The Legal Landscape for Opioid Treatment Agreements.

Policy Points Opioid treatment agreements (OTAs) are controversial because of the lack of evidence that their use reduces opioid-related harms and the potential risks they pose of stigmatizing patients and undermining the clinician-patient relationship. Even so, their use is now required in most jurisdictions, and their use is influencing the outcomes of civil and criminal lawsuits. More research is needed to evaluate how OTAs are implemented given existing requirements. If additional research does not resolve the current level of uncertainty regarding OTA benefits, then policymakers in jurisdictions where they are required should consider eliminating OTA mandates or providing flexibility in the legal requirements to make room for clinicians and health care institutions to implement best practices. CONTEXT: Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids' risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices. METHODS: We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes. FINDINGS: Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions' requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts' reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability. CONCLUSIONS: Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician-patient relationships and patient care within the bounds of relevant legal requirements and risks.

Clinician Perspectives on Opioid Treatment Agreements: A Qualitative Analysis of Focus Groups.

BACKGROUND: Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For patients on LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians use them and if OTAs themselves modify clinician prescribing practices. OBJECTIVE: To determine how clinicians use OTAs and the potential impacts of OTAs on opioid prescribing. DESIGN: We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT, and two who did not. PARTICIPANTS: 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive, convenience sampling. APPROACH: Discussions were recorded, transcribed, and analyzed for themes using reflexive thematic analysis by a multidisciplinary team. KEY RESULTS: Our analysis identified three main themes: (1) OTAs did not influence clinicians' decisions whether to use LTOT generally but did shape clinical decision-making for individual patients; (2) clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful; (3) there is a potential misalignment between the intended purposes of OTAs and their implementation. CONCLUSION: This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact the clinicians' decisions about whether to use LTOT generally, they do sometimes influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs' purposes, which shows the need for more clarity about how OTAs could be used to promote shared decision-making, joint accountability, informed consent, and patient education.

E-Cigarettes and the Multiple Responsibilities of the FDA.

This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA's obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the public about the health risks and benefits of products it regulates, it also has other roles (and attendant responsibilities) that inform when and how it should disseminate information. In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices. In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence.

Opioid Treatment Agreements and Patient Accountability.

Opioid treatment agreements are written agreements between physicians and patients enumerating the risks associated with opioid medications along with the requirements that patients must meet to receive these medications on an ongoing basis. The choice to use such agreements goes beyond the standard informed consent process and has a distinctive symbolic significance. Specifically, it suggests that physicians regard it as important to hold their patients accountable for adhering to various protocols regarding the use of their opioid medications. After laying out a taxonomy of accountability relations between physicians and patients, I argue that opioid treatment agreements are justifiable for physicians to use in their provision of care only if they improve patient or public health outcomes, which has yet to be demonstrated.

'First Do No Harm': physician discretion, racial disparities and opioid treatment agreements.

The increasing use of opioid treatment agreements (OTAs) has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable.