Pain Management

61. 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."

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.

62. 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)."

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.

63. 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."

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.

64. 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"

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.

65. Health Care Reform and Development of Pain Management Policies

Laws & Policies

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

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.

66. 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"

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.

67. 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)."

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.

68. 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)."

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.

69. 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)."

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.
The Federation of State Medical Board's Model Policy on the Use of Controlled Substances for the Treatment of Pain (2004) is available at

70. 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."

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.

71. 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."

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.

72. 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."

Transform Drug Policy Foundation, "After the War on Drugs: Blueprint for Regulation," (Bristol, United Kingdom: September 2009), p. 32.

73. 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."

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.

74. 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."

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.

75. State Prescription Drug Monitoring Programs

"There have been significant advances in implementing PDMPs, 49 states and Washington, D.C. now have operational PDMPs. PDMPs help providers understand their patients’ medication histories, as well as problematic behaviors that signal a need for more in-depth conversations about pain and substance use. The Bureau of Justice Assistance (BJA) supported PDMP expansion grants in 11 states in 2015. ONC, SAMHSA, and CDC all have funded research and standards development for PDMP improvements. The IHS, DoD, and VA have piloted the integration of PDMP systems within their electronic health records systems. In July 2016, both VA and IHS announced new policies that require prescribers to check the PDMP prior to making a decision to prescribe controlled medications.
"Historically, the ability of states to share data has been limited, but agencies are currently involved in efforts to enhance the interoperability of state PDMPs. At the time of this writing, two electronic data sharing hubs are operational, enabling 43 states to work through one or both to share PDMP data with at least one other state. Funding from BJA and DoD has been used to enhance this interstate data sharing.
"PDMPs are only one approach to monitoring. The DoD, VA, and CMS all have initiated drug utilization review programs for some of their patient populations to better coordinate care for individuals who are prescribed opioid medications. Many hospitals administer patient surveys to determine whether their pain was managed adequately. CMS has proposed new questions for these surveys that avoid the perception that performance is linked to prescribing opioid medications for pain control.14"

Office of National Drug Control Policy, "National Drug Control Strategy 2016," (Washington, DC: Executive Office of the President, January 2017), p. 67.

76. 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."

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.

77. 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."

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.

78. 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."

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.

79. 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."

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.

80. 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"

"Clinical Guideline for the 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.