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Managing Pain Prescriptions For Patient, Community and Practice Safety

Managing Pain Prescriptions For Patient, Community and Practice Safety. Grant D. Beardsley , MS, MT(ASCP ), NRCC/TC Clinical Toxicologist, PeaceHealth Laboratories June 4, 2013. Questions Confronting Providers. “Is my patient taking the medications I prescribed?”

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Managing Pain Prescriptions For Patient, Community and Practice Safety

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  1. Managing Pain PrescriptionsFor Patient, Community and Practice Safety Grant D. Beardsley, MS, MT(ASCP), NRCC/TCClinical Toxicologist, PeaceHealth Laboratories June 4, 2013

  2. Questions Confronting Providers • “Is my patient taking the medications I prescribed?” • Adherence, non-adherence, diversion…. • “Is my patient taking drugs I did not prescribe?” • Illicit drug use • Non-medical use of scheduled prescriptions • Prescriptions from other providers • “What is the reliability of a urine drug test?” • Potential for misinterpretation of test results • How accurate is the testing, can someone cheat the test • How often should a patient be tested

  3. Nationally Recognized Guidelines & Recommendations • American Academy of Family Practitioners • Centers for Disease Control & Prevention • Washington State Agency Medical Directors’ Group • Institute for Clinical Systems Improvement (ICSI) • American Academy of Pain Medicine & American Pain Society in Opioid Treatment Guidelines All of the above organizations endorse periodic patient assessment with urine drug testing.

  4. Compliance vs. Non-Compliance Retrospective study of 470 non-cancer COT patients; urine drug tests included confirmation. Michna, Edward, et al., Clin J Pain 23:173-179, Feb 2007

  5. Incidence of Aberrant Urine Drug Testing Results Owen, Graves T., et al. Urine Drug Testing: Current Recommendations and Best Practices, Pain Physician 2012. 15:ES119-ES133, ISSN 2150-1149

  6. Frequency of Drug Testing • Assessment: • Current and past substance abuse increases risks for COT • Objective risk assessment (ORT, SOAPP-R, psychologist) • COT Patient Agreement in place • Expectation for requested urine drug testing to assure safety • Monitor of medication misuse • Aberrant behaviors • Random pill counts Source: From Washington State Agency Medical Directors Group. Interagency Guidelines on Opioid Drug Dosing for Chronic Non-Cancer Pain,” 2010 Update. Pain Physician 2012; 15:ES119-ES133; ISSN 2150-1149.

  7. Recommendations: Urine Drug Testing Frequency Source: Washington State Agency Medical Directors Group. Interagency Guidelines on Opioid Drug Dosing for Chronic Non-Cancer Pain,” 2010 Update.

  8. Recommendations: Urine Drug Testing Frequency aUndesirable effects associated with opioid use (misuse, abuse, addiction or diversion). Source: Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130.

  9. Laboratory Methods in Pain Management • Initial Testing (“screen”) • Immunoassays • Enzymatic assays • Confirmation Testing (Mass-spectrometry) • GC-MS • LC-MS/MS • LC-TOF MS

  10. Screen & Confirmation Definitions • Screen: qualitative (+/-) • detect many drugs or drug classes • confidence in results is variable • immunoassay also used in “point of care test” (POC) • Confirmation: • high confidence in identifying individual drugs • High sensitivity and specificity • qualitative or quantitative • usually chromatography-mass spectrometry.

  11. Point-of-Care Drug Test • Instant testing has value in clinical practice: • Rapid turnaround-time for test results • Ease of use, convenient • Device must be CLIA waived • Detects some pain medications and most illicit drugs • Allows provider-patient discussions • Disadvantages: • False-positive results (cross-reactivity) • False-negative results (fails to detect) • Subjective interpretation • Ethanol, oxymorphone, hydrocodone, hydromorphone, buprenorphine, fentanyl, carisoprodol, and tramadol are not detected

  12. Question: Which of the following explains a positive opiate screen test (unconfirmed)? • codeine use • heroin use • morphine use • poppy-seed ingestion • possible hydrocodone use • all the above

  13. Initial Drug Screen by Immunoassay • Commercial screening reagents used with automated analyzer: Amphetamines Ethanol (Note: not immunoassay) Barbiturates Methadone Benzodiazepines Phencyclidine Cannabinoids (THCA) Cocaine Propoxyphene Opiates (Codeine & morphine) • Confirm positive screen tests using quantitative GC/MS (Gas Chromatography / Mass Spectrometry)

  14. Analytical Requirements • Drugs of Abuse • Commercial reagents on automated immunassay analyzer • Confirmation using GC-MS • Pain Management Analgesics • Commercial immunoassay reagents are generally not sensitive enough to detect opioids at lower concentrations • GC-MS or LC-MS-MS • LC-MS-MS required for lower cutoffs • Lower cutoffs are required for pain management • Negative result is a red flag

  15. Opiate Immunoassay Screen Test • Patients may be “fired” from the practice based on a negative screen result for a prescribed medication • Opiate screen: designed to detect morphine and codeine only • Opiate screen does not detect: • Oxycodone • Methadone • Fentanyl • Hydrocodone (+/-) • Hydromorphone • Oxymorphone • Tramadol, buprenorphine, carisoprodol Most prescription opioid analgesics are not “opiates” (codeine & morphine) http://www.painphysicianjournal.com/2008/march/2008;11;S155-S180.pdf

  16. Potential for False-Negative…..

  17. Importance of Low Detection Limits Study of 77,881 urine specimens positive for opioids using cutoff levels of 50 ng/mL or higher showed1 • 59% were missed by typical POC tests (2000 ng/mL); erroneously reported opioid-negative. • 23% were missed by typical tests (300 ng/mL) used by clinical, hospital and reference laboratories. 1 Evans M, Kriger S, Gunn J, Schwilke G. (2009) Effective monitoring of opiates in chronic pain patients. Practical Pain Management. (6):32-33.

  18. Solution: Opiates-Opioids by HPLC/MS/MS Quantitative Analysis • Codeine • Morphine • Hydrocodone • Hydromorphone • Oxycodone • Oxymorphone • Meperidine • Fentanyl • Norfentanyl • 6-Monoacetyl morphine Gourlay, DL, Heit, HA. Patient Centered Approach to UDT in the Chronic Pain Patient. PainWeek, Las Vegas, NV; Sept 9, 2011.

  19. HPLC/MS/MS

  20. Laboratory Clinical Drug Testing Pt Protect ® Program* • Reduce false-negative, eliminate false-positive results • Opiates-Opioids direct to mass spectrometry analysis • Drug Abuse Screen panel with positives confirmed by GC/MS • Interpretive summaries • Saves time • Toxicologists available for consultation • Interpretive comments on source of drug & metabolites • Differentiate between poppy seed and morphine use * Portion covered by U.S. Patent No. 8,067,243

  21. Pt Protect® Patent A unique, evidence-based algorithm provides interpretive comments; objective interpretation The HPLC/MS/MS method used to determine 10 opiates and opioids present in a specimen • PeaceHealth Laboratories took a focused effort to help ensure the safety of patients, doctors and communities. • Provider sees interpretation continuity every time with each test on every patient. * U.S. Patent No. 8,067,243

  22. 29-year-old female • Chronic back pain after minor auto accident • Oxycodone prescribed • Pain management panel ordered for documentation

  23. Interpretation of Opiate/Opioid Test Results • Understanding opiate-opioid metabolism is critical for interpretation of test results. • Historical knowledge of metabolism was data based on standard opiate-opioid doses. • That knowledge has been challenged more recently by new findings in high dose pain medication. Oxycodone 5 mg tablet Oxycodone 80 mg tablet

  24. Pharmacokinetics

  25. Major and Minor Metabolic Pathways for Opiates & Opioids Poppy Seeds and Morphine Drugs 6-Monoacetylmorphine Morphine Codeine Minor Metabolism (High dose morphine) Minor Metabolism (High dose codeine) Hydromorphone Heroin Hydrocodone Oxymorphone Oxycodone

  26. Benzodiazepines, Urine Source: Clinical Toxicology Testing; CAP Press (2012).

  27. Benzodiazepine metabolism • Complicated metabolism for many benzodiazepines • Parent medication frequently not found in urine • Immunoassays may target the parent medication and have poor cross-reactivity to the metabolites • Patients may be taking more than one benzodiazepine • Significant patient safety issue when taken with opiate/opioids

  28. Example: Rx - Clonazepam • Benzodiazepines Screen - Positive by Instant Cup Test. • Is confirmation test necessary? Yes – Confirmation test shows patient taking lorazepam and alprazolam, in addition to clonazepam

  29. Negative result for a prescribed medication • Patient non-adherence, possible diversion • Patient did not use the medication correctly • Less than prescribed dose • Less frequently than prescribed • Variable drug delivery or not well absorbed • Rapid metabolism/elimination • Diluted or adulterated urine specimen • Immunoassay screen failed to detect lower drug concentration • Clerical or analytical error

  30. Positive result for a drug not prescribed • Drug was used: • Previous prescription • Illicit use (Street purchase or theft) • Prescription obtained from another provider • Incorrect prescription was filled • Non-medical use (Shared prescription) • Metabolite detected from a legitimate prescription • Codeine (high dose)  hydrocodone • Morphine (high dose)  hydromorphone • Poor test method specificity (Immunoassay) • Prescription manufacturing impurity

  31. Acceptable Opioid Process Impurities in Commercial Drug Substances NB: New methods eliminate these impurities for hydrocodone and hydromorphone; Both varieties are available. Information from API Manufacturers’ Certificates of Analysis.

  32. Amphetamine positive test: The sources of amphetamine? • Adderall® - racemic, amphetamine salts • Dexedrine®, Dextrostat® - dextroamphetamine • Vyvanse® is lisdexamfetamine (l-Lysine-d-amphetamine), a prodrug metabolized to amphetamine. • NOT Methylphenidate (Ritalin®, Concerta®) Methylphenidate and metabolite (ritanilic acid) are not detected by routine immunoassay screens and GC/MS confirmation tests.

  33. Methamphetamine & “Ecstasy” 6% 6% J.H. Delgado, et al. Acute, transient urinary retention from combined ecstasy and methamphetamine use. J Emerg Med:26,2. February 2004, Pages 173–175.

  34. Methamphetamine positive test: Why? Methamphetamine and amphetamine (metabolite) are found in urine after methamphetamine use: • d-methamphetamine sources: Desoxyn®, illicit methamphetamine • l-methamphetamine sources: • metabolite of selegiline (Eldepryl®, Emsam®, Zelapar®) • Vick’sVapor-Inhaler® (desoxyephedrine) • d/l-methamphetamine sources: illicit methamphetamine, Didrex® (benzphetamine metabolite) • NOT Methylphenidate (Ritalin®, Concerta®) Methylphenidate and metabolite (ritanilic acid) are not detected by immunoassay screens and routine GC/MS confirmation tests.

  35. Schedule a presentation for your providers Cecelia MorrowLaboratory Outreach Coordinator503-561-2868Cecelia.Morrow@SalemHealth.org

  36. Thank youGrant D. Beardsley, M.S., MT(ASCP), NRCC/TCClinical Toxicologist, PeaceHealth Laboratories Questions?

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