This paper reports on a discrete-time, deterministic, compartmental model that was developed and analyzed to provide insight into how the use of anthrax vaccine before or after a large-scale attack can reduce casualties. The results indicate that, regardless of which vaccination policy is adopted, a rapid and effective post-attack medical response has a large impact on the number of lives that can be saved by post-exposure prophylaxis (PEP) campaign. It is shown that for each day that a mass prophylaxis campaign is delayed, more casualties and deaths result than for each day that the completion of the campaign is delayed.
This paper summarizes findings from a national stakeholder meeting that highlighted the need to integrate home health care employers, workers, community advocates, and labor unions into pandemic planning processes.
The deliberate dissemination of Bacillus anthracis spores via the US mail system in 2001 confirmed their potential use as a biological weapon for mass human casualties. This dramatically highlighted the need for specific medical countermeasures to enable the authorities to protect individuals from a future bioterrorism attack. Although vaccination appears to be the most effective and economical form of mass protection, current vaccines have significant drawbacks that justify the immense research effort to develop improved treatment modalities. After eight years and an expenditure of more than $50 billion, only marginal progress has been made in developing effective therapeutics. This article summarizes the most important medical countermeasures that have mostly been developed since the 2001 events, and highlights current problems and possible avenues for future research.
Medical countermeasures (MCMs) are life-saving medicines and medical supplies regulated by the U.S. Food and Drug Administration (FDA) that can be used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear (CBRN) threats, emerging infectious diseases or a natural disaster.
The aims of this review are to collate and assess the literature concerning the willingness of health care personnel to work during a disaster, to identify gaps in the literature as areas for future investigation, and to facilitate evidence-based disaster planning. The current evidence indicates there may be certain factors related to willingness to work (or lack of willingness) in the disaster including the type of disaster, concern for family, and concerns about personal safety. Barriers to the willingness to work have been identified including pet care needs and the lack of personal protective equipment. These findings have significant implications for community and organizational emergency planning and policymaking in an environment defined by limited resources.
This policy statement provides recommendations to close the remaining gaps for the development and use of MCMs in children during public health emergencies or disasters. The progress made by federal agencies to date to address the needs of children and the shared commitment of collaboration that characterizes the current relationship between the pediatric health community and the federal agencies responsible for MCMs should encourage all child advocates to invest the necessary energy and resources now to complete the process of remedying the remaining significant gaps in preparedness.
At least five extraordinary policy interventions have been introduced by governments with the aim of stimulating the commercial development of novel medical countermeasures: (1) allocating earmarked public funds, (2) granting comprehensive legal protections to pharmaceutical companies against injury compensation claims, (3) introducing bespoke pathways for regulatory approval, (4) instantiating extraordinary emergency use procedures allowing for the use of unapproved medicines, and (5) designing innovative logistical distribution systems for mass drug administration outside of clinical settings. This article argues that those combined efforts are spawning a new, government-led and quite exceptional medical countermeasure regime operating beyond the conventional boundaries of pharmaceutical development and regulation. In the first comprehensive analysis of the pharmaceuticalization dynamics at play in national security policy, this article unearths the detailed array of policy interventions through which governments are also becoming more deeply imbricated in the pharmaceuticalization of society.
Therapeutic countermeasures (e.g., vaccines and antiviral medications) and nonpharmaceutical interventions (e.g., infection control, social separation, and quarantine) form the 2 principal strategies for prevention and response. This commentary focuses on the ethical and legal considerations for medical countermeasures.
This review presents a summary of the key scientific and regulatory challenges facing medical countermeasure development, approval and use. It also describes the approaches Food & Drug Administration (FDA) is taking through the FDA’s Medical Countermeasures Initiative to address these key challenges.
This article summarizes the US governments’ 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.
The threat of an influenza pandemic has been at the forefront of public health preparedness for more than 5 years. The national planning effort has included stockpiling antiviral drugs in the Centers for Disease Control and Prevention’s Strategic National Stockpile (SNS). This article highlights the composition of the SNS before the 2009 H1N1 pandemic and includes considerations for future antiviral stockpile purchases, focusing on the emergence of oseltamivir resistance and the need for additional pediatric supplies.
The 2009 H1N1 pandemic stimulated a nationwide response that included a mass vaccination effort coordinated at the federal, state, and local levels. This article examines a sampling of state and local efforts during the pandemic in order to better prepare for future public health emergencies involving mass distribution, dispensing, and administration of medical countermeasures. In this analysis, the authors interviewed national, state, and local leaders to gain a better understanding of the accomplishments and challenges of H1N1 vaccination programs during the 2009-10 influenza season.
The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective. The PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as several interagency partners: the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), the Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA).
A public health emergency, such as an influenza pandemic, will lead to shortages of mechanical ventilators, critical care beds, and other potentially life-saving treatments. This paper analyzes the ethical principles that could guide allocation and propose an allocation strategy that incorporates and balances multiple morally relevant considerations, including saving the most lives, maximizing the number of life-years saved, and prioritizing patients who have had the least chance to live through life’s stages.