An Emergency Preparedness Response to Opioid-Prescribing Enforcement Actions in Maryland, 2018-2019.

Federal and state enforcement authorities have increasingly intervened on the criminal overprescribing of opioids. However, little is known about the health effects these enforcement actions have on patients experiencing disrupted access to prescription opioids or medication-assisted treatment/medication for opioid use disorder. Simultaneously, opioid death rates have increased. In response, the Maryland Department of Health (MDH) has worked to coordinate mitigation strategies with enforcement partners (defined as any federal, state, or local enforcement authority or other governmental investigative authority). One strategy is a standardized protocol to implement emergency response functions, including rapidly identifying health hazards with real-time data access, deploying resources locally, and providing credible messages to partners and the public. From January 2018 through October 2019, MDH used the protocol in response to 12 enforcement actions targeting 34 medical professionals. A total of 9624 patients received Schedule II-V controlled substance prescriptions from affected prescribers under investigation in the 6 months before the respective enforcement action; 9270 (96%) patients were residents of Maryland. Preliminary data indicate fatal overdose events and potential loss of follow-up care among the patient population experiencing disrupted health care as a result of an enforcement action. The success of the strategy hinged on endorsement by leadership; the establishment of federal, state, and local roles and responsibilities; and data sharing. MDH's approach, data sources, and lessons learned may support health departments across the country that are interested in conducting similar activities on the front lines of the opioid crisis.

How a major incident plan can be used in an acute healthcare setting.

All NHS Trusts face a diverse range of potential threats and disruptions that can overwhelm the delivery of their routine healthcare services. Major incidents range from significant infrastructure failure to responding to significant casualty numbers from natural disasters and malicious incidents. Major incident plans are one of the body of documents that support trusts and in this instance acute NHS trusts in emergency preparedness. Major incident plans can be used as a reference point for staff of all disciplines, that is, clinical and non-clinical. Major incident plans incorporate the requirements of the Civil Contingencies Act 2004 for NHS-funded providers to ensure trusts conduct risk assessments, emergency planning, cooperating with other organisations, and internal and external communication. This paper summarises some of the key aspects in the construction and the use of major incident plans in acute care trusts.

Funding Public Health Emergency Preparedness in the United States.

The historical precedents that support state and local leadership in preparedness for and response to disasters are in many ways at odds with the technical demands of preparedness and response for incidents affecting public health. New and revised laws and regulations, executive orders, policies, strategies, and plans developed in response to biological threats since 2001 address the role of the federal government in the response to public health emergencies. However, financial mechanisms for disaster response-especially those that wait for gubernatorial request before federal assistance can be provided-do not align with the need to prevent the spread of infectious agents or efficiently reduce the impact on public health. We review key US policies and funding mechanisms relevant to public health emergencies and clarify how policies, regulations, and resources affect coordinated responses.

Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. Final rule.

This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.

An Assessment of State Board of Pharmacy Legal Documents for Public Health Emergency Preparedness.

Objective. To estimate pharmaceutical emergency preparedness of US states and commonwealth territories. Methods. A quantitative content analysis was performed to evaluate board of pharmacy legal documents (ie, statutes, rules, and regulations) for the presence of the 2006 Rules for Public Health Emergencies (RPHE) from the National Association of Boards of Pharmacy's (NABP) Model Pharmacy Practice Act. Results. The median number of state-adopted RPHE was one, which was significantly less than the hypothesized value of four. Rule Two, which recommended policies and procedures for reporting disasters, was adopted significantly more than other RPHE. Ten states incorporated language specific to public health emergency refill dispensing, and among these, only six allowed 30-day refill quantities. Conclusion. Based on the 2006 NABP model rules, it does not appear that states are prepared to expedite an effective pharmaceutical response during a public health emergency. Boards of pharmacy should consider adding the eight RPHE to their state pharmacy practice acts.

Adapting to the Changing Climate: An Assessment of Local Health Department Preparations for Climate Change-Related Health Threats, 2008-2012.

BACKGROUND: Climate change poses a major public health threat. A survey of U.S. local health department directors in 2008 found widespread recognition of the threat, but limited adaptive capacity, due to perceived lack of expertise and other resources. METHODS: We assessed changes between 2008 and 2012 in local public health departments' preparedness for the public health threats of climate change, in light of increasing national polarization on the issue, and widespread funding cutbacks for public health. A geographically representative online survey of directors of local public health departments was conducted in 2011-2012 (N = 174; response rate = 50%), and compared to the 2008 telephone survey results (N = 133; response rate = 61%). RESULTS: Significant polarization had occurred: more respondents in 2012 were certain that the threat of local climate change impacts does/does not exist, and fewer were unsure. Roughly 10% said it is not a threat, compared to 1% in 2008. Adaptation capacity decreased in several areas: perceived departmental expertise in climate change risk assessment; departmental prioritization of adaptation; and the number of adaptation-related programs and services departments provided. In 2008, directors' perceptions of local impacts predicted the number of adaptation-related programs and services their departments offered, but in 2012, funding predicted programming and directors' impact perceptions did not. This suggests that budgets were constraining directors' ability to respond to local climate change-related health threats. Results also suggest that departmental expertise may mitigate funding constraints. Strategies for overcoming these obstacles to local public health departments' preparations for climate change are discussed.

Health Resources Priority and Allocations System (HRPAS). Interim final rule.

This interim final rule establishes standards and procedures by which the U.S. Department of Health and Human Services (HHS) may require that certain contracts or orders that promote the national defense be given priority over other contracts or orders. This rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule will implement HHS's administration of priorities and allocations actions, and establish the Health Resources Priorities and Allocation System (HRPAS). The HRPAS will cover health resources pursuant to the authority under Section 101(c) of the Defense Production Act as delegated to HHS by Executive Order 13603. Priorities authorities (and other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation) may be re-delegated by the Secretary. The Secretary retains the authority for allocations.

Preparedness for a major incident: creation of an epidemiology protocol for a health protection register in England.

Large incidents and natural disasters are on the increase globally. They can have a major impact lasting many years or decades; and can affect large groups of people including those that are more susceptible to adverse consequences. Following a major incident, it may be considered necessary to establish a register of those people affected by the incident to provide appropriate advice on relevant immediate and longer-term public health interventions that may be required, provide reassurance to the public that their care is paramount, to reassure the worried well to avoid them inappropriately overwhelming local services, and to facilitate epidemiological investigations. Arrangements for the prompt follow-up of populations after large incidents or disasters have been agreed in England and a protocol for establishing a register of individuals potentially affected by a large incident has been developed. It is important for countries to have a protocol for implementing a health register if the circumstances require one to be in place, and are supported by Public Health Authorities. Health registers facilitate the initial descriptive epidemiology of exposure and provide the opportunity of carrying out long term analytical studies on the affected population. Such epidemiological studies provide a greater understanding of the impact that a large incident can have on health, which in turn helps in the planning of health care provision. Registers can also assist more directly in providing access to individuals in need of physical and mental health interventions. The challenge that still remains is to formally pilot the register in the field and refine it based on that experience.

Legal issues affecting children with preexisting conditions during public health emergencies.

Among the millions of children in the United States exposed to public health emergencies in recent years, those with preexisting health conditions face particular challenges. A public health emergency may, for example, disrupt treatment regimens or cause children to be separated from caregivers. Ongoing shortages of pediatricians and pediatric subspecialists may further exacerbate the risks that children with preexisting conditions face in disaster circumstances. The US Department of Homeland Security recently called for better integration of children's needs into all preparedness activities. To aid in this process, multiple legal concerns relevant to pediatricians and pediatric policymakers must be identified and addressed. Obtaining informed consent from children and parents may be particularly challenging during certain public health emergencies. States may need to invoke legal protections for children who are separated from caregivers during emergencies. Maintaining access to prescription medications may also require pediatricians to use specific legal mechanisms. In addition to practitioners, recommendations are given for policymakers to promote effective pediatric response to public health emergencies.

Emergency detention of persons with certain mental disorders during public health disasters: legal and policy issues.

Public health emergencies (disasters) are associated with mental health conditions ranging from mild to severe. When persons pose a danger to themselves or others, a brief emergency detention allows a mental health assessment to determine if a lengthier involuntary civil commitment is needed. Involuntary commitment requires participation of the civil justice system to provide constitutionally mandated due process protections. However, disasters may incapacitate the judicial system, forcing emergency detainees to be prematurely released if courts are unavailable. The authors review state laws regarding emergency detention of persons deemed a potential mental health-related danger. Although some states are well prepared for the dual impact of disasters on mental health and the court system, important gaps exist. The authors recommend that state laws anticipate the need for brief extensions of emergency detention periods without court participation. States should also include mental health considerations in their disaster preparedness plans for the court system.

Evaluation of Brazil's public health surveillance system within the context of the International Health Regulations (2005).

OBJECTIVE: To evaluate Brazil's public health surveillance system (HSS), identifying its core capacities, shortcomings, and limitations in dealing with public health emergencies, within the context of the International Health Regulations (IHR 2005). METHODS: In 2008-2009 an evaluative cross-sectional study was conducted using semistructured questionnaires administered to key informants (municipal, state, and national government officials) to assess Brazilian HSS structure (legal framework and resources) and surveillance and response procedures vis-à-vis compliance with the IHR (2005) requirements for management of public health emergencies of national and international concern. Evaluation criteria included the capacity to detect, assess, notify, investigate, intervene, and communicate. Responses were analyzed separately by level of government (municipal health departments, state health departments, and national Ministry of Health). RESULTS: Overall, at all three levels of government, Brazil's HSS has a well-established legal framework (including the essential technical regulations) and the infrastructure, supplies, materials, and mechanisms required for liaison and coordination. However, there are still some weaknesses at the state level, especially in land border areas and small towns. Professionals in the field need to be more familiar with the IHR 2005 Annex 2 decision tool (designed to increase sensitivity and consistency in the notification process). At the state and municipal level, the capacity to detect, assess, and notify is better than the capacity to investigate, intervene, and communicate. Surveillance activities are conducted 24 hours a day, 7 days a week in 40.7% of states and 35.5% of municipalities. There are shortcomings in organizational activities and methods, and in the process of hiring and training personnel. CONCLUSIONS: In general, the core capacities of Brazil's HSS are well established and fulfill most of the requisites listed in the IHR 2005 with respect to both structure and surveillance and response procedures, particularly at the national and state levels.

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.

Evaluation of Brazil's public health surveillance system within the context of the International Health Regulations (2005) / Evaluación del sistema de vigilancia de salud pública del Brasil dentro del contexto del Reglamento Sanitario Internacional (2005)

OBJECTIVE: To evaluate Brazil's public health surveillance system (HSS), identifying its core capacities, shortcomings, and limitations in dealing with public health emergencies, within the context of the International Health Regulations (IHR 2005). METHODS: In 2008-2009 an evaluative cross-sectional study was conducted using semistructured questionnaires administered to key informants (municipal, state, and national government officials) to assess Brazilian HSS structure (legal framework and resources) and surveillance and response procedures vis-à-vis compliance with the IHR (2005) requirements for management of public health emergencies of national and international concern. Evaluation criteria included the capacity to detect, assess, notify, investigate, intervene, and communicate. Responses were analyzed separately by level of government (municipal health departments, state health departments, and national Ministry of Health). RESULTS: Overall, at all three levels of government, Brazil's HSS has a well-established legal framework (including the essential technical regulations) and the infrastructure, supplies, materials, and mechanisms required for liaison and coordination. However, there are still some weaknesses at the state level, especially in land border areas and small towns. Professionals in the field need to be more familiar with the IHR 2005 Annex 2 decision tool (designed to increase sensitivity and consistency in the notification process). At the state and municipal level, the capacity to detect, assess, and notify is better than the capacity to investigate, intervene, and communicate. Surveillance activities are conducted 24 hours a day, 7 days a week in 40.7% of states and 35.5% of municipalities. There are shortcomings in organizational activities and methods, and in the process of hiring and training personnel. CONCLUSIONS: In general, the core capacities of Brazil's HSS are well established and fulfill most of the requisites listed in the IHR 2005 with respect to both structure and surveillance and response procedures, particularly at the national and state levels.

OBJETIVO: Evaluar el sistema de vigilancia de salud pública del Brasil, identificando sus capacidades básicas, deficiencias y limitaciones para manejar emergencias de salud pública, dentro del contexto del Reglamento Sanitario Internacional (RSI 2005). MÉTODOS: En el período 2008-2009 se llevó a cabo un estudio transversal de evaluación utilizando cuestionarios semiestructurados administrados a informantes clave (funcionarios del gobierno municipal, estatal y nacional) a fin de evaluar la estructura del sistema de vigilancia de salud pública del Brasil (marco jurídico y recursos), y la vigilancia y los procedimientos de respuesta, con relación al cumplimiento de los requisitos del RSI 2005 para el manejo de emergencias de salud pública de importancia nacional e internacional. Los criterios de evaluación incluyeron la capacidad de detectar, evaluar, notificar, investigar, intervenir y comunicar. Las respuestas se analizaron por separado según el nivel gubernamental (departamentos de salud municipales y estatales y ministerio de salud nacional). RESULTADOS: En general, en los tres niveles del gobierno, el sistema de vigilancia de salud pública del Brasil tiene un marco jurídico bien establecido (incluidas las reglamentaciones técnicas esenciales) y la infraestructura, los suministros los materiales y los mecanismos requeridos para el enlace y la coordinación. Sin embargo, todavía hay algunos puntos débiles a nivel estatal, especialmente en las zonas fronterizas y los pueblos pequeños. Los profesionales de campo deben conocer más la herramienta de decisión del anexo 2 del RSI 2005 (diseñada para aumentar la sensibilidad y la consistencia del proceso de notificación). En el nivel estatal y municipal, la capacidad para detectar, evaluar y notificar es mejor que la capacidad para investigar, intervenir y comunicar. Las actividades de vigilancia se llevan a cabo 24 horas al día, 7 días a la semana, en 40,7% de los estados y 35,5% de los municipios. Existen deficiencias en las actividades de organización y los métodos, y en el proceso de contratación y capacitación del personal. CONCLUSIONES: En general, las capacidades básicas del sistema de vigilancia de salud pública del Brasil están bien establecidas y cumplen la mayoría de los requisitos enumerados en el RSI 2005, tanto con respecto a la estructura como a la vigilancia y los procedimientos de respuesta, en particular en los niveles nacional y estatal.

The evolution of law in biopreparedness.

The decade following the terrorist attacks on September 11, 2001, and ensuing anthrax exposures that same fall has seen significant legal reforms designed to improve biopreparedness nationally. Over the past 10 years, a transformative series of legal changes have effectively (1) rebuilt components of federal, state, and local governments to improve response efforts; (2) created an entire new legal classification known as "public health emergencies"; and (3) overhauled existing legal norms defining the roles and responsibilities of public and private actors in emergency response efforts. The back story as to how law plays an essential role in facilitating biopreparedness, however, is pocked with controversies and conflicts between law- and policymakers, public health officials, emergency managers, civil libertarians, scholars, and others. Significant legal challenges for the next decade remain. Issues related to interjurisdictional coordination; duplicative legal declarations of emergency, disaster, and public health emergency; real-time legal decision making; and liability protections for emergency responders and entities remain unresolved. This article explores the evolving tale underlying the rise and prominence of law as a pivotal tool in national biopreparedness and response efforts in the interests of preventing excess morbidity and mortality during public health emergencies.

Preventing biological weapon development through the governance of life science research.

The dual-use dilemma in the life sciences-that illicit applications draw on the same science and technology base as legitimate applications-makes it inherently difficult to control one without inhibiting the other. Since before the September 11 attacks, the science and security communities in the United States have struggled to develop governance processes that can simultaneously minimize the risk of misuse of the life sciences, promote their beneficial applications, and protect the public trust. What has become clear over that time is that while procedural steps can be specified for assessing and managing dual-use risks in the review of research proposals, oversight of ongoing research, and communication of research results, the actions or decisions to be taken at each of these steps to mitigate dual-use risk defy codification. Yet the stakes are too high to do nothing, or to be seen as doing nothing. The U.S. government should therefore adopt an oversight framework largely along the lines recommended by the National Science Advisory Board for Biosecurity almost 5 years ago-one that builds on existing processes, can gain buy-in from the scientific community, and can be implemented at modest cost (both direct and opportunity), while providing assurance that a considered and independent examination of dual-use risks is being applied. Without extraordinary visibility into the actions of those who would misuse biology, it may be impossible to know how well such an oversight system will actually succeed at mitigating misuse. But maintaining the public trust will require a system to be established in which reasonably foreseeable dual-use consequences of life science research are anticipated, evaluated, and addressed.

From biodefence to biosecurity: the Obama administration's strategy for countering biological threats.

The Seventh Review Conference of the Biological Weapons Convention (BWC), the first international treaty to outlaw an entire class of weapons, was held in Geneva in December 2011. On 7 December, Secretary of State Hillary Clinton became the highest-ranking US government official to address a BWC meeting. Secretary Clinton told the assembled delegation that 'we view the risk of bioweapons attack as both a serious national security challenge and a foreign policy priority'. At the same time, she warned that a large-scale disease outbreak 'could cripple an already fragile global economy'. Secretary Clinton's speech reflected a new understanding that the range of biological threats to international security has expanded from state-sponsored biological warfare programmes to include biological terrorism, dual-use research and naturally occurring infectious diseases such as pandemics. Recognizing these changes, President Barack Obama released a new national strategy for countering biological threats in 2009. This strategy represents a shift in thinking away from the George W. Bush administration's focus on biodefence, which emphasized preparing for and responding to biological weapon attacks, to the concept of biosecurity, which includes measures to prevent, prepare for and respond to naturally occurring and man-made biological threats. The Obama administration's biosecurity strategy seeks to reduce the global risk of naturally occurring and deliberate disease outbreaks through prevention, international cooperation, and maximizing synergies between health and security. The biosecurity strategy is closely aligned with the Obama administration's broader approach to foreign policy, which emphasizes the pragmatic use of smart power, multilateralism and engagement to further the national interest. This article describes the Obama administration's biosecurity strategy; highlights elements of continuity and change from the policies of the Bush administration; discusses how it fits into Obama's broader foreign policy agenda; and analyses critical issues that will have to be addressed in order to implement the strategy successfully.