Guidelines for Urine Drug Monitoring for the Pain Patient in ...

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Guidelines for Urine Drug Monitoring for the Pain Patient in a Clinical Practice 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

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Presentation Objectives: Guidelines for Urine Drug Monitoring (UDM) for the Pain Patient in a Clinical Practice

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 UDMUnderstand the purpose and limits of UDMUnderstand why, when and for whom to use UDMUse the results of UDM to improve communication with their patients

HEIT TEMPLATE.PPT 3 “Who judges the judge”

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ReisfieldGM, Webb FJ et al.J of Opioid Management3(6): Nov-Dec 2007;333-37

Physicians’ Proficiency in UDM InterpretationPhysicians’ Proficiency in UDM Interpretation

60 of 80 physicians completed the studyGroup A: 75% (44) ordered UDTsGroup B: 16% (16) did not order UDTs

All were asked 7 basic questions of interpreting the results of UDTsConclusion

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

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Urine Drug Monitoring(UDM): Purpose, Why, Whom, When Do You Test?

Of course it’s milk! What did you expect?

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Purpose of Urine Drug MonitoringPurpose 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 issuesNot for forensics purposes

HA Heit, D L Gourlay: Urine Drug Testing in Pain Medicine: J Pain Sympt Manage.

2004:27(3): 260-67

D Gourlay, HA Heit (co-authors), Y Caplan:Urine Drug Testing in Clinical Practice,

Dispelling the Myths & Designing Strategies. http://www.familydocs.org/assets/171_UDT%202006.pdf .

3rd Edition. November 2006.

http://www.familydocs.org/assets/171_UDT 2006.pdf

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Urine Drug MonitoringUrine 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


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Substances DetectedUDTs can detect −

Parent drug and/or metabolitesDemonstrate recent use−

Prescription medications−

Illegal substances


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Assess only the presence of a particular drug and/or metabolite in a specific concentration at a specific moment in timeA positive result does not diagnose

Drug addictionPhysical dependenceImpairment


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Positive results do not provide enough information to determine

Exposure timeDoseFrequency of use


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Pharmacogenetics of DrugsPharmacogenetics 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 safetyWill not know the patient’s response to a given drug until after it is given

Benefit or adverse reaction?

Healthline.comPharmacogenetics of opioids


Examples: Pharmacogenetics of DrugsExamples: Pharmacogenetics of DrugsMethadone

Half-life is 14 - 40 hours−

Mark individual variationExtensive 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

Inturrisi, C.E., Clinical pharmacology of opioids for pain. Clin J Pain, 2002. 18(4 Suppl): p. S3-13.


Value of Urine Drug Concentrations (ng/dL) of the Drug and Metabolite(s) and Time of Their Detection 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.

Personal communicationHoward A. Heit M.D.


Value of Urine Drug Concentrations (ng/dL) (cont’d)Value of Urine Drug Concentrations (ng/dL) (cont’d)

Route and rate of distribution Membrane permeabilityBlood perfusion of organs and tissues

Extent of Distribution Lipid SolubilityPlasma protein bindingIntracellular binding

Drug-Drug InteractionsDrug/Food-Herbal Interactions

Cytochrome P450 inhibitors and inducersEnzyme deficiencies



Value of Urine Drug Concentrations (ng/dL) (cont’d)Value of Urine Drug Concentrations (ng/dL) (cont’d)

Up or down regulationPharmacokineticsPharmacodynamicsPharmacogenetics PolymorphismsEnterohepatic RecyclingRenal and Hepatic functionDisease StatesBody Weight, Surface Area, and Muscle MassCardiac OutputAge



Value of Urine Drug Concentrations Value of Urine Drug Concentrations

Measurements from UDMAmount 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 informationInterpreting UDT beyond the current scientific knowledgemay put clinicians and patients at medical and/or legal risk

MROALERTNovember 6 Vol.XVII; No. 9(1-4)


Why to Test?Why to Test?

Patient advocacyIdentify 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

HA Heit, D Gourlay: Urine Drug Testing in Pain Medicine:

J Pain Sympt Manage. 2004:27(3): 260-67


Whom and When to Test?Whom and When to Test?



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

Katz, N., Fanciullo, GJThe Clinical J of PainVol. 18. No. 4, S 2002

S76-82


Whom to Test?Whom to Test?

Have a consistent protocol for UDM in your practiceApplies to everyone in your pain/addiction practice−

All new patients on the initial visitRandom drug testing on all patients in your practice two to three times a yearMore frequent testing on a case by case determination



Whom and When to TestWhom and When to Test

There are no pathognomonic signs of addiction/ misuse or diversion/traffickingTreatment agreements

−

Random UDT


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Frequency of TestingFrequency of Testing

Clinical judgmentDisease of addiction −

Test as many times as is necessary to document that the patient is adhering to the mutually agreed- upon treatment plan

Pain management−

Random testing two to three times per year may be adequate

−

If the patient is displaying aberrant behavior






When to Test?


Whom and When to Test (cont’d)Whom and When to Test (cont’d)

PatientsNew patients to be started or already on a controlled substanceAfter making a major change in treatment or modification of therapyResistant to full evaluation Request a specific drug???Display aberrant behaviorSupport referral for treatment −

Psychiatric treatment−

Misuse/addiction


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UDM ResultsUDM Results

Consult with laboratory regarding ANY unexpected resultsSchedule an appointment to discuss abnormal/unexpected results with the patientDiscuss 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


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Dispelling the Myths & Designing Strategies. http://www.familydocs.org/assets/171_UDT%202006.pdf

. 3rd Edition. November 2006.



Summary of Guidelines for Urine Drug MonitoringSummary of Guidelines for Urine Drug Monitoring

Physicians’ guidelinesBe 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 judgmentConsult with laboratory regarding any unexpected resultsChart results and interpretation of UDMUse the results of UDM to strengthen the doctor-patient relationship to support positive changes in behavior when necessary


Conclusion: Role of Urine Drug Monitoring in Pain Patients: Is It Worth It?

I Believe the Answer is Yes!

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 addictionOther relevant medical conditions or diagnoses

The use of UDM shouldBe consensualBe designed to help patientsAssist physicians to advocate for their patients


Two thongs do not make a right:The physician and patent have to get it right in UDM!

HEIT TEMPLATE.PPT 30Appropriate use of UDM will benefit your patients

HEIT TEMPLATE.PPT 31“We have to raise our standard in UDM”



Practical StrategiesPractical StrategiesSelect a testing laboratoryEstablish one or more routine UDT panelsRecommended drugs/drug classes to screen

Cocaine *Opiates *PCP*Marijuana*Amphetamines (including ecstasy)* Buprenorphine, methadone, fentanylBenzodiazepinesAdditional tests may be added as needed−

Opioid panel by GC/MS without LLD

* = NIDA Five






Drug-Class–Specific Windows of DetectionDrug-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


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