Legal Authority for Emergency Medical Services to Increase Access to Buprenorphine Treatment for Opioid Use Disorder.

Treatment with buprenorphine significantly reduces both all-cause and overdose mortality among individuals with opioid use disorder. Offering buprenorphine treatment to individuals who experience a nonfatal opioid overdose represents an opportunity to reduce opioid overdose fatalities. Although some emergency departments (EDs) initiate buprenorphine treatment, many individuals who experience an overdose either refuse transport to the ED or are transported to an ED that does not offer buprenorphine. Emergency medical services (EMS) professionals can help address this treatment gap. In this Concepts article, we describe the federal legal landscape that governs the ability of EMS professionals to administer buprenorphine treatment, and discuss state and local regulatory considerations relevant to this promising and emerging practice.

Equity First: Conceptualizing a Normative Framework to Assess the Role of Preemption in Public Health.

Policy Points Preemption is a legal doctrine whereby a higher level of government may limit or even eliminate the power of a lower level of government to regulate a certain issue. Some state legislatures are using preemption with increasing regularity to thwart local policies that have the potential to reduce health inequities. Despite recent trends, preemption is not inherently adversarial to public health, equity, or good governance but rather reflects its wielder's goals and values. Existing frameworks for assessing preemption fail to reconcile its potential to both advance and hinder health equity. An equity-first preemption framework can facilitate case-by-case assessments of whether preemption is likely to worsen inequities or whether it is an appropriate response to address existing inequities. Robust empirical evidence is needed to develop and operationalize such a framework. CONTEXT: Due to the inequitable distribution of various social determinants of health, disparities in health and well-being are tied to where an individual lives. In the United States, a zip code often better predicts a person's health than their genetic code. As communities seek to redress these inequities, many find that, due to state preemption, their zip code also dictates their ability to pursue more equitable laws through local government action. Preemption is a legal doctrine whereby a higher level of government may limit or even eliminate the power of a lower level of government to regulate a certain issue. METHODS: We conducted a literature review to survey existing scholarship about the effects of preemption on public health and health equity using online databases such as PubMed, WestLaw, and Google Scholar. We also cohosted a series of cross-sector, interdisciplinary research convenings with preemption, public health, and equity experts. Based on our findings, this article reviews the role of law and policy in the genesis of health inequities and highlights how preemption has both created and alleviated such inequities. We demonstrate how a normative framework rooted in redressing health inequities can advance a more just approach to preemption and outline a research agenda to support future action. FINDINGS: Law and policy have been central to creating health inequities, and while those same tools can promote health equity, some state legislatures are using preemption with increasing regularity to thwart local policies that may improve health and equity. Nevertheless, preemption is not inherently adversarial to public health, equity, or good governance. Preemptive federal civil rights laws, for example, have countered government-sanctioned discrimination. However, existing frameworks for assessing preemption fail to reconcile its potential to both advance and hinder health equity. CONCLUSIONS: Shortcomings in existing preemption frameworks demonstrate the need for new approaches to elevate equity as a central consideration in assessing preemption. We propose the development of an equity-first preemption framework to establish evidence-based criteria for assessing when preemption will enhance or inhibit equity and a research agenda for developing the evidence necessary to inform and operationalize the framework. An equity-first reconceptualization of preemption can help ensure that local governments remain places of innovation while allowing states and the federal government to block local actions that are likely to create or perpetuate inequities.

Over the counter naloxone needed to save lives in the United States.

The United States continues to face a public health emergency of opioid-related harm, the effects of which could be dramatically reduced through increased access to the opioid antagonist naloxone. Unfortunately, naloxone is too often unavailable when and where it is most needed, partly due to its continued status as a prescription medication. Although states and the federal Food and Drug Administration (FDA) have acted to increase access to naloxone, these changes are insufficient to address this unprecedented crisis. In this Commentary, we argue that FDA can and should immediately reclassify naloxone from prescription-only to over-the-counter status, a change that could save hundreds if not thousands of lives in the United States every year.

Simulating the Impact of a Cigarette Minimum Floor Price Law on Adult Smoking Prevalence in California.

INTRODUCTION: Minimum floor price laws (MFPLs) are an emerging tobacco control policy that sets a minimum price below which a specific tobacco product cannot be sold. MFPLs target cheaper products and may disproportionately impact consumers choosing low price brands or using discounts to reduce prices. We developed a static microsimulation model for California, United States to project short-term effects of different MFPL options for a 20-stick pack of cigarettes on adult smoking behaviors. AIMS AND METHODS: We simulated 300 000 individuals defined by race and ethnicity, sex, age, and poverty status. Smoking behaviors and cigarette prices were assigned based on demographic distributions in the 2014-2016 California Behavioral Risk Factor Surveillance System. We drew 100 random samples (n = 30 000), weighted to state-level California demographic characteristics. We simulated six MFPL options and modeled impacts on smoking prevalence and cigarette consumption, in general, and separately for those in households below or above 250% of the federal poverty level, assuming a price elasticity of -0.4. RESULTS: Predicted changes in prices, prevalence, and consumption increased exponentially as the floor price increased from $7.00 to $9.50. Assuming 15% policy avoidance, projected increases in average cigarette prices ranged from $0.19 to $1.61. Decreases in smoking prevalence ranged from 0.05 to 0.43 percentage points, and decreases in average monthly cigarette consumption ranged from 1.4 to 12.3 cigarettes. Projected prices increased, and prevalence and consumption decreased, more among individuals in households below 250% federal poverty level. CONCLUSIONS: MFPLs are a promising tobacco control strategy with the potential to reduce socioeconomic disparities in cigarette smoking prevalence and consumption. IMPLICATIONS: Despite reductions in adult smoking prevalence, significant socioeconomic disparities remain, with lower-income groups smoking at substantially higher levels than higher-income groups. Policies that set a floor price below which a tobacco product cannot be sold could reduce socioeconomic disparities in smoking, depending on variation in prices paid by smokers prepolicy. By using a microsimulation model to predict changes in smoking for different population groups in California under several floor price scenarios, this study demonstrates that MFPLs have the potential to reduce adult smoking prevalence overall, and especially for lower-income tobacco users.

Advancing Diabetes-Related Equity Through Diabetes Self-Management Education and Training: Existing Coverage Requirements and Considerations for Increased Participation.

America is in the grips of a diabetes epidemic. Underserved communities disproportionately bear the burden of diabetes and associated harms. Diabetes self-management education and training (DSME/T) may help address the epidemic. By empowering patients to manage their diabetes, DSME/T improves health outcomes and reduces medical expenditures. However, participation in DSME/T remains low. Insurance coverage offers 1 approach for increasing participation in DSME/T. The impact of DSME/T insurance coverage on advancing diabetes-related health equity depends on which types of insurers must cover DSME/T and the characteristics of such coverage. We conducted a legal survey of DSME/T coverage requirements for private insurers, Medicaid programs, and Medicare, finding that substantial differences exist. Although 43 states require that private insurers cover DSME/T, only 30 states require such coverage for most or all Medicaid beneficiaries. Public health professionals and decision makers may find this analysis helpful in understanding and evaluating patterns and gaps in DSME/T coverage.

Paraphernalia Laws, Criminalizing Possession and Distribution of Items Used to Consume Illicit Drugs, and Injection-Related Harm.

The United States remains in the grip of an unprecedented epidemic of drug-related harm. Infections of HIV, hepatitis C, and endocarditis related to lack of access to new syringes and subsequent syringe sharing among people who inject drugs have increased alongside a surge in opioid overdose deaths.Overwhelming evidence shows that using a new syringe with every injection prevents injection-related blood-borne disease transmission. Additionally, there is promising research suggesting that the distribution of fentanyl test strips to people who inject drugs changes individuals' injection decisions, which enables safer drug use and reduces the risk of fatal overdose. However, laws prohibiting the possession of syringes and fentanyl test strips persist in nearly every state.The full and immediate repeal of state paraphernalia laws is both warranted and needed to reduce opioid overdose death and related harms. Such repeal would improve the health of people who inject drugs and those with whom they interact, reducing the spread of blood-borne disease and fatal overdose associated with infiltration of illicitly manufactured fentanyl into the illicit drug supply. It would also free up scarce public resources that could be redirected toward evidence-based approaches to reducing drug-related harm.

Self-regulating profession? Administrative discipline of "pill mill" physicians in Florida.

BACKGROUND: A relatively large number of "pill mills," in which physicians prescribed and sometimes dispensed controlled substances without medical justification, operated in Florida beginning in the mid-2000s. Investigations into these operations have resulted in the arrest and conviction of dozens of physicians for activities related to illegal trafficking in controlled substances. METHODS: Using information from the federal Drug Enforcement Administration, the Florida Department of Health, and court records, we constructed a database of Florida-licensed medical doctors who had been indicted or convicted of crimes related to illegal prescribing of controlled substances in Florida during 2010-2015. We then determined whether and when physicians in this data set were temporarily or permanently barred from practicing medicine in the state. RESULTS: We identified 43 physicians who faced criminal action for prescribing-related crimes during the study period. Twenty-eight of these physicians had been convicted or pled guilty as of September 30, 2016, of which 25 (89%) had been permanently barred from practicing medicine in the state. Only 1 of the 25 physicians permanently lost their license before they had been convicted or pled guilty. On average, physicians did not lose their license to practice for more than 9 months (291 days) after being convicted and 587 days after being indicted of a crime directly related to illegal prescribing of controlled substances. Seventeen physicians (68%) maintained their licenses for at least 1 year after being indicted. CONCLUSIONS: This review suggests that the adoption of a more proactive and streamlined process may reduce the time from when physicians are indicted or convicted of illegally prescribing or dispensing controlled substances to board investigation and potential sanction, potentially reducing opioid-related adverse events in the state.

State legal innovations to encourage naloxone dispensing.

OBJECTIVES: The opioid overdose epidemic continues to claim the lives of tens of thousands of Americans every year. Increased access to the opioid antagonist naloxone can reduce opioid-related morbidity and mortality. In this commentary, we describe several recent legal innovations designed to encourage pharmacists to ensure that naloxone is available when and where it is needed, and dispel some common misconceptions regarding potential legal risks associated with pharmacy naloxone dispensing. DATA SOURCES: Data are drawn from state laws and regulations, as catalogued by the Westlaw database. SUMMARY: States have rapidly modified law and policy to increase layperson access to naloxone. As of August 2016, 44 states permit naloxone to be prescribed for administration to a person with whom the prescriber does not have a prescriber-patient relationship. Forty-two states permit naloxone to be dispensed via a non-patient-specific mechanism such as a standing or protocol order, and 5 states permit some pharmacists to prescribe naloxone on their own authority. The liability risk associated with naloxone dispensing is no higher than any other medication, and may be lower than some. However, to encourage the prescription and dispensing of naloxone, 36 states provide additional protection from civil liability for pharmacy naloxone dispensing, and 32 states provide protection from potential criminal action. Naloxone access laws in 31 states explicitly provide that dispensing naloxone as permitted by law cannot be grounds for disciplinary action by the state board of pharmacy or similar entity. CONCLUSION: Pharmacists are key members of the health care team and are uniquely situated to reduce potential opioid overdose risk. Pharmacists should be aware of and utilize innovative state laws designed to increase access to naloxone.

Examining National Public Health Law to Realize the Global Health Security Agenda.

Where the Global Health Security Agenda (GHSA) seeks to accelerate progress toward a world safe and secure from public health emergencies, the realization of GHSA 'Action Packages' will require national governments to establish necessary legal frameworks to prevent, detect, and respond to infectious disease. By analyzing the scope and content of existing national legislation in each of the GHSA Action Packages, this comparative cross-national research has developed a framework that disaggregates the legal domains necessary to meet each Action Package target. Based upon these legal domains, this study developed an assessment tool that can identify specific attributes of national legislation. This article applies this tool to assess the legal environment in twenty Sub-Saharan African countries, examining the content of laws across the GHSA Action Packages, analyzing the legal domains necessary to implement each Action Package, and highlighting specific national laws that reflect attributes of each legal domain.

Engaging Law Enforcement in Overdose Reversal Initiatives: Authorization and Liability for Naloxone Administration.

Opioid overdose is reversible through the timely administration of naloxone, which has been used by emergency medical services for decades. Law enforcement officers (LEOs) are often the first emergency responders to arrive at an overdose, but they are not typically equipped with naloxone. This is rapidly changing; more than 220 law enforcement agencies in 24 states now carry naloxone. However, rollout in some departments has been hampered by concerns regarding officer and agency liability. We systematically examined the legal risk associated with LEO naloxone administration. LEOs can be authorized to administer naloxone through a variety of mechanisms, and liability risks related to naloxone administration are similar to or lower than those of other activities in which LEOs commonly engage.

Deep brain stimulation for the treatment of resistant hypertension.

Hypertension is a leading risk factor for the development of several cardiovascular diseases. As the global prevalence of hypertension increases, so too has the recognition of resistant hypertension. Whilst figures vary, the proportion of hypertensive patients that are resistant to multiple drug therapies have been reported to be as high as 16.4 %. Resistant hypertension is typically associated with elevated sympathetic activity and abnormal homeostatic reflex control and is termed neurogenic hypertension because of its presumed central autonomic nervous system origin. This resistance to conventional pharmacological treatment has stimulated a plethora of medical devices to be investigated for use in hypertension, with varying degrees of success. In this review, we discuss a new therapy for drug-resistant hypertension, deep brain stimulation. The utility of deep brain stimulation in resistant hypertension was first discovered in patients with concurrent neuropathic pain, where it lowered blood pressure and improved baroreflex sensitivity. The most promising central target for stimulation is the ventrolateral periaqueductal gray, which has been well characterised in animal studies as a control centre for autonomic outflow. In this review, we will discuss the promise and potential mechanisms of deep brain stimulation in the treatment of severe, resistant hypertension.

Drug-related physician continuing medical education requirements, 2010-2020.

INTRODUCTION: The crisis of drug-related harm in the United States continues to worsen. While prescription-related overdoses have fallen dramatically, they are still far above pre-2010 levels. Physicians can reduce the risk of overdose and other drug-related harms by improving opioid prescribing practices and ensuring that patients are able to easily access medications for substance use disorder treatment. Most physicians received little or no training in those subjects in medical school. It is possible that continuing medical education can improve physician knowledge of appropriate prescribing and substance use disorder treatment and patient outcomes. METHODS: Descriptive legal review. Laws in all 50 states and the District of Columbia were searched for provisions that require all or most physicians to receive either one-time or continuing medical education regarding controlled substance prescribing, pain management, or substance use disorder treatment. RESULTS: There has been a rapid increase in the number of states with relevant requirements, from three states at the end of 2010 to 42 at the end of 2020. The frequency and duration of required education varied substantially across states. In all states, the number of hours required in relevant topics is a small fraction of overall required continuing education, an average of 1 h per year. Despite recent shifts in the substances driving overdose, most requirements remain focused on opioids. CONCLUSION: While most states have now adopted continuing education requirements regarding controlled substance prescribing, pain management, or substance use disorder treatment, these requirements comprise a small component of the required post-training education requirements. Research is needed to determine whether this training translates into reductions in drug-related harm.

Enhancing the Piezoelectric Properties of 3D Printed PVDF Using Concurrent Torsional Shear Strain.

Extrusion-based polymer 3D printing induces shear strains within the material, influencing its rheological and mechanical properties. In materials like polyvinylidene difluoride (PVDF), these strains stretch polymer chains, leading to increased crystallinity and improved piezoelectric properties. This study demonstrates a 400% enhancement in the piezoelectric property of extrusion-printed PVDF by introducing additional shear strains during the printing process. The continuous torsional shear strains, imposed via a rotating extrusion nozzle, results in additional crystalline ß-phases, directly impacting the piezoelectric behavior of the printed parts. The effect of the nozzle's rotational speed on the amount of ß-phase formation is characterized using FTIR. This research introduces a new direction in the development of polymer and composite 3D printing, where in-process shear strains are used to control the alignment of polymer chains and/or in-fill phases and the overall properties of printed parts.

Legal and policy changes urgently needed to increase access to opioid agonist therapy in the United States.

The United States continues to face a public health crisis of opioid-related harm, the effects of which could be dramatically reduced through increased access to opioid agonist therapy with the medications methadone and buprenorphine. Despite overwhelming evidence of their efficacy, unduly restrictive federal, state, and local regulation significantly impedes access to these life-saving medications. We outline immediate, concrete steps that federal, state, and local governments can take to change law from barrier to facilitator of evidence-based treatment for opioid use disorder. These include removing onerous restrictions on the prescription and dispensing of buprenorphine and methadone for opioid agonist therapy, requiring insurance coverage of these medications, and mandating that they be provided in correctional settings and promoted by drug courts. Finally, we argue that jurisdictions should proactively offer opioid agonist therapy to individuals at high risk of overdose, remove barriers to establishing methadone treatment facilities, and address underlying social determinants and barriers to treatment. These changes have the ability to save thousands of lives annually.

The effect of wedge and tibial slope angles on knee contact pressure and kinematics following medial opening-wedge high tibial osteotomy.

BACKGROUND: High tibial osteotomy is a surgical procedure to treat medial compartment osteoarthritis in varus knees. The reported success rates of the procedure are inconsistent, which may be due to sagittal plane alignment of the osteotomy. The objective of this study was to determine the effect of changing tibial slope, for a range of tibial wedge angles in high tibial osteotomy, on knee joint contact pressure location and kinematics during continuous loaded flexion/extension. METHODS: Seven cadaveric knee specimens were cycled through flexion and extension in an Oxford knee-loading rig. The osteotomy on each specimen was adjusted to seven clinically relevant wedge and slope combinations. We used pressure sensors to determine the position of the centre of pressure in each compartment of the tibial plateau and infrared motion capture markers to determine tibiofemoral and patellofemoral kinematics. FINDINGS: In early knee flexion, a 5° increase in tibial slope shifted the centre of pressure in the medial compartment anteriorly by 4.5mm (P≤0.001), (from the neutral slope/wedge position). Increasing the tibial slope also resulted in the tibia translating anteriorly (P≤0.001). INTERPRETATION: Changes to the tibial slope during high tibial osteotomy for all tested wedge angles shifted the centre of pressure in both the medial and lateral compartments substantially and altered knee kinematics. Tibial slope should be controlled during high tibial osteotomy to prevent unwanted changes in tibial plateau contact loads.

Collaborating for Health: Health in All Policies and the Law.

This article introduces and defines the Health in All Policies (HiAP) concept and examines existing state legislation, with a focus on California. The article starts with an overview of HiAP and then analyzes the status of HiAP legislation, specifically addressing variations across states. Finally, the article describes California's HiAP approach and discusses how communities can apply a HiAP framework not only to improve health outcomes and advance health equity, but also to counteract existing laws and policies that contribute to health inequities.

Physician continuing education to reduce opioid misuse, abuse, and overdose: Many opportunities, few requirements.

BACKGROUND: The opioid overdose epidemic in the United States is driven in large part by inappropriate opioid prescribing. Although most American physicians receive little or no training during medical school regarding evidence-based prescribing, substance use disorders, and pain management, some states require continuing medical education (CME) on these topics. We report the results of a systematic legal analysis of such requirements, together with recommendations for improved physician training. METHODS: To determine the presence and characteristics of CME requirements in the United States, we systematically collected, reviewed, and coded all laws that require such education as a condition of obtaining or renewing a license to practice medicine. Laws or regulations that mandate one-time or ongoing training in topics designed to reduce overdose risk were further characterized using an iterative protocol RESULTS: Only five states require all or nearly all physicians to obtain CME on topics such as pain management and controlled substance prescribing, and fewer than half require any physicians to obtain such training. CONCLUSIONS: While not a replacement for improved education in medical school and post-graduate clinical training, evidence-based CME can help improve provider knowledge and practice. Requiring physicians to obtain CME that accurately presents evidence regarding opioid prescribing and related topics may help reduce opioid-related morbidity and mortality. States and the federal government should also strongly consider requiring such training in medical school and residency.

Lessons learnt from the painful shoulder; a case series of malignant shoulder girdle tumours misdiagnosed as frozen shoulder.

Adhesive capsulitis or frozen shoulder is a common condition characterized by shoulder pain and stiffness. In patients in whom conservative measures have failed, more invasive interventions such as arthrographic or arthroscopic distension can be very effective in relieving symptoms and improving range of movement. However, absolute contraindications to these procedures include the presence of neoplasia around the shoulder girdle. We present five cases referred to our institution where the diagnosis of shoulder joint malignancy was delayed, following prolonged, ineffective treatment for frozen shoulder. These cases highlight the importance of careful review of the radiology and the need for reconsideration of the diagnosis in refractory "frozen shoulder".