Despite widespread use in treating patients with chronic pain, there is little evidence that opioid agreements help reduce opioid misuse.
Despite widespread use of opioid agreements in the management of patients with chronic pain, there is little evidence that these documents help reduce opioid misuse. Many experts are convinced that the potential harm to the physician-patient relationship caused by the use of opioid agreements is reason for discarding them altogether in favor of other approaches that educate patients about the dangers of opioid misuse and their responsibilities during treatment.
In “How Useful Are Patient Opioid Agreements and Urine Drug Testing?”, published on the Psychiatric Times website, Steven King, MD, MS, clinical professor of psychiatry at the New York University School of Medicine, wrote that although he does not object to the use of written patient opioid agreements (POAs) and urine drug testing (UDT) when managing patients with chronic pain, he has never used a POA and rarely uses UDT. King said that he forgoes the use of these tools, despite the fact that “guidelines on the use of prescription opioids do suggest that written POAs and UDT might benefit some patients,” because “there does not appear to be any firm evidence that these tools reduce the likelihood that opioids will be used in unintended ways.”
King noted that although the “Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain,” published by the American Pain Society (APS) and the American Association of Pain Medicine (AAPM), suggested the use of written management plans when using opioids to treat chronic noncancer pain, the authors of the guidelines found little evidence in the literature to support these recommendations, along with “insufficient evidence to guide specific recommendations on which provisions to include” in the written plans.
The authors of the study “Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients with Chronic Pain” performed a literature search for “original research addressing opioid medications, chronic pain, and treatment agreements or urine drug testing, with a sample size of 50 participants or more.” According to King, the authors could only find 11 studies (several of which the authors rated as being of only “fair” or “poor” quality) that met these criteria, with the results varying widely (in the seven studies that did not include the use of comparison groups, 3-43% of patients whose management plans included the use of POAs and/or UDT still misused opioids). The authors of the study concluded that “Relatively weak evidence supports the effectiveness of opioid treatment agreements and urine drug testing in reducing opioid misuse by patients with chronic pain. Further research on effective ways to monitor and reduce opioid misuse is needed, especially in primary care settings.”
In addition to the lack of clinical evidence supporting the use of POAs and/or UDT, King suggested that there may be other factors arguing against their use in the management of patients with chronic pain: the use of POAs and UDT “may limit how one deals with questionable behavior by patients” and may give health care providers “a false sense of security that their use will significantly reduce or even eliminate the risk of the misuse of opioids.” The specificity implied by the use of a written agreement or contract may lead to disputes with the patient if (when?) a situation arises that is not explicitly accounted for in the document, potentially placing physicians “in a debate with the patient about the fairness of adding new restrictions.” According to King, including vague, open-ended language allowing the physician to add to or modify the document to account for unforeseen situations puts you “back at square one in saying that the POA is a guide rather than a firm agreement.” Confining the use of POAs and UDT to patients who are more likely to misuse their medications may also be fraught with difficulty because “unless the patient has a history of substance abuse, it is often difficult—if not impossible—to accurately determine the risk level for the misuse of opioids legitimately prescribed for the treatment of pain,” King wrote.
Doing more harm than good?
Other pain clinicians share similar concerns over the potential downsides of using opioid agreements when managing patients with chronic pain. In “Opioid Agreements: Helping or Harming the Physician-Patient Relationship?”, published in Pain Medicine News, Gabriel Miller noted that a panel convened by the American Journal of Bioethics to address the use of opioid agreements identified several unintended consequences associated with their use, including “stigmatizing pain patients; creating barriers to opioid prescribing; undermining physician—patient trust; contributing to the “legalization” of medicine; and eroding the ethical responsibility of physicians to put the patients’ needs above their own—in this case, the ‘chilling effect’ of increased regulation by state medical boards and the US Drug Enforcement Administration.”
The article includes quotes from several prominent pain experts who confirm the misconceptions surrounding the use of these documents, lack of evidence for their effectiveness, and the potential harm they can cause to the physician-patient relationship. Miller noted that one of the most important concerns with opioid agreements is that they underscore the inherently unequal power dynamic at the core of the physician-patient relationship, especially in the case of patients with chronic pain who must sign the document in order to receive their medications, and can cultivate a sense of mistrust between patient and provider. Another potential danger associated with the proliferation of opioid agreements is that “their significance may become diluted” and “they risk becoming another bureaucratic hurdle for physicians to jump through,” especially in the case of drugs like the fentanyl product Abstral, which requires the use of a patient—prescriber agreement that “must be countersigned by both patient and provider and faxed to the Abstral REMS program within 10 days” in order for the patient to receive the medication.
Rather than being an end unto itself, the opioid agreement should be viewed as an opportunity “to open an ongoing dialogue about the risks of opioids and what the patient and physician can expect from each other.” According to palliative care and pain management specialist Steve Passik, PhD, quoted in the article, “If the emphasis is on getting a piece of paper signed, one that people sign but may or may not read, may or may not understand, then to me it’s hurting the process, rather than helping it.” Rather than use the agreement as a pretext for refusing treatment or “firing” a patient for breaking the terms of the agreement, Passik told Miller that the best option is to continue treating the patient for substance abuse or dependence, because “it’s never been shown that firing someone from pain management necessarily helps their substance abuse problem… Why lose the leverage we have when offering help with pain to also try to help the person with an addiction?”
Other providers remain convinced of the benefits of opioid agreements when managing patients with chronic pain. The site OpioidRisk.com, funded by the National Institute of Drugs and Addiction, lists several benefits of using a written opioid agreement. In one study, a majority of providers using treatment agreements “reported that the use of this tool increased their sense of mastery and comfort with prescribing controlled drugs.” Another study found that agreements “reinforce expectations about safe use of opioids in higher risk patients; make the opioid therapy plan clear for the patient, the patient's family, and other providers of the patient; assist in patient education; and clarify many aspects of treatment,” including:
HCPLive wants to know:
Do you use opioid agreements in your practice? If so, have they been an effective component of pain management?
If you do not use opioid agreements, why not? Do you agree with the concerns over effectiveness, potential harm to the physician-patient relationship, and other issues raised by the experts quoted in this article?
If you do use opioid agreements, what kind of language and requirements does it include? What are the penalties for noncompliance?
Would you fire a patient for noncompliance with the terms of the opioid agreement?
Do these documents provide any extra legal protection for physicians who prescribe pain medications with a high risk of abuse, misuse, or diversion?
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