Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance.

Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs. A handheld device was used to collect identifying information (e.

Regulatory underpinnings of Global Health security: FDA's roles in preventing, detecting, and responding to global health threats.

In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats.

Ethical considerations: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

Background: Mass critical care entails time-sensitive decisions and changes in the standard of care that it is possible to deliver. These circumstances increase provider uncertainty as well as patients' vulnerability and may, therefore, jeopardize disciplined, ethical decision-making. Planning for pandemics and disasters should incorporate ethics guidance to support providers who may otherwise make ad hoc patient care decisions that overstep ethical boundaries.

Legal preparedness: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

Background: Significant legal challenges arise when health-care resources become scarce and population-based approaches to care are implemented during severe disasters and pandemics. Recent emergencies highlight the serious legal, economic, and health impacts that can be associated with responding in austere conditions and the critical importance of comprehensive, collaborative health response system planning. This article discusses legal suggestions developed by the American College of Chest Physicians (CHEST) Task Force for Mass Critical Care to support planning and response efforts for mass casualty incidents involving critically ill or injured patients.

Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.

Meeting the challenges of medical countermeasure development.

Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking.

Legal considerations during pediatric emergency mass critical care events.

Introduction: Recent public health emergencies, such as the 2009 Influenza A/H1N1 Pandemic and Hurricane Katrina, underscore the importance of developing healthcare response plans and protocols for disasters impacting large populations. Significant research and scholarship, including the 2009 Institute of Medicine report on crisis standards of care and the 2008 Task Force for Mass Critical Care recommendations, provide guidance for healthcare responses to catastrophic emergencies. Most of these efforts recognize but do not focus on the unique needs of pediatric populations.

Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts.

In a public health emergency involving significant surges in patients and shortages of medical staff, supplies, and space, temporarily expanding scopes of practice of certain healthcare practitioners may help to address heightened population health needs. Scopes of practice, which are defined by state practice acts, set forth the range of services that licensed practitioners are authorized to perform. The U.

Public health and medical responses to the 1957-58 influenza pandemic.

As the U.S. prepares to respond this fall and winter to pandemic (H1N1) 2009, a review of the 1957-58 pandemic of Asian influenza (H2N2) could be useful for planning purposes because of the many similarities between the 2 pandemics.

Healthcare coalitions: the new foundation for national healthcare preparedness and response for catastrophic health emergencies.

After 9/11 and the 2001 anthrax letters, it was evident that our nation's healthcare system was largely underprepared to handle the unique needs and large volumes of people who would seek medical care following catastrophic health events. In response, in 2002 Congress established the Hospital Preparedness Program (HPP) in the U.S.

Is obesity really the next tobacco? Lessons learned from tobacco for obesity litigation.

This article draws important lessons from the history of tobacco litigation that can be applied to the current obesity problem in the United States. The author's close analysis of potential issues surrounding the obesity problem in this country yields the conclusion that litigation alone may not be the best answer. Her article offers a compelling perspective on the history of tobacco litigation, a thorough analysis of the issues surrounding the obesity problem and several potential perspectives on dealing with the situation at hand.