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Pain Management and Prescription Drugs

Subsection Links:
Basic Data (Description, Prevalence, Societal Response)
Laws and Policies
Prescription Drug Monitoring Programs (PDMPs)
Other Sociopolitical and Clinical Research

Related Chapters:
Addictive Properties
Diversion of Pharmaceutical Drugs
Heroin

(Note: For an excellent training video and other materials regarding Naloxone and opiate overdose reversal, check out this resource from the Chicago Recovery Alliance, http://www.anypositivechange.org/menu.html.)

  1. Basic Data

    "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 5.
    http://www.nap.edu/openbook.php?record_id=13172

  2. (Law Enforcement's "Chilling Effect" on Pain Treatment) "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."

    Source: 
    "Balance, Uniformity and Fairness: Effective Strategies for Law Enforcement for Investigating and Prosecuting the Diversion of Prescription Pain Medications While Protecting Appropriate Medical Practice," Center for Practical Bioethics (Kansas City, MO: September 2009), p. 3.
    http://www.fsmb.org/pdf/pub_bbpi_policy_brief.pdf

  3. (Reasons Why Many in the US Receive Inadequate Treatment for Pain) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 8.
    http://www.nap.edu/openbook.php?record_id=13172

  4. (Opioid Use and Risks) "Opioid analgesics are useful in managing severe acute or chronic pain. They are often underused, resulting in needless pain and suffering because clinicians often underestimate the required dosage, overestimate the duration of action and risk of adverse effects, and have unreasonable concerns about addiction (see Drug Use and Dependence: Opioids). 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. However, addiction (loss of control, compulsive use, craving and use despite harm) is very rare in patients with no history of substance abuse. Before opioid therapy is initiated, clinicians should ask about risk factors for abuse and addiction. These risk factors include prior alcohol or drug abuse, a family history of alcohol or drug abuse, and a prior major psychiatric disorder. If risk factors are present, treatment may still be appropriate; however, the clinician should use more controls to prevent abuse (eg, small prescriptions, frequent visits, no refills for “lost” prescriptions) or should refer the patient to a pain specialist or an addiction medicine specialist experienced in pain management."

    Source: 
    "Treatment of Pain." The Merck Manual for Health Professionals. Merck & Co. Inc. Last accessed November 26, 2012.
    http://www.merckmanuals.com/professional/neurologic_disorders/pain/treat...

  5. (Prevalence of Undertreatment of Pain) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 153.
    http://www.nap.edu/openbook.php?record_id=13172

  6. (Unrelieved Pain A Serious Health Problem In The US) "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 veterans27-30 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"

    Source: 
    Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)" (Madison, WI: University of Wisconsin Carbone Cancer Center, July 2014), p. 10.
    http://www.painpolicy.wisc.edu/achieving-balance-state-pain-policy-progr...
    http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/prc20...

  7. (Balancing Control And Availability In Pain Management) "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)."

    Source: 
    Pain & Policy Studies Group. Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (CY 2013). (University of Wisconsin Carbone Cancer Center: Madison, WI, July 2014), p. 17.
    http://www.painpolicy.wisc.edu/achieving-balance-federal-and-state-pain-...
    http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/evalg...

  8. (Barriers to Effective Pain Care) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), pp. 153-154.
    http://www.nap.edu/openbook.php?record_id=13172

  9. (Majority of Pain Patients Use Prescription Drugs Properly) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 145.
    http://www.nap.edu/openbook.php?record_id=13172

  10. (Tolerance of Opiates and Escalation of Effective Dosage) "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."

    Source: 
    "Treatment of Pain." The Merck Manual for Health Professionals. Merck & Co. Inc. Last accessed April 6, 2013.
    http://www.merckmanuals.com/professional/neurologic_disorders/pain/treat...

  11. (Regulatory Barriers to Adequate Pain Care) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 145.
    http://www.nap.edu/openbook.php?record_id=13172

  12. (Risk of Opioid Medication Abuse by Pain Patients) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 146.
    http://www.nap.edu/openbook.php?record_id=13172

  13. (Prosecutions and Administrative Reviews for Prescribing Opiates)
    "Total Cases
    "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."

    Source: 
    Goldenbaum, Donald M.; Christopher, Myra; Gallagher, Rollin M.; Fishman, Scott; Payne, Richard; Joranson, David; Edmondson, Drew; McKee, Judith; Thexton, Arthur, "Physicians Charged with Opioid Analgesic-Prescribing Offenses" Pain Medicine (Glenview, IL: American Academy of Pain Medicine, September 2008) Volume 9, Issue 6, pp. 741.
    http://onlinelibrary.wiley.com/doi/10.1111/j.1526-4637.2008.00482.x/pdf

  14. (Influence of Drug Control Policy on Pain Medicine) "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."

    Source: 
    Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)" (Madison, WI: University of Wisconsin Carbone Cancer Center, July 2014), p. 11.
    http://www.painpolicy.wisc.edu/achieving-balance-state-pain-policy-progr...
    http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/prc20...

  15. (Prevalence and Cost of Migraines) "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"

    Source: 
    Aukerman, Glen; Knutson, Doug; and Miser, William F. M., "Management of the Acute Migraine Headache," American Family Physician (Shawnee Mission, KS: American Academy of Family Physicians, December 2002), Volume 66, Issue 11, p. 2123.
    http://www.aafp.org/afp/2002/1201/p2123.pdf

  16. (Global Pain Growth Projection) "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"

    Source: 
    Taylor, Allyn L. "Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations Single Convention on Narcotic Drugs," Journal of Law, Medicine & Ethics (Washington, DC: Georgetown University Law Center, January 2008 ) Vol. 35, No. 556, p. 558.
    http://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1088150_code238438.pdf?a...

  17. (Barriers to Adequate Pain Care) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), pp. 46-47.
    http://www.nap.edu/openbook.php?record_id=13172

  18. (Insurance Barriers to Adequate Pain Treatment) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 156.
    http://www.nap.edu/openbook.php?record_id=13172

  19. (Significance and Growing Prevalence of Lower Back Pain) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 64.
    http://www.nap.edu/openbook.php?record_id=13172

  20. (Rise in Opiate Prescriptions in US) "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."

    Source: 
    Christo,Paul J.; Manchikanti, Laxmaiah; Ruan, Xiulu; Bottros, Michael; Hansen, Hans; Solanki, Daneshvari R.; Jordan, Arthur E.; and Colson, James , "Urine Drug Testing In Chronic Pain," Pain Physician (Paducah, KY: American Society of Interventional Pain Physicians, March/April 2011), Vol. 14, Issue 2, p. 124.
    http://www.painphysicianjournal.com/2011/march/2011%3B14%3B123-143.pdf

  21. (Undertreatment of Pain More Common Among African-American Patients Than Whites) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 68.
    http://www.nap.edu/openbook.php?record_id=13172

  22. (War on Pain Doctors) "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."

    Source: 
    Libby, Ronald T., "Treating Doctors as Drug Dealers The DEA’s War on Prescription Painkillers," CATO Institute (Washington, DC: June 2005), p. 21.
    http://www.csdp.org/research/cato_libby_pain_analysis.pdf

  23. (Growth of Federal Oxycontin Investigations and Arrests) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, Dec. 2003), p. 37.
    http://www.gao.gov/new.items/d04110.pdf

  24. (Prevalence of Neuropathic Pain) "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]"

    Source: 
    Collen, Mark, "Prescribing Cannabis for Harm Reduction," Harm Reduction Journal (London, United Kingdom: January 2012) Vol. 9, Issue 1, p. 1.
    http://www.harmreductionjournal.com/content/pdf/1477-7517-9-1.pdf

  25. (Pain-Related Lost Productivity) 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."

    Source: 
    Stewart, Walter F., PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Richard Lipton, MD, "Lost Productive Time and Cost Due to Common Pain Conditions in the US Workforce," Journal of the American Medical Association (Chicago, IL: American Medical Association, Nov. 12, 2003), Vol. 290, No. 18, p. 2449.
    http://jama.jamanetwork.com/article.aspx?articleid=197628

  26. (Limited Data Available on Pain Treatment) "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."

    Source: 
    Stewart, Walter F., PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Richard Lipton, MD, "Lost Productive Time and Cost Due to Common Pain Conditions in the US Workforce," Journal of the American Medical Association (Chicago, IL: American Medical Association, Nov. 12, 2003), Vol. 290, No. 18, p. 2453.
    http://jama.jamanetwork.com/article.aspx?articleid=197628

  27. (Cost of Pain-Related Lost Productivity) "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."

    Source: 
    Stewart, Walter F., PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Richard Lipton, MD, "Lost Productive Time and Cost Due to Common Pain Conditions in the US Workforce," Journal of the American Medical Association (Chicago, IL: American Medical Association, Nov. 12, 2003), Vol. 290, No. 18, p. 2452.
    http://jama.jamanetwork.com/article.aspx?articleid=197628

  28. (Populations At Increased Risk For Chronic Pain And For Inadequate Treatment) "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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), pp. 64-65.
    http://www.nap.edu/openbook.php?record_id=13172

  29. (Undertreatment of Pain Among Those With Chemical Dependency) "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."

    Source: 
    Rosenblum, Andrew, PhD, Herman Joseph, PhD, Chunki Fong, MS, Steven Kipnis, MD, Charles Cleland, PhD, Russell K. Portenoy, MD, "Prevalence and Characteristics of Chronic Pain Among Chemically Dependent Patients in Methadone Maintenance and Residential Treatment Facilities," Journal of the American Medical Association (Chicago, IL: American Medical Association, May 14, 2003), Vol. 289, No. 18, p. 2377.
    http://jama.jamanetwork.com/article.aspx?articleid=196537

  30. (Barriers to Availability of Legal Opioid Analgesics in the US) "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 Ն65 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 Ͻ .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 Ն65 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."

    Source: 
    Carmen R. Green, S. Khady Ndao-Brumblay, Brady West, and Tamika Washington, "Differences in Prescription Opioid Analgesic Availability: Comparing Minority and White Pharmacies Across Michigan," The Journal of Pain - October 2005 (Vol. 6, Issue 10, Pages 689-699, DOI: 10.1016/j.jpain.2005.06.002), p. 694.
    Abstract: http://www.ncbi.nlm.nih.gov/pubmed/16202962

  31. (Undertreatment of Pain Among the Elderly) "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.)"

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), pp. 79-80.
    http://www.nap.edu/openbook.php?record_id=13172

  32. (Racial and Socioeconomic Disparities in Availability of Opioid Analgesic Availability) "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."

    Source: 
    Carmen R. Green, S. Khady Ndao-Brumblay, Brady West, and Tamika Washington, "Differences in Prescription Opioid Analgesic Availability: Comparing Minority and White Pharmacies Across Michigan," The Journal of Pain - October 2005 (Vol. 6, Issue 10, Pages 689-699, DOI: 10.1016/j.jpain.2005.06.002), p. 695.
    Abstract: http://www.ncbi.nlm.nih.gov/pubmed/16202962
    http://www.jpain.org/article/S1526-5900%2805%2900730-3/abstract

  33. (Global Lack of Pain Relief) "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]."

    Source: 
    Nickerson, Jason W., and Attaran, Amir, "The Inadequate Treatment of Pain: Collateral Damage from the War on Drugs," PLoS Medicine (Cambridge, United Kingdom: Public Library of Science, Jan. 2012) Vol. 9, Issue 1, p. 1.
    http://www.plosmedicine.org/article/fetchObjectAttachment.action;jsessio...

  34. (Global Medical Opiate Shortage) "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."

    Source: 
    Marie-Josephine Seya, Susanne F. A. M. Gelders, Obianuju Uzoma Achara, Barbara Milani, and Willem Karel Scholten, "A First Comparison Between the Consumption of and the Need for Opioid Analgesics at Country, Regional, and Global Levels," Journal of Pain & Palliative Care Pharmacotherapy. 2011;25:6–18. ISSN: 1536-0288 print / 1536-0539 online. DOI: 10.3109/15360288.2010.536307
    http://apps.who.int/medicinedocs/documents/s17976en/s17976en.pdf

  35. (Global Lack of Access to Pain Medication) "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"

    Source: 
    Jürgens, Ralf; Csete, Joanne; Amon, Joseph J.; Baral, Stefan; and Beyrer, Chris, "People who use drugs, HIV, and human rights," The Lancet (London, United Kingdom: August 7, 2010) Vol. 376, Issue 9739, pp. 478-479.
    http://www.canadianharmreduction.com/sites/default/files/Ralf%20Jurgens%...

  36. (Unrelieved Pain Continues To Burden Americans) "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)."

    Source: 
    Pain & Policy Studies Group. Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (CY 2013). (University of Wisconsin Carbone Cancer Center: Madison, WI, July 2014), p. 13.
    http://www.painpolicy.wisc.edu/achieving-balance-federal-and-state-pain-...
    http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/evalg...

  37. (Reasons for Non-Prescription Use of Prescription Opioids by US High School Seniors) "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%).

    Source: 
    Sean Esteban McCabe, Phd, et al., "Motives for Nonmedical Use of Prescription Opioids among High School Seniors in the United States: Self-Treatment and Beyond," Archives of Pediatric and Adolescent Medicine, 2009 August; 163(8): 739-744. doi:10.1001/archpediatrics.2009.120.
    http://www.ncbi.nlm.nih.gov/pubmed/19652106
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2975027/pdf/nihms-164105.pdf

  38. 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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  39. (Prevalence of Chronic Pain) 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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  40. (Pain Relief and Non-Prescription Use of Prescription Opioids by US High School Seniors) "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."

    Source: 
    Sean Esteban McCabe, Phd, et al., "Motives for Nonmedical Use of Prescription Opioids among High School Seniors in the United States: Self-Treatment and Beyond," Archives of Pediatric and Adolescent Medicine, 2009 August; 163(8): 739-744. doi:10.1001/archpediatrics.2009.120.
    http://www.ncbi.nlm.nih.gov/pubmed/19652106
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2975027/pdf/nihms-164105.pdf

  41. (Non-Medical Use of Pain Relievers) "The number and percentage of persons aged 12 or older who were current nonmedical users of pain relievers in 2011 (4.5 million or 1.7 percent) were lower than those in 2010 (5.1 million or 2.0 percent) and 2009 (5.3 million or 2.1 percent)."

    Source: 
    Substance Abuse and Mental Health Services Administration, Results from the 2011 National
    Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012, p. 14.
    http://www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresults2011.pdf

  42. (Source of Pain Relievers Used Non-Medically) "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."

    Source: 
    Substance Abuse and Mental Health Services Administration, Results from the 2011 National
    Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012, p. 28.
    http://www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresults2011.pdf

  43. (Source For Pain Relievers Used Non-Medically Which Were Obtained From A Friend Or Relative For Free) "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."

    Source: 
    Substance Abuse and Mental Health Services Administration, Results from the 2011 National
    Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012, p. 28.
    http://www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresults2011.pdf

  44. (Pain Treatment and Opioid Abuse) "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."

    Source: 
    Joranson, David E., MSSW, Karen M. Ryan, MA, Aaron M. Gilson, PhD, June L. Dahl, PhD, "Trends in Medical Use and Abuse of Opioid Analgesics," Journal of the American Medical Association, Vol. 283, No. 13, April 5, 2000, p. 1713.
    http://jama.jamanetwork.com/article.aspx?articleid=192551

  45. (Prescription Opioid Overdose) "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."

    Source: 
    Kanny, Dafna; Garvin, William S.; and Balluz, Lina, "Vital Signs: Binge Drinking Prevalence, Frequency, and Intensity Among Adults — United States, 2010," Morbidity and Mortality Weekly Report (Atlanta, GA: Centers for Disease Control and Prevention, January 13, 2012) Vol. 61, No. 1, p. 10.
    http://www.cdc.gov/mmwr/pdf/wk/mm6101.pdf

  46. (Overdose Risk Based on Prescription Type) "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."

    Source: 
    Bohnert, Amy S.B., et al., "Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths," Journal of the American Medical Association, April 6, 2011, Vol 305, No. 13, pp. 1319-1320.
    http://jama.jamanetwork.com/article.aspx?articleid=896182

  47. (Prescribing Patterns and Opioid Overdose-Related Deaths) "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."

    Source: 
    Bohnert, Amy S.B., et al., "Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths," Journal of the American Medical Association, April 6, 2011, Vol 305, No. 13, p. 1315.
    http://jama.jamanetwork.com/article.aspx?articleid=896182

  48. (Prescribing Patterns and Opioid Overdose-Related Deaths) "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."

    Source: 
    Bohnert, Amy S.B., et al., "Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths," Journal of the American Medical Association, April 6, 2011, Vol 305, No. 13, p. 1315.
    http://jama.jamanetwork.com/article.aspx?articleid=896182

  49. (Factors Influencing Methadone-Related Mortality) "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)."

    Source: 
    Center for Substance Abuse Treatment, "Methadone-Associated Mortality: Report of a National Assessment, May 8-9, 2003," CSAT Publication No. 28-03 (Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 2004), p. 11.
    http://www.atforum.com/SiteRoot/pages/addiction_resources/CSAT-MAM_Final...

  50. (Deaths Related to Opioid Analgesic Use) "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."

    Source: 
    Paulozzi, Leonard J., "Opioid Analgesic Involvement in Drug Abuse Deaths in American Metropolitan Areas," American Journal of Public Health (Vol 96, No. 10), October 2006, p. 1756.
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1586142/pdf/0961755.pdf

  51. (Oxycodone Production Quotas) "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"

    Source: 
    Ferrara, Melissa M., "The Disparate Treatment of Medications and Opiate Pain Medications Under the Law: Permitting the Proliferation of Opiates and Limiting Access to Treatment," Seton Hall Law Review (South Orange, NJ: Seton Hall University, May 24, 2012) Volume 42, Issue 2, pp. 751-752.
    http://scholarship.shu.edu/cgi/viewcontent.cgi?article=1431&context=shlr

  52. Laws & Policies

    (Health Care Reform and Development of Pain Management 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."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 47.
    http://www.nap.edu/openbook.php?record_id=13172

  53. (Progress In Achieving Balance In Pain Management Policy In The US) "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"

    Source: 
    Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)" (Madison, WI: University of Wisconsin Carbone Cancer Center, July 2014), p. 23.
    http://www.painpolicy.wisc.edu/achieving-balance-state-pain-policy-progr...
    http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/prc20...

  54. (Pain Contracts) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 147.
    http://www.nap.edu/openbook.php?record_id=13172

  55. (Strategies to Reduce Risk of Abuse) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 146.
    http://www.nap.edu/openbook.php?record_id=13172

  56. (Development of Pain Management Model Policy) "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)."

    Source: 
    Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 144.
    http://www.nap.edu/openbook.php?record_id=13172
    The Federation of State Medical Board's Model Policy on the Use of Controlled Substances for the Treatment of Pain (2004) is available at http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/model...

  57. (AMA on Controlled Substances and Pain) "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."

    Source: 
    American Medical Association, "About the AMA Position on Pain Management Using Opioid Analgesics," 2010.
    http://www.ama-assn.org/go/painpolicy

  58. (American Medical Association on the Undertreatment of Pain, 2004) "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."

    Source: 
    American Medical Association, "About the AMA Position on Pain Management Using Opioid Analgesics," 2004.
    Note: This report no longer available on the AMA's website, however its content is discussed in "California law eases threat to pain medication prescribers," American Medical News, Sept. 13, 2004.
    http://www.amednews.com/article/20040913/profession/309139960/1/

  59. (Legal Opium Producers) "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."

    Source: 
    Transform Drug Policy Foundation, "After the War on Drugs: Blueprint for Regulation," (Bristol, United Kingdom: September 2009), p. 32.
    http://www.tdpf.org.uk/resources/publications/after-war-drugs-blueprint-...

  60. (International Law and the "Central Principle of Balance") "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."

    Source: 
    Taylor, Allyn L. "Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations Single Convention on Narcotic Drugs," Journal of Law, Medicine & Ethics (Washington, DC: Georgetown University Law Center, January 2008) Vol. 35, No. 556, p. 564.
    http://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1088150_code238438.pdf?a...

  61. Prescription Drug Monitoring Programs

    (State Prescription Drug Monitoring Programs, 2012) "Prescription drug monitoring programs (PDMPs) are now authorized in 48 states and only two states (Missouri and New Hampshire) and the District of Columbia lack legislation authorizing a PDMP. States such as Maryland, Georgia, and Arkansas recently passed legislation to establish PDMPs. In addition, states are beginning to share data across state lines. Ohio and Kentucky successfully shared data in a test pilot and many other states are expected to increase their data sharing capabilities over the next several months."

    Source: 
    Office of National Drug Control Policy, "National Drug Control Strategy," (Washington, DC: Executive Office of the President, April 2012), p. 48.
    http://www.whitehouse.gov/sites/default/files/ondcp/2012_ndcs.pdf

  62. (PDMP Definition) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, Dec. 2003), p. 15.
    http://www.gao.gov/new.items/d04110.pdf

  63. (Impact of PDMPs on Drugs Being Prescribed) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 16.
    http://www.gao.gov/new.items/d02634.pdf

  64. (Physician Concerns Over PDMPs) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 18.
    http://www.gao.gov/new.items/d02634.pdf

  65. (Effectiveness of PDMPs) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 15.
    http://www.gao.gov/new.items/d02634.pdf

  66. (PDMPs and Reduction of Diversion) "States with PDMPs have realized benefits in their efforts to reduce drug diversion. These include improving the timeliness of law enforcement and regulatory investigations. For example, Kentucky's state drug control investigators took an average of 156 days to complete the investigation of an alleged doctor shopper prior to the implementation of the state's PDMP. The average investigation time dropped to 16 days after the program was established. In addition, law enforcement officials in Kentucky and other states view the programs as a deterrent to doctor shopping, because potential diverters are aware that any physician from whom they seek a prescription may first examine their prescription drug utilization history based on PDMP data."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 3.
    http://www.gao.gov/new.items/d02634.pdf

  67. (Effects of PDMPs) "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"

    Source: 
    "Use of Chronic Opioid Therapy in Chronic Noncancer Pain: Evidence Review," The American Pain Society in Conjunction with The American Academy of Pain Medicine (Glenview, IL: American Pain Society, February 2009), pp. 98-99.
    http://www.americanpainsociety.org/uploads/pdfs/Opioid_Final_Evidence_Re...

  68. (PDMP Growth) "As users become more familiar with the benefits of PDMP report data, requests and the attendant costs to provide them may increase. In Kentucky, Nevada, and Utah, usage has increased substantially, mostly because of the increased number of requests by physicians to check patients' prescription drug histories. In Kentucky, these physician requests increased from 28,307 in 2000, the first full year of operation, to 56,367 in 2001, an increase of nearly 100 percent. Law enforcement requests increased from 4,567 in 2000 to 5,797 in 2001, an increase of 27 percent. Similarly, Nevada's requests from all authorized users have also increased-from 480 in 1997, its first full year, to 6,896 in 2001, an increase of about 1,400 percent. Additionally, as a PDMP matures, the needs it addresses may change, and operating costs may increase as a result."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 14.
    http://www.gao.gov/new.items/d02634.pdf

  69. (PDMP start-ups) "Officials from DEA, the Alliance [National Alliance for Model State Drug Laws], and state PDMPs told us that states considering establishing a PDMP, or expanding an existing one, face several challenges. These include educating the public and policymakers about the extent of prescription drug diversion and abuse in their state and the benefits of a PDMP, responding to the concerns of physicians, patients, and pharmacists regarding the confidentiality of prescription information, and funding the cost of program development and operations. Given a state's particular funding availability and budget priorities, program costs can be a major hurdle. The start-up costs for the three most recent PDMPs were $415,000 for Kentucky, $134,000 for Nevada, and $50,000 for Utah. Estimated annual operating costs for these PDMPs varied from a high of about $500,000 in Kentucky, to $150,000 in Utah and $112,000 in Nevada. Costs in these three states vary because of differences in the PDMP systems implemented, the number of pharmacies reporting drug dispensing data, and the number of practitioners and law enforcement agencies seeking information from the systems."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, pp. 3-4.
    http://www.gao.gov/new.items/d02634.pdf

  70. (PDMPs and Neighboring States) "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."

    Source: 
    General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, pp. 16-17.
    http://www.gao.gov/new.items/d02634.pdf

  71. Sociopolitical and Clinical Research

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

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  72. (Alternative Therapies) "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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  73. (Opioids and Impairment) "Opioids are associated with adverse events such as sedation and dizziness that could potentially impact driving or work safety83. However, some studies suggest that opioids do not necessarily impair or may improve psychomotor and cognitive functioning in patients on opioids for chronic noncancer pain.224-227"

    Source: 
    "Use of Chronic Opioid Therapy in Chronic Noncancer Pain: Evidence Review, " The American Pain Society in Conjunction with The American Academy of Pain Medicine (Glenview, IL: American Pain Society, February 2009), p. 65.
    http://www.americanpainsociety.org/uploads/pdfs/Opioid_Final_Evidence_Re...

  74. (Likelihood of Seeing a Physician for Pain) "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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  75. (Medical Cannabis Laws and Opioid Overdose Mortality Rates) "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."

    Source: 
    Bacchuber, Marcus A., MD; Saloner, Brendan, PhD; Cunningham, Chinazo O., MD, MS; and Barry, Colleen L., PhD, MPP. "Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010." JAMA Intern Med. doi:10.1001/jamainternmed.2014.4005. Published online August 25, 2014.
    http://archinte.jamanetwork.com/article.aspx?articleid=1898878

  76. (Pain-Related Lost Productive Time) "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%)."

    Source: 
    Stewart, Walter F., PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Richard Lipton, MD, "Lost Productive Time and Cost Due to Common Pain Conditions in the US Workforce," Journal of the American Medical Association (Chicago, IL: American Medical Association, Nov. 12, 2003), Vol. 290, No. 18, p. 2446.
    http://jama.jamanetwork.com/data/Journals/JAMA/4903/JOC31480.pdf

  77. (Self-Medication with Alcohol) "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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  78. (Pain-Related Lost Productive Time) "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)."

    Source: 
    Stewart, Walter F., PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Richard Lipton, MD, "Lost Productive Time and Cost Due to Common Pain Conditions in the US Workforce," Journal of the American Medical Association (Chicago, IL: American Medical Association, Nov. 12, 2003), Vol. 290, No. 18, p. 2449.
    http://jama.jamanetwork.com/article.aspx?articleid=197628

  79. (Pain Patients in Methadone Treatment) "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."

    Source: 
    Rosenblum, Andrew, PhD, Herman Joseph, PhD, Chunki Fong, MS, Steven Kipnis, MD, Charles Cleland, PhD, Russell K. Portenoy, MD, "Prevalence and Characteristics of Chronic Pain Among Chemically Dependent Patients in Methadone Maintenance and Residential Treatment Facilities," Journal of the American Medical Association (Chicago, IL: American Medical Association, May 14, 2003), Vol. 289, No. 18, p. 2376.
    http://jama.jamanetwork.com/article.aspx?articleid=196537

  80. (Pain Patients in Treatment) "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."

    Source: 
    Rosenblum, Andrew, PhD, Herman Joseph, PhD, Chunki Fong, MS, Steven Kipnis, MD, Charles Cleland, PhD, Russell K. Portenoy, MD, "Prevalence and Characteristics of Chronic Pain Among Chemically Dependent Patients in Methadone Maintenance and Residential Treatment Facilities," Journal of the American Medical Association (Chicago, IL: American Medical Association, May 14, 2003), Vol. 289, No. 18, pp. 2376-2377.
    http://jama.jamanetwork.com/article.aspx?articleid=196537

  81. (Pain Patients in Methadone Treatment) "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."

    Source: 
    Rosenblum, Andrew, PhD, Herman Joseph, PhD, Chunki Fong, MS, Steven Kipnis, MD, Charles Cleland, PhD, Russell K. Portenoy, MD, "Prevalence and Characteristics of Chronic Pain Among Chemically Dependent Patients in Methadone Maintenance and Residential Treatment Facilities," Journal of the American Medical Association (Chicago, IL: American Medical Association, May 14, 2003), Vol. 289, No. 18, p. 2377.
    http://jama.jamanetwork.com/article.aspx?articleid=196537

  82. (Reasons for Changing Doctors) "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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  83. (Getting Pain Under Control) "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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  84. (Chronic Pain Severity and 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."

    Source: 
    Roper Starch Worldwide, Inc., "Chronic Pain In America: Roadblocks To Relief," research conducted for the American Pain Society, the American Academy of Pain Medicine and Janssen Pharmaceutica, Jan. 1999.

  85. (US Department of Veterans Affairs, Medical Marijuana, and Pain Management) "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."

    Source: 
    Petzel, Robert A., Letter to Michael Krawitz from the Dept. of Veterans Affairs concerning its postion on medical marijuana, (Washington, DC: Department of Veterans Affairs, Under Secretary for Health, July 6, 2010).
    http://www.veteransformedicalmarijuana.org/files/Undersecretary-Jun6.pdf