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.

Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE.

The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and subsequent reuse has the potential to substantially mitigate shortages. Here we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist equipment (TOMI; Frederick, MD), in a sealed environment chamber.

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.

A key goal of regulatory agencies for medical products is to make innovative products available to patients and the medical community in a timely manner in order to improve the quality of public health and health care. Thus, regulators must respond quickly to emerging technologies. It is a horizon scanning method, based on which the Japanese regulatory agency will have the expertise prior to review of forthcoming products of evolving technologies.

Associations between tobacco use patterns and demographic characteristics of sexual minority and heterosexual youth: Results from a nationwide online survey.

Introduction: Youth are at risk for tobacco use, and previous research has pointed to increased vulnerabilities associated with sexual minority identity. For example, LGB youth have increased odds for using tobacco than their heterosexual peers, and bisexual youth have higher odds of smoking than other sexual identity groups. As new tobacco products proliferate and health risks from dual/poly use grow, increased understanding of tobacco use patterns by sexual minority youth is needed.

Public research funding and pharmaceutical prices: do Americans pay twice for drugs?

In the debate over prescription drug pricing, some pharmaceutical industry critics claim that U.S. taxpayers pay twice for costly therapies, because publicly supported research is a major contributor to drug discovery and American taxpayers are inadequately rewarded for their research investment due to high drug prices.

Meta-Analysis of PD-L1 Expression As a Predictor of Survival After Checkpoint Blockade.

Purpose: Programmed cell death receptor ligand 1 (PD-L1) expression is the most studied biomarker to predict the efficacy of immune checkpoint inhibitors (ICIs), but its clinical significance is controversial. We estimated the distribution of PD-L1 expression scores (ie, tumor proportion score or combined proportion score) and the relationship between PD-L1 levels and ICIs' impact on overall survival (OS).

Methods: We reconstructed, pooled, and analyzed individual-level data on 7,617 patients with cancer from 14 randomized clinical trials.

Maternal DNMT3A-dependent de novo methylation of the paternal genome inhibits gene expression in the early embryo.

De novo DNA methylation (DNAme) during mammalian spermatogenesis yields a densely methylated genome, with the exception of CpG islands (CGIs), which are hypomethylated in sperm. While the paternal genome undergoes widespread DNAme loss before the first S-phase following fertilization, recent mass spectrometry analysis revealed that the zygotic paternal genome is paradoxically also subject to a low level of de novo DNAme. However, the loci involved, and impact on transcription were not addressed.

Sociodemographic differences in single, dual, and poly tobacco use among Appalachian youth.

Introduction: Patterns of youth tobacco use, including use of multiple products, have likely shifted as e-cigarettes have grown in popularity. However, there is limited understanding of dual and poly tobacco use and the associated disparities, especially among Appalachian youth.

Methods: We analyzed Youth Appalachian Tobacco Study data (n=1116) to estimate prevalence of current (past-30 day) cigarette, e-cigarette, and smokeless tobacco use by gender, race/ethnicity, age, school type, state, smartphone use, and number of household tobacco users.

Considerations for the Selection and Use of Disinfectants Against SARS-CoV-2 in a Health Care Setting.

Proper disinfection using adequate disinfecting agents will be necessary for infection control strategies against coronavirus disease 2019 (COVID-19). However, limited guidance exists on effective surface disinfectants or best practices for their use against severe acute respiratory coronavirus 2. We outlined a process of fully characterizing over 350 products on the Environmental Protection Agency List N, including pH, method of delivery, indication for equipment sterilization, and purchase availability.

Fentanyl panic goes viral: The spread of misinformation about overdose risk from casual contact with fentanyl in mainstream and social media.

Background: Fueled by misinformation, fentanyl panic has harmed public health through complicating overdose rescue while rationalizing hyper-punitive criminal laws, wasteful expenditures, and proposals to curtail vital access to pain pharmacotherapy. To assess misinformation about health risk from casual contact with fentanyl, we characterize its diffusion and excess visibility in mainstream and social media.

Methods: We used Media Cloud to compile and characterize mainstream and social media content published between January 2015 and September 2019 on overdose risk from casual fentanyl exposure.

Applying the proportionality principle to COVID-19 antibody testing.

As the COVID-19 pandemic continues to ravage the globe, many nations have started to relax stringent restrictions in an effort to restart the economy. While Member States of the European Union have approached reopening without the use of antibody testing for COVID-19, such testing may be central to a long-term, sustainable strategy for international travel, employment, and the allocation and monitoring of vaccines. As the use of antibody testing to dictate the enjoyment of individual freedom remains highly controversial, we describe its use in the context of three case studies (return to the workplace, travel and vaccination), applying the substantive legal balancing entailed in the proportionality principle.

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19.

The novel coronavirus disease 2019 (COVID-19) global pandemic has shifted how many patients receive outpatient care. Telehealth and remote monitoring have become more prevalent, and measurements taken in a patient's home using biometric monitoring technologies (BioMeTs) offer convenient opportunities to collect vital sign data. Healthcare providers may lack prior experience using BioMeTs in remote patient care, and, therefore, may be unfamiliar with the many versions of BioMeTs, novel data collection protocols, and context of the values collected.

Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic.

Background: Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of products such as protective face shields. No clear path exists, however, for introducing a locally fabricated product into a clinical setting.

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States.

In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a "life cycle" approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements.

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators.

Background: In response to supply shortages during the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or "masks"), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under "reuse" and "extended use" policies. However, the reusability of N95 masks is often limited by degradation or breakage of elastic head bands and issues with mask fit after repeated use. The purpose of this study was to develop a frame for N95 masks, using readily available materials and 3D printing, which could replace defective or broken bands and improve fit.

Assessing the quality of nontraditional N95 filtering face-piece respirators available during the COVID-19 pandemic.

Background: During the current COVID-19 pandemic, supply chains for Personal Protective Equipment (PPE) have been severely disrupted and many products, particularly surgical N95 filtering facepiece respirators (FFRs; "masks") are in short supply. As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed 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 mask in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer.

Germany's digital health reforms in the COVID-19 era: lessons and opportunities for other countries.

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany's new (Digitale-Versorgung-Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e.

Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany.

Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the US, it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been implemented.

A review of nutrition and dietary interventions in oncology.

The complex cellular mechanisms and inter-related pathways of cancer proliferation, evasion, and metastasis remain an emerging field of research. Over the last several decades, nutritional research has prominent role in identifying emerging adjuvant therapies in our fight against cancer. Nutritional and dietary interventions are being explored to improve the morbidity and mortality for cancer patients worldwide.

Optimality of testing procedures for survival data in the nonproportional hazards setting.

Most statistical tests for treatment effects used in randomized clinical trials with survival outcomes are based on the proportional hazards assumption, which often fails in practice. Data from early exploratory studies may provide evidence of nonproportional hazards, which can guide the choice of alternative tests in the design of practice-changing confirmatory trials. We developed a test to detect treatment effects in a late-stage trial, which accounts for the deviations from proportional hazards suggested by early-stage data.