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10 Articles in Volume 12, Issue #7
August 2012 Pain Research Updates
Cash Patient: A Clinical Dilemma
Common Opioid-Drug Interactions: What Clinicians Need to Know
Compliance in Pain Patients: Balancing Need to Test With Need to Treat
Cytochrome P450 Testing In High-dose Opioid Patients
Discharging a Patient Suspected of Diversion
Examining the Safety of Joint Injections In Patients on Warfarin
Genomic Medicine
Letters to the Editor from August 2012
Minimally Invasive Spine Surgery— Who Can it Help?

Compliance in Pain Patients: Balancing Need to Test With Need to Treat

Legislators, medical boards, and physicians groups continue to try to balance the need to maintain access to pain medication for patients with chronic pain with the need to protect the public from abuse and diversion.

The use of opioids for the management of chronic pain of noncancer origin has elicited a flurry of controversy. This is due to an epidemic rise in overdose deaths and increased diversion of scheduled medications. (For the purposes of this article, “scheduled medications” will indicate Schedule II and III medications.) To counter misuse and diversion, legislators in multiple states have enacted laws to crack down on “pill mills,” “doctor shoppers,” questionable pain clinics, and even individual physicians. Several medical societies, state medical boards, and now state legislation recommend or even require the use of urine drug monitoring (UDM) for pain patients on chronic opioid therapy (COT). For example, the American Pain Society, American Academy of Pain Medicine, Florida Board of Medicine, and recent legislation in Kentucky all include UDM.1-3 Even though there are numerous suggestions and policies recommending UDM when opioids are prescribed, the use/compliance with UDM is low. For example, amongst primary care physicians (PCPs)—who represent the largest group of physicians prescribing long-term opioid therapy—one study found that PCPs utilized UDM in only 8% of patients.4 Anecdotally, the number of UDM requests also is low among pain specialists.

Although frequently cited as part of a standard approach in the treatment of chronic pain patients on opioid therapy, there is little evidence that the use of UDM reduces diversion, abuse, misuse, or overdose deaths. Monitoring of patients on opioids is no different than monitoring HbA1c in patients with diabetes or blood pressure in patients with hypertension. Monitoring is a guidepost, and this is how UDM should be considered and presented to patients.

Table: Seven specific recommendations for how to perform urine drug monitoring

Consensus Recommendations
Since there is little data concerning the use of UDM and less data on the outcomes of UDM, a consensus panel comprised of 11 thought leaders in the field of pain and addiction medicine worked extensively through numerous meetings, teleconferences, and e-mails to finalize and propose recommendations for the use of UDM.It was clear quickly that any recommendations made by such a consensus panel should be labeled as “expert-based recommendations based on evolving, but weak, evidence.”5 There were five questions proposed to the consensus panel5:

  • Whom to test
  • How to test
  • When to test
  • How to interpret test results
  • How to handle test discrepancies

Whom to Test
The first recommendation of the consensus panel was, “All patients who are prescribed a short- or long-acting opioid for long-term pain management (defined as >3 months by the recommendations panel) should be tested.”5

How to Test
The second question, “how to test patients,” involved significant discussion and included seven specific recommendations (Table 1). Patients should have any policies involving UDM clearly discussed and spelled out. This may include a written agreement, which both the patient and physician sign. This agreement should include responsibilities of both the patient and physician, as well as what is expected and what is required from each. Specific testing should be individualized: test for the drugs the patient is taking, what might be expected in a given patient, and potential illicit drugs. Point-of-care testing, enzyme linked, can be used for screening and aberrant results can then be sent for verification using gas chromatography/mass spectrometry. Temperature and specific gravity should be obtained and recorded for each urine test. The date and time of the last dose taken of each prescribed pain medication should be obtained and recorded as well. This can be crucial for interpreting unexpected results, especially when short-acting opioids are taken on an “as needed basis” (prn).

When to Test
The initial drug screen is a component of risk stratification of each patient when opioid therapy is likely. Further, UDM tests help in monitoring patients who have been risk stratified. Risk stratification—using the Webster & Webster’s Opioid Risk Tool (ORT) or SOAPP-R (the Screener and Opioid Assessment for Patients with Pain-Revised) to name just two tools—as well as other aspects of the patient evaluation, places patients in low-, medium-, or high-risk categories.6 Risk factors help determine follow-up visits, number of days of an opioid prescription, and frequency of UDM. Some of these risk factors include results from risk assessment baseline screening tests, smoking history, past medical history, psychiatric diagnosis that predisposes to abuse and misuse, history of prior opioid misuse, personal or family history of substance dependency, and social environment that predisposes to abuse or misuse.7-10

Each clinic should develop a procedure for routine, but unscheduled, UDM for all patients on opioids. The frequency of testing would be further refined based on the patient’s risk assessment. Risk should be reassessed and should not be considered static, since so many factors can affect risk and many of these can change over time. Collaborating with an addiction specialist can be incorporated into a management plan depending on the individual patient, their risk stratification, and the individual clinic. A pill count can be conducted by the clinician at the time of the patient’s appointment—patients should be told to bring all their medications with each visit. Practitioners should be aware of their specific state regulatory and legislative requirements.

Interpreting Results
Interpretation of test results is complicated and requires a thorough understanding of the laboratory reports and how tests are performed. For more information, the author refers readers to Gourlay and Heit.11 When UDM is performed and results are obtained there are four potential outcomes:

  • Test is appropriate for medications prescribed
  • Prescribed drug is not detected
  • An illicit drug is detected
  • A nonprescribed scheduled drug or drug of concern (eg, carisoprodol) is detected

Test Discrepancies
If the prescribed drug is not detected, there are a number of possibilities including diversion, hoarding, not taking the medication/never got the prescription filled, laboratory error, binge use, taking the medication on an occasional basis and not as prescribed, rapid metabolism (relatively rare—consider a genetic test if patient’s self-report is credible), and drug–drug interaction. Additionally, because prn medications may be taken intermittently and have a relatively short half-life, they may legitimately be out of the body by the time the urine is obtained; it’s important to note for each prescribed drug the time of the last dose taken.

If an illicit drug is detected, the potential causes include deliberate use or abuse of the illicit drug, addiction, seeking additional pain relief, false positive/laboratory error, self-medication, and bartering the prescribed drug in exchange for illicit drugs or other goods/services.

If a nonprescribed drug is detected, the possibilities include the same causes as outlined when the prescribed drug is not detected, as well as the potential for multiple prescribers. It is to be expected, however, that both the prescribed drug and its metabolite will appear in the urine. This is often interpreted falsely as a “positive drug test.” Prescribers need to have a thorough understanding of how opioids are metabolized to prevent patients from being accused of misuse or abuse of a medication. For example, codeine is metabolized to morphine, hydrocodone to hydromorphone, and oxycodone to oxymorphone. Therefore, a UDM should find, for example, hydromorphone in the urine of patients prescribed hydrocodone. Although this paper is not meant to be a thorough explication of metabolism of opioids and UDM, there are references that discuss this issue.11

Table: Actions recommended when diversion is suspected

Verify Results
With any UDM abnormality, the clinician must verify the results with the laboratory. It is critical that the clinician develop a good relationship with the laboratory. A phone call can frequently settle a potential aberrant finding. Obviously, all findings should be documented and a follow-up visit should be scheduled as soon as feasible.

Clinicians should always discuss UDM findings with the patient in an open-ended (ie, nonjudgmental, non-accusatory) manner. Does the patient have an explanation for the findings? Do the patient’s statements match or contradict test results? Review the initial treatment agreement with the patient. Counsel the patient as appropriate and consider retesting or additional testing. For any positive urine test result, there are four options: maintain current therapy (justify reasons via documentation and additional contingencies in ongoing plan of care); change therapy and/or discontinue opioids; consider outcomes of retention versus discharge of the patient from the practice; communicate with the patient’s other providers, when possible.

The use of UDM requires, as with any testing, that the physician understand its limitations and strengths.

Diversion and Addiction
Perhaps the most serious finding would be diversion. If diversion is suspected, Table 2 outlines the actions recommended by the consensus panel.5,12

If diversion is confirmed, the opioid may be discontinued and the authorities can be notified (where criminal behavior—eg, altering prescriptions, forging prescriptions, diversion, stolen prescriptions, confirmed doctor shopping—is suspected). Consider outcomes of retention versus discharge of the patient from the practice.

Where addiction is suspected, the following actions are recommended:

  • Co-management with an addiction specialist in abuse and decide whether to continue or discontinue the opioid
  • Follow the five “Ss” and consider referral to an addiction specialist or 12-step program. It is important to confirm participation in a program and work in collaboration with the addiction specialist.

The role of UDM can be summarized by a mnemonic: the five “Ps”; protect patients, protect practitioners, protect access (to valuable therapies, ie, maintain opioid availability for medical necessity), protect the community and society, and promote the cost-effective use of health care resources.

Last updated on: October 26, 2012
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