that prevention of opioid overdose deaths should focus on strategies that target 1) high-dosage medical users and 2) persons who seek care from multiple doctors, receive high doses, and likely are involved in drug diversion."

"There is some evidence that higher prescribed doses increase the risk of drug overdose among individuals treated with opioids for chronic non-cancer pain.⁴ Specifically, the risk of drug-related adverse events is higher among individuals prescribed opioids at doses equal to 50 mg/d or more of morphine. The association of opioid prescribing patterns with risk of over-dose may vary across groups of patients; opioid treatment recommendations for pain are typically specific to particular subgroups such as those with chronic noncancer pain,⁵ cancer-related pain, and substance use disorders.⁶ However, potential subgroup differences in opioid prescribing have not been examined."

"Still, methadone is a potent drug; fatal overdoses have been reported over the years (Baden, 1970; Gardner, 1970; Clark, et al., 1995; Drummer, et al., 1992). As with most other opioids, the primary toxic effect of excessive methadone is respiratory depression and hypoxia, sometimes accompanied by pulmonary edema and/or aspiration pneumonia (White and Irvine, 1999; Harding-Pink, 1993). Among patients in addiction treatment, the largest proportion of methadone-associated deaths have occurred during the drug's induction phase, usually when (1) treatment personnel overestimate a patient's degree of tolerance to opioids, or (2) a patient uses opioids or other central nervous system (CNS) depressant drugs in addition to the prescribed methadone (Karch and Stephens, 2000; Caplehorn, 1998; Harding-Pink, 1991; Davoli, et al., 1993). In fact, when deaths occur during later stages of treatment, other drugs usually are detected at postmortem examination (Appel, et al., 2000). In particular, researchers have called attention to the 'poison cocktail' resulting from the intake of multiple psychotropic drugs (Borron, et al., 2001; Haberman, et al., 1995) such as alcohol, benzodiazepines, and other opioids. When used alone, many of these substances are relatively moderate respiratory depressants; however, when combined with methadone, their additive or synergistic effects can be lethal (Kramer, 2003; Payte and Zweben, 1998).
"It is important to note that postmortem blood concentrations of methadone do not appear to reliably distinguish between individuals who have died from methadone toxicity and those in whom the presence of methadone is purely coincidental (Drummer, 1997; Caplan, et al., 1983)."

"By 2002, opioid analgesics were involved in more deaths than either of the illicit drugs responsible for most urban drug abuse in the 1990s: heroin and cocaine. These trends are generally consistent with trends in drug-related emergency department visits reported by DAWN from 1997 to 2002: a 101.4% increase in opioid analgesics, a 23.7% increase in cocaine, and a 32.2% increase in heroin.

"The increased involvement of these analgesics is related to exponential growth in their domestic sales over the past decade as physicians began to treat chronic pain with stronger analgesics.¹⁰ Oxycodone sales in grams increased 402.9% from 1997 to 2002; methadone (excluding that used in narcotics treatment programs) increased 410.8%; and fentanyl increased 226.7%.11 OxyContin, introduced in 1996, accounted for 68% of oxycodone sales by 2002."

"Until 2011, the DEA had increased the quota for oxycodone every year since 2002¹⁰¹ with the exception of 2008, when the quota remained unchanged from 2007.¹⁰² In 2010, the quota for oxycodone available for sale was 105,500,000 grams.¹⁰³ In 2002, the quota for oxycodone available for sale was 34,482,000 grams, which means that over that eight-year period, the DEA permitted a 206% increase in the oxycodone quota.¹⁰⁴ The DEA decreased the quota to 98,000,000 grams in 2011.¹⁰⁵ OxyContin is available in seven dosage strengths, ranging from ten milligram to eighty milligram tablets.¹⁰⁶ Although oxycodone is used in other medications, if one assumes, for illustrative purposes, that OxyContin was the only medication manufactured from oxycodone, the 2010 quota would permit the production of between 15,050,000,000 (for ten milligram tablets) and 1,881,250,000 (for eighty milligram tablets) tablets of OxyContin. Although the DEA has the power to limit OxyContin production through its quota authority, the DEA has dramatically increased the availability of oxycodone over the last eight years. While this may be warranted for legitimate users, the increase remains in stark contrast to the limited availability of addiction-assistance medications.¹⁰⁷ Additionally, while the rate of marijuana dependence or abuse has remained steady over the last eight years, the number of people suffering from pain reliever dependence or abuse has increased from 1.5 million to 1.9 million over the same period of time.¹⁰⁸"

Laws & Policies

"With the passage of the Patient Protection and Affordable Care Act in March 2010, the U.S. health care system may undergo profound changes, although how these changes will evolve over the next decade is highly uncertain. Health care reform or other broad legislative actions may offer new opportunities to prevent and treat pain more effectively. Both clinical leaders and patient advocates must pursue these opportunities and be alert to any evidence that barriers to adequate pain prevention and treatment are increasing.
"To remediate the mismatch between knowledge of pain care and its application will require a cultural transformation in the way clinicians and the public view pain and its treatment. Currently, the attitude is often denial and avoidance. Instead, clinicians, family members, employers, and friends inevitably must rely on a person’s ability to express his or her subjective experience of pain and learn to trust that expression, and the medical system must give these expressions credence and endeavor to respond to them honestly and effectively."

"Alabama and Idaho now join Georgia, Iowa, Kansas, Maine, Massachusetts, Michigan, Montana, Oregon, Rhode Island, Vermont, Virginia, Washington, and Wisconsin as having the most balanced policies in the country related to pain management, including with the appropriate use of pain medications for legitimate medical purposes. Over time, these 15 states took advantage of available policy templates and resources, and repealed all excessively restrictive and ambiguous policy. This achievement does not mean that their work is finished, because policy needs to be properly implemented (see next section). Importantly, there is no ceiling on policy quality, so states with high grades should continue to explore how additional policy can help to improve access to pain management while avoiding the adoption of restrictive requirements or limitations. In fact, 25 states that achieved an A for positive language in the past have continued to adopt policy language promoting appropriate pain management during this evaluation timeframe.^h"

"Another control strategy that has gained traction is opioid 'contracts' or 'treatment agreements' between health care providers and patients, under which medication use by highrisk patients is closely monitored. In a study of a primary are clinic’s use of such contracts, three-fifths of patients adhered to the agreement (with a median follow-up of 23 months) (Hariharan et al., 2006). However, many pain experts have concluded that pain agreements/contracts do not necessarily improve the treatment of pain or minimize diversion and abuse of prescription drugs, particularly when used indiscriminately. A systematic review of the literature found only weak evidence to support either pain contracts or urine tests as a strategy for reducing opioid abuse (Starrels et al., 2010)."

"Current voluntary strategies to reduce opioid abuse include
"• the clinician’s assessment in a history and physical exam that includes psychosocial factors, family history, and risk of abuse;
"• the clinician’s regular monitoring of the progress of patients on opioids and assessment for aberrant behavior that may indicate abuse;
"• random urine drug screening and pill counts for patients at risk;
"• state prescription drug monitoring programs (the U.S. Justice Department and other agencies have cooperated in forming an interstate information exchange for such programs);
"• new drug formulations intended to prevent abuse by (1) hindering the extraction of active ingredients through physical barrier mechanisms, (2) releasing agents that neutralize the opioid effects when products are tampered with, and (3) introducing substances that cause unpleasant side effects when drugs are consumed to excess (Fishbain et al., 2010); and
"• removing unused drugs from home medicine cabinets and disposing of them at 'drug take-back' events (see Box 2-4 in Chapter 2) (Office of National Drug Control Policy, 2010)."

"In the wake of criticism of state medical boards’ actions against physicians who prescribed large amounts of opioids, the Federation of State Medical Boards developed a model policy in 1998—since adopted by many individual state boards—that supports use of opioids for pain management if appropriately documented by the treating physician (Federation of State Medical Boards of the United States, 2004). State medical boards generally are believed to be the best locus for sanctioning physicians for their opioid prescribing patterns, as opposed to criminal prosecution (Reidenberg and Willis, 2007). However, sanctions and prosecutions are rare: between 1998 and 2006, only 0.1 percent of practicing physicians were charged by prosecutors, medical licensing boards, or other administrative agencies with opioid-related prescribing offenses, providing 'little objective basis for concern that pain specialists have been ‘singled out’ for prosecution or administrative sanctioning' (Goldenbaum et al., 2008, p. 2)."

"The AMA [American Medical Association] supports the position that:
"1. physicians who appropriately prescribe and/or administer controlled substances to relieve intractable pain should not be subject to the burdens of excessive regulatory scrutiny, inappropriate disciplinary action, or criminal prosecution. It is the policy of the AMA that state medical societies and boards of medicine develop or adopt mutually acceptable guidelines protecting physicians who appropriately prescribe and/or administer controlled substances to relieve intractable pain before seeking the implementation of legislation to provide that protection;
"2. education of medical students and physicians to recognize addictive disorders in patients, minimize diversion of opioid preparations, and appropriately treat or refer patients with such disorders; and
"3. the prevention and treatment of pain disorders through aggressive and appropriate means, including the continued education of physicians in the use of opioid preparations."

"Unbalanced and misleading media coverage on the abuse of opioid analgesics not only perpetuates misconceptions about pain management; it also compromises the access to adequate pain relief sought by over 75 million Americans living with pain.
"In the past several years, there has been growing recognition on the part of health care providers, government regulators, and the public that the undertreatment of pain is a major societal problem.
"Pain of all types is undertreated in our society. The pediatric and geriatric populations are especially at risk for undertreatment. Physicians' fears of using opioid therapy, and the fears of other health professionals, contribute to the barriers to effective pain management."

"Almost half¹⁴ of global opium is legally produced for processing into various opiate based medicines. Any country can formally apply to the UN’s Commission on Narcotic Drugs to cultivate, produce and trade in licit opium, under the auspices of the UN Single Convention on Narcotics Drugs 1961 and under the supervision and guidance of the International Narcotic Control Board (INCB). As of 2001 there were eighteen countries that do, including Australia, Turkey, India, China and the UK."

"In 1998, WHO [World Health Organization], in cooperation with its collaborating center at the University of Wisconsin, elaborated the concept of the 'Central Principle of Balance' in order to guide the development of national drug regulatory policies pursuant to the Single Convention.⁶⁴ According to WHO, 'The Central Principle of Balance' represents the dual imperative of preventing the abuse, trafficking, and diversion of narcotic drugs while, at the same time, ensuring medical availability. As stated by WHO, 'When misused, opioids pose a threat to society; a system of control is necessary to prevent abuse, trafficking, and diversion, but the system of control is not intended to diminish the medical usefulness of opioids, nor interfere in their legitimate medical uses and patient care.'⁶⁵

"The concept of the Central Principle of Balance should not be limited to national regulatory policies, but should also guide the development and implementation of international drug control policies."

"Prescription drug monitoring programs are designed to facilitate the collection, analysis, and reporting of information on the prescribing, dispensing, and use of controlled substances within a state. They provide data and analysis to state law enforcement and regulatory agencies to assist in identifying and investigating activities potentially related to the illegal prescribing, dispensing, and procuring of controlled substances."

"There have been significant advances in implementing PDMPs, 49 states and Washington, D.C. now have operational PDMPs. PDMPs help providers understand their patients’ medication histories, as well as problematic behaviors that signal a need for more in-depth conversations about pain and substance use. The Bureau of Justice Assistance (BJA) supported PDMP expansion grants in 11 states in 2015. ONC, SAMHSA, and CDC all have funded research and standards development for PDMP improvements. The IHS, DoD, and VA have piloted the integration of PDMP systems within their electronic health records systems. In July 2016, both VA and IHS announced new policies that require prescribers to check the PDMP prior to making a decision to prescribe controlled medications.

"Historically, the ability of states to share data has been limited, but agencies are currently involved in efforts to enhance the interoperability of state PDMPs. At the time of this writing, two electronic data sharing hubs are operational, enabling 43 states to work through one or both to share PDMP data with at least one other state. Funding from BJA and DoD has been used to enhance this interstate data sharing.

"PDMPs are only one approach to monitoring. The DoD, VA, and CMS all have initiated drug utilization review programs for some of their patient populations to better coordinate care for individuals who are prescribed opioid medications. Many hospitals administer patient surveys to determine whether their pain was managed adequately. CMS has proposed new questions for these surveys that avoid the perception that performance is linked to prescribing opioid medications for pain control.¹⁴"

"States with PDMPs [prescription drug monitoring programs] have experienced considerable reductions in the time and effort required by law enforcement and regulatory investigators to explore leads and the merits of possible drug diversion cases. The presence of a PDMP helps a state reduce its illegal drug diversion, but diversion activities may increase in contiguous states without PDMPs."

"The presence of a PDMP [prescription drug monitoring program] may also have an impact on the use of drugs more likely to be diverted. For example, DEA rank-ordered all states for 2000 by the number of OxyContin prescriptions per 100,000 people. Eight of the 10 states with the highest number of prescriptions-West Virginia, Alaska, Delaware, New Hampshire, Florida, Pennsylvania, Maine, and Connecticut-had no PDMPs, and only 2 did-Kentucky and Rhode Island. Six of the 10 states with the lowest number of prescriptions-Michigan, New Mexico,14 Texas, New York, Illinois, and California-had PDMPs, and 4-Kansas, Minnesota, Iowa, and South Dakota-did not."

"Physicians are concerned that their prescribing decisions and patterns may be questioned and that they could be investigated without sufficient cause. Some physicians contend that patients may suffer because physicians will be reluctant to prescribe appropriate controlled substances to manage a patient's pain or treat their condition. Patients are concerned that their personal information may be used inappropriately by those with authorized access or shared with unauthorized entities. Pharmacists have also expressed concerns."

"Although several studies found implementation of prescription monitoring programs for Schedule II opioids associated with a decrease in prescription rates for Schedule II opioids and a shift towards increased rates of Schedule III, non-monitored opioid prescribing, the studies were not designed to determine whether the changes were due to a decrease in inappropriate or unnecessary Schedule II opioid use, or if these changes resulted in subsequent undertreatment of pain.^{317, 318} No study has evaluated patient outcomes such as pain relief, functional status, ability to work, and abuse/addiction associated with implementation of a prescription monitoring program, formulary restriction, or other policies related to opioids prescribing. Claims of positive effects of prescription monitoring programs on reducing diversion are primarily based on anecdotal reports of impressions of efficacy from policymakers and law enforcement officials.³¹⁶"

"The existence of a PDMP [prescription drug monitoring program] within a state, however, appears to increase drug diversion activities in contiguous non-PDMP states. When states begin to monitor drugs, drug diversion activities tend to spill across boundaries to non-PDMP states. One example is provided by Kentucky, which shares a boundary with seven states, only two of which have PDMPs—Indiana and Illinois. As drug diverters became aware of the Kentucky PDMP’s ability to trace their drug histories, they tended to move their diversion activities to nearby nonmonitored states. OxyContin diversion problems have worsened in Tennessee, West Virginia, and Virginia—all contiguous non-PDMP states—because of the presence of Kentucky’s PDMP, according to a joint federal, state, and local drug diversion report."

"Definitions of CAM differ. For example, a study of CAM in hospices identified practices as diverse as massage therapy, supportive group therapy, music therapy, pet therapy, and guided imagery or relaxation, not all of which are usually associated with CAM (Bercovitz et al., 2011). Acupuncture, chiropractic ­spinal manipulation, magnets, massage therapy, and yoga often are considered CAM pain treatments. According to the National Institutes of Health’s (NIH) National Center for Complementary and Alternative Medicine, additional CAM therapies used for pain include dietary supplements, such as glucosamine and chondroitin intended to improve joint health; various herbs; acupuncture; and mind–body approaches, such as meditation and yoga (NIH and NCCAM, 2010)."

"CAM holds special appeal for many people with pain for several reasons:

• "deficits in the way that many physicians treat pain, using only single modalities without attempting to track their effectiveness for a particular person over time or to coordinate diverse approaches;
• "the higher preponderance of pain in women (see Chapter 2), given that 'women are more likely than men to seek CAM treatments; (IOM, 2005, p. 10); and
• "a welcoming, less reserved attitude toward people with pain on the part of CAM practitioners and an apparent willingness to listen to the story of a patient’s pain journey.

"Whatever the reasons, pain is a common complaint presented to CAM practitioners (NIH and NCCAM, 2010). In 2007, 44 percent of people with pain or neurologic conditions sought help from CAM practitioners (Wells et al., 2010).

"In 2002, three-fifths of people who turned to CAM for relief of back pain found a 'great deal' of benefit as a result (Kanodia et al., 2010). The National Center for Complementary and Alternative Medicine’s strategic plan, released in February 2011, supports the development of better strategies for managing back pain, in particular."

"For which pain conditions are CAM treatments most often used? In the 2007 National Health Interview Survey (NHIS), adults reported using CAM in the previous year most often to treat various musculoskeletal problems. Just over 17 percent of adults — more than 14 million Americans—used CAM for back pain/problems, almost 6 percent (5 million) for neck pain/problems, 5 percent for joint pain/stiffness (5 million), and 44 percent specifically for arthritis (3 million). An additional 1.5 million used CAM for other musculoskeletal problems, 1 million for severe headache or migraine, 11 million for 'regular headaches,' and 0.8 million for fibromyalgia (Barnes et al., 2008). Rates of reported use of CAM for these conditions had remained relatively unchanged since 2002. Even among children, NHIS data show that CAM therapies are used most often for back or neck pain (7 percent of all children).⁷"

"The quality of life has improved significantly among those who have their pain under control."

"Medical therapies are not providing sufficient relief, since the majority of chronic pain sufferers, especially those with severe pain, have also turned to non-medicinal therapies. The primary one is a hot/cold pack. Surprisingly, almost all of the major non-medicinal therapies currently used are perceived as providing more relief by their users than OTCs, the most widely used medicines; the one exception are herbs/dietary supplements/vitamins which are perceived as offering the least amount of relief than any medicines or other major non-medicinal therapies.

"The overall favorable perceptions of non-medicinal therapies are driven by those with moderate pain. Although those with very severe pain are more likely to use them, they have a significantly lower opinion of their efficacy versus medicinal therapies."

"Almost all chronic pain sufferers have gone to a doctor for relief of their pain at one time or another. Almost 4 of every 10 are not currently doing so, since they think either there is nothing more a doctor can do or in one way or another their pain is under control or they can deal with it themselves.

"This is not the case with those having very severe pain; over 7 of every 10 are currently going to a doctor for pain relief. In addition, significant numbers of those with very severe pain are significantly more likely to require emergency room visits, hospitalization and even psychological counseling or therapy to treat their pain.

"A significant proportion (over one-fourth) of all chronic pain sufferers wait for at least 6 months before going to a doctor for relief of their pain because they underestimate the seriousness of it and think they can tough it out."

"In an analysis of death certificate data from 1999 to 2010, we found that states with medical cannabis laws had lower mean opioid analgesic overdose mortality rates compared with states without such laws. This finding persisted when excluding intentional overdose deaths (ie, suicide), suggesting that medical cannabis laws are associated with lower opioid analgesic overdose mortality among individuals using opioid analgesics for medical indications. Similarly, the association between medical cannabis laws and lower opioid analgesic overdose mortality rates persisted when including all deaths related to heroin, even if no opioid analgesic was present, indicating that lower rates of opioid analgesic overdose mortality were not offset by higher rates of heroin overdose mortality. Although the exact mechanism is unclear, our results suggest a link between medical cannabis laws and lower opioid analgesic overdose mortality."

"A small, but significant, percent of chronic pain sufferers have at one time or another turned to alcohol for relief; this occurred more often among middle age adults and men."

"A total of 52.7% of the workforce reported having headache, back pain, arthritis, or other musculoskeletal pain in the past 2 weeks. Overall, 12.7% of the workforce lost productive time in a 2-week period due to a common pain condition; 7.2% lost 2 h/wk or more of work. Headache was the most common pain condition resulting in lost productive time, affecting 5.4% (2.7% with >= 2/wk) of the workforce (Table 1), which was followed by back pain (3.2%), arthritis (2.0%), and other musculoskeletal pain (2.0%)."

"Lost productive time varied to some degree in the workforce. First, little or no variation was observed by age. In large part, the lack of differences by age was due to the counterbalancing effects of different pain conditions. Headache, common at younger ages (ie, 18-34 years), rapidly declines in prevalence thereafter. In contrast, the other 3 pain conditions are either more common with increasing age (eg, arthritis) or peak at a later age than headache (eg, back pain)."

"Although MMTP [Methadone Maintenance Treatment Program] patients were significantly more likely than inpatients to report chronic pain, and almost a quarter reported that pain was one of the reasons for first using drugs, there was relatively little evidence that pain was associated with current levels of substance abuse. In the multivariate analysis, the associations between chronic pain and the substance abuse behaviors observed in the bivariate analysis (pain as a reason for first using drugs and drug craving) were not sustained. Moreover, the bivariate associations that were found in the inpatient group between chronic pain and multiple drug use, and between pain and the use of illicit drugs to treat pain complaints, were not identified among MMTP patients."

"Chronic pain sufferers are having difficulty in finding doctors who can effectively treat their pain, since almost one half have changed doctors since their pain began; almost a fourth have made at least 3 changes. The primary reasons for a change are the doctor not taking their pain seriously enough, the doctor's unwillingness to treat it aggressively, the doctor's lack of knowledge about pain and the fact they still had too much pain. This level of frustration is significantly higher among those with very severe pain where the majority have changed doctors at least once and almost of every 3 have done it 3 or more times. Their primary reason for changing was still having too much pain after treatment."

"Just over one-half of chronic pain sufferers say their pain is pretty much under control. But, this can be attributed primarily to those with moderate pain. The majority of those with the most severe pain do not have it under control and among those who do, it took almost half of them over a year to reach that point. In contrast, 7 of every 10 with moderate pain say they have it under control and it took the majority less than a year to reach that point. Pain can become more severe even when it is under control. Among those with very severe pain, 4 of every 10 said their pain was moderate or severe before getting their pain under control."

"Chronic pain sufferers currently taking narcotic pain relievers differ from other chronic pain sufferers as to the severity of their pain, being less likely to have it under control, changing doctors more often, requiring more intensive treatment at hospitals, taking more pills per day, more likely following their doctors prescribed regimen and lastly, to being referred to a specialized program/clinic for their pain."

"If a Veteran obtains and uses medical marijuana in manner consistent with state law, testing positive for marijuana would not preclude the Veteran from receiving opioids for pain management in the Department of Veteran Affairs (VA) facility. The Veteran would need to inform his provider of the use of medical marijuana, and of any other non-VA prescribed medications he or she is taking to ensure that all medications, including opioids, are prescribed in a safe manner. Standard pain management agreements should draw a clear distinction between use of illegal drugs, and legal medical marijuana. However, the discretion to prescribe, or not prescribe, opioids in conjunction with medical marijuana, should be determined on clinical grounds, and thus will remain the decision of the individual health care provider. The provider will take the use of medical marijuana into account in all prescribing decisions, just as the provider would for any other medication. This is a case-by-case decision, based on the provider's judgment, and the needs of the patient."