Brooke Courtney

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. Using historical surveillance reports, published literature, and media coverage, this article provides an overview of the epidemiology of and response to the 1957-58 influenza pandemic in the U.S., during which an estimated 25% of the population became infected with the new pandemic virus strain. While it cannot be predicted with absolute certainty how the H1N1 pandemic might play out in the U.S. this fall, lessons from the 1957-58 influenza pandemic provide useful and practical insights for current planning and response efforts.

Maximizing State and Local Medical Countermeasure Stockpile Investments through the Shelf-Life Extension Program

101 THE U.S. DEPARTMENT OF DEFENSE (DoD) and other federal agencies, including the U.S. Department of Health and Human Services (HHS) through its Strategic National Stockpile (SNS), maintain significant amounts of pre-positioned medicines and vaccines—also known as medical countermeasures—to prepare for public health and medical emergencies. To have rapid access to critical medicines to protect their first responders, healthcare workers, and other critical infrastructure (as well as the general public, under certain circumstances) before the SNS or other federal assets arrive in response to a public health emergency, many states and local jurisdictions have also purchased and locally pre-positioned their own supplies of antivirals (eg, Tamiflu® for an influenza pandemic) and antibiotics (eg, ciprofloxacin and doxycycline for an anthrax attack). While all medicines have an expiration date set by the manufacturer, the actual shelf life of certain products, if stored properly, can be much longer.1,2 In the mid-1980s, the military faced challenges with expiring stockpiles of critical medicines, which led to the development of the Shelf-Life Extension Program (SLEP). This federal initiative is designed to defer and reduce the replacement costs of federal stockpiles of critical medicine by extending the drugs’ useful shelf life through periodic Food and Drug Administration (FDA) stability testing and strict environmental controls.3,4 Currently, only select federal stockpiles are eligible for SLEP; state and local medical countermeasure stockpiles are not permitted to participate, and no similar program exists for these caches.5 Therefore, the antivirals and antibiotics being stockpiled at the state and local levels must be discarded when their expiration date is reached, even though federal agencies participating in SLEP are receiving shelflife extensions for the same medicines and federal funds or federal subsidies have often been used to purchase the stockpiles. Because of a lack of practical alternatives, including product rotation, state and local jurisdictions that stockpile countermeasures will have caches of medicine with expired dates of use. The impact of this is significant, as it will lead to an additional and unnecessary taxpayer burden to regularly replace expired stockpiles every few years. It also has the potential to put critical health and infrastructure employees at risk during actual emergencies if jurisdictions facing budget constraints determine that they are unable to afford to replace their expired caches. This article provides an overview of SLEP and its shelflife and cost benefits, state and local antiviral and antibiotic stockpiling efforts, and recommendations for maximizing the shelf life of critical medicines being stockpiled at the

Community Resilience Roundtable on the Implementation of Homeland Security Presidential Directive 21 (HSPD-21)

269 ON APRIL 23, 2008, THE CENTER for Biosecurity of the University of Pittsburgh Medical Center (UPMC) convened an invitational meeting to discuss community resilience for catastrophic health events and to help inform implementation planning for Homeland Security Presidential Directive 21 (HSPD-21). Released in October of 2007, HSPD-21 identified community resilience as one of the “four most critical components of public health and medical preparedness” alongside biosurveillance, countermeasure distribution, and mass casualty care, and the directive also asserted “the important roles of individuals, families, and communities” in managing public health emergencies.1 Meeting attendees (listed in the sidebar) included officials who authored HSPD-21 and those charged with its execution, grassroots leaders who have prioritized disaster management in their hometowns and among vulnerable populations, public health and emergency management practitioners, scholars of disasters and resilience, and staff to members of Congress with jurisdiction over homeland security and public health matters. Individual comments made during the event were not for attribution. The day’s agenda was organized into 3 structured discussions: roundtable participants considered which definition(s) of community resilience best advanced the policy agenda, they reviewed prior public participation programs for disasters for relevant lessons, and they made recommendations for federal program and budget priorities in keeping with the value placed on resilience by the presidential directive. The organization of this report reflects the 3-part agenda. Opening each conversation was a presentation from the Center for Biosecurity and invited speakers, accompanied by the results of a brief survey circulated in advance of the meeting to spur discussion. Among the issues polled were attendees’ own concepts of community resilience, concrete techniques for building resilience, and the role of the federal government in helping state and local authorities promote resilient communities. A majority of participants (n 20) completed the survey. The following report is an overview of prepared remarks, pre-event survey findings, and the major themes that arose in the roundtable discussions. We first provide some brief background knowledge on HSPD-21.

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.S. has had limited experience with temporarily expanding scopes of practice during emergencies. However, during the 2009 H1N1 pandemic response, many states took some form of action to expand the practice scopes of certain categories of practitioners in order to authorize them to administer the pandemic vaccine. No standard legal approach for expanding scopes of practice during emergencies exists across states, and scope of practice expansions during routine, nonemergency times have been the subject of professional society debate and legal action. These issues raise the question of how states could effectively implement expansions for health services beyond administering vaccine and ensure consistency in expansions across states during catastrophic events that require a shift to crisis standards of care. This article provides an overview of scopes of practice, a summary of the range of legal and regulatory approaches used in the U.S. to expand practice scopes for vaccination during the 2009 H1N1 response, and recommendations for future research.

Five Legal Preparedness Challenges for Responding to Future Public Health Emergencies

journal of law, medicine & ethics Since the anthrax attacks of 2001 and the severe acute respiratory syndrome (SARS) outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses.1 The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) pursuant to the revised International Health Regulations [IHR (2005)], and many governments declared national or regional emergencies.2 At the U.S. federal level, the Secretary of Health and Human Services (HHS) made public health emergency and Public Readiness and Emergency Preparedness (PREP) Act declarations. In addition, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) (to allow the emergency use of certain antiviral medications, diagnostic tests, and respirators during the pandemic), and President Obama declared a National Emergency (to authorize the use of temporary waivers or modifications of certain federal requirements related to health care facility responses).3 Select state and local governments also declared emergencies.4 Collectively, these actions changed the legal playing field and facilitated pandemic responses. However, legal preparedness challenges remain an obstacle to improving readiness for future public health threats. This article provides a brief summary of five U.S. legal preparedness topics that warrant additional consideration: (1) EUA implementation at the local level; (2) expansion of health care practitioner scopes of practice; (3) evidence base for non-pharmaceutical interventions; (4) crisis care liability protections for health care practitioners; and (5) liability associated with failing to adequately plan for disasters.

Resource-Poor Settings: Infrastructure and Capacity Building: Care of the Critically Ill and Injured During Pandemics and Disasters: CHEST Consensus Statement

BACKGROUND Planning for mass critical care (MCC) in resource-poor or constrained settings has been largely ignored, despite their large populations that are prone to suffer disproportionately from natural disasters. Addressing MCC in these settings has the potential to help vast numbers of people and also to inform planning for better-resourced areas. METHODS The Resource-Poor Settings panel developed five key question domains; defining the term resource poor and using the traditional phases of disaster (mitigation/preparedness/response/recovery), literature searches were conducted to identify evidence on which to answer the key questions in these areas. Given a lack of data upon which to develop evidence-based recommendations, expert-opinion suggestions were developed, and consensus was achieved using a modified Delphi process. RESULTS The five key questions were then separated as follows: definition, infrastructure and capacity building, resources, response, and reconstitution/recovery of host nation critical care capabilities and research. Addressing these questions led the panel to offer 33 suggestions. Because of the large number of suggestions, the results have been separated into two sections: part 1, Infrastructure/Capacity in this article, and part 2, Response/Recovery/Research in the accompanying article. CONCLUSIONS Lack of, or presence of, rudimentary ICU resources and limited capacity to enhance services further challenge resource-poor and constrained settings. Hence, capacity building entails preventative strategies and strengthening of primary health services. Assistance from other countries and organizations is needed to mount a surge response. Moreover, planning should include when to disengage and how the host nation can provide capacity beyond the mass casualty care event.

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. The suggestions in this chapter are important for all of those involved in a pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS Following the CHEST Guidelines Oversight Committees methodology, the Legal Panel developed 35 key questions for which specific literature searches were then conducted. The literature in this field is not suitable to provide support for evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process resulting in seven final suggestions. RESULTS Acceptance is widespread for the health-care communitys duty to appropriately plan for and respond to severe disasters and pandemics. Hospitals, public health entities, and clinicians have an obligation to develop comprehensive, vetted plans for mass casualty incidents involving critically ill or injured patients. Such plans should address processes for evacuation and limited appeals and reviews of care decisions. To legitimize responses, deter independent actions, and trigger liability protections, mass critical care (MCC) plans should be formally activated when facilities and practitioners shift to providing MCC. Adherence to official MCC plans should contribute to protecting hospitals and practitioners who act in good faith from liability. Finally, to address anticipated staffing shortages during severe and prolonged disasters and pandemics, governments should develop approaches to formally expand the availability of qualified health-care workers, such as through using official foreign medical teams. CONCLUSIONS As a fundamental element of health-care and public health emergency planning and preparedness, the law underlies critical aspects of disaster and pandemic responses. Effective responses require comprehensive advance planning efforts that include assessments of complex legal issues and authorities. Recent disasters have shown that although law is a critical response tool, it can also be used to hold health-care stakeholders who fail to appropriately plan for or respond to disasters and pandemics accountable for resulting patient or staff harm. Claims of liability from harms allegedly suffered during disasters and pandemics cannot be avoided altogether. However, appropriate planning and legal protections can help facilitate sound, consistent decision-making and support response participation among health-care entities and practitioners.

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. Using a three‐pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures – and the systems to deliver them – and the requisite support of all stakeholders, including national leadership.

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 FDAs 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. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDAs global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.

Global Public Health Legal Responses to H1N1

journal of law, medicine & ethics Introduction Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A (H1N1) virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, from global to local. Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization (WHO) reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher.1 Several explanations may be offered, in hindsight, to explain the lower-than-expected morbidity and mortality rates. The rates might represent a momentous success for public health, validating the strategies — including legal strategies — employed to stem the spread of the disease. The result might also be attributed to epidemiological fortuity, since this strain of influenza A (H1N1) virus proved less virulent than initially feared. Public health systems would not likely have functioned or responded as well had the strain been more deadly. Alternatively, some have described the public health response as an overreaction, questioning the designation of this outbreak as a pandemic and arguing that public health efforts may have been motivated by bad faith decisions or conflicts of interest within public health systems and institutions.2 Our analysis suggests that the 2009 influenza A (H1N1) virus prompted a number of legal responses that were integral to the resulting public health outcomes. Legal frameworks supported a complex global response, requiring the combined efforts of governments, inter-governmental and non-profit institutions, and private entities. The application of these frameworks demanded international cooperation among these actors on activities including disease surveillance and sharing of information and resources. In addition, laws impacted access to pharmaceutical countermeasures such as vaccines and antiviral medication. Governments also employed public health powers to institute a variety of non-pharmaceutical countermeasures in an attempt to control the spread of the virus, including quarantine, school closures, and other social distancing measures. Three key examples of global public health legal responses to the H1N1 pandemic are illustrated below: (1) the role of Mexico as a first responder; (2) the first conceptual and operational test of the revised International Health Regulations (IHR (2005)); and (3) the legal and policy complications raised by virus-sharing agreements between countries.