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INTRODUCTION

 

Many patients with chronic pain experience improved function, meaningful pain relief, and improved quality of life from opioid therapy. But opioid treatment has a high-potential for misuse, abuse, and diversion, and may not improve function.

Therefore, proper prescribing of controlled substances is critical to patients’ health and to safeguard society against abuse and diversion.

In addition to those noted in other Southwest Labs University learning modules, a number of organizations and agencies have developed recommendations and guidelines that include the use of urine drug testing (UDT) as a tool to assist clinicians to responsibly prescribe opioids when managing chronic pain.

For example, clinical practice guidelines for chronic pain management published by the American Pain Society/American Academy of Pain Medicine and the Department of Veterans Affairs/Department of Defense include a provision for UDT.

However, neither guideline provides instruction for how UDT should be performed in clinical practice nor how to interpret UDT results. In addition, many state medical boards and agencies have developed policies or guidelines that require or suggest the use of UDT in certain situations.

Despite potentially serious outcomes from UDT for some patients (e.g., dismissal or changes to the treatment plan), clinicians often lack training in the use of UDT, and UDT is often underused or used inappropriately in clinical practice.

Before ordering UDT, clinicians should understand methods of testing, the potential benefits and limitations of UDT, and how to interpret results, so that they can rationally employ a patient-centered UDT process in clinical practice.

This module is based upon recommendations from the Center for Independent Healthcare Education Centers for Disease Control and, Federation of State Medical Boards.

This supplement will assist you in providing additional guidance to clinicians on how to appropriately use UDT to improve patient care. Each can be pointed to as authoritative guidance that has been issued by large and highly respected agencies.

It is worth restating that any test, including UDT, must meet the basic standards of medical necessity if it is to be a credible element of clinical care. All 3 of the following elements must be addressed:

  • Why was the test ordered?

  • What results were obtained?

  • What changes in clinical course were made (including staying the course, if appropriate) as a result of these test results?

Failure to ask, answer, and document in the medical record, these key elements of medical necessity may result in denied claims or worse, leave the clinician open to medicolegal exposure.

BACKGROUND

 

Most studies indicate that urine drug testing (UDT) is generally underutilized in clinical practice, both in primary care and specialty practices. The following statistics emphasize that point:

  • Eighteen months following the introduction of opioid-dosing guidelines in Washington State in 2007, which included a recommendation for judicious use of random UDT, a survey of primary care physicians found that 20% of respondents were using random UDT always or almost always, 18% often, 32% sometimes, and 30% never or almost never.
     

  • A 2006 to 2011 study of a cohort of Medicare patients prescribed extended-release oxycodone found that at least one UDT was billed in only 14% of cases, although the frequency of UDT did increase from 9% in 2006 to 19% in 2011.
     

  • A retrospective review of medical records of 1612 patients in primary care practices receiving opioid analgesics for chronic noncancer pain found that only 8% of providers had utilized UDT.
     

  • Following institution of an intake assessment for risk of problematic medication use that included a provision for UDT, a chart review of new patients in a pain management center still found that only 19% had a urine sample submitted for testing.
     

  • A retrospective review of medical records of pain patients seen in an outpatient palliative care clinic over a 6-month period found that only 4% of visits included UDT. However, when utilized, 56% of UDT results were aberrant (negative for prescribed opioids, positive for nonprescribed drugs, or positive for illicit drugs).
     

  • A retrospective review of medical records of patients who had filled at least 6 prescriptions for opioid medications over a 1-year period in primary care clinics associated with a large VA medical center found that only 15% included documentation of UDT, despite this being recommended in VA chronic pain management guidelines.
     

  • A retrospective chart review of primary care patients with chronic noncancer pain who received opioid prescriptions for 3 or more consecutive months in a VA medical center found that when patients had a UDT result that was positive for illicit drugs or unreported opioids or that was negative for the prescribed opioids, only 28% of patient charts had any documentation of discussion with the patient or discontinuation of their opioid therapy by the prescriber. In the majority of cases, the current opioid prescriptions were continued as usual.

The appropriate use of UDT, as one of several medical management tools (e.g., treatment agreements, pain scales, pill counts, querying state prescription monitoring programs [PMPs]), can help clinicians manage prescribing of controlled substances by improving adherence monitoring and offering greater protection from drug misuse and diversion.

MUTUALLY AGREED UPON GUIDANCE

 

The Center for Independent Healthcare Education, Centers for Disease Control and the Federation of State Medical Boards all agree that urine drug testing (UDT) should be considered a Core Clinical Tool as part of a comprehensive risk management strategy.

Key points that are common amongst the three groups include:

  • A working relationship with the testing laboratory is essential to accurately interpret UDT results.
     

  • UDT is something that should be Done For Patients rather than something that is Done To Them.
     

  • UDT is an objective tool to assist in credible patient advocacy.
     

  • UDT can aid the clinician in detecting misuse or abuse of illicit or non-prescribed drugs.
     

  • UDT can help guide patient assessment, management & referral in order to improve patient care, reduce stigma, & contain risk.
     

  • An inappropriately negative UDT result may indicate drug diversion.
     

  • Performing UDT on a new patient that is already being treated with a controlled substance can determine if the drug and/or its metabolites are detectable in urine.
     

  • When used with an appropriate level of understanding, UDT may improve a clinician’s ability to manage therapy with prescription drugs (including controlled substances), to assist in the diagnosis of substance misuse or addiction, to guide treatment, and to advocate for patients.
     

  • The clinician can use UDT to help motivate patient behavioral changes and maintain healthy changes that have already been made.
     

  • Quantitative UDT is often the only way to determine if an analyte pattern represents an expected metabolite of a legitimately prescribed medication or the unsanctioned use of another non-prescribed agent.
     

  • Any test, including UDT, must meet the basic standards of medical necessity.

UDT GUIDANCE

 

Center for Independent Healthcare Education

The Center for Independent Healthcare Education has issued comprehensive guidance for “UDT in Clinical Practice.” The guidance is structured around; Why to Test, Whom to Test and When to Test. The following summarizes the key points contained in the recommendations.

WHY TO TEST

 

Advocate for Patients

Clinicians can use UDT as an objective tool to assist in credible patient advocacy, for example in family and workplace situations. Examples of situations in which UDT may be used as a tool for patient advocacy include workers compensation and divorce/child custody cases. UDT used with accurate record keeping and due care can complement other methods used by clinicians to document patient stability in such situations.

Identify Use of Illicit or Nonprescribed Licit Drugs

UDT can aid the clinician in detecting misuse or abuse of illicit or nonprescribed licit drugs. UDT results that corroborate the clinical history of self-reported use should be used to assist the patient in adopting more appropriate behavior; UDT results that are in conflict with the patient’s self-report should be further investigated, with significant tightening of boundaries as a condition of ongoing treatment with controlled substances (e.g., limited dispensing by individual prescriptions or sequential prescriptions [i.e., “Do not fill until _/_/_”], increased frequency of appointments, pill counts, referral to or consultation with an addiction specialist and/or other mental health care specialist).

 

As Part of Universal Precautions

A “Universal Precautions” approach to the assessment and ongoing management of chronic pain patients recommends 10 principles (Appendix A) and a triage scheme for stratifying risk that includes recommendations for management and referral. Universal Precautions is less about the opioid molecule and more about a balanced approach to the treatment of chronic pain.

Suspected Diversion

Diversion is the intentional removal of a medication from legitimate distribution and dispensing channels for illicit sale, distribution, or use. UDT cannot identify diversion, which is much more complex than the simple presence or absence of a drug in urine. An inappropriately negative UDT result may however, indicate drug diversion, and it also opens up a differential diagnosis that may occur secondary to maladaptive drug-taking behavior, such as bingeing, running out of the prescribed controlled substance early, and multiple other actors (e.g., cessation or change of insurance coverage, or monetary difficulties).

WHOM TO TEST

 

New Patients Already Receiving a Controlled Substance

In addition to history, physical examination, contacting past providers, requesting past medical records, and querying state PMPs, performing UDT on a new patient who is already being treated with a controlled substance can determine whether the drug and/or its metabolite(s) are detectable in his or her urine. When clinicians introduce UDT as a clinical tool rather than a pejorative test, most patients will be more comfortable with this request.

Patients that are Resistant to Full Evaluation

Patients who refuse physical examination and thorough evaluation to confirm their presenting condition, or who are reluctant to undergo diagnostic tests, including UDT, may be poor candidates for therapy with a controlled substance. Such patients may also be unwilling to give permission for clinicians to obtain past medical records or to communicate with past providers.

Patients that Request a Specific Drug

Although patients may request a specific drug because it has worked for them in the past, refusal of other rational pharmacologic trials or generic substitutions should be a cautionary point; for example, a claim of allergy to all but one specific drug with high misuse potential is a significant warning sign.

Patients that Display Aberrant Behavior

Patients who display problematic drug-related behavior often repeatedly want appointments toward the end of office hours or at the end of the week, telephone or arrive after office hours or when they know that their primary provider is not available, and may insist on being seen immediately because they are late (for their flight, meeting, child’s soccer game, etc.).

Patients in Recovery

Patients who have struggled with substance-use disorders in the past are often reluctant to accept even rational pharmacotherapy for pain management. In these cases, routine UDT may provide both reassurance and objective evidence to the treatment team, the patient, and the patient’s family of appropriate attention to the increased risks in this patient population.

Special Populations (palliative care, obstetrics, etc.)

Palliative Care: Patients with life-limiting illnesses, including cancer, are not exempt from the problems of drug misuse, substance abuse, and addiction.

Obstetrics: The use of UDT in the obstetric population may help to identify use of illicit drugs and alcohol and provide an opportunity to educate patients and motivate, where necessary, positive behavioral change. OB-GYN is covered in detail in Modules 7 and P1 of the Southwest University Clinical Sales Specialist training course.

WHEN TO TEST

 

When Meeting a Patient for the First Time

UDT should be considered as a part of the evaluation of any new patient who is taking controlled substances or for whom controlled substances are being considered. Discussing UDT with all patients presenting with chronic pain can help to normalize this strategy. Even in the absence of controlled substances, UDT can be an effective tool in clarifying otherwise challenging cases where treatment goals are not being achieved.

When Starting Treatment with a Controlled Substance

Routine screening for a personal or family history of misuse or addiction in all patients is appropriate before prescribing a controlled substance. This should include a detailed history, but may also include UDT to determine if the patient is taking or has recently taken illicit and/or licit but un-prescribed substances.

When Making Major Changes in Treatment

Modification of therapy, particularly a dose increase, should depend on the evaluation of progress toward stated treatment objectives (e.g., decreased pain and increased function), while monitoring for side effects and aberrant behaviors. If these treatment objectives are not being achieved despite medication adjustments, UDT may assist with monitoring patient adherence before making further changes to the treatment plan. If concerns arise that a patient is misusing the prescribed medication or other substances, UDT results may be helpful for documentation and to guide treatment.

To Support a Decision to Refer

The Federation of State Medical Boards Model Policy on the “Use of Opioid Analgesics in the Treatment of Pain”recommends that special attention, such as monitoring, documentation, and consultation/referral, should be given to patients who are at increased risk for misusing medications (e.g., personal or significant family history of substance misuse or addiction, or comorbid psychiatric disorder).

Unexpected positive or negative UDT results should be verified, where necessary, through discussion with the laboratory. When such UDT results cannot be clarified through discussion with the patient, they are useful to suggest and support a decision to refer a patient to a specialist experienced in treating patients with complex conditions, such as a pain management specialist or someone who is knowledgeable in addiction medicine.

CENTERS FOR DISEASE CONTROL

 

CDC conducted a clinical systematic review of the scientific evidence to identify the effectiveness, benefits, and harms of long-term opioid therapy for chronic pain, consistent with the GRADE approach. Long-term opioid therapy is defined as use of opioids on most days for >3 months. 

The review concluded, among other things, that when prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider periodic urine drug testing to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

CDC also reviewed clinical guidelines that were relevant to opioid prescribing and could inform or complement the CDC recommendations under development (e.g., guidelines on nonpharmacologic and nonopioid pharmacologic treatments and guidelines with recommendations related to specific clinician actions such as urine drug testing or opioid tapering protocols).

With respect to risk stratification approaches, the CDC found that potential benefits of PDMPs and urine drug testing include the ability to identify patients who might be at higher risk for opioid overdose or opioid use disorder, and help determine which patients will benefit from greater caution and increased monitoring or interventions when risk factors are present.

The CDC also noted that clinicians do not consistently use practices intended to decrease the risk for misuse, such as PDMPs, urine drug testing, and opioid treatment agreements. Among other things, this is likely due in part to perceived inadequate time to discuss the rationale for urine drug testing and to order confirmatory testing, and feeling unprepared to interpret and address results.

CDC searched for evidence on opioid therapy compared with other treatments; costs of misuse, abuse, and overdose from prescription opioids; and costs of specific risk mitigation strategies (e.g., urine drug testing).

Yearly direct and indirect costs related to prescription opioids have been estimated (based on studies published since 2010) to be $53.4 billion for nonmedical use of prescription opioids; $55.7 billion for abuse, dependence (i.e., opioid use disorder), and misuse of prescription opioids; and $20.4 billion for direct and indirect costs related to opioid-related overdose alone.

The CDC recommendations, among other things, include:

  • Clinicians should discuss planned use of precautions to reduce risks, including use of prescription drug monitoring program information and urine drug testing.
     

  • If clinicians suspect their patient might be sharing or selling opioids and not taking them, clinicians should consider urine drug testing to assist in determining whether opioids can be discontinued without causing withdrawal.
     

  • Urine drug tests can provide information about drug use that is not reported by the patient. In addition, urine drug tests can assist clinicians in identifying when patients are not taking opioids prescribed for them, which might in some cases indicate diversion or other clinically important issues such as difficulties with adverse effects.

  • Experts agreed that prior to starting opioids for chronic pain and periodically during opioid therapy, clinicians should use urine drug testing to assess for prescribed opioids as well as other controlled substances and illicit drugs that increase risk for overdose when combined with opioids, including nonprescribed opioids, benzodiazepines, and heroin.
     

  • Clinicians should be familiar with the drugs included in urine drug testing panels used in their practice and should understand how to interpret results for these drugs.
     

  • Before ordering urine drug testing, clinicians should have a plan for responding to unexpected results. Clinicians should explain to patients that urine drug testing is intended to improve their safety and should also explain expected results (e.g., presence of prescribed medication and absence of drugs, including illicit drugs, not reported by the patient).
     

  • Clinicians should ask patients about use of prescribed and other drugs and ask whether there might be unexpected results. This will provide an opportunity for patients to provide information about changes in their use of prescribed opioids or other drugs.
     

  • Clinicians should discuss unexpected results with the local laboratory or toxicologist and with the patient.
     

  • Clinicians should use unexpected results to improve patient safety (e.g., change in pain management strategy, tapering or discontinuation of opioids, more frequent re-evaluation, offering naloxone, or referral for treatment for substance use disorder, all as appropriate).
     

  • If clinicians suspect opioid use disorder based on patient concerns or behaviors or on findings in prescription drug monitoring program data or from urine drug testing, they should discuss their concern with their patient and provide an opportunity for the patient to disclose related concerns or problems.

FEDERATION OF STATE MEDICAL BOARDS

 

In April 2017, the Federation of State Medical Boards adopted as policy, the “Guidelines for the Chronic Use of Opioid Analgesics”

The policy document includes relevant recommendations identified by the workgroup, and is in keeping with recent releases of advisories issued by the CDC and FDA. The policy is intended as a resource providing overall guidance to state medical and osteopathic boards in assessing physicians’ management of pain in their patients and whether opioid analgesics are used in a medically appropriate manner.

The policy recommends periodic and unannounced drug testing for opioids and other medications when deemed appropriate by the clinician with potential for substance use disorder and as part of an overarching risk mitigation strategy.

It states that periodic and unannounced drug testing are useful in monitoring adherence to the treatment plan, as well as in detecting the use of non-prescribed drugs. Additionally, that drug testing is an important monitoring tool because self-reporting of medication use is not always reliable and behavioral observations may detect some problems but not others.

The policy strongly recommends that patients being treated for addiction be tested as frequently as necessary to ensure therapeutic adherence, but for patients being treated for pain, clinical judgment trumps recommendations for frequency of testing.

The policy also strongly recommends that treatment agreements include, among other things, a provision that patients agree to periodic drug testing.

The policy notes that urine may be the preferred biologic specimen for testing because of its ease of collection and storage and the cost-effectiveness of such testing.

For drug testing in a pain practice, it states that it is important to identify the specific drug and metabolites, not just the class of the drug which requires the use of gas or liquid chromatography.

In general, the Federation of State Medical Board’s guidance is consistent with that found in the Center for Independent Healthcare Education and the CDC documents.

APPENDIX A

 

The 10 Principles of Universal Precautions

  1. Make a diagnosis with appropriate differential and a plan for further evaluation and investigation of underlying conditions to try to address the medical condition that is responsible for the pain.

  2. Psychologic assessment, including risk of addictive disorders.

  3. Informed consent.

  4. Treatment agreement.

  5. Pre-/post-treatment assessment of pain level and function.

  6. Appropriate trial of opioid therapy +/- adjunctive medication.

  7. Reassessment of pain score and level of function.

  8. Regularly assess the “Four As” of pain medicine.

    • a.   Analgesia

    • b.   Activity

    • c.   Adverse reactions

    • d.  Aberrant behavior

  9. Periodically review management of the underlying condition that is responsible for the pain, the pain diagnosis and comorbid conditions relating to the underlying condition, and the treatment of pain and comorbid disorders.         

  10. Documentation of medical management and of pain management according to state guidelines and requirements for safe prescribing.

SOURCES

 

“Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care” Center for Independent Healthcare Education, 2015

“CDC Guideline for Prescribing Opioids for Chronic Pain” Centers for Disease Control, 2016

“Guidelines for the Chronic Use of Opioid Analgesics” Federation of State Medical Boards, 2017

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