Pharmacological and toxicological profile of opioid-treated, chronic low back pain patients entering a mindfulness intervention randomized controlled trial

Authors

  • Aleksandra Zgierska, MD, PhD
  • Margaret L. Wallace, PharmD, BCACP
  • Cindy A. Burzinski, MS
  • Jennifer Cox, BS
  • Miroslav Backonja, MD

DOI:

https://doi.org/10.5055/jom.2014.0222

Keywords:

chronic low back pain, urine drug testing, long-term opioid

Abstract

Objective: Refractory chronic low back pain (CLBP) often leads to treatment with long-term opioids. Our goal was to describe the pharmaco-toxicological profile of opioid-treated CLBP patients and identify potential areas for care optimization.

Design: Cross-sectional analysis.

Setting: Outpatient primary care.

Participants: CLBP patients prescribed 30 mg/d of morphine-equivalent dose (MED) for 3 months.

Outcome Measures: Self-reported clinical, medication (verified) and substance use, and urine drug testing (UDT) data were collected.

Results: Participants (N = 35) were 51.8 ± 9.7 years old, 80 percent female with CLBP for 14.2 ± 10.1 years, treated with opioids for 7.9 ± 5.7 years, with severe disability (Oswestry Disability Index score: 66.7 ± 11.4), and average pain score of 5.6 ± 1.5 (0-10 rating scale). Participants reported using tobacco (N = 14), alcohol (N = 9) and illicit drugs or unprescribed medications (N = 10). On average, participants took 13.4 ± 6.8 daily medications, including 4.7 ± 1.8 pain-modulating and 4.7 ± 2.0 sedating medications. Among prescribed opioids, 57.1 percent were long-acting and 91.4 percent were short-acting, with a total of 144.5 ± 127.8 mg/d of MED. Sixteen participants were prescribed benzodiazepines and/or zolpidem/zaleplon. Fifteen participants had UDT positive for illicit drugs or unprescribed medications; in addition, eight tested positive for alcohol and 19 for cotinine. Compared to those with negative UDTs, those with positive UDTs (N = 15) received lower daily “total” and “extended release” opioid doses, and were more likely to test positive for cotinine (p < 0.05).

Conclusions: Study findings corroborate existing evidence for high medication burden and high likelihood of substance misuse among opioid-treated CLBP patients. Further research is needed to help understand causality and ways to optimize care and clinical outcomes.

Author Biographies

Aleksandra Zgierska, MD, PhD

Assistant Professor, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin

Margaret L. Wallace, PharmD, BCACP

Research Fellow, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin

Cindy A. Burzinski, MS

Assistant Researcher, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin

Jennifer Cox, BS

Research Specialist, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin

Miroslav Backonja, MD

Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin; Clinical Research Company Lifetree, Salt Lake City, Utah

References

Martin BI, Turner JA, Mirza SK, et al.: Trends in health care expenditures, utilization, and health status among US adults with spine problems, 1997-2006. Spine (Phila Pa 1976). 2009; 34(19): 2077-2084.

US Department of Health and Human Services: Healthy people 2020: 2020 topics and objectives (arthritis, osteoporosis, and chronic back conditions). Available at http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=3. Accessed March 31, 2014.

Manek NJ, MacGregor AJ: Epidemiology of back disorders: Prevalence, risk factors, and prognosis. Curr Opin Rheumatol. 2005; 17(2): 134-140.

Dillie KS, Fleming MF, Mundt MP, et al.: Quality of life associated with daily opioid therapy in a primary care chronic pain sample. J Am Board Fam Med. 2008; 21(2): 108-117.

Manchikanti L, Helm S II, Fellows B, et al.: Opioid epidemic in the United States. Pain Physician. 2012; 15(3 Suppl): ES9-ES38.

Office of National Drug Control Policy (ONCDP): Epidemic: Responding to America's Prescription Drug Abuse Crisis. 2011. Available at http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan_0.pdf. Accessed March 31, 2014.

Chou R, Ballantyne JC, Fanciullo GJ, et al.: 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): 147-159.

Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of national findings. US Department of Health and Human Services, SAMHSA, Office of Applied Studies, 2010. Available at http://oas.samhsa.gov/nsduh/2k9nsduh/2k9resultsp.pdf. Accessed August 30, 2011.

FDA Center for Drug Evaluation and Research Division of Anesthesia and Analgesia Division: Risk evaluation and mitigation strategies (REMS) for extended-release and long-acting opioid analgesics. Paper presented at Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Adelphie, MD, July 22 and 23, 2010.

Manchikanti L, Fellows B, Ailinani H, et al.: Therapeutic use, abuse, and nonmedical use of opioids: A ten-year perspective. Pain Physician. 2010; 13(5): 401-435.

Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies: The DAWN report: Trends in Emergency Department visits involving nonmedical use of narcotic pain relievers. 2010. Available at http://www.oas.samhsa.gov/2k10/DAWN016/OpioidED.htm. Accessed March 24, 2014.

National Center for Injury Prevention and Control, Centers for Disease Control and Prevention: Unintentional drug poisoning in the United States. 2010. Available at http://www.cdc.gov/HomeandRecreationalSafety/pdf/poison-issue-brief.pdf. Accessed March 24, 2014.

National Center on Addiction and Substance Abuse at Columbia University (CASA): Missed Opportunity: National Survey of Primary Care Physicians and Patients on Substance Abuse. New York: CASA, 2000.

Gomes T, Juurlink DN, Dhalla IA, et al.: Trends in opioid use and dosing among socio-economically disadvantaged patients. Open Med. 2011; 5(1): e13-e22.

Gomes T, Redelmeier DA, Juurlink DN, et al.: Opioid dose and risk of road trauma in Canada: A population-based study. JAMA Internal Med. 2013; 173(3): 196-201.

Fairbank JC, Couper J, Davies JB, et al.: The Oswestry low back pain disability questionnaire. Physiotherapy. 1980; 66(8): 271-273.

Cleland J, Gillani R, Bienen EJ, et al.: Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain. Pain Pract. 2011; 11(1): 57-69.

Keller S, Bann CM, Dodd SL, et al.: Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004; 20(5): 309-318.

Von Korff M, Jensen MP, Karoly P: Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000; 25(24): 3140-3151.

Sobell LC, Brown J, Leo GI, et al.: The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996; 42(1): 49-54.

Sobell LC, Sobell MB: Timeline Followback: A technique for assessing self-reported alcohol consumption. In Litten RZ, Allen J (eds.): Measuring Alcohol Consumption: Psychosocial and Biological Methods. New Jersey: Humana Press, 1992: 41-72.

McPherson M: Demystifying Opioid Conversion Calculations: A Guide to Effective Dosing, 1st ed. Bethesda, MD: American Society of Health System Pharmacists, 2009.

Jacox A, Carr D, Payne R, et al.: Management of Cancer Pain, Clinical Practice Guideline, No. 9, AHCPR Publication No. 94-0592. Rockville, MD: Agency for Health Care Policy and Research, US Department of Helath and Human Services, Public Health Service, 1994.

Pereira J, Lawlor P, Vigano A, et al.: Equianalgesic dose ratios for opioids. A critical review and proposals for long-term dosing. J Pain Symptom Manage. 2001; 22(2): 672-687.

Grond S, Radbruch L, Meuser T, et al.: High-dose tramadol in comparison to low-dose morphine for cancer pain relief. J Pain Symptom Manage. 1999; 18(3): 174-179.

McAuley D: Benzodiazepine dose conversions (oral), 2013. Available at http://globalrph.com/benzodiazepine_calc.htm. Accessed March 31, 2014.

Harris PA, Taylor R, Thielke R, et al.: Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Informatics. 2009; 42(2): 377-381.

IBM Corporation: IBM SPSS Statistics Version 21 [computer program]. Armonk, NY: IBM Corporation, 2012.

Deyo RA, Smith DH, Johnson ES, et al.: Opioids for back pain patients: Primary care prescribing patterns and use of services. J Am Board Fam Med. 2011; 24(6): 717-727.

Manchikanti L, Abdi S, Atluri S, et al.: American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I—evidence assessment. Pain Physician. 2012; 15(3 Suppl): S1-S65.

Manchikanti L, Abdi S, Atluri S, et al.: American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2—guidance. Pain Physician. Jul. 2012; 15(3 Suppl): S67-S116.

Taylor R Jr, V Pergolizzi J Jr, Puenpatom RA, et al.: Economic implications of potential drug-drug interactions in chronic pain patients. Expert Rev Pharmacoecon Outcomes Res. 2013; 13(6): 725-734.

Sjogren P, Gronbaek M, Peuckmann V, et al.: A populationbased cohort study on chronic pain: The role of opioids. Clin J Pain. 2010; 26(9): 763-769.

Manchikanti L, Manchukonda R, Pampati V, et al.: Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids? Pain Physician. 2006; 9(2): 123-129.

Michna E, Jamison RN, Pham LD, et al.: Urine toxicology screening among chronic pain patients on opioid therapy: Frequency and predictability of abnormal findings. Clin J Pain. 2007; 23(2): 173-179.

Gupta A, Patton C, Diskina D, Cheatle M: Retrospective review of physician opioid prescribing practices in patients with aberrant behaviors. Pain Physician. 2011; 14(4): 383-389.

Christo PJ, Manchikanti L, Ruan X, et al.: Urine drug testing in chronic pain. Pain Physcian. 2011; 14(2): 123-143.

Reisfield GM: Medical cannabis and chronic opioid therapy. J Pain Palliative Care Pharmacother. 2010; 24(4): 356-361.

Bennett MI, Bagnall AM, Raine G, et al.: Educational interventions by pharmacists to patients with chronic pain: Systematic review and meta-analysis. Clin J Pain. 2011; 27(7): 623-630.

O'Brien EM, Staud RM, Hassinger AD, et al.: Patient-centered perspective on treatment outcomes in chronic pain. Pain Med. 2010; 11(1): 6-15.

Published

09/01/2014

How to Cite

Zgierska, MD, PhD, A., M. L. Wallace, PharmD, BCACP, C. A. Burzinski, MS, J. Cox, BS, and M. Backonja, MD. “Pharmacological and Toxicological Profile of Opioid-Treated, Chronic Low Back Pain Patients Entering a Mindfulness Intervention Randomized Controlled Trial”. Journal of Opioid Management, vol. 10, no. 5, Sept. 2014, pp. 323-35, doi:10.5055/jom.2014.0222.