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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 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. (shrink)

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Philosophical views of responsibility often identify responsible agency with capacities like rationality and self-control. Yet in ordinary life, we frequently hold individuals responsible who are deficient in these capacities, such as children or people with mental illness. The existing literature that addresses these cases has suggested that we merely pretend to hold these agents responsible, or that they are responsible to a diminished degree. In this paper, I demonstrate that neither of these approaches is satisfactory, and offer an alternative focused (...) on the role relationships play in determining whether it is appropriate to hold someone responsible. I argue that relationships are sources of normative expectations about how parties in that relationship ought to behave, and that we can be responsible in virtue of being subject to these norms. This is so, not only for those who are impaired or immature, but for all of us. (shrink)

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The increasing use of opioid treatment agreements 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. There are no data in this work. (shrink)

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The idea that agent-regret is an important phenomenon in healthcare seems clear. Enck and Condley (2025) do an excellent job giving examples where clinician agent-regret seems understandable. Nonetheless, they focus almost exclusively on the importance of preserving clinician agency in these cases which, while likewise important, fails to fully capture their significance. Cases such as Dr. C’s and Nurse M’s are ones where there are clearly victims even if there are no wrongdoers; this is likely part of why Dr. C (...) and Nurse M feel alienated from colleagues who insist they have nothing to feel badly about, having acted in line with professional guidelines. Addressing the ongoing concerns of those victims may be helpful for all parties involved, including perhaps alleviating some of the clinicians’ agent-regret. But regardless of its effects, recognizing the parties impacted by Dr. C’s and Nurse M’s actions is an important part of properly understanding and taking responsibility for those actions. (shrink)

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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 relationships between physicians and patients, I argue that opioid treatment agreements are only justifiable for physicians to use in their provision of care if they improve public health outcomes, which has yet to be demonstrated. (shrink)

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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. (shrink)

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Following Strawson, many philosophers have claimed that holding someone responsible necessitates its being appropriate to feel or express the negative reactive attitudes (e.g., resentment) toward her. This view, while compelling, is unable to capture the full range of cases in which we hold others responsible in ordinary life. Consider the parent who holds her five-year-old responsible for not teasing his sister, or the therapist who holds her patient responsible for avoiding self-injurious behavior. Holding responsible in such cases requires enforcing normative (...) expectations, but these norms can (and typically should) be enforced without involving the negative reactive attitudes. To demonstrate this, I consider how responsibility attributions function in psychotherapy, as well as in other contexts where the negative reactive attitudes do not have a natural home. (shrink)

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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. (shrink)

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We appreciate that all our commentators accepted the central framework we argued for, namely that the FDA has multiple roles and attendant responsibilities, and we are excited to see this framework...

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