Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015.

Importance: Increasing prices of antidiabetic medications in the US have raised substantial concerns about the effects of drug affordability on diabetes care. There has been little rigorous evidence comparing the experiences of patients with diabetes across different types of insurance coverage.

Objective: To compare the utilization patterns and costs of prescription drugs to treat diabetes among low-income adults with Medicaid vs those with Marketplace insurance in Colorado during 2014 and 2015.

Association between electronic nicotine delivery systems (ENDS) device and E-liquid alterations and flavor use with clinical and EVALI-like symptoms.

Studies reporting clinical symptoms related to electronic nicotine delivery systems (ENDS) usage, especially types of devices and e-liquids, are sparse. The sample included 1,432 current ENDS users, ages 18-64, from a nationwide online survey conducted in 2016. ENDS use included device types, nicotine content, flavors, and e-liquid used.

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.

The mission of medicines regulatory agencies is to ensure the timely access of innovative products for patients to improve public health. Thus, regulators should foresee evolving technologies and build expertise prior to reviewing innovative products. Novel modalities and new classes of therapeutics in biological or cell-based products represent a regulatory challenge because of knowledge gaps, as exemplified by the unexpected cytokine release syndrome in the first-in-human clinical trial of the CD28 super-agonist.

Turning Neural Prosthetics Into Viable Products.

Academic researchers concentrate on the scientific and technological feasibility of novel treatments. Investors and commercial partners, however, understand that success depends even more on strategies for regulatory approval, reimbursement, marketing, intellectual property protection and risk management. These considerations are critical for technologically complex and highly invasive treatments that entail substantial costs and risks in small and heterogeneous patient populations.

A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China.

On June 23, 2020, Prolia (denosumab) was approved by the National Medical Products Administration (NMPA) in the People's Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is , a transliteration from the English name "Prolia", which has an implied meaning of "to give strength to everyone"- a suitable name for a potent anti-resorptive therapy. The approval was supported by a novel marketing authorization application (MAA) that included data from Prolia's global clinical trial program establishing favorable efficacy and safety, augmented by results from a real-world evidence (RWE) study confirming the effectiveness and safety of Prolia in clinical practice within Taiwan and Hong Kong.

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation.

Appalachian youth e-cigarette harm perceptions and tobacco use.

Introduction: E-cigarettes are the most popular tobacco product among youth. Although harm perceptions have been linked to youth e-cigarette use, little research focuses on vulnerable populations, such as Appalachian youth. This study examines associations between e-cigarette harm perceptions and tobacco use among a sample of Appalachian youth.

Quantifying the feasibility of shortening clinical trial duration using surrogate markers.

The potential benefit of using a surrogate marker in place of a long-term primary outcome is very attractive in terms of the impact on study length and cost. Many available methods for quantifying the effectiveness of a surrogate endpoint either rely on strict parametric modeling assumptions or require that the primary outcome and surrogate marker are fully observed that is, not subject to censoring. Moreover, available methods for quantifying surrogacy typically provide a proportion of treatment effect explained (PTE) measure and do not directly address the important questions of whether and how the trial can be ended earlier using the surrogate marker.

Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report.

Introduction: In mid-February, the nationwide immunization plan for the prevention of coronavirus disease 2019 (COVID-19) started in Japan (at first primarily focused on health professionals) using an mRNA-based vaccine (Pfizer/BioNTech). During the phase-in period from February to March, attention was focused on post-vaccination anaphylaxis and anaphylactoid symptoms from the viewpoint of ensuring the safety of the vaccination program.

Objective: The aim of this report was to provide an update on the status of anaphylaxis and anaphylactoid symptoms occurring after vaccination for COVID-19, as reported under the Adverse Event Following Immunization (AEFI) reporting system in Japan.

Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic.

Background: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union.

Methods: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier.

Tobacco Use Status and Temptation to Try E-Cigarettes among a Sample of Appalachian Youth.

E-cigarettes are commonly used tobacco products among youth populations, including Appalachian youth. However, knowledge of the extent to which tobacco use status relates to temptation to try e-cigarettes is limited. Data from the Youth Appalachian Tobacco Study ( = 1047) were used.

Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users.

Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide. Against this backdrop, many look to the expanding market for biosimilars-follow-on products to biologic drugs-as a vehicle for controlling pharmaceutical spending. This study explores the early years of entry of biosimilars and related follow-on products in the US.

Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma.

The Japanese Ministry of Health, Labour and Welfare approved a drug called borofalan ( B), a treatment system, and a dose calculation program for boron neutron capture therapy (BNCT) in March 2020. The application pertaining to the products submitted to the Pharmaceuticals and Medical Devices Agency was supported by a Japanese, open-label, uncontrolled trial (Study 002) in patients with unresectable, locally recurrent head and neck squamous cell carcinoma after chemoradiotherapy or radiotherapy, or in those with unresectable locally advanced or locally recurrent (LA/LR) head and neck nonsquamous cell carcinoma. The drug was administered as a single intravenous dose using infusion rates of 200 mg/kg per hour for the first 2 hours after the start of administration and 100 mg/kg per hour during irradiation.

A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.

The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions.

De novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

The rapid spread of COVID-19 and disruption of normal supply chains resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria represents a substantial barrier to new approaches to address these shortages. We sought to apply open-source product development to PAPRs to enable alternative sources of supply and further innovation.

Ushering in safe, effective, secure, and ethical medicine in the digital era.

From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The Covid-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years or decades, to unfold over days, weeks, and months. Yet the scaffolding for this roadmap had already emerged prior to the Covid-19 pandemic.

Sex differences in associations between receiving and sharing tobacco-related information and tobacco product use among Appalachian Youth.

Introduction: Given that Appalachian youth tobacco use rates are higher than the US national average, it is important to understand whether sex differences shape associations between receiving and sharing product information and using tobacco.

Methods: Middle and high school students in rural Appalachia (n=1038) were surveyed about tobacco-related perceptions and behaviors, including ways youth receive and share conventional tobacco-related and e-cigarette-related information. Youth were characterized as tobacco users (i.

Building resilient medical technology supply chains with a software bill of materials.

An exploited vulnerability in a single software component of healthcare technology can affect patient care. The risk of including third-party software components in healthcare technologies can be managed, in part, by leveraging a software bill of materials (SBOM). Analogous to an ingredients list on food packaging, an SBOM is a list of all included software components.

Tobacco perceptions and practices: User groups and demographic characteristics, Mississippi, USA.

Introduction: Despite decreases in the overall US smoking rate, tobacco use remains more common in some areas and by some groups. Deeper understanding of group differences is needed in order to tailor public health campaigns to the interests, perceptions and experiences of targeted audiences. Although some differences have been identified across African American and Caucasian smokers in the United States, additional insight is needed regarding factors that differentiate these groups.

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018.

Objective: Buprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions.

Methods: We first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA.