Pain Medicine 2014; 15: 1999–2002 Wiley Periodicals, Inc.
Ethics Forum Urine Drug Screening: Necessary or Alienating? Pain medicine holds a unique and dubious distinction as one of the most regulated area of medical practice . The government has directly and indirectly mandated that when opioids are involved, the prescriber possesses dual roles as care provider and police. Indeed, urine drug screening in opioid-prescribed patients is strongly recommended in both state and national guidelines as an aspect of diligent opioid risk mitigation . Various reasons underlie the urine drug screening recommendation. Protecting the patient is one rationale; ideally, early detection of aberrant behaviors will lead to proper treatment and strategies to reduce potential patient harm. However, another rationale for drug testing involves protecting society, and therefore extends beyond the scope of the patient. Such rationales provide ripe fodder for discussion of the ethics involved in patient care policy, and allow for appreciation of the benefits of urine drug screens as well as the potential unintended consequences. How may the issues of individual and society safety be balanced through policies of urine drug screening? Given that patients’ levels of overall satisfaction with pharmacological treatment of chronic pain is far from optimal , we must ask how mandatory urine drug screening might flavor their opinion of their doctor and therefore their overall satisfaction with their pain care. This edition of the Ethics Forum discusses the ethical ramifications of urine drug screens—performed in their most common form at point of care testing by the cup— through two disparate views on the topic, both presented by highly esteemed experts in the field. The position against urine drug screening is presented by Drs. Daniel Goldberg and Benjamin Rich, both of whom are bioethicists as well as attorneys. The position in favor of urine drug screening is taken by Dr. Peggy Compton, a clinician and established researcher on opioid risk mitigation. BETH D. DARNALL, PhD* and MICHAEL E. SCHATMAN, PhD, CPE† *Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Palo Alto, California; †Foundation for Ethics in Pain Care, Bellevue, Washington, USA References 1 Kulich R, Loeser JD. The business of pain medicine: The present mirrors antiquity. Pain Med 2011;12: 1063–75. 2 Manchikanti L, Atluri S, Trescot AM, Giordano J. Monitoring opioid adherence in chronic pain patients: Tools, techniques, and utility. Pain Physician 2008; 11:S155–80.
3 Jouini G, Choinie`re M, Martin E, et al. Pharmacotherapeutic management of chronic noncancer pain in primary care: Lessons for pharmacists. J Pain Res 2014;7:163–73.
Trust but Verify Addiction is a disease of behavior. Substances with abuse liability not only engage powerful midbrain reward pathways but “hijack” frontal lobe motivational and decision-making systems, such that essentially all intentional behaviors increasingly center on obtaining and using the drug . As reflected in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for substance abuse disorders , the ability to engage in functional behaviors is severely limited, with the inability to control substance use being diagnostic of the disorder. Thus, to treat the disease of addiction, interventions aimed at increasing behavioral control over use are among the most effective . Early in remission, or in situations in which the risk of relapse is high, substance abusers are often best supported by controls external to their own behavior, as other strategies are likely to fail for them. In addiction treatment, urine toxicology is a commonly used external control, not to sanction patients for continued substance use but to evaluate behavioral control over use . Certainly, long-term exposure to opioids for the treatment of chronic noncancer pain presents a situation in which uncontrolled use is a potential outcome. For the great many pain patients who present with few risk factors for addiction, behavioral control over use is likely to be a nonissue. However, patients at higher risk, including those with histories of substance abuse, require greater oversight and behavioral control. But in that it is impossible for the pain clinician to predict with certainty which patients will develop behavioral problems with opioid use, an objective indicator is needed. Not unlike evaluating serum liver function indicators for all patients taking a medication with the potential for hepatotoxicity, monitoring for evidence of “toxic” behaviors via urine toxicology is necessary for medications carrying a risk for addiction . For patients at lower risk for hepatotoxicity or substance abuse, the assays may be collected on a less frequent basis, but monitoring will still be required. Urine toxicology is not the only indicator of inappropriate medication use. Treatment agreements drawn up between the pain patient and prescribing clinician typically identify other medication use behaviors indicative of poor use control . These often include requirements that the patient obtain medication from a single provider, not increase dose or dosing frequency without
consultation with the clinician, and not calling the office for early refills. As with urine toxicology, the ideal goal of these agreements is not to penalize misuse, but to monitor for the adverse event of uncontrolled medication use behavior, so that interventions can be introduced when indicated. Rather than conceptualized as thwarting the development of a therapeutic relationship or communicating mistrust, urine toxicology provides verification that patient use accords with the treatment plan.
7 Centers for Disease Control and Prevention. Policy Impact: Prescription Painkiller Overdoses. US Department of Health and Human Services, Centers for Disease Control and Prevention; 2013. Available at: http://www.cdc.gov/homeandrecreationalsafety/rxbrief/ (accessed October 2014).
In the current epidemic of prescription opioid abuse with related mortality , urine toxicology serves a greater public health interest as well. If prescribed opioids are absent in a pain patient’s urine, diversion may be an issue, with the clinician unknowingly but effectively serving as a source of opioid analgesics on the black market. By validating appropriate opioid use via urine toxicology, a “trust, but verify” approach ensures that the clinician is doing no harm, to the patient and the community, in the provision of chronic opioid therapy.
Few Benefits, Likely Harms: Against Universal Random Urine Drug Screening in Pain Management
PEGGY COMPTON, RN, PhD, FAAN School of Nursing and Health Studies, Georgetown University, Washington DC, USA
References 1 Jones JL, Esber GR, McDannald MA, et al. Orbitofrontal cortex supports behavior and learning using inferred but not cached values. Science 2012; 338(6109):953–6. doi: 10.1126/science.1227489. 2 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Arlington, VA: American Psychiatric Publishing; 2013. 3 National Institute on Drug Abuse. Principles of Drug Addiction Treatment: A Research-Based Guide, 3rd edition. 2012. NIH Pub Number: 12-4180. Available at: http://www.drugabuse.gov/publications/principlesdrug-addiction-treatment/evidence-based-approachesto-drug-addiction-treatment/behavioral-therapies (accessed May 2014). 4 Alford DP. Chronic back pain with possible prescription opioid misuse. JAMA 2013;309(9):919–25. doi: 10.1001/jama.2013.522. 5 Chang YP, Compton P. Management of chronic pain with chronic opioid therapy in patients with substance use disorders. Addict Sci Clin Pract 2013;8(1):21. doi: 10.1186/1940-0640-8-21. 6 Starrels JL, Becker WC, Alford DP, et al. Systematic review: Treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med 2010;152(11):712–20. doi: 10.7326/ 0003-4819-152-11-201006010-00004.
There are three reasons why we oppose universal mandatory random urine drug screening (RUDS) in chronic pain management . First, there is extremely weak evidence supporting its efficacy. Second, whatever purpose is meant to be accomplished via such screening can already be accommodated via the informed consent process. Third, such screening carries a significant likelihood of stigmatizing already disadvantaged populations. As to the first rationale, there is very little evidence demonstrating that opioid agreements improve treatment efficacy or reduce prescription drug misuse . Indeed, a general Cochrane review of physician–patient contracts noted insufficient evidence upon which to “base a recommendation for the routine use of contracts as a means of improving patient adherence” . With the significant potential harms discussed below, only robust evidence could possibly justify universal urine drug screening. Such a quantum of evidence does not exist at this time. Second, nonadherence is widespread . The potential risks to patients who fail to take many non-opioid medications as directed can be significant . Yet there have been no calls for universal administration of RUDS in any other setting than the treatment of patients with chronic noncancer pain. This singular focus strongly suggests purposes beyond ensuring quality patient care, such as fear of regulatory scrutiny and potential legal liability. Moreover, the risks, benefits, and therapeutic regimen of opioid analgesia can be cogently conveyed in a detailed informed consent to a treatment document . Such a document should not involve any marked variation for patients using opioids as informed consent is essential to good patient care and because patients are accustomed to these documents in many care settings. Physicians can utilize the many existing screening tools to identify patients who may be at a genuinely increased risk of misuse, abuse, or diversion of prescription medications. Imposing RUDS only on patients for whom the results of such screening indicate a legitimate basis for concern should be sufficient for compliance with the minimal standard of acceptable care in the treatment of patients with opioids for chronic noncancer pain.
Ethics Forum Third, the common refrain that RUDS avoids discrimination is false on its face. RUDS necessarily distinguish and classify opioid-prescribed pain patients. While such distinction and classification does not by itself constitute stigma, the subsequent assignation of deviance that does so is never far off in chronic pain encounters . The evidence suggests that chronic pain sufferers endure persistent and relatively common stigma from health care providers, caregivers, and others involved in chronic pain management . It defies credulity to suggest that people suffering from a highly stigmatized illness experience are as a population likely to escape such stigma following the obvious class-wide mistrust embodied in RUDS. (Whether mistrust is intended is irrelevant given that such will likely be how many pain patients construe the mandate). Finally, because members of already marginalized communities are most likely to experience chronic pain in general and chronic pain stigma in particular, RUDS may intensify chronic pain inequities . Doing so violates mandates of social justice and is morally unacceptable.
DANIEL S. GOLDBERG, JD, PhD* and BEN A. RICH, JD, PhD† *Department of Bioethics and Interdisciplinary Studies, Brody School of Medicine, East Carolina University, Greenville, North Carolina; †UC Davis School of Medicine, Sacramento, California, USA
References 1 Goldberg DS, Rich BA. Pharmacovigilance and the plight of chronic pain patients: In pursuit of a realistic and responsible ethic of care. Indiana Health Law Rev 2014;11:83–122. 2 Fishman SM, Gallagher RM, McCarberg BH. The opioid treatment agreement: A real-world perspective. Am J Bioeth 2010;10(11):14–5. 3 Bosch-Capblanch X, Abba K, Prictor M, Garner P. Contracts between patients and healthcare practitioners for improving patients’ adherence to treatment, prevention and health promotion activities. Cochrane Database Syst Rev 2007;(2):Art. No.: CD004808, doi: 10.1002/14651858.CD004808.pub.3. 4 Zullig LL, Peterson ED, Bosworth HB. Ingredients of successful interventions to improve medication adherence. JAMA 2013;310(24):2611–2. 5 Morrissey PE, Flynn ML, Lin S. Medication noncompliance and its implications in transplant recipients. Drugs 2007;67(10):1463–81. 6 Goldberg DS. Beyond Opioids: The Bioethics of Pain Management. New York: Routledge Press; 2014.
7 Jackson JE. Stigma, liminality, and chronic pain: Mind–body borderlands. Am Ethnol 2005;32(3): 332–53.
Urine Drug Screening: Opioid Risks Preclude Complete Patient Autonomy The authors of this column underscore the complexity of the issue of urine drug screening, which is not unexpected given their divergent professional backgrounds. Dr. Compton provides a cogent argument for the need to detect addiction and therefore protect the patient, while Drs. Goldberg and Rich assert that urine drug screening contaminates the doctor–patient relationship and consequently contributes to stigmatization. As such, a fundamental tension exists between patient protection and patient costs or harms that result from the practice. In support of Dr. Compton’s view, new data suggest that among individuals with a new episode of chronic pain, being exposed to prescription opioids strongly predicted incident opioid use disorder . Accordingly, one could argue that opioids themselves pose a significant patient risk, and therefore prescribers are beholden to monitor these risks and act quickly to treat any harms that develop. The challenge is to find the balance that serves the greatest good for the person seeking care as well as for society as a whole. Toward that end, Drs. Goldberg and Rich highlight the lack of evidence to support random urine drug screening (RUDS). The rationale and concept may have good face validity; however, if the clinical data are missing, legislation may be premature, and the balance begins to lean toward minimizing use of urine drug screening. Drs. Goldberg and Rich point out that the issue is not dichotomous; rather, patient selection is key to minimizing potential harms of urine drug screening. In this view, using clinical judgment and observing for signs of aberrant behaviors could be considered the threshold to request a urine test for a patient. In other words, verify only after “trust” has been breached. However, the possibility exists that waiting for that initial breach of trust may result in a patient’s overdose and death. Physicians’ ethical responsibility to protect society as a whole cannot be ignored. This is a primary rationale for urine drug screening, as the practice could stem the illicit use of prescription opioids. Drs. Goldberg and Rich note that the current evidence basis for RUDS is weak. In a recent systematic review of opioid prescribing guidelines, 9 of the 13 guidelines reviewed were found to recommend urine drug testing as a useful tool, but there was significant variability in terms of for whom testing is recommended. The authors concluded that the utility of urine drug testing risk mitigation is supported by observational data and expert consensus as set forth in the majority of guidelines . Even with urine drug testing, providers must be vigilant for risks and signs of aberrant behavior , as the tests are
not fail-proof. Theoretically, those who are most motivated to game the tests can do so with relative ease assuming they are aware that the time frame of accuracy for urine tests is no more than 4 days for all substances measured (except for marijuana that is used on a chronic basis) . As such, urine drug testing only describes patient behavior for the few days prior to their medical visit. Our primary conclusion is that more and better data are needed to determine the efficacy of urine drug testing as a deterrent for aberrant behavior and diversion, and as a mitigator of diversion, overdose and death. An ethical imperative exists for national funding to be allocated to support studies on these topics. However, even with the lack of empirical support, a moral imperative is written into the American Medical Association Code of Ethics: “As a member of this profession, a physician must recognize responsibility to patients first and foremost, as well as to society. . . .” . While there are potential dangers of opioid misuse to individual patients and society as a whole, the physician imperative and code of ethics emphasize the individual benefit of the patient first. While we believe the current balance tips toward utilization of urine drug testing for patients receiving chronic opioid therapy, utilization should be justified in directly benefiting the individual patient.
BETH D. DARNALL, PhD* and MICHAEL E. SCHATMAN, PhD† *Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Palo Alto, California; †Foundation for Ethics in Pain Care, Bellevue, Washington, USA
References 1 Edlund MJ, Martin BC, Russo JE, et al. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: The role of opioid prescription. Clin J Pain 2014;30:557–64. 2 Nuckols TK, Anderson L, Popescu I, et al. Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med 2014; 160(1):38–47. 3 Christo PJ, Manchikanti L, Ruan X, et al. Urine drug testing in chronic pain. Pain Med 2011;14:123–43. 4 American Medical Association. Principles of medical ethics: Preamble; 2001. Available at: http://www. ama-assn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics/principles-medical-ethics. page (accessed June 2014).
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