Optimizing Home Oxygen Therapy. An Official American Thoracic Society Workshop Report.

More than 1.5 million adults in the United States use supplemental oxygen for a variety of respiratory disorders to improve their quality of life and prolong survival. This document describes recommendations from a multidisciplinary workshop convened at the ATS International Conference in 2017 with the goal of optimizing home oxygen therapy for adults. Ideal supplemental oxygen therapy is patient-specific, provided by a qualified clinician, includes an individualized prescription and therapeutic education program, and offers oxygen systems that are safe, promote mobility, and treat hypoxemia. Recently, patients and clinicians report a growing number of problems with home oxygen in the United States. Oxygen users experience significant functional, mechanical, and financial problems and a lack of education related to their oxygen equipment-problems that impact their quality of life. Health care providers report a lack of readily accessible resources needed to prescribe oxygen systems correctly and efficiently. Patients with certain lung diseases are affected more than others because of physically unmanageable or inadequate portable systems. Analysis is needed to quantify the unintended impact that the Centers for Medicare and Medicaid Services Competitive Bidding Program has had on patients receiving supplemental oxygen from durable medical equipment providers. Studies using effectiveness and implementation research designs are needed to develop and evaluate new models for patient education, identify effective ways for stakeholders to interface, determine the economic benefit of having respiratory therapists perform in-home education and follow-up testing, and collaborate with technology companies to improve portable oxygen devices. Generation of additional evidence of the benefit of supplemental oxygen across the spectrum of advanced lung diseases and the development of clinical practice guidelines should both be prioritized.

Strengthening global health security by developing capacities to deploy medical countermeasures internationally.

In 2014, the United States in partnership with international organizations and nearly 30 partner countries launched the Global Health Security Agenda (GHSA) to accelerate progress to improve prevention, detection, and response capabilities for infectious disease outbreaks that can cause public health emergencies. Objective 9 of the GHSA calls for improved global access to medical countermeasures and establishes as a target the development of national policy frameworks for sending and receiving medical countermeasures from and to international partners during public health emergencies. The term medical countermeasures refers to vaccines, antimicrobials, therapeutics, and diagnostics that address the public health and medical consequences of chemical, biological, radiological, and nuclear events; pandemic influenza; and emerging infectious diseases. They are stockpiled by a few countries to protect their own populations and by international organizations, such as the World Health Organization (WHO), for the international community, typically for recipients with limited resources. However, as observed during the 2009 H1N1 influenza pandemic, legal, regulatory, logistical, and funding barriers slowed the ability of WHO and countries to quickly deploy or receive vaccine. Had the 2009 H1N1 influenza pandemic been more severe, the world would have been ill prepared to cope with the global demand for rapid access to medical countermeasures. This article summarizes the US government efforts to develop a national framework to deploy medical countermeasures internationally and a number of engagements to develop regional and international mechanisms, thus increasing global capacity to respond to public health emergencies.

Legal considerations in a nuclear detonation.

This article summarizes public health legal issues that need to be considered in preparing for and responding to nuclear detonation. Laws at the federal, state, territorial, local, tribal, and community levels can have a significant impact on the response to an emergency involving a nuclear detonation and the allocation of scarce resources for affected populations. An understanding of the breadth of these laws, the application of federal, state, and local law, and how each may change in an emergency, is critical to an effective response. Laws can vary from 1 geographic area to the next and may vary in an emergency, affording waivers or other extraordinary actions under federal, state, or local emergency powers. Public health legal requirements that are commonly of concern and should be examined for flexibility, reciprocity, and emergency exceptions include liability protections for providers; licensing and credentialing of providers; consent and privacy protections for patients; occupational safety and employment protections for providers; procedures for obtaining and distributing medical countermeasures and supplies; property use, condemnation, and protection; restrictions on movement of individuals in an emergency area; law enforcement; and reimbursement for care.

Emergency Use Authority and 2009 H1N1 influenza.

This article discusses the steps that the Department of Health and Human Services follows to authorize emergency use of products under section 564 of the Federal Food, Drug and Cosmetic Act through Emergency Use Authorizations. We provide examples of when the department might authorize such emergency use and describe the products for which the department has authorized emergency use for the current H1N1 influenza pandemic as of September 1, 2009.