review article rational urine drug monitoring in patients

Review Article

Rational Urine Drug Monitoring in PatientsReceiving Opioids for Chronic Pain ConsensusRecommendations

Charles E Argoff MD Daniel P Alford MD MPHdagger

Jeffrey Fudin PharmD DAIPM FCCP FASHPDagger

Jeremy A Adler MS PA-Csect Matthew J Bair MDMSpara Richard C Dart MD PhDk Roy GandolfiMDkk Bill H McCarberg MD FABPM Steven PStanos DOdaggerdagger Jeffrey A Gudin MDDaggerDagger Rosemary CPolomano PhD RN FAANsectsect and Lynn R WebsterMDparapara

Department of Neurology Albany Medical Center

Albany New York daggerDepartment of Medicine Boston

University School of Medicine and Boston Medical

Center Boston Massachusetts DaggerScientific and

Clinical Affairs Remitigate LLC Delmar New YorksectPacific Pain Medicine Consultants Encinitas

California paraHSRampD Center for Health Information and

Communication Richard L Roudebush VA Medical

Center Indiana University School of Medicine and

Regenstrief Institute Indianapolis Indiana kRocky

Mountain Poison and Drug Center Denver ColoradokkIntermountain Healthcare Salt Lake City Utah

Department of Family Medicine University of

California at San Diego School of Medicine San

Diego California daggerdaggerSwedish Pain Services Swedish

Health System Seattle Washington DaggerDaggerDepartment of

Pain Management and Palliative Care Englewood

Hospital and Medical Center Englewood New

Jersey sectsectDepartment of Biobehavioral Health

Sciences University of Pennsylvania School of

Nursing Philadelphia Pennsylvania paraparaScientific

Affairs PRA International Salt Lake City Utah USA

Correspondence to Lynn R Webster MD Scientific

Affairs PRA International 3838 South 700 East

Suite 202 Salt Lake City UT 84106 USA Tel

801-892-5140 Fax 801-269-9427 E-mail

lrwebstermdgmailcom

Funding sources Financial support for this report was

provided by restricted grants from Aegis Sciences

Corporation Alere Toxicology Millennium Health and

Quest Diagnostics to the American Academy of Pain

Medicine (AAPM) The commercial sponsors had no

direct or indirect input on the content of the manu-

script This document was sponsored by the AAPM

with technical and editorial support from Carolyn

Green PhD of MedLogix Communications LLC and

was developed on the basis of published literature as

well as discussions and voting outcomes from a panel

of experts who attended virtual consensus meetings

on August 11 and 18 2016 All authors participated in

the meeting preparation of the manuscript critical re-

vision and final approval for submission The authors

did not receive an honorarium to participate

Disclosure and conflicts of interest CEA has received

consulting and speaker fees from AstraZeneca and

Depomed Inc JF has received payment for expert

testimony advisory board andor speaker fees from

AstraZeneca Clarity Collegium Pharmaceutical

Daiichi Sankyo Depomed Inc Endo

Pharmaceuticals Iroko Pharmaceuticals LLC Kaleo

Inc Kashan Pharma KemPharm Inc Millennium

Health LLC Pernix Therapeutics and Scilex

Pharmaceuticals and has ownership in Remitigate

LLC JAA has received advisory board andor

speaker fees from AstraZeneca Depomed Inc Endo

Pharmaceuticals Galena Biopharma Inc Janssen

Pharmaceuticals Inc Jazz Pharmaceuticals plc

Medtronic Inc Millennium Health LLC Pfizer Inc

St Jude Medical Inc XenoPort Inc and Zogenix

Inc RCD is Executive Director of RADARS System

which is supported by subscription fees from multiple

producers of pharmaceutical opioids BHM has

received advisory board fees from AstraZeneca

Collegium Pharmaceutical Depomed Inc Inspirion

Pharmaceuticals LLC Iroko Pharmaceuticals LLC

Janssen Pharmaceuticals Inc Kaleo Inc

Mallinckrodt Pharmaceuticals Millennium

Pharmaceuticals Inc Pfizer Inc Salix

Pharmaceuticals Inc Takeda Pharmaceutical Co

Ltd and Zogenix Inc and had received stock

VC 2017 American Academy of Pain Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (httpcreativecommonsorg

licensesby-nc40) which permits non-commercial re-use distribution and reproduction in any medium provided the original work is properly cited

For commercial re-use please contact journalspermissionsoupcom 97

Pain Medicine 2018 19 97ndash117doi 101093pmpnx285

Dow

nloaded from httpsacadem

icoupcompainm

edicinearticle191974683199 by guest on 22 March 2021

holdings from BioSpecifics Technologies Corp

Galena Biopharma Inc Johnson amp Johnson Inc

Nektar Therapeutics and PDL BioPharma Inc SPS

has received consulting fees from AstraZeneca

Collegium Pharmaceutical Daiichi Sankyo Depomed

Inc Endo Pharmaceuticals and Salix

Pharmaceuticals Inc JAG has received consulting

and speaker fees from AstraZeneca BDSI Collegium

Pharmaceutical Daiichi Sankyo Depomed Inc Endo

Pharmaceuticals Inspirion Pharmaceuticals LLC Insys

Iroko Pharmaceuticals Kaleo Inc Purdue Pharma LP

Quest Diagnostics and Salix Pharmaceuticals Inc

RCP has received consulting and speaker fees from

Salix Pharmaceuticals Inc Mallinckrodt

Pharmaceuticals and Shionogi Inc LRW has received

consulting and travel fees from AstraZeneca and advi-

sory board and travel fees from Depomed Inc DPA

MJB and RG have nothing to disclose

Abstract

Objective To develop consensus recommenda-tions on urine drug monitoring (UDM) in patientswith chronic pain who are prescribed opioids

Methods An interdisciplinary group of clinicianswith expertise in pain substance use disordersand primary care conducted virtual meetings to re-view relevant literature and existing guidelines andshare their clinical experience in UDM before reach-ing consensus recommendations

Results Definitive (eg chromatography-based)testing is recommended as most clinically appropri-ate for UDM because of its accuracy however institu-tional or payer policies may require initial use ofpresumptive testing (ie immunoassay) The rationalchoice of substances to analyze for UDM involvesconsiderations that are specific to each patient andrelated to illicit drug availability Appropriate opioidrisk stratification is based on patient history (espe-cially psychiatric conditions or history of opioid orsubstance use disorder) prescription drug monitor-ing program data results from validated risk assess-ment tools and previous UDM Urine drugmonitoring is suggested to be performed at baselinefor most patients prescribed opioids for chronic painand at least annually for those at low risk two ormore times per year for those at moderate risk andthree or more times per year for those at high riskAdditional UDM should be performed as needed onthe basis of clinical judgment

Conclusions Although evidence on the efficacy ofUDM in preventing opioid use disorder overdoseand diversion is limited UDM is recommended by

the panel as part of ongoing comprehensive riskmonitoring in patients prescribed opioids forchronic pain

Key Words Urine Drug Monitoring PainManagement Chronic Pain Substance UseDisorders Opioids Screening Tools

Introduction

Key Issues Regarding Drug Monitoring for PatientsPrescribed Opioids for Chronic Pain

Rationale for Drug Monitoring

Opioid analgesics are prescribed for up to one-third ofpatients with chronic pain treated in primary care clinics[1] but may be associated with unintended consequen-ces of misuse opioid use disorder overdose and diver-sion Morbidity and mortality presumably due torespiratory depression increase with concomitant useof opioids and other central nervous system depres-sants (eg benzodiazepines nonbenzodiazepine sleepmedications muscle relaxants tricyclic antidepressantsand alcohol) [2ndash5] Prescription opioid use has report-edly decreased from 2010 to 2014 [6] and opioid-related deaths also decreased from 2010 to 2012 [7]However deaths from illicitly produced fentanyl andrelated compounds [8ndash12] and heroin [713] have in-creased across various time periods in the past decade

Patients often do not voluntarily report prescription drugmisuse or illicit substance use [1415] and some mayfeign symptoms to obtain opioids for diversion [16]which necessitates objective assessments such as drugmonitoring [17] Although opioid use is monitored pri-marily for patient and public safety drug monitoring hasimportant implications for compliance with regulatorymandates and standards for responsible opioid pre-scribing [18ndash22] Urine drug monitoring (UDM) has theadded benefit of improving patient adherence to opioidtherapy [2324] potentially leading to better patient out-comes and greater trust between provider and patient

Types of Drug Monitoring and Terminology

This consensus report focuses on UDM although druguse can be detected via multiple biological samples(eg oral fluid blood hair [25]) Use of nonurine matri-ces may prevent sample alteration and avoid privacyconcerns however urine testing has been widelyadopted in clinical practice for monitoring because ofadequate drug concentration in the urine accuracy ofdeveloped tests and clinically relevant detection win-dows (ie three to five days) [25ndash27]

In this consensus report the term urine drug monitoring(UDM) is used instead of urine drug screening urinetoxicology screening or urine drug testing The UDM

Argoff et al

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icoupcompainm


term conveys an ongoing process rather than a singletesting event and UDM has a nonpunitive patient-centric connotation as variations on the term drugtesting may be associated with punitive intent in lay lan-guage Diversion is used in this consensus report tomean a transfer (eg giving selling) of prescriptiondrugs for unlawful distribution or use [20] Misuse is de-fined as taking medications in a manner other than pre-scribed even when treating a medical condition [2028]Substance use disorders are a cluster of cognitive be-havioral and physiological symptoms indicating contin-ued use of a psychoactive substance (eg to getldquohighrdquo) despite negative consequences and harm[2930] Opioid use disorder is characterized by signsand symptoms of compulsive prolonged self-administration of opioids in doses exceeding a medicallyappropriate amount or for no legitimate medical purposedespite clinically and functionally significant impairmentssuch as health problems and failure to meet major so-cial responsibilities [30] Because the colloquial labelsldquodirtyrdquo and ldquocleanrdquo to describe UDM results can stigma-tize patients and reduce their likelihood of seeking andaccepting recommended help [31] ldquoinconsistent withtherapyrdquo ldquounexpected resultsrdquo ldquoconsistent withtherapyrdquo and ldquoexpected resultsrdquo are used in this report

Description of UDM Technologies

A presumptive UDM test is a screening immunoassaythat is relatively inexpensive can be used in the office atpoint of care (POC) and produces a rapid result (egwithin minutes) [28] Clinicians may be unfamiliar withthe characteristics of immunoassays which have vari-able sensitivity and specificity (eg 0ndash50 missedpositive results and 11ndash100 incorrectly identifiedpositive results across drug classes) [32] and maytherefore miss substances that can lead to inaccurateimmunoassay results (Figure 1) [33ndash40] The classicldquourine screen testsrdquo are often enzyme immunoassaysthat target amphetaminesmethamphetamines canna-bis cocaine phencyclidine and opioids (ie theldquofederal fiverdquo [41]) and are based on a specific antidrugantibody reaction [42] Opiate immunoassays can moreaccurately detect naturally occurring opiate alkaloids(ie morphine codeine) than commonly prescribed syn-thetic (eg fentanyl methadone) and semisynthetic(eg buprenorphine oxycodone oxymorphone hydro-morphone) opioids [42] Immunoassays are at bestsemiquantitative (ie an estimate of levels only) becauseof cross-reaction across multiple drugs [43] Reasonablysensitive options are now available for testing manycommon drug classes [43]

Definitive UDM can be used for initial or confirmatorytesting (ie to verify the results of a presumptive testthat are contested by the patient) and includes qualita-tive or quantitative gas chromatography (GC)ndashmassspectrometry (MS) liquid chromatography (LC)ndashMS andLCndashtandem MS (LC-MSMS) technologies [2844]

Definitive testing is often more specific and usually moresensitive than immunoassay for the substances testedbut it is also more costly [28] Although some immuno-assays can detect chemical adulterants (ie any sub-stance that lessens validity of testing) [45] definitivetesting is less susceptible to adulterants and decreasesthe likelihood of inaccurate or false results [28]Definitive testing accurately identifies metabolites to con-firm that the parent drug was indeed ingested [28] andcan also detect potentially abnormal opioid metabolism[46] Metabolite results may be confusing to clinicianswho are not aware that some prescribed opioids aremetabolites of others (eg oxymorphone is a metaboliteof oxycodone and hydromorphone is a metabolite ofhydrocodone [18])

UDM Challenges and Unmet Needs

Although the effectiveness of UDM as a risk mitigationtool or strategy against overdose opioid use disorderand diversion has been inadequately studied nationalguidelines from the last decade [18ndash2240] have recom-mended UDM as best practice in patients prescribedopioids for chronic pain These guidelines usually sug-gest initial immunoassay before (confirmatory) definitiveUDM because of cost concerns [182040]

Potential conflicts of interest (eg clinic owners finan-cially benefiting from frequent POC testing [47] andcommercial laboratories promoting the use of definitiveUDM beyond clinically appropriate thresholds) have ledpayers to increase scrutiny of UDM [4849] Current re-strictive payer policies can limit use of and reimburse-ment for UDM Reimbursement changes regularly andauthors recommend that clinicians refer to currentCenters for Medicare and Medicaid Services (CMS) re-imbursement policies (Table 1) [44] and commercial in-surance coverage benefits [50] as well as considervariations in costs across practice settings to stay up todate on changes Of note costs of appropriate UDMmay be offset by savings in overall health care (ie viaimprovement in care and reductions in drug misuseopioid use disorder and diversion) [51] but this relation-ship requires further study

Clinicians receive minimal education on UDM and oftenlack adequate knowledge of how to both choose an ap-propriate UDM test [52] and interpret complex results[53] Lack of understanding can lead to misinterpretationof UDM results failure to identify patterns of harmfuldrug use and inappropriate management of patientsClinicians may compromise patient care by denying ap-propriate treatment or discharging patients from theirpractice after inaccurately concluding that they are mis-using or diverting opioids owing to a false-positive orfalse-negative UDM result [5253]

With UDM as a current best practice and given its inher-ent complexities in clinical practice updated guidance isneeded The purpose of this consensus report is to pro-vide clinicians with a framework for practical and rational

Urine Drug Monitoring for Chronic Pain

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icoupcompainm


(ie high-value and individualized) UDM in patients re-ceiving opioids for chronic pain This report presents thefollowing information

bull discussions and views of a multidisciplinary consen-sus panel regarding recent UDM guidelines andliterature

bull best practices for UDM in patients prescribed opioidtherapy for chronic pain

bull areas for further UDM research and evaluation

These consensus recommendations are intended for abroad range of physicians and other health care profes-sionals (eg pharmacists physician assistants [PAs]nurse practitioners and certified registered nurse anes-thetists) involved in the management of patients withchronic pain

Methods

Phase 1 Prioritizing Issues of Greatest Importance toUDM on the Basis of Research Published Guidelinesand Panel Member Experiences

A diverse group of panelists from various clinical settings(eg pain medicine addiction medicine internal medi-cine primary care pharmacotherapeutics and toxicol-ogy) were recruited to serve as experts in UDM as wellas to provide a payer perspective when possible Beforethe UDM consensus panel meeting the panelists wereasked to provide topics for consensus recommendationfollowed by feedback on a preliminary list of questionson these topics the co-chairs (CEA and LRW chosenfor their in-depth experience and long-standing associa-tion with the American Academy of Pain Medicine

Amphetamines

bull Amantadinebull Bupropionbull Chlorpromazinebull Desipraminebull Dimethylamylaminebull Labetalolbull Meorminbull Ofloxacinbull Phenterminebull Phenylephrinebull Promethazinebull Pseudoephedrinebull Ranidinebull Selegilinebull Tolmen (assay

absorbance limits exceeded)

bull Trazodone

Benzodiazepines

bull Oxaprozinbull Sertraline

Cocaine

bull Coca leaf teabull Salicylates (false

negave)

Cannabis

bull Efavirenzbull Hemp seed oilbull NSAID (ie

ibuprofen and naproxen)

bull Pantoprazole

bull Tolmen (false negave)

OpioidsHeroin

bull Dextromethorphanbull Diphenhydraminebull Poppy seeds

bull Rifampin

bull Quininebull Quinolone

anbiocs

bull Tolmen (false negave)bull Verapamil

The supporng reference is a case study

Figure 1 Agents that may interfere (false positive unless otherwise specified) with urine drug monitoring results forvarious classes of immunoassays [33ndash40] NSAIDfrac14nonsteroidal anti-inflammatory drug

Table 1 Selected CPT and HCPCS G codes for UDM [44 50]

Test Type Description AMA CPT Code CMS HCPCS G Code

Presumptive

Read by direct optical observation only 80305 G0477

Instrument-assisted direct optical observation 80306 G0478

Performed by instrument chemistry analyzers 80307 G0479

Definitive

1ndash7 drug classes Individual CPT codes

for each drug

G0480

8ndash14 drug classes G0481


22 drug classes G0483

AMAfrac14American Medical Association CMSfrac14Centers for Medicare and Medicaid Services CPTfrac14Current Procedural

Terminology HCPCSfrac14Healthcare Common Procedure Coding System UDMfrac14urine drug monitoring

Argoff et al

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icoupcompainm


[AAPM]) adjudicated any discrepancies to develop the fi-nal list of questions

1 Which UDM test(s) should be used and in whichpatients prescribed opioids for chronic pain shouldthe tests be used according to a medical literaturereview clinical experience clinical chemistry of drugtesting and practical considerations

2 How should patients undergoing UDM be stratifiedfor opioid misuse risk

3 How often should UDM occur in patients with lowmedium and high risk for opioid misuse or opioiduse disorder

For background the panel members identified existingguidelines that have been most influential in UDM inchronic pain practice Articles were obtained fromPubMed using the search terms urine drug testing andchronic pain Studies published from June 13 2012 (iethe date of the previous guidelines specific to UDM [40])to April 6 2016 (the date of the search) were includedSearch results were filtered to exclude narrative reviewscase reports studies involving nonurine matrices (egblood oral fluid hair) laboratory tests and any studieswith findings not relevant to the three selected questionson UDM Studies in patients with cancer pain were ex-cluded to narrow the patient population similar to otherguidelines [18ndash20] however this should not be construedas a recommendation to not perform UDM in patientsprescribed opioids for cancer-related chronic pain To ad-dress potential literature gaps additional references (egkey landmark studies) were identified through referencelists and by panelist recommendations

Using the process followed by the Centers for DiseaseControl and Prevention (CDC) Guideline for PrescribingOpioids for Chronic Pain [1854] an abbreviated Grading ofRecommendations Assessment Development andEvaluation (GRADE) methodology was performed Studieswere evaluated and graded as type 1 through 4 which gen-erally corresponded to the following study categories [54]

1 randomized controlled trials (RCTs) or observationalstudies with overwhelming evidence

2 RCTs with important limitations or observational stud-ies with exceptionally strong evidence

3 observational studies or RCTs with notable limitations

4 clinical experience and observations observationalstudies with important limitations or RCTs with sev-eral major limitations

Phase 2 Convening Expert Panel Members forInteractive Discussions and Voting to Reach Consensus

Consensus panel meetings for UDM occurred via web-based teleconferences on August 11 and 18 2016 for

a total of five hours Section leaders (JF JAG RCPand DPA selected by co-chairs to lead discussions)reviewed the literature and led interactive discussionsabout the main questions related to UDM before con-sensus on recommendations was reached with a modi-fied nominal group technique [5556] This consensusmethod was selected because of its demonstrated va-lidity long history of use and time efficiency as well asthe ability for all panelists to provide input [57] After ev-ery panelist provided an answer to a question panelistsvoted for their preferred answer if multiple options wereproposed Additional discussion cycles and voting wereperformed until consensus was reached

Phase 3 Preparation of the Consensus Report

The content of this report reflects an extensive review ofexisting UDM research and guidelines discussion fromseveral meetings and communications among the ex-pert panelists and consensus recommendationsPanelists reviewed and revised content in multiplestages of manuscript development before finalization

Results

Six recent guidelines that address UDM in patients withchronic pain were identified by panelists as most rele-vant to the three key questions The literature searchfound 85 studies pertaining to UDM 21 additional refer-ences were added to address gaps in the existing litera-ture on topics requested by panelists After filtering forrelevance to the three main questions (performed by aneditorial service directed by the authors) 41 referencesfrom the expanded literature search were included all ofwhich were graded for scientific merit as type 3 (lowquality) or 4 (lowest quality) by the authors Validationstudies even when well designed were not consideredequivalent to RCTs and were rated as lower quality

All graded references are included in the RelevantLiterature sections for each question Because of thelack of high-quality evidence addressing the priorityissues for this report recommendations were notassigned a strength category Recommendations(Figure 2) should be considered consensus opinionsbased on evolving evidence

Discussion and Recommendations

Question 1 Which UDM Test(s) Should Be Used andin Which Patients Prescribed Opioids for Chronic PainShould the Tests Be Used According to a MedicalLiterature Review Clinical Experience ClinicalChemistry of Drug Testing and PracticalConsiderations

Expert Panel Recommendations

Use definitive UDM testing (eg with GC-MS LC-MSor LC-MSMS) as the most accurate method for


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assessing baseline opioid use and opioid misuse in al-most all patients with chronic pain being considered foropioids as well as for ongoing monitoring of patients re-ceiving opioids for chronic pain unless presumptivetesting is required by institutional or payer policies A ra-tional approach to choosing the most relevant analytes(ie substances to be tested) for UDM testing is pro-posed (in the Expert Panel Discussion section for ques-tion 1) and should be documented by the clinician

Existing Guidelines

In contrast to this expert panelrsquos recommendation pre-viously published guidelines suggest that patientsundergo presumptive testing with immunoassay whenthey are prescribed opioids for chronic pain[18202240] some guidelines specify that the testshould be POC [2040] Confirmatory definitive tests aregenerally reserved for resolving unexpected results fromimmunoassays [18202240] or for detecting specificopioids that cannot be identified with standard immu-noassays [18] According to the CDC [18] CMS [58]and other payer policies [5059] definitive testing is ap-propriate only when it affects clinical decision-makingand patient management The Washington State guide-lines suggest considering the following drugs for aUDM panel in addition to medications prescribed alco-hol amphetamines barbiturates benzodiazepinescannabinoids cocaine fentanyl methadone opiatesand oxycodone [22]

Relevant Literature

Surveys indicate that UDM in patients prescribedopioids for chronic pain varies widely (ie 19ndash636of patients receive UDM at some point during treatment[60ndash63] and 69ndash100 of clinicians administer UDM[295263ndash66]) which demonstrates a need for guid-ance Traditionally POC immunoassays have been usedfor initial screening in UDM because they provide rapidresults at relatively low cost [28] However false-positiveresults (eg 22 for opiate immunoassays [32]) can becaused by cross-reactivity [28] and false-negativeresults (eg 30 for opiate assays [32]) may occur be-cause of drug concentration cutoffs and cross-reactivityin particular among drugs in similar chemical classes[67] Some opioids and benzodiazepines are not welldetected by immunoassays [67]

Compared with immunoassays definitive testing candetect a greater number of compounds (eg variousbenzodiazepines [67ndash69]) and demonstrates higher sen-sitivity and specificity [70] The gold standard of defini-tive testing was considered to be GC-MS [71] but LC-MSMS has become a favored method [28] because itis associated with less drug interference and can beperformed with smaller urine volumes than for GC-MS[71] Validation of two new LC-MSMS methods wasidentified through our literature search [7273] As a ca-veat detection of metabolites of some prescriptionopioids (eg buprenorphine by certain routes ofadministration) or illicit substances (eg heroin) with

Baseline

bull Definive tesng at baseline for paents prescribed opioids for chronic pain unless presumpve tesng is required by instuonal or payer policy

bull A raonal approach to choosing the most relevant substances to analyze is recommended

Risk Assessment

bull Obtain relevant paent historybull Use validated tools to assess risk for aberrant medicaon-taking behavior opioid

misuse opioid use disorder and potenal respiratory depressionoverdosebull Check PDMPs and previous UDM resultsbull Evaluate behaviors indicave of risk

Low Risk

UDM at least annually

Moderate Risk

UDM ge2 mes per year

High Risk


Figure 2 Consensus recommendations PDMPfrac14prescription drug monitoring program UDMfrac14 urine drugmonitoring

Argoff et al

102

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icoupcompainm


LC-MSMS is challenging in part because of insufficientsensitivity of tests and individual variation in drug metab-olism [7475]

Although (confirmatory) definitive testing is often used toverify unexpected immunoassay results recent evidencesuggests that it is more accurate than immunoassay atassessing patientsrsquo substance use at initial screening[76ndash78] A hybrid UDM approach in which each drugwas measured with either immunoassay or LC-MS(depending on which platform has better accuracy andspeed for each drug) reduced the need for confirmationtesting and time to results [79] In a study at a privatepain practice clinicians and patients discussed unex-pected results from initial immunoassay UDM and opennonjudgmental communication was emphasized thisapproach led to only 3 to 5 of cases requiring con-firmatory GC-MS testing [80] The clinical utility of a hy-brid immunoassayLC-MS approach and of effectivepatient communication to prevent the need for confir-matory GC-MS testing will need to be furtherestablished

Expert Panel Discussion

The panelists expressed concerns about limited sensitiv-ity and specificity as well as misinterpretation errors withclass-specific immunoassays especially in the primarycare setting The initial low cost of immunoassays maybe negated by their potential inaccuracy which can in-crease the downstream financial burden to confirm con-flicting or unexpected results and potentially increasecosts for additional treatments and office visits when apatient is inappropriately continued or discontinued fromopioids because of misinterpretation of results Definitivetesting although often more expensive than immunoas-say initially includes a more comprehensive panel ofsubstances and is more sensitive and specific fordetecting adherence to prescribed opioids and use ofother substances For these reasons several panelistsconsider definitive testing to be the most rational choicefor UDM and elect to use it exclusively for both prelimi-nary testing and follow-up testing when results are con-tested by the patient

The expert panel recognizes that not all clinicians havereliable access to definitive testing laboratories andsome payers reimburse for definitive testing only afteran immunoassay result is inconsistent with therapy Therecommendations in this consensus are intended to beconsidered together with practical clinical and payerconcerns When required by payers and institutionsimmunoassays may be sufficient for monitoring low-riskpatients particularly when clinicians and patients en-gage in open communication

Given the potentially high cost of definitive testing ratio-nal selection of analytes is recommended Appropriatesubstances to analyze for UDM include all controlled

substances (and selected noncontrolled coanalgesicssuch as antidepressants and anticonvulsants) that a pa-tient is prescribed as well as substances unexpectedlyfound at previous UDM Inclusion of additional medica-tions andor alcohol is driven by their potential for harm(ie risk-relevant testing) For identification of substan-ces most likely to be used and diverted consult recentnational survey results [81] and relevant geographic data[82] Greater numbers of analytes will likely need to betested for patients at higher risk for substance usedisorders

Complexities regarding UDM test properties necessitatethat clinicians have access to an expert (eg toxicolo-gist knowledgeable pain or addiction specialist pathol-ogist) when choosing the most appropriate test andinterpreting unexpected results Clinicians should alsobe aware of relevant state mandates regulations andguidelines [83] descriptions of UDM requirements bystate are available from state medical boards and theAAPM website (httpwwwpainmedorgadvocacystate-updates)

Question 2 How Should Patients Undergoing UDMBe Stratified for Opioid Misuse Risk


To guide UDM frequency assess and stratify patientswho are prescribed opioid therapy for chronic pain withthe following strategies

bull Perform a physical examination and obtain relevantpatient history for eventsdiagnoses and behaviorsthat have been shown to predict opioid misuse andopioid use disorder (eg history of substance use dis-orders psychiatric conditions sexual abuse) includinginformation from previous providers for patients trans-ferring care

bull Use validated tools to assess the risk for aberrantmedication-taking behavior opioid misuse opioid usedisorder and the potential for respiratory depressionoverdose

bull Check prescription drug monitoring programs(PDMPs) and previous UDM results when available

Existing Guidelines

Some guidelines [182022] recommend the use of riskassessment tools to stratify patients receiving opioidsthe Opioid Risk Tool (ORT) and Screener and OpioidAssessment for Patients with PainndashRevised (SOAPPVR -R)are frequently mentioned in other guidelines[18224084] Tools deemed most relevant by panelistson the basis of validation studies and use in practiceare described in Table 2 [18192284ndash94] There is aneed for further clinical validation of existing tools [19]and for development of newer and more accurate toolsthat incorporate additional risk factors [1895] Risk tools


103

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icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm


are just one part of a comprehensive patient evaluation[2040]

Relevant Literature

Several tools for predicting and determining current risk ofaberrant medication-taking behaviors (eg lost prescrip-tion request for early refill) opioid misuse and opioid usedisorder are reported in the literature [96ndash99] In a painclinicndashbased study a semistructured clinical interview byan addiction psychologist was more sensitive than theORT Pain Medication Questionnaire and SOAPP-R atpredicting aberrant drug-related behavior [98] TheSOAPP-R showed the highest sensitivity of these self-report measures but may overestimate risk [98]

The use of external information (eg PDMPs) can alsoimprove patient management [100] In a university-based multidisciplinary pain management center misuseand diversion were detected more frequently by addingUDM andor a PDMP check to a baseline strategy ofcomparing patient reports and review of medicalrecords [101] However a systematic review of primarycare pain clinic and Veterans Administration (VA)Medical Center settings concluded that no single proce-dure or set of variables was sufficient to identify patientswith chronic pain who are at risk for opioid misuse orharmful substance use [97]


The expert panelists suggest that patients be assessedfor risk of aberrant medication-taking behavior misuseand opioid use disorder to determine the frequency ofUDM A high-dose cutoff alone (eg 120-mg morphineequivalent dose per day [22]) was perceived as being in-adequate for identifying high-risk patients because highdoses may be appropriate to accommodate develop-ment of tolerance in specific patients [192187] In addi-tion patients predisposed to misuse may be at risk ofopioid use disorder or unsafe use even with low tomoderate doses

No specific risk assessment tool or behavioral assess-ment is recommended by panelists Clinicians are en-couraged to choose one or more of the many availabletools that match their preferences and can be incorpo-rated into their electronic medical records and workflow Understanding why specific factors predict risk ismore important than knowledge of the risk assessmenttools themselves (Figure 3 [1997102ndash107]) Risk strati-fication is not static and regular reevaluation of patientcircumstances (eg loss of a job divorce) is recom-mended An unexpected UDM result increases apatientrsquos risk of misuse and opioid use disorder neces-sitates more frequent testing and prompts reconsidera-tion of whether to modify opioid therapy or refer thepatient to a pain or addiction specialist

A comprehensive evaluation to assess the presence orrisk of misuse and opioid use disorder includes ques-tions about patientsrsquo history of substance use disordersand current clinical characteristics (eg from a physicalexamination) input from patientsrsquo family members andother health care providers (eg psychiatrists previouspain specialists) and pill counts Behaviors that may in-dicate increased likelihood of misuse or opioid use dis-order include requests for early refills [108]unauthorized dose escalations [109] and use of anotherindividualrsquos medication [109] Substance use disorder isgenerally associated with one or more of the four ldquoCsrdquo(ie impaired Control over use Compulsive useContinued use despite harm and Craving) [110]

A few simple questions (eg single-item screeningquestions [SISQs] for alcohol and drug use [93111]) fol-lowed by a discussion with patients is an efficient wayfor clinicians to incorporate risk assessment into theirpractice Reviewing a patientrsquos history of controlled sub-stance prescriptions in the PDMP is another method forassessing potential opioid misuse or substance use dis-order Clinicians should be aware of their statersquos regula-tions recommendations and resources regardingPDMPs [112] All states have or are planning to imple-ment a PDMP but reporting times vary and not everyprovider is required to participate in PDMPs in all states[112ndash114] The Comprehensive Addiction and RecoveryAct of 2016 is intended to improve the efficiency ofthese programs to track prescription drug use and helpprevent inappropriate use [115] Despite their inconsis-tencies PDMPs (when available) have become standardof care as part of patient risk evaluation WhetherPDMP data will predict aberrant behaviors or other ad-verse outcomes is not yet known and represents a gapin the science and an unmet need

Question 3 How Often Should UDM Occur in Patientswith Low Medium and High Risk for Opioid Misuseor Opioid Use Disorder

Expert Panel Recommendation

Perform UDM at baseline in patients prescribed opioidsfor chronic pain During ongoing monitoring performUDM at least annually for low-risk patients two or moretimes per year for moderate-risk patients and three ormore times per year for high-risk patients Additionalmonitoring can be performed at any risk level as fre-quently as necessary according to clinical judgment

Existing Guidelines

Recent guidelines recommend UDM at least annually forall patients regardless of risk [18] every six months totwo years for patients at low risk for opioid misuse oropioid use disorder [202240] one to three times peryear for moderate-risk patients [2022] and at least twoto four times per year for high-risk patients [202240]

Argoff et al

106

Dow


icoupcompainm


The CDC Guideline for Prescribing Opioids for ChronicPain does not recommend tailoring the monitoringschedule according to risk because tools that predictharmful use lack sufficient accuracy [18] Several guide-lines [182122] suggest periodic UDM testing duringscheduled visits truly random testing outside of sched-uled clinic visits may not be feasible in many settings(eg primary care) or appropriate for all patients [18]

Relevant Literature

The identified studies related to UDM frequency do notdifferentiate strategies for low- moderate- and high-risklevels Nevertheless clinical trials assessing the effectsof UDM on outcomes are particularly relevant to deci-sions regarding frequency of monitoring (SupplementaryTable 1) Adherence to prescribed opioids is higher withmore frequent UDM according to a retrospective analy-sis of patients with chronic pain in private practices[116] In two prospective trials at an interventional painmanagement practice adherence monitoring that in-cluded random UDM was associated with reductions inindicators of opioid misuse (determined via periodicchart review UDM pill counts and verification of infor-mation with treating clinicians and pharmacies) [24] andillicit drug use (determined via UDM) [117] In anotherstudy a comprehensive risk reduction strategy includ-ing UDM led to decreased pill confiscations by law en-forcement agents and improved primary care providersrsquoperceptions of the overall quality of pain management[118] A structured program designed to support pri-mary care providers with chronic pain management ledto a greater-than-two-fold increase in UDM 22 months

after initiation of the program which was associatedwith a 727 relative decrease in total emergency de-partment (ED) visits and a 596 relative decrease inunscheduled primary care provider visits per patient onaverage [119]

The main negative clinical consequence of UDMreported in the literature was a lower likelihood ofpatients attending a second visit at an urban academicpain clinic after urine testing was used in the first officevisit [120] Individuals with positive test results for an il-licit substance were less likely to attend the second visitthan those with a negative result [120] Although thisstudy suggests that UDM at first visit may hinderpatient-clinician trust patient response to UDM mayvary by clinical setting by how the rationale for UDM isexplained to the patient and by the degree to whichUDM becomes routine in clinical practice

Many studies showed significant benefits of UDM how-ever a few did not No association between UDM and all-cause mortality was found in VA patients [121] althoughan association was not necessarily expected in this sam-ple of patients with a high burden of comorbiditiesAnother study conducted in a large health care systemshowed that an opioid risk reduction initiative (includingrecommendations on UDM) increased use of UDM with-out affecting rates of unexpected results (eg negative forprescribed opioids or positive for cannabis) [122]

Several studies and surveys of physicians (eg pain andaddiction specialists) nurses PAs and other health careprofessionals mainly from pain practices and academiccenters have assessed the frequency of UDM during

Risk Factors for Opioid

MisuseUse Disorder

Self-reported craving Indicates desire to use the

drug and leads to connued opioid use

Family history of substance use disorders

Genec factors can influence addicon

History of substance or tobacco use

Shown to be strongly predicve History of preadolescent

sexual abuse Leads to post-traumac stress disorder which is

associated with substance use

Psychiatric history (egdepression)

Opioids may be misused for their mood-altering

properes Demographic factors (egyounger age male sex)

May be due to differences in awareness of risks and

willingness to engage in risk-taking behavior

Figure 3 Explanations for risk factors of opioid misuse and opioid use disorder [1997102ndash107]


107

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icoupcompainm


opioid therapy for chronic pain [296580123124]which provides context for recommendations on fre-quency Patients with chronic pain received an averageof 34 UDM tests per year according to a 2007 study ina Kentucky private pain practice [80] The frequency ofUDM testing increased by an average of 34 yearlyfrom 2005 to 2008 in a clinical laboratory serving a largeacademic center [123] Surveys indicated that individualpain and addiction experts differed in their frequency ofUDM use from testing at every office visit to yearly[2965] although most preferred random testing[65124] As a caveat these surveys did not focus onprimary care settings


The expert panel did not specify how the relative riskcategories should be determined aside from suggestingseveral potential risk assessment tools and strategies(see the Question 2 section) Baseline UDM testing is tobe performed either before initiation of opioid therapyor for those continuing opioid therapy from another pro-vider within three months of the first office visit If thepatient received UDM testing from another providerwithin the previous year and the results were consistentwith prescribed opioid therapy no immediate retestingmay be needed to continue therapy

Regular UDM is recommended even in low-risk patientsbecause their circumstancesbehaviors can change overthe course of therapy Patients at especially low risk(eg receiving low-dose as-needed opioids) mayrequire infrequent UDM (eg every two years) Moderate-risk patients may become higher or lower risk dependingon their environment and stressors intense monitoring isusually not required in these patients but periodic reevalu-ation of their situationsrisk factors is appropriate

High-risk patients require more frequent individualizedUDM testing than those at low or moderate risk al-though the evidence supporting the effectiveness of in-tense monitoring is weak Most primary care providerscan best care for high-risk patients by referring them toa pain and addiction specialist when available Primarycare clinicians who are trained in chronic pain manage-ment utilize UDM are experienced in interpreting UDMresults and have access to consultant toxicologists maybe able to appropriately care for high-risk patientsandor comanage them with a pain specialist Currentguidelines for UDM in patients with substance usedisorder recommend use of personalized testingregimens [28]

Additional Expert Panel Recommendations andDiscussion

UDM Rationale

Clinicians are encouraged to include information relatedto UDM in patient-provider agreements and explain to

patients that the primary goals of UDM are to improvethe safety and effectiveness of therapy by monitoringadherence Furthermore UDM is strongly recommendedas part of a universal precautions approach [125]Consistent UDM results provide objective data to sup-port decision-making during chronic opioid therapy

UDM Process

The panelists recommend that clinicians discuss theUDM process openly with patients as they do with allother clinical testing and document the time of lastmedication use before urine collection Unexpectedresults may be caused by laboratory errors (eg mislab-eling) or by sample adulteration including substitution ofsynthetic or another individualrsquos urine Signs of tamper-ing include temperature outside the normal range of90 F to 100 F within four minutes of sample collectionpH outside the normal range of 45 to 80 low creati-nine concentration (ie 20 mgdL) low specific gravity(ie 1003) presence of adulterants or detection ofparent drug without metabolites [28] Variation in metab-olite levels may also result from pharmacogenetic anom-alies or drug-drug interactions affecting drugmetabolism [28126]

Strategies to prevent sample tampering depend on theclinical setting and can include observed collection(viewed as overly invasive of a patientrsquos privacy) achain-of-custody protocol (ie documentation for han-dling of the specimen) and a truly random collection(ie a protocol to notify the patients of required testingwithin a set period) [28] Although observed urine sam-ple collection at pain clinics has been recommended[83] this practice and chain-of-custody protocols aretypically not followed Despite risk-mitigation strategiesdedicated individuals can still manipulate their UDMsamples or consume prescribed medication before of-fice visits to conceal misuse or diversion Patients withan opioid use disorder may not be able to control theirdrug use to avoid unexpected UDM results despitescheduled collection

Alcohol Screening

For patients with a substance use disorder alcohol maybe problematic and prohibited in any amount for otherpatients with chronic pain only high-risk alcohol use(eg binge drinking) is a concern Many opioids includeblack box warnings about the concurrent use of alcoholbecause of the potential for fatal overdose [127] Onereviewed guideline recommends screening for alcoholwith UDM in patients with chronic pain [22] ethyl glucu-ronide ethyl sulfate or ethanol in UDM indicates alcoholuse [128] As a caveat immunoassay and definitiveUDM may not differentiate between alcoholic beveragesand alcohol-containing medications mouthwashes andhand sanitizers [28] Instead of UDM the panelists

Argoff et al

108

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icoupcompainm


recommend the SISQ ldquoHow many times in the past yearhave you had (five or more drinks [men] four or moredrinks [women]) in a dayrdquo from the National Institute onAlcohol Abuse and Alcoholism [111] to identify un-healthy alcohol use as this question is simple to admin-ister and is validated [129] In primary care settings thesensitivity of the alcohol SISQ for identifying alcohol usedisorder is 88 and the specificity is 84 [130]

Cannabis Screening

Practices for cannabis screening vary [131] individualprescribers can decide whether detecting cannabis byUDM is appropriate by consulting local laws [132133]and common practice as well as by considering theadvantagesdisadvantages discussed below At the timeof this publication cannabis is federally illegal (ie clas-sified by the US Drug Enforcement Administration asSchedule 1 under the Controlled Substances Act) butseveral states have passed legislation to decriminalize itfor medical andor recreational use [131ndash134] The CDCGuideline for Prescribing Opioids for Chronic Pain indi-cates that the clinical implications of a positive UDM re-sult for cannabis are uncertain [18] the VAUSDepartment of Defense guidelines estimate the length oftime it can be detected in urine [21] and theWashington State guidelines suggest implementing anoffice policy for patients who use cannabis [22] Theseguidelines [182122] and this consensus report do notprovide formal graded recommendations for or againstUDM screening for cannabis or for interpretation of theresults

Clinicians who avoid cannabis testing may miss criticalinformation that could inform patient monitoring and im-prove safety Data from Colorado indicate increased EDvisits hospitalizations and proportions of fatal motor ve-hicle accidents related to cannabis intoxication after de-criminalization [134ndash136] Illegal use of cannabis is amarker for opioid misuse and substance use disorders[137] and a rationale to classify a patient as high riskAnother concern is that patients may divert prescriptionopioids to purchase cannabis

If clinicians choose to assess patientsrsquo nonprescriptioncannabinoid use there is a validated SISQ for drugs in-cluding cannabis (ie ldquoHow many times in the past yearhave you used an illegal drug or used a prescriptionmedication for nonmedical reasonsrdquo) [93] with a sensi-tivity of 97 and a specificity of 79 for substance usedisorders in primary care settings [130] Although somemetabolites of synthetic cannabinoids (eg spice) canbe analyzed with specialized immunoassayschromatographyspectrometry-based assays are betterfor assessing the many emerging synthetic cannabi-noids and their metabolites [138]

A subject of ongoing debate is whether co-administration of opioids and cannabis (used

recreationally or medically) is safe or reasonable for clini-cians to allow Cannabis is increasingly accepted formedical purposes especially for cancer pain syn-dromes However allowing patients with chronic pain touse cannabis is a potential liability for clinicians (includ-ing pharmacists) regardless of the drugrsquos legal status intheir state [139] The safety of cannabis for patients withchronic pain is not clearly established [140] and little isknown regarding the safety of concurrent use withopioids apart from the potential opioid-sparing effects ofcannabis [141] The composition and dose of the manyactive components in cannabis vary widely [133142]which leads to variable toxicity [143] and complicatessafety studies Cannabinoids may inhibit cytochromeP450 2D6 [144] (involved in opioid metabolism [145])and therefore affect both the efficacy of opioids and theability to detect metabolites in UDM The panelists pro-posed that a single clinician be responsible for manag-ing both opioid and cannabis use in states where thedrug has been decriminalized and the benefits of con-current use outweigh the risks

Interpreting UDM Results and Implications forChanging Clinical Practice

The panelists believe that clinicians should follow manu-facturer instructions for specific POC UDM tests and di-rect any questions about interpreting results to anexpert in toxicology or clinical pathology Laboratoriesperforming UDM have a responsibility to provide cleartest results answer questions and offer support on clin-ical decisions When clinicians are confronted with un-expected results potential causes for false-positive andfalse-negative results (eg quinolone antibiotics tolme-tin Figure 1) are important to investigate A summary ofcommunications and discussions about results with thelaboratory and other experts can be included in themedical record to document the medical necessity oftesting and related clinical decision-making

Communications with patients about the purpose andresults of UDM should be nonjudgmental and nonpuni-tive and should focus on safety and risks associatedwith misuse and opioid use disorder To avoid unex-pected results open discussion with patients is recom-mended and may include asking questions such as ldquoIfwe test you today what will we find in your urine Willthere be any surprisesrdquo Development of a plan to ad-dress UDM results that are inconsistent with therapy issuggested to mitigate safety risks for patients and po-tential regulatory board sanctions for clinicians Of noteUDM results that are consistent with prescribed opioidscannot differentiate among appropriate use occasionaluse or misuse and opioid use disorder negative UDMresults for prescribed opioids cannot distinguishbetween infrequent need for medicine overuse and run-ning out falsification of the urine sample and diversionResults of UDM are only part of the clinical information


109

Dow


icoupcompainm


(eg including patient history) that must be consideredbefore a treatment plan is changed

Detailed recommendations on proper opioid prescribingand appropriate changes to patient care after unex-pected UDM results are outside the scope of this con-sensus report but are discussed in other guidelines[18202240] In brief options to address unexpectedUDM results include open and nonjudgmental discus-sions with patients additional confirmation testing in-creased monitoring a switch to a nonopioid painmedication or referral for treatment of an opioid usedisorder [18202240]

Three studies from the Philadelphia VA Medical Center in-vestigated how UDM results affected provider behavior[119146147] additional research to determine how UDMresults should influence patientsrsquo therapy is warranted Inthe absence of this information a follow-up consensusmeeting to evaluate expert opinion was suggested

Conclusions

In summary the expert panel made the following rec-ommendations regarding UDM (Figure 2)

1 Use definitive UDM testing (eg with GC-MS LC-MS or LC-MSMS) as the most clinically appropriatemethod for assessing baseline opioid use and opioidmisuse in most patients with chronic pain being con-sidered for opioids as well as for ongoing monitoringof patients receiving opioids for chronic pain unlesspresumptive testing is required by institutional orpayer policies A rational approach to choosing themost relevant analytes for UDM testing is proposedand should be documented by the clinician

2 To guide UDM frequency assess and stratify patientsprescribed opioid therapy for chronic pain with thefollowing strategies

bull perform a physical examination and obtain relevantpatient history for eventsdiagnoses and behaviorsthat have been shown to predict opioid misuseand opioid use disorder (eg history of substanceuse disorders psychiatric conditions sexual abuse)including information from previous providers forpatients transferring care

bull use validated tools to assess risk for aberrantmedication-taking behavior opioid misuse opioiduse disorder and the potential for respiratory de-pressionoverdose

bull check PDMPs and previous UDM results whenavailable

3 Perform UDM at baseline in patients receiving opioidsfor chronic pain During ongoing monitoring performUDM at least annually for low-risk patients two ormore times per year for moderate-risk patients andthree or more times per year for high-risk patientsAdditional monitoring can be performed as frequently

as necessary according to clinical judgment (egworrisome patient behavior related to the prescribedmedication)

The recommendations in this consensus report are meantto provide practical advice on implementing rational UDMacross a broad range of clinical practices in a patient-centric manner Some clinicians may not have access toappropriate resources to perform routine definitive UDMor to refer patients to pain specialists alternatives are pro-vided in the expert panel discussion sections Higher-quality studies on patient outcomes with UDM areneeded As a next step a consensus recommendationinitiative similar to this one that discusses appropriate clini-cian actions in response to test results that are inconsis-tent with prescribed therapy is warranted

Authorsrsquo Contributions

All authors contributed to the comprehensive review ofthe published literature consensus meeting discussionsanalysis and interpretation of data drafting of the manu-script critical revision of the manuscript for scientificsoundness and intellectual content and approval of thefinal manuscript JF JAG RCP and DPA contributed topresentation of the literature at the consensus meetingCEA and LRW provided general supervision

Supplementary Data

Supplementary Data may be found online at httppainmedicineoxfordjournalsorg

References1 Prunuske JP St Hill CA Hager KD et al Opioid

prescribing patterns for non-malignant chronic painfor rural versus non-rural US adults A population-based study using 2010 NAMCS data BMC HealthServ Res 201414(1)563

2 Gudin JA Mogali S Jones JD Comer SD Risksmanagement and monitoring of combination opioidbenzodiazepines andor alcohol use Postgrad Med2013125(4)115ndash30

3 Dasgupta N Funk MJ Proescholdbell S et alCohort study of the impact of high-dose opioid anal-gesics on overdose mortality Pain Med 201617(1)85ndash98

4 Larochelle MR Zhang F Ross-Degnan D WharamJF Trends in opioid prescribing and co-prescribingof sedative hypnotics for acute and chronic muscu-loskeletal pain 2001-2010 PharmacoepidemiolDrug Saf 201524(8)885ndash92

5 Jarzyna D Jungquist CR Pasero C et al AmericanSociety for Pain Management Nursing guidelineson monitoring for opioid-induced sedation and

Argoff et al

110

Dow


icoupcompainm


respiratory depression Pain Manag Nurs 201112(3)118ndash45e10

6 Cicero TJ Ellis MS Harney J Shifting patterns ofprescription opioid and heroin abuse in the UnitedStates N Engl J Med 2015373(18)1789ndash90

7 Rudd RA Paulozzi LJ Bauer MJ et al Increases inheroin overdose deathsmdash28 states 2010 to 2012MMWR Morb Mortal Wkly Rep 201463(39)849ndash54

8 Office of the Chief Medical Examiner Connecticutaccidental drug intoxication deaths 2017Available at httpwwwctgovocmelibocmeAccidentalDrugIntoxication2012-2016pdf (accessedMarch 2017)

9 New Hampshire Information and Analysis CenterNew Hampshire drug monitoring initiative 2016Available at httpswwwdhhsnhgovdcbcsbdasdocumentsdmi-june-16pdf (accessed March 2017)

10 Office of the Maine Attorney General Overdosedeaths claim more than one person per day in Maineduring 2016 2017 Available at httpwwwmainegovagnewsarticleshtml idfrac14729779 (accessedMarch 2017)

11 Casale JF Mallette JR Guest EM Analysis of illicitcarfentanil Emergence of the death dragonForensic Chem 2017374ndash80

12 Somerville NJ OrsquoDonnell J Gladden RM et alCharacteristics of fentanyl overdosemdashMassachusetts 2014-2016 MMWR Morb MortalWkly Rep 201766(14)382ndash6

13 Frank RG Pollack HA Addressing the fentanylthreat to public health N Engl J Med 2017376(7)605

14 Matteliano D Chang YP Describing prescriptionopioid adherence among individuals with chronicpain using urine drug testing Pain Manag Nurs201516(1)51ndash9

15 Zgierska A Wallace ML Burzinski CA Cox JBackonja M Pharmacological and toxicological pro-file of opioid-treated chronic low back pain patientsentering a mindfulness intervention randomized con-trolled trial J Opioid Manag 201410(5)323ndash35

16 Frannis FW Jr Musings of a cynical curmudgeonPain or feign Oncology (Williston Park) 201327769ndash72

17 Centers for Disease Control and PreventionChecklist for prescribing opioids for chronicpain 2016 Available at httpwwwcdcgov

drugoverdosepdfPDO_Checklist-apdf (accessedAugust 2016)

18 Dowell D Haegerich TM Chou R CDC guideline forprescribing opioids for chronic painmdashUnited States2016 MMWR Recomm Rep 201665(1)1ndash49

19 Chou R Fanciullo GJ Fine PG et al Clinical guide-lines for the use of chronic opioid therapy in chronicnoncancer pain J Pain 200910(2)113ndash30

20 Manchikanti L Kaye AM Knezevic NN et alResponsible safe and effective prescription ofopioids for chronic non-cancer pain AmericanSociety of Interventional Pain Physicians (ASIPP)guidelines Pain Physician 201720S3ndash92

21 Department of Veterans Affairs Department ofDefense VADoD clinical practice guideline foropioid therapy for chronic pain 2017 Availableat httpswwwhealthqualityvagovguidelinesPaincotVADoDOTCPG022717pdf (accessed October2017)

22 Washington State Agency Medical Directorsrsquo GroupInteragency guideline on prescribing opioids forpain 2015 Available at httpwwwagencymeddir-ectorswagovFiles2015AMDGOpioidGuidelinepdf(accessed April 2016)

23 Pesce A West C Rosenthal M et al Illicit drug usein the pain patient population decreases with contin-ued drug testing Pain Physician 201114(2)189ndash93

24 Manchikanti L Manchukonda R Damron KS et alDoes adherence monitoring reduce controlled sub-stance abuse in chronic pain patients PainPhysician 2006957ndash60

25 Milone MC Laboratory testing for prescriptionopioids J Med Toxicol 20128(4)408ndash16

26 Bush DM The US mandatory guidelines forfederal workplace drug testing programs Currentstatus and future considerations Forensic Sci Int2008174(2ndash3)111ndash9

27 The National Academy of Clinical BiochemistryLaboratory medicine practice guidelines Using clini-cal laboratory tests to monitor drug therapy in painmanagement patients 2016 Available at httpswwwaaccorgmediapractice-guidelinespain-managementrough-draft-pain-management-lmpg-v6aaccpdf lafrac14en (accessed March 2017)

28 American Society of Addiction Medicine Drug test-ing A white paper of the American Society ofAddiction Medicine (ASAM) 2013 Availableat httpwwwasamorgdocsdefault-sourcepublic-


111

Dow


icoupcompainm


policy-statementsdrug-testing-a-white-paper-by-asampdf (accessed July 2016)

29 Kirsh KL Baxter LE Rzetelny A Mazuk M PassikSD A survey of ASAM membersrsquo knowledge atti-tudes and practices in urine drug testing J AddictMed 20159(5)399ndash404

30 American Psychiatric Association DSM-5 TaskForce Diagnostic and Statistical Manual of MentalDisorders DSM-5 Washington DC AmericanPsychiatric Association 2013 Available at httpHZ9PJ6FE4Tsearchserialssolutionscom Vfrac1410ampLfrac14HZ9PJ6FE4TampSfrac14JCsampCfrac14TC0000893411ampTfrac14marcamptabfrac14BOOKS (accessed May 2017)

31 Kelly JF Wakeman SE Saitz R Stop talking lsquodirtyrsquoClinicians language and quality of care for the lead-ing cause of preventable death in the United StatesAm J Med 2015128(1)8ndash9

32 Kirsh KL Heit HA Huskey A et al Trends in druguse from urine drug testing of addiction treatmentclients J Opioid Manag 201511(1)61ndash8

33 Moeller KE Lee KC Kissack JC Urine drug screen-ing Practical guide for clinicians Mayo Clin Proc200883(1)66ndash76

34 Saitman A Park HD Fitzgerald RL False-positiveinterferences of common urine drug screen immuno-assays A review J Anal Toxicol 201438(7)387ndash96

35 Joseph R Dickerson S Willis R et al Interferenceby nonsteroidal anti-inflammatory drugs in EMIT andTDx assays for drugs of abuse J Anal Toxicol 199519(1)13ndash7

36 Wagener RE Linder MW Valdes R Jr Decreasedsignal in Emit assays of drugs of abuse in urine afteringestion of aspirin Potential for false-negativeresults Clin Chem 199440608ndash12

37 Lehmann T Sager F Brenneisen R Excretion ofcannabinoids in urine after ingestion of cannabisseed oil J Anal Toxicol 199721(5)373ndash5

38 Brahm NC Yeager LL Fox MD Farmer KC PalmerTA Commonly prescribed medications and potentialfalse-positive urine drug screens Am J Health SystPharm 201067(16)1344ndash50

39 Felton D Zitomersky N Manzi S Lightdale JR 13-year-old girl with recurrent episodic persistent vom-iting Out of the pot and into the fire Pediatrics2015135(4)e1060ndash3

40 Peppin JF Passik SD Couto JE et alRecommendations for urine drug monitoring as a

component of opioid therapy in the treatment ofchronic pain Pain Med 201213(7)886ndash96

41 Florete OG Jr Urinary drug testing in pain manage-ment Pract Pain Manag 2017 Available at httpswwwpracticalpainmanagementcomtreatmentspharmacologicalopioidsurinary-drug-testing-pain-management (accessed March 31 2017)

42 Tenore PL Advanced urine toxicology testing JAddict Dis 201029(4)436ndash48

43 DePriest AZ Black DL Robert TA Immunoassay inhealthcare testing applications J Opioid Manag201511(1)13ndash25

44 Centers for Medicare and Medicaid ServicesCalendar year (CY) 2017 clinical laboratory feeschedule (CLFS) final determinations 2017 Availableat httpswwwcmsgovMedicareMedicare-Fee-for-Service-PaymentClinicalLabFeeSchedDownloadsCY2017-CLFS-Codes-Final-Determinationspdf(accessed April 2017)

45 Dasgupta A Chughtai O Hannah C Davis B WellsA Comparison of spot tests with AdultaCheck 6and Intect 7 urine test strips for detecting the pres-ence of adulterants in urine specimens Clin ChimActa 2004348(1ndash2)19ndash25

46 Trescot AM Faynboym S A review of the role ofgenetic testing in pain medicine Pain Physician201417(5)425ndash45

47 Gourlay DL Helt HA Caplan YH Urine drug testingin clinical practice The art and science of patientcare edition 6 2016 Available at httpwwwremi-tigatecomwp-contentuploads201511Urine-Drug-Testing-in-Clinical-Practice-Ed6_2015-08pdf(accessed October 2017)

48 Weaver C Mathews AW Doctors cash in on drugtests for seniors and Medicare pays the bill TheWall Street Journal 2014 Available at httpwwwwsjcomarticlesdoctors-cash-in-on-drug-tests-for-seniors-and-medicare-pays-the-bill-1415676782(accessed September 2016)

49 Lipman AG The controversy over urine drug testingin pain management patient monitoring J PainPalliat Care Pharmacother 201327(4)320ndash1

50 UHA Health Insurance Urine drug screening 2016Available at httpsuhahealthcomuploadsformsform_dia_Urine-Drug-Screening-UDSpdf (accessedApril 2017)

51 Laffler A Murphy R Winegarden W et al An eco-nomic analysis of the costs and benefits associated

Argoff et al

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with regular urine drug testing for chronic painpatients in the United States 2011 Available athttpswwwresearchgatenetprofileCharles_Mikelpublication268175852_An_Economic_Analysis_of_the_Costs_and_Benefits_Associated_with_Regular_Urine_Drug_Testing_for_Chronic_Pain_Patients_in_the_United_States_Laffer_Associates_An_Economic_Analysis_of_the_Costs_and_Benefitlinks5571bfe-b08ae7536374c5d4epdf (accessed April 2016)

52 Reisfield GM Webb FJ Bertholf RL Sloan PAWilson GR Family physiciansrsquo proficiency in urinedrug test interpretation J Opioid Manag 20073(6)333ndash7

53 Starrels JL Fox AD Kunins HV Cunningham COThey donrsquot know what they donrsquot know Internalmedicine residentsrsquo knowledge and confidence inurine drug test interpretation for patients withchronic pain J Gen Intern Med 201227(11)1521ndash7

54 Ahmed F Advisory Committee on ImmunizationPractices Handbook for Developing Evidence-BasedRecommendations Version 12 Atlanta GA USDepartment of Health and Human Services CDC2013 Available at httpwwwcdcgovvaccinesaciprecsGRADEabout-gradehtmlresources (accessedNovember 2016)

55 Gallagher M Hares T Spencer J Bradshaw CWebb I The nominal group technique A researchtool for general practice Fam Pract 199310(1)76ndash81

56 Jones J Hunter D Consensus methods for medicaland health services research BMJ 1995311(7001)376ndash80

57 Harvey N Holmes CA Nominal group techniqueAn effective method for obtaining group consensusInt J Nurs Pract 201218(2)188ndash94

58 Palmetto GBA Controlled substance monitoring anddrugs of abuse coding and billing guidelines (M00109V9) 2015 Available at httpwwwpalmettogbacompalmettoprovidersnsfDocsCatProvidersJM20Part20BBrowse20by20TopicLab9SDPFR2173(accessed September 2016)

59 Moda Health Plan Inc Therapeutic drug monitoring2016 Available at httpswwwmodahealthcompdfsmed_criteriaTherapeuticDrugMonitoringpdf(accessed September 2016)

60 Bauer SR Hitchner L Harrison H Gerstenberger JSteiger S Predictors of higher-risk chronic opioidprescriptions in an academic primary care settingSubst Abus 201637(1)110ndash7

61 Khalid L Liebschutz JM Xuan Z et al Adherenceto prescription opioid monitoring guidelines amongresidents and attending physicians in the primarycare setting Pain Med 201516(3)480ndash7

62 Morasco BJ Peters D Krebs EE et al Predictorsof urine drug testing for patients with chronic painResults from a national cohort of US veteransSubst Abus 201637(1)82ndash7

63 Pergolizzi J Pappagallo M Stauffer J et al The roleof urine drug testing for patients on opioid therapyPain Pract 201010(6)497ndash507

64 Levy S Harris SK Sherritt L Angulo M Knight JRDrug testing of adolescents in ambulatory medicinePhysician practices and knowledge Arch PediatrAdolesc Med 2006160(2)146ndash50

65 Owen GT Burton AW Schade CM Passik S Urinedrug testing Current recommendations and bestpractices Pain Physician 201215(suppl 3)ES119ndash33

66 Bhamb B Brown D Hariharan J et al Survey ofselect practice behaviors by primary care physicianson the use of opioids for chronic pain Curr MedRes Opin 200622(9)1859ndash65

67 Pesce A Rosenthal M West R et al An evaluationof the diagnostic accuracy of liquidchromatography-tandem mass spectrometry versusimmunoassay drug testing in pain patients PainPhysician 201013273ndash81

68 Manchikanti L Malla Y Wargo BW Fellows BComparative evaluation of the accuracy of benzodi-azepine testing in chronic pain patients utilizing im-munoassay with liquid chromatography tandemmass spectrometry (LCMSMS) of urine drug test-ing Pain Physician 201114259ndash70

69 Melanson SE Ptolemy AS Wasan AD Optimizingurine drug testing for monitoring medication compli-ance in pain management Pain Med 201314(12)1813ndash20

70 Dickerson JA Laha TJ Pagano MB OrsquoDonnell BRHoofnagle AN Improved detection of opioid use inchronic pain patients through monitoring of opioidglucuronides in urine J Anal Toxicol 201236(8)541ndash7

71 Mikel C Pesce A West C A tale of two drug test-ing technologies GC-MS and LC-MSMS PainPhysician 201013(1)91ndash2

72 Cao Z Kaleta E Wang P Simultaneous quantitationof 78 drugs and metabolites in urine with a


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dilute-and-shoot LC-MS-MS assay J Anal Toxicol201539(5)335ndash46

73 Wang J Yang Z Lechago J Rapid and simulta-neous determination of multiple classes of abuseddrugs and metabolites in human urine by a robustLC-MSMS methodmdashapplication to urine drug test-ing in pain clinics Biomed Chromatogr 201327(11)1463ndash80

74 Markman JD Barbosa WA Gewandter JS et alInterpretation of urine drug testing results in patientsusing transdermal buprenorphine preparations forthe treatment of chronic noncancer pain Pain Med201516(6)1132ndash6

75 Knight J Puet BL DePriest A et al Prevalence ofheroin markers in urine for pain managementpatients Forensic Sci Int 201424379ndash83

76 Manchikanti L Malla Y Wargo BW Fellows BComparative evaluation of the accuracy of immuno-assay with liquid chromatography tandem massspectrometry (LCMSMS) of urine drug testing(UDT) opioids and illicit drugs in chronic painpatients Pain Physician 201114175ndash87

77 Darragh A Snyder ML Ptolemy AS Melanson SKIMS CEDIA and HS-CEDIA immunoassays are in-adequately sensitive for detection of benzodiaze-pines in urine from patients treated for chronic painPain Physician 201417(4)359ndash66

78 Smith ML Hughes RO Levine B et al Forensicdrug testing for opiates VI Urine testing for hydro-morphone hydrocodone oxymorphone and oxyco-done with commercial opiate immunoassays andgas chromatography-mass spectrometry J AnalToxicol 199519(1)18ndash26

79 McMillin GA Marin SJ Johnson-Davis KL LawlorBG Strathmann FG A hybrid approach to urinedrug testing using high-resolution mass spectrome-try and select immunoassays Am J Clin Pathol2015143(2)234ndash40

80 Gilbert JW Wheeler GR Mick GE et al Urine drugtesting in the treatment of chronic noncancer pain ina Kentucky private neuroscience practice The po-tential effect of Medicare benefit changes inKentucky Pain Physician 201013187ndash94

81 Center for Behavioral Health Statistics and QualityBehavioral health trends in the United States Resultsfrom the 2014 National Survey on Drug Use andHealth (HHS Publication No SMA 15-4927 NSDUHSeries H-50) 2014 Available at httpswwwsamhsagovdatasitesdefaultfilesNSDUH-FRR1-2014NSDUH-FRR1-2014pdf (accessed March 2017)

82 Hughes A Williams MR Lipari RN et alPrescription drug use and misuse in the UnitedStates Results from the 2015 National Survey onDrug Use and Health NSDUH Data Review 2016Available at httpswwwsamhsagovdatasitesdefaultfilesNSDUH-FFR2-2015NSDUH-FFR2-2015htm (accessed March 2017)

83 Federation of State Medical Boards Guidelines for thechronic use of opioid analgesics 2017 Available athttpswwwfsmborgMediaDefaultPDFAdvocacyOpioid20Guidelines20As20Adopted20April202017_FINALpdf (accessed June 2017)

84 Chou R Fanciullo GJ Fine PG et al Opioids forchronic noncancer pain Prediction and identificationof aberrant drug-related behaviors A review of theevidence for an American Pain Society andAmerican Academy of Pain Medicine clinical prac-tice guideline J Pain 200910(2)131ndash46

85 Belgrade MJ Schamber CD Lindgren BR TheDIRE score Predicting outcomes of opioid prescrib-ing for chronic pain J Pain 20067(9)671ndash81

86 Passik SD Kirsh KL Whitcomb L et al A new toolto assess and document pain outcomes in chronicpain patients receiving opioid therapy Clin Ther200426(4)552ndash61

87 Manchikanti L Abdi S Atluri S et al AmericanSociety of Interventional Pain Physicians (ASIPP)guidelines for responsible opioid prescribing inchronic non-cancer pain Part Indashevidence assess-ment Pain Physician 201215S1ndash65

88 Couwenbergh C Van Der Gaag RJ Koeter M DeRuiter C Van den Brink W Screening for substanceabuse among adolescents validity of the CAGE-AIDin youth mental health care Subst Use Misuse200944(6)823ndash34

89 Brown RL Rounds LA Conjoint screening question-naires for alcohol and other drug abuse Criterionvalidity in a primary care practice Wis Med J 199594135ndash40

90 Wu SM Compton P Bolus R et al The addictionbehaviors checklist Validation of a new clinician-based measure of inappropriate opioid use inchronic pain J Pain Symptom Manage 200632(4)342ndash51

91 Gross R Long S Cox S Predicting opioid misusewith a brief screener of catastrophizing (abstract197) J Pain 201617(4)S25

92 Zedler B Xie L Wang L et al Development of arisk index for serious prescription opioid-induced

Argoff et al

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respiratory depression or overdose in VeteransrsquoHealth Administration patients Pain Med 201516(8)1566ndash79

93 Smith PC Schmidt SM Allensworth-Davies D SaitzR A single-question screening test for drug use inprimary care Arch Intern Med 2010170(13)1155ndash60

94 Zedler BK Saunders WB Joyce AR Vick CCMurrelle EL Validation of a screening risk indexfor serious prescription opioid-induced respiratorydepression or overdose in a US commercial healthplan claims database Pain Med 201719(1)68ndash78

95 Volkow ND McLellan AT Opioid abuse in chronicpainndashmisconceptions and mitigation strategies NEngl J Med 2016374(13)1253ndash63

96 Jamison RN Martel MO Edwards RR et alValidation of a brief Opioid Compliance Checklist forpatients with chronic pain J Pain 201415(11)1092ndash101

97 Turk DC Swanson KS Gatchel RJ Predictingopioid misuse by chronic pain patients Asystematic review and literature synthesis Clin JPain 200824(6)497ndash508

98 Jones T Moore T Levy JL et al A comparison ofvarious risk screening methods in predictingdischarge from opioid treatment Clin J Pain 201228(2)93ndash100

99 Atluri S Akbik H Sudarshan G Prevention of opioidabuse in chronic non-cancer pain An algorithmicevidence based approach Pain Physician 201215(suppl 3)ES177ndash89

100 Katz N Fanciullo GJ Role of urine toxicology test-ing in the management of chronic opioid therapyClin J Pain 200218(suppl 4)S76ndash82

101 Hamill-Ruth RJ Larriviere K McMasters MGAddition of objective data to identify risk for medi-cation misuse and abuse The inconsistency scorePain Med 201314(12)1900ndash7

102 Cheatle MD OrsquoBrien CP Mathai K et al Aberrantbehaviors in a primary care-based cohort ofpatients with chronic pain identified as misusingprescription opioids J Opioid Manag 20139(5)315ndash24

103 Rice JB White AG Birnbaum HG et al A modelto identify patients at risk for prescription opioidabuse dependence and misuse Pain Med 201213(9)1162ndash73

104 Webster LR Webster RM Predicting aberrantbehaviors in opioid-treated patients Preliminaryvalidation of the opioid risk tool Pain Med 20056(6)432ndash42

105 Grattan A Sullivan MD Saunders KW CampbellCI Von Korff MR Depression and prescription opi-oid misuse among chronic opioid therapy recipi-ents with no history of substance abuse Ann FamMed 201210(4)304ndash11

106 Minutillo A Pacifici R Scaravelli G et al Genderdisparity in addiction An Italian epidemiologicalsketch Ann Ist Super Sanita 201652(2)176ndash83

107 Tsui JI Anderson BJ Strong DR Stein MDCraving predicts opioid use in opioid-dependentpatients initiating buprenorphine treatment A longi-tudinal study Am J Drug Alcohol Abuse 201440(2)163ndash9

108 Meltzer EC Rybin D Meshesha LZ et al Aberrantdrug-related behaviors Unsystematic documenta-tion does not identify prescription drug use disor-der Pain Med 201213(11)1436ndash43

109 Passik SD Kirsh KL Donaghy KB Portenoy RKPain and aberrant drug-related behaviors in medi-cally ill patients with and without histories of sub-stance abuse Clin J Pain 200622(2)173ndash81

110 Savage SR Joranson DE Covington EC et alDefinitions related to the medical use of opioidsEvolution towards universal agreement J PainSymptom Manage 200326(1)655ndash67

111 Smith PC Schmidt SM Allensworth-Davies DSaitz R Primary care validation of a single-question alcohol screening test J Gen Intern Med200924(7)783ndash8

112 National Alliance for Model State Drug Laws 2015annual review of prescription monitoring programs2015 Available at httpwwwnamsdlorglibrary1810E284-A0D7-D440-C3A9A0560A1115D7(accessed October 2017)

113 Prescription Drug Monitoring Program Training andTechnical Assistance Center State profilesAvailable at httpwwwpdmpassistorgcontentstate-profiles (accessed October 2017)

114 Missouri Governor Executive order 17-18 2017Available at httpswwwsosmogovlibraryrefer-enceorders2017eo18 (accessed October 2017)

115 GovTrackus S 524 (114th) Comprehensive ad-diction and recovery Act of 2016 Summary 2016Available at httpswwwgovtrackuscongress


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bills114s524summary (accessed September2016)

116 Yee DA Hughes MM Guo AY et al Observationof improved adherence with frequent urine drugtesting in patients with pain J Opioid Manag 201410(2)111ndash8

117 Manchikanti L Manchukonda R Pampati V et alDoes random urine drug testing reduce illicit druguse in chronic pain patients receiving opioids PainPhysician 20069123ndash9

118 Bujold E Huff J Staton EW Pace WD Improvinguse of narcotics for nonmalignant chronic painA lesson from Community Care of North CarolinaJ Opioid Manag 20128(6)363ndash7

119 Wiedemer NL Harden PS Arndt IO GallagherRM The opioid renewal clinic A primary caremanaged approach to opioid therapy in chronicpain patients at risk for substance abuse PainMed 20078(7)573ndash84

120 Krishnamurthy P Ranganathan G Williams CDoulatram G Impact of urine drug screening on noshows and dropouts among chronic pain patientsA propensity-matched cohort study Pain Physician20161989ndash100

121 Gaither JR Goulet JL Becker WC et al The as-sociation between receipt of guideline-concordantlong-term opioid therapy and all-cause mortalityJ Gen Intern Med 201631(5)492ndash501

122 Turner JA Saunders K Shortreed SM et alChronic opioid therapy risk reduction initiativeImpact on urine drug testing rates and resultsJ Gen Intern Med 201429(2)305ndash11

123 Melanson SE Kredlow MI Jarolim P Analysisand interpretation of drug testing results frompatients on chronic pain therapy A clinical labora-tory perspective Clin Chem Lab Med 200947971ndash6

124 Benzon HT Kendall MC Katz JA et alPrescription patterns of pain medicine physiciansPain Pract 201313(6)440ndash50

125 Gourlay DL Heit HA Almahrezi A Universal pre-cautions in pain medicine A rational approach tothe treatment of chronic pain Pain Med 20056(2)107ndash12

126 Smith HS The metabolism of opioid agents andthe clinical impact of their active metabolites Clin JPain 201127(9)824ndash38

127 FDA New safety measures announced for opioidanalgesics prescription opioid cough products andbenzodiazepines 2016 Available at httpswwwfdagovDrugsDrugSafetyInformationbyDrugClassucm518110htm (accessed May 2017)

128 Reisfield GM Goldberger BA Pesce AJ et alEthyl glucuronide ethyl sulfate and ethanol in urineafter intensive exposure to high ethanol contentmouthwash J Anal Toxicol 201135(5)264ndash8

129 McNeely J Cleland CM Strauss SM et alValidation of self-administered single-item screen-ing questions (SISQs) for unhealthy alcohol anddrug use in primary care patients J Gen InternMed 201530(12)1757ndash64

130 Saitz R Cheng DM Allensworth-Davies D WinterMR Smith PC The ability of single screeningquestions for unhealthy alcohol and other drug useto identify substance dependence in primary careJ Stud Alcohol Drugs 201475(1)153ndash7

131 Manchikanti L Abdi S Atluri S et al AmericanSociety of Interventional Pain Physicians (ASIPP)guidelines for responsible opioid prescribing inchronic non-cancer pain Part 2ndashguidance PainPhysician 201215S67ndash116

132 Hood G Regulatorily mandated urine drug testingMarijuana other consequences 2012 Available athttpboardsmedscapecomforums 1282a355be7 commentfrac141 (accessed August 2016)

133 Wallace M Furnish T What steps should be takento integrate marijuana into pain regimens PainManag 20155(4)225ndash7

134 Davis JM Mendelson B Berkes JJ et al Publichealth effects of medical marijuana legalization inColorado Am J Prev Med 201650(3)373ndash9

135 Barker L Hall K Van Dyke M Retail MarijuanaPublic Health Advisory Committee Monitoring possi-ble marijuana related health effects Summary andkey findings 2015 Available at httpsdrivegooglecomdrivefolders0BxqXhstk92DbV2VxZzVhWjJCd00(accessed September 2016)

136 Salomonsen-Sautel S Min SJ Sakai JT ThurstoneC Hopfer C Trends in fatal motor vehicle crashesbefore and after marijuana commercialization inColorado Drug Alcohol Depend 2014140137ndash44

137 Reisfield GM Wasan AD Jamison RN The preva-lence and significance of cannabis use in patientsprescribed chronic opioid therapy A review of theextant literature Pain Med 200910(8)1434ndash41

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138 Kronstrand R Brinkhagen L Birath-Karlsson CRoman M Josefsson M LC-QTOF-MS as a supe-rior strategy to immunoassay for the comprehen-sive analysis of synthetic cannabinoids in urineAnal Bioanal Chem 2014406(15)3599ndash609

139 Marcoux RM Larrat EP Vogenberg FRMedical marijuana and related legal aspects P T201338(10)612ndash9

140 Nugent SM Morasco BJ OrsquoNeil ME et al Theeffects of cannabis among adults with chronic painand an overview of general harms A systematicreview Ann Intern Med 2017167(5)319ndash31

141 Leung L Cannabis and its derivatives Reviewof medical use J Am Board Fam Med 201124(4)452ndash62

142 Borgelt LM Franson KL Nussbaum AM WangGS The pharmacologic and clinical effects ofmedical cannabis Pharmacotherapy 201333(2)195ndash209

143 Cooper ZD Adverse effects of synthetic cannabi-noids Management of acute toxicity and with-drawal Curr Psychiatry Rep 201618(5)52

144 Yamaori S Okamoto Y Yamamoto I Watanabe KCannabidiol a major phytocannabinoid as a po-tent atypical inhibitor for CYP2D6 Drug MetabDispos 201139(11)2049ndash56

145 Monte AA Heard KJ Campbell J et al The effectof CYP2D6 drug-drug interactions on hydrocodoneeffectiveness Acad Emerg Med 201421(8)879ndash85

146 Barth KS Becker WC Wiedemer NL et alAssociation between urine drug test results andtreatment outcome in high-risk chronic pain patientson opioids J Addict Med 20104(3)167ndash73

147 Meghani SH Wiedemer NL Becker WC GracelyEJ Gallagher RM Predictors of resolution of aber-rant drug behavior in chronic pain patients treatedin a structured opioid risk management programPain Med 200910(5)858ndash65


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pnx285-TF1

holdings from BioSpecifics Technologies Corp

Galena Biopharma Inc Johnson amp Johnson Inc

Nektar Therapeutics and PDL BioPharma Inc SPS

has received consulting fees from AstraZeneca

Collegium Pharmaceutical Daiichi Sankyo Depomed

Inc Endo Pharmaceuticals and Salix

Pharmaceuticals Inc JAG has received consulting

and speaker fees from AstraZeneca BDSI Collegium

Pharmaceutical Daiichi Sankyo Depomed Inc Endo

Pharmaceuticals Inspirion Pharmaceuticals LLC Insys

Iroko Pharmaceuticals Kaleo Inc Purdue Pharma LP

Quest Diagnostics and Salix Pharmaceuticals Inc

RCP has received consulting and speaker fees from

Salix Pharmaceuticals Inc Mallinckrodt

Pharmaceuticals and Shionogi Inc LRW has received

consulting and travel fees from AstraZeneca and advi-

sory board and travel fees from Depomed Inc DPA

MJB and RG have nothing to disclose

Abstract

Objective To develop consensus recommenda-tions on urine drug monitoring (UDM) in patientswith chronic pain who are prescribed opioids

Methods An interdisciplinary group of clinicianswith expertise in pain substance use disordersand primary care conducted virtual meetings to re-view relevant literature and existing guidelines andshare their clinical experience in UDM before reach-ing consensus recommendations

Results Definitive (eg chromatography-based)testing is recommended as most clinically appropri-ate for UDM because of its accuracy however institu-tional or payer policies may require initial use ofpresumptive testing (ie immunoassay) The rationalchoice of substances to analyze for UDM involvesconsiderations that are specific to each patient andrelated to illicit drug availability Appropriate opioidrisk stratification is based on patient history (espe-cially psychiatric conditions or history of opioid orsubstance use disorder) prescription drug monitor-ing program data results from validated risk assess-ment tools and previous UDM Urine drugmonitoring is suggested to be performed at baselinefor most patients prescribed opioids for chronic painand at least annually for those at low risk two ormore times per year for those at moderate risk andthree or more times per year for those at high riskAdditional UDM should be performed as needed onthe basis of clinical judgment

Conclusions Although evidence on the efficacy ofUDM in preventing opioid use disorder overdoseand diversion is limited UDM is recommended by

the panel as part of ongoing comprehensive riskmonitoring in patients prescribed opioids forchronic pain

Key Words Urine Drug Monitoring PainManagement Chronic Pain Substance UseDisorders Opioids Screening Tools

Introduction

Key Issues Regarding Drug Monitoring for PatientsPrescribed Opioids for Chronic Pain

Rationale for Drug Monitoring

Opioid analgesics are prescribed for up to one-third ofpatients with chronic pain treated in primary care clinics[1] but may be associated with unintended consequen-ces of misuse opioid use disorder overdose and diver-sion Morbidity and mortality presumably due torespiratory depression increase with concomitant useof opioids and other central nervous system depres-sants (eg benzodiazepines nonbenzodiazepine sleepmedications muscle relaxants tricyclic antidepressantsand alcohol) [2ndash5] Prescription opioid use has report-edly decreased from 2010 to 2014 [6] and opioid-related deaths also decreased from 2010 to 2012 [7]However deaths from illicitly produced fentanyl andrelated compounds [8ndash12] and heroin [713] have in-creased across various time periods in the past decade

Patients often do not voluntarily report prescription drugmisuse or illicit substance use [1415] and some mayfeign symptoms to obtain opioids for diversion [16]which necessitates objective assessments such as drugmonitoring [17] Although opioid use is monitored pri-marily for patient and public safety drug monitoring hasimportant implications for compliance with regulatorymandates and standards for responsible opioid pre-scribing [18ndash22] Urine drug monitoring (UDM) has theadded benefit of improving patient adherence to opioidtherapy [2324] potentially leading to better patient out-comes and greater trust between provider and patient

Types of Drug Monitoring and Terminology

This consensus report focuses on UDM although druguse can be detected via multiple biological samples(eg oral fluid blood hair [25]) Use of nonurine matri-ces may prevent sample alteration and avoid privacyconcerns however urine testing has been widelyadopted in clinical practice for monitoring because ofadequate drug concentration in the urine accuracy ofdeveloped tests and clinically relevant detection win-dows (ie three to five days) [25ndash27]

In this consensus report the term urine drug monitoring(UDM) is used instead of urine drug screening urinetoxicology screening or urine drug testing The UDM

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Methods



Amphetamines



bull Trazodone

Benzodiazepines


Cocaine


negave)

Cannabis



bull Pantoprazole


OpioidsHeroin


bull Rifampin


anbiocs






Presumptive




Definitive


for each drug

G0480






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Results








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Existing Guidelines


Relevant Literature



Baseline



Risk Assessment



Low Risk


Moderate Risk


High Risk



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Existing Guidelines



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Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1












99

Dow


icoupcompainm







Methods



Amphetamines



bull Trazodone

Benzodiazepines


Cocaine


negave)

Cannabis



bull Pantoprazole


OpioidsHeroin


bull Rifampin


anbiocs






Presumptive




Definitive


for each drug

G0480






Argoff et al

100

Dow


icoupcompainm

















Results








101

Dow


icoupcompainm



Existing Guidelines


Relevant Literature



Baseline



Risk Assessment



Low Risk


Moderate Risk


High Risk



Argoff et al

102

Dow


icoupcompainm
















Existing Guidelines



103

Dow


icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1






Methods



Amphetamines



bull Trazodone

Benzodiazepines


Cocaine


negave)

Cannabis



bull Pantoprazole


OpioidsHeroin


bull Rifampin


anbiocs






Presumptive




Definitive


for each drug

G0480






Argoff et al

100

Dow


icoupcompainm

















Results








101

Dow


icoupcompainm



Existing Guidelines


Relevant Literature



Baseline



Risk Assessment



Low Risk


Moderate Risk


High Risk



Argoff et al

102

Dow


icoupcompainm
















Existing Guidelines



103

Dow


icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1
















Results








101

Dow


icoupcompainm



Existing Guidelines


Relevant Literature



Baseline



Risk Assessment



Low Risk


Moderate Risk


High Risk



Argoff et al

102

Dow


icoupcompainm
















Existing Guidelines



103

Dow


icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


Existing Guidelines


Relevant Literature



Baseline



Risk Assessment



Low Risk


Moderate Risk


High Risk



Argoff et al

102

Dow


icoupcompainm
















Existing Guidelines



103

Dow


icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1















Existing Guidelines



103

Dow


icoupcompainm


Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1

Ta

ble

2S

um

mary

of

tools

toass

ess

risks

with

op

ioid

s

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Opio

idR

isk

Tool(O

RT

)5

10-ite

mpatient

self-r

eport

tool

[84]

that

assesses

risk

of

ab-

err

ant

dru

g-r

ela

ted

behavio

rs

[19]

1m

in[2

2]

Yes

[22]

With

acuto

ffscore

ofgt

4or

unspeci-

fied

sensitiv

ity

from

20

to99

and

specific

ity

from

16

to88

were

report

ed

for

dete

cting

risk

of

opio

idove

rdose

addic

tion

abuse

or

mis

use

(5stu

die

s)

[18]

ndash

Scre

ener

and

Opio

id

Assessm

ent

for

Patients

with

Pain

ndash

Revis

ed

(SO

AP

P-R

)

524-ite

mpatient

self-r

eport

tool

[22]

that

assesses

risk

of

dru

g-r

ela

ted

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

ofgt

3or

unspeci-

fied

sensitiv

ity

was

from

25

to

53

and

specific

ity

was

from

62

to73

for

dete

cting

risk

of

opio

id

ove

rdose

addic

tion

abuse

or

mis

-

use

for

likelih

ood

ratios

clo

se

to1

(2stu

die

s)

[18]

D

esig

ned

topre

-

vent

patient

de-

ception

[84]

R

equires

licens-

ing

agre

em

ent

[22]

but

no

fee

for

indiv

idual

clin

icaluse

Curr

ent

Opio

idM

isuse

Measure

(CO

MM

)

417-ite

mpatient

self-r

eport

tool

toid

entify

patients

receiv

ing

long-t

erm

opio

idth

era

py

who

are

exhib

itin

gaberr

ant

behavio

rs[1

9]

lt10

min

[22]

Yes

[22]

With

acuto

ffscore

of

10

sensitiv

ity

was

74

and

specific

ity

was

73

and

with

acuto

ffscore

of

9

sen-

sitiv

ity

was

77

and

specific

ity

was

66

for

the

dete

ction

of

aberr

ant

dru

g-r

ela

ted

behavio

r(1

stu

dy)

[84]

Requires

licensin

g

agre

em

ent

[22]

but

no

fee

for

in-

div

idualclin

ical

use

Dia

gnosis

In

tracta

bili

ty

Ris

k

Effic

acy

(DIR

E)

37-ite

mclin

icia

nin

terv

iew

to

pre

dic

teff

icacy

of

analg

esia

and

patient

adhere

nce

with

long-t

erm

opio

idtr

eatm

ent

[85]

lt2

min

[22]

Yes

[22]

At

acuto

ffpoin

tof

13

sensitiv

ity

was

94

and

specific

ity

was

87

for

poor

vs

goodfair

adhere

nce

(1stu

dy)

[85]

ndash

Pain

Assessm

ent

and

Docum

enta

tion

Tool

(PA

DT

)

2C

linic

ian-d

irecte

din

terv

iew

with

4dom

ain

sto

docum

ent

po-

tentially

aberr

ant

dru

g-r

ela

ted

behavio

rduring

treatm

ent

of

pain

[19]

lt10

min

[86]

Yes

[19]

No

stu

die

sid

entified

Addre

sses

abuse

risk

inonly

a

sm

all

com

po-

nent

of

the

tool

[87]

(continued)

Argoff et al

104

Dow


icoupcompainm


Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1

Ta

ble

2C

ontin

ued

Tool

Num

ber

of

Guid

elin

es

Mentionin

gD

escription

Tim

eto

Com

ple

teV

alid

ation

Sum

mary

of

Dia

gnostic

Accura

cy

Additio

nalN

ote

s

Cut

dow

nA

nnoye

d

Guilt

yE

ye-O

pener

Adapte

dto

Inclu

de

Dru

gs

(CA

GE

-AID

)

14-q

uestion

patient

self-r

eport

pare

nt-

report

or

clin

icia

n-r

e-

port

toolto

scre

en

for

sub-

sta

nce

use

dis

ord

ers

[88]

lt5

min

[22]

Yes

[22]

Acuto

ffof

2le

dto

sensitiv

ity

of

91

and

specific

ity

of

98

inadole

s-

cents

a

cuto

ffof

1le

dto

sensitiv

ity

of

88

and

specific

ity

of

55

in

adults

[88]

acuto

ffof

1le

dto

sen-

sitiv

ity

of

79

and

specific

ity

of

77

and

acuto

ffof

2le

dto

sensi-

tivity

of

70

and

specific

ity

of

85

inadults

(2stu

die

sto

tal)

[89]

ndash

Addic

tion

Behavio

rs

Check

list

(AB

C)

120-ite

mclin

icia

n-a

dm

inis

tere

d

toolto

track

behavio

rschar-

acte

ristic

of

addic

tion

to

opio

ids

inpatients

with

chro

nic

pain

[90]

Described

as

ldquobriefrdquo

[90]

Yes

[90]

At

acuto

ffof

3(u

sin

gA

BC

data

from

initia

lvis

itonly

)sensitiv

ity

was

875

0

and

specific

ity

was

861

4

(1stu

dy)

[90]

ndash

Sin

gle

-Ite

mF

orm

of

the

Copin

g

Str

ate

gie

sQ

uestion-

naire

01

question

(ldquoItrsquos

terr

ible

and

I

feelit

isneve

rgoin

gto

get

bett

errdquo

)to

pre

dic

topio

idm

is-

use

risk

[91]

Very

brief

only

1question

[91]

Yes

[91]

Ishig

hly

pre

dic

tive

vs

SO

AP

P-R

(1stu

dy)

[91]

Stu

dy

publis

hed

as

an

abstr

act

Ris

kIn

dex

for

Ove

rdose

or

Serious

Opio

id-I

nduced

Respirato

ry

Depre

ssio

n

(RIO

SO

RD

)

017-ite

m[9

2]

and

16-ite

m[9

4]

clin

icia

n-a

dm

inis

tere

dto

olto

assess

risk

of

ove

rdose

or

sero

us

opio

id-induced

respi-

rato

rydepre

ssio

n

Not

specifie

dYes

(17-ite

mve

rsio

n

ina

Vete

rans

Health

Adm

inis

tration

pop-

ula

tion

[92]

and

16-

item

vers

ion

ina

com

merc

ialhealth

pla

ncla

ims

data

-

base

[94])

Excelle

nt

agre

em

ent

betw

een

pre

-

dic

ted

and

observ

ed

incid

ences

acro

ss

risk

cla

sses

85

(17-ite

m)

to90

accura

cy

(16-ite

m)

indis

-

cri

min

ating

betw

een

patients

with

and

without

an

eve

nt

[929

4]

ndash

Sin

gle

-ite

mscre

enin

g

question

for

curr

ent

dru

guse

01

question

(ldquoH

ow

many

tim

es

inth

epast

year

have

you

used

an

illegaldru

gor

used

apre

scription

medic

ation

for

nonm

edic

alre

asonsrdquo)

toas-

sess

curr

ent

dru

guse

[93]

Very

brief

only

1question

[93]

Yes

[93]

Sensitiv

ity

for

substa

nce

use

dis

or-

ders

self-r

eport

ed

curr

ent

dru

g

use

and

dru

guse

dete

cte

dby

ora

l

fluid

testing

or

self-r

eport

100

929

and

847

respective

ly

specific

ity

for

these

measure

s

735

941

and

962

respective

ly[9

3]

ndash


105

Dow


icoupcompainm



Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


Relevant Literature











Existing Guidelines


Argoff et al

106

Dow


icoupcompainm



Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


Relevant Literature







MisuseUse Disorder
















107

Dow


icoupcompainm








UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1







UDM Rationale



UDM Process



Alcohol Screening


Argoff et al

108

Dow


icoupcompainm



Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


Cannabis Screening










109

Dow


icoupcompainm





Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1




Conclusions












Supplementary Data








Argoff et al

110

Dow


icoupcompainm




























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1



























111

Dow


icoupcompainm



























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


























Argoff et al

112

Dow


icoupcompainm

























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1
























113

Dow


icoupcompainm























Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1






















Argoff et al

114

Dow


icoupcompainm



























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1


























115

Dow


icoupcompainm

























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1
























Argoff et al

116

Dow


icoupcompainm













117

Dow


icoupcompainm


pnx285-TF1












117

Dow


icoupcompainm


pnx285-TF1

review article rational urine drug monitoring in patients

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