Monday, October 8, 2012

Why Use UDT in Pain Management?

Understanding UDTPart 2: An Underused Tool for Improved Patient Care
By Stewart B. Leavitt, MA, PhD and Gary M. Reisfield, MD

Much has been written about the utility of urine drug testing, or UDT, in improving care in pain management, but its use remains surprisingly low. This is particularly true in primary care settings, where physicians, nurse practitioners, physician assistants, and clinical pharmacists treat the majority of chronic pain in the United States.

In Part 1 of this series on “Understanding UDT in Pain Care” [here], we noted that clinical drug testing— as one component of ongoing opioid analgesic therapy — is a critical aspect of pharmacovigilance for assuring effective, safe pain management. We also described the many consensus guidelines and expert recommendations advocating UDT as an emerging standard of care in this context.

Yet, UDT appears to be a widely underused clinical tool, and in this article we examine research describing the extent of this problem and some of the barriers that have hindered the widespread application of UDT in pain care settings. Finally, we examine the rationales for UDT, as expressed by experts in the field.

The Wallflower of Pain Management

Like the pretty girl at the dance without a partner, UDT has often been underappreciated and neglected as a companion to safe and effective pain care. Even though UDT is one of the few objective tools available for monitoring medication adherence, misuse, and diversion, its use by clinician groups evaluated in research studies has been variably low — ranging from 7% to 64% — across practices involved in treating chronic pain. Here is a brief summary:

  • An early report sponsored by the National Center for Addiction and Substance Abuse discussed a survey of 648 primary care providers. Only 32% performed careful substance abuse screening, including UDT, in their patients with chronic pain who were prescribed opioid analgesics [CASA 2000].

  • More than a decade ago, Adams et al. [2001] audited medical records of 209 adults with chronic pain who had been prescribed opioid analgesics from 12 family medicine practices (74 practitioners) in Wisconsin. Written treatment agreements were used by 42% of the practitioners, but UDTs were ordered by only 8%.

  • In 2006, Bhamb et al. surveyed 248 primary care physicians to assess their opioid prescribing practices. Though most expressed concerns about prescription drug abuse (84%), addiction (75%), adverse drug effects (68%), opioid tolerance (61%), and medication interactions (32%), only 7% reported ordering UDTs before prescribing opioids and only 15% reported ordering UDTs as part of ongoing opioid management.

  • In April 2007 the state of Washington introduced voluntary guidelines for opioid prescribing , specifying "best practice" policies, which included the judicious use of random UDT. Yet, 18 months later, a survey of primary care physicians in the state found that only 38% were using random UDT often or always [CDC 2012]. (The state legislature later instituted more restrictive mandates regarding opioid prescribing, but the type and frequency of UDT were not specified [Washington 2012]).

  • More recently, Pergolizzi et al. [2010] reported surveying 99 attendees at the 2008 American Congress of Pain Medicine about their UDT practices and attitudes in the setting of long-term opioid therapy. Eighteen percent of respondents indicated that they never performed UDTs, and few had an established testing protocol. UDT was motivated more by a desire to detect undisclosed substances and to uncover diversion than to support patient assessment and diagnosis.

  • A retrospective medical records review of 1,612 patients receiving opioids for chronic noncancer pain in primary care practices by Starrels et al. [2011] found that UDT had been ordered in only 8% of patients. Testing appeared to be used selectively in patients with the highest perceived risk, such as those with prior drug misuse or mental health disorders.

  • In a small study, Boeding and Hamill-Ruth [2012] surveyed 44 primary care, urgent care, and emergency medicine physicians about their opioid prescribing strategies. Most respondents (84%) prescribed these analgesics about twice weekly for chronic pain, but the use of UDT was quite variable: 41% prior to beginning opioid therapy, 64% for random monitoring of ongoing opioid therapy, and 9% prior to increasing or switching an opioid prescription.

There is anecdotal evidence that clinicians specializing in pain medicine more routinely use UDT as a component of opioid prescribing [Peppin et al. 2012]. However, from the reports noted above, it appears that other practitioners — representing settings in which most chronic pain is managed — have mostly eschewed the use of UDT.

Low Proficiency in Using UDT

Why is UDT underutilized? One reason is that most healthcare providers have little or no training in how best to use UDT and interpret results [Pergolizzi et al. 2010]. A number of studies have confirmed this lack of proficiency:

  • A study of primary care physicians specializing in adolescent medicine, many of whom had incorporated UDT into their practices, found that most lacked essential knowledge regarding proper specimen collection and validation, interpretation of positive and negative results, and the need for confirmatory testing [Levy et al. 2006]. For example, merely 12% of the physicians surveyed knew that oxycodone is not detectable by most opiate screening immunoassays; only 40% knew that ingestion of poppy seeds could produce a positive screen for opiates; and fewer than 50% knew the time limits for detection of cannabis metabolite in the urine of regular cannabis users.

  • In a survey of basic UDT knowledge among physicians in attendance at 3 regional opioid education programs, 114 participants completed a 7-item multiple choice questionnaire involving UDT interpretation in patients using prescription opioids, heroin, marijuana, or poppy seed-containing food products. Of 77 physicians who employed UDT in their practices, none answered all questions correctly and only 30% answered more than half the questions correctly. Physicians who used UDT were no more likely to respond correctly to any of the items than those who did not use UDT [Reisfield et al. 2007A].

  • A second study by Reisfield et al. [2007B] administered an identical 7-item survey, this time to physicians attending a family medicine review course. Among 60 family physicians completing the survey, none of the 44 who typically ordered UDT in their practices answered more than 5 of the 7 questions correctly, and only 20% of them answered more than half of the questions correctly. The physicians who ordered UDT performed better than those who did not order UDT on only 4 of the 7 questions, but there were no significant differences between groups on any particular question.

Results of these studies, particularly the more recent ones, are disconcerting when considering the number of excellent educational resources on UDT that have become available during the past decade. Evidently, there is a need for more intensive educational time and effort devoted to this subject.

Subjective Impressions Are Misleading

Practitioners treating patients with pain commonly rely on their clinical judgment and intuition when making prescribing decisions, yet these often are inadequate when it comes to identifying patients who might abuse or otherwise misuse their medications [McCarberg 2011]. And, a basic challenge underlying the need for objective medication monitoring begins with the subjective nature of pain [Laffer et al. 2011]. Several studies have highlighted these concerns:

  • In a seminal work, Katz et al. [2003] performed a retrospective study of the relative value of aberrant behaviors and UDT in detecting opioid-related problems. Of their 122 patients on long-term opioid therapy, 27 (22%) had one or more behavioral issues and 36 (29%) had abnormal urine drug test results. Of the 36 patients with abnormal drug test results, 26 (72%) evidenced no behavioral issues, demonstrating the limited sensitivity of aberrant behaviors in detecting opioid-related problems.

  • In the survey noted above by the National Center on Addiction and Substance Abuse [CASA 2000], more than 90% of the 648 participating primary care providers failed to identify substance abuse in adults, and few (17%) felt they were capable of detecting drug abuse.

  • Bronstein et al. [2011] asked 62 physicians from 50 states to identify, using their usual risk assessment tools, which of their patients were at risk for medication misuse. Urine drug test results were compared to physicians’ assessments. Physicians were correct in their identification of nonadherent patients (defined as absence of prescribed medications or presence of illicit drugs in urine) 72% of the time. However, physicians were correct in their identification of adherent patients only 40% of the time. Put another way, practitioners were wrong in their assessment of presumably adherent patients 60% of the time, and they were wrong in their assessment of nonadherent patients about 30% of the time. Bronstein and colleagues note that, statistically, the clinicians’ ability to correctly categorize patients as being adherent with their opioid regimens was only slightly better than chance.

  • Practitioners’ vulnerability to deception was highlighted in a review by Jung and Reidenberg [2007]. The authors identified 6 studies that examined the ability of “standardized patients” (ie, healthy individuals following a script presenting specific painful illnesses) to deceive physicians. Notwithstanding the fact that all physicians were aware of the parameters of the study, and knew that some of the “patients” would actually be feigning pain conditions, they identified deception only about 10% of the time.

Identifying patients who are nonadherent with their opioid treatment plans remains a clinical challenge. Studies to date emphasize that subjective methods — such as patient self-reports and clinician judgments — may significantly underestimate the prevalence of problematic prescription medication use and illicit drug abuse [Bair and Krebs 2010].

Barriers to Implementing UDT

As noted above, available evidence suggests relatively limited adoption of UDT in various clinical settings in which pain is treated with opioid analgesics, and a low level of proficiency among practitioners who do utilize UDT. So, what are the factors that account for this?

In the study by Bhamb et al. [2006], noted above, participating practitioners were concerned about drug abuse, addiction, adverse effects, tolerance, and medication interactions in their patients. However, routine UDT use was predicted by their having a system or protocol in place to track patients who were prescribed opioids. Most did not have such a system.

More recently, in the aforementioned study by Boeding and Hamill-Ruth [2012], physicians identified the following issues as barriers to the use of UDT (with percentages of respondents); cost of testing (39%), time limitations (25%), staff and facility availability (25%), and concern about compromising the doctor patient relationship (25%). In other studies and commentary [Bair and Krebs 2010; Gourlay et al. 2012; Levy et al. 2006; McCarberg 2011; Peppin et al. 2012; Pergolizzi et al. 2010; Reisfield et al. 2007A,B, 2010; Starrels et al. 2010, 2011], those issues have been echoed, plus the following have been noted:

  • Lack of knowledge regarding specifics of UDT, including correct ordering and interpretation, and how to best use results for guiding clinical decision-making and patient counseling.
  • Concern about the risk of misinterpreting of UDT, with resultant harm to adherent patients.
  • The incorrect belief of clinicians that their patients are not at risk for prescription misuse or other drug problems, and that UDT would be a waste of time and money.
  • Inadequate evidence for improved clinical outcomes resulting from UDT.

There is a need for more and better research to confirm the role of UDT in preventing opioid-related problems and for improving medication adherence and clinical outcomes. The relatively few research studies to date examining UDT knowledge and practices among clinicians have important limitations. For the most part, they have been observational, of modest size and scope, and have focused on self-reports of select groups of clinicians. Many of the studies date back a decade or more, and it is unknown if the UDT knowledge and usage gaps have closed in recent years, especially in response to heightened concerns about opioid-related morbidity and mortality.

In an editorial, Bair and Krebs [2010] observed that, considering the many potential barriers, it is not surprising that UDT is infrequently used. They believe that healthcare systems and individual practices need to be redesigned to support the routine use of UDT and other monitoring strategies.

Rationales for UDT in Everyday Pain Practice

UDT in PracticeAssuming that barriers impeding the use of UDT in pain care are surmountable, the question becomes, what is the role of UDT and why should it be more widely used as a central component of pharmacovigilance?

As we noted in Part 1 of this series, UDT is the most widely accessible and objective method for pharmacovigilance in pain treatment settings, and is an essential tool for tracking patients’ adherence to prescribed medication regimens and for detecting drug misuse, abuse, and diversion. Balance is required, however, in using UDT to mitigate opioid risk while optimizing therapeutic outcomes. The vast literature on UDT offers several rationales for drug testing, but they generally align with one of two perspectives:

  1. Protective/Defensive — focuses on protecting prescribers from legal or regulatory scrutiny while defending against the misuse, abuse, or diversion of prescription medications and/or the use of illicit drugs [eg, Christo et al. 2011].

  2. Proactive/Patient-Centric — focuses on monitoring approaches that emphasize mitigating harm to the patient while maximizing short- and long-term benefits of analgesic therapy [eg, Gourlay et al. 2012].

A protective/defensive approach is understandable — and ultimately may help to preserve appropriate access to opioid therapy by curtailing opioid-related problems. However, commentators have noted that this approach sometimes stems from prescribers’ often unrealistic fears of regulatory censure or liability, as well as disproportionate concerns about aberrant patient behaviors [Collen 2009; Fishbain et al. 2010; Fishman 2012; Nafziger and Bertino 2009; Reisfield et al. 2007A; Starrels et al. 2010]. Such concerns have also contributed to the undertreatment of pain with opioid analgesics [Moore et al. 2009], and in some cases a defensive posture may reflect an underlying bias against opioid analgesics, both in acute and in chronic pain contexts.

While a well-designed drug testing program can serve as a “paper trail” — demonstrating pharmacovigilance and adherence to “best practices” — there also are some limitations of a Protective/Defensive approach to consider:

  • Practitioners may end up “treating test results” rather than targeting individual needs of patients, and this may hinder rather than facilitate optimal pain-treatment outcomes.

  • If a “trust but verify” approach to testing is applied inequitably, it can foster conflict, undermine patient-provider relationships, and diminish therapeutic outcomes.

  • Inordinate time and effort can be expended if practitioners become engrossed in “cat and mouse” pursuits, using UDT to “catch” misbehavers. There is also risk associated with misdiagnosis and wrongful discharge due to misinterpretation of or over-reliance on test results. The majority of patients — those who do try to be adherent with therapy — will find this offensive, while the “professional delinquents” — those who make a habit of (or profit from) drug abuse or diversion — may learn through trial and error how to avoid the traps.

On the other hand, the literature suggests that the second perspective on UDT — Proactive and Patient-Centered — can benefit individual patients and, thereby, pain management objectives, in a number of ways [Gourlay et al. 2012; Laffer et al. 2011; SAMHSA 2012; Schonwald 2012; Webster and Dove 2007]:

  • Before beginning a trial of opioid therapy, UDT can aid in identifying pre-existing substance-use disorders that, unaddressed, might preclude effective pain management. (Although abnormal UDT results, in and of themselves, are not diagnostic of substance-use disorders.)

  • UDT serves as an adjunct to a patient’s self-report of recent prescription and illicit drug use, since research has established that, for a variety of reasons, patients may not be forthcoming about all medications/drugs they are taking [this will be discussed more thoroughly in an upcoming article in this series].

  • There is an essential safety role of UDT in identifying medications or substances a patient is using that could interact with prescribed analgesics and have potential for serious adverse events or overdose (such as, prescribing opioids in a patient taking sedative/hypnotics or using alcohol).

  • In patients who are not experiencing expected pain relief from particular medications, UDT can suggest pharmacokinetic factors – such as ultrarapid metabolizer phenotypes or cytochrome P450 inducers – that may be responsible for suboptimal analgesia.

  • Periodic, and preferably random, UDT may change behaviors, encouraging patient adherence to prescribed medication regimens and thereby increasing the chances that the therapy will improve pain, function, and quality of life.

  • UDT results comprise objective data that support clinical impressions of medication adherence and/or abstinence from substances of abuse for legal and workers’ compensation cases, insurers, or family members, so that useful medications may continue to be prescribed.

  • Along these lines, UDT records supporting adherence to medication regimens, as well as use of or abstinence from other substances, can provide important information when coordinating care with other providers. For example, it may be important for them to know how adherent a patient is with prescribed regimens.

  • In cases of inappropriate UDT results — such as the presence of nonprescribed controlled medications or illicit drugs — that information can be used to initiate a dialogue with the patient to determine the nature of the problem and to explore options for treatment or further evaluation.

Although most discussions of UDT focus on opioids, there are other medications (eg benzodiazepines, barbiturates) used in pain management that could and, at times, should, be monitored via UDT for the sake of patient safety and therapeutic effectiveness. As well, numerous authors [eg, Bair and Krebs 2010; Fishman 2012; Gourlay et al. 2012; Reisfield et al. 2007A,B] have emphasized the importance of developing a relationship with a single drug-testing laboratory to become familiar with its specific tests and threshold values, methods of reporting, and procedures for consultation with laboratory scientists.

Summary: Treating Patients Not Test Results

In pain management, as in all other areas of medicine, the emphasis should be on treating patients, not test results. And, as Gourlay and colleagues [2012] have stressed, like any other medical test, UDT should be performed with the primary goal of improving patient care.

In the case of opioid analgesics, there are the added goals of mitigating risks of medication misuse, abuse, and diversion. However, in today’s regulatory climate, healthcare providers may become too focused on using UDT to protect themselves from being misled by the minority of persons who seek opioids for nonmedical purposes.

McBane and Wiegle [2010] and others [eg, Peppin et al. 2012] have observed that, when used skillfully, UDT may actually strengthen the practitioner-patient relationship. For that to happen, however, the practitioner must be able to empathically communicate with patients about the goals of testing, and must be knowledgeable about how to correctly order tests, interpret test results, and deal constructively with confirmed, unexpected results.

As noted in Part 1 of this series, a well-designed and consistently applied drug testing program can be an important and objective tool for aiding clinical decision-making, but it is not the only tool. Healthcare providers should integrate UDT results with other information, including screening questionnaires, patient history and self-reports, collateral information from patients’ family, friends, and co-workers (obtained with patient permission), pill counts, data from Prescription Drug Monitoring Programs (as available), consultation with diagnostic laboratory professionals and, of course, their clinical judgment [Gourlay et al. 2012; SAMHSA 2012].

As with all other components of pain management, practitioners need to consider the advantages of UDT while also taking into account limitations and cost concerns. UDT is a relatively straightforward diagnostic tool and there are many reasons for its widespread application in pain management contexts. However, there also are some complexities surrounding its effective use, and there is a need for clinician training programs, continuing education, and further research in this aspect of pharmacovigilance in chronic pain management.


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About the Authors:

Gary Reisfield, MDGary M. Reisfield, MD, is the Chief of Pain Management Services, Division of Addiction Medicine, Department of Psychiatry, at the University of Florida College of Medicine. He is board-certified in anesthesiology, pain medicine, and addiction medicine. He is a gubernatorial appointee to the Implementation and Oversight Task Force of Florida’s Prescription Drug Monitoring Program, a member of the editorial review board of the Journal of Opioid Management, and a certified Medical Review Officer. Dr. Reisfield has participated as a consultant to Millennium Laboratories.

Stewart B. Leavitt, MA, PhDStewart B. Leavitt, MA, PhD, is Executive Director and Editor of Pain Treatment Topics and was formerly the founding Editor of Addiction Treatment Forum. He studied biomedical communications at the University of Illinois Medical School, Chicago, and served as a Commissioned Officer in the U.S. Public Health Service. His advanced degrees are from Northwestern University, Evanston, IL, focusing on health/medical research and education. Dr. Leavitt’s work is supported in part by unrestricted medical education grants from Purdue Pharma LP, Endo Pharmaceuticals, and Millennium Laboratories.

Proviso: This UPDATES series on “Making Sense of UDT” was supported in part by an educational grant from Millennium Laboratories, a diagnostics company. However, this organization had no role in the concept, research, development, or approval of any contents in this series. All facts are from the sources cited; any opinions are expressly those of the authors and do not necessarily reflect the positions of Pain Treatment Topics, nor its staff and advisors or educational supporters/sponsors.

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