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Appropriate Use of Drug Testing in Clinical Addiction Medicine

Journal of Addiction Medicine: May/June 2017 - Volume 11 - Issue - p 1–56
doi: 10.1097/ADM.0000000000000322
Consensus Statement

Received 13 April, 2017

Accepted 13 April, 2017

Expert Panel Members (in alphabetical order)

 Louis Baxter, Sr., MD, DFASAM

 Lawrence Brown, MD, MPH, DFASAM

 Matthew Hurford, MD, Expert Panel Moderator

 William Jacobs, MD

 Kurt Kleinschmidt, MD

 Marla Kushner, DO, DFASAM

 Lewis Nelson, MD

 Michael Sprintz, DO, FASAM

 Mishka Terplan, MD, MPH, FASAM

 Elizabeth Warner, MD

 Timothy Wiegand, MD, FACMT, FAACT

ASAM Quality Improvement Council (in alphabetical order)

 John Femino, MD, DFASAM

 Kenneth Freedman, MD, MS, MBA, DFASAM

 Barbara Herbert, MD, DFASAM

 Margaret Jarvis, MD, DFASAM, Chair

 Margaret Kotz, DO, DFASAM

 David Pating, MD, FASAM

 Sandrine Pirard, MD, PhD, MPH, FAPA, FASAM

 Robert Roose, MD, MPH, FASAM

 Brendan McEntee, ASAM Staff

 Penny Mills, MBA, ASAM, Executive Vice President

 Taleen Safarian, ASAM Staff

Special External Reviewer

 Michael Miller, MD, DFASAM, FAPA

IRETA Team Members (in alphabetical order)

 Peter Cohen, MD, Medical Advisor

 Leila Giles, BS

 Matthew Hurford, MD, Expert Panel Moderator

 Piper Lincoln, MS

 Dawn Lindsay, PhD

 Peter Luongo, PhD

 Jessica Williams, MPH

Disclosure information for the ASAM Expert Panel Members and Quality Improvement Council is available in Appendix 6.

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INTRODUCTION

Purpose

The purpose of the Appropriate Use of Drug Testing in Clinical Addiction Medicine is to provide guidance about the effective use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction. This document draws on existing empirical evidence and clinical judgment on drug testing with the goal of improving the quality of care that people with addiction receive.

By focusing on the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk of, addiction, the appropriateness document:

Identifies current clinical practice and disagreement regarding the use of drug testing.

Utilizes the Research and Development/University of California Los Angeles (RAND/UCLA) Appropriateness Method, which combines existing empirical evidence and clinical expertise to develop recommendations for appropriate practice.

Compiles recommendations in a comprehensive document for use by a variety of providers who utilize drug testing.

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Background

Drug testing uses a biological sample to detect the presence or absence of a specific drug (or drugs) as well as drug metabolites within a specific window of time. No universal standard exists today in clinical drug testing for addiction identification, diagnosis, treatment, medication monitoring, or recovery.

The American Society of Addiction Medicine (ASAM) recognizes that the absence of guidance creates a vacuum. Even in the context of limited research about how to approach a given clinical practice, providers and payers make decisions about what kind of care patients should and do receive. This appropriateness document is intended to guide provider decisions about drug testing to improve the quality of care that patients with addiction receive.

It is ASAM policy that the elements of drug testing (eg, matrix, drug panel, testing technology) be determined by the provider based on patient-specific needs, not by arbitrary limits from insurance providers [1]. However, most physicians and other providers employing drug testing in addiction care have operated without authoritative guidance about how this therapeutic tool should be utilized effectively in treatment.

ASAM has produced 2 key documents related to drug testing: “Public Policy Statement on Drug Testing as a Component of Addiction Treatment and Monitoring Programs and in other Clinical Settings” and “Drug Testing: A White Paper of the American Society of Addiction Medicine” [1,2]. Neither document provides specific guidance and neither was developed using a rigorous methodology to develop practice recommendations.

In its 2010 policy statement, ASAM recognized drug testing as part of medical care for people being treated for addiction. The Statement expressed ASAM policy that drug testing should not face undue restrictions; decisions about the types and frequency of testing should be made by the ordering physician; and arbitrary limits on reimbursement by payers interfere with the physician's judgment and violate federal parity laws. The Statement provided a brief review of drug testing purposes, practices, and procedures that are recommended by ASAM.

The White Paper provided extensive background regarding the science and current practices of drug testing in various contexts, as well as broad suggestions for ways to improve drug testing in clinical practice. However, the White Paper acknowledged that more specific clinical guidance was needed and would be forthcoming from ASAM.

In the White Paper, ASAM advocates for the use of “smarter” drug testing as follows:

Smarter drug testing means the increased use of random testing rather than the more common scheduled testing, and it means testing not only urine but also other matrices such as blood, oral fluid (saliva), hair, nails, sweat and breath when those matrices match the intended assessment process. In addition, smarter testing means testing based upon clinical indication for a broad and rotating panel of drugs rather than only testing for the traditional five-drug panel that was designed not by practicing physicians or researchers, but by the federal government for government-mandated testing such as that required of commercial drivers. Smarter testing means improved sample collection and detection technologies to decrease sample adulteration and substitution. Designing appropriate steps to respond to the efforts of individuals trying to subvert the testing process must be considered when evaluating the costs/benefit ratio of different testing matrices, recognizing that such countermeasures may have a dramatic impact on the usefulness of testing. Smarter drug testing means careful consideration of the financial costs of testing in relationship to the value and in many cases, medical necessity, of the test results. It means considering the advantages and limitations of the many testing technologies available today. [2]

This appropriateness document is designed to guide providers toward “smarter” drug testing.

Addiction treatment is increasingly delivered in primary care offices, with the proliferation of addiction medications such as buprenorphine and naltrexone. Drug-testing technology using matrices such as oral fluid (saliva), sweat, and hair is becoming increasingly sophisticated. Although urine is still by far the most common matrix, an evidence base is building for alternatives. And finally, the availability of synthetic drugs (some designed specifically to evade detection by drug testing) has grown dramatically and will continue to do so. According to ASAM's White Paper, the dramatic proliferation of potentially addictive drugs is one of the most challenging problems facing drug testing today [2]. Consistent with the “smarter” drug testing paradigm, the ASAM White Paper states, “The most important challenge in drug testing today is not the identification of every drug we are technologically capable of detecting, but to do medically necessary and accurate testing for those drugs that are most likely to impact clinical outcomes.”

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Cost Considerations

This document is designed to convey statements about drug testing as part of appropriate clinical care. It is not an analysis of the cost benefits of drug testing using various technologies or under various circumstances. However, ASAM is acutely aware that this document will be released in a context where a lack of clarity about the appropriate use of drug testing has led not only to inconsistent clinical practice, but also unethical and/or fraudulent activities.

The inappropriate use of drug testing can have extraordinary costs to third-party payers, taxpayers, and at times the patients who are receiving care. Though non-monetary, this has also cost the addiction treatment field because of loss of credibility. Examples of inappropriate and often-costly drug-testing practices are (1) the routine use of large, arbitrary test panels, (2) unnecessarily frequent drug testing without consideration for the drug's window of detection, and (3) the confirmation and quantification of all presumptive positive and negative test results [3,4].

It is ASAM's position that these and other inappropriate drug-testing practices are harmful not only because they waste valuable resources but because they do not fit the standards of appropriate clinical care. Providers have an obligation to ensure the highest possible quality of treatment for all patients, which includes the appropriate use of clinical drug testing. One of the purposes of this document is to clarify appropriate clinical use of drug testing and, in so doing, shine a light on drug-testing practices that are clearly outside of these boundaries. The delineation of appropriate treatment practices will confer multiple benefits; most importantly, it will improve patient care. At the same time, it will reduce waste and fraud.

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How to Use This Document

Unlike clinical guidelines that typically focus on either more generalized or disease-specific recommendations, this appropriateness document determines when, where, and how often a drug test should be performed for the identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction.

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Providers

This document contains practical information to guide the appropriate use of drug testing to help identify, diagnose, treat, and support recovery for patients with or at risk of addiction. Providers are encouraged to utilize this appropriateness document to improve their quality of care, recognizing that it will be necessary to seek supplemental information when questions arise that this document does not comprehensively address. For example, providers seeking specific guidance for interpreting drug test results should consider consulting with a laboratory or a physician with Medical Review Officer (MRO) certification.

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Payers

The primary audience for this document are providers who utilize drug testing in clinical settings. It is not designed as a template for payer policies. For example, it would be inappropriate to translate the statement that “during the initial phase of treatment, drug testing should be at least weekly” into a payer policy that will not reimburse drug tests that are more frequent than weekly.

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Administrators

Healthcare administrators in residential, outpatient, and other settings should reference this document as a guide for appropriate practice related to drug testing. This document may inform policy decisions related to establishing or improving a drug-testing program in a variety of clinical settings.

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Scope of Project

This document focuses on clinical drug testing for identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction. ASAM recognizes that drug testing is used in other contexts (eg, criminal justice, workplace, and pain management settings). ASAM's intent with this document, however, is to focus primarily on patients in addiction treatment and recovery, where drug testing is used to assess the patient for indicators of a substance use disorder (SUD), monitor the effectiveness of the treatment plan, and support recovery, and to also focus on selected special populations at risk for addiction. Although ASAM acknowledges that these recommendations may be applied to other settings where drug testing is utilized, note that the materials reviewed and methodology used were restricted to the populations and settings described.

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Included and Excluded Settings

Inasmuch as the scope of the project includes the recognition of addiction, which often occurs in general healthcare settings, these settings are included briefly in this context. This document excludes recommendations for federally mandated workplace forensic testing, which are regulated by Substance Abuse and Mental Health Services Administration (SAMHSA). Drug testing in the contexts of criminal justice and pain management is also outside the scope of this document.

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Types of Tests

This document will address considerations involved in the timing and selection of presumptive and definitive drug testing. Also, while urine drug testing (UDT) is the most common type of test utilized in the identification, diagnosis, treatment, and monitoring of patients with addiction, ASAM recognizes that drug test technology utilizing biological matrices such as oral fluid, hair, and sweat is becoming increasingly advanced and widespread.

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Settings

This document includes recommendations about the frequency and duration of drug testing according to ASAM levels of care (eg, Outpatient and Residential) and includes a section on considerations for Opioid Treatment Services (OTS), including Opioid Treatment Programs (OTP) as well as Office-Based Opioid Treatment (OBOT). Also, while not an ASAM level of care, the document also includes recommendations for patients in recovery residences. In cases where no specific guidance was recommended for a particular level of care, the reader is directed back to the general principles section regarding appropriate clinical practice.

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Special Populations

This document includes considerations for the following special populations: adolescents, pregnant women, people in recovery, and health and other professionals. For adolescents, the focus is in general healthcare settings and not in addiction treatment settings because there are unique considerations for drug testing adolescents in general healthcare settings. For pregnant women, the focus is also primarily in general healthcare settings for pregnant and postpartum women.

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Intended Audience

This appropriateness document is intended for addiction specialists and for all providers utilizing drug testing in the context of the identification, diagnosis, treatment, and monitoring of patients with, or at risk for, addiction. This document will also be useful for physicians and other providers concerned about the possibility of addiction in their patient population.

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Qualifying Statement

This document is intended to aid providers in their clinical decision-making and patient management. The document strives to identify and define clinical decision-making junctures that meet the needs of most patients in most circumstances. Recommendations in this document are not intended to substitute for independent clinical judgment based on the particular facts and circumstances presented by individual patients. Clinical decision-making should involve consideration of the quality and availability of expertise and services in the community wherein care is provided. In circumstances in which the document is being used as the basis for regulatory or payer decisions, improvement in quality of care should be the goal. Because lack of patient understanding and adherence may adversely affect outcomes, providers should make every effort to promote the patient's understanding of, and adherence to, prescribed and recommended pharmacological and psychosocial treatments and any associated testing. Patients should be informed of the risks, benefits, and alternatives to a particular treatment or test, and should be an active party to shared decision-making whenever feasible. Recommendations in this document do not supersede any federal or state regulation.

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Terminology and Key Terms

Below are brief definitions of select key terms and explanations of how they are used in this document. For example, the term “provider” is used throughout this document to refer to any individual or organization who may utilize clinical drug testing for identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction. This includes addiction treatment clinicians, addiction treatment programs, drug treatment programs and primary or general healthcare physicians. Please refer Appendix 2: Glossary and Terms to clarify the use of other specific terms. Appendix 1: Abbreviations and Acronyms provides further clarification.

Analyte: The component of a biological sample that is identified and measured. In drug testing, both parent drugs and the products of drug metabolism are targeted. Their presence indicates exposure to a substance or family of substances.

Definitive testing: In contrast to presumptive testing, testing performed using a method with high sensitivity and specificity that is able to identify specific drugs, their metabolites, and/or drug quantities. Definitive testing is likely to take place in a laboratory and each individual test can be expensive. Gas or liquid chromatography combined with mass spectrometry is the gold standard method in definitive drug testing.

Expected test results: In the context of addiction treatment that includes medication (eg, buprenorphine) an expected test result is positive for prescribed medication and negative for other addictive substances.

Matrix (plural matrices): The biological material used for analysis in a drug test. Examples include blood, urine, oral fluid (spit/saliva), hair, nails, sweat, and breath.

Negative test result: The result reported by a test that fails to detect the presence of a target substance in a sample. This can indicate either a complete lack of the drug or drug metabolite or a level too low to be detected by the test. In this document, a “negative test result” refers to a test result showing no use of non-prescribed addictive substances. However, in the context of addiction treatment that includes medication, the terms positive and negative have been replaced with “unexpected” and “expected.”

Patient: Anyone who receives care for an addiction in a specialty addiction treatment center or other healthcare setting.

Point of collection test/point of care test: A drug test performed at the site where the sample is collected using either an instrumented or non-instrumented commercial device (eg animmunoassay test strip or dipstick or a machine-based immunoanalyzer with optical reader).

Positive test result: The result reported by a test that detects the presence of a target substance in a sample. In this document, a “positive test result” refers to a test result showing the use of non-prescribed addictive substances. However, in the context of addiction treatment that includes medication, the terms positive and negative have been replaced with “unexpected” and “expected.”

Presumptive testing: In contrast to definitive testing, testing performed using a method with lower sensitivity and/or specificity, which establishes preliminary evidence regarding the absence or presence of drugs or metabolites in a sample.

Provider: Used throughout the appropriateness document, this term is intentionally broad. It encompasses anyone (an individual or organization) who participates in providing care to patients with addiction, including staff at specialty addiction treatment centers or other healthcare settings that provide addiction treatment.

Unexpected test results: In the context of addiction treatment that includes medication (eg, buprenorphine), an unexpected test result could be (a) negative for prescribed medication, (b) positive for other addictive substance, or (c) both.

Window of detection: The range of time that a substance can be detected in a sample. It refers both to the time to detection (time to be absorbed and distributed to sample material) and time to clearance (time to be metabolized/eliminated/excreted). Each matrix and analyte has a different window of detection, ranging from minutes to months.

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PART 1: PRINCIPLES OF DRUG TESTING IN ADDICTION TREATMENT

Clinical Value of Drug Testing

Principles of Biological Detection of Substance Use

Drug tests are tools that provide information about an individual's substance use. Any practitioner involved with the care of patients with addiction should understand what information drug testing can and cannot convey. Drug testing has been referred to as “the technology of addiction treatment” [5], but like any technology, its value depends on whether it is utilized correctly. Drug testing is an effective technology when the right test is selected for the right person at the right time.

Drug tests are designed to detect whether a substance has been used within a particular window of time. The test involves collecting a biological sample, also called a specimen, which is tested for the presence or absence of a specific substance or substances. While it can be a powerful tool, a drug test is designed to answer a rather narrow question: is substance X detected in sample Y? The answer is limited to the substance or substances that are targeted by the test, the individual sample which was tested (representing the patient's biological state at the time of collection), and the detection method used by the test. If the answer is yes, the result is labeled “positive” and if no, the result is labeled “negative.”

A positive drug test result indicates that the patient providing the sample had a detectable amount of the targeted substance(s) in his or her system when the sample was collected. The timing of sample collection is important. Substances have a constant rate of elimination from the body, but the rate varies across biological sample type, or matrix. Some drug tests may be better or worse at detecting a substance in a particular matrix, which means it is important for a provider to understand the test's sensitivity and specificity to gauge the possibility of false negatives or positives. But even the most effective test under ideal circumstances can only measure the presence of a substance within the window of time it remains detectable in the body, also called the window of detection.

A positive drug test is not sufficient evidence for a diagnosis of an SUD. It does not explain whether a patient's symptoms are caused by the presence of a substance. In most cases, a drug test does not measure impairment and in most cases a drug test does not measure patterns of use over time.

It is important not to over-interpret a negative test result. A negative result does not mean that a patient has not used substances; it merely means that the patient has not used the substance(s) targeted by the test within the window of detection or used an amount less than the test is capable of detecting. Not only does an accurate negative test result not rule out substance use, it also does not rule out SUD, which can be present without recent substance use.

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Drug Testing and Self-Reported Substance Use

If the appropriate interpretation of a drug test result is so narrow, why test at all? Drug testing provides another source of information to complement self-report, collateral report, and provider assessment. Having an additional, alternative means of assessing a patient's recent substance use is important to treatment planning and ongoing treatment adjustment.

Because individuals with addiction pathologically pursue reward and/or relief by substance use, some patients will give inaccurate or incomplete histories. Therefore, it behooves providers to verify self-report with biological testing. In contrast to a patient's self-report, biological test results are considered “objective” in that they are not subject to limitations caused by memory, social acceptability, or missing information. For example, a patient might not accurately remember his or her substance use history, may try to minimize or overstate his or her past use, and may not be aware of the composition of the substances he or she has consumed, especially as synthetic drugs increase in prevalence.

Patients facing potential negative consequences if substance use is detected, such as increased sanctions or legal action, may be less likely to self-report accurately. For example, a multi-site trial of patients with prescription drug use disorders concluded that “self-reports of substance use are most likely to be valid when participants believe that they will not suffer negative consequences” as a result of their report [6]. In situations where substance use may result in these consequences, the combination of self-reported use and drug test results may lead to a more accurate picture of recent substance use.

Due to its inherent limitations, drug testing should not be relied upon as the sole measure of a patient's substance use. All drug testing should be accompanied by a discussion with the patient about his or her substance use. A patient's self-report provides additional clinically relevant information that drug testing cannot. In the event that a patient's self-reported substance use differs from the results of a drug test, the provider should use the discrepancy as a springboard for therapeutic discussions.

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Drug Testing and Patient Outcomes

The decision to use any tool in health care should be grounded in the principles of improved patient care and outcomes. Although evidence is limited that the use of drug testing in addiction treatment improves patient outcomes, the expert panel cited extensive clinical experience supporting the use of drug testing to improve patient outcomes.

Moreover, two 2014 studies illuminated the currently unrealized role of drug tests in addiction treatment. Blum et al [7] looked at whether drug test results are useful indicators of patients’ progress in treatment and concluded that testing for both prescribed addiction medications and illicit drug use can improve a provider's ability to determine the effectiveness of the current treatment approach. However, a systematic review of patient charts concluded that drug testing does not appear to change the way patients are managed by their treatment providers, although it was unclear whether these results were due to provider behavior or actual lack of effect of drug testing on management or outcome of patients in addiction treatment [8]. Together, these results suggest that drug testing has the potential to improve patient outcomes if used correctly and consistently to monitor and adjust treatment plans. Drug testing should be used widely in addiction treatment settings and its use should be integrated into the process of making treatment decisions.

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Drug Testing and Evidence-Based Therapy

Although drug testing in addiction treatment settings is common, providers have heretofore received very limited guidance on how drug testing should be integrated with evidence-based addiction treatment.

The most extensively researched behavioral therapy used in conjunction with drug testing is contingency management. Contingency management can involve tying behavioral incentives to the result of a drug test and has been shown to be an effective approach to addiction treatment [9]. It is clear that the contingency management model fits well with drug testing [10] and the expert panel recommends combining the 2. When using drug testing as part of contingency management, providers should also seek self-reported information from patients about substance use.

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Clinical Use of Drug Testing

Therapeutic Tool

Drug testing should be used as a tool for supporting recovery rather than exacting punishment. Every effort should be made to persuade patients that drug testing is a therapeutic, rather than punitive, component of treatment. This process may require time and multiple conversations. If drug testing is used in such a way that it creates an “us versus them” mentality, it is at odds with the therapeutic alliance. In fact, drug testing can be thought of as a tool to improve the therapeutic alliance in that it transfers the role of detector from the provider to the test.

Using drug testing as a therapeutic tool means addressing test results as a part of therapy. Drug testing should be used to explore denial, motivation, and actual substance use behaviors. Test results that do not align with a patient's self-report should generate therapeutic discussion with the patient. If a patient refuses to undergo a drug test, that refusal should be an area of focus for the patient's treatment plan. Some of the value of using drug test results as a topic of therapeutic discussion has been demonstrated by 2 qualitative studies that showed favorable responses to drug test discussions among some patients in treatment [11,12].

In addition to measuring treatment efficacy, drug testing may also serve as a source of motivation and reinforcement for abstinence [13]. Providers should use negative test results as a source of encouragement.

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Assessment

Drug testing should be a key component of assessment for SUD and should be used to assist in treatment planning.

Test results should always be combined with patient history, psychosocial assessment, and a physical examination during an assessment. According to ASAM's Principles of Addiction Treatment, “Laboratory testing in the clinical setting is intended to guide diagnosis and treatment planning...the provider must combine the findings from the history and physical examination with that of the laboratory testing for accurate interpretation and management” [14]. The results of the medical and psychosocial assessment generate valuable information (eg, types of substances used) that should inform the provider's decision about drug testing (see Choosing a Test, p. 7).

It is recommended that treatment providers include drug testing at intake. Drug test results at intake have been determined to be a useful predictor of treatment outcomes [15,16]. Patients who submit a positive drug test at intake may benefit from different approaches to treatment than patients who submit a negative test [17].

Drug testing as part of an initial assessment provides additional benefits. For example, test results can help illuminate any links between substance use and psychiatric or medical symptoms a patient is experiencing. For a patient presenting with altered mental status, a negative drug test result may support differentiation between intoxication and/or presence of an underlying psychiatric and/or medical condition that should be addressed in treatment planning. Drug testing can also verify a patient's substance use history or demonstrate a discrepancy between self-reported use and test results. Finally, drug tests may be used to help determine optimal placement in a level of care using The ASAM Criteria, particularly in assessing Dimension 1 (Acute Intoxication and/or Withdrawal Potential), Dimension 4 (Readiness to Change), and Dimension 5 (Relapse, Continued Use, or Continued Problem Potential).

Drug testing may also assist providers in re-assessing patient needs while the patient is receiving treatment. For example, it is appropriate to conduct drug tests when patients display a change in clinical status, such as apparent sedation/ataxia/agitation or other behavior change that might indicate recent drug exposure.

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Monitoring

Drug testing should be used to monitor the effectiveness of a patient's treatment plan. If a goal of treatment is to reduce or eliminate substance use, drug testing can be thought of as an ongoing measure of treatment performance. A pattern of tests that are positive for expected prescribed medications and negative for other unexpected substance use, in combination with other indicators, suggest a patient's treatment plan is effective. In contrasts, tests that are positive for unexpected substance use (and/or negative for expected prescribed substances) suggest that the treatment plan should be adjusted. If a provider is making treatment adjustments, test results can be helpful in determining optimal placement in a level of care. Providers should note that immediate cessation of substance use early in treatment may not be a realistic treatment goal. The section on Responding to Test Results provides more detail on the appropriate response to test results.

Drug testing is only one measure of one treatment goal and it should not be the only method of detecting substance use or monitoring treatment outcomes; results should be interpreted in the context of collateral and self-report and other indicators.

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Summary of Recommendations

Clinical Value of Drug Testing

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Principles of Biological Detection of Substance Use

* Providers should understand that drug tests are designed to measure whether a substance has been used within a particular window of time.

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Drug Testing and Self-Reported Substance Use

* Drug testing should be used in combination with a patient's self-reported information about substance use.

* Drug testing is an important supplement to self-report because patients may be unaware of the composition of the substances(s) they have used.

* Drug testing is particularly appropriate for patients facing negative consequences if substance use is detected, who are therefore less likely to provide accurate self-reported substance use information.

* Discrepancy between self-report and drug tests results can be a point of engagement for the provider.

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Drug Testing and Patient Outcomes

* Because evidence suggests that drug testing assists with monitoring adherence and abstinence in treatment and can improve patient outcomes, drug testing should be used widely in addiction treatment settings.

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Drug Testing and Evidence-Based Therapy

* Contingency management is most extensively researched behavioral therapy used in conjunction with drug testing. When utilizing contingency management therapy to encourage abstinence, providers should consider incorporating drug testing.

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Clinical Use of Drug Testing

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Therapeutic Tool

* Drug testing is recommended as a therapeutic tool as part of evidence-based addiction treatment.

* Providers should utilize drug testing to explore denial, motivation, and actual substance use behaviors with patients.

* If drug-testing results contradict self-reports of use, therapeutic discussions should take place.

* Providers should present drug testing to patients as a way of providing motivation and reinforcement for abstinence.

* Providers should educate patients as to the therapeutic purpose of drug testing. To the extent possible, persuade patients that drug testing is therapeutic rather than punitive to avoid an “us versus them” mentality.

* If a patient refuses a drug test, the refusal itself should be an area of focus in the patient's treatment plan.

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Assessment

* Treatment providers should include drug testing at intake to assist in a patient's initial assessment and treatment planning.

* Results of a medical and psychosocial assessment should guide the process of choosing the type of drug test and matrix to use for assessment purposes.

* Drug test results should not be used as the sole determinant in assessment for SUD. They should always be combined with patient history, psychosocial assessment, and a physical examination.

* Drug testing may be used to help determine optimal placement in a level of care.

* Drug testing can serve as an objective means of verifying a patient's substance use history.

* Drug testing can demonstrate a discrepancy between a patient's self-report of substance use and the substances detected in testing.

* For a patient presenting with altered mental status, a negative drug test result may support differentiation between intoxication and/or presence of an underlying psychiatric and/or medical condition that should be addressed in treatment planning.

* Drug testing can be helpful if a provider is required to document a patient's current substance use.

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Monitoring

* Drug testing should be used to monitor recent substance use in all addiction treatment settings.

* Drug testing should be only one of several methods of detecting substance use or monitoring treatment; test results should be interpreted in the context of collateral and self-report and other indicators.

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PART 2: PROCESS OF DRUG TESTING IN ADDICTION TREATMENT

Choosing a Test

When choosing a test, providers will make decisions about the following factors:

The information they wish to gain from testing

The substance or substance(s) targeted

Matrix sample collected

The reliability/usefulness of the result

Cost

“Smarter” drug testing means that providers actively address these factors in the process of choosing a drug test, rather than defaulting to perceived organizational or industry norms [2].

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Clinical Necessity and Value

Tests should be chosen based on the information they are expected to reveal. All tests are designed to answer certain questions and all tests have limitations. Providers should first determine the purpose of the test—what question it needs to answer—and choose the test best able to provide that answer.

Test selection should be individualized based on a patient's clinical needs and their self-reported substance use (see Drug testing and self-reported substance use, p. 5). When possible, it is recommended that providers conduct a drug test after obtaining a patient's self-report. Admitted use and knowledge of preferred substances can guide the provider's process of choosing a drug test.

Individualization of testing does not mean that every patient will get a different test, but that he or she can if the circumstances warrant it. The expert panel concluded that the use of a routine test panel is generally acceptable practice. However, this should not block the ability of providers to use alternative matrices and tests, individualized to the patient's needs.

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Identifying Substance(s) of Interest

The substances targeted in a patient's routine drug test should be adjusted based on the patient's drug of choice, prescribed medications, and drugs commonly used in the patient's geographic location and peer group.

It is generally useful for addiction treatment programs/providers to establish a routine panel based on the most commonly used substances in their treatment population with consideration for regional patterns of use.

Substance use trends vary considerably by region. Providers should be aware of which drugs tend to be prevalent in their region and attentive to new substance use trends and emerging drugs (many of them synthetic) that may become available to their patient population for the first time. Note that an important area for future research is when and how to identify novel synthetic drugs, such as cannabinoids and cathinones, for various patient populations.

Because emerging drugs will continue to proliferate, providers will always be playing catch-up when trying to detect substance use. Test panels should be updated regularly to address local substance use trends. A testing laboratory can be a valuable resource regarding information related to changes in substance use at the local level. Medical toxicologists can also provide information on regional variations in drug use or on local trends.

Providers should not rely on a 5-panel screen known as the NIDA-5 (or SAMHSA-5) as a routine drug panel. This panel is intended for workplace drug testing; the substances targeted and their associated cutoff levels are not appropriate for the clinical care of patients with addiction.

Providers should be aware that some drugs share common metabolites. For example, codeine and heroin are both metabolized to morphine. The detection of morphine indicates that an individual has been exposed to one of these opioids, but that result by itself cannot determine if the drug that was consumed was morphine, codeine or heroin. Detecting which opioid requires a test for either a parent drug (eg, heroin) or an analyte specific to that substance (eg, 6-monoacetylmorphine [6-MAM]).

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Matrix Advantages and Disadvantages

Urine, blood, exhaled breath, oral fluid (saliva), sweat, and hair are some biological samples (known as matrices) that are used in drug testing. As defined by ASAM, “smarter” drug testing means using the matrix best able to answer the clinical question at hand. Although urine is the best established matrix in addiction treatment settings, other matrices provide different levels of sensitivity and specificity over different windows of detection. For example, heroin is rapidly converted to 6-MAM and subsequently to morphine. Heroin or 6-MAM must be detected to specifically confirm heroin rather than general opiate use. While 6-MAM remains present at detectable concentrations in oral fluid for longer than urine, the subsequent metabolic products remain detectable in urine for longer than oral fluid.

A main consideration in matrix choice is also its varying susceptibility to sample tampering. Rotating matrices can reduce the potential for tampering with samples. However, providers should understand the advantages and disadvantages of each matrix before considering such strategies.

The use of an alternative matrix is also appropriate if a particular sample type cannot be collected (eg, patients on dialysis, who are bald or have dry mouth or shy bladder) or when a sample collection technique is too invasive (such as direct observed urine testing for a patient with sexual trauma). If a given sample is likely to be prone to confounds, providers should choose an alternative matrix. For example, heavily chemically treated hair is not appropriate for drug testing.

Clinical considerations that pertain to matrices are covered more fully in Part 4: Biological Matrices.

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Presumptive and Definitive Tests

Drug testing can be divided into 2 classes: presumptive and definitive. Presumptive tests generally have lower sensitivity and/or specificity compared to definitive tests.

The primary benefit of presumptive testing methods is a much faster turnaround time to receive results, which allows for a more rapid therapeutic response that can more meaningfully link substance use and behavior. Therefore, presumptive tests should be used when it is a priority to have more immediate (although potentially less accurate) results. If a patient disputes the results of a presumptive test, the test should be confirmed using a definitive method. If a patient confirms that he or she used a substance detected by a presumptive test, it is not necessary to perform a definitive test to confirm the result. Presumptive testing should be a routine part of initial and ongoing assessment of a patient's use of substances.

Definitive testing should be used whenever a patient disputes the findings of a presumptive test, when a provider wants to detect a specific substance not adequately identified by presumptive methods (eg, heroin rather than opiates) or when the results will inform a decision with major clinical or non-clinical implications for the patient (eg, treatment transition, changes in medication therapies, changes in legal status).

If a provider expects the result of a presumptive test to be positive (eg, a patient reports recent use), and information regarding specific substance and/or quantity is desired, it may be appropriate to skip the presumptive test in favor of a definitive test. When ordering a definitive test, providers should advise the testing laboratory of suspected or expected substance(s) in the specimen. Providers should be aware that many laboratories do not automatically perform definitive testing on positive presumptive results (known as “reflex testing”) and may require an additional order for such testing to occur.

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Use of Specific Terms

Presumptive and definitive tests are often referred to using terminology, which actually describe differences in analytical method (eg, immunoassay vs. chromatography/mass-spectrometry), test setting (eg, the point of care or in a laboratory) or underlying purpose (eg, screening or confirmation). While some of these differences may have fallen neatly within the category of presumptive and definitive testing in the past, advances in technology have made these generalizations increasingly inaccurate. Table 1 illustrates a number of terms often used interchangeably to refer to presumptive and definitive tests.

In this document, the terms “presumptive” and “definitive” are used, except when referring to a specific aspect of a test (eg, Point of Care Tests).

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Immunoassay Versus Chromatography/Mass Spectrometry

For the most part, presumptive testing uses immunoassay technology and definitive testing uses a combination of various chromatography and mass spectrometry techniques. However, there are some immunoassays, which can be used as definitive tests (eg, Immunoassays for cocaine metabolites are quite specific).

Immunoassays use antibodies designed to bind with a specific drug (eg, methadone), metabolite (eg, 6-MAM) or class of compounds (eg, opiates, which detects morphine) in a sample. If no drug compounds are present in a sample, the antibodies will instead bind with a conjugate compound and register as a colored line in the test readout area. Immunoassays have varying degrees of sensitivity and specificity depending on the particular antibodies and the cutoff value used. A cutoff value is the amount of substance that needs to be detected in a sample for it to be considered positive. Test results are positive if there is enough drug or metabolite present in a sample to react with a predetermined threshold of antibodies in the assay.

Gas or liquid chromatography combined with mass spectrometry are the gold standard methods of drug testing. Chromatography is used to separate a specimen into its component parts and mass spectrometry to identify those parts. These methods are both highly sensitive and highly specific. This testing is likely to take place in a laboratory and each individual test can be expensive.

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Screening Versus Confirmation

The terms “screening” and “confirmation” refer to the purpose of the test. A common practice in testing is to first screen samples using an inexpensive test to rule out likely negative samples and then confirm potential positive results using a highly specific test. Often, immunoassay methods are used to screen samples and positively screened samples are confirmed using a chromatography/mass-spectrometry method or an immunoassay using a lower cutoff value and/or one targeting specific substances within a class.

When using a cutoff, a negative result does not exclude the presence of a drug or metabolite in a sample, but reflects it was not a sufficient amount to cross the cutoff limit. Screening tests often use cutoffs chosen to minimize the incidence of false positives. This, consequently, increases the incidence of false negatives. Many laboratories and point of care tests (POCTs) use screening cutoff levels calibrated for workplace or law enforcement drug testing. These cutoffs may be set very high to identify individuals which use large amounts of a substance and minimizes false positives from accidental environmental exposure (eg, from second-hand marijuana smoke); therefore, they may not be appropriate for clinical use. Providers should know the cutoff concentration used for immunoassay when interpreting a presumptive or definitive test result of “no drug present.”

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Class or Category Test Versus Specific Substance Test

A drug “screen” can also refer to an immunoassay, which reacts to the presence of a class of drugs. The specific substance is then “confirmed” using a test method, which can identify a specific substance or metabolite. It is often only possible to test for specific substance using chromatography/mass-spectrometry, but immunoassays are also available that are highly targeted and specific to individual substances.

The degree of an immunoassay's specificity depends on the extent to which antibodies will bind specifically with a target compound while excluding structurally related compounds, also known as cross-reactivity. The less specific an immunoassay is for a single substance, the higher the cross-reactivity is for other substances. For example, standard opiate immunoassays target morphine-like molecules and best detect morphine and codeine. They show moderate cross-reactivity with the morphine-derived semi-synthetics hydrocodone and hydromorphone, and poor cross-reactivity with thebaine-derived semi-synthetics oxycodone and oxymorphone. Fentanyl, meperidine, methadone, and buprenorphine have negligible to no cross-reactivity with a standard opiate immunoassay. Semi-synthetic opioids less structurally similar to morphine and fully synthetic opioids are better detected with immunoassays that use different antibodies that are specific to these analytes.

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Qualitative Versus Quantitative

A qualitative test is one that detects the presence or absence of a particular compound in a sample. A quantitative test is one that measures the quantity of a particular compound in a sample. Immunoassays are qualitative tests. Most chromatography/mass-spectrometry techniques are quantitative. Quantitative results are reported as the concentration within a sample. The concentrated amount should be used cautiously when interpreting the dose or timing of substance use because of individual differences in metabolism.

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POCT Versus Laboratory

While definitive testing used to be the performed exclusively in the lab, the line is becoming increasingly blurry due to enhancements in the quality and availability of point of care testing (POCT). Although simple POCTs, such as urine dipstick technologies, are prone to lower accuracy and precision, newer POCT analyzers have significantly greater quality control and rival central laboratory analysis in terms of their sensitivity and specificity. For routine clinical use, POCT (including newer urine dipstick testing) is more efficient and economical and provides reliable results. For high stakes testing (eg, testing that will inform an irreversible clinical decision), formal laboratory analysis remains the “gold standard” testing methodology (Table 2).

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Cost

Providers should always consider cost both to patients and insurers when choosing drug tests. Smarter drug testing means careful consideration of the financial costs of testing in relationship to the value and in many cases, medical necessity, of the test results [2].

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Responding to Test Results

According to the ASAM White Paper, “All physicians (and others) involved in drug testing should determine the questions the test are intended to answer before the testing is administered and should have a plan for what to do with the results” [2]. It is important for providers to attach a meaningful response to test results, both positive and negative, and deliver it as quickly as possible. Although negative and positive test results can provide valuable information about recent substance use, providers should be aware that a positive drug test does not diagnose a SUD and a negative test result does not rule out a SUD (see Clinical Value of Drug Testing, p. 4).

Drug testing should function as a therapeutic tool (see Clinical Use of Drug Testing, p. 5), so a provider's response to test results should not be confrontational. This approach can perpetuate an “us versus them” mentality that reduces the effectiveness of drug testing to support recovery.

Providers may also be compelled to make significant, sometimes irreversible, clinical decisions on the basis of drug test results. For example, a provider may consider whether a patient should be transferred to a higher level of care after multiple positive test results. Providers are encouraged to consider all relevant factors when making a significant clinical decision, rather than drug test results exclusively, keeping in mind that immediate abstinence may not be a realistic goal for patients in the early stages of treatment.

Providers should also be aware that all tests have some rate of false-positive and false-negative outcomes (Table 3). False positives occur when a negative sample is incorrectly labeled as positive. This can occur if the target analyte is present in the sample, but for reasons other than a patient knowingly consuming an addictive substance. Perhaps the most infamous example of false positives of this kind comes from consuming poppy seeds, which produce a detectable amount of morphine in the body. The amount produced, however, results in a much lower body tissue concentration of morphine than that resulting from typical recreational or medicinal opioid use. Samples can also become contaminated through handling collection containers after the use of alcohol-containing hygiene products or hand sanitizers. The use of a detection threshold, or cutoff limit, is meant to reduce false-positive results from unintentional, incidental contact with a substance by effectively decreasing the sensitivity of a test.

Of greater concern are false positives resulting from the misidentification of a similar substance for the target. The list of potential sources of false positives is too extensive to list here, but a few noted examples include; cough suppressants resulting in positive opioid results, ephedrine in cold medicine resulting in positive result for amphetamines, and antidepressants resulting in positive opioid results. Comprehensive reviews of sources of false positives have been published for UDT [18,19], but providers should be aware that new examples of false positives are continuously detected for various tests, and tests are continuously updated and refined to address these limitations. Providers without formal toxicology training can participate in available courses, and/or should collaborate with a medical toxicologist, a toxicologist from the testing laboratory, or a physician certified as an MRO. Providers could consider MRO training and/or certification through organizations including the American Association of MROs and/or the Medical Review Office Certification Council.

False negatives occur when a positive sample is incorrectly labeled as negative. Sometimes this is the result of the use of a cutoff limit. In this case, a negative result does not exclude the presence of a drug or metabolite, but reflects it was not a sufficient amount to cross the cutoff limit.

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Unclear Test Results

When test results are unclear, providers should communicate with the testing laboratory to properly interpret them. It is important that the relationship between an addiction treatment provider and a testing laboratory be collaborative (see Choosing a laboratory, p. 14) to enable proper interpretation of test results. Providers may also consider consulting with a medical toxicologist or MRO for assistance in interpreting unclear test results. Sometimes test results are unclear because of tampering (dilution, substitution, or adulteration). When a provider suspects tampering may have occurred, he or she may have the option to retain the sample for additional testing (including specimen validity testing), use a different matrix, or change/add to the test panel. The original sample should not be discarded; instead, it should be retained to help investigate whether and how tampering occurred. Note that urine is the matrix most prone to sample tampering; see Urine, p. 17, for more detail on avoiding and responding to tampering with urine samples.

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Presumptive Test Results

There are 2 possible outcomes to a presumptive test: positive and negative.

Positive presumptive test results should be referred to as “presumptive positive” results until confirmed by a definitive test, although it is not always necessary to perform a definitive test on a presumptive positive sample (see Presumptive and definitive tests, p. 12). An appropriate response to a presumptive positive test result includes speaking with the patient, discussing possible cross-reactivity related to medications or food, and ordering a definitive test if the patient's self-report is not consistent with the presumptive test result. Providers may also want to consult with their testing laboratory for assistance interpreting the presumptive positive result.

Presumptive tests are often called “qualitative tests” because they are designed to measure the presence or absence of the target drug/analyte, rather than the amount. Because presumptive tests use cutoff values and are designed to have high sensitivity and lower specificity, providers should use caution when interpreting and responding to presumptive test results.

Particularly in the case of presumptive tests, providers should remember that a negative test result does not rule out substance use (which could have occurred outside the window of detection, below the cutoff value or been excluded from the test panel) or SUD (which is a clinical diagnosis). If presumptive test results are negative, but the patient exhibits signs of use (eg, through signs of intoxication or withdrawal), it is appropriate to confirm using a definitive test with greater sensitivity. Providers may also want to expand the drug panel to include previously untargeted substances.

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Definitive Test Results

The results of a definitive test can be taken as conclusive. In the event of a positive definitive test, providers should consider adjusting the patient's treatment plan. The patient may benefit from intensified treatment or the addition of an adjunctive treatment element.

Even if the result of a definitive test is quantitative, providers should use caution when using test results to draw conclusions about the amount or pattern of a patient's substance use. There are some tests and methods that are better at correlating the quantity of drug measured in a sample with amount used. For example, a blood or breath test for ethanol or hair test for the metabolite ethyl glucuronide (EtG) can indicate point-in-time or average-over-time alcohol use. The concentration of ethanol or EtG in urine, however, is dependent on additional factors such as hydration and metabolic health (see Comparing Matrices, p. 35). For questions about interpreting a positive test result, providers should consult with their testing laboratory.

In the event of a negative definitive test, providers should be mindful of the limitations of drug testing (see Clinical Value of Drug Testing, p. 4) and not over-interpret its significance. A patient whose definitive test results are negative may still have engaged in substance use (outside of the window of detection of the test) or have an SUD (which is a clinical diagnosis).

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Test Scheduling

Test schedule is an area of interest for providers and payers. There is very little guidance about clinically appropriate test schedules, which has led to both an over-and under-utilization of drug testing, and generally, an approach to test scheduling that does not meet the standards of “smarter” testing.

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Test Frequency

For patients in addiction treatment, frequency of testing should be dictated by patient acuity and level of care. For recommendations related to specific level of care, see Part 5: Settings.

There is no magic formula for determining the test frequency a patient should receive. The expert panel strongly disagreed with statements about specific numerical limitations on drug test frequency. For example, the panel agreed that the following statement is inappropriate: “Drug testing should be scheduled no more than 24 times per year.”

In accordance with the principle of “smarter” drug testing, the provider's therapeutic questions should dictate the frequency of drug testing. In formulating questions, providers should be aware that there is currently insufficient evidence that more frequent testing leads to decreased substance use. Based on these questions, providers should look to the tests’ detection capabilities and windows of detection to help determine the frequency of testing. (See Appendix 4: Windows of Detection Table for a chart describing matrices and windows of detection for various target analysis.)

As a general principle, drug testing should be scheduled more frequently at the beginning of treatment. The Expert Panel recommends that a patient in early recovery be tested at least weekly. As the patient becomes more stable in recovery, the frequency of drug testing should be decreased, but performed at least on a monthly basis. Individual consideration may be given for less frequent testing if a patient is in stable recovery.

If the patient returns to substance use after a period of abstinence, the provider should resume the early recovery testing schedule, possibly in conjunction with an adapted or intensified treatment plan.

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Random Testing

Whatever the frequency, clinical consensus favors unannounced drug testing over scheduled drug testing and random testing schedules to fixed testing schedules [2,13,20]. A fixed schedule (eg, every Monday) offers patients increased opportunity to engage in sample tampering. Even if the frequency is within a test's normal window of detection (eg, a urine immunoassay screen for amphetamines every Monday and Thursday) it is possible for a patient to engage in substance use on Thursday night and not produce a positive result on Monday morning. Although not always possible to implement, a random testing schedule can eliminate such strategic workarounds by making patients unaware of when exactly they will be tested.

Providers should note that the way randomization is applied to scheduling in a clinical setting can make it more or less effective. The purest form of randomization is to have a set probability (eg, 15%) that a patient could be tested on any given day. This is akin to rolling a die every day and testing whenever a 6 appears. While this eliminates known safe periods, the length of time a patient may go between testing can be quite long.

To avoid unknown testing intervals, many addiction treatment providers randomly select a day from a fixed interval [21]. Once the day is selected, however, no testing will occur until the start of the next interval, leaving the problem of known non-testing periods if the selected day occurs early within the interval (eg, Monday from a weekly interval). Instead, providers can randomly select the interval from a set of allowable days between testing (eg, 2, 3, … 6, 7 days). This limits both the maximum interval between tests and known non-testing periods.

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Summary of Recommendations

Choosing a Test

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Clinical Necessity and Value

* Before choosing the type of test and matrix, providers should determine the questions they are seeking to answer and familiarize themselves with the benefits and limitations of each test and matrix.

* Test selections should be individualized based on specific patients and clinical scenarios.

* Patients’ self-reported substance use can help guide test selection.

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Identifying Substance(s) of Interest

* Drug-testing panels should be based on the patient's drug of choice, prescribed medications, and drugs commonly used in the patient's geographic location and peer group.

* Addiction treatment programs/providers should establish a routine immunoassay panel.

* Providers should not rely on the NIDA 5 (also known as the SAMHSA 5) as a routine drug panel.

* Test panels should be regularly updated based on changes in local and national substance use trends. Providers should collaborate with the testing laboratory when determining the preferred test selections to obtain information about local and demographic trends in substance use.

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Matrix Advantages and Disadvantages

* Providers should understand the advantages and disadvantages of each matrix before considering rotational strategies.

* If a particular specimen cannot be collected (eg, due to baldness, dry mouth, shy bladder), providers should consider collecting an alternative specimen.

* If a given sample is likely to be prone to confounds, providers should choose an alternative matrix. For example, heavily chemically treated hair is not appropriate for drug testing.

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Presumptive and Definitive Tests

* Presumptive testing should be a routine part of initial and ongoing patient assessment.

* Presumptive testing should be used when it is a priority to have more immediate (although less accurate) results.

* Providers should know the cutoff threshold concentrations that their laboratory uses when interpreting a report of “no drug present.”

* Federal cutoff threshold concentrations used for occupational testing are not appropriate for clinical use.

* Definitive testing techniques should be used whenever a provider wants to detect specific substances not identified by presumptive methods, quantify levels of the substance present, and refine the accuracy of the results.

* Definitive testing should be used when the results inform clinical decisions with major clinical or non-clinical implications for the patient (eg, treatment transition, changes in medication therapies, changes in legal status).

* If a patient disputes the findings of a presumptive test, a definitive test should be done.

* When ordering a definitive test, providers should advise the testing laboratory if the presence of any particular substance or group of substances is suspected or expected.

* Because not all laboratories automatically perform a definitive test of positive presumptive results (the common term for this is “reflex” testing), providers should be aware that laboratories may require a specific order for definitive testing.

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Cost

* Providers should always consider cost both to patients and insurers when utilizing drug testing.

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Responding to Test Results

* Providers should attach a meaningful therapeutic response to test results, both positive and negative, and deliver it to patients as quickly as possible.

* Providers should not take a confrontational approach to discussing positive test results with patients.

* Providers should be aware that immediate abstinence may not be a realistic goal for patients early in treatment.

* When making patient care decisions, providers should consider all relevant factors surrounding a case rather than make a decision based solely on the results of a drug test. Considering all relevant factors is particularly important when using drug test results to help make irreversible patient care decisions.

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Unclear Test Results

* Providers should contact the testing laboratory if they have any questions about interpreting a test result or to request information about the laboratory procedures that were used.

* Providers may consult with a medical toxicologist or a certified MRO for assistance in interpreting drug test results.

* If the provider suspects the test results are inaccurate, he or she should consider repeating the test, changing the test method, changing/adding to the test panel, adding specimen validity testing, or using a different matrix.

* If tampering is suspected, samples should not be discarded. Rather, further testing should be performed to help identify whether and how tampering occurred.

* Providers should consider samples that have been tampered with to be presumptive positive.

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Presumptive Test Results

* Positive presumptive test results should be viewed as “presumptive positive” results until confirmed by an independent chemical technique such as gas chromatography mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS).

* An appropriate response to positive presumptive test results includes speaking with the patient.∘Providers should seek definitive testing if the patient denies substance use.∘Providers should review all medications, herbal products, foods, and other potential causes of positive results with the patient.

* An appropriate response to positive presumptive test results may include speaking with the laboratory for assistance in interpreting the test results.

* Because presumptive tests may use cutoff values, a negative presumptive test result should not be over-interpreted. It does not rule out substance use or SUD, as the latter is a clinical diagnosis.

* It is appropriate to consider ordering a definitive test if presumptive test results are negative, but the patient exhibits signs of relapse.

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Definitive Test Results

* In the event of a positive definitive test result, consider intensifying treatment or adding adjunctive treatments.

* An appropriate response to positive definitive test results may include speaking with the laboratory for assistance in interpretation.

* Providers should use caution when using drug test results to interpret a patient's amount or frequency of substance use. Individual metabolism and variability in absorption should be considered.

* Providers should not over-interpret a negative definitive test result. It does not rule out substance use or SUD, as the latter is a clinical diagnosis.

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Test Scheduling

Test Frequency

* For people in addiction treatment, frequency of testing should be dictated by patient acuity and level of care.

* Providers should look to tests’ detection capabilities and windows of detection to determine the frequency of testing.

* Providers should understand that increasing the frequency of testing increases the likelihood of detection of substance use, but there is insufficient evidence that increasing the frequency of drug testing has an effect on substance use itself.

* Drug testing should be scheduled more frequently at the beginning of treatment; test frequency should be decreased as recovery progresses.

* During the initial phase of treatment, drug testing should be done at least weekly. When possible, testing should occur on a random schedule.

* When a patient is stable in treatment, drug testing should be done at least monthly. Individual consideration may be given for less frequent testing if a patient is in stable recovery. When possible, testing should occur on a random schedule.

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Random Testing

* Random unannounced drug tests are preferred to scheduled drug tests.

* A random-interval schedule is preferable to a fixed-interval schedule because it eliminates known non-testing periods (eg, if Monday is randomly selected from a week interval, the patient knows they will not be tested Tuesday-Saturday) and it is preferable to a truly random schedule because it limits the maximum number of days between tests.

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PART 3: ADDITIONAL CONSIDERATIONS FOR DRUG TESTING IN ADDICTION TREATMENT

Documentation and Confidentiality

Addiction treatment providers and programs should have testing procedures in writing and share these with patients. One way to do this is to incorporate information about drug testing into patients’ treatment agreements. Providers should also carefully document drug-testing procedures and rationale for individual patients. Documentation should include:

Rationale for drug test types

Rationale for drug-testing decisions

Potential sources of cross-reactivity, including various foods and current medications

Particular characteristics of the sample with potential to lead to problems with interpretation (eg, hair that has been chemically treated)

Test results

Sometimes providers are asked to share test results with outside entities, such as social services agencies or the criminal justice system. The expert panel suggests that providers keep test results confidential to the extent permitted by law and use caution when sharing test results with outside entities. Providers should ensure that the patient has given informed consent for sharing test results; however, even when patients have authorized the release of test results, providers should be mindful that the aims and methods of employment-related drug testing and forensic drug testing are different from the aims and methods of clinical drug testing. Optimally, test results should be confirmed with a definitive test, although it may be appropriate to share presumptive results when they are negative. When sharing presumptive test results, ensure that they are clearly labeled “presumptive.” Providers are responsible for providing patient education about confidentiality, consent, and sharing test results with outside entities.

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Practitioner Education and Expertise

Knowledge and Proficiency

The accuracy of any drug test is predicated on the use of valid testing procedures, which include sample collection, analysis, and interpretation of results. Inadequate provider proficiency can result in inaccurate test results. The outcomes of a drug test can have serious consequences for patients; therefore, providers have a responsibility to ensure that they and their staff have the knowledge and proficiency necessary to carry out their roles in the drug-testing protocol.

A provider's necessary level of knowledge and proficiency about drug testing depends on his or her role in the testing process. Providers who order tests should primarily be aware of the limitations of testing, common sources of false-positive and false-negative results, and tradeoffs between testing methods. They should:

Be familiar with the limitations of presumptive testing

Be familiar with the potential for cross-reactivity in drug testing (see Responding to Test Results, p. 10)

Be familiar with the potential for sample tampering to obscure test results (see Urine sample integrity, p. 17)

Understand the benefits of alternative matrices to urine (eg, oral fluid, hair, etc)

Be aware of the costs of different test methods

Interpretation of drug test results is usually not extensively covered in medical school. Individuals who interpret test results should have some knowledge of toxicology and other issues related to proper interpretation. Providers without formal toxicology training can participate in available courses, and/or should collaborate with a medical toxicologist, a toxicologist from their laboratory, or a physician certified as a MRO. Providers could consider MRO training and/or certification through organizations including the American Association of MROs and/or the Medical Review Office Certification Council.

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Language and Attitude

Successfully sending the message that drug testing is a therapeutic tool rather than a punitive measure will depend on providers and programs using therapeutic language and a proactive attitude towards testing and test results. Providers should use neutral terminology that does not further stigmatize addiction and its symptoms. Test results should be referred to using the terms “positive” or “negative” as opposed to “clean” or “dirty.” These terms are consistent with a growing body of research literature and clinical guidance about non-stigmatizing language [22,23].

Furthermore, staff attitudes toward drug testing and drug test results should remain consistent throughout the organization. If some members of the treatment team convey the message that drug testing is an important part of proactively addressing continued symptomatology while other members are dismissive, patients will benefit less from drug testing as a therapeutic tool.

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Test Facilities and Devices

Addiction treatment providers can choose to conduct their own testing on-site, send samples to a qualified laboratory, or both. These choices involve tradeoffs in quality, turnaround time for results, availability of test technology, and cost.

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Point of Care Tests

Some addiction treatment providers perform on-site drug testing using Point of Care Tests (POCTs). There are advantages and disadvantages to POCTs. The most significant advantage of POCTs is the short turnaround time for results, which can be available within minutes. This allows providers to respond to a patient's use of substances quickly and meaningfully (see Responding to Test Results, p. 10).

However, it is important to recognize that many POCTs use immunoassay technology, which (varying by the substances being detected and the matrix being used), can have drawbacks. POCTs may be vulnerable to cross-reactivity, detect classes of drugs rather than specific drugs, and require confirmation by a definitive test. Another major disadvantage of POCTs is that despite internal quality control measures, improper sample handling can result in inaccurate results. It has been said that “the single most important quality issue surrounding POCT devices is the initial and ongoing training of the individual(s) performing the testing to maintain competency” [24].

Ongoing staff training and quality control are essential. Individuals who collect, store, and interpret POCTs should be educated about the devices’ sensitivity, the spectrum of analytes detected, the potential for cross-reactivity, cutoff values, and the nomenclature of the device being used. Users of POCTs should refer to the POC package insert or the manufacturer to determine the device's capabilities.

To ensure POCTs are being used effectively, providers should conduct individual- and organization-level evaluations of staff proficiency by comparing POCT results to the results of a qualified laboratory. POC testing can be implemented comprehensively or on a more limited basis. For example, one provider may use POCTs to conduct all presumptive testing while another uses POCTs only to confirm self-reported substance use that could be detected by the test's panel. Depending on the extent of POCT use, cost should be a consideration when deciding whether to use a POCT protocol. There are costs associated with the extra staff time and space as well as the equipment and supplies necessary to perform the test, staff training, quality assurance procedures, and documentation of POC testing.

Office based testing is most practically done utilizing Clinical Laboratory Improvement Amendments (CLIA)-waived tests. CLIA-waived tests are POCTs defined by the FDA as “simple” and having an “insignificant risk for an erroneous result.” More information from the FDA can be found on the website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm. Additional resources, including online training and recommendations for the use of CLIA-waived tests can be found on the CMS website: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/waivetbl.pdf. When considering a CLIA waiver, providers should keep in mind that some states have regulations that differ from the federal guidelines pertaining to waivers to perform this type of POCT procedure.

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Choosing a Laboratory

Regardless of whether a provider uses POCTs, the selection of an appropriate laboratory is an important component of an effective drug-testing protocol. It is important to choose carefully. Providers should contact the director or a medical toxicologist at the prospective laboratory directly to discuss panels, types of drug tests, testing procedures, and technical assistance. Some laboratories are geared toward workplace testing; this is not ideal for an addiction treatment setting. It is more appropriate to work with a laboratory that has experience working with addiction treatment settings. Also look for a laboratory that allows providers to order specific tests for each patient because drug testing in addiction treatment should be individualized.

The ability to consult with laboratory staff when needed is an important consideration in choosing a laboratory. The relationship between the testing laboratory and the addiction treatment center should be collaborative. Providers should be able to communicate with the testing laboratory about test panels, detecting sample tampering, test result interpretation, and regional drug use trends.

Certification requirements should be reviewed. Laboratories that perform forensic drug testing for federal agencies and federally regulated industries are required to maintain a national certification overseen by the Department of Health and Human Services (HHS). Typically, it is not necessary for a laboratory working with an addiction treatment provider to have an HHS certification. However, it is important to confirm that the laboratory follows established federal and state regulations. The CLIA of 1967 and of 1988 set forth conditions that all laboratories must meet to be certified to perform testing on biological specimens. Additionally, state clinical laboratory programs operate under individual state laws; these state programs are usually authorized through the Centers for Medicare & Medicaid Services. Providers should investigate whether state law requires a specific certification for a testing laboratory working with an addiction treatment provider. A list of state CLIA contacts is available on the Centers for Medicare and Medicaid Services website (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA).

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Summary of Recommendations

Documentation and Confidentiality

* Addiction treatment programs should provide written drug-testing procedures to patients. Procedures should be reviewed with the patient at the start of his or her treatment.

* Providers should document the rationale for the drug tests they order and the clinical decisions that are based upon drug test results.

* Providers should ask patients about and document potential sources of cross-reactivity, including various foods and current medications.

* Particular characteristics of a sample with the potential to lead to problems with interpretation (eg, hair that has been chemically treated) should be documented at the time of collection.

* Test results should be documented.

* Test results should be kept confidential to the extent permitted by law. Providers should thoroughly explain to patients all rules regarding confidentiality, consent, and sharing test results with outside entities.

* In general, providers should use caution when sharing test results with outside entities such as justice settings or employers. When sharing test results with outside entities, it is optimal that positive results be verified with a definitive test.

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Practitioner Education and Expertise

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Knowledge and Proficiency

* Providers responsible for ordering tests should be familiar with the limitations of presumptive and definitive testing.

* Providers responsible for ordering tests should be familiar with the potential for cross-reactivity in drug testing.

* Providers responsible for ordering tests should consider the possible impact of tampering on test results. Providers should note that tampering is more likely in settings where consequences for substance use are severe, such as discharge from treatment.

* Providers responsible for ordering tests should understand the potential benefits of alternative matrices to urine (eg, oral fluid, hair, etc).

* Providers responsible for ordering tests should be aware of the costs of different test methods.

* If the provider responsible for making clinical decisions based on test results does not have training in toxicology, he or she should collaborate with a medical toxicologist, a toxicologist from the testing laboratory, or an individual with MRO certification, as needed.

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Language and Attitude

* Providers should communicate with patients about drug testing using non-stigmatizing language. For example, results should be discussed as “positive” or “negative” as opposed to “clean” or “dirty.”

* Providers should exhibit a consistent and positive attitude toward drug testing. Ambivalent attitudes toward drug testing among staff can be a barrier to its effective use.

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Test Facilities and Devices

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Point of Care Tests

* Staff training and demonstrated proficiency is particularly important for organizations that use point of care tests (POCTs).

* Providers performing POCTs should be evaluated for their proficiency. POCTs should be performed only by providers who demonstrate adequate proficiency with the drug test in question. Facilities using POCTs should periodically evaluate the accuracy of their system in comparison to a qualified laboratory.

* Users of POCT devices need to be educated about the tests.∘They need to understand the statistical and analytical sensitivity of the device.∘They need to understand the spectrum of analytes (drugs and metabolites) detected by the device.∘They need to understand any known interferences from drugs or metabolites that could affect interpretation of results.∘They need to understand the nomenclature of the device.

* Users of POCTs should refer to the POC package insert and/or the manufacturer to determine the device's capabilities.

* Cost issues should be considered when deciding to initiate a POCT protocol. These include costs associated with additional staff time and training, space to perform testing, quality assurance procedures, and documentation of POCT results.

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Choosing a Laboratory

* Providers should seek to work with a laboratory that has expertise in drug testing in addiction treatment settings.

* When selecting a laboratory, providers should investigate whether state law requires a specific certification.

* It is important to work with a laboratory qualified to perform accurate tests and assist in the interpretation of results.

* Providers should work to create a collaborative relationship with the laboratory; important areas for collaboration are test panel selection, detecting sample tampering, interpreting test results, and regional drug use trends.

* When selecting a laboratory, providers should contact the toxicology director or a medical toxicologist at the laboratory to discuss panels, types of drug tests, testing procedures, and technical assistance.

* Because drug testing should be individualized, laboratories should allow providers to order specific tests for each patient.

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PART 4: BIOLOGICAL MATRICES

Comparing Matrices

Urine, blood, exhaled breath, oral fluid (saliva), sweat and hair are some biological samples that are used in drug testing. Smarter testing involves choosing the matrix best capable of detecting the substance of interest within the desired window of detection, and this often involves making tradeoffs in terms of test capabilities. See Table 4 for information about relative advantages and disadvantages of available matrices. Appendix 4: Windows of Detection Table contains detection windows for specific parent drugs and metabolites in urine, blood and oral fluid.

Biological drug testing detects the presence or absence of parent drug compounds and/or their metabolites, which remain in the body for longer periods of time, in a biological sample. Drugs and their metabolites become present in the body primarily by being absorbed into the bloodstream and then distributed to other matrices via mechanisms such as passive diffusion and ultrafiltration. Specific mechanisms will be discussed in the section for each matrix addressed in this document.

The physiological distribution of drugs implies a varying relationship between the concentration a drug or metabolite has in different matrices depending on properties such as lipid solubility, acid dissociation (pKa) and protein binding tendency. For example, drugs that are more acidic (eg, benzodiazepines) will have higher concentrations in fluids with higher pH (eg, plasma/blood) while more basic drugs (eg, amphetamines and opiates) will have higher concentrations in fluids with lower pH (eg, saliva/oral fluid).

The relationship between concentration and matrix depends on (a) the pharmacokinetic profile of the drug; (b) the consumer's underlying health functioning; and (c) the pattern, dose and route of drug administration. These factors influence the absorption, distribution, and elimination of the drug and ultimately determine their window of detection. For example, tetrahydrocannabinol (THC), the primary compound in cannabis, is highly lipid soluble and binds to fat cells in the body. A person who uses cannabis once may only test positive for 24 hours, while a person who has used chronically may test positive for a month or longer after cessation as stored THC continues to be eliminated from the body [31] (Table 5).

In general, the longest windows of detection occur in hair, followed by sweat, urine, oral fluid and blood [29]. But maximum detection time is not the only important criteria for choosing a test. Other factors to consider include:

Time to detection

Time to obtain results (availability of POCT)

Ease of collection (need for trained personnel, collection facilities)

Invasiveness/unpleasantness of collection

Availability of the sample (eg, renal health, shy bladder, baldness, dry mouth)

Susceptibility of the sample to tampering

The accuracy of any drug test is predicated on obtaining a valid specimen. The nature of addiction may lead some patients to try to mask continued substance use or relapse. The pressure to do so may depend on the severity of the consequences they will face if detected, such as increased sanctions, or legal action (see Drug testing and self-reported substance use, p. 5).

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Urine

Basics of Urine Drug Testing

As the kidneys filter the bloodstream, waste and other by-products including metabolites are extracted and eliminated along with water from the body as urine. It takes approximately 2 hours after use for a substance to be detected in urine, a longer time to detection than for other bodily fluids such as saliva and breath [32]. The window of detection for most substances of interest is 1–3 days and up to 4 days in some cases and is dependent on factors such as fluid intake and urinary pH. The concentration of a drug or its metabolites in urine represents the amount, which has accumulated in the bladder since the last void.

See Table 4 for more information about the advantages and disadvantages of UDT in comparison to alternative matrices.

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Use of Urine Drug Testing in Addiction Treatment

At this time, urine is the most well-established and well-supported biological matrix for presumptive detection of substance use in addiction treatment settings. Urine is the most commonly used biological specimen for drug and alcohol testing in clinical settings [33]. Urine is also the best established matrix in POC testing. UDT represents a mature technology; because of its popularity, the drug-testing industry has focused development on producing more rapid and less expensive technologies for testing urine. This means there are many testing options available, generally at lower cost compared to other matrices.

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Disadvantages of Urine Drug Testing

There are 2 major drawbacks to UDT: (1) the ease of sample tampering through substitution, dilution, and adulteration, and (2) the invasiveness and resource intensity of witnessed sample collection, the primary means of countering sample tampering.

If appropriate measures to reduce urine sample tampering are not able to be taken and tampering is of high concern, providers should consider testing an alternative specimen. The use of alternative matrices to complement UDT could take place in a number of ways, including on a clinic-wide basis by rotating the collection of specimen types (see Matrix advantages and disadvantages, p. 7) or on an individual collection-by-collection basis.

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Urine Sample Integrity

Urine is the specimen most prone to sample tampering. UDT can be circumvented through sample substitution, dilution and adulteration by ingesting something prior to a test (in vivo) or adding something to a sample (ex vivo) with the purpose of obscuring the test results. A substituted sample is one that replaces the patient's urine with another sample, either urine or some other liquid. Diluting a urine sample makes it less likely that a drug or its metabolite(s) can be detected above the cutoff threshold of an immunoassay test. Adulteration involves the use of a masking agent that destroys the presence of drugs in urine or interferes with the enzymatic reactivity of an immunoassay test.

There are measures that can be taken to mitigate the risk of urine sample tampering and ensure sample integrity, described in the following sections. Providers should choose a urine sample collection method that will protect patients’ dignity and privacy while minimizing opportunities for tampering. Each clinic should have clear specimen tampering and diversion control strategies in place and these should be discussed with patients. In order for sample tampering policies to have their intended effect, providers should be trained appropriately in these measures.

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Observed Urine Sample Collection

The primary method used to prevent urine sample tampering is direct observation of urination by a staff member of the same gender during collection. Observation prevents several common ex vivo methods of substitution, dilution and adulteration at the time of collection. For example, substitution generally requires a patient to carry the replacement sample in a container with them to the bathroom. A patient can dilute a sample by adding liquids such as water or colored fluids (apple juice, lemonade) to the sample container. Adulterants that are added to a sample container include many household chemicals. The most commonly used chemicals include table salt (sodium chloride), vinegar, Drano, dish soap, hand soap, liquid laundry bleach, denture cleansing tablets, lemon juice, ascorbic acid, hydrogen peroxide, and rubbing alcohol (isopropyl alcohol) [34].

If there are concerns about urine sample tampering, or if a provider suspects sample tampering has occurred, sample collection should be observed. (See Signs of urine sample tampering for a discussion of what constitutes reasonable concern or suspicion regarding tampering). If collection was previously unobserved, this change should be explained to the patient and described as being undertaken in their best interest. This may provide an opportunity for therapeutic discussion about the patient's health and well-being, which underlie the decision to change collection procedure.

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Limitations of Observed Urine Sample Collection

There are a few problems with singular reliance on observed sample collection as a tampering mitigation strategy. First, observed urine collection does not completely prevent sample tampering. Supervised collection addresses ex vivo, but not in vivo methods of sample tampering. For example, urine can be made dilute by rapidly consuming large amounts of fluid approximately 1 to 2 hours prior to the test (water loading) or taking diuretics. Adulterants taken prior to providing a sample include oxidizing agents such as nitrites or agents, which affect urine pH such as soda crackers.

Routine observed collection may not be feasible, even when tampering is suspected, due to staffing issues. Same-sex staff might not be available to supervise patients or a patient/staff member's gender identity may not fit into the traditional male/female dyad, which can complicate the issue of same-sex observation. Direct observation of urination is potentially embarrassing and uncomfortable for both the patient and person supervising collection. Staff may avoid very close observation and miss the use of commercially available sample substitution devices.

Direct observation of urination can be seen by patients as a perceived violation of trust and respect and patients frequently indicate they would prefer an alternative specimen be collected if available [35]. Consider the use of unobtrusive sample collection method for patients with a history of psychological trauma, particularly sexual trauma. Observed urination may be distressing for these patients.

Given these limitations, providers should utilize other strategies—either in addition to or instead of—observed collection to mitigate urine sample tampering.

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Unobserved Urine Sample Collection

Having a well set up bathroom collection area can remove some opportunities for sample tampering during unobserved collection. Although all of the following may not be possible in all facilities, providers should employ appropriate measures to decrease the likelihood of urine sample tampering during unobserved collection. Do not allow patients to carry personal items with them into the collection area. Ensure that potential adulterants, such as soap, ammonia, or bleach are not readily available in the collection area. Place blue dye in the toilet and turn off the water source to the collection area during collection. Provide an alternative hand cleansing option to patients as they exit the bathroom.

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Specimen Validity Testing

Urine sample integrity can be verified through specimen validity testing. Specimen validity testing indicates that a sample has been tampered with by detecting the presence of adulterants or the absence of biological indicators of normal human urine. Specimen validity testing can detect both in vitro and in vivo methods of tampering. However, not all adulterants can be detected in standard adulterant test, including Visine eye drops and newer adulterants such as Urine Luck, UrinAid, Klear, and Whizzies [34].

Definitive testing should always include specimen validity testing which measures creatinine concentration, pH level and specific gravity. At the presumptive testing stage, not all samples need to be tested for specimen validity. However, some POCT devices include specimen validity tests for specific gravity and pH.

If a sample is suspected of having been tampered with then it should be tested for specimen validity, including creatinine concentration, pH level, specific gravity and adulterants. (See Signs of urine sample tampering, p. 18 for a discussion of what constitutes reasonable concern or suspicion regarding tampering.)

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Signs of Urine Sample Tampering

There are differing opinions on what criteria best indicate that urine sample tampering may have occurred. SAMHSA's guidelines for urine sample verification in federal workplace testing programs are a useful reference point [20]. With regard to sample integrity, most of the SAMHSA guidelines are considered appropriate in the addiction treatment context with the exception of universal presumptive specimen validity testing. This would be difficult to undertake given the cost and currently available technology.

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Unusual Specimen Characteristics

All urine samples should be inspected for unusual characteristics that indicate that tampering may have occurred. Characteristics include:

Unexpected temperature

Unusual color

Unusual smell

Soapy appearance, cloudiness or particles floating in the liquid

A recently provided sample should be within expected body temperature range, approximately 90 to 100 degrees within 4 minutes of production. This can be evaluated using a heat sensitive strip on the outside of a collection cup. A sample that is too cold suggests that a substitute sample or cold liquid was added to the sample. A sample that is too hot suggests that a chemical heat pack like a hand warmer was used to try to mask the addition of a cold liquid.

A visual inspection can indicate that a sample may be dilute or adulterated. Dilute urine is lighter in color than normal urine, which ranges from light/pale yellow to dark/deep amber. Nitrites also tend to make the color of urine dark. Urine that has been diluted with liquids such as vinegar, ascorbic acid and rubbing alcohol can sometimes be detected by their distinct smell. Table salt (sodium chloride) and denture tablets may be visible as undissolved granules. Dish and hand soap will give the sample a soapy appearance.

If the sample exhibits unusual specimen characteristics, perform specimen validity testing. Sample inspection should not be relied upon solely as evidence of sample tampering, but as an indication of the need for further testing [36,37]. Abnormal urine appearance can also be the result of a urinary tract infection, kidney stones, yeast infection, diet (eg, beets, asparagus) and the use of over-the-counter vitamins and medications (eg, ex-lax, Vitamin B) [38].

Requiring a minimum volume sample can help to increase the reliability of temperature readings and visual inspection as well as ensure there will be enough specimen available for testing.

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Unusual Behavior

The expert panel advised broad use of clinical judgment in identifying behavioral signs that a patient may have tampered with a urine sample.

If a patient's behavior suggests that he or she has recently used an illicit substance, but continues to produce negative urine test results, sample collection should be observed and specimen validity testing conducted. A patient may also continue to produce negative urine test results for reasons that are related to the testing procedure including the use of a substance not targeted in the test or is using an amount below the threshold of detection for the cutoff used by the test. The provider could adjust the test panel or order a more sensitive test (see Choosing a Test, p. 7) (Table 6).

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Responding to Specimen Validity Test Results

Samples are considered substituted or invalid if they fail some aspect of specimen validity testing. It is appropriate for practitioners to consider samples that have been tampered with to be presumptive positive. Providers should respond as they would to a presumptive positive drug test result and rapidly involve the patient in therapeutic discussion (see Responding to Test Results, p. 10).

If a specimen is invalid, most labs will stop the testing process on the assumption that the concentration of a drug or metabolite as measured in the sample will be uninterpretable. In the case of dilute urine, however, the creatinine concentration of the sample can be used to normalize drug concentrations.

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Dilute Urine Samples

Dilution is the most common cause of an invalid sample. A combination of low creatinine (below 20 mg/dL) and specific gravity is used to indicate that a sample is dilute. Expert panel members commented that dilution is usually the result of deliberate water loading. Practitioners can employ a number of solutions to decrease the likelihood of collecting a dilute sample. For patients with a history of dilute urine samples, providers should:

Advise the patient to decrease water intake prior to sample collection

Collect samples first thing in the morning

Collect samples before work or on days off (if a patient's occupation involves the need to hydrate heavily)

Consider the use of an alternative matrix

There are some health conditions, primarily kidney ailments and diabetes, which can lead to unusually high or low specific gravity and low creatinine levels [40]. However, a dilute urine sample resulting from an underlying health condition, such as Diabetes Insipidus, is very rare. Providers should first advise patients with a dilute sample about apparent tampering and evaluate for an underlying etiology only if the trend continues.

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Urine Testing for Specific Substances

Urine is the most well-established and well-supported biologic matrix when conducting drug testing for patients with addiction, but its utility depends on the substance of interest and the information the provider needs. Providers should consider the questions they are seeking to answer when conducting a urine test for a substance of interest and be aware of known detection issues. For example, THC is detectable in urine, but it is difficult to distinguish when the substance was used. See Appendix 4: Windows of Detection Table for window of detection for specific substances in urine as compared to oral fluid and blood.

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Alcohol

Alcohol use can be detected through the direct measurement of ethyl alcohol (EtOH) or one of its metabolites. EtOH has a very short detection window of approximately 10–12 hours and varies considerably by consumption pattern, hydration level and individual metabolism. If providers are interested in detecting such recent alcohol consumption, a breath test may be more convenient than urine EtOH.

Instead of EtOH, providers are encouraged to use tests of ethyl metabolites, which are detectable in urine for longer periods of time. The expert panel primarily encouraged the use of direct alcohol metabolites EtG and/or ethyl sulfate (EtS), detectable in urine for up to 1 to 2 days and widely available in testing. The expert panel also briefly reviewed the use of phosphatidyl ethanol (PEth) and found its extended window of detection to have promising clinical applications; however, most panel members expressed that they were not yet familiar with this technology and it is not yet widely available. No existing recommendations were found regarding testing of fatty acid ethyl ester (FAEE) in urine. FAEEs are formed by the reaction of ethanol with free fatty acids and their amount does not correlated with the amount of alcohol consumed [41]. EtG, EtS, PEth, and FAEEs are considered direct biomarkers of alcohol use because there are present only when alcohol has been consumed. Indirect markers including carbohydrate-deficient transferrin and gamma glutamyl transferase are used primarily to evaluate chronic excessive alcohol consumption, rather than the clinical determination of recent alcohol consumption, and were not reviewed by the panel.

Although rare, it is possible for exposure to ethanol-containing products such as hand sanitizer to result in a positive EtG or EtS test [42]. Patients should be advised to avoid the use of ethanol-containing products before an EtG or EtS test.

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Amphetamines

Urine testing is helpful when assessing a patient's amphetamine use. However, there are known limitations to urine immunoassays for amphetamines and providers should be cautious when interpreting their results. Standard amphetamine immunoassays target amphetamine, which is also a direct metabolite of methamphetamine. Amphetamine immunoassays are also subject to many false-positives compared to other drug class assays. For example, Adderall and Benzedrine contain amphetamine, Vicks Inhalers contain methamphetamine, and Bupropion is known to result in positive methylenedioxymethamphetamine (MDMA) test results. Providers should know the sensitivity and specificity of the test being used for each of the amphetamine variants. The testing laboratory will have this information.

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Benzodiazepines

Urine testing is helpful when assessing a patient's benzodiazepine use. There are known limitations to urine immunoassays for benzodiazepines and providers should be cautious when interpreting their results. Most general benzodiazepine assays have very low sensitivity to clonazepam and lorazepam. Some assay tests perform better than others, however, and depend on the antibodies used by the manufacturer. Providers should know the sensitivity and specificity of the test being used for each of the benzodiazepine variants. The provider's laboratory will have this information.

Immunoassays are generally not sensitive to therapeutic doses of benzodiazepines. Providers should know the cutoff limits of the test being used. If a patient's benzodiazepine immunoassay is negative, but the patient states that he or she is taking their medication as prescribed, providers can request a definitive test if they wish to confirm use.

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Opiate/Opioids

Urine testing is helpful when assessing a patient's opioid use. There are known limitations to urine immunoassays for opiate use and providers should be cautious when interpreting their results. Providers should carefully review the testing report produced by the laboratory to ensure they understand which opiates and opioids a test is capable of detecting. Semi-synthetic and synthetic opioids may not be included in a test for opiates using immunoassay technology.

A standard opiate immunoassay will detect the use of morphine, codeine (which is metabolized to morphine) and heroin (which is metabolized to 6-MAM and subsequently to morphine) and return a positive opiate result. Metabolites specific to codeine must be detected to confirm codeine use. Heroin or 6-MAM must be detected to confirm heroin use. Hydrocodone and hydromorphone (a metabolite of hydrocodone) are also detected in most standard opiate immunoassays.

Oxycodoneand oxymorphone (a metabolite of oxycodone) are detected in a few but not most standard opiate immunoassays depending on the antibodies used by the manufacturer. One author listed the cross-reactivity of standard opiate immunoassays with oxycodone as ranging between 1% and 10% in 2012 [34]. Providers should be aware of the cross-reactivity of the assay they are using.

Meperidine, methadone, buprenorphine, and fentanyl will not be detected in a standard opiate immunoassay and require their own test.

Although rare, the consumption of poppy seeds can result in a positive opiate immunoassay test result and patients should be instructed to avoid the consumption of poppy seeds. The cutoff designated by SAMHSA for use in the Federal Workplace Guidelines is designed to eliminate positive opiate results from poppy seed consumption. Providers who use a lower cutoff for their clinical population may have an increased risk of positives from this type of exposure (see Presumptive and definitive tests, p. 8).

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Cocaine

Cocaine use can be detected in urine. Urine testing targets the cocaine metabolite benzoylecgonine (BZE) as cocaine itself has a very short half-life. Compared with opiate, benzodiazepine, and amphetamine tests, presumptive tests for cocaine are more sensitive and specific because they target a specific analyte.

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Cannabis

Cannabis use can be detected in urine. Urine testing targets THC metabolite THC-9-carboxylic acid (THC-COOH).

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Blood

Basics of Blood Testing

Blood is mainly composed of plasma, serum, white blood cells and red blood cells. Although whole blood samples are sometimes analyzed, more often they are filtered and only plasma or serum is analyzed. Blood testing allows for the precise measurement of drug concentration levels and can be used to interpret dose or timing, which can be very useful in emergency situations.

See Table 4 for more information about the advantages and disadvantages of blood testing in comparison to other matrices.

See Appendix 4: Windows of Detection Table for windows of detection for various substances in blood as compared to urine and oral fluid.

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Use of Blood Testing in Addiction Treatment

The relevance of blood testing is limited mostly to emergency situations where there is a need to assess impairment and degree of intoxication, and is primarily used to assess alcohol use. Drawbacks to blood testing include the need for staff to be trained in phlebotomy, the invasiveness of drawing blood, and the fact that collected blood samples are hazardous to handle.

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Breath

Basics of Breath Testing

Drugs are detected in exhaled breath as aerosolized particles formed from the fluid lining of the lungs. In the context of alcohol testing, a breath test represents the amount of alcohol present in exhaled breath, which is diffused into the air held in the lungs from pulmonary capillary blood. Breath alcohol concentration (BrAC) can then be used to estimate blood alcohol concentration (BAC).

See Table 4 for more information about the advantages and disadvantages of breath testing in comparison to other matrices.

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Use of Breath Testing in Addiction Treatment

Breath testing has primarily been directed at the detection of recent alcohol use and impairment; it currently represents the most used matrix for POC alcohol testing. Such devices have largely been developed for roadside and other forensic testing environments. This means that while such devices will be relatively simple to use and provide rapid results, cutoff levels may be optimized to identify degree of intoxication or use above a legal limit and may be of less value when applied to a clinical population or setting. Similarly, remote breath monitoring for alcohol use, while a promising technology, was outside the scope of the current project and was not considered.

Two known drawbacks of breath testing are sample contamination from food or oral hygiene products, which contain alcohol and insufficient breath volume [34]. Some devices require larger sample volumes than others and getting a sufficient breath volume is necessary for devices to work properly.

Researchers have begun to expand the substances detected in breath beyond alcohol. In a recent study, testing patients in an outpatient addiction treatment program for amphetamine, benzodiazepine, cannabis, cocaine, buprenorphine, methadone and opioid use, using definitive breath testing was determined to be viable and preferred by patients over urine testing [43].

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Oral Fluid

Basics of Oral Fluid Testing

Drugs are present in oral fluid primarily through passive diffusion from the bloodstream to salivary glands and through absorption and excretion by mucous membranes in the oral cavity during ingestion or inhalation. Because oral fluid testing is primarily blood-based, oral fluid drug concentrations generally correlate with plasma concentrations and provide a good indication of parent drug presence and impairment [44]. However, if a substance is consumed orally, it will often be present at very high concentrations due to direct contact with mouth surfaces, which make it difficult to correlate concentration and intoxication for a period of about 2 hours after dosing.

See Table 4 for more information about the advantages and disadvantages of oral fluid testing in comparison to other matrices.

See Appendix 4: Windows of Detection Table for more information about oral fluid's window of detection for various substances in comparison to urine and blood.

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Use of Oral Fluid Testing in Addiction Treatment

Oral fluid testing is appropriate for presumptive detection of substance use in addiction treatment settings. Oral fluid has gained attention as a possible replacement for urine as the matrix of choice in drug testing [45]. The expert panel did not prefer its use over UDT at this time, but suggested that oral fluid may have certain advantages which can be capitalized on in clinical practice.

Although oral fluid offers a shorter window of detection than urine (12–48 hours for most substances), it is unobtrusively collected, does not require the same staff and bathroom facility resources, and so far, does not suffer from the same sample tampering problems that urine has. Oral fluid is also more likely to contain detectable concentrations of parent drug compounds, making it possible to identify the drug consumed, while urine typically targets metabolites, which may be shared across drug class. For example, 6-MAM, a direct marker for heroin, is present in oral fluid at high concentrations but quickly degrades in urine.

Like breath testing, oral fluid has been primarily developed and evaluated for use in roadside and other forensic settings, although it is being increasingly studied in clinical applications [44]. Oral fluid has also been the focus of a great deal of POCT device development.

Drawbacks to oral fluid testing include difficulty with sample collection due to dry mouth, sample contamination from smoking and eating, and oral cavity contamination from recently consumed drugs. Also, while a 2008 study found that commercially available adulterants designed to mask positive results are less effective than those found for urine testing, adulteration methods for oral fluid may become more sophisticated as the technology becomes more widely used [44].

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Collection of Oral Fluid Samples

One benefit of oral fluid testing is that sample collection is observed, but is unobtrusive. Oral fluid is collected with a device such as an absorbent pad that is held in the mouth for 30 to 60 seconds before placing the pad into a container. Oral fluid collection with a device such as a pad is preferable to direct expectoration into a container. The pad serves to filter contaminants such as food particles, making them a more precise measurement tool than expectoration [46]. The pad can also help stimulate saliva production, although this may affect pH level and skew analyte concentrations. Dry mouth is a common side effect of the use of many illicit drugs such as cannabis and amphetamines as well as prescription medications. Small oral fluid sample volumes mean there may not be enough specimen available for analysis and prevents retesting of the same sample for validity or subsequent definitive testing [47].

Contamination from food particles can interfere with test results. Providers should encourage patients to abstain from eating for 15 to 60 minutes prior to sample collection. Contamination of the oral cavity from recently consumed drugs can skew quantitative results. If a patient recently took a drug by mouth (ingestion or inhalation), it is recommended that practitioners wait at least 2 hours before collecting an oral fluid sample. Qualitative detection of recent use, however, will still be valid [28].

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Sweat

Basics of Sweat Testing

The mechanism by which drugs are incorporated into sweat is not fully understood and several potential mechanisms have been proposed, including diffusion from blood vessels passing by sweat glands or through sebaceous glands also present on the surface of the skin, which primarily excrete lipids [32].

Sweat is collected continuously by an absorbent pad or “sweat patch” that is held close to the skin with an adhesive area, similar to a Band-Aid. Drug concentrations represent an individual's accumulated use of substances over the period the patch was worn, usually 1 to 2 weeks, but can be up to 4 weeks. Drawbacks to this method include possible external contamination and the loss of patch adhesion over time, which can result in the sweat patch falling off for some patients [24,48].

See Table 4 for more information about the advantages and disadvantages of sweat testing in comparison to other matrices.

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Use of Sweat Testing in Addiction Treatment

As a new technology, little research exists regarding the use of sweat testing in addiction treatment settings. At this time, there is insufficient evidence to support the routine use of sweat testing in addiction treatment. More research is needed before sweat testing can be recommended over urine testing in clinical settings.

An overview of sweat testing literature considers the practice to be promising [32]. A wide detection window that captures any substance use may be advantageous for some patients, although that window comes with the tradeoff of delay between use and therapeutic response. Sweat testing is also a form of prospective detection, that is, the device is applied prior to the activity that it is supposed to detect. For patients who view testing as having a helpful deterrent effect, prospective testing methods may be additionally beneficial (see Clinical Use of Drug Testing, p. 5). The sweat patch also offers a passive collection technique that does not require intensive staff training.

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Hair

Basics of Hair Testing

Hair can be thought as a continuous collection device which absorbs compounds as blood passes through the hair follicle and as sweat gathers and is absorbed around the base of a growing hair shaft. Scalp hair is the most commonly tested sample, but pubic, armpit and facial hair can be also be used. Head hair provides a window of detection of approximately 3 months; body hair, which grows much more slowly, can be used to detect use up to 12 months [49,50]. Hair testing does not detect recent use or impairment. Hair takes approximately 8 days to grow from the follicle to above the scalp, making it possible to collect. Drug and metabolite compounds in hair also begin to degrade over time, limiting interpretation to segments of hair grown in the prior 3 months. Chemical treatments such as dyeing, bleaching, perming, and straightening can alter the structure of hair and degrade drug compounds that may be present [51].

The literature on hair testing shows variability in drug absorption based on hair's characteristics, including pigmentation, texture and porosity, which may lead to incidental racial discrimination [42,52]. Drug compounds are incorporated into dark and thick hair at greater concentrations compared to lighter or thinner hair, although large sample studies suggest these differences do not lead to a significant race effect.

Hair testing appears to be useful for detecting amphetamines, cocaine, opioids, phencyclidine, and MDMA, but less so for marijuana [53].

See Table 4 for more information about the advantages and disadvantages of hair testing in comparison to other matrices.

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Use of Hair Testing in Addiction Treatment

The routine use of hair testing is not appropriate for most addiction treatment settings. While the primary advantage of hair testing is the wide window of detection, hair testing is costly, and interpretation of hair test results is potentially discriminatory and can be confounded by passive external contamination.

The window of detection for hair testing is clinically relevant in a few situations. Practitioners may want to know about a patient's past 3-month substance use when assessing a patient and creating a treatment plan. Hair testing may also be useful during long-term monitoring. The cost may be prohibitive, however, if repeated tests are needed over a long period of time.

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Collection of Hair Samples

If hair is collected, patients should be asked about their use of chemical hair treatments (eg, dying, bleaching, perming, and relaxers) at the time of sample collection. Use of chemical hair treatments should be recorded and non-head hair (ie, pubic, arm, beard) or an alternative specimen should be collected if possible.

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Summary of Recommendations

Urine

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Use of Urine Drug Testing in Addiction Treatment

* Urine should be considered the most well-established and well-supported biological matrix for presumptive detection of substance use in a clinical setting.

* Urine should be considered the best established matrix for POCTs.

* If tampering is of high concern or appropriate measures to reduce the likelihood of tampering cannot be taken, providers should consider using an alternative specimen type.

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Urine Sample Integrity

* Urine should be considered the matrix most prone to sample tampering through dilution, adulteration and substitution.

* Providers should choose collection methods that protect patients’ dignity and privacy while minimizing opportunities for tampering.

* Observed sample collection can deter urine sample tampering; if there are concerns about tampering, collection should be observed by a same-gender staff member.

* Observed urine sample collection does not completely prevent sample tampering; providers should consider other strategies to mitigate urine sample tampering.

* Providers should consider the use of an unobtrusive sample collection method for patients with a history of psychological trauma, especially sexual trauma.

* Providers should employ appropriate measures in the facility where patients provide specimens to decrease the likelihood of urine sample tampering during unobserved collection.∘Do not allow personal items in the collection area.∘Ensure that potential adulterants, such as soap, ammonia, or bleach are not readily available in the collection area.∘Consider placing blue dye in the toilet and turn off the water source to the collection area during collection.

* If a provider suspects that a patient has engaged in substance use but continues to produce negative urine test results, sample collection should be observed and specimen validity testing should be conducted.

* If a sample is suspected of having been tampered with, it should be tested for specimen validity including creatinine concentration, pH level, specific gravity and adulterants.

* All samples undergoing definitive testing should be tested for creatinine concentration, pH level and specific gravity (if creatinine is low).

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Signs of Urine Sample Tampering

* All urine samples should be checked for unusual specimen characteristics. Characteristics include:∘Temperature outside expected range of 90–100 degrees within 4 minutes of production (This can be checked using a heat sensitive strip).∘Unusual color or smell, soapy appearance, cloudiness or particles floating in the liquid.

* If a urine sample exhibits unusual specimen characteristics, the sample should undergo specimen validity testing to help identify whether and how tampering occurred.

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Responding to Specimen Validity Test Results

* Providers should consider samples that have been tampered with to be presumptive positive.

* For patients with past incidences of dilute urine samples, it is advisable to collect samples in the morning or request that patients decrease water intake prior to sample collection.

* For patients with past incidences of dilute urine samples, use creative solutions, such as collecting before work, on days off, or use an alternative matrix.

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Urine Testing for Specific Substances

* Urine testing for the use of alcohol is appropriate with current clinical tools. EtG is an appropriate target metabolite when monitoring a patient for complete alcohol abstinence.∘Ethanol-containing products, including hand sanitizers and mouthwash, should be avoided before an EtG test.

* Urine testing is helpful when assessing amphetamine use. Particular caution should be paid to the interpretation of amphetamine immunoassays due to known limitations in specificity.

* Urine testing is helpful when assessing benzodiazepine use.∘Particular caution should be paid to the interpretation of benzodiazepine immunoassays due to known limitations in specificity.∘Immunoassay results should be used cautiously when monitoring a patient's adherence to prescribed benzodiazepines. If a patient reports that he or she is taking the drug but a urine drug screen is negative, further analysis using definitive testing should be considered.

* Urine testing is helpful when assessing opioid use.∘Particular caution should be paid to the interpretation of opiate immunoassays due to known limitations in specificity.∘Patients should be instructed to avoid the consumption of food items that contain poppy seeds because they can result in a positive opiate test.

* Urine testing is helpful when assessing cannabis use, although it is difficult to determine the timing or cessation of consumption in chronic users due to extended windows of detection for THC.

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Blood

* The relevance of blood testing in addiction treatment is limited mostly to emergency situations where there is a need to assess intoxication or impairment.

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Breath

No statements about the appropriateness of breath testing were endorsed by the Expert Panel.

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Oral Fluid

* Oral fluid testing is appropriate for presumptive detection of substance use in addiction treatment settings.

* Oral fluid collection with a device that facilitates saliva collection is preferable to expectoration.

* The creation of a sample for oral fluid testing should be observed.

* It is recommended that patients abstain from eating for 15–60 minutes prior to oral fluid sample collection.

* If a patient recently took a drug by mouth (ingestion or inhalation), it is recommended to wait at least 2 hours before collecting an oral fluid sample.

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Sweat

* There is insufficient evidence to support the use of sweat testing in addiction treatment. More research is needed before sweat testing can be recommended over urine testing in clinical settings.

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Hair

* Hair testing in addiction treatment can detect long-term patterns of use. Routine use of hair testing is not appropriate for addiction treatment.

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PART 5: SETTINGS

Although the Principles of Drug Testing (Part 1) apply broadly to addiction treatment settings, some settings and levels of care warrant specific guidance. The ASAM Criteriais a widely accepted standard model for describing the continuum of addiction care [54]. Within The ASAM Criteria are 5 broad levels of care (ranging from 0 to 4) that reflect a continuum of service intensity with sublevels within each.

0.5: Early Intervention

1.0: Outpatient Services

2.0: Intensive Outpatient/Partial Hospitalization Services

3.0: Residential/Inpatient Care

4.0: Medically Managed Intensive Inpatient Services

OTS: Opioid Treatment Services

Very little research has examined optimal drug-testing practices specific to ASAM levels of care. As a result, this document groups recommended practices into two level-of-care categories: 1) Outpatient and Intensive Outpatient Services (Levels 1 and 2), and 2) Residential/Inpatient and Medically-Managed Intensive Inpatient Services (Levels 3 and 4). This document also examines drug-testing practices in OTS, with special consideration for OTPs and OBOT. Drug testing in OTS will differ from other levels of care because patients are on prescribed opioid agonist and/or antagonist medications. While this complicates the interpretation of opioid drug test results, the use of drug testing can assist in monitoring patients’ response to different medication doses, monitoring adherence and in monitoring for possible medication diversion. Finally, this document considers drug testing in sober living environments known as recovery residences, which are not included in The ASAM Criteria, but often serve as an important component of the continuum of care for patients with addiction.

This document points specifically to the importance of maintaining a therapeutic drug-free environment in settings where patients are being treated—that is, in Level 3 and 4 facilities as well as recovery residences. Because these are structured settings, drug testing is an important tool because it helps ensure a safe, recovery-oriented environment.

The following recommendations are designed to provide additional guidance to providers working with addiction patients in specific settings.

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Outpatient Services (1.0) and Intensive Outpatient/Partial Hospitalization Services (2.0)

The ASAM Criteria defines Level 1 Care as “organized outpatient treatment services” that are “tailored to each patient's level of clinical severity and function and are designed to help the patient achieve changes in his or her substance use.” Level 2 care includes intensive outpatient programs (9–19 hours of structured programming per week for adults) and partial hospitalization services (20 or more hours of clinically intensive programming per week, typically with direct access to psychiatric, medical, and laboratory services).

Because the opportunity for substance use is greater in outpatient treatment than in more intensive levels of care, drug testing has a particularly important role in monitoring substance use.

Whenever possible, the schedule of drug testing should be random and unannounced (see Test Scheduling, p. 11).

In outpatient care, drug testing should be scheduled on days following weekends, holidays and paydays whenever feasible. Providers should communicate with patients about plans for these additional tests to avoid the “us against them” mentality and nurture the therapeutic alliance. Additional drug testing should be considered if a patient is experiencing stressful psychological events.

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Residential/Inpatient Services (3.0) and Medically Managed Intensive Inpatient Services (4.0)

Residential/Inpatient Services (Level 3.0) are defined by The ASAM Criteria as “organized treatment services in a 24-hour residential setting” and Medically Managed Intensive Inpatient Services (Level 4.0) are defined as “an organized service delivered in an inpatient setting” usually requiring ongoing nursing/medical care in addition to addiction treatment.

Drug testing plays an important role in both assessment and in maintaining a drug-free therapeutic environment in residential treatment and can alert providers when the therapeutic and treatment environment has been compromised by smuggled drugs [2]. Drug testing can also be used to support recovery when patients leave the addiction treatment facility on passes. When residents are off-site for a period of time, they should be asked to provide a sample for drug testing shortly following their return. Providers should communicate with patients about plans for these additional tests to avoid the “us against them” mentality.

To the extent that residential programs are predicated on the goal of abstinence, drug testing is useful in assessing whether patients are having difficulty accomplishing this goal.

Drug testing can be used to support recovery in residential treatment.

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Opioid Treatment Services (OTS)

The ASAM Criteria defines OTS as “a collection of pharmacological and nonpharmacological treatment.” Pharmacological treatments for opioid use disorders include agonist (methadone, buprenorphine) and antagonist (naltrexone) medications [2]. Two specific services in this category are OTPs and OBOT (including buprenorphine and naltrexone). Considerations relevant to OTPs and OBOT are discussed below.

The primary purposes of drug testing in the context of OTS are: a) detecting substance use that could complicate treatment response and patient management; b) monitoringadherence with the prescribed medication; and c) monitoring possible diversion. Providers should note that drug tests play a particularly important role in patient safety in the context of OTS because they can identify potentially lethal drug combinations, such as benzodiazepines with opioid agonists.

Drug testing has potential application across all stages of OTS, including pre-induction assessment and treatment planning, active treatment, and during maintenance and recovery. Consistent with the Principles of Drug Testing (Part 1), OTS providers should utilize drug testing during the assessment phase and throughout treatment. Furthermore, drug testing in OTS may be paired with the contingency management, a research-supported practice that offers incentives for predefined behaviors.

A final important consideration for OTS is provider education about the use of drug tests to detect opiates, semi-synthetic opioids, and synthetic opioids. There is considerable nuance to distinguishing specific opioids using drug tests, which is important for OTS providers who need to distinguish between opioid agonists prescribed to support recovery and opiate/opioid use that is inconsistent with the treatment plan. As with benzodiazepines, the use of illicit opiates or opioids could be lethal in combination with prescribed opioid agonists.

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A Note on Language

In OTS, an “expected” drug test result is positive for the patient's prescribed medication, but negative for all other unexpected substances. An “unexpected” drug test result could be negative for the prescribed medication, positive for unexpected substance(s), or both.

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Testing Schedule

The frequency and duration of drug testing in OTS should be individualized, depending upon the stage of treatment as well as other patient factors. There is no “magic number” or appropriate frequency of testing that can be applied to every patient, although providers should note that federal regulations set annual minimum numbers in OTPs. In OTS, testing should be more frequent during the induction and stabilization phase of treatment and less frequent during the maintenance stage. Testing may be more frequent during the induction stage to ensure that the patient has stabilized on the initial dose. The expert panel found drug testing during and after tapering from medications to be an important way to support a patient's recovery, and suggested that providers may want to consider increasing drug-testing frequency during and after tapering from medications.

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Responding to Test Results

In OTS, a common incentive for an expected drug test is to offer take-home doses. Providers should respond to expected drug test results with positive feedback and consider the use of take-home medication as an incentive.

Providers should be aware that one of the purposes of drug testing in OTS is detecting possible diversion. For example, the presence of a prescribed medication's metabolites indicates that it was consumed and metabolized. High concentrations of a parent drug in the absence of its metabolites are observed when small amounts of medication are added to the sample during collection. If this pattern is observed, providers should assess the patient for potential diversion. However, a test that is negative for prescribed medication should not be interpreted on its own as diversion; it could indicate a more rapid metabolism and the need for a higher dose.

Consistent with the Principles of Drug Testing, it is not appropriate to respond punitively to unexpected drug test results in OTS treatment. Rather, unexpected results could indicate a need for a higher level of care, a higher dose of medication, a different testing schedule (eg, unannounced, with greater frequency), and/or increased patient education.

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Considerations for Opioid Treatment Program Settings

While OTPs can utilize methadone, buprenorphine, and naltrexone, the most common medication used in OTPs is methadone.

With regard to testing frequency in OTPs, the 8 times per year currently required by SAMHSA's Federal Guidelines for Opioid Treatment Programs should be viewed as a minimum [55]. Many patients will require more frequent testing, and determinations about optimal frequency are best made on an individualized basis. In OTPs, the expert panel concluded that unexpected drug test results could lead to a number of responses including discontinuation of take-home doses, a more frequent or more random drug-testing schedule, increased counseling and peer group sessions tailored to individuals with unexpected drug test results in OTPs. Providers should communicate to patients that these responses are not designed to be punitive, but as increased support for the patient in the context of his or her treatment plan.

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Considerations for Office-Based Opioid Treatment Settings

OBOT comprises the use of buprenorphine and/or naltrexone. There are several formulations of both buprenorphine and naltrexone, but this document does not address specific considerations for different formulations. No research was located that distinguished between, for example, drug-testing practices for sublingual buprenorphine as opposed to the subdermal buprenorphine implant.

In order to provide OBOT, providers should have access to a drug-testing laboratory. The test panel should always include the therapeutic drug and/or its metabolites to indicate that medication was consumed; this helps providers monitor medication adherence and also evaluate for possible diversion. However, drug testing should not be the only strategy for reducing or preventing diversion: providers should also use other measures, such as increased office visits, Prescription Monitoring Programs, observed dosing, and medication counts. With regard to frequency, the expert panel recommended that buprenorphine patients receive drug testing at least monthly, unless otherwise clinically indicated. Patients who are stable in their recovery may require less frequent testing.

Before beginning naltrexone, it is critical that a patient be withdrawn from opioids. Therefore, a negative drug test result should be obtained before beginning treatment with naltrexone. Drug testing also is indicated throughout treatment using naltrexone. With regard to frequency, the expert panel recommended that naltrexone patients receive drug testing at least monthly, unless otherwise clinically indicated.

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Recovery Residences

According to the National Association for Recovery Residences, “Recovery Residence (RR) is a broad term describing a sober, safe, and healthy living environment that promotes recovery from alcohol and other drug use and associated problems. At a minimum, RRs offer peer-to-peer recovery support with some providing professionally delivered clinical services all aimed at promoting abstinence-based, long-term recovery” [56]. Drug testing is particularly important in an environment where abstinence is a therapeutic social norm, and recovery residences fit this criterion. Because the integrity of the group relies on each participant's ongoing sobriety, weekly drug testing (or more frequent if there is suspicion of substance use) is appropriate in a recovery residence; participants may be expelled from the facility if a drug test result indicates substance use. Weekly testing can use presumptive methods; weekly definitive test panels in recovery residences are a potential opportunity for fraud (for a discussion, see Cost Considerations, p. 2). However, as in any setting, a drug test result used as input to a major decision such as program expulsion should use a definitive testing method. Expulsion should not interfere with an individual's continued therapeutic relationship with his or her outpatient addiction treatment provider.

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Summary of Recommendations

Outpatient Services (1.0) and Intensive Outpatient/Partial Hospitalization Services (2.0)

* Because the opportunity for substance use is greater in outpatient treatment than in more intensive levels of care, drug testing has a particularly important role in monitoring substance use.

* Providers should implement a random unannounced schedule of testing in outpatient services whenever possible, because the patient's opportunity for substance use is greater relative to residential treatment.

* Drug testing should be scheduled on days following weekends, holidays and paydays when feasible. Providers should communicate with patients about plans for additional drug tests around events/special occasions.

* Additional drug testing should be considered if a patient is experiencing stressful psychological events.

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Residential/Inpatient Services (3.0) and Medically Managed Intensive Inpatient Services (4.0)

* Drug testing plays an important role in maintaining a drug-free therapeutic environment in residential treatment.

* When residents leave the treatment program on passes, they should be asked to provide a sample for drug testing shortly after their return. Providers should communicate with patients about plans for additional drug testing following their return.

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Opioid Treatment Services

* The primary purposes of drug testing in the context of OTS are (a) detecting substance use that could complicate treatment response and patient management; (b) monitoring adherence with the prescribed medication; and (c) monitoring possible diversion.

* Drug testing can be an important tool for detecting the use of substances that can be lethal in combination with a prescribed opioid agonist medication (eg, benzodiazepines).

* Drug testing has potential application across all stages of OTS including pre-induction assessment and treatment planning, active treatment, and during maintenance and recovery. Providers should utilize drug testing during the assessment phase and throughout treatment.

* Providers should utilize drug testing as an aspect of contingency management in OTS.

* Provider education should include knowledge of the metabolic pathways of commonly prescribed opioids.

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Testing Schedule

* Drug-testing frequency is determined by stage of treatment as well as other patient factors and should be individualized.

* Testing should be more frequent during the stabilization period, and less frequent during the maintenance period.

* Drug testing during and after tapering from methadone or buprenorphine continues to be an important way to support a patient's recovery; providers may want to consider increasing drug-testing frequency during tapering and in the period after tapering.

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Responding to Test Results

* Expected drug test results (ie, positive for prescribed medication and negative for unexpected substances) should be praised and responded to with tangible contingencies such as take-home doses of medication.

* High concentration of a parent drug in the absence of its metabolites is consistent with sample tampering in the form of post-collection addition of the drug to the sample and potential diversion. In this case, a follow-up assessment should be conducted with the patient.

* A test that is negative for the prescribed medication (eg, negative for buprenorphine in a patient prescribed buprenorphine) should not be used on its own to determine that diversion is occurring.

* Unexpected drug test results could indicate the need for 1 or more of the following responses: (1) a higher level of care; (2) a higher dose of medication;(3)a different schedule of testing, such as random rather than scheduled and/or more frequent; and/or (4) increased education for the patient.

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Considerations for Opioid Treatment Program Settings

* For patients in OTP settings, the federally mandated “eight tests per year” should be seen as a minimum, and it is often appropriate to perform testing more frequently than 8 times per year; determinations about testing frequency and duration should be made with consideration of individual patients, as noted above.

* For patients in OTP settings, provider response to unexpected test results can include discontinuation or reduction of take home doses of medication, more frequent or random schedule of drug testing, and increased counseling and peer group sessions.

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Considerations for Office-Based Opioid Treatment Settings

* For patients in OBOT settings, the drug test panel should include the therapeutic drug and/or its metabolites.

* In addition to drug testing, diversion can be reduced or prevented by frequent office visits, Prescription Monitoring Programs, observed dosing, and medication counts.

* In order to provide buprenorphine or naltrexone treatment, providers must have access to drug-testing laboratories.

* Frequency of drug testing in buprenorphine treatment should be at least monthly, unless otherwise clinically indicated (eg, patients who have become stable in recovery may require less frequent testing).

* Drug testing (and negative test result for opioids) is indicated before starting treatment of opioid use disorder using naltrexone. Drug testing also is indicated throughout treatment using naltrexone.

* Frequency of drug testing in treatment of opioid use disorder using naltrexone should be at least monthly, unless otherwise clinically indicated.

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Recovery Residences

* Weekly random drug testing is appropriate in a recovery residence.

* Any patient expelled from a recovery residence should be able to continue an ongoing therapeutic relationship with his or her outpatient addiction treatment provider.

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PART 6: SPECIAL POPULATIONS

Adolescents

Healthcare for adolescents and adults bears many similarities. Many of the general principles of drug testing for adults remain unchanged for adolescents. However, there are some important factors with this population, which deserve unique consideration before deciding when and how to drug test an adolescent.

Unlike the majority of this appropriateness document, this guidance for adolescents is not to be applied to patients in addiction treatment. Rather, the following recommendations address care for adolescents in general healthcare settings.

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When to Test Adolescents

Adolescent drug testing is only to be used in some scenarios. It is not appropriate or necessary to conduct a drug test for all adolescents in general healthcare settings. The American Academy of Pediatrics (AAP) suggests drug testing as an aspect of adolescents’ recovery programs, or as a component of assessment for substance use as suspected by a parent or other adult [36,57]. High-risk populations may benefit from use of drug testing to assist in early identification of substance use, a group including but not limited to those with known past substance use, those in treatment for mental health disorders, those with a history of past trauma, and those with declining academic performance.

When an adult observes symptoms characteristic of substance use in an adolescent, providers should use drug testing as part of an assessment for a possible SUD. However, as with adults, drug testing of adolescents should not be used in isolation. ASAM and SAMHSA recommend that drug testing be used in primary care settings in combination with the results of standardized screening questionnaires [2].

Adolescents in long-term recovery from an addiction can benefit from drug testing in general healthcare settings. Monitoring adolescents using drug testing can facilitate therapeutic conversations about recurrent substance use and drug testing can give the patient extrinsic motivation to follow their treatment plan and help the provider make adjustments, as needed.

A primary care physician (PCP) may be called upon to administer a drug test. A PCP should be an informed practitioner if he or she chooses to use this tool. As long as he or she is familiar with the general principles of drug testing, the PCP may order a test. If he or she does not have proficiency in drug testing, the physician ought to refer the patient to a specialist for treatment or consult with a medical toxicologist or MRO about conducting drug tests or interpreting their results.

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Adolescents and Self-Reported Substance Use

Though an adolescent reports substance use and/or substance use history, drug testing may still provide additional value. Although commonly assumed to be the case, research is mixed with regard to whether adolescents are less likely than adults to self-report accurately. For example, 1 study found low correlations between self-report and drug test results among adolescents in a “high-risk urban setting” [58], whereas concordance between the 2 were found to be relatively high among teens in addiction treatment [59]. These results suggest that setting might be a factor in the accuracy of self-report. Moreover, perception of negative consequences if substance use is detected seems to contribute to lower likelihood of accurate self-report (see Drug testing and self-reported substance use, p. 5).

As with adults, there is also the concern that illicitly acquired substances may contain compounds different from those the person using them believes to be present. This is of particular relevance to adolescents as they are more likely to obtain substances through friends without knowing their origin and have less practical knowledge about the substances they use.

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Adolescents and Home Testing Kits

Many pharmacies sell home drug testing kits over the counter. Providers should not encourage the use of home drug testing on adolescents. The results of a drug test require careful interpretation and knowledge that untrained persons do not possess. The general population lacks training. Administering tests or properly interpreting results requires knowledge in light of the sensitivity and specificity of the test. In addition, parental drug testing could damage the parent-child relationship [36]. Encourage parents who wish to test their child to instead work with a medical professional who can evaluate whether it is appropriate to conduct a test. Note that primary care professionals do not always have training in drug test interpretation.

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Adolescent Consent

ASAM, AAP, and ACOG all discourage performing drug testing on adolescents who have not had the opportunity to give informed consent [36,45,60].

Exceptions exist where it is appropriate to waive the need for consent. Situations where the patient's safety could be compromised should be handled on a case-by-case basis. For example, an adolescent patient experiencing a seizure or other medical emergency may be drug tested in the absence of his or her consent. A patient who is under medical supervision following a suicide attempt is included in this emergency designation.

If an adolescent refuses to consent to a drug test in a non-emergency situation, respect his or her autonomy. In the meantime, continue the evaluation through alternative methods including verbal screening and reports from family members. Alternatively, providers can refer the adolescent to a specialist with additional mental health or substance use expertise. If drug testing continues to be warranted and the patient continues to be treated by the PCP, he or she can suggest drug testing again after the patient has grown more comfortable with the provider.

Providers should explain drug-testing protocols in full before initiating the process. This helps the adolescent make an informed decision. It also encourages trust in the patient-provider relationship.

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Adolescent Confidentiality

An open flow of information between guardians and children should typically be encouraged. Before beginning the drug testing process, ask the adolescent for permission to share the results with parents/guardians and discuss confidentiality with parents/guardians in order to encourage parental involvement. Adolescents often feel strongly about confidentiality and providers can encourage young patients to share test results with their parents by explaining how this could benefit their health and help create an environment of familial trust and respect.

Providers should respect the patient's decision if he or she asks to keep test results private. Even if the adolescent does not share his or her results with guardians, providers are still in a position to make decisions based on those results.

Providers should also talk to the parents or guardians of adolescent patients about their confidentiality policy. This can help guardians understand what they will or will not be told, and encourage their communication and involvement. It also sets shared expectations.

Note that there are legal and ethical caveats that prevent providers from promising unconditional confidentiality to adolescent patients. If a medical professional suspects that an adolescent patient's drug use puts him or her in imminent danger of acute physical harm to themselves or others, the provider may be obligated to tell an adult authority. Providers should know relevant federal and state laws and consider where this line should be drawn, given that risk of harm is a spectrum and not simple to quantify.

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Choosing a Test Panel for Adolescent Patients

Drug test panels for adolescents should include the substances most used by the demographic. Providers should be aware of demographic trends in substance use among adolescents, which may differ from trends among adults. Youth often have access to fewer options than adults, making their choices based on availability more than personal preference. Provides are advised to consult with their testing laboratory about local drug trends, particularly those affecting adolescents.

Patterns of use for adolescents are known to differ from those of adults. Access to preferred substances may be sporadic, and as such, a patient may rotate through a variety of substances based on availability. This can make targeting a test panel challenging and increases the importance of self-report and knowledge of patient history and local trends.

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Responding to Positive Test Results

If a true positive drug test result indicates that an adolescent is engaging in high-risk substance use, the provider should assist the patient and his or her parent or guardian in developing a plan for monitoring and treatment. Both the patient and his or her parents or guardians should be actively involved in the development of a plan of action, if possible. Mere awareness of an adolescent's substance use is not a satisfactory end result of a positive drug test.

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Pregnant Women

Many principles of drug testing for a general population apply to pregnant patients. However, there are some important factors with this population that deserve unique consideration before deciding when and how to utilize drug testing for a pregnant patient.

Note that this section does not refer specifically to patients who are receiving addiction treatment. Rather, these recommendations primarily apply to pregnant and postpartum women in general healthcare or prenatal care settings. Additional guidance on addressing substance use among pregnant patients from the perspectives of screening and treatment as well as regulatory and law enforcement considerations is available in the ASAM Policy Statement “Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids” [61], which was published after this project was well underway, and could therefore not be included in the full process.

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Consequences and Confidentiality

Providers have an obligation to be aware that there are serious legal and social consequences of detecting and monitoring substance use among pregnant women. In some cases, state reporting requirements may conflict with 42 Code of Federal Regulation (CFR) Part 2, which is federal law. 42 CFR Part 2 is a federal regulation that protects the confidentiality of patient addiction treatment records.

According to SAMHSA, 42 CFR Part 2 does not protect patient information in states where maternal substance use is considered child abuse or neglect and requires reporting to state or local authorities [62]. In 23 states plus the District of Columbia, laws designate substance use during pregnancy to be child abuse. (As of 2017, these states included Alabama, Arizona, Arkansas, Colorado, the District of Columbia, Florida, Illinois, Indiana, Iowa, Louisiana, Maryland, Minnesota, Missouri, Nevada, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, and Wisconsin.) [63]. ASAM opposes policies that define substance use by pregnant women as “child abuse or maltreatment” and carry penalties, rather than providing these women with effective health care [61].

However, given that many pregnant women do face consequences if substance use is detected, providers who treat pregnant patients should be knowledgeable about federal- and state-level laws pertaining to confidentiality and reporting requirements. ASAM recommends that, with the exception of emergency situations, pregnant women should provide explicit written consent for drug testing including during labor and delivery [61]. This informed consent should include an understanding of the possible consequences of test results.

Providers should refer to SAMHSA's TIP 51 “Substance Abuse Treatment: Addressing the Specific Needs of Women” for information on ethical and legal issues in substance-using pregnant women and their children [64]. If questions arise during specific cases, providers can consult with an attorney or their state medical society about balancing their responsibility to uphold 42 CFR Part 2 and state reporting requirements.

Patient confidentiality should be maintained to the full extent permitted by state and federal law. This includes the results of drug tests and any associated diagnoses. The role of the provider is to help his or her patients improve and maintain their health. Though the provider is obligated to follow reporting mandates, fulfilling this duty is not his or her primary function. The expert panel recommends that providers have honest and straightforward discussions with pregnant patients about confidentiality. Providers should assure pregnant patients that in general, private medical information will not be shared with any third parties, and then clearly communicate the exceptions.

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Screening, Assessment, and Monitoring

A review of recommendations for clinical management of substance use in pregnancy encouraged screening for all women of childbearing age. These procedures could be followed by drug testing only if the screening questions indicated substance use [65]. ACOG recommends that pregnant women be screened at the first prenatal visit about past and present use of alcohol, tobacco, and other drugs using validated screening questions [45]. The expert panel recommends that comprehensive substance use assessment, which may include drug testing with the patient's consent, be considered part of obstetrical practice. Providers working with this population should learn about and appropriately use clinical laboratory testing (see Practitioner Education and Expertise, p. 13). Providers should be aware that there are serious consequences that transcend health associated with drug testing in this population, and know that there are other ways to assess for substance use. Furthermore, for a pregnant patient with a history of addiction, the postpartum period is a time of increased vulnerability. Relapse assessment, which may include drug testing, should be part of the postpartum visit. Postpartum is a period of increased stressors, which can be a barrier to recovery. Again, providers have an obligation to keep in mind the serious potential consequences associated with drug testing in postpartum as well as pregnant patients.

For providers who do not specialize in the treatment of addiction, the ability to refer patients to appropriate care is essential. Providers should create links to a variety of addiction treatment settings in their communities that serve pregnant women, so that pregnant patients with SUDs can access appropriate care.

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Patient-Provider Relationship

A woman who perceives mistreatment or experiences discrimination from her healthcare provider may avoid prenatal care to the detriment of her own health and that of her future child [65,66]. During any appointment where drug testing is discussed or performed, providers should emphasize the therapeutic reasons for the practice. Both the provider and patient should be aware that drug testing is intended to help both the woman and her family and does not serve a punitive purpose (see Clinical Use of Drug Testing, p. 5).

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Test Considerations

The hormonal chemistry of pregnancy does not affect the results of the urine drug test. Therefore, urine is an appropriate matrix for drug testing of pregnant women. Providers can rotate matrices based on clinical judgment (see Comparing Matrices, p. 16).

The American College of Obstetricians and Gynecologists and ASAM jointly recommend that all pregnant women should be asked about alcohol use using a validated instrument and receive a brief intervention, if necessary [2,45]. Providers should inform patients that there is no known safe level of drinking during pregnancy. If the provider suspects Alcohol Use Disorder or the patient displays known risk factors, a laboratory test for alcohol use is warranted. More information about detecting alcohol in urine and alternative matrices is available in Appendix 4: Windows of Detection Table.

There is some evidence that pregnant women are less willing to disclose use of opioids and benzodiazepines than other substances [67]. These substances can have repercussions for maternal and fetal health. Including them in the test panel can provide important information that impacts clinical decision making. For example, if a provider learns that a pregnant patient is using opioids, and an assessment shows the patient has an opioid use disorder, opioid agonist medication (either methadone or buprenorphine) is the standard of care [61].

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Test Results

It is important to respond proactively to test results that indicate a pregnant woman is using substances. Most general principles about responding to test results still apply (see Responding to Test Results, p. 10).

As a follow-up to a presumptive positive test, use definitive testing to clearly identify individual drugs. Because of the limitations of presumptive testing (see Presumptive and definitive tests, p. 8) and the known social and legal consequences of detecting substance use during pregnancy, definitive test should be conducted to confirm presumptive positive test results.

In keeping with the principles of Screening, Brief Intervention and Referral to Treatment (SBIRT), providers can respond to a positive drug test by conducting a brief intervention that contains preventive education, offering a referral to treatment, or (if the provider offers addiction care such as buprenorphine) creating a treatment plan for the patient. It is important that providers be familiar with local treatment resources and programs for pregnant women. Any referrals to nearby programs can thus take into consideration factors that could impact the patient's success, such as transportation access, financial impact, childcare options, and co-occurring medical needs.

If the patient is already receiving addiction treatment, ASAM recommends that the presence of a positive result on a urine drug test be used to increase the intensity of the treatment plan [61]. According to ASAM, “It should not be used as a basis for termination of treatment services or as the basis for arrest, incarceration, or as a prima faciae basis for reflexive revocation of probation or parole, particularly in this vulnerable population.” [61]

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People in Recovery

Continuing Care

Many have argued that most patients receive an inadequate “dose” of addiction treatment and little support in the form of continuing care [53]. The appropriate duration of treatment and continuing care depends on the type and degree of substance use.

The expert panel agreed that 5 years of monitoring with a drug-testing component is appropriate for most patients in stable recovery, although this rarely occurs in practice. As with addiction treatment, there is evidence that any approach to drug testing people in recovery should be individualized based on the severity and chronicity of the addiction.

The Recovery Management Checkup (RMC) model [68] is a promising approach to ongoing intervention and treatment re-engagement, as needed. An RMC consists of periodic interviews with patients after leaving a formal treatment setting, an assessment of individual's recovery needs, discussion of desired behavior change using a Motivational Interviewing approach, and referral to additional services as needed. Drug testing is not a central component of the RMC model; typically, RMCs rely on self-report using a standardized interview instrument. However, when the RMC has utilized urine testing as adjunct to self-report, it has improved the accuracy of self-reported substance use [69]. This suggests that it is feasible to integrate drug testing into RMCs and that such an addition could improve the effectiveness of the intervention.

The most well-known use of drug testing as a part of continuing care is within Physicians Health Programs (PHPs). Although PHPs are overseen by states (and therefore vary), Table 7 illustrates consistent elements of PHPs. This model has been highly effective among physicians and other healthcare professionals [70]. Drug testing is a consistent element of PHPs and generally occurs periodically for 5 years after a physician leaves a formal treatment setting. A positive definitive test result triggers an immediate re-evaluation of the patient to consider the benefits of a different treatment approach or a more intensive level of care. This model, including regular drug testing, may have applications for other populations who would benefit from continuing care [10].

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Health and Other Professionals

Because of the exceptional outcomes that PHPs produce, their use should continue among physicians and expanded to include other health professionals and for other safety sensitive professionals. Drug testing is an important component of PHPs and is especially helpful because health professionals have increased access to psychoactive substances. Professionals in recovery who have significant occupational exposure to addictive substances should receive more frequent drug testing.

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Summary of Recommendations

Adolescents

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When to Test Adolescents

* Use drug testing to assist in early identification of substance use in high-risk populations of adolescents including but not limited to those with known past substance use and those in treatment for mental health disorders.

* Drug testing to monitor adolescents in addiction treatment or recovery from an SUD can be performed by providers in primary care.

* When an adult observes symptoms characteristic of substance use in an adolescent, providers should use drug testing as part of an assessment for a possible addiction.

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Adolescents and Self-Reported Substance Use

* Even if an adolescent reports substance use, providers should consider drug testing for additional information because adolescents are less likely to self-report accurately.

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Adolescents and Home Testing Kits

* Because of a variety of limitations with home drug testing process and interpretation, providers should not encourage the use of home drug testing for adolescents.

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Adolescent Consent

* Before beginning the drug testing process with an adolescent, providers should explain drug-testing protocols in full.

* Drug testing an adolescent without his or her consent is not appropriate, except in emergency situations (eg, accidents, suicide attempts, and seizures).

* Providers should acquire consent before drug testing an adolescent with symptoms such as school failure, fatigue, or excessive moodiness. Because these are not emergency situations, they are not hazardous enough to warrant skipping this step.

* If an adolescent refuses to consent to a drug test, the provider should clearly document refusal and continue to evaluate the possibility of SUD through other methods and refer the patient to a specialist with additional mental health or substance use expertise.

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Adolescent Confidentiality

* Before beginning the drug testing process, providers should ask the adolescent for permission to share the results with parents/guardians and discuss confidentiality with parents/guardians in order to encourage parental involvement.

* If an adolescent declines to share drug test results, the provider should not share them unless there is an acute risk of harm to the patient or others.

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Choosing a Test Panel for Adolescent Patients

* Drug test panels for adolescents should include the substances most used by the demographic.

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Responding to Positive Test Results

* If a positive definitive drug test result indicates that an adolescent is engaging in high-risk substance use, the provider should assist the patient and his or her parent or guardian in developing a plan for monitoring and treatment.

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Pregnant Patients

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Consequences and Confidentiality

* Providers should be aware of the adverse legal and social consequences of detecting substance use among pregnant women. They should familiarize themselves with local and state reporting requirements before conducting a drug test and relay this information to their patient before conducting a drug test.

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Screening, Assessment, and Monitoring

* Comprehensive substance use assessment, which may include drug testing, is part of obstetrical best practices. Providers working with this population should learn about and appropriately use clinical laboratory tests.

* For a pregnant patient with a history of addiction, providers should be aware that the postpartum period is a time of increased vulnerability. Therefore, assessment for relapse, which may include drug testing, should be part of the postpartum visit.

* Providers should keep drug test results and associated diagnoses confidential to the extent permitted by law.

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Patient-Provider Relationship

* When speaking with patients, providers should emphasize the therapeutic reasons for drug testing to avoid stigmatization.

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Test Considerations

* In a prenatal care setting, routine Screening and Brief Intervention for alcohol use should be conducted. Laboratory testing for alcohol use is not recommended except in cases of suspected or known risk factors for Alcohol Use Disorder.

* As pregnant women who use substances are less willing to disclose use of opioids and benzodiazepines than other substances, testing for opioids and benzodiazepines helps identify an often underreported behavior.

* Urine is an appropriate matrix for drug testing women who are pregnant.

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Test Results

* As a follow up to a presumptive positive test result, providers should use definitive tests to clearly identify individual drugs.

* Responses to positive drug test results can include: patient education, referral to treatment, and the creation of a treatment plan.

* Providers should be familiar with local treatment resources and programs for pregnant women.

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People in Recovery

* It is appropriate to conduct drug testing for a minimum of 5 years in healthcare settings for most patients in stable recovery. The frequency of drug testing for patients in stable recovery should depend on the severity and chronicity of the patient's addiction.

* It is appropriate for patients in stable recovery to receive periodic RMCs that include a drug-testing component.

* Immediate evaluation for treatment or treatment intensification as a response to a positive drug test result is appropriate for most patients in stable recovery.

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Health and Other Professionals

* Drug testing is especially useful in supporting recovery of individuals who have increased access to psychoactive substances, including healthcare professionals and professionals in safety sensitive positions. Additional testing should be considered for those in recovery who have significant occupational exposure to addictive substances.

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AREAS FOR FURTHER RESEARCH

Part 1: Principles of Drug Testing in Addiction Treatment

* Further research is needed on whether and how drug testing can be used to determine efficacy of and adjustments to treatment plans.

* Additional research is needed on the relationship between drug testing and functional status and other addiction treatment outcomes. Further research should include mediators and moderators of the relationship.

* More research is needed on the utility of clinical drug testing in populations where SUD is often identified, including primary care, emergency room, and pain management patients.

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Part 2: Process of Drug Testing in Addiction Treatment

* Significantly more research is needed on optimal testing frequency as well as the relationship between specific frequency and duration of drug testing and treatment monitoring and outcomes.

* Additional research is needed on how to utilize drug testing to detect novel and synthetic drugs (eg, cannabinoids, cathinones).

* While evidence suggests that random testing schedules are more effective than testing on a predictable timeline, further study is needed to determine whether there are situations where non-random testing is sufficient.

* Further and ongoing research is needed on which drugs should be included in drug test panels.

* Further research is needed on determinations of when a definitive test as follow up or in place of a presumptive test should occur.

* Additionally, more research is needed on the benefits of forgoing presumptive testing and beginning with definitive testing, and on discerning the roles of different kinds of definitive testing.

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Part 3: Additional Considerations for Drug Testing in Addiction Treatment

* More research on effective personnel training to increase the reliability of drug testing conducted at the point of care is needed.

* The development of appropriate cutoffs for POCT needs more research. Though manufacturer recommended cutoffs are generally more appropriate for workplace rather than clinical drug testing, producing guidelines for a clinical setting requires more information.

* Further research is needed on the effects of conducting onsite testing and interpretation versus routinely sending tests to a laboratory for results.

* Further research on the impact of insurer regulations and restrictions on drug testing, addiction treatment, and overall healthcare costs would be useful.

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Part 4: Biological Matrices

* Further research is needed to develop a protocol for evaluating sample tampering in UDT. Further research is also needed to clarify what methods should be employed to verify specimen validity in alternative matrices.

* Additional study is required to determine the detectability of cannabis use in multiple matrices, namely oral fluid and hair.

* Research is lacking on what substances’ metabolites can be helpfully detected through hair testing. More information on false positives, environmental adulterants, and detection windows would be beneficial.

* More research is needed on whether hair and nail testing is clinically useful in ascertaining substance use patterns and history.

* More research is needed on the utility of sweat testing in addiction treatment settings.

* Additional research is needed on oral fluid, including which specific drugs/metabolites oral fluid testing might best detect.

* Further research on tobacco testing in the context of addiction treatment would be useful.

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Part 5: Settings

* Further research is needed on the role of drug testing for identification of potential issues in primary care or other settings outside of addiction treatment such as mental health settings.

* Before making any specific recommendations of frequency or duration specific to level of care, further research should occur.

* Further research will be required to offer complete information regarding appropriate drug testing panels in OTS. The same applies to the role of drug testing in determining optimal dosing in the context of OTS.

* In the context of OTS, further research is needed on frequency of drug testing and on response to drug testing results.

* Further research is needed to determine whether testing frequency should vary between full agonists, partial agonists, and antagonists when treating addiction involving opioid use.

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Part 6: Special Populations

* While it is agreed that instances exist where an adolescent ought to be drug tested regardless of their own desires, the exact circumstances would benefit from further refinement.

* Further research is needed to determine what, if any, clinical benefit there is to routinely utilizing drug testing with pregnant women.

* Additional research is needed on what methods might be utilized to test for identification of alcohol use during pregnancy.

* Further research is needed on how widely the drug testing standards developed for PHPs could be applied to other addiction treatment programs.

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Appendix 1: Abbreviations and Acronyms

6-MAM 6-Monoacetylmorphine

AAP American Academy of Pediatrics

AGOC American Congress of Obstetricians and Gynecologists

ASAM American Society of Addiction Medicine

CLIA Clinical Laboratory Improvement Amendments

EtOH Ethyl alcohol or ethanol

EtG Ethyl glucuronide

EtS Ethyl sulfate

MRO Medical Review Officer

NIDA National Institutes of Drug Abuse

OBOT Office-Based Opioid Treatment

OTP Opioid Treatment Program

OTS Opioid Treatment Services

PCP Primary Care Physician

PHP Physician Health Program

POCT Point of Care Testing

RAM RAND/UCLA Appropriateness Method

SAMHSA Substance Abuse and Mental Health Services Administration

SBI Screening and Brief Intervention

SBIRT Screening, Brief Intervention, and Referral to Treatment

SUD Substance Use Disorder

UDT Urine drug testing

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Appendix 2: Glossary and Terms

Below are terms that are used throughout the appropriateness document. Note that some terms listed below are used to convey a specific meaning for the purposes of this appropriateness document (eg, “provider”).

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Terms and Definitions

Abstinence: Intentional and consistent restraint from the pathological pursuit of reward and/or relief that involves the use of substances and other behaviors. These behaviors may involve, but are not necessarily limited to, gambling, video gaming, spending, compulsive eating, compulsive exercise, or compulsive sexual behaviors. Note that patients in opioid agonist therapy may be considered abstinent if they are not pathologically pursuing the use of substances and other behaviors.

Adherence: Adherence is a term that health professionals have been using increasingly to replace the term “compliance.” Refers to how closely patients cooperate with, follow, and take personal responsibility for the implementation of their treatment plans. Often used with the more narrow sense of how well patients accomplish the goal of persistently taking medications, and also refer more broadly to all components of treatment. Assessment of patients’ efforts to accomplish the goals of a treatment plan is essential to treatment success. These efforts occur along a complex spectrum from independent proactive commitment, to mentored collaboration, to passive cooperation, to reluctant partial agreement, to active resistance, and to full refusal. Attempts to understand factors that promote or inhibit adherence/compliance must take into account behaviors, attitudes, willingness, and varying degrees of capacity and autonomy.

Adolescence: The American Academy of Pediatrics categorizes adolescence as the totality of 3 developmental stages—puberty to adulthood—which occur generally between 11 and 21 years of age.

Addiction: A primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits, caused by prior repeated drug use, leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors. Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one's behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.

Analyte: The component of a biological sample that is identified and measured. In drug testing, both parent drugs and the products of drug metabolism are targeted. Their presence indicates exposure to a substance or family of substances.

ASAM Criteria dimensions: The ASAM Criteria use 6 dimensions to create a holistic biopsychosocial assessment of an individual to be used for service planning and treatment. Dimension 1 is acute intoxication or withdrawal potential. Dimension 2 is biomedical conditions and conditions. Dimension 3 is emotional, behavioral, or cognitive conditions or complications. Dimension 4 is readiness for change. Dimension 5 is continued use or continued problem potential. Dimension 6 is recovery/living environment.

Collateral report: Information delivered by a third party, commonly a family member or partner, about a patient's substance use or signs of substance use.

Confounds: Any variable present in a drug testing process that prevents the accuracy of results. For example, eating a food that produces a false-positive result. The influence of a confound may be applied accidentally, as when a patient cannot produce a urine sample due to a shy bladder, or with intent, as when a patient dilutes a urine sample.

Conjugate: A compound produced by the chemical joining of at least 2 other compounds.

Contingency management: An evidence-based psychosocial intervention in which patients are given tangible rewards to reinforce positive behaviors such as abstinence. Also referred to as motivational incentives.

Continuing care: After completion of a formal addiction treatment program, aftercare is a stage of continued assistance to a person in recovery. Although intensity of care is reduced in this stage, the patient still has a support system and often may retain contact with a professional. Aftercare includes the development and use of skills and strategies for life in recovery.

Cross-reactivity: Immunoassays suffer from a lack of specificity, in that they will react to compounds with similar chemical structures. This is known as cross-reactivity. They target compounds present in the body for reasons other than the consumption of illicit substances. For example, consuming poppy seeds and drugs derived from the poppy plant will both metabolize to detectable amounts of morphine in the body.

Definitive testing: In contrast to presumptive testing, testing performed using a method with high sensitivity and specificity that is able to identify specific drugs, their metabolites, and/or drug quantities. Definitive testing is likely to take place in a laboratory and each individual test can be expensive. Gas or liquid chromatography combined with mass spectrometry is the gold standard method in definitive drug testing.

Drug testing: The process of analyzing a biological specimen to check for the presence of chemicals that indicate exposure to selected substances.

Expected test results: In the context of addiction treatment that includes medication (eg, buprenorphine) an expected test result is positive for prescribed medication and negative for other substance use.

False negative: The analytical failure to detect the presence of a drug or drug metabolite that is present in the specimen. A false negative on a screening immunoassay test can be discovered by confirmation testing using GC-MS or LC-MS/MS testing when these tests are used on samples that have been screened as negative.

False positive: The reporting of a positive drug or drug metabolite that is not present in the specimen. A false positive on a screening immunoassay test is often discovered by confirmation testing using GC-MS or LC-MS/MS testing.

Clinical false positive—Apositive test result caused by incidental or extraneous exposure to a substance.

Analytical false positive—Apositive test result caused by changes in the sample, which may be related to physical disease or conditions of the donor or improper or delayed storage, and others.

Federal cutoff concentrations: SAMHSA issues recommended drug test cutoff levels for the substances and substance metabolites tested during the standard workplace drug testing analysis. The standard focuses on the “SAMHSA Five,” the substances for which workplaces typically screen (amphetamines, cannabinoids, cocaine, opiates, and phencyclidine). This standard is not appropriate to apply to drug testing in the context of addiction treatment.

Fixed testing schedule: (See also: Random testing schedule) A predictable time when drug testing will occur, such as every Monday or every 10 days. This is discouraged as patients can use knowledge of the routine to strategically use substances on days when the detection risk is smallest.

General healthcare setting: A widely defined term in this document indicating a setting where healthcare is provided that is not primarily an addiction treatment service.

Induction (office and home): The phase of opioid treatment during which maintenance medication dosage levels are adjusted until a patient attains stabilization. Buprenorphine induction may take place in an office-based setting or home-based setting. Methadone induction must take place in an OTP.

Level of care: Section 4 of the appropriateness document addresses the use of drug testing across the ASAM Levels of Care, which are listed below. In addition to the 5 broad Levels of Care, the section addresses drug testing in OTS, and when medications are used to treat addiction involving opioid use in primary care settings.

0.5—Early Interventions

1.0—Outpatient Services

2.0—Intensive Outpatient/Partial Hospitalization Services

3.0—Residential/Inpatient Services

4.0—Medically Managed Intensive Inpatient Services

Opioid Treatment Service

Maintenance: Pharmacotherapy on a consistent schedule for persons with an addiction, usually with an agonist or partial agonist, which mitigates cravings and withdrawal symptoms. Maintenance treatments are also designed to mitigate against the risk of overdose. Depending on the individual, these treatment plans can be time-limited or remain in place lifelong. Methadone, buprenorphine, and naltrexone are among medications prescribed.

Matrix (matrices): The biological material used for analysis in a drug test. Examples include blood, urine, oral fluid (spit/saliva), hair, nails, sweat, and breath.

Medical Review Officer (MRO): A physician trained and certified to interpret drug test results and to validate the testing process. To become a certified MRO, physicians must take an in-person training course. Their training includes collection procedures for urine specimens; chain of custody, reporting, and record keeping; and interpretation of drug and validity tests results. Re-certification must be undergone every 5 years. This is a federally defined role.

Medical Toxicologist: A physician trained in this formal medical subspecialty has focused training in the diagnosis, management and prevention of adverse health effects due to medications, occupational and environmental toxins, biological agents, and clinical evaluation of patients.

Metabolite: A product of the metabolism or metabolic process. Urine drug tests typically identify the presence of 1 or more metabolites that can originate in a potentially addictive substance.

Negative Test Result (See also: Positive test result): The result reported by a test that fails to detect the presence of a target substance in a sample. This can indicate either a complete lack of the drug or drug metabolite or a level too low to be detected by the test. In this document, a “negative test result” refers to a test result showing no use of non-prescribed addictive substances. However, in the context of addiction treatment that includes medication, the terms positive and negative have been replaced with “unexpected” and “expected.”

Office-Based Opioid Treatment (OBOT): Physicians in private practices (and Nurse Practitioners and Physician Assistants who have recently been given the authority to prescribe under the 2016 Comprehensive Addiction and Recovery Act) or a number of types of public sector clinics can be authorized to prescribe outpatient supplies of the partial opioid agonist buprenorphine. There is no regulation per se of the clinic site itself, but of the individual physician who prescribes buprenorphine.

Opioid Treatment Program (OTP): A program certified by the United States, Substance Abuse and Mental Health Services Administration (SAMHSA), usually comprising a facility, staff, administration, patients, and services, that engages in supervised assessment and treatment, using methadone, buprenorphine, or naltrexone, of individuals who are addicted to opioids. An OTP can exist in a number of settings including, but not limited to, intensive outpatient, residential, and hospital settings. Services may include medically supervised withdrawal and/or maintenance treatment, along with various levels of medical, psychiatric, psychosocial, and other types of supportive care.

Opioid Treatment Services (OTS): An umbrella term that encompasses a variety of pharmacological and nonpharmacological treatment modalities. This term broadens understanding of opioid treatments to include all medications used to treat opioid use disorders and the psychosocial treatment that is offered concurrently with these pharmacotherapies. Pharmacological agents include opioid agonist medications such as methadone and buprenorphine, and opioid antagonist medications such as naltrexone.

Patient: Used throughout the appropriateness document, this term is intentionally broad. It encompasses anyone who receives care for an addiction in a specialty addiction treatment center or other healthcare setting.

Point of Collection Tests/Point of Care Tests (POCT): A drug test performed at the site where the sample is collected using either an instrumented or non-instrumented commercial device (eg, a, immunoassay test strip or dipstick or machine-based immunoanalyzer); in distinction to a laboratory-developed test. (A POC test is often referred to as an “instant test”; “home drug test” kits purchasable by laypersons are also POC tests).

Positive Test Result: The result reported by a test that detects the presence of a target substance in a sample. In this document, a “positive test result” refers to a test result showing the use of non-prescribed addictive substances. However, in the context of addiction treatment that includes medication, the terms positive and negative have been replaced with “unexpected” and “expected.”

Presumptive Testing: In contrast to definitive testing, testing performed using a method with lower sensitivity and/or specificity which establishes preliminary evidence regarding the absence or presence of drugs or metabolites in a sample. The results of presumptive tests are qualitative in that they detect the presence or absence of particular compound, but not their quantity. Immunoassays are good at identifying true negative samples (high sensitivity) and are therefore well suited for use as a screen to eliminate cases from further analysis.

Provider: Used throughout the appropriateness document, this term is intentionally broad. It encompasses anyone who participates in providing care to patients with addiction, including staff at specialty addiction treatment centers or other healthcare settings that provide addiction treatment.

Random Testing Schedule: (See also: Fixed testing schedule) A recurring drug testing plan with varying amounts of days between testing that cannot be predicted. Clinical consensus favors random testing schedules to fixed testing schedules. A random schedule can eliminate “safe” periods where a patient might choose to use without detection.

Recovery: The process of sustained action that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction. This effort is in the direction of a consistent pursuit of abstinence, addressing impairment in behavioral control, dealing with cravings, recognizing problems in one's behaviors and interpersonal relationships, and dealing more effectively with emotional responses. Recovery actions lead to reversal of negative, self-defeating internal processes and behaviors, allowing healing of relationships with self and others. The concepts of humility, acceptance, and surrender are useful in this process.

Recovery residence (RR): Recovery residence is a broad term describing a sober, safe, and healthy living environment that promotes recovery from alcohol and other drug use and associated problems. At a minimum, RRs offer peer-to-peer recovery support with some providing professionally delivered clinical services all aimed at promoting abstinence-based, long-term recovery

Reflex testing: A practice where a laboratory automatically performs definitive testing on positive presumptive results for the purposes of refining the information the sample can provide. If a laboratory does not practice “reflex testing,” this action requires an additional order from the provider.

Relapse: A process in which an individual who has established abstinence or sobriety experiences recurrence of signs and symptoms of active addiction, often including resumption of the pathological pursuit of reward and/or relief through the use of substances and other behaviors. When in relapse, there is often disengagement from recovery activities. Relapse can be triggered by exposure to rewarding substances and behaviors, by exposure to environmental cues to use, and by exposure to emotional stressors that trigger heightened activity in brain stress circuits. The event of using or acting out is the latter part of the process, which can be prevented by early intervention.

Sample/specimen: The biological substrate that is submitted to be tested. A “sample” refers to the part collected from a patient for testing (part of a whole). A “specimen” refers to what is analyzed (the sample becomes its own entity).

Sample tampering: This term refers to any deliberate attempt to falsify drug test results. Examples of tampering would include dilution of the sample, adulteration through addition of various substances to the sample, or substitution with a sample from another person.

Sensitivity: Also called the “true positive rate” or the “recall rate” in some fields, sensitivity measures the proportion of actual positives which are correctly identified as such (eg, the percentage of sick people who are correctly identified as having the condition). Sensitivity refers to the likelihood that a given test is able to detect the presence of a drug or metabolite that is actually in the specimen.

Specificity: Measures the proportion of negatives that are correctly identified as such (eg, the percentage of healthy people who are correctly identified as not having the condition, sometimes called the “true negative rate”). Specificity refers to the likelihood that a given test is able to identify the specific drug or metabolite of interest in the specimen and not to erroneously label other drugs or metabolites falsely.

Stabilization: Includes the medical and psychosocial processes of assisting the patient through acute intoxication and withdrawal to the attainment of a medically stable, fully supported, substance-free state. This often is done with the assistance of medications, though in some approaches to detoxification, no medication is used.

Substance use: Used instead of “drug use” or “drug and alcohol use,” this term refers to the use of psychoactive drugs, which may include illegal drugs, medications, or alcohol. This does not refer to nicotine.

Substance use disorder (also substance-related disorder) (SUD): This term is used as defined in the Diagnostic and Statistical Manual 5 (DSM-5). It is abbreviated here as “SUD.”

Substitution: when a previously collected biological specimen is used in place of a specimen collected at the time of the drug test. For example, if a donor provides previously collected urine (from herself or someone else, or even non-human urine) in place of their own urine at the time of the test.

Toxicology screening: Also called “toxicology testing,” this term refers to the process of testing for the presence of toxins or poisons. Clinical drug testing in addiction treatment settings has different aims than does toxicology screening in emergency medical settings or intensive care settings, and thus should not be referred to as “toxicology screening” or “toxicology testing.”

Treatment plan: A therapeutic strategy that may incorporate patient education, drug therapy, and the participation of health professionals. Treatment plans are especially important in the optimal management of complex or chronic illnesses such as addiction.

Unexpected test results: In the context of addiction treatment that includes medication (eg, buprenorphine), an unexpected test result could be a) negative for prescribed medication, b) positive for other substance use or c) both.

Validity testing: A test used to determine if a specimen is adulterated, diluted, substituted, or otherwise invalid.

Window of detection: The range of time that a substance can be detected in a biological sample given the cutoff values for the test being performed. It refers both to the time to detection (time to be absorbed and distributed to sample material) and time to clearance (time to be metabolized/eliminated/excreted). A test conducted before the substance or its metabolites have adequately entered the biological sample reads as negative. Each matrix and analyte has a different window of detection, ranging from minutes to months.

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Appendix 3: Methodology

Appropriateness Document Versus Clinical Guideline

In March 2016, ASAM contracted with the Institute for Research, Education, and Training in Addiction (IRETA) to develop an appropriateness document addressing drug testing in the context of addiction treatment using the RAND/UCLA Appropriateness Method (RAM). The RAM is ideal for the identification of under use or overuse of specific clinical procedures or tests, as well as in situations where rigorous clinical trials are lacking.

The purpose of this appropriateness document is to determine when, where or how often a drug test should be performed for the identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction. The document takes into account:

Available scientific evidence;

Individual patient characteristics;

Risk/benefit of testing;

Available healthcare resources.

Clinical guidelines, on the other hand, typically focus on either more generalized or disease-specific recommendations—such as ASAM's National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use.

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Overview of Approach

The RAND/UCLA Appropriateness Method provides a specific process for combining the best available scientific evidence with the collective clinical judgment of field experts to arrive at recommended practices. The RAND/UCLA Appropriateness Method is ideal for the identification of under use or overuse of specific clinical procedures or tests, as well as in situations where rigorous clinical trials are lacking. This use of the RAND/UCLA method will produce a set of appropriateness statements regarding the use of drug testing in the identification, diagnosis, treatment and promotion of recovery for patients with, or at risk for, addiction.

ASAM's Quality Improvement Council (QIC) was the oversight committee for the development of the appropriateness document. The QIC appointed a 11-member expert panel to participate throughout the development process, rate treatment scenarios, and review the draft document. In selecting the panel members, the QIC made every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities among members of the expert panel. All QIC members, expert panel members, and external reviewers of the document were required to disclose all current related relationships, which are presented in Appendices 6 and 7.

The expert panel was comprised of experts and researchers from multiple disciplines, medical specialties, and subspecialties, including academic research, internal medicine, adolescent medicine, pain medicine, emergency medicine, medical toxicology, anesthesiology, psychiatry, and obstetrics/gynecology. Physicians with both allopathic and osteopathic training were represented. Furthermore, the panel members represented a range of practice settings including OTPs, physician health programs, private practice, and academic medical centers. The expert panel was assisted by a technical team from IRETA. The moderator and medical advisor was selected by the IRETA project team and approved by the QIC.

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Task 1: Collecting Existing Research and Guidelines and Policies

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Review of Existing Clinical Guidelines

Existing clinical guidelines were located primarily via a structured internet search with the keywords “drug testing,” “guidelines,” and “insurance.” Treatment Improvement Protocols (TIPs) and Technical Assistance Publications (TAP) published by the Substance Abuse and Mental Health Services Administration (SAMHSA) were utilized. Publications by authoritative professional societies, including the American Society of Addiction Medicine (ASAM), the American Academy of Pediatrics (AAP), and the American College of Obstetrics and Gynecologists (ACOG) were also consulted. References from these existing guidelines were consulted to locate additional resources (see Appendix 5 for a complete list of clinical guidelines reviewed).

Overall, the review of existing guidelines revealed that numerous consensus panels and expert groups have offered guidance on the use drug testing for patients with addiction. However, with the notable exceptions of SAMHSA's TIP 40 and TIP 43, very few of these guidelines address specific levels of care.

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Review of Existing Payer Policies

Although not typically evidence-based, a representative sample of payer policies was consulted, to provide information about the patient populations, and types and frequency of drug testing currently being reimbursed in clinical care. ASAM provided suggestions of payer policies to review. Overall, the review of selected payer policies demonstrated that there is a wide range of drug-testing services that are considered medically necessary or reimbursable by insurance plans. Statements from representative payer policies were selected and incorporated into the draft appropriateness statements.

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Review of Research Literature

A review of empirical evidence regarding drug testing in clinical contexts for people with addiction was conducted. Relevant research was identified in the PubMed database using the MeSH search terms Substance-Related Disorders and Substance Abuse Detection. To capture the most up-to-date findings for the field's rapidly evolving detection capabilities, the search was limited to articles published in the previous 10 years. Earlier papers important to the field were identified through reverse citation search and included in the development of statements, but not the literature review. In order to have a complete picture of relevant research on this topic, this review was not limited to randomized controlled trials or similarly rigorous methodologies; it included cohort studies and case studies [72]. Of the 866 articles identified, 113 were retained following a title and abstract review for relevance to the topic of biological detection of addictive substances in an appropriate population or setting.

The literature review sought to evaluate the state of the research literature on drug testing in the identification, diagnosis, treatment, and monitoring of patients with, or at risk for, addiction. Overall, the literature review revealed that drug testing has rarely been examined for its value as a clinical intervention. Many research studies include drug testing as an outcome measure of treatment adherence or progress, but few examined whether and how drug testing itself works to improve outcomes for patients with addiction (Fig. 1).

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Task 2: Development of Statements

To develop the appropriateness statements, a 1-day meeting was held with the project team and Medical Advisor. During this meeting, the team discussed the reviews of existing clinical guidelines, payer policies and research literature. Statements in these existing publications pertaining to the appropriate use of drug testing in the identification, diagnosis, treatment, and monitoring of patients with, or at risk for, addiction were identified and discussed.

Each appropriateness statement was rated by the project team on quality of clinical consensus and empirical evidence. A high clinical evidence rating was reserved for statements supported by multiple sources. A high empirical evidence rating was reserved for statements emerging from multiple studies using rigorous study methodology (eg, randomized control trials).

There were some clinical areas relevant to addiction treatment settings where adequate empirical evidence or existing clinical recommendations were not found (eg, certain levels of care). In these situations, appropriateness statements were generated in conjunction with the Medical Advisor and the lack of the existing evidence was clearly documented.

The statements and supporting evidence ratings were organized in an appropriateness statement document.

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Task 3: Development of the Background Paper

A background paper was developed as a companion piece to the appropriateness statement document. It was organized in direct parallel to the statement document, with each statement or set of statements in the appropriateness statement document corresponding to a description of the statement's source and the strength of evidence.

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Task 4: Expert Rating, First Round

Each expert rated the appropriateness of each statement on a 1 to 9 Likert scale, where 1 = the statement is extremely inappropriate, 5 = uncertainty or neutrality about the appropriateness of the statement and 9 = the statement is extremely appropriate. Appropriateness refers to whether the expected benefit of following the statement outweighs any anticipated risks by a sufficiently wide margin that it is worth following the statement [72]. The experts were asked to use their own best clinical judgment (rather than perception of what other experts might say) considering an average patient presenting to an average provider who performs drug testing in an average setting that provides care for patients with addiction. Some sections pertained specifically to special populations or settings; the experts were made aware of appropriateness statements intended for specific populations or settings.

Panel members were encouraged to refer to the background paper for a discussion of each appropriateness statement and the clinical or empirical evidence supporting it. Panel members were also encouraged to make comments and suggest changes that could be made to improve each statement and identify gaps in the statements.

Each statement was classified by Appropriateness (“inappropriate,” “uncertain,” or “appropriate”) in accordance with the panel's median score and by Agreement (“agree” or “disagree”) in accordance with the distribution of panel's scores. Statements with median scores in the 1 to 3 range were classified as inappropriate, those in the 4 to 6 range as uncertain, and those in the 7 to 9 range as appropriate. Statements with no more than 2 panelist ratings outside of the Appropriateness category were classified as with agreement and those with 3 or more panelist ratings outside the Appropriateness category as with disagreement. The “three or more” cutoff for disagreement is commonly used for panel sizes of 8 to 10 members. It indicates that at least one-third of the panelists view a statement differently than (at least) another one-third of the panelists.

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Task 5: Expert Panel Meeting

The 11-member expert panel came together for a 2-day meeting to discuss their ratings, focusing on statements about which they disagreed. The goal of the discussion was to discern whether discrepant ratings were due to real clinical disagreement or to fatigue or misunderstanding (“artifactual” disagreement). The expert panel was encouraged to modify statements and suggest additional statements during the discussion.

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Task 6: Expert Rating, Second Round

After the expert panel meeting, each expert rated the appropriateness of the subset of previously disagreed upon or uncertain statements, as well as the new statements that were constructed, on a 1 to 9 Likert scale, where 1 = the statement is extremely inappropriate, 5 = uncertainty or neutrality about the appropriateness of the statement and 9 = the statement is extremely appropriate. A summary of the statements, their final ratings and associated evidence is included in the evidence table, which is a separate supplemental document.

The RAND/UCLA Method provides for a third round of rating for necessity. Necessity refers to practices that must be offered to patients fitting a particular clinical description, in that it would be considered improper care not to offer them. Hence, necessity is a more stringent criterion than appropriateness, and was premature to address in the context of drug testing for addiction treatment.

There is an urgent need for further research in several aspects of drug testing in addiction treatment. A section entitled Areas for Further Research was developed based upon the literature review, areas yielding little agreement among the expert panel, and input from all stakeholders.

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Task 7: Compilation of the Appropriateness Document

The first draft of the appropriateness document was created and sent to the expert panel and ASAM staff. During a subsequent teleconference held in January 2017, ASAM shared feedback with the project team regarding the document, and a revised version was provided.

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Task 8: External Review

ASAM directed an external review of the appropriateness document. Input was solicited from ASAM members; stakeholders including experts from the addiction treatment community, professional societies and others. The document was also available on the ASAM website for the public at large to review and submit comments. The external review period was conducted from February 3, 2017 to February 28, 2017.

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ASAM Policy on Document Updates

Board approved clinical documents will be considered for reaffirmation, update, or sunset at least every 5 years based on a review of published literature since the document was published; FDA decisions (eg, new product approvals or labeling changes); or other significant practice or policy developments. Based on the QIC's review, it will determine if the revisions require a full update. Clinical documents should go through a full update when new evidence suggests the need to modify clinically important recommendations. This would be particularly true if new evidence shows that a recommended intervention causes previously unknown substantial harm, or that a new intervention is significantly superior to a previously recommended intervention, or that a recommendation can be applied to new populations. Final Board approval will be required for all document modifications.

The QIC will consider focused updates for guidelines every 2 years when advancements in addiction research and practice warrant. This will include a review of the literature and inclusion of any new drug formulations or information in medical research or practice that requires a focused update. The QIC may, at its discretion, choose to consider a focused update sooner, if important changes have taken place that affect selected recommendations and clinical practice would benefit from selected updates when a complete update may not be necessary. More specifically, the following scenarios can be used to determine the type of focused updates needed:

* Scenario 1: No new evidence. Insert box at top of guideline that summarizes literature search including dates and number of abstracts reviewed, and indicates no new evidence identified and thus no changes to recommendations. Approval by QIC and Guideline Committee chair. To Executive Committee of Board of Directors for final approval.

* Scenario 2: New evidence/no change to recommendations. Summary of search and review, plus include a list of relevant references identified. Approval by QIC and Guideline Committee chair. To Executive Committee of Board of Directors for final approval.

* Scenario 3: New evidence/recommendations change. Current review and approval process for substantive updates and publication in print and online versions of journal. For recommendations that require input from the Guideline Committee, they will go through a similar process that was used to develop the original recommendations. All changes need to be reviewed and approved by chairs of the QIC and Guideline Committee. To Executive Committee of Board of Directors for final approval.

* Scenario 4: Ad hoc, rapid update. New evidence or treatment practice/change to recommendations. Publish a focused update with notice in journal with summary of key new evidence. Would allow for more rapid change to a guideline without a formal, comprehensive literature search and review. Change would be made to selected recommendations based on relevant published high-impact evidence or regulatory decisions. All changes need to be reviewed and approved by chairs of the QIC and Guideline Committee. If warranted, they may also need to go to the Guideline Committee for review. To Executive Committee of Board of Directors for final approval.

If the recommendations have changed, all changes to the full guideline will be made online using a different font or italics. The associated resources, including the pocket guide, phone app, and slide deck will also be updated.

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Appendix 4: Windows of Detection Table

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Appendix 5: Clinical References

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Appendix 6: ASAM Expert Panel and Quality Improvement Council Disclosures

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Appendix 7: External Reviewer Relationships With Industries and Other Entities

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