Clinical Drug Testing In Primary Care

Clinical Drug Testing in Primary CareAdulteration, Substitution, and Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Adulteration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Substitution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Dilute Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Cross-Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Amphetamines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Benzodiazepines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Marijuana/Cannabis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Opioids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Other Substances of Abuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60PCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Club Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60LSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Inhalants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Appendix A—Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Appendix B—Laboratory Initial Drug-Testing Methods . . . . . . . . . . . . . . . . . . . . 71Appendix C—Laboratory Confirmatory Drug-Testing Methods . . . . . . . . . . . . . . 73Appendix D—Laboratory Specimen Validity-Testing Methods . . . . . . . . . . . . . . 75Appendix E—Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Appendix F—Expert Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Appendix G—Consultants and Field Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Appendix H—Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83vi

ExhibitsExhibit 1-1. U.S. Department of Health and Human ServicesFederal Mandatory Workplace Guidelines Cutoff Concentrationsfor Initial and Confirmatory Drug Tests in Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Exhibit 1-2. Comparison of Federal WorkplaceDrug Testing and Clinical Drug Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Exhibit 2-1. Window of Detection for Various Matrices . . . . . . . . . . . . . . . . . . . . . . . . . . 12Exhibit 3-1. Advantages and Disadvantagesof Different Matrices for Drug Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Exhibit 3-2. Comparison of Laboratory Tests and POCTs . . . . . . . . . . . . . . . . . . . . . . . . 24Exhibit 3-3. Federal and State Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Exhibit 4-1. Motivational Interviewing Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Exhibit 4-2. The CAGE-AID Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Exhibit 4-3. Brief Intervention Elements: FRAMES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Exhibit 4-4. Patient Flow Through Screeningand Referral in Primary Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Exhibit 5-1. Barbiturates—Window of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Exhibit 5-2. Benzodiazepines—Window of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Exhibit 5-3. Opioids—Window of Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59vii

Chapter 1—IntroductionIn This Chapter Audience for the Tap Organization of theTap Reasons To UseClinical Drug Testingin Primary Care Primary Care andSubstance UseDisorders Development of DrugTesting Workplace DrugTesting Drug Testing inSubstance AbuseTreatment andHealthcare Settings Differences BetweenFederal Workplaceand Clinical DrugTesting CautionAudience for the TAPThis Technical Assistance Publication (TAP), Clinical DrugTesting in Primary Care, is for clinical practitioners—physicians, nurse practitioners, and physician assistants—who provide primary care in office settings and communityhealth centers. The publication provides information thatpractitioners need when deciding whether to introduce drugtesting in their practices and gives guidance on implementingdrug testing.The TAP does not address drug testing for law enforcementor legal purposes, nor does it include testing for the use ofanabolic steroids or performance-enhancing substances.This TAP describes some of the ways that drug testing cancontribute to the assessment, diagnosis, and treatmentof patients seen in primary care, the management of thetreatment of chronic pain, and the identification andtreatment of substance use disorders.Organization of the TAPThis chapter briefly describes the role of drug testing inprimary care settings and its historical roots in workplacetesting. Chapter 2 defines the terms and practices used indrug testing. Chapter 3 presents the mechanics of testingand describes the steps that primary care practitioners cantake to prepare themselves, their staffs, and their officespaces for drug testing. Chapter 4 provides informationabout implementing testing in clinical practice. Importantaspects of urine drug testing for specific drugs are presentedin Chapter 5. Appendices A–H include the bibliography;overviews of technical information on specific tests usedfor initial or screening tests, confirmatory tests, andspecimen validity tests; a glossary of terms; the membersof the expert panel, consultants, and field reviewers; andacknowledgments.1

Clinical Drug Testing in Primary CareReasons To Use Clinical DrugTesting in Primary CareThe term drug testing can be confusingbecause it implies that the test will detectthe presence of all drugs. However, drugtests target only specific drugs or drugclasses and can detect substances onlywhen they are present above predeterminedthresholds (cutoff levels). The term drugscreening can also be deceptive because itis often used to describe all types of drugtesting. However, drug screening is usuallyused in forensic drug testing to refer to theuse of immunoassay tests to distinguishspecimens that test negative for a drug and/ormetabolite from positive specimens. For thepurpose of this TAP, the term drug testing isused.When used appropriately, drug testing canbe an important clinical tool in patient care.The types of clinical situations in whichclinical drug testing can be used includepain management with opioid medications,office-based opioid treatment, primarycare, psychiatry, and other situations whenhealthcare providers need to determinealcohol or other substance use in patients.Drug testing is also used to monitor patients’prescribed medications with addictivepotential. Patients sometimes underreportdrug use to medical professionals (Chen,Fang, Shyu, & Lin, 2006), making somepatients’ self-reports unreliable. Drugtest results may provide more accurateinformation than patient self-report.Although drug testing can be a useful toolfor making clinical decisions, it should not bethe only tool. When combined with a patient’shistory, collateral information from a spouseor other family member (obtained withpermission of the patient), questionnaires,biological markers, and a practitioner’sclinical judgment, drug testing providesinformation that: Can affect clinical decisions on a patient’ssubstance use that affects other medicalconditions.2 Can affect clinical decisions aboutpharmacotherapy, especially withcontrolled substances. Increases the safety of prescribingmedications by identifying the potential foroverdose or serious drug interactions. Helps clinicians assess patient use ofopioids for chronic pain management orcompliance with pharmacotherapy foropioid maintenance treatment for opioiduse disorders. Helps the clinician assess the efficacy ofthe treatment plan and the current levelof care for chronic pain management andsubstance use disorders (SUDs). Prevents dangerous medicationinteractions during surgery or othermedical procedures. Aids in screening, assessing, anddiagnosing an SUD, although drug testingis not a definitive indication of an SUD. Identifies women who are pregnant, or whowant to become pregnant, and are usingdrugs or alcohol. Identifies at-risk neonates. Monitors abstinence in a patient with aknown SUD. Verifies, contradicts, or adds to a patient’sself-report or family member’s report ofsubstance use. Identifies a relapse to substance use.Primary Care and Substance UseDisordersPractitioners can use drug testing to helpmonitor patients’ use of prescribed scheduledmedications, as part of pharmacovigilance,and to help identify patients who may needan intervention for SUDs.For the purpose of this TAP, substancesrefers to alcohol and drugs that can beabused. As defined by the Diagnostic andStatistical Manual of Mental Disorders,

Chapter 1―IntroductionFourth Edition, Text Revision (DSM IV-TR; American Psychiatric Association[APA], 2000), a substance-related disorderis a disorder related to the consumption ofalcohol or of a drug of abuse (APA, 2000).Substance use disorders (SUDs) includesboth substance dependence and substanceabuse (APA, 2000). Substance dependencerefers to “a cluster of cognitive, behavioral,and physiological symptoms indicating thatthe individual continues use of the substancedespite significant substance-relatedproblems. There is a pattern of repeated selfadministration that can result in tolerance,withdrawal, and compulsive drug-takingbehavior” (APA, 2000). Substance abuserefers to “a maladaptive pattern of substanceuse manifested by recurrent and significantadverse consequences related to the repeateduse of substances” (APA, 2000). In this TAP,the term substance abuse is sometimes usedto denote both substance abuse and substancedependence as they are defined in the DSMIV-TR (APA, 2000).SUDs can have serious medical complicationsand serious psychosocial consequences andcan be fatal. Treatment of other medicaldisorders (e.g., HIV/AIDs, pancreatitis,hypertension, diabetes, liver disorders) maybe complicated by the presence of an SUD.As the front line in health care, medicalpractitioners are ideally situated to identifysubstance use problems. The 2009 NationalSurvey on Drug Use and Health (SubstanceAbuse and Mental Health ServicesAdministration [SAMHSA], 2010a) found that23.5 million (9.3 percent) persons ages 12 orolder needed treatment for an illicit drug1or alcohol use problem. Of this population,only 2.6 million (1.0 percent) persons ages12 or older (11.2 percent of those who neededtreatment) received treatment at a specialtyfacility. Thus, 20.9 million (8.3 percent) of thepopulation age 12 or older needed substanceabuse treatment but did not receive it in thepast year (SAMHSA, 2010a). Therefore, avisit to a primary care practitioner may bean excellent opportunity for such people to be1Includes the nonmedical use of prescription-typepain relievers, tranquilizers, stimulants, and sedatives.diagnosed with SUDs. Moreover, the numberof people ages 12 or older seeking help forSUDs from a doctor in private practiceincreased from 460,000 in 2005 to 672,000 in2008 (SAMHSA, 2006; SAMHSA, 2009).Despite the potential benefits of drug testing(such as monitoring pain medication) topatient care, few primary care practitionersuse it. For example, a small study conductedon the medical management of patients withchronic pain in family practices found thatonly 8 percent of physicians surveyed useddrug testing (Adams et al., 2001).Development of Drug TestingDrug testing performed for clinical reasonsdiffers substantially from workplace drugtesting programs. However, clinical drugtesting draws on the experience of FederalMandatory Workplace Drug Testing and,to understand drug testing, a review ofworkplace drug testing may be helpful. Animportant reason for clinical practitionersto become familiar with Federal MandatoryWorkplace Drug Testing is that the majorityof drug testing is done for workplacepurposes. For this reason, most laboratoriesand many point-of-care tests (POCTs) usethe cutoff concentrations established by theMandatory Guidelines for Federal WorkplaceDrug Testing Programs, discussed in Chapter 2.There are three categories of drug testing:(1) federally regulated for selected Federalemployees (including military personneland those in safety-sensitive positions);(2) federally regulated for non-Federalemployees in safety-sensitive positions (i.e.,airline and railroad personnel, commercialtruckers, school bus drivers); and (3)nonregulated for non-Federal employees.Commercial truck drivers, railroad employeesand airline personnel make up the largestgroup of individuals being drug tested.The purpose of both Federal (alwaysregulated) and non-Federal (may benonregulated) workplace drug testing is toensure safety in the workplace by preventing3

Clinical Drug Testing in Primary Carethe hiring of individuals who use illicit drugsand identifying employees who use illicitdrugs.Workplace Drug TestingDrug-testing methods have been availablefor approximately 50 years (Reynolds, 2005).Because of drug use in the U.S. military, by1984, the military established standards forlaboratories and testing methods and createdthe first system for processing large numbersof drug tests under strict forensic conditionsthat could be defended in a court of law.In 1986, an Executive Order initiated theFederal Drug-Free Workplace Program thatdefined responsibilities for establishing aplan to achieve drug-free workplaces. In1987, Public Law 100-71 outlined provisionsfor drug testing programs in the Federalsector. In 1988, Federal mandatory guidelinesset scientific and technical standards fortesting Federal employees. In 1989, the U.S.Department of Transportation (DOT) issuedregulations requiring the testing of nearly 7million private-sector transportation workersin industries regulated by DOT.The Federal mandatory guidelines includedprocedures, regulations, and certificationrequirements for laboratories; outlined thedrugs for which testing was to be performed;set cutoff concentrations; and stated reportingrequirements that included mandatory medicalreviews by a specially trained physicianMedical Review Officer (MRO). Because apositive result does not automatically identifyan employee or job applicant as a personwho uses illicit drugs, the MRO interviewsthe donor to determine whether there is analternative medical explanation for the drugfound in the specimen. The Federal mandatoryguidelines recommended that the initialscreening test identify the presence of thefollowing commonly abused drugs or their4metabolites (SAMHSA, 2008): Amphetamines (amphetamine,methamphetamine) Cocaine metabolites Marijuana metabolites Opiate metabolites (codeine, morphine) Phencyclidine (PCP)These substances are generally called the“Federal 5,” but over the years they have alsobeen called the “NIDA 5” and “SAMHSA 5.”The Federal mandatory guidelines have beenupdated and revised over the years to reflecttechnological and process changes (Exhibit1-1). The guidelines, last updated in 2008(effective May 1, 2010), are available at http://dwp.samhsa.gov/DrugTesting/Level 1 Pages/mandatory guidelines5 1 10.html.Revisions for testing of other matrixes (e.g.,hair, oral fluid, sweat) and the use of POCTswere proposed in 2004 (SAMHSA, 2008), buthave not been finalized.Although Federal agencies are requiredto have drug-free workplace programs fortheir employees, private-sector employersthat do not fall under Federal regulationscan establish their own drug-free workplaceprograms and establish their ownregulations, testing matrices, and testingmethods. Non-Federal employees can betested for a broader range of drugs than thefederally mandated drugs. Many States havelaws and regulations that affect when, where,and how employers can implement drug-freeworkplace programs (search in http://www.dol.gov).Laboratories are accredited by the NationalLaboratory Certification Program (NLCP)to meet the minimum requirements of theFederal mandatory guidelines. This programresides in SAMHSA in the Department ofHealth and Human Services (HHS).

Chapter 1―IntroductionExhibit 1-1. U.S. Department of Health and Human Services Federal Mandatory WorkplaceGuidelines Cutoff Concentrations for Initial and Confirmatory Drug Tests in UrineFederal CutoffConcentrations (ng/mL)Initial Test AnalyteMarijuana metabolites50Cocaine metabolites150Opiate metabolites (codeine/morphine )2,00016-Acetylmorphine (6-AM)10Amphetamines (Amphetamine /methamphetamine)5002Phencyclidine (PCP)25Methylenedioxymethamphetamine (MDMA)500Federal CutoffConcentrations (ng/mL)250Confirmatory Test ene

drug screening. can also be deceptive because it is often used to describe all types of drug testing. However, drug screening. is usually used in forensic drug testing to refer to the use of immunoassay tests to distinguish specimens that test negative for a drug and/or metabolite from posi