Compliance in Pain Patients: Balancing Need to Test With Need to Treat
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.
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.5 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.
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
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.