Guidelines for Urine Drug Monitoring for the Pain Patient in a Clinical Practice
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1 Guidelines for Urine Drug Monitoring for the Pain Patient in a Clinical Practice Howard A. Heit, M.D., F.A.C.P., F.A.S.A.M. Board Certified in Internal Medicine and Gastroenterology/Hepatology Certified in Addiction Medicine and as a Medical Review Officer Chronic Pain Specialist Assistant Clinical Professor, Georgetown University HEIT TEMPLATE.PPT 1
2 Presentation Objectives: Guidelines for Urine Drug Monitoring (UDM) for the Pain Patient in a Clinical Practice After attending this presentation, participants should be able to: Become proficient in some areas of UDM Understand the purpose and limits of UDM Understand why, when and for whom to use UDM Use the results of UDM to improve communication with their patients 2 HEIT TEMPLATE.PPT 2
3 HEIT TEMPLATE.PPT 3 Who judges the judge
4 HEIT TEMPLATE.PPT 4
5 Physicians Proficiency in UDM Interpretation 60 of 80 physicians completed the study Group A: 75% (44) ordered UDTs Group B: 16% (16) did not order UDTs All were asked 7 basic questions of interpreting the results of UDTs Conclusion Group A None of physicians answered more that 5/7 questions correctly Only 20% answered more than half of the questions correctly Did better than group B in only 4/7 questions HEIT TEMPLATE.PPT 5 ReisfieldGM, Webb FJ et al. J of Opioid Management 3(6): Nov-Dec 2007;333-37
6 Of course it s milk! What did you expect? HEIT TEMPLATE.PPT 6 Urine Drug Monitoring(UDM): Purpose, Why, Whom, When Do You Test?
7 Purpose of Urine Drug Monitoring Urine drug testing in clinical practice Consensual diagnostic test Full explanation to and for the benefit of the patient Provide objective documentation of compliance with the mutually agreed-upon treatment plan Aid in the diagnosis and treatment of the disease of addiction or drug misuse Advocate for the patient in family and social issues Not for forensics purposes D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 7 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
8 Urine Drug Monitoring Urine may be the best biologic specimen for determining the presence or absence of certain drugs. Increased window of detection compared to blood Typically 1-3 days for most drugs and/or metabolites Less costly than blood levels Non-invasive D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 8 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
9 Urine Drug Monitoring Substances Detected UDTs can detect Parent drug and/or metabolites Demonstrate recent use Prescription medications Illegal substances D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 9 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
10 Urine Drug Monitoring Assess only the presence of a particular drug and/or metabolite in a specific concentration at a specific moment in time A positive result does not diagnose Drug addiction Physical dependence Impairment D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 10 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
11 Urine Drug Monitoring Positive results do not provide enough information to determine Exposure time Dose Frequency of use D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. HEIT TEMPLATE.PPT 3rd Edition. 11 November HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
12 Pharmacogenetics of Drugs The genetics that deals with the relationship between inherited genes and the ability of the body to metabolize drugs Variation in patient or group responses to drug therapy Drug efficacy Drug safety Will not know the patient s response to a given drug until after it is given Benefit or adverse reaction? HEIT TEMPLATE.PPT 12 Healthline.com Pharmacogenetics of opioids
13 Examples: Pharmacogenetics of Drugs Methadone Half-life is hours Mark individual variation Extensive biotransformation in the liver Cytochrome P- 450 Enzyme System CYP 3A4 is main subtype enzyme» Activity can vary by as much as 50-fold» Unpredictable in metabolism, effects, and side effects HEIT TEMPLATE.PPT 13 Inturrisi, C.E., Clinical pharmacology of opioids for pain. Clin J Pain, (4 Suppl): p. S3-13.
14 Value of Urine Drug Concentrations (ng/dl) of the Drug and Metabolite(s) and Time of Their Detection In addition to multiple technical considerations during these analytical procedures, there are numerous factors that influence the absorption, distribution, metabolism and elimination of a drug. HEIT TEMPLATE.PPT 14 Personal communication Howard A. Heit M.D.
15 Value of Urine Drug Concentrations (ng/dl) (cont d) Route and rate of distribution Membrane permeability Blood perfusion of organs and tissues Extent of Distribution Lipid Solubility Plasma protein binding Intracellular binding Drug-Drug Interactions Drug/Food-Herbal Interactions Cytochrome P450 inhibitors and inducers Enzyme deficiencies HEIT TEMPLATE.PPT 15 Personal communication Howard A. Heit M.D.
16 Value of Urine Drug Concentrations (ng/dl) (cont d) HEIT TEMPLATE.PPT 16 Up or down regulation Pharmacokinetics Pharmacodynamics Pharmacogenetics Polymorphisms Enterohepatic Recycling Renal and Hepatic function Disease States Body Weight, Surface Area, and Muscle Mass Cardiac Output Age Personal communication Howard A. Heit M.D.
17 Value of Urine Drug Concentrations Measurements from UDM Amount of drug and/or metabolite(s), ng/dl Should not be used to extrapolate backward and make specific determinations regarding ingestion of the prescribed controlled substance Software and laboratory products have not been fully validated scientifically to give this information Interpreting UDT beyond the current scientific knowledge may put clinicians and patients at medical and/or legal risk HEIT TEMPLATE.PPT 17 MROALERT November 6 Vol.XVII; No. 9(1-4)
18 Why to Test? Patient advocacy Identify use of undisclosed substances To aid in the diagnose, or disprove, misuse/addiction of illicit or nonprescribed licit drugs Does not rule out a pain problem But requires careful evaluation of the boundaries of the treatment plan Uncovering diversion/trafficking HEIT TEMPLATE.PPT 18 HA Heit, D Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
19 HEIT TEMPLATE.PPT 19 Whom and When to Test?
20 Urine Drug Monitoring Study of 122 chronic pain patients on long-term opioid therapy Problems Positive UDM One or more behavior issues Found that reliance on aberrant behavior to trigger a UDM Will miss more than 50% of those individuals using unprescribed/illicit drugs HEIT TEMPLATE.PPT 20 Katz, N., Fanciullo, GJ The Clinical J of Pain Vol. 18. No. 4, S 2002 S76-82
21 Whom to Test? Have a consistent protocol for UDM in your practice Applies to everyone in your pain/addiction practice All new patients on the initial visit Random drug testing on all patients in your practice two to three times a year More frequent testing on a case by case determination HEIT TEMPLATE.PPT 21 Personal communication Howard A. Heit M.D.
22 Whom and When to Test There are no pathognomonic signs of addiction/ misuse or diversion/trafficking Treatment agreements Random UDT D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. HEIT TEMPLATE.PPT 3rd Edition. 22 November HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
23 Frequency of Testing Clinical judgment Disease of addiction Test as many times as is necessary to document that the patient is adhering to the mutually agreedupon treatment plan Pain management Random testing two to three times per year may be adequate If the patient is displaying aberrant behavior D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 23 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
24 HEIT TEMPLATE.PPT 24 When to Test?
25 Whom and When to Test (cont d) Patients New patients to be started or already on a controlled substance After making a major change in treatment or modification of therapy Resistant to full evaluation Request a specific drug??? Display aberrant behavior Support referral for treatment Psychiatric treatment Misuse/addiction D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November HEIT TEMPLATE.PPT 25 HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
26 UDM Results Consult with laboratory regarding ANY unexpected results Schedule an appointment to discuss abnormal/unexpected results with the patient Discuss in a positive, supportive fashion to enhance readiness to change/ motivational enhancement therapy (MET) opportunities Use results to strengthen physician-patient relationship and support positive behavior change Chart results and interpretation D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. HEIT TEMPLATE.PPT. 3rd 26 Edition. November HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
27 Summary of Guidelines for Urine Drug Monitoring Physicians guidelines Be proficient in UDM interpretation Explain to the patient Benefits of UDM Why urine may be the best biologic specimen for UDM Your consistent practice protocol for UDM Frequency of testing is based on clinical judgment Consult with laboratory regarding any unexpected results Chart results and interpretation of UDM Use the results of UDM to strengthen the doctor-patient relationship to support positive changes in behavior when necessary HEIT TEMPLATE.PPT 27
28 HEIT TEMPLATE.PPT 28 Conclusion: Role of Urine Drug Monitoring in Pain Patients: Is It Worth It? I Believe the Answer is Yes! UDM is a simple but effective tool in the assessment and ongoing management of patients Being treated with opioids for chronic pain (not acute pain) Have the disease of addiction Other relevant medical conditions or diagnoses The use of UDM should Be consensual Be designed to help patients Assist physicians to advocate for their patients
29 Two thongs do not make a right: The physician and patent have to get it right in UDM! HEIT TEMPLATE.PPT 29
30 Appropriate use of UDM will benefit your patients HEIT TEMPLATE.PPT 30
31 HEIT TEMPLATE.PPT 31 We have to raise our standard in UDM
32 HEIT TEMPLATE.PPT 32
33 Practical Strategies Select a testing laboratory Establish one or more routine UDT panels Recommended drugs/drug classes to screen Cocaine * Opiates * HEIT TEMPLATE.PPT 33 PCP* Marijuana* Amphetamines (including ecstasy)* Buprenorphine, methadone, fentanyl Benzodiazepines Additional tests may be added as needed Opioid panel by GC/MS without LLD * = NIDA Five D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. 3rd Edition. November 2006.
34 Drug-Class Specific Windows of Detection Indicates how long after administration a person excretes the drug and/or metabolite at a concentration above a specific test cutoff concentration Governed by several factors Dose Route of administration Metabolism Urine volume ph D Gourlay, HA Heit (co-authors), Y Caplan: Urine Drug Testing in Clinical Practice, Dispelling the Myths & Designing Strategies. HEIT TEMPLATE.PPT 3rd Edition. 34 November HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage. 2004:27(3):
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