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Editorials |

Chronic Noncancer Pain Management and Opioid Overdose: Time to Change Prescribing Practices FREE

A. Thomas McLellan, PhD; and Barbara J. Turner, MSEd, MD, Executive Deputy Editor
[+] Article and Author Information

From the White House Office of National Drug Control Policy; Washington, DC 20503; and Executive Deputy Editor


Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2667.

Corresponding Author: A. Thomas McLellan, PhD, White House Office of National Drug Control Policy, 750 17th Street Northwest, Washington, DC 20503; e-mail, amclellan@ondcp.eop.gov.

Current Author Addresses: Dr. McLellan: White House Office of National Drug Control Policy, 750 17th Street Northwest, Washington, DC 20503.

Dr. Turner: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.


Ann Intern Med. 2010;152(2):123-124. doi:10.7326/0003-4819-152-2-201001190-00012
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At this writing, opioids are the most commonly prescribed class of medication in the United States (1). Prescription of some opioids, such as methadone, has increased more than 800% in the past 10 years (2). This increase in opioid prescribing has caused an increase in overdoses and deaths. Opioid overdose is among the most common causes of accidental death nationwide (3). The increase in deaths due to prescription opioids is a major public health priority and not just a concern for individual physicians and their patients.

It is easy to blame the growing epidemic of opioid overdose and death on manipulative patients who misrepresent pain symptoms to obtain drugs to abuse or sell. A recent report (4) on overdose deaths in West Virginia found that 51% occurred in persons who had never actually been prescribed an opioid (that is, prescription diversion) and that another 20% occurred in persons who had received prescriptions from 5 or more physicians (that is, “doctor shopping”). In an accompanying editorial (5), we acknowledged the role of the patient in adverse events from opioids but also suggested opportunities for physicians to stem the rise in prescription opioid deaths.

In this issue, Dunn and colleagues (6) identify a potential role for physicians in reducing prescription opioid overdose and death. The authors examined stably insured patients with a range of noncancer pain diagnoses in the Group Health Cooperative network in Washington. Doctor shopping with multiple opioid prescriptions was probably minimal in this setting, which had a systemwide electronic health record. Patients most likely to seek drugs from multiple physicians probably left the system, as did one third of the study sample during the 4-year follow-up. Yet, even in this closed system, the rates of documented serious overdose incidents and deaths were substantial (117 and 17 per 100 000 person-years, respectively). True rates were probably even higher because of inevitable gaps in the reporting of these events.

A disturbing observation from Dunn and colleagues' study was that many overdose incidents might have been averted by changes in prescriber practices. First, the raw data (unadjusted) revealed more overdoses in patients who were diagnosed with depression or substance abuse or who were concurrently prescribed sedative-hypnotics (for example, benzodiazepines). It is unknown whether these patients were first treated, as they should have been, with alternative nonopioid pharmacologic and nonpharmacologic approaches (for example, physical therapy) to manage chronic pain. Regardless, depression, substance use, and benzodiazepine use are all well-known risks for adverse events from opioids (7); therefore, these persons require substantial education and close oversight if opioids are prescribed.

The authors did not evaluate other risk factors for opioid misuse, including history of illicit drug use (because it is infrequently entered as a diagnosis). When alcohol use is recorded, it is located in the social history, where it rarely affects prescribing (8). Substance abuse screening and brief intervention protocols have been shown to reduce substance use–related problems (9) but have not been widely incorporated into physician practice (10). Physicians may fear finding an addiction, which many are unprepared to treat (11). But brief screening discussions about substance use—not just addiction—are needed to reduce opioid overdose as well as other drug–alcohol or drug–drug interactions.

A unique contribution of this study is the examination of the relationship between overdose events and the timing and morphine-equivalent dose of the prescribed drug. As expected, the authors found that risk for an adverse event was greatest shortly after the initial opioid prescription or after a refill. These data reinforce the importance of closely monitoring patients who are prescribed opioids. The authors also report a dose–response relationship between higher morphine-equivalent doses and risk for opioid-related overdose. Although the highest dose of opioids (≤100-mg morphine equivalents) was received during only 2% of the follow-up, the associated annual overdose rate was very high during that period: 1791 per 100 000 person-years. Low doses rarely resulted in adverse events. Prescribing opioids at high doses is both dangerous and questionable for indications other than methadone treatment of opioid dependence.

Opioid therapy can be monitored by making an opioid agreement with the patient when therapy is initiated. The agreement is updated whenever therapy is modified. Typically, these agreements not only set out the responsibilities of both patient and provider when these drugs are used but also make clear the potential dangers of using these drugs other than as prescribed. Dunn and colleagues' findings reinforce the importance of goal-directed opioid therapy, in which continued or increased doses of opioid therapy should be contingent on clear improvements in function and quality of life (for example, resuming more normal activities) (7). Long-term opioid therapy carries too many risks to justify use without improvements in health status.

Of note, the patients in Dunn and colleagues' study received prescriptions primarily for short-acting opioids, namely hydrocodone and oxycodone. Although not specified, these drugs were probably in formulations with acetaminophen. Not only are short-acting opioids associated with greater risk for tolerance and dependence (12), a recent panel of the U.S. Food and Drug Administration (13) recommended that these combination drugs be removed because of acetaminophen-related hepatotoxicity. Acetaminophen poisoning was not examined in this study but represents yet another risk that patients and physicians should seek to reduce.

Finally, Dunn and colleagues' findings strengthen the argument for an easy-to-use, real-time, prescription-drug monitoring program in which physicians can track all opioid prescriptions for a patient. Two promising systems, one designed by the Department of Health and Human Services and one by the Department of Justice, are in testing now. However, neither is fully satisfactory. To be successful, the program needs to be readily accessible for all health care clinical information systems, including pharmacies. The White House Office of National Drug Control Policy and other federal agencies are actively collaborating on development of this key resource to help physicians reduce patient abuse of prescriptions (for example, doctor shopping) and adverse drug interactions.

It is easy to suggest time-consuming, unreimbursed approaches to improve the safety of opioid prescribing without specifying how they can be incorporated into already overburdened clinical settings. Frankly, we do not know how to increase clinical diligence without additional work, time, or money, although technology can facilitate some of these suggested practice changes. The threat to patient safety is too great to allow current pain management and opioid-prescribing practices to remain as they are. Dunn and colleagues' data show the need to assess the risk for opioid misuse, provide close oversight, dose judiciously, and continually reevaluate the benefit of these potentially risky drugs. Smarter, more responsible practices are the only hope to avoid tragic, avoidable deaths.

References

Kuehn BM.  Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007; 297:249-51. PubMed
CrossRef
 
U.S. Department of Justice Drug Enforcement Administration.  ARCOS: Automation of Reports and Consolidated Orders System. Accessed atwww.deadiversion.usdoj.gov/arcos/index.htmlon 7 December 2009.
 
Centers for Disease Control and Prevention (CDC).  Unintentional poisoning deaths—United States, 1999-2004. MMWR Morb Mortal Wkly Rep. 2007; 56:93-6. PubMed
 
Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D. et al.  Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008; 300:2613-20. PubMed
 
McLellan AT, Turner B.  Prescription opioids, overdose deaths, and physician responsibility [Editorial]. JAMA. 2008; 300:2672-3. PubMed
 
Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD. et al.  Opioid prescriptions for chronic pain and overdose. A cohort study. Ann Intern Med. 2010; 152:85-92.
 
Gourlay DL, Heit HA, Almahrezi A.  Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005; 6:107-12. PubMed
 
Turner BJ, McLellan AT.  Methodological challenges and limitations of research on alcohol consumption and effect on common clinical conditions: evidence from six systematic reviews. J Gen Intern Med. 2009; 24:1156-60. PubMed
 
Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW.  Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009; 99:280-95. PubMed
 
Compton WM, Volkow ND.  Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend. 2006; 81:103-7. PubMed
 
Miller NS, Sheppard LM, Colenda CC, Magen J.  Why physicians are unprepared to treat patients who have alcohol- and drug-related disorders. Acad Med. 2001; 76:410-8. PubMed
 
Zacny J, Bigelow G, Compton P, Foley K, Iguchi M, Sannerud C.  College on Problems of Drug Dependence task force on prescription opioid non-medical use and abuse: position statement. Drug Alcohol Depend. 2003; 69:215-32. PubMed
 
Kuehn BM.  FDA focuses on drugs and liver damage: labeling and other changes for acetaminophen. JAMA. 2009; 302:369-71. PubMed
 

Figures

Tables

References

Kuehn BM.  Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007; 297:249-51. PubMed
CrossRef
 
U.S. Department of Justice Drug Enforcement Administration.  ARCOS: Automation of Reports and Consolidated Orders System. Accessed atwww.deadiversion.usdoj.gov/arcos/index.htmlon 7 December 2009.
 
Centers for Disease Control and Prevention (CDC).  Unintentional poisoning deaths—United States, 1999-2004. MMWR Morb Mortal Wkly Rep. 2007; 56:93-6. PubMed
 
Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D. et al.  Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008; 300:2613-20. PubMed
 
McLellan AT, Turner B.  Prescription opioids, overdose deaths, and physician responsibility [Editorial]. JAMA. 2008; 300:2672-3. PubMed
 
Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD. et al.  Opioid prescriptions for chronic pain and overdose. A cohort study. Ann Intern Med. 2010; 152:85-92.
 
Gourlay DL, Heit HA, Almahrezi A.  Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005; 6:107-12. PubMed
 
Turner BJ, McLellan AT.  Methodological challenges and limitations of research on alcohol consumption and effect on common clinical conditions: evidence from six systematic reviews. J Gen Intern Med. 2009; 24:1156-60. PubMed
 
Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW.  Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009; 99:280-95. PubMed
 
Compton WM, Volkow ND.  Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend. 2006; 81:103-7. PubMed
 
Miller NS, Sheppard LM, Colenda CC, Magen J.  Why physicians are unprepared to treat patients who have alcohol- and drug-related disorders. Acad Med. 2001; 76:410-8. PubMed
 
Zacny J, Bigelow G, Compton P, Foley K, Iguchi M, Sannerud C.  College on Problems of Drug Dependence task force on prescription opioid non-medical use and abuse: position statement. Drug Alcohol Depend. 2003; 69:215-32. PubMed
 
Kuehn BM.  FDA focuses on drugs and liver damage: labeling and other changes for acetaminophen. JAMA. 2009; 302:369-71. PubMed
 

Letters

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Editorial Correction Requested on Urgent Basis
Posted on February 14, 2010
Howard G Kornfeld
Howard Kornfeld, M.D., Pain Medicine Fellowship Program, University of California, San Francisco
Conflict of Interest: None Declared

Several days ago, I was preparing some reading material for the trainees in pain medicine that I give a seminar for as part of my clinical faculty teaching at UCSF and I was reviewing a copy of the recent editorial (1) co-authored by Dr. McLellan, the current Deputy Director of the White House Office of National Drug Control Policy (ONDCP) and Dr. Turner, the Executive Deputy Editor of this journal, written in response to the study published by Dunn KM, et al in the same issue (2).

I will not comment here on the cohort study on opioid overdose nor will I comment on the general details of the editorial itself. Both publications make important contributions to the field of pain medicine and public health and I predict that the issues raised will stimulate thinking and responses that will lead to significant academic and policy dialogue.

I want to suggest, however, that the authors consider immediately retracting or modifying one of the statements made in the editorial. It reads, "Prescribing opioids at high doses is both dangerous and questionable for indications other than methadone treatment of opioid dependence."

Those familiar with the pain medicine literature (3-6) and the standards of care across the United States (7) will know that the statement overreaches and appears to overlook those cases, ostensibly a minority, of both malignant and non-malignant pain, in which the appropriate use of high dose opioids has been both successful and accepted by the medical community and has become an essential part of the practice of medicine for a particular patient. Both the literature and the medical board guidelines emphasize diligent selectivity and continuous and careful monitoring, particularly where the opioid dose is significant and long term, but wisely avoid absolute statements that question or label as dangerous a particular clinical practice.

Because this statement has the imprimatur of both the White House ONDCP and the Annals of Internal Medicine, and that adverse consequences may occur both therapeutically and in medical-legal contexts as a result of this statement, I believe that it is important to correct this statement without delay.

References:

1. McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: Time to change prescribing practices. Ann Intern Med. 2010; 152:123-124.

2. Dunn KM, Saunders, KW, Rutter CM, Banta-Green, CJ, Merrill JO, Sullivan MD, et al. Opioid Prescriptions for chronic pain and overdose. A cohort study. Ann Intern Med. 2010;152:85-92.

3. Rosenblum A, Marsch LA, Herman, J, and Portenoy, RK. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008 October;16(5):405-416.

4. Chou, R. 2009 Clinical Guidelines from the American Pain Society and the American Academy of Pain Medicine on the use of chronic opioid therapy in chronic noncancer pain: What are the key messages for clinical practice? Pol Arch Med Wewn. 2009 Jul-Aug;119(7-8):469-77.

5. Fields, HL. Should we be reluctant to prescribe opioids for chronic non-malignant pain? Pain.129(2007):233-234.

6. Katz, N. Opioids: After thousands of years, still getting to know you. Clin J Pain. 2007;May;23(4):303-306.

7. Medical Board of California, Guidelines for Prescribing Controlled Substances for Pain. Adopted by Board in 1994 and revised in 2007. http://www.medbd.ca.gov/pain_guidelines.htm

Conflict of Interest:

None declared

RE: CHRONIC NONCANCER PAIN MANAGEMENT AND OPIOID OVERDOSE:TIME TO CHANGE PRESCRIBING PRACTICES
Posted on February 17, 2010
Stephen G. Gelfand, MD, FACP
Appalachian Regional Rheumatology, Boone, NC
Conflict of Interest: None Declared

In addition to the overdose and mortality risks from prescription opioids discussed in the Editorial of January 18th edition of the Annals [1], three additional opioid-related issues require attention. These include: the real possibility that many people who have overdosed or died from illegally diverted prescription opioids [or heroin]initially became addicted through the use of a legitimate prescription, the prominent role of psychological disorders which have significantly contributed to the overprescription of opioid analgesics, and the likelihood that extended- release and long-acting opioids carry greater risks for addiction, overdose and death than shorter-acting agents.

It appears that there is a significant volume of people who overdosed or died from diverted prescription opioids or heroin [obtained either from the street or from friends or relatives] who may have initially been prescribed an opioid for some type of pain which lead to addiction, and then to the above drug-seeking behaviors associated with this disease. Likewise, many of the addicts who now obtain most of their opioids through illegal 'doctor shopping' may have developed their addiction through an initial or continued legal prescription for pain. These common situations underscore the importance of prudent, selective prescribing of opioids for specific clinical indications for chronic noncancer pain [if at all], with close attention to the risk/benefit ratio and to recently established guidelines, as well as to careful monitoring and knowing when to discontinue or taper patients off these potent brain-active drugs.

As stated in the Editorial, opioid overdose and death was associated with depression, benzodiazepine use and history of substance abuse. This suggests that there is a significant volume of opioid prescriptions written for chronic noncancer pain in which psychological disorders are present but often missed, such as a spectrum of anxiety syndromes and depressive disorders. Since psychological co-morbidities are common in chronic noncancer pain disorders, particularly in the setting of fibromyalgia [2,3], treatment with nonopioid agents and nonpharmacological approaches are indicated, which may also include referral for psychological/behavioral therapies [4].

My own observations from clincial practice and as a national disability peer-reviewer in rheumatology, is that there is a large population of patients with undiagnosed or underdiagnosed psychological disorders which have been inadequately addressed by focusing mainly on chronic pain symptoms misattributed solely to a somatic structure such as degenerative discs, 'arthritis' or muscle tissue such as in fibromyalgia. These somatic 'labels' then become the indication to prescribe opioids for presumed tissue pain, while the psychological disorders underlying the pain often go unrecognized. This then predisposes to the persistence of symptoms, drug dependence, continued dysfunction, and also increases the quest for long-term disability. These factors have become a major contributor to the rising tide of healthcare costs currently affecting our nation, and unless recognized, will continue to fuel the prescription opioid epidemic and all its adverse consequences, including addiction, overdose, and death.

Finally, as noted in the Editorial, the Dunn study[5] focused on short-acting opioids used by over 90% of the cohort, but if extended- release and long-acting opioids like Oxycontin and methadone had been the predominent drugs studied, the outcomes would most likely have been worse, especially since oxycodone and methadone have resulted in the highest reported mortality figures[6]. It is hoped that the Annals articles will stimulate further studies and discussions about the problems of prescription opioids which continue to take a large toll on the public health and social systems of our nation.

References:

[1]McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: Time to change prescribing practices. Ann Intern Med. 2010; 152:123-124.

[2]Winfield JB. Psychological determinants of fibromyalgia and related syndromes. Curr Rev Pain. 2000; 4:276-286.

[3]Arnold LM et al. Comorbidity of fibromyalgia and psychiatric disorders. J Clin Psychiatry. 2006; 67:1219-1225.

[4]Thieme K et al. Responder criteria for operant and cognitive-behavioral treatment of fibromyalgia syndrome. Arthitis Rheum. 2007; 57:830-836.

[5]Dunn KM et al. Opioid prescriptions for chronic pain and overdose. A cohort study. Ann Intern Med. 2010; 152:85-92.

[6] Florida Department of Law Enforcement. 2009 interim report of drugs identified in deceased persons by Florida Medical Examiners. Nov. 2009. [www.fdle.state.fl.us/publications/Examiners/2009DrugReport.pdf].

Conflict of Interest:

None declared

Re:RE: CHRONIC NONCANCER PAIN MANAGEMENT AND OPIOID OVERDOSE:TIME TO CHANGE PRESCRIBING PRACTICES
Posted on February 19, 2010
A. Thomas McLellan
White House Office of National Drug Control Policy
Conflict of Interest: None Declared

The remarks submitted by Drs. Gelfand and Kornfeld in response to our editorial about prescription opioids and overdose (1) exemplify the wide spectrum of opinions about the use of opioids for chronic non-cancer pain. Dr. Gelfand questions the use of these drugs in persons with mental health disorders and Dr. Kornfeld takes issue with our suggestion that high dose opioids should be avoided. However, Dr. Gelfand accurately emphasizes the high prevalence of comorbid mental health disorders in persons prescribed opioids. In a national population-based community survey, persons with a history a mood disorder (e.g., depression, anxiety disorder) were over four-times more likely to report subsequent opioid treatment than persons without such a history (2). We agree with him that physicians need to address mental health disorders when treating pain but we would not deny a potentially beneficial therapy to patients just because they have such a disorder.

In his remarks supporting the use of high dose opioids, Dr. Kornfeld does not distinguish whether this treatment is for cancer or non-cancer pain but our editorial and the paper by Dunn et al. (3) concern only non-cancer pain. The American Pain Society (APS)-American Academy of Pain Medicine (AAPM) Opioids Guidelines Panel stated that "...there is little evidence to guide safe and effective prescribing at higher [opioid] doses and there is no standardized definition for what constitutes a "high" dose (4)." The Panel raises serious concerns, as do we, about high dose opioid therapy (which they define as >200 mg daily of oral morphine or equivalent) because of the risks of diversion, opioid-related adverse effects, changes in health status, and poor adherence to the opioid treatment plan.

If patients do require high dose therapy, the Opioids Guidelines Panel recommends using complementary non-opioid therapies to help reduce reliance on opioids and possibly rotating opioids along with dose reductions (4). An APS-AAPM panel has identified related research gaps including: "What are the benefits and harms of high (>200 mg/d of morphine or equivalent) versus lower doses of opioids for chronic noncancer pain?" and "Are high doses of opioids associated with different or unique harms compared with lower doses?" (5). Such fundamental gaps in our knowledge along with worrisome evidence of serious risks do raise serious questions about the use of high dose opioids for non-cancer pain management.

Finally, we thank Dr. Reidenberg for discovering an omitted word. The sentence in our editorial to which he refers should have read: "Opioid overdose is among the most common causes of unintentional death nationwide." We have issued a correction.

The opinions expressed here do not necessarily represent those of the White House Office of National Drug Control Policy

References

1.McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010;152(2):123-4.

2. Sullivan MD, Edlund MJ, Zhang L, Unutzer J, Wells KB. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med. 2006;166(19):2087-93.

3.Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010;152(2):85-9

4. Chou R, Fanciullo GJ, Fine PG, et al. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):131-46

5. Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):147-59

Conflict of Interest:

None declared

Re:Re:RE: CHRONIC NONCANCER PAIN MANAGEMENT AND OPIOID OVERDOSE:TIME TO CHANGE PRESCRIBING PRACTICES
Posted on February 23, 2010
Scott M. Fishman, MD
No Affiliation
Conflict of Interest: None Declared

Although we agree with almost all of the points made in the commentary by Drs. McLellan and Turner (1), one statement must be highlighted. We suspect that the far over-reaching statement "Prescribing opioids at high does is both dangerous and questionable for indications other than methadone treatment of opioid dependence" was an oversight since it is so clearly an extreme position that must be challenged. Obviously, there are some cases in which high dosages of opioids are not "questionable." Allowing this statement to stand casts a cloud on physicians who appropriately use moderate to high dosages of opioids for legitimate patients (2). As others have said, this statement should be retracted by the authors.

Unfortunately, despite an otherwise fine commentary, the authors' response to the problem with this one statement has fallen short. Reliance upon certain assertions made in the American Pain Society/American Academy of Pain Medicine (APS-AAPM) guidelines article and companion piece (in which PGF participated) to support their statement is far beyond what we know to be the intentions of those publications (3,4). Once this singular, hyperbolic and potentially harmful statement is retracted, the authors are to be congratulated on a thoughtful and informative commentary.

On behalf of the American Academy of Pain Medicine

References:

1. McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010;152(2):123-4.

2. Fishman SM. Responsible Opioid Prescribing. Federation of State Medical Boards and Waterford Life Sciences, 2008, Washington, DC

3. Chou R, Fanciullo GJ, Fine PG, et al. Opioids for chronic noncancer pain:prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):131-46.

4. Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):147-59.

Conflict of Interest:

None declared

Re: HIGH DOSE OPIOID CONTROVERSY
Posted on February 25, 2010
Stephen G. Gelfand, MD, FACP
Appalachian Regional Rheumatology, Boone, NC
Conflict of Interest: None Declared

Part of the difference of opinion being expressed in regard to whether or not high dosages of opioids can be safely given over the long- term to some patients with chronic noncancer pain stems from different patient populations seen in pain management compared to primary care and certain specialty practices. The small subgroup of patients who have improved both symptomatically and functionally with long-term high dose opioid therapy are far more likely to be seen in pain management practices, although the specific clinical characteristics of this subgroup need to be further studied and defined.

However, when the same approach to opioid dosage escalation is applied to the much greater number of chronic noncancer pain patients seen outside of pain management settings, and at the same time primary care physicians are given the message that there is no defined maximum dose of opioid analgesics and the ceiling dose to effectiveness is related only to side effects, the most serious of which is respiratory depression [1], the risks may then far outweigh the benefits. This is especially true in chronic noncancer pain patients with frequent co-morbid psychological disorders [2] and/or histories of substance abuse.

References:

[1]Clinical issues in opioid prescribing: considerations for the practitioner in the use of opioids in managing moderate to severe pain. Partners Against Pain Brochure 2005.Purdue Pharma L.P.:8-9.

[2]Wassan AD et al. Psychiatric history and psychologic adjustment as risk factors for aberrant drug-related behavior among patients with chronic pain. Clin J Pain.2007;23[4]:307-15.

Conflict of Interest:

None declared

What about those who benefit from this therapeutic option?
Posted on February 26, 2010
Will Rowe
American Pain Foundation
Conflict of Interest: None Declared

Dear Editors:

I am writing to express my concern about a statement contained in your recent editorial in the Annals of Medicine which says, "Prescribing opioids at high doses is both dangerous and questionable for indications other than methadone treatment of opioid dependence." While I agree with other recommendations you make with respect to the need to better select and better monitor patients for high dose opioids, I believe that the study you reflect upon in your article, other literature and clinical experience do not support the recommendation to limit high dose opioid therapy to methadone treatment for opioid dependence. Such a statement, coming from you and the Office of National Drug Control Policy, can have serious negative consequences for many patients who benefit from this treatment choice and the providers who properly utilize high dose therapy in their practice.

The Guidelines for Use of Chronic Opioid Therapy for Chronic, Non-Cancer Pain recently issued by the American Pain Society and the American Academy of Pain Medicine articulate legitimate use and the special considerations to be utilized in high-dose opioid therapy. The experience of many patients and clinicians also corroborates the safe but more considered use of this treatment option. For patients, many who have explored and found other options insufficient, high-dose opioid therapy offers perhaps the last option for relief and the only avenue for a normal life.

We urge you to retract the statement that would lead to eliminating this important treatment option many people suffering from severe pain.

Conflict of Interest:

None declared

RE: CHRONIC NONCANCER PAIN MANAGEMENT AND OPIOID OVERDOSE:TIME TO CHANGE PRESCRIBING PRACTICES
Posted on March 1, 2010
Howard G Kornfeld
Pain Medicine Fellowship Program, University of California, San Francisco
Conflict of Interest: None Declared

Drs. McLellan and Turner were thoughtful to reply to my letter and to that of Dr. Gelfand. I had taken issue with the statement, made in their editorial that, "Prescribing opioids at high doses is both dangerous and questionable for indications other than methadone treatment of opioid dependence." Dr. Gelfand had expressed a number of concerns about the use of opioids, including their use in patients with mental health disorders.

Drs. McLellan and Turner characterized my remarks as supporting the use of high dose opioids. I want to clarify that what I support, in both my role as an addiction medicine physician and an ABMS certified pain medicine specialist, is the inclusion of a range of doses of opioid medication as being appropriate over a wide spectrum, given the vast clinical variation present in chronic pain patients. Higher doses, prescribed long term, should generally be prescribed to a minority of the patients with chronic non-cancer pain.

Drs. McLellan and Turner suggest that I did not distinguish between cancer and non-cancer pain. Although they are correct, and indeed their editorial was aimed at non-cancer pain, it is also true that the broad statement in their editorial that I took issue with likewise did not distinguish between the two. Furthermore, concerns and issues around appropriate opioid treatment in cancer pain can often significantly overlap, if not become indistinguishable from, concerns and issues with respect to opioid management of chronic non-cancer pain.

A strategy for the management of pain that is infrequently discussed in the American pain literature and one that may confer excellent efficacy, as well as much greater safety than full opioid agonists, is the use of buprenorphine, a partial mu opioid agonist, in the management of chronic pain. Although buprenorphine is best known in the United States in recent years as a treatment for opioid addiction, it has a thirty-year history of use as an analgesic around the world. In the U.S. it has been available as a parenteral analgesic since 1981, and in Europe it has been available as a sublingual tablet over this same time period. For the past ten years, transdermal buprenorphine has enjoyed a growing application in Europe for chronic cancer and non-cancer pain and has been the subject of commensurate attention in published studies and reports (1-6). It appears to have significant utility in those chronic non-cancer pain syndromes that have raised the most concern including neuropathic pain, hyperalgesia, and those associated with aberrant or addictive behaviors. And to the issue studied by Dunn, et al, buprenorphine is much less prone to be associated with overdose death due to its much more limited depression of the central respiratory drive. Understandings of the "ceiling effect" of buprenorphine are evolving towards greater appreciation of its efficacy in chronic human pain, approaching the effectiveness of full agonist opioids.

Perhaps this controversy over the statement made in the editorial by McLellan and Turner can stimulate us to explore the unrealized potential for buprenorphine and, in particular, motivate greater study and interest of this medication for pain in the United States.

References

1. Kress H. Clinical update on the pharmacology, efficacy and safety of transdermal buprenorphine. Eur J Pain. 2009 Mar;13(3):219-30.

2. Sittl R. Transdermal buprenorphine in cancer pain and palliative care. Palliative Med. 2006;20:s25-s30.

3. Vadivelu N, Hines RL. Management of chronic pain in the elderly: focus on transdermal buprenorphine. Clin Inter Aging. 2008;3(3):421-430.

4. Malinoff HL, Barkin RL, Wilson G. Sublingual buprenorphine is effective in the treatment of chronic pain syndrome. Am J Ther. 2005;Sep- Oct;12(5):379-84.

5. Johnson RE, Fudala PJ, Payne R. Buprenorphine: Considerations for pain management. J Pain Symp Management. 2005;29(3):297-326.

6. Vadivelu N, Hines RL. Buprenorphine: A unique opioid with broad clinical applications. J Opioid Management. 2007;3(1):49-58.

Conflict of Interest:

None declared

Comments on Opioid Pain Relievers & Overdose Potential - The Real Danger is Untreated/Undertreated Pain
Posted on March 6, 2010
Heather O. Grace
No Affiliation
Conflict of Interest: None Declared

by Heather O. Grace

I am writing in response to Dr. A. Thomas McLellan's editorial online at: www.annals.org/content/152/2/123.full.

I hate having intractable pain, degenerative disc disease and neurological conditions that can prevent me from completing the simplest tasks. However, I can say with confidence that I am in no danger of overdose!

No true pain patient is at risk of overdose when managed via regular visits to a competent doctor. Under 2% of people taking opioids ever overdose. In fact, the study Dr. McLellan references had even lower rates of overdose--and those at risk appear to mainly be patients on low dose therapies.

It took me over five years of severe pain to find a doctor who would do anything and everything to help me. Unfortunately, I was at the end of my rope, suicidal, by that point.

That doctor saved my life. Our system is broken--not serving severe chronic pain patients like me. If Dr. McLellan is truly concerned about pain patients dying, then I ask:

What about the deaths of patients who don't get pain relief because the DEA restrictions have created a climate of fear among doctors? If you consider the deaths due to heart attack or stroke, in addition to those via suicide, the loss of life is far greater than the loss due to overdose.

Access to medication is a constant concern (fear, really) for pain patients. Patients often have a medication that works, then it is suddenly no longer available. The DEA limits access to many opioids. Worse still, the DEA also routinely accesses confidential prescription records of individual patients--without warrants--in order to target doctors treating high-dose opioid patients.

John Stossel, the famed journalist who was also treated for a serious pain condition, spoke on The O'Reilly Factor on Feb 23, and on his own show, Stossel, on Feb 25, 2010.

He said: "The Drug Enforcement Agency's war on drug dealers has led them to watch pain-management doctors like hawks. Drugs like Vicodin and OxyContin provide wonderful pain relief. But because they are also taken by 'recreational' drug users, doctors go to jail for prescribing quantities that the DEA considers 'inappropriate.' As a result, pain specialists are scared into underprescribing painkillers. Sick people suffer horrible pain needlessly." Source: www.creators.com/opinion/john-stossel/whose-body-is-it-2010-02-24.html

"The system is broken, and patients are suffering," said Claudia Schlosberg, from the American Society of Consultant Pharmacists. "Law enforcement concern has to be compatible with meeting patients' needs. Right now it's not." Source: www.painreliefnetwork.org/page/2/

And there are serious health implications: Dr. Forest Tennant, a founder of the American Society of Addiction Medicine has identified Cardiac Adrenal Pain Syndrome: "Severe pain is well-known to stimulate the cardiac and adrenal systems...The tachycardia and hypertension is caused by pain's over-stimulation of the nervous system. It's the root cause of cardiac and adrenal complications." Source: www.healthcentral.com/chronic-pain/c/3388/69308/information

Treating severe pain patients is not the mystery many people might think it is. Doctors can use objective scales to diagnose patients: blood pressure/pulse, visible inspection, MRIs/CAT scans and bloodwork.

If Dr. McLellan wants to truly help prevent deaths of pain patients, then there are 3 things I recommend the current administration focus its' efforts on:

1. Revise DEA mandate that creates prescription fears even for doctors who treat legitimate pain patients. Don't restrict access to any of the FDA-approved opioids.

2. Ensure pain treaters have access to appropriate documentation on HOW to objectively diagnose pain patients, such as the article written by Dr. Forest Tennant, who has treated pain patients for 25 years. Source: www.pain-topics.org/pdf/Tennant-PainSigns.pdf

3. Create a nationwide Pain Patient's Bill of Rights, similar to the one in California. Include the CA patient rights, plus the objective diagnostic criteria, as noted in #2, above.

By doing all three, a more comprehensive system of care will be in place, throughout the country. People are beginning to open their eyes to the truth about opioids. The Stossel Show is a wonderful step in the right direction. You, Dr. McLellan, as the Deputy Director of the Office of National Drug Control Policy, can be on the forefront of meaningful differences in the quality of care. Plus, with education comes less severe uncontrolled pain and, most certainly, less needless deaths.

I realize it is hard to understand our plight as someone on the outside of all this suffering. I didn't understand use of morphine or methadone until I was suffering and near my own demise. I urge you, Dr McLellan, to look at things from a fresh perspective, talking to pain patients and their doctors, to see what it is to live with pain. We take our opioids just as diabetics take insulin. There really is no difference.

Please, Dr. McLellan, as the #2 Drug Czar working under Director, R. Gil Kerlikowske, you have the power to make positive changes to the way pain patients are treated. I urge you to take a stand in the right direction--to help pain patients--we are counting on you!

Conflict of Interest:

1. I am a pain patient with severe neurologic injury, taking life-saving opioids since 2007. 2. Provide concomitant therapeutic items (nonprescription) via ThePainStore.com.

From one Pain Patient to another: Survival vs. "Rights"
Posted on March 16, 2010
Betts Tully
Chronic pain patient
Conflict of Interest: None Declared

Response to pain patient Heather Grace

First, I would like to congratulate Dr.'s Mclellan and Turner, as well as all the other Dr.'s, who have supported their position on this long overdue attention to the responsibility/role physicians must take in prescribing opioids for chronic non-cancer pain.

I am a former medically prescribed "pain patient", treated for 8 years with high dose opioids. I say former because I took myself off of all narcotic pain relievers in 2008, much to the dismay of my "pain management" doctor. I am currently on a non-narcotic regimen to treat my pain. My etiology is 2 back surgery's, and degenerative disc disease. In 2001,within a 10 month period, I was put on OxyContin, starting with 20mg and escalating to 280mg daily, with 8 Norco breakthrough. No other medical regimen was employed. When it became evident that I was horribly addicted to this drug, my doctor abandoned me. My life was forever altered by that event. I have never taken an opioid/narcotic drug outside the medical setting. Nor have I ever "doctor shopped".

As I read Ms. Grace's comment/position on her impassioned defense of taking opioids for pain, I was immediately struck with compassion for the delusions she seems to suffer from, in relation to her own medical care. It reminded me of myself 7 years ago, when I desperately tried to get medical information on the situation I found myself in. I had gone from a productive person dealing with back pain, to a zombie, for lack of a better description, constantly in need of pain medications, just to get through the day. Like her, I constantly worried more about "not getting my drugs". I sympathized with all those patients, like me, who were just trying to get some "pain relief". I was told not to worry about addiction, since I had "real" pain. I used the word "medication", not opiate or narcotic. I assumed my doctors knew what they were doing, and would not do anything to harm me. But in the long run, I had to admit that I was addicted to narcotics, regardless of whether I had pain or not, or under a physicians care. Not dependant, addicted. Physically, and emotionally addicted. A condition that, eventually, far outwieghed any benefits of relieving my back pain.

It took me years to understand what had really happened to me. And accept responsibility for my own survival. I could have been one of the thousands of medically prescribed pain patients, who have either died, or are still struggling with the added burden of an unwanted addiction. But I am here to tell you that, in my estimation, the medical profession, as well as regulatory agencies, who should have kept me safe, as well as medically informed, let me down. They allowed self-serving pharmaceutical companies to influence and manipulate standard medical practice. They over-prescribed, and under-treated my chronic pain. Through self education, I have realized the many different ways in which my pain can be treated, outside of opioid therapy

The sheer statistics regarding medically prescibed opiates in relation to overdose and addiction are self-evident. They can no longer be ignored. The once tauted "less than 1% of chronic pain patients become addicted" is, today, a medical mirage. The studies that should have been done prior to the radical change in opioid prescribing practices in the late 90's, are now emerging, and as does this editorial, they all call for "caution", not "agression" when dealing with chronic pain and opioids. For many, this common advice, is too late.

I thank all the doctors, who will speak out about this crisis, and who will work to re-engineer the education of physicians, as well as patients, on the risks and benefits of long term opiate therapy for non- cancer patients. At the very least, doctors who wish to operate in this field should be trained/educated, based on sound medical principal, not on junk science coming out of pharmaceutical companies. Perhaps then you will not hear patients or pain foundations talk to you about their concerns about the "DEA",or the odd behavior of defending the extremely small percentage of doctors, who have gone to jail, or the latest one, an analogy of diabetes to pain. Especially, since insulin, to my knowledge , does not have the side effect of addiction, as opiates do.

I hope McLellan and Turner's message is the beginning of the end of this epidemic, and that we see that there are many more dedicated doctors, who will work to turn this sorry situation around. I hope that all the Heather Grace's, who have been so obviously effected by mis-information, will learn that they must become their own advocate and that good medical practice, based in sceintific evidence, is in her best interest. They could begin by looking up the definition of iatrogenic addiction, instead of listening to Fox's John Stossel, or any of the other heavily Pharma funded pain foundations, who do not have her best interest in mind. I hope she does not ever become a name in a medical report for "accidental" overdose like the pain patient, who was found dead by her daughter recently. NCBI report below.

The "real" danger, Heather, is in being treated (for anything), without adequate, studied, reliable, and appropriate information. The protection of your supply of narcotics should not be your only medical concern. Good doctors will not dismiss your pain. Good doctors will treat your condition on the whole, not just your pain. That should be your goal also. And above all, please know that you have a "right" to proper management of your disease and your pain, not a "right" to narcotics.

NCBI report: http://www.ncbi.nlm.nih.gov/pubmed/20190634?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1

My testimony to the FDA last spring: A CHRONIC PAIN PATIENTS PERSPECTIVE ON THE DAMAGE DONE BY AN UNPREPARED AND INADEQUATE SYSTEM TO DELIVER PAIN MANAGEMENT APPROPRIATELY http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064809e6c97&disposition=attachment&contentType=xml

Conflict of Interest:

None declared

A "High Dose" Intractable Pain Patient Responds
Posted on March 10, 2010
Radene Marie Cook
IPPU; APF: Aniwaya Artistry
Conflict of Interest: None Declared

As one who benefits greatly from opioid therapy and specifically high dose opioid therapy, I am compelled to respond to A. Thomas McLellan's editorial. More than just discounting one person's opinion, I hope that my disclosure here will enlighten those who are interested in treating pain as the TRUE chronic pathology it is. There is plenty of research to validate how much opioids belong as a valid part of medical treatments and are readily available to those who seek them out. My continually improving health status is the proof I offer here as a reason to NOT throw out "the baby with the bathwater", or opioid therapy for the 98.2% who are not suffering from overdose episodes, but are given some relief from suffering with otherwise unrelenting pain.

I survived a plane accident in 2000 while on the job. Subsequent surgeries and a vast series of insults --including many non-opioid "treatments" -- to my already injured spine eventually caused Adhesive Arachnoiditis with Central Pain Syndrome, CRPS Type II, Cauda Equina Syndrome and significant Epidural Fibrosis. I failed the pump trial. I failed the trial for a Spinal Cord Stimulator. My pain level was so severe that my body functions were shutting down a few times a month. All of my vitals and adrenal hormone levels were erratic and rated for extreme stress: Coritsol was through the roof, RHR @ 102 and above for at least 2 years. Thyroid would not function even when taking Synthroid at 400mcg! That was my health picture in a nutshell for four years.

Then I began a non-compounded opioid schedule in September of 2004 in conjunction with other topicals and supplements for comfort and tissue healing. In direct contrast to the old wisdom that said a patient would simply become tolerant and never reach a satiated level, I was titrated to the amount of opioid I am on now after 1 1/2 years. That means for 4 years, I have been on the same dose that is a great balance between analgesia and side effects. Within those for years, I have gained a life outside of my bed. I create art, I write, I research my syndromes and the pathology of chronic pain religiously as well as advocating for the pain community at large. My RHR sits between 76 and 85, depending on where my pain flares are for the day. My thyroid is finally functioning beautifully, my Cortisol levels are now at normal. Testosterone and Pregnenolone are at normal levels without further supplementing. My co-morbid health issues continue to improve as my pain stays under control. Though disabled because of my spinal cord injury, I now have a productive, full life. I began a home based business in art. I am the picture of what successful opioid therapy looks like. And I thank God every day of my life for doctors who are willing to treat me with this condition and will cooperate to the fullest, as I KNOW other pain patients would, with any monitoring or paperwork or tests they need to show that all is going well and prove the success of my treatment outside the doctor's doors.

So much of what we know about the actions of opiates has been clouded by the fact that the research has been done from the addiction discipline, NOT strictly the therapeutic, analgesic, pain management discipline. I plead with those who read this to start now or continue researching this avenue from the "opioid pain patient=?" equation (and NOT what it does to addicts without pain) so that others can theoretically see what many of us know by experience--opioid therapy is a great tool in the pain management arsenal.

Conflict of Interest:

I am an intractable pain patient who is taking life-saving opioid treatment.

opinions generally do not constitute historical value
Posted on September 23, 2011
Darren McKinley
none
Conflict of Interest: None Declared

There are glaring defects that undermine the value of "Chronic Noncancer Pain Management and Opioid Overdose: Time to Change Prescribing Practices". Doesn't the ONDCP have more important issues to deal with, like the war on illegal drugs. It is already really, really hard to find a doctor that will prescribe narcotics long term. That in and of itself is proof the DEA and other agencies have scared doctors into under- prescribing or not prescribing. In the end, the article was published as an editorial (opinion) by a person that is against drugs and is for drug rehabilitation.

Conflict of Interest:

chronic pain and pain medicine

Re:A "High Dose" Intractable Pain Patient Responds
Posted on January 18, 2012
Tom J, Cuddy, musician
caregiver
Conflict of Interest: None Declared

I find it revealing that virtually none of the many articles about the "prescription drug crisis" give more than lip service to patients who benefit from opioid therapy. They interview doctors, government officials, addicts in recovery anyone except for patients who suffer, and suffer barely touches it, from intractable pain. One pain scale I saw rated severe neuralgia type pain ( such as RSD) as the equivalent of limb amputation without anesthesia. Even if a patient has been successfully restored to mobility and has no problems with keeping an opioid contract they will be pressured to change modality, even to risky and extreme treatments such is intra-spinal ketamine. The actions of the DEA and State medical boards make it now impossible for patients who need opioids to get them. Pain of this intensity kills. I guess their lives are worth less than the lives of someone who overdoses. Tom Cuddy

Conflict of Interest:

I am the caregiver for an intractable pain patient diagnosed RSD failed back surgery syndrome.

Re:Re:What about those who benefit from this therapeutic option?
Posted on April 2, 2012
Michael, Whitworth, Pain Medicine Physician
APM
Conflict of Interest: None Declared

The draconian pronouncement of high dose opioids as universally unsafe unfortunately demonstrates the author's inability to stratify risks, and tacitly assumes physicians and patients lack the intelligence to assume certain risks during treatment. Certain surgical procedures are high risk, yet are routinely performed because the patients are given the informed consent that weigh the risk. The risk: benefit ratio of such surgeries are often undetermined yet the surgeries may provide a reduction in suffering that would not otherwise be available. Opioids, even high dose opioids, may provide similar therapies, and absurd pronouncements such as this is an affront to those physicians and patients who appropriately manage such risk. The article was designed to denigrate and destroy via a biased interpretation of data with unidentified prescribing models being employed by the physicians in the study. If controls on follow-up frequency, use of concurrently known sedative drugs (74% of your population was using concurrent sedative-hypnotics), and employment of monitoring modalities (UDS, pill counts, PMP queries) were used, I submit the overdose proclivity would drop dramatically. Most conscientious pain physicians know this. However even if there were not employment of such strategies, the idea that patients, when informed consent is obtained outlining such risks, should be precluded from the use of high dose opioids because of a governmental or journal sanctioned inflammatory proclamation is not only overreaching into the doctor-patient decision- making but is actually bad medicine. It is not lost on the readers that such proclamations will have long term effects on policies around the country that in effect will deny patients the right to determine if the risk is appropriate for them.

Conflict of Interest:

None declared

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