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

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:10.5055/jom.2011.0088

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.

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