This article explores challenges to accessing opioid treatment programs in rural areas, and offers solutions that would ease these problems.

In this issue of the Hastings Center Report, Joshua Rager and Peter Schwartz suggest using opioid treatment agreements as public health monitoring tools to inform patients about “the requirements entailed by undergoing opioid therapy,” rather than as contractual agreements to alter patients’ individual behavior or to benefit them directly. Because Rager and Schwartz's argument presents suspected OTA violations as a justification to stop providing opioids yet does not highlight the broader epistemic and systemic context within which clinicians (...) prescribe these medications, their proposal may perpetuate a climate of distrust and stigmatization without correcting systemic factors that may have placed patients and others at risk in the first place. Given the context of epistemic uncertainty regarding opioid safety and efficacy, insufficient training for opioid prescribers, and inadequate patient education, I propose replacing OTAs, which have a narrow focus on patient behaviors, with opioid treatment plans, which would promote mutual, collaborative, and shared decision-making on the most appropriate pain management program. An OTP can be ethically justified as a tool to prevent and treat iatrogenic addiction under a specific paradigm—one that adopts a default position of professional epistemic humility and holds all collaborative parties accountable in chronic pain management. (shrink)

Opioid agonist treatment, including methadone, is the safest and most effective method for treating opioid use disorders and reduces opioid overdose deaths. While access to methadone is highly regulated by federal law, a substantial portion of states impose stricter barriers.

Supply-side interventions such as prescription drug monitoring programs, “pill mill” laws, and dispensing limits have done little to quell the burgeoning opioid crisis. An increasingly popular demand-side alternative to these measures – now adopted by 38 jurisdictions in the USA and 7 provinces in Canada — is court-mandated involuntary commitment and treatment. In Massachusetts, for example, Part I, Chapter 123, Section 35 of the state's General Laws allows physicians, spouses, relatives, and police officers to petition a court to (...) involuntarily commit and treat a person whose alcohol or drug abuse poses a likelihood of serious harm. This paper explores the ethical underpinnings of this law as a case study for others. First, we highlight the procedural and substantive standards of Section 35 and evaluate the application of the law in practice, including the frequency with which it has been invoked and outcomes. We then use this background to inform an ethical critique of the law. Specifically, we argue that the infringement of autonomy and privacy associated with involuntary intervention under Section 35 is not currently justified on the grounds of a lack of evidenced benefits and a risk of significant of harm. Further ethical concerns also arise from a lack of standard of care provided under the Section 35 pathway. Based on this analysis, we advance four recommendations for change to mitigate these ethical shortcomings. (shrink)

This article argues that correctional institutions violate the Eighth Amendment when they refuse to establish MAT programs and prevent doctors from exercising medical judgment to properly treat incarcerated people with OUD.

This paper seeks to understand the treatment effect of Prescription Drug Monitoring Programs on opioid prescription rates. Using county-level panel data on all opioid prescriptions in the U.S. between 2006 and 2015, we investigate whether state interventions like PDMPs have heterogeneous treatment effects at the sub-state level, based on regional and temporal variations in policy design, extent of urbanization, race, and income. Our models comprehensively control for a set of county and time fixed effects, countyspecific and (...) time-varying demographic controls, potentially endogenous time-series trends in prescription rates, and other state-level opioid interventions such as Naloxone Access and Good Samaritan laws, Medicaid expansion, and the provision of Methadone Assistance Treatment. We find that PDMPs are only effective in reducing prescription rates if they obligate doctors to check for patients' history prior to filling out a prescription, but the frequency at which a state requires its PDMP to be updated is irrelevant to its effectiveness. Moreover, the significant treatment effects of PDMPs are almost exclusively driven by urban and predominantly white counties, with the relatively more affluent regions showing greater responsiveness than their less affluent counterparts. (shrink)

While much of the social and political attention surrounding the nationwide opioid epidemic has focused on the dramatic increase in overdose deaths among white, middle-class, suburban and rural users, the impact of the epidemic in Black communities has largely been unrecognized. Though rates of opioid use at the national scale are higher for whites than they are for Blacks, rates of increase in opioid deaths have been rising more steeply among Blacks than whites over the last five (...) years. Moreover, the rate of opioid overdose deaths among Blacks already exceeds that of whites in several states. The lack of discussion of Black overdose deaths in the national opioid discourse further marginalizes Black people, and is highly consistent with a history of framing the addictions of people of color as deserving of criminal punishment, rather than worthy of medical treatment. This article argues that, because racial inequalities are embedded in American popular and political cultures as well as in medicine, the federal and state governments should develop more culturally targeted programs to benefit Black communities in the opioid crisis. Such programs include the use of faith-based organizations to deliver substance use prevention and treatment services, the inclusion of racial impact assessments in the implementation of drug policy proposals, and the formal consideration of Black people's interaction with the criminal justice system in designing treatment options. (shrink)

Methadone maintenance treatment (MMT) is a harm reduction approach for persons who wish to stop using opioids and is rather effective if used for a minimum of 12 months. Notably, research demonstrates that many persons enrolled in MMT programs discontinue care before this time, limiting its effects. To better understand this process, we undertook an exploratory descriptive qualitative study and interviewed 12 men and women who were using MMT. Using the theoretical work of Foucault and Hardt and Negri, the (...) interview data highlighted that MMT continues to be strongly stigmatized, and that it is a system of care that involves rewards and penalties, based on if patients behave according to prescribed norms. These results suggest that MMT is a disciplinary mechanism, albeit one that impedes its own access. We consequently recommend that healthcare providers work to facilitate access to MMT, which means altering care delivery. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by (...) extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

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)

In lieu of an abstract, here is a brief excerpt of the content:When Is Enough, Enough?Megan HomsyThis was a case that stuck with many members of our transplant team for a long time. The patient was a 44-year-old Caucasian male evaluated for a liver transplant with a diagnosis of hepatitis C virus (HCV), originally diagnosed 11 years before the transplant evaluation. The patient met the criteria for the following substance use diagnoses: alcohol use disorder moderate in sustained remission, in a (...) controlled environment, opioid use disorder, severe, in sustained remission, on maintenance therapy, in a controlled environment, stimulant use disorder, amphetamine-type, severe, in early remission, in a controlled environment and stimulant use disorder, cocaine-type, severe in early remission, in a controlled environment.The patient had been living in a sober living housing program for approximately ten months prior to his transplant evaluation with me, his social worker. He had also been diagnosed with depression and bipolar disorder. He had been intermittently linked with mental health services and had participated in numerous detox and substance abuse programs over the last ten years, with varying degrees of success. He was in dual diagnosis treatment (i.e., treatment for co-occurring substance use and mental health disorders) through his Suboxone clinic and was completing toxicology screenings on a biweekly basis.After concluding the minimum three months of drug and alcohol treatment set forth by the state's Organ Transplantation Consortium, the patient graduated from his sober living program, moved in with his sister, and was listed for a liver transplant.The patient was transplanted five months after his clinic evaluation. At the time of the surgery, the patient's Suboxone was abruptly discontinued and replaced with IV Dilaudid. Within days of his transplant, the patient frequently expressed concerns about his pain. Several medical services attempted to manage the pain medications, resulting in his pain management plan being changed repeatedly and much confusion over his current medication regimen. During his liver transplant hospitalization, the RN found the patient with a needle in his arm, and after a search of the patient's hospital room, the hospital police found drug paraphernalia and illicit substances. The patient was eventually discharged to an inpatient substance abuse program, which he left before completing the program and against medical advice.During his first year post-transplant, I attempted to arrange other various treatment programs for him (most of which he did not follow through with) and to find housing for him (as he had been forced to leave his sister's home after his relapse). Eventually, the patient was incarcerated on drug-related charges. Numerous times, the patient missed completing his labs and his post-transplant appointments. He did not refill his immunosuppressant medications, and for lengthy periods of time, he was unreachable by the transplant care team, which resulted in my team members and I calling the patient's family, other providers, and the police for safety checks.In the aftermath of these issues, my colleagues and I had to reckon with the realization that we had failed the patient. As a team, our transplant center created a task force to review this case and what to do in the future to prevent such breakdowns in patient care. We created protocols for managing patients who, at the time of their transplant, are on Medication Assisted Treatment (MAT) such as Suboxone and methadone. Staff across the multidisciplinary team attended trainings regarding addiction, pain management, and best practices for MAT services. Additionally, our transplant center collaborated with our hospital's addiction treatment program for a streamlined referral process for transplant patients to addiction services.This patient's case and its sensational nature resulted in many conversations, both professional and unprofessional. Members of the social worker department became aware that personnel within transplant, though not involved in patient care, were inappropriately discussing this patient's case and engaging in unprofessional behavior. Said actions led to the termination of a member of the transplant team. I was placed in the unenviable [End Page E3] position of having to report this behavior to hospital management and legal teams to protect a vulnerable patient.The ethical challenge behind this case really stems from the transplant team attempting to balance two... (shrink)

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)

In order to receive controlled pain medications for chronic non-oncologic pain, patients often must sign a “narcotic contract” or “opioid treatment agreement” in which they promise not to give pills to others, use illegal drugs, or seek controlled medications from health care providers. In addition, they must agree to use the medication as prescribed and to come to the clinic for drug testing and pill counts. Patients acknowledge that if they violate the opioid treatment agreement, they (...) may no longer receive controlled medications. OTAs have been widely implemented since they were recommended by multiple national bodies to decrease misuse and diversion of narcotic medications. But critics argue that OTAs are ethically suspect, if not unethical, and should be used with extreme care if at all. We agree that OTAs pose real dangers and must be implemented carefully. But we also believe that the most serious criticisms stem from a mistaken understanding of OTAs’ purpose and ethical basis. (shrink)

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)

In this issue of the Hastings Center Report, Joshua Rager and Peter Schwartz reframe the justification for the use of opioid treatment agreements. Instead of documents used to define the roles and responsibilities of doctors and patients to one another in the course of opioid treatment for chronic pain and to describe the risks and benefits of therapy for the individual, OTAs are now proposed for use as “surveillance and monitoring” instruments. As such, they are specifically (...) meant to disclose the risks of opioid therapy and to describe the other processes and tools used to monitor abuse and diversion of medications. Given the crisis of the opioid overdose and death epidemic, along with this repurposing of OTAs as disclosure documents primarily, Rager and Schwartz argue that patient consent is not needed and that OTAs should be universally applied in clinical practices. We can all agree on the big picture goal of limiting the number of opioid prescriptions in order to minimize the tragedy of opioid overdose deaths. We disagree, though, about the acceptable level of collateral damage to people in pain who fall victim to fighting the war against the so-called opioid epidemic. (shrink)

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)

PurposeThe purpose of this study is to describe the implementation and outcomes of an Eye Movement and Desensitization Reprocessing treatment-program for women with posttraumatic stress disorder after childbirth.MethodsA prospective cohort-study with pre- and post-measurements was carried out in the setting of an academic hospital in the Netherland. Included were women who gave birth to a living child at least 4 weeks ago, with a diagnosis of PTSD, or severe symptoms of PTSD combined with another psychiatric diagnosis. All received (...) up to 8 sessions of EMDR-therapy. The posttraumatic stress disorder Checklist for DSM-5 was administered before and after treatment. Trauma history was assessed before treatment with the Life Events Checklist for the DSM-5, the Childhood Trauma Questionnaire and the Childbirth Perception Scale. Descriptive statistics were used.ResultsForty-four women were referred, 26 met the inclusion criteria. After treatment, none of the women met the criteria for diagnosis of PTSD after on average 5 weekly sessions of EMDR- therapy. These outcomes are promising, as they were achieved in women with relatively high levels of psychiatric comorbidity and high rates of previous mental health treatment.ConclusionImplementing an EMDR-treatment program for women with PTSD after childbirth in the setting of an academic hospital is feasible and effective. Key factors for success include a close collaboration between the relevant hospital departments and a thorough case conceptualization addressing the etiology of the PTSD. (shrink)

Brazil has occupied a central role in the access to medicines movement, especially with respect to drugs used to treat those with the human immunodeficiency virus that causes the acquired immune deficiency syndrome. Contrary to previous literature centered on the role of the domestic pharmaceutical industry, politicians seeking electoral gains, and civil society activists, I argue that the state, especially the National AIDS Program, led the struggle in contesting a corporate-driven international intellectual property regime. After reviewing the origins of (...) Brazil’s treatment policies and patent reforms, I trace the actions and relationships between the state, civil society, transnational corporations, and local industry in three instances when Brazilian officials used compulsory licenses to reduce the price of medicines. Coalition-building and “naming and shaming” tactics contributed to Brazil’s success, while changing pharmaceutical capabilities limited more aggressive actions. (shrink)

SUSANNE UUSITALO,ANNA AXELIN | : Infants born to opioid-dependent women are typically admitted to neonatal intensive-care units for management of neonatal abstinence syndrome, and their treatment requires medical decision making. It is not only the infants’ vulnerability, in terms of their incompetence and medical condition, that is present in those circumstances, but also the mothers’ situational vulnerability, which arises with the possibility of their engagement in medical decision making regarding their infants. Vulnerability is a concept that has often, (...) if not always, been traced back to individuals. In this paper, we suggest that in some cases evaluations and attributions of vulnerability to either individuals or populations fall short of capturing all aspects of vulnerability. We ask whether this individual-based evaluation is sufficient for identifying all the vulnerabilities arising in the situation. Moreover, we suggest that the “unit” of vulnerability attribution, typically a person who is a likely target of harm and/or moral violations, should not simply be reduced to the individual. Rather, the unit should in some cases be seen as constituted by an entity that is interpersonal in nature. The kind of real vulnerability that we identify in this paper is inherently embedded in a dyadic relationship, and notions of vulnerability that decompose social relations into individuals run the risk of missing the vulnerability in question. We elaborate this kind vulnerability by discussing of role of opioid-dependent mothers in decision making about their infants’ treatment. | : Les nourrissons nés de femmes dépendantes aux opioïdes sont généralement admis dans des unités de soins intensifs néonatals pour la prise en charge du syndrome d’abstinence néonatale, et leur traitement nécessite une prise de décision médicale. Ce n’est pas seulement la vulnérabilité des nourrissons, en termes d’incompétence et de dépendance médicale, qui est présente dans ces circonstances, mais aussi la vulnérabilité situationnelle des mères, qui découle de la possibilité de leur participation à la prise de décision médicale concernant leurs enfants. La vulnérabilité est un concept qui a souvent, sinon toujours été relié à des individus. Dans cet article, nous suggérons que, dans certains cas, les évaluations et les attributions de vulnérabilité aux individus ou aux populations ne permettent pas de saisir tous les aspects de la vulnérabilité. Nous demandons si cette évaluation individuelle est suffisante pour identifier toutes les vulnérabilités qui apparaissent dans la situation. De plus, nous suggérons que l’« unité » d’attribution de la vulnérabilité, généralement une personne qui est une cible probable de dommages ou de violations morales, ne devrait pas simplement être réduite à l’individu. Au contraire, l’unité devrait dans certains cas être considérée comme une entité de nature interpersonnelle. Le type de vulnérabilité réelle que nous identifions dans cet article est intrinsèquement intégré dans une relation dyadique, et les notions de vulnérabilité qui décomposent les relations sociales en individus risquent de manquer la vulnérabilité en question. Nous développons ce type de vulnérabilité en discutant du rôle des mères dépendantes aux opioïdes dans la prise de décision concernant le traitement de leurs enfants. (shrink)

Intravenous drug abusers may incur bloodstream infections, in particular those involving the heart valves, that often require extended courses of antibiotics, commonly on the order of six weeks.Conventional wisdom has dictated that even when patients are sufficiently well to not need ongoing hospitalization, it is unsafe to complete their antibiotic course in any setting other than in a closely supervised facility, even if this is contrary to their wishes. The assumption has been that such patients would be at risk of (...) using their indwelling intravenous catheter for illicit purposes. Recent advances in the care of patients who suffer from addiction disorders suggest that when patients receive state-of-the-art addiction treatment, many may be able to continue their intravenous antibiotic course unsupervised, at home. This represents a departure from the parentalistic model of care of impaired patients who are prone to self-harm, moving towards a model that respects autonomy and trusts patients who are in recovery to continue their care in a manner that is self-beneficial. (shrink)

Maternal opioid use during pregnancy is a growing national problem and can lead to newborns developing neonatal opioid withdrawal syndrome soon after birth. Recent data demonstrates that nearly every 15 min a baby is born in the United States suffering from NOWS. The primary treatment for NOWS is opioid replacement therapy, commonly oral morphine, which has neurotoxic effects on the developing brain. There is an urgent need for non-opioid treatments for NOWS. Transcutaneous auricular neurostimulation, a (...) novel and non-invasive form of electrostimulation, may serve as a promising alternative to morphine. tAN is delivered via a multichannel earpiece electrode worn on and around the left ear, targeting two cranial nerves—the vagus and trigeminal nerves. Prior research suggests that auricular neurostimulation exerts an anxiolytic effect on the body by releasing endogenous opioids and reduces withdrawal symptoms in adults actively withdrawing from opioids. In this first-in-human prospective, open-label trial, we investigated tAN as an adjuvant to morphine therapy in eight infants >33 weeks gestational age suffering from NOWS and receiving oral morphine treatment. Infants received tAN for 30 min 1 h before receiving a morphine dose. tAN was delivered at 0.1 mA below perception intensity at two different nerve targets on the ear: Region 1, the auricular branch of the vagus nerve; and Region 2, the auriculotemporal nerve. tAN was delivered up to four times daily for a maximum of 12 days. The primary outcome measures were safety [heart rate monitoring, Neonatal Infant Pain Scale, and skin irritation] and morphine length of treatment. tAN was well-tolerated and resulted in no unanticipated adverse events. Comparing to the national average of 23 days, the average oral morphine LOT was 13.3 days and the average LOT after tAN initiation was 7 days. These preliminary data suggest that tAN is safe and may serve as a promising alternative adjuvant for treating NOWS and reducing the amount of time an infant receives oral morphine. (shrink)

PrécisDespite significant scholarship, research, and funding dedicated to implementing criminal diversion programs over the past two decades, persons with serious mental illness and substance use disorders remain substantially overrepresented in United States jails and prisons. Why are so many U.S. adults with behavioral health problems incarcerated instead of receiving treatment and other support to recover in the community? In this paper, we explore this persistent problem within the context of “relentless unmet need” in U.S. behavioral health (Alegría et al., (...) 2021). (shrink)

Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize (...) that it should be considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT. (shrink)

The use of opioid contracts, which often require patients to submit to random drug screens, have become widespread amongst physicians using opioids to treat chronic pain. The main purpose of the contract is to improve care through better adherence to opioid therapy but there is little evidence as to its efficacy. The author suggests the use of opioid contracts and random drug testing destroys patients' trust which impacts health outcomes, and that physicians' motivation for their use are (...) concerns about prosecution, medication abuse and misuse, and addiction. Statistics are provided to counter fears, and evidence is offered suggesting opioid contracts are unenforceable and lack efficacy; random drug testing is often inconclusive, and a patient's trust improves adherence to treatment. (shrink)

Introduction: Neurobiological systems engineering models are useful for treating patients. We show a model of “high opioid tone” autism and present a hypothesis about how autism is caused by administration of opioids during childbirth.Main Symptoms: Clinical diagnosis of autism in a 25 year old man was confirmed by a Social Responsiveness Scale self-rating of 79, severe, and a Social Communications Questionnaire by the patient's father scoring 27. Cold pressor time was 190 seconds—unusually long, consonant with the high pain tolerance (...) of autism.Therapeutic Intervention and Outcomes: At naltrexone 50 mg/day SRS fell to 54 and SCQ-−2–9; both non-significant. CPT fell to 28, repeat 39 s. Improved relatedness was experienced ambivalently, understood as feelings never before experienced—causing pain. Non-compliance with naltrexone was followed by cutting open his palm and drinking alcoholically. Transference focused psychotherapy has helped him remain naltrexone—compliant while he works on issues of identity and relatedness.Conclusion: The model suggests studies that could be conducted to both prevent and treat this form of autism. (shrink)

We read with interest the extended essay published from Riisfeldt and are encouraged by an empirical ethics article which attempts to ground theory and its claims in the real world. However, such attempts also have real-world consequences. We are concerned to read the paper’s conclusion that clinical evidence weakens the distinction between euthanasia and normal palliative care prescribing. This is important. Globally, the most significant barrier to adequate symptom control in people with life-limiting illness is poor access to opioid (...) analgesia. Opiophobia makes clinicians reluctant to prescribe and their patients reluctant to take opioids that might provide significant improvements in quality of life. We argue that the evidence base for the safety of opioid prescribing is broader than that presented, restricting the search to palliative care literature produces significant bias as safety experience and literature for opioids and sedatives exists in many fields. This is not acknowledged in the synthesis presented. By considering additional evidence, we reject the need for agnosticism and reaffirm that palliative opioid prescribing is safe. Second, palliative sedation in a clinical context is a poorly defined concept covering multiple interventions and treatment intentions. We detail these and show that continuous deep palliative sedation is a specific practice that remains controversial globally and is not considered routine practice. Rejecting agnosticism towards opioids and excluding CDPS from the definition of routine care allows the rejection of Riisfeldt’s headline conclusion. On these grounds, we reaffirm the important distinction between palliative care prescribing and euthanasia in practice. (shrink)

Pain management has improved in the past few decades. Opioid analgesics have become the mainstay in the treatment of cancer pain whilst inter-disciplinary pain management programmes are the generally accepted approach to chronic pain of non-malignant origin. Recently some pain specialists have advocated the use of opioids in the long-term management of non-cancer pain. This has raised some fundamental questions about the purpose of pain management. Is it best to opt for maximum pain relief and comfort, or should (...) one emphasise function and activity as higher priorities? Will the use of opioids create more autonomy for pain sufferers or will this add handicaps to lives which are already limited? Until more clinical outcome data are available we advocate caution in the use of opioid analgesia. Such caution can, and does, raise questions about the rights of the patient and the rights of the prescriber in a context where the facts do not point to a clear course of action. (shrink)

Concerns that cash payments to people who inject drugs (PWID) to reimburse research participation will facilitate illicit drug purchases have led some ethical authorities to mandate department store/supermarket vouchers as research reimbursement. To examine the relative efficacy of the two forms of reimbursement in engaging PWID in research, clients of two public opioid substitution therapy clinics were invited to participate in a 20–30 min, anonymous and confidential interview about alcohol consumption on two separate occasions, 4 months apart. Under the (...) crossover design, at Time 1, clients of Clinic 1 were offered $A20 cash as reimbursement, while clients of Clinic 2 were offered an $A20 voucher; at Time 2, the form of reimbursement was reversed. Using clinic records to determine the denominator (number of clients dosed), we found that compared with clients offered a voucher, a significantly higher proportion of clients who were offered cash participated in the survey (58% (139/241) vs 74% (186/252); χ2=14.27; p=0.0002). At first participation, respondents most commonly reported planning to purchase food/drinks/groceries (68%), cigarettes (21%) and transport/fuel (11%) with their payments, with those reimbursed in cash more likely to report planning to fund transport/fuel (19% vs 1%; p<.01) and less likely to report planning to purchase food/drinks/groceries (62% vs 76%; p=0.02). Just three out of 155 cash participants reported planning to purchase illicit drugs with their payment. Results demonstrate that modest cash payments enhanced recruitment of this group, an important consideration given the challenges of delineating the parameters of a population defined by illegal activity, seemingly without promoting excessive additional drug use. (shrink)

We build on an existing a term-sequent logic for the λ-calculus. We formulate a general sequent system that fully integrates αβη-reductions between untyped λ-terms into first order logic. We prove a cut-elimination result and then offer an application of cut-elimination by giving a notion of uniform proof for λ-terms. We suggest how this allows us to view the calculus of untyped αβ-reductions as a logic programming language (as well as a functional programming language, as it is traditionally seen).

The spinal mechanisms of action of opioids under normal conditions are reasonably well understood. The spinal effects of opioids can be enhanced or reduced depending on pathology and activity in other segmental and nonsegmental pathways. This plasticity will be considered in relation to the control of different pain states using opioids. The complex and contradictory findings on the supraspinal actions of opioids are explicable in terms of heterogeneous descending pathways to different spinal targets using multiple transmitters and receptors – therefore (...) opioids can both increase and decrease activity in descending pathways. These pathways could exhibit considerable plasticity. There is increasing evidence that delta opioid receptor agonists have the potential to replace morphine as major analgesics with reduced side-effect profiles. The concept of preemptive analgesia, based on preventing the induction of some of the negative plastic influences on opioid controls and the detrimental effects of pain, is sound, but experimental verification in the clinical setting is difficult. For example, a delayed compensatory upregulation of inhibitory systems, particularly in inflammation, may counter persistent painful inputs. Combination therapy with opioids may be beneficial in many pain states where either negative influences are blocked or inhibitory controls are enhanced. Finally, developmental aspects of these systems are discussed in connection with the treatment of pain in young children, where inhibitory systems in the spinal cord are immature. (shrink)

Patients living with chronic pain require appropriate access to opioid therapy along with improved access to pain care and additional therapeutic options. It's both medically reasonable and ethical to consider opioid therapy as a treatment option in the management of chronic, non-cancer pain for a subset of patients with severe pain that is unresponsive to other therapies, negatively impacts function or quality of life, and will likely outweigh the potential harms. This paper will examine opioid therapy (...) in the setting of the opioid epidemic, why critics feel that the CDC guideline has resulted in harsh consequences for patients and their physicians, and the rationale for opioid therapy as a means of providing ethical and compassionate pain care. (shrink)

Ethical clinical practice requires cultural competency. In the United States, Hispanics report stronger attitudinal barriers to drug abuse treatment than any other racial/ethnic group. Hispanics report feeling that drug abuse treatment providers do not understand their unique cultural needs and are unfamiliar with their experiences of discrimination and immigration. Using this case study to explore broader ethical and policy issues, this study investigates the extent to which US universities train counselors to address the culturally specific needs of Hispanic (...) patients and how this is reflected in practice in Los Angeles County. Based on a content analysis of the required courses, syllabi, and course descriptions at 30 universities related to culture/race/racism/ethnicity/diversity at the undergraduate and graduate levels on the addiction therapist track, and thematic analysis of eight in-depth interviews with counselors working in outpatient rehabilitation centers in Los Angeles, I argue that cultural competency education for drug abuse counselors is too surface level and infrequent to adequately prepare students for a career in addiction counseling for Hispanic clients. Significant changes must be made to how cultural diversity is valued and prioritized in the field of psychology to provide better care for Hispanic people with a substance use disorder and fulfill the moral obligation to eliminate this health disparity. Although this study focuses on counselors in Los Angeles, these findings are relevant for professionals and healthcare systems across the United States and beyond who seek to provide equitable and effective care for Hispanic patients. (shrink)

I very much enjoyed reading the interesting and original article by Steel and colleagues (2017). But I found myself strongly disagreeing with its conclusion once the real point of the argument became clear to me. At the same time, I believe that the authors are correct to draw attention to the importance of context and inequities in framing discussions of the ethics of voluntary consent in heroin prescription research. I begin with a brief summary of the authors’ conclusion, quoting directly (...) and adding my own emphases, since there are major philosophical points I wish to make that hinge on nuances in wording... (shrink)

Among those who discuss America's opioid crisis, it is popular to claim that we know what we, as a society, ought to do to solve the problem—we simply don't want it badly enough. We don't lack knowledge; we lack the will to act and to fund the right policies. In fact, I've heard two versions of this. Among those who focus on prescription opioids, it is clear that we ought to stop prescribing so many powerful opioid painkillers. And (...) among my public health colleagues focusing on illicit drug use, it is clear that we ought to expand addiction treatment and harm‐reduction services. The problem, however, is that the second claim is not obvious (and, indeed, is denied by many Americans), and the first claim probably isn't even true (at least, not in so crude a form). In short, the opioid crisis presents not only a problem of political will but also one of ethics. It will take work to discover or justify our normative claims in this arena. (shrink)

Parts I through III of this paper will examine several, increasingly comprehensive forms of aggregation, ranging from insurance reimbursement “lock-in” programs to PDMPs to completely unified electronic medical records. Each part will advocate for the adoption of these aggregation systems and provide suggestions for effective implementation in the fight against opioid misuse. All PDMPs are not made equal, however, and Part II will, therefore, focus on several elements — mandating prescriber usage, streamlining the user interface, ensuring timely data uploads, (...) creating a national data repository, mitigating privacy concerns, and training doctors on how to respond to perceived doctor-shopping — that can make these systems more effective. In each part, we will also discuss the privacy concerns of aggregating data, ranging from minimal to significant, and highlight the unique role of stigma in motivating these concerns. In Part IV, we will conclude by suggesting remedial steps to offset this loss of privacy and to combat the stigma around SUDs and mental health disorders in general. (shrink)

BackgroundAs opioid use disorder (OUD) incidence and its associated deaths continue to persist at elevated rates, the development of novel treatment modalities is warranted. Recent strides in this therapeutic area include novel anti-opioid vaccine approaches. This work compares logistical and ethical considerations surrounding currently available interventions for opioid use disorder with an anti-opioid vaccine approach.MethodsThe opinions of student pharmacists and practicing pharmacists assessing knowledge, perceptions, and attitudes toward current and future OUD management strategies were characterized (...) using a staged, multi-modal research approach incorporating a focus group, pilot survey development and refinement, and final survey deployment. Survey responses were assessed using one- and two-way parametric and non-parametric analyses where appropriate, and multi-dimensional matrix profiles were compared using z-tests following an exhaustive combinatorial sum of differences calculation between items within each compared matrix.ResultsFocus group content analysis revealed a high level of agreeableness among participants regarding anti-opioid vaccine technology and a sense of shared ownership regarding solutions to the opioid epidemic at large. Pilot survey results demonstrated subject ability to consider both pragmatic and ethical considerations related to current therapeutics and novel interventions in a single instrument, with high endurance amongst engaged subjects. Access inequality was the most concerning ethical consideration identified for anti-opioid vaccines. Support for anti-opioid vaccine implementation across various clinical scenarios was strongest for voluntary use amongst individuals in recovery, and lowest for mandatory use in at-risk individuals.ConclusionsEthical and logistical concerns surrounding anti-opioid vaccines were largely similar to those for current OUD therapeutics overall. Anti-opioid vaccines were endorsed as helpful potential additions to current OUD therapeutic approaches, particularly for voluntary use in the later stages of clinical progression. (shrink)

Depression is the principal cause of illness and disability in the world. Studies charting the prevalence of depression among children and adolescents report high percentages of youngsters in both groups with depressive symptoms. This review analyzes the construct and explanatory theories of depression and offers a succinct overview of the main evaluation instruments used to measure this disorder in children and adolescents, as well as the prevention programs developed for the school environment and the different types of clinical treatment (...) provided. The analysis reveals that in mental classifications, the child depression construct is no different from the adult one, and that multiple explanatory theories must be taken into account in order to arrive at a full understanding of depression. Consequently, both treatment and prevention should also be multifactorial in nature. Although universal programs may be more appropriate due to their broad scope of application, the results are inconclusive and fail to demonstrate any solid long-term efficacy. In conclusion, we can state that: (1) There are biological factors (such as tryptophan—a building block for serotonin-depletion, for example) which strongly influence the appearance of depressive disorders; (2) Currently, negative interpersonal relations and relations with one's environment, coupled with social-cultural changes, may explain the increase observed in the prevalence of depression; (3) Many instruments can be used to evaluate depression, but it is necessary to continue to adapt tests for diagnosing the condition at an early age; (4) Prevention programs should be developed for and implemented at an early age; and (5) The majority of treatments are becoming increasingly rigorous and effective. Given that initial manifestations of depression may occur from a very early age, further and more in-depth research is required into the biological, psychological and social factors that, in an interrelated manner, may explain the appearance, development and treatment of depression. (shrink)

In response to a sharp rise in opioid-involved overdose deaths in the USA, states have deployed increasingly aggressive strategies to limit the loss of life, including civil commitment—the forcible detention of individuals whose opioid use presents a clear and convincing danger to themselves or others. While civil commitment often succeeds in providing short-term protection from overdose, emerging evidence suggests that it may be associated with long-term harms, including heightened risk of severe withdrawal, relapse and opioid-involved mortality. To (...) better assess and mitigate these harms, states should collect more robust data on long-term health outcomes, decriminalise proceedings and stays, provide access to medications for opioid use disorder and strengthen post-release coordination of community-based treatment. (shrink)

At the end of life, pain management is commonly a fundamental part of the treatment plan for patients where curative measures are no longer possible. However, the increased recognition of opioid diversion for secondary gain coupled with efforts to treat patients in the home environment towards the end of life creates the potential for ethical dilemmas in the palliative care management of terminal patients in need of continuous pain management. We present the case of an end-stage patient with (...) rectal cancer who required a continuous residential narcotic infusion of fentanyl for pain control due to metastatic disease. His functional status was such that he had poor oral intake and ability to perform other activities of daily living, but was able to live at home with health agency nursing care. The patient presented to this institution with a highly suspect history of having lost his fentanyl infusion in a residential accident and asking for a refill to continue home therapy. The treating physicians had concerns of diversion of the infusion medication by caregivers and were reluctant to continue the therapeutic relationship with the patient. This case exemplifies the tension that can exist between wanting to continue with palliative care management of an end-stage patient and the fear of providers when confronted by evidence of potential diversion of opioid analgesic medications. We elucidate how an ethical framework based on a combination of virtue and narrative/relationship theories with reference to proportionality can guide physicians to a pragmatic resolution of these difficult situations. (shrink)

In recent years, the opioid crisis in the United States has sparked significant discussion on doctor–patient interactions concerning chronic pain treatments, but little to no attention has been given to investigating the vocal aspects of patient talk. This exploratory sociolinguistic study intends to fill this knowledge gap by employing prosodic discourse analysis to examine context-specific linguistic features used by the interlocutors of two distinct medical interactions. We found that patients employed both low pitch and creak as linguistic resources when (...) describing chronic pain, narrating symptoms and requesting opioids. The situational use of both features informs us about the linguistic ways in which patients frame fraught issues like chronic pain in light of the current opioid crisis. This study expands the breadth of phonetic analysis within the domain of discourse analysis, serving to illuminate discussions surrounding the illocutionary role of the lower vocal tract in expressing emotions. (shrink)