Assessment, stratification, and monitoring of the risk for prescription opioid misuse and abuse in the primary care setting

Authors

  • James Brown, MD
  • Beatrice Setnik, PhD
  • Keung Lee, MD, PhD
  • Linda Wase, MD
  • Carl L. Roland, PharmD
  • Jody M. Cleveland, MS
  • Sherry Siegel, MD
  • Nathaniel Katz, MD, MS

DOI:

https://doi.org/10.5055/jom.2011.0088

Keywords:

drug abuse, illicit drugs, morphine, opioid analgesics, primary care

Abstract

Objectives: To evaluate potential for and incidence of aberrant drug-related behaviors among patients with chronic, moderate-to-severe pain in a primary care setting and to determine investigator compliance with universal precautions (UP) approach to pain management.
Design: Open label, multicenter.
Setting: Primary care centers (N = 281) across the United States.
Patients: Opioid naïve and opioid experienced with chronic, moderate-to-severe pain (N = 1,487).
Interventions: Morphine sulfate extended-release capsules for ≤4 months. Tools comprising UP approach were treatment agreement, card for obtaining/tracking prescriptions, Screener and Opioid Assessment for Patients with Pain®-Revised questionnaire, pill counts, pain-patient follow-up tool, investigator assessment/plan, and urine drug screens (UDSs).
Outcome measures: Proportion of patients at low, moderate, and high risk of opioid misuse/abuse based on prespecified criteria and investigator judgment, proportion of patients with aberrant drug-related behaviors, and proportion of investigators compliant with UP approach.
Results: Patients were primarily white (87 percent), women (57 percent); mean age, 53 years (range, 21-92 years). At baseline, 47 percent were considered low risk for opioid misuse/abuse, 52 percent moderate, and 1 percent high. UDSs were positive for illicit/nonprescribed drugs in a proportion of patients throughout the study. Overall, 64 percent of investigators were compliant with major components of UP approach in ≥75 percent of their patients. However, there was a tendency for investigators to assign risk levels for opioid misuse/abuse as lower than protocol specified.
Conclusions: Most patients in these primary care study centers were categorized as at least moderate risk for opioid misuse/abuse at baseline. Most primary care investigators complied with the UP approach to pain management and risk assessment. The completion of the brief training and clinical use of the tools during the study led to retained behavior change, but there was a tendency for investigators to assign lower risk levels than those that were protocol-specified, suggesting a need for better understanding of factors influencing investigator decisions.

Author Biographies

James Brown, MD

Jena Medical, Ormond Beach, Florida.

Beatrice Setnik, PhD

Director, Medical Development-Neuroscience, Pfizer Inc, Cary, North Carolina.

Keung Lee, MD, PhD

Randolph Medical Associates, Asheboro, North Carolina.

Linda Wase, MD

Sr. Vice President and Chief Medical Officer, Archimedes Pharma US Inc., Bedminster, New Jersey; Former Executive Vice President of Medical Affairs, King Pharmaceuticals®, Inc, Bridgewater, New Jersey.

Carl L. Roland, PharmD

Senior Director, Neurosciences Medical Development, Pfizer Inc, Cary, North Carolina.

Jody M. Cleveland, MS

Statistician, Pfizer Inc, Cary, North Carolina.

Sherry Siegel, MD

Medical Director, Neurosciences Division, Integra Life Sciences Corporation, Plainsboro, New Jersey.

Nathaniel Katz, MD, MS

Analgesic Solutions, Natick, Massachusetts; Tufts University School of Medicine, Boston, Massachusetts.

References

Chou R, Fanciullo GJ, Fine PG, et al.: Opioid treatment guidelines. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009; 10(2): 113-130.

Birnbaum HG, White AG, Reynolds JL, et al.: Estimated costs of prescription opioid analgesic abuse in the United States in 2001: A societal perspective. Clin J Pain. 2006; 22(8): 667-676.

Passik SD: Issues in long-term opioid therapy: Unmet needs, risks, and solutions. Mayo Clin Proc. 2009; 84(7): 593-601.

Denisco RA, Chandler RK, Compton WM: Addressing the intersecting problems of opioid misuse and chronic pain treatment. Exp Clin Psychopharmacol. 2008; 16(5): 417-428.

Gagnon AM, Kahan M, Srivastava A: Opioid use and abuse: Is there a problem? Clin J Pain. 2007; 23(8): 661-662.

Katz NP, Adams EH, Chilcoat H, et al.: Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007; 23(8): 648-660.

Passik SD, Kirsh KL: Forget the recipes: Let’s talk data. Pain Med. 2009; 9(12): 261-265.

Ives TJ, Chelminski PR, Hammett-Stabler CA, et al.: Predictors of opioid misuse in patients with chronic pain: A prospective cohort study. BMC Health Serv Res. 2006; 6: 46-55.

Fleming MF, Balousek SL, Klessig CL, et al.: Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain. 2007; 8(7): 573-582.

Gourlay DL, Heit HA, Almahrezi A: Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Med. 2005; 6(2): 107-112.

Gianutsos LP, Safranek S, Huber T: Clinical inquiries: Is there a well-tested tool to detect drug-seeking behaviors in chronic pain patients? J Fam Pract. 2008; 57(9): 609-610.

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): 131-146.

King Pharmaceuticals®, Inc: Avinza [Package Insert]. Bristol, TN: King Pharmaceuticals®, Inc, April 2008.

Brown J, Setnick B, Lee K, et al.: Effectiveness and safety of morphine sulfate extended-release capsules in patients with chronic, moderate-to-severe pain in a primary care setting. J Pain Res. In press.

Butler SF, Fernandez K, Benoit C, et al.: Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008; 9(4): 360-372.

Innovacon, Inc.: Multi-CLIN™ Drug Screen Test Device [Package Insert]. San Diego, CA: Innovacon, Inc, October 2006.

Gourlay DL, Heit HA, Caplan YH: Urine Drug Testing in Clinical Practice: Dispelling the Myths and Designing Strategies. Stamford, CT: Pharmacom Group, 2006: 1-25; Vol. 3.

Cleeland CS, Ryan KM: Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994; 23(2): 129-138.

Manchikanti L, Atluri S, Trescot AM, et al.: Monitoring opioid adherence in chronic pain patients: Tools, techniques, and utility. Pain Physician. 2008; 11: S155-S180.

Heit HA, Gourlay DL: Urine testing in pain medicine. J Pain Symptom Manage. 2004; 27(3): 260-266.

Compton P: The role of urine toxicology in chronic opioid analgesic therapy. Pain Manag Nurs. 2007; 8(4): 166-172.

Moeller KE: Urine drug screening: Practical guide for clinicians. Mayo Clin Proc. 2008; 83(1): 66-76.

Reisfield GM, Salazar E, Bertholf RL: Rational use and interpretation of urine drug testing in chronic opioid therapy. Ann Clin Lab Sci. 2007; 37(4): 301-314.

Michna E, Jamison RN, Pham L-D, 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.

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: 123-129.

Gilbert JW, Wheeler GR, Mick GE, et al.: Urine drug testing in the treatment of chronic noncancer pain in a Kentucky private neuroscience practice: The potential effect of Medicare benefit changes in Kentucky. Pain Physician. 2010; 13: 187-194.

Manchikanti L, Pampati V, Damron KS, et al.: Prevalence of illicit drug use in patients without controlled substance abuse in interventional pain management. Pain Physician. 2003; 6(2): 173-178.

Sullivan MD, Edlund MJ, Fan MY, et al.: Risks for possible and probable opioid misuse among recipients of chronic opioid therapy in commercial and Medicaid insurance plans: The TROUP study. Pain. 2010; 150(2): 332-339.

Fishbain DA, Cole B, Lewis J, et al.: What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors? A structured evidence-based review. Pain Med. 2008; 9(4): 444-459.

Starrels JL, Becker WC, Alford DP, et al.: Systematic review: Treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. 2010; 152: 712-720.

Jamison RN, Ross EL, Michna E, et al.: Substance misuse treatment for high-risk chronic pain patients on opioid therapy: A randomized trial. Pain. 2010; 150(3): 390-400.

Gourlay DL, Heit HA: Pain and addiction: Managing risk through comprehensive care. J Addict Dis. 2008; 27(3): 23-30.

Gourlay DL, Heit HA: Universal precautions revisited: Managing the inherited pain patient. Pain Med. 2009; 10 (Suppl 2): S115-S123.

Published

11/01/2017

How to Cite

Brown, MD, J., B. Setnik, PhD, K. Lee, MD, PhD, L. Wase, MD, C. L. Roland, PharmD, J. M. Cleveland, MS, S. Siegel, MD, and N. Katz, MD, MS. “Assessment, Stratification, and Monitoring of the Risk for Prescription Opioid Misuse and Abuse in the Primary Care Setting”. Journal of Opioid Management, vol. 7, no. 6, Nov. 2017, pp. 467-83, doi:10.5055/jom.2011.0088.