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“ Managing a Patient’s Pain in Today’s Regulated Environment” ASPMN 2009 NATIONAL CONFERENCE Lunch Symposium September 14, 2009 Moderated by Mary Milano-Carter
[object Object],[object Object],[object Object],Learning Objectives
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Agenda
[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Analyzing the Results ,[object Object]
Legal Rationale for Drug Screening ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Analgesia Abuse
Clinical Rationale for Drug Screening ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Drug Screening for Inappropriate Drug Use ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Guidelines for Prescription Drug Monitoring in COT ,[object Object],[object Object],[object Object],Chou R, et al.  J Pain . 2009;10 :113-130.
Value of Drug Screening ,[object Object],[object Object],[object Object],[object Object],[object Object]
Emerging Technologies: Biologic Drug Screening Tools ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Urine Drug Testing Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Laboratory Drug Testing ,[object Object],[object Object],[object Object],[object Object]
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) ,[object Object],[object Object],[object Object]
Interpreting the Report
 
Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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

  • 1. “ Managing a Patient’s Pain in Today’s Regulated Environment” ASPMN 2009 NATIONAL CONFERENCE Lunch Symposium September 14, 2009 Moderated by Mary Milano-Carter
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  • 5. The Value of Urine Drug Monitoring in Chronic Opioid Therapy Patients Harry Leider, MD, MBA Chief Medical Officer, Senior VP Ameritox, Inc.
  • 6. 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.
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  • 16. 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
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  • 19. 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
  • 20. 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 *
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  • 22. 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
  • 23. Error Rates in Point of Care Testing Ameritox data on file
  • 24. 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.
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