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Anesth Analg 2004;99:304-305
© 2004 International Anesthesia Research Society
doi: 10.1213/01.ANE.0000127716.40469.C4


LETTERS TO THE EDITOR

Monitoring of Patients Receiving Long-Term Opioid Therapy

Laxmaiah Manchikanti, MD, Mark V. Boswell, MD, and Vijay Singh, MD

Pain Management Center of Paducah, Paducah, KY Department of Anesthesiology, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Cleveland OH Pain Diagnostics Associates, Niagara, WI

To the Editor:

In a recent study, Katz et al. (1) examined the role of urine toxicology in addition to behavioral monitoring in patients receiving opioid therapy for chronic pain. We do not agree with their contention that, of all the previously published studies on opioids for chronic noncancer pain, only one study systematically monitored patients for addiction by surveying patients for "addictive behaviors" (2). Contrary to the above description, there have been numerous systematic evaluations of drug abuse and addictive behaviors and descriptions of screening tools in the pain management literature. Manchikanti et al. (3), in a randomized clinical evaluation, systematically determined the prevalence of opioid abuse in interventional pain medicine practice settings, reporting an incidence of abuse of 24%. Manchikanti et al. (4) evaluated 500 patients and noted a 17.8% prevalence of controlled substance abuse by patients with chronic pain.

Further, Manchikanti et al. (5,6) showed illicit drug use in patients with or without controlled substance abuse in interventional pain management settings. They identified a 14% to 16% prevalence of illicit drug use by patients without controlled substance abuse (5,6), and a 34% prevalence of illicit drug abuse by patients with controlled substance abuse (6). The drugs most frequently abused in both groups of patients were cocaine and marijuana.

Recently, Atluri and Sudarshan (7), based on an evaluation of abnormal urine drug screens among patients with chronic nonmalignant pain treated with opioids, showed that 55% were not taking their prescribed opioid, 39% were taking opioids that were not prescribed, and 46% of the patients were using illicit drugs.

Screening for controlled substance abuse in pain management settings has been described using multiple tools (8–12). Fishman et al. (13) and Passik and Kirsh (14) have described the need to identify predictors of apparent drug-related behavior and addiction in patients being treated with opioids for pain, and adherence monitoring with drug surveillance in chronic opioid therapy.

Katz et al. (1) also showed that of the 122 patients, only 22% had behavioral issues, whereas 29% had a positive urine toxicology screen. Further, they showed that a combination of positive urine toxicology and behavioral issues was present in only 8% of the patients. In addition, of the 95 patients with no behavioral issues, 21% had a positive urine screen, compared with 29% in the overall population. Thus, the authors concluded that monitoring patients with behavioral observations alone would have missed 49% of the patients with problems, whereas monitoring with urine toxicology alone would have missed 32% of the patients with a problem. It is distressing to note that, of the patients with no behavioral issues, 21% had a positive urine screen. Furthermore, 72% (26 of 36) of patients with positive urine toxicology screens also had no identifiable behaviors thought to be useful in screening patients for drug use. These results are similar to or even worse than the previously reported results of illicit drug use of 14%–16% in patients who appeared compliant with prescriptions for controlled substances (5,6).

Prescription monitoring programs, such as the ones enacted in Kentucky, Nevada, and Utah are extremely helpful for physicians monitoring opioid use or abuse. However, those programs are limited in their scope in that they can only monitor patients within their respective states, and such programs are available in only 3 out of the 50 states (15). An additional 14 programs in other states are not useful to physicians for monitoring controlled substance use or abuse.

A national electronic monitoring system, such as that proposed by the National All Schedules Prescription Electronic Reporting Act (NASPER) would be extremely useful for physicians, by allowing them to effectively monitor controlled substance use by their patients (16,17). This may have the added benefits of improving patient access to pain management services, and helping physicians identify and offer treatment to their patients who may be abusing controlled substances or illicit drugs

References

  1. Katz NP, Sherburne S, Beach M, et al. Behavioral monitoring and urine toxicology testing in patients receiving long-term opioid therapy. Anesth Analg 2003; 97: 1097–102.[Abstract/Free Full Text]
  2. Dunbar SA, Katz NP. Chronic opioid therapy for nonmalignant pain in patients with a history of substance abuse: report of 20 cases. J Pain Symptom Manage 1996; 11: 163–71.[ISI][Medline]
  3. Manchikanti L, Pampati V, Damron K, et al. Prevalence of opioid abuse in interventional pain medicine practice settings: a randomized clinical evaluation. Pain Physician 2001; 4: 358–65.[Medline]
  4. Manchikanti L, Pampati V, Damron KS, et al. Prevalence of prescription drug abuse and dependency in patients with chronic pain in western Kentucky. J Ky Med Assoc 2003; 101: 511–7.[Medline]
  5. Manchikanti L, Pampati V, Damron K, et al. Prevalence of illicit drug use in patients without controlled substance abuse in interventional pain management. Pain Physician 2003; 6: 173–8.
  6. Manchikanti L, Damron K, Beyer C, Pampati V. A comparative evaluation of illicit drug use in patients with or without controlled substance abuse in interventional pain management. Pain Physician 2003; 6: 281–5.
  7. Atluri S, Sudarshan G. Evaluation of abnormal urine drug screens among patients with chronic non-malignant pain treated with opioids. Pain Physician 2003; 6: 407–9.[Medline]
  8. Manchikanti L, Singh V, Damron KS, et al. Screening for controlled substance abuse in interventional pain management settings: evaluation of an assessment tool. Pain Physician 2003; 6: 425–33.[Medline]
  9. Chabal C, Erjavec MK, Jacobson L, et al. Prescription opiate abuse in chronic pain patients: clinical criteria, incidence, and predictors. Clin J Pain 1997; 13: 150–5.[ISI][Medline]
  10. Compton P, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and "problematic" substance use: evaluation of a pilot assessment tool. J Pain Symptom Manage 1998; 16: 355–63.[ISI][Medline]
  11. Atluri S, Sudarshan G. A screening tool to determine the risk of prescription opioid abuse among patients with chronic non-malignant pain. Pain Physician 2002; 5: 447–8.
  12. Friedman R, Li V, Mehrotra D. Treating pain patients at risk: evaluation of a screening tool in opioid-treated pain patients with and without addiction. Pain Med 2003; 4: 182–5.[Medline]
  13. Fishman SM, Wilsey B, Yang J, et al. Adherence monitoring and drug surveillance in chronic opioid therapy. J Pain Symptom Manage 2000; 20: 293–307.[Medline]
  14. Passik SD, Kirsh KL. The need to identify predictors of aberrant drug-related behavior and addiction in patients being treated with opioids for pain. Pain Med 2003; 4: 186–9.[Medline]
  15. United States General Accounting Office Report to the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. State Monitoring Programs Provide Useful Tool to Reduce Diversion. May 2002.
  16. Manchikanti L, Brown K, Singh V. National All Schedules Prescription Electronic Reporting Act NASPER: balancing substance abuse and medical necessity in interventional pain management. Pain Physician 2002; 5: 294–319.[Medline]
  17. National All Schedules Prescription Electronic Reporting Act of 2003 (H. R. 3015), September 4, 2003; 108th Congress, 1st Session.

 

Response

Nathaniel Katz, MD, Gilbert Fanciullo, MD, and Janet E. Vielguth, RN

Harvard Medical School, Cambridge, MA

In Response:

We are delighted that Manchikanti et al. have taken an interest in the problem of prescription opioid abuse among patients with chronic pain. They argue that there have been "numerous systematic evaluations of drug abuse and addictive behaviors and descriptions of screening tools in the pain management literature," missed in our review. Of the 12 references provided to support this point, six (1–6) were in a non-Medline indexed journal that did not appear in our literature review. Three more (7–9) appeared in 2003, after our paper was submitted for publication. One (10) was a review of methods to monitor compliance among chronic pain patients.

The two remaining papers, one of which was cited in our review (11), were indeed important contributions. We failed to cite the study by Chabal et al. (12) and appreciate Dr. Manchikanti for bringing it to our attention. However, upon re-reviewing the references pointed out by Manchikanti et al., our conclusions still stand. While important preliminary efforts, none of the references cited represent efforts that define and validate the construct of opioid abuse by modern standards of instrument validation. (See Jensen (13) for a recent review.) Nor do any of the studies in the Medline-indexed literature attempt to prospectively determine the epidemiology of prescription opioid abuse using even nonvalidated instruments.

Interestingly, most of the non-Medline studies were authored by Manchikanti et al. and appeared in the journal Pain Physician, which shares an address with Dr. Manchikanti’s clinical practice and is the official journal of a society that Dr. Manchikanti serves as President and Executive Director. We applaud the recent efforts of Manchikanti et al. to contribute to the literature in this important and controversial area and hope in the future to see their work in indexed journals that offer the credibility of an independent peer-review process.

We do share the opinion of Manchikanti et al. that physicians do not have sufficiently accurate tools in the clinical practice setting to detect prescription opioid abuse and that a national prescription monitoring program, if constructed carefully and thoughtfully, could help address this problem, and thereby improve the management of both chronic pain and prescription opioid abuse.

We stand by our conclusions that there has not yet been an acceptable validated instrument developed to measure prescription opioid abuse in chronic pain patients, and that therefore the epidemiology of this important and devastating condition remains to be determined. We join Dr. Manchikanti and his colleagues in our mutual efforts to create new knowledge in this area.

References

  1. Manchikanti L, Pampati V, Damron K, et al. Prevalence of opioid abuse in interventional pain medicine practice settings: a randomized clinical evaluation. Pain Physician 2001; 4: 358–65.
  2. Manchikanti L, Pampati V, Damron K, et al. Prevalence of illicit drug use in patients without controlled substance abuse in interventional pain management. Pain Physician 2003; 6: 173–8.
  3. Manchikanti L, Pampati V, Damron K, et al. A comparative evaluation of illicit drug use in patients with or without controlled substance abuse in interventional pain management. Pain Physician 2003; 6: 281–5.
  4. Atluri S, Sudarshan G. Evaluation of abnormal urine drug screens among patients with chronic non-malignant pain treated with opioids. Pain Physician 2003; 6: 407–9.
  5. Manchikanti L, Singh V, Damron K, et al. Screening for controlled substance abuse in interventional pain management settings: evaluation of an assessment tool. Pain Physician 2003; 6: 425–33.
  6. Atluri S, Sudarshan G. A screening tool to determine the risk of prescription opioid abuse among patients with chronic non-malignant pain. Pain Physician 2002; 5: 447–8.
  7. Manchikanti L, Pampati V, Damron K, et al. Prevalence of prescription drug abuse and dependency in patients with chronic pain in western Kentucky. J Ky Med Assoc 2003; 101: 511–7.
  8. Friedman R, Li V, Mehrotra D. Treating pain patients at risk: evaluation of a screening tool in opioid-treated pain patients with and without addiction. Pain Med 2003; 4: 182–5.
  9. Passik SD, Kirsh KL. The need to identify predictors of aberrant drug-related behavior and addiction in patients being treated with opioids for pain. Pain Med 2003; 4: 186–9.
  10. Fishman SM, Wilsey B, Yang J, et al. Adherence monitoring and drug surveillance in chronic opioid therapy. J Pain Symptom Manage 2000; 20: 293–307.
  11. Compton P, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and "problematic" substance use: evaluation of a pilot assessment tool. J Pain Symptom Manage 1998; 16: 355–63.
  12. Chabal C, Erjavec Jacobson L, et al. Prescription opiate abuse in chronic pain patients: clinical criteria, incidence, and predictors. Clin J Pain 1997; 13: 150–5.
  13. Jensen MP. Questionnaire validation: a brief guide for readers of the research literature. Clin J Pain 2003; 19: 345–52.[ISI][Medline]




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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press