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“The Value of Drug Monitoring in Chronic Opioid Therapy Patients”

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“The Value of Drug Monitoring in Chronic Opioid Therapy Patients” delivered by Dr. Harry Leider, M.D., MBA, and Chief Medical Officer of Ameritox, Inc. This presentation was delivered during the ...

“The Value of Drug Monitoring in Chronic Opioid Therapy Patients” delivered by Dr. Harry Leider, M.D., MBA, and Chief Medical Officer of Ameritox, Inc. This presentation was delivered during the ”Managing a Patient’s Pain in Today’s Regulated Environment” portion of the 2009 ASPMN Annual Conference.

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    “The Value of Drug Monitoring in Chronic Opioid Therapy Patients” “The Value of Drug Monitoring in Chronic Opioid Therapy Patients” Presentation Transcript

    • “ Managing a Patient’s Pain in Today’s Regulated Environment” ASPMN 2009 NATIONAL CONFERENCE Lunch Symposium September 14, 2009 Moderated by Mary Milano-Carter
      • Describe components of the new “Opioid Treatment Guidelines”
      • Discuss the role of Urine Drug Monitoring in prescribing opioid therapy
      • Discuss federal and state guidelines and appropriate documentation related to treatment
      Learning Objectives
      • “ Clinical Aspects of Risk Management in Opioid Prescribing”
        • Steven D. Passik, PhD
      • “ The Value of Urine Drug Monitoring in Chronic Opioid Therapy Patients”
        • Harry Leider, MD, MBA
      • “ Protecting Your Practice Through Compliance”
        • Timothy J. Kappes, PhD
      • Question and Answer/Moderated Panel Discussion
      Agenda
      • Session scheduled for 90 minutes
      • Hold questions for panel discussion
      • Set cell phones to vibrate
      • Handouts of presentation have been provided
      Housekeeping
    • The Value of Urine Drug Monitoring in Chronic Opioid Therapy Patients Harry Leider, MD, MBA Chief Medical Officer, Senior VP Ameritox, Inc.
    • Harry L. Leider, MD, MBA, FACPE     Dr. Leider has over 20 years experience as a physician executive. He currently is the Chief Medical Officer and Senior Vice President of Ameritox, a national medication adherence company. Prior to joining Ameritox, he was the Chief Medical Officer of XLHealth, a Disease Management firm and Medicare health plan.   Dr. Leider serves as a core faculty member for the American College of Physician Executives, and is the organization’s President and Chairman of the Board. He serves on the editorial boards of: Disease Management and Health Outcomes , Physician Executive, and Disease Management . He is a founding board member of the Disease Management Association of America, and is on the Board of the Institute of Aging at the University of Pennsylvania.   Dr. Leider obtained a BA from Pennsylvania State University, an MD from the University of Pennsylvania, and while a Robert Wood Johnson Clinical Scholar, earned his MBA from the University of Washington. Dr. Leider is currently a Senior Scholar in the School of Population Health at Thomas Jefferson University.
    • Physicians Cannot Reliably Assess Opioid Misuse 0
      • Reasons for unreliable assessment of opioid misuse
        • Self-report of drug use, prescribed or otherwise, among patients with chronic pain treated with opioids is often unreliable.
      • Solutions to improve patient management
        • Use of external sources of information, such as testing of biologic material (eg, urine), interviews with spouses, review of medical records, or input from prescription monitoring programs, may improve patient management.
      Proportion of patients (n=122) on COT with either a positive urine toxicology test or presence of 1 or more behavioral problems/issues Katz N, Fanciullo G. Clin J Pain . 2002;18 (suppl 4):S76-S82. COT=continuous opioid therapy. Only 43% of patients with a documented “problem” were correctly identified by a physician Presence of Behavioral Problems/Issues Yes No Total
      • Urine toxicology testing
      • Positive
      • Negative
      8% 14% 21% 57% 29% 71% Total 22% 78% 100%
    • Urine Toxicology Screening Among Chronic Pain Patients on Opioid Therapy: Frequency and Predictability of Abnormal Findings Michna, E. et al. Clin J Pain, 23(2), Feb. 2007
      • Retrospective review of 470 charts
      • Attempted to correlate abnormal urine screening results…
        • Absence of prescribed drug
        • Presence of non-prescribed controlled substance or illicits
        • Similar to our view of “noncompliance” without our “ranges”
      • … with certain patient descriptors
        • Higher quantities of opioid prescribed
        • Opioids with perceived higher abuse potential
        • Multiple pain sites
        • Age (young) and gender (male)
    • Analyzing the Results
      • No relationship between gender, pain site, type of opioid, dose, prescribing physician and abnormal result
    • Legal Rationale for Drug Screening
      • Provides data to address multiple issues
      • Safeguard of schedule II controlled substance mandate deters multiple requests by patient for fill/refill of prescriptions
        • What constitutes a refill?
      • Encourages physicians to identify patients who knowingly abuse their medications
        • Legal ramifications may discourage dispensing to patients they know are abusing their medication
      • Prompts physicians to seriously consider any expressed concern, such as by family members, about patient substance abuse
      Analgesia Abuse
    • Clinical Rationale for Drug Screening
      • Serves as an important part of a comprehensive patient management strategy
      • Helps identify drug seekers and patients with addiction issues and assists in early diagnosis of relapse or drug misuse
      • Provides an indication of patient compliance to prescribed regimen, such as if the patient is taking
        • prescribed medications
        • prescribed dose
        • medications not prescribed
        • illegal drugs
    • Drug Screening for Inappropriate Drug Use
      • Know that no single behavior is pathognomonic for a substance-use disorder 1
      • Various screening techniques must be implemented to evaluate whether a patient is likely to abuse prescription opioids
      • Screening score is not diagnostic nor should test results be used to identify patients who should not receive opioids
      • Results of a drug screening test should
        • Determine the appropriate level of drug dosing and ongoing monitoring for a particular patient
        • Mitigate legal and regulatory risk
      • Gourlay D, Heit H. Pain Med. 2006;7:210-211.
    • New Guidelines for Prescription Drug Monitoring in COT
      • Recently released guidelines from the American Pain Society state that continuous opioid treatment (COT) for chronic noncancer pain can be an effective therapy for carefully selected and monitored patients
        • In patients on COT who are at high risk or who have engaged in aberrant drug-related behaviors, clinicians should periodically obtain urine drug screens or other information to confirm adherence to the COT plan of care (strong recommendation, low-quality evidence)
        • In patients on COT not at high risk and not known to have engaged in aberrant drug-related behaviors, clinicians should consider periodically obtaining urine drug screens or other information to confirm adherence to the COT plan of care (weak recommendation, low-quality evidence)
      Chou R, et al. J Pain . 2009;10 :113-130.
    • Value of Drug Screening
      • Serves as deterrent
      • Provides objective evidence to guide treatment and management of patient with chronic pain
        • Indicates compliance with prescribed medication and abstinence from drugs of abuse
        • Aids in diagnosis of drug abuse
      • Demonstrates clinician’s commitment to preventing misuse of prescribed controlled substances by reporting that misuse to regulatory agencies
    • Emerging Technologies: Biologic Drug Screening Tools
      • Biologic specimens evaluated for presence of drugs include
        • Hair and nails
        • Saliva
        • Blood
        • Sweat
        • Urine
      • Factors that influence selection of a biologic specimen for drug analysis include ease of collection, analytical and testing considerations, and interpretation of results
      • Urine is currently most widely used and extensively validated biologic specimen for drug testing
      • Clinical utility of other tests remains to be seen because they are lacking data about false-positive and false-negative results, interferences, and cross-reactivity
    • Retention Time in Urine Note: Interpretation of retention time must take into account variability of urine specimens, drug metabolism and half-life, patient’s physical condition, fluid intake, and method and frequency of ingestion. These are general guidelines only. 0 Drug Approximate Retention Time Amphetamines 48 hours Barbiturates Short-acting (eg, secobarbital), 24 hours Long-acting (eg, phenobarbital), 2-3 weeks Benzodiazepines 3 days, if therapeutic dose ingested Up to 4-6 weeks after extended dosage (ie, 1 or more years) Ethanol 2-4 hours Methadone Approximately 3 days Propoxyphene 6-48 hours Cannabinoids Moderate smoker (4 times/wk) 5 days Heavy smoker (smoking daily) 10 days Chronic smoker 20-28 days
    • Drug Screening: Urine Drug Testing
      • Pros
        • Generally considered most effective biologically-based method for determining presence/absence of most drugs
        • Has 1- to 3-day window of detection for most drugs
        • Can detect parent drug and/or its metabolite(s) and thus can demonstrate recent use of prescription medications (eg, opioids, benzodiazepines, amphetamines, barbiturates) and illegal substances (eg, heroin, cocaine, marijuana, phencyclidine)
      • Cons
        • Not all substances can be detected
        • False-positive and false-negative results and misinterpretation common
        • Many potentially confounding metabolic and technical factors
        • Clinicians unprepared to address unanticipated results
    • Urine Drug Testing Methods
      • Workplace-based drug testing
        • Utilizes immunoassay (mostly dipstick tests)
        • Allows for high cutoff concentrations in confirming illicit drug use
        • Is class-specific, typically does not identify individual drugs within a class, for example
          • Opiates are responsive for morphine and codeine, but do not distinguish which is present
          • Semisynthetic/synthetic opioids show lower sensitivity
        • Provides limited or no toxicology supported interpretation
      • Laboratory-based drug-specific testing
        • Includes gas chromatography, mass spectrometry, or high-performance liquid chromatography
        • Identifies or confirms presence or absence of specific drug and/or its metabolites
        • Provides toxicology supported interpretation
      • Drug testing method chosen will depend on reason for undertaking test
    • Choice of Urine Screening Methodology Dependent on Desired Specificity Urine Drug Screening 0 GC=gas chromatography; MS=mass spectrometry; HPLC=high-performance liquid chromatography. Laboratory-based Drug-specific Identification MS GC HPLC Synthetic/ Semisynthetic Opioids: Methadone, Fentanyl, Oxycodone Immunoassay Natural Opiates: Morphine Codeine
    • Federally Mandated Immunoassay Screening and Confirmation Cutoff Concentrations 0 * Cutoff concentrations used for drugs in federally regulated testing, particularly opioids, are too high to be of value in clinical practice. * * * * Marijuana Cocaine Opiates Amphetamine 5-45 Days 50 ng/mL 2-3 Days 30 0 n g / mL 1-2 Days 200 0 n g / mL 1-5 Days 100 0 n g / mL Phencyclidine 8-30 Days 25 n g / mL The Federal Five *
    • Point of Care vs. Laboratory Drug Testing: Pros and Cons Pros Cons Point of Care (POC) Drug Testing
      • Rapid turnaround time
      • Portability
      • Ease of use
      • Requiring minimal training to achieve proficiency
      • Subjective nature of qualitative assays; lacks specificity
      • Lacks adequate quality assurance and control
      • Data management issues
      • Cost
      • Lacks independent scientific/clinical support from manufacturer
      • False-positive or false negative results
      Laboratory Drug Testing
      • Confirmation of presence of specific drugs
      • Higher specificity and sensitivity
      • Technology supported by expert clinical and scientific personnel
        • Presence of potentially confounding metabolic and technical factors vary by manufacturer
    • Interpretation of UDT Results Wolff K, et al. Addiction . 1999;94:1279-1298. Patient has taken drug Patient has not taken drug Positive result True positive False positive Negative result False negative True negative
    • Error Rates in Point of Care Testing Ameritox data on file
    • Patented Methodology The Rx Guardian Report presents customized results for every patient using its patented methodology to generate ranges based on the patient’s height, weight, gender, age, and prescribed dosage.
    • Patented Methodology (cont’d)
      • Rx Guardian’s hydrocodone ranges were studied independently by Lifetree Clinical Research
        • The study evaluated the expected ranges for hydrocodone used by Rx Guardian with a urine immunoassay at 3 doses of hydrocodone using steady-state urine samples
        • The results demonstrated that Rx Guardian’s hydrocodone range is able to measure, with a 95% confidence limit, if patients (based on normalized urine results) are compliant with their hydrocodone dosing regimen
    • Interpreting the Report
    •  
    • Conclusions
      • Subpopulation of patients with chronic pain at significant risk and includes those receiving continuous opioid therapy resulting in
          • Increased risk of diversion, abuse, supplementation, and death
          • Significantly higher medical costs
          • Substantial medical and legal risk for physicians
      • Routine monitoring using proven methodologies improves patient management and reduces risk to patient and physician
      • Urine drug testing proven as simple and effective tool for assessment and ongoing management of patients
          • Beneficial for patients treated over the long-term with opioids, those at higher risk for addiction, and those with other relevant medical conditions or diagnoses