SUBSTANCE ABUSE
Drug tests identify specific drugs, drug classes, and drug metabolites in the body fluids or tissue; they are a commonly utilized tool in the treatment of individuals with drug addiction. Drug tests are often used to identify drug use, misuse, diversion, or a suspected substance use disorder or relapse. According to the 2010 policy statement by the American Society of Addiction Medicine (ASAM), urine drug testing (UDT) is a useful diagnostic and therapeutic tool in the care and management of individuals treated for addiction.
PAIN MANAGEMENT
According to the American Society of Interventional Pain Physicians (ASIPP), approximately one third of individuals receiving treatment for chronic pain do not use opioids as prescribed. Because of its noninvasive collection and the ability to test for a wide range of drugs on test panels, urine testing is the most commonly used method for monitoring individuals who are most likely to deviate from treatment protocol.
A 2013 systematic review of guidelines that address management of opioid use for chronic pain identified nine guidelines with recommendations on UDT. The recommendations varied widely; two guidelines recommend mandatory testing for all patients, one recommends testing only individuals at increased risk of medication abuse, and two state that testing patients at low risk of abuse is not cost-effective. If UDT is used, the commended frequency of follow-up testing was at least quarterly in one guideline, at least yearly in one guideline, and randomly in two guidelines.
ASIPP recommends implementation of UDT both for monitoring and for decreasing prescription drug abuse or illicit drug use in individuals receiving chronic pain management. Management of individuals in pain management and substance abuse treatment settings typically comprises a multifaceted approach. Prior to drug testing, an individual's full informed consent and written agreement on monitoring is generally required. According to the Joint Guidelines by the U.S. Department of Veteran’s Affairs (VA) and Department of Defense (DOD), an individual's refusal to consent to regular urine testing should be considered a factor in the overall assessment of the patient’s ability to adhere to treatment. An individual is most likely to relapse during the Stabilization Phase, which typically lasts for the first 4 weeks after initiating treatment, rather than during the Maintenance Phase. The Joint Clinical Practice Guidelines for Management of Opioid Therapy for Chronic Pain by the VA/DOD recommend periodic random urine drug tests to confirm adherence to the treatment plan with increased frequency based on the individual's risk level. The 2010 Canadian Guidelines for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain also recommend the use of urine drug screening to establish a baseline measure of risk and monitoring for compliance.
EXAMPLES OF DRUG CLASSES IN PAIN MANAGEMENT AND SUBSTANCE ABUSE FOR WHICH DRUG TESTING MAY BE USED
OPIOIDS
Opioids are a class of pain medications generally used for moderate to severe chronic pain and are commonly delivered intravenously, orally, or topically. Common opioids used to treat chronic pain include codeine, oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, and pentazocine.
NON-OPIOID ANALGESICS
Non-opioid analgesics are pain medications typically prescribed for mild to moderate pain and may be taken in combination with opioid medication. Non-opioid analgesics may be short acting or long acting, and include medications such as ibuprofen and other nonsteroidal anti-inflammatory drugs.
SKELETAL MUSCLE RELAXANTS
Skeletal muscle relaxants are centrally acting agents that may be used for either treatment of spasticity or treatment of musculoskeletal conditions. Typically, the mechanism of action may differ between classes of skeletal muscle relaxants. Common skeletal muscle relaxants are baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, dantrolene, metaxalone, methocarbamol, orphenadrine, and tizanidine.
AMPHETAMINES
Amphetamines are stimulant medications often prescribed to treat attention deficit hyperactivity disorder and can be taken in tablet or capsular forms with varying dosage. Other types of amphetamines, such as speed or crystal methamphetamine, are produced illegally.
CANNABINOIDS
Cannabinoids are natural compounds and can be classified as phytocannabinoids, which are substances produced from plant leaves, flowers, stems from the Cannabis sativa plant, and are ingested; purified cannabinoids, which are naturally occurring from purified plant sources (e.g., tetrahydrocannabinol [THC] or cannabidiol [CBD]); or synthetic cannabinoids, which are analogues of natural cannabinoids that are chemically synthesized. Synthetic cannabinoids are classified as a Class I substance and are illegal to possess, sell, and use.
CATEGORIES AND METHODS OF DRUG TESTING
Although drugs can be identified in any specimen (e.g., urine, blood, oral fluid, hair, nails, sweat, and breath), the most common specimen for testing is urine.
There are two primary categories of drug testing: Presumptive and Definitive. Presumptive drug tests detect the presence or absence of drug or drug classes; they do not typically indicate a specific level of drug but rather give a positive or negative result. Definitive drug tests are typically considered the gold standard of confirmatory testing. Unlike presumptive tests, these tests are able to quantify the amount of drug or metabolite present in the sample. In most cases, an individual’s current drug use is verified by an initial drug screen prior to receiving pain management or substance abuse treatment. Relapse during the early stages of treatment (e.g., Stabilization Phase) is more common than during the Maintenance Phase; therefore, individuals in the Stabilization Phase may require more frequent drug testing. Although most guidelines and clinicians believe routine monitoring of individuals receiving treatment should be incorporated into the treatment plan, a general consensus on optimal frequency and interval of testing has not yet been established.
Other methods of drug testing are being investigated, including oral fluid testing and hair testing.
In oral fluid testing, the liquid samples are obtained from the oral cavity. The matrix of the sample obtained vary depending on the collection method used (e.g., spitting, suctioning, draining, or collection on some type of absorbent material). Concentration of drug in the matrix may also vary depending on the method used to recover oral fluid form the collection device (e.g., centrifugation or by applying pressure). Whereas oral fluid testing may have some practical advantage to urine testing, in that samples can be obtained under direct supervision and without the loss of privacy, oral fluid testing may not reflect blood levels, as there may be a residual amount of drug (specifically those ingested or smoked) remaining in the oral cavity after recent use.
A total of three studies have compared oral fluid testing and urine testing using paired samples collected concurrently to evaluate the diagnostic accuracy of oral fluid testing to urine testing in pain management patients or substance abuse patients. The studies report sensitivities in the range of 75% to 100% with variability in the sensitivity by type of drug and specificities greater than 90% across different drugs. No studies were identified on the clinical utility of oral fluid testing in pain management or substance abuse treatment.
Hair is made up of proteins that trap chemical in the blood at the time the hair was made in the hair follicle. As human hair is expected to grow 1.5 inches per month, a 1.5-inch sample can be used to reveal drug use during the previous 90-day period. While this method of testing is noninvasive and easy to collect, variations in the hair texture as well as cosmetic hair treatments can affect drug incorporation in hair and the accuracy of drug tests on hair samples. Additionally, hair testing cannot detect recent drug use (i.e., within the past 7 days); it is difficult to detect single episodes or light drug use; and a positive result could be caused by environmental exposure. There are no studies comparing the diagnostic accuracy of hair testing to urine testing in a substance abuse or pain management setting; however, a relatively small study of hair testing in individuals beginning psychiatric treatment was compared to urine testing. The hair analysis revealed a higher prevalence of drug use than urine for most drugs as the hair analysis detected drug use anytime during the past several months, while urine analysis detected drug use in the past several days. Therefore, hair testing cannot detect recent drug use and thus has limited applicability to pain management or substance abuse treatment setting.
Overall, the current published evidence does not permit a conclusion on the impact of hair or oral fluid drug testing on clinical outcomes. Based on the available evidence and clinical practice guidelines, UDT may be useful under certain circumstances when criteria are met.
SPECIMEN VALIDITY/ADULTERATION TESTING
Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted may include, but is not limited to, pH, specific gravity, oxidants, and creatinine.
Urine for clinical drug testing is the specimen of choice because of its high drug concentrations and well-established testing procedures. Nevertheless, urine is one of the easiest specimens to adulterate. Urine samples can be diluted, swapped for another individual’s, or tampered with using commercially available or homemade products that change the chemical profile of the urine. If the clinician suspects that a sample has been adulterated, substituted, swapped, or otherwise altered in attempt to defeat evaluation and monitoring, the clinician may choose to evaluate specimen validity using built-in validity tests such as temperature, creatinine, and pH readings, or to witness collection (if no alternative matrix sampling is available such as blood or saliva). Most basic urine immunoassays have specimen validity checks built in to the screening process and allow for a basic determination of potential urine sample tampering (dilution, substituted specimen, etc.). Pain management laboratories may have specimen validity testing protocols. However, these too are deemed quality-control measures.
PANEL DRUG TESTS/TESTING (INCLUDING PROPRIETARY TESTS)
Panel Drug Tests/Testing, including proprietary tests, lack published peer-reviewed data regarding analytic validity; therefore, technical accuracy and precision for them cannot be established. Clinical validity data are typically missing to evaluate any specific and proprietary features (e.g., algorithm and/or index) of these tests. Additionally, high-quality clinical studies are still warranted to gain data regarding clinical utility of these tests.
SUMMARY
Individuals in pain management programs and substance abuse treatment may misuse prescribed opioids and/or may use nonprescribed drugs. Thus, these individuals are often assessed before treatment and monitored while receiving treatment. UDT can be part of this monitoring strategy; it is most often used as part of a multifaceted intervention that includes other components such as individual contracts.
For individuals who have chronic pain treated with opioids and who undergo UDT, the evidence includes nonrandomized comparative studies and a systematic review. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. There is insufficient evidence on diagnostic accuracy. No randomized controlled trials (RCTs) evaluating clinical utility were identified. Several nonrandomized comparative studies have provided inconclusive evidence on whether UDT in the pain management setting improves outcomes for individuals. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have a drug addiction and are in substance abuse treatment and undergo UDT, the evidence includes two RCTs. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. No studies were identified that evaluated the accuracy of UDT compared with a valid reference standard in individuals undergoing substance abuse treatment. One RCT focused specifically on testing to determine eligibility for take-home methadone. The second RCT found that UDT identified drug use in a substantial number of individuals who denied illicit usage; the impact on treatment success was not addressed. The evidence is insufficient to determine the effects of the technology on health outcomes.
Clinical inputs appear to indicate that UDT is standard of care and support the medical necessity of UDT under certain circumstances with defined protocols and algorithms. In 2010, the American Society of Addiction Medicine (ASAM) issued an updated policy statement (from 2005) on drug testing in the substance abuse treatment programs (an update since then could not be located). As stated therein, it is ASAM policy that: “Urine drug testing [UDT] is a key diagnostic and therapeutic tool that is useful for patient care and in monitoring of the ongoing status of a person who has been treated for addiction. As such, it is a part of medical care, and should not face undue restrictions.” Thus, UDT may be considered medically necessary in selected situations with established planning, and finite parameters for routine testing contributing to clinical care.
For individuals who have chronic pain treated with opioids or have a drug addiction and are in substance abuse treatment and receive oral fluid drug testing, the evidence includes diagnostic accuracy studies using UDT as the reference standard. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. The limited number of studies on diagnostic accuracy of oral fluid testing compared with UDT had variable findings. No studies were identified assessing the impact of oral fluid testing on health outcomes compared with UDT or no drug testing. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have chronic pain treated with opioids or have a drug addiction and are in substance abuse treatment and receive hair drug testing, the evidence includes one diagnostic accuracy study in the psychiatric treatment setting. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. Hair testing cannot detect recent drug use (i.e., in the past few days) and thus has limited applicability to pain management or substance abuse treatment settings, except, perhaps, for initial intake. There are no studies comparing the diagnostic accuracy of hair testing compared to UDT in either setting. However, one relatively small study tested the hair and urine of known drug users recruited from a psychiatric clinic. The study looked for drug use over the past several months rather than the shorter time frame generally needed in pain management or drug treatment settings. No studies were identified on the clinical utility of hair testing in pain management or substance abuse treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.
In April 2017, ASAM’s expert panel and Quality Improvement Council et al. (with endorsement by American College of Medical Toxicology), published a consensus statement on Appropriate Use of Drug Testing in Clinical Addiction Medicine. “… 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.”
In addition to other evidentiary limitations for routine clinical uses, there is insufficient reliable evidence that panel drug tests/testing, including proprietary tests, result in net health improvements.