Knowledge, attitudes, and practices associated with bioterrorism preparedness in healthcare workers: a systematic review.

Introduction: Bioterrorism is an important issue in the field of biosecurity, and effectively dealing with bioterrorism has become an urgent task worldwide. Healthcare workers are considered bioterrorism first responders, who shoulder essential responsibilities and must be equipped to deal with bioterrorism. This study aims to extract and summarize the main research components of the bioterrorism knowledge, attitude, and practice dimensions among healthcare workers. Method: This study utilized a systematic review research design based on the PRISMA 2020 guidelines. A literature search was conducted in the PubMed, Web of Science, and Scopus databases for peer-reviewed literature, and the Mixed Methods Appraisal Tool (MMAT) version 2018 was used to assess the quality of the literature. Result: A total of 16 studies were included in the final selection. Through the analysis and summary of the included studies, three main aspects and 14 subaspects of the knowledge dimension, three main aspects and 10 subaspects of the attitude dimension, and two main aspects and six subaspects of the practice dimension were extracted. Conclusion: This study conducted a literature review on bioterrorism knowledge, attitudes, and practices for healthcare workers based on the PRISMA 2020 guidelines. The findings can guide improvements in health literacy and provide beneficial information to professional organizations that need to respond effectively to bioterrorism.

United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism.

INTRODUCTION: Nuclear reactor incidents and bioterrorism outbreaks are concerning public health disasters. Little is known about US Food and Drug Administration (FDA)-approved agents that can mitigate consequences of these events. We review FDA data supporting regulatory approvals of these agents. AREAS COVERED: We reviewed pharmaceutical products approved to treat Hematopoietic Acute Radiation Syndrome (H-ARS) and to treat or prevent pulmonary infections following Bacillus anthracis (anthrax) exposure. Four drugs were approved for H-ARS: granulocyte-colony stimulating factor (G-CSF), granulocyte/macrophage colony stimulating factor, pegylated G-CSF, and romiplostim. For bioterrorism-associated anthrax, the FDA approved five antibiotics (doxycycline, penicillin-G, levofloxacin, moxifloxacin, and ciprofloxacin), two monoclonal antibodies (obiltoxaximab and raxibacumab), one polyclonal antitoxin (Anthrax Immune Globulin Intravenous) and two vaccines (Anthrax Vaccine Adsorbed and Anthrax Vaccine Adsorbed with an adjuvant). A national stockpile system ensures that communities have ready access to these agents. Our literature search was based on data included in drugs@FDA (2001-2023). EXPERT OPINION: Two potential mass public health disasters are aerosolized anthrax dissemination and radiological incidents. Five agents authorized for anthrax emergencies only have FDA approval for this indication, five antibiotics have FDA approvals as antibiotics for common infections and for bacillus anthrax, and four agents have regulatory approvals for supportive care for cancer and for radiological incidents.

Epidemiology of Pathogens Listed as Potential Bioterrorism Agents, the Netherlands, 2009‒2019.

We provide incidences (cases/10 million persons) in the Netherlands during 2009-2019 for pathogens listed as potential bioterrorism agents. We included pathogens from the highest categories of the European Medicines Agency or the US Centers for Disease Control and Prevention. Notifiable diseases and recently published data were used to calculate the average annual incidence. Coxiella burnetii had the highest incidence because of a Q fever epidemic during 2007-2010. Incidence then decreased to 10.8 cases/. Pathogens with an incidence >1 were Brucella spp. (2.5 cases), Francisella tularensis (1.3 cases), and Burkholderia pseudomallei (1.1 cases). Pathogens with an incidence <1 were hemorrhagic fever viruses (0.3 cases), Clostridium botulinum (0.2 cases), and Bacillus anthracis (0.1 cases). Variola major and Yersinia pestis were absent. The generally low incidences make it unlikely that ill-meaning persons can isolate these pathogens from natural sources in the Netherlands. However, the pathogens are stored in laboratories, underscoring the need for biosecurity measures.

Review of Restricted Experiment Requests, Division of Select Agents and Toxins, US Centers for Disease Control and Prevention, 2014-2021.

The US Centers for Disease Control and Prevention Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins within United States as part of the Federal Select Agent Program. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. In a previous study, we evaluated restricted experimental requests submitted to DSAT for review between 2006 and 2013. The purpose of this study is to provide an updated analysis of requests to conduct potential restricted experiments submitted to DSAT between 2014 and 2021. This article describes the trends and characteristics of the data associated with restricted experimental requests involving select agents and toxins that have an impact on public health and safety (US Department of Health and Human Services agents only) or both public health and safety and animal health or products (overlap agents). From January 2014 to December 2021, DSAT received 113 requests to conduct potential restricted experiments; however, 82% (n=93) of those requests were determined not to meet the regulatory definition of a restricted experiment. Of the 20 requests that met the definition of a restricted experiment, 8 were denied because the experiments had the potential to compromise disease control in humans. DSAT continues to encourage entities to practice due diligence and request a review of research that could potentially meet the regulatory definition of a restricted experiment out of an abundance of caution to protect public health and safety and prevent any potential compliance action.

Benchtop DNA synthesis raises alarms.

Report calls for safeguards against misuse for bioterror.

Blind spots in biodefense.

In October, the Biden administration released its National Biodefense Strategy (NBS-22), the first update since the COVID-19 pandemic began. Although the document notes that one of the lessons of the pandemic is that threats originating anywhere are threats everywhere, it frames threats as largely external to the United States. NBS-22 focuses primarily on bioterrorism and laboratory accidents, neglecting threats posed by routine practices of animal use and production inside the United States. NBS-22 references zoonotic disease but assures readers that no new legal authorities or institutional innovations are needed. Although the US is not alone in failing to confront these risks, its failure to comprehensively address them echoes across the globe.

Modeling on the Effects of Deliberate Release of Aerosolized Inhalational Bacillus anthracis (Anthrax) on an Australian Population.

This study aimed to determine optimal mitigation strategies in the event of an aerosolized attack with Bacillus anthracis, a category A bioterrorism agent with a case fatality rate of nearly 100% if inhaled and untreated. To simulate the effect of an anthrax attack, we used a plume dispersion model for Sydney, Australia, accounting for weather conditions. We determined the radius of exposure in different sizes of attack scenarios by spore quantity released per second. Estimations of different spore concentrations were then used to calculate the exposed population to inform a Susceptible-Exposed-Infected-Recovered (SEIR) deterministic mathematical model. Results are shown as estimates of the total number of exposed and infected people, along with the burden of disease, to quantify the amount of vaccination and antibiotics doses needed for stockpiles. For the worst-case scenario, over 500,000 people could be exposed and over 300,000 infected. The number of deaths depends closely on timing to start postexposure prophylaxis. Vaccination used as a postexposure prophylaxis in conjunction with antibiotics is the most effective mitigation strategy to reduce deaths after an aerosolized attack and is more effective when the response starts early (2 days after release) and has high adherence, while it makes only a small difference when started late (after 10 days).

Predictors of bioterrorism preparedness among clinical nurses: A cross-sectional study.

BACKGROUND: Bioterrorism is terrorism that causes death, injury, or illness by the intentional release of viruses, bacteria, fungi, or toxins. Bioterrorism cannot be prevented; therefore, having the ability to recognize and respond to the consequences of infection caused by biological agents is imperative. This study aimed to examine the level of bioterrorism preparedness and identify the influencing factors of bioterrorism preparedness among nurses, who are early responders to bioterrorism. METHODS: This study had a predictive correlational study design. It surveyed 245 clinical nurses currently working in general hospitals. We used a structured questionnaire consisting of items about general characteristics, knowledge about bioterrorism, awareness of bioterrorism risk, perception of institutional bioterrorism preparedness, attitude toward bioterrorism, and bioterrorism preparedness. The collected data were analyzed using descriptive statistics and by performing a t-test, chi-square test, analysis of variance, post-hoc test, correlational analysis, and regression analysis. RESULTS: Bioterrorism preparedness was significantly positively correlated with the perception of institutional and frontline bioterrorism preparedness and attitude toward bioterrorism. It was also significantly influenced by sex, undergraduate bioterrorism education, employee bioterrorism education, perception of governmental bioterrorism preparedness, and attitude toward bioterrorism. The greatest predictors of bioterrorism preparedness were attitude toward bioterrorism, perception of institutional bioterrorism preparedness, and undergraduate bioterrorism education, which explained 39 % of the variance of bioterrorism preparedness. CONCLUSION: This study found that clinical nurses' awareness and attitude toward bioterrorism are important factors in their bioterrorism preparedness and that attention to and education about bioterrorism are crucial to enhance clinical nurses' bioterrorism preparedness. Continued research is needed to establish a bioterrorism response system and relevant educational programs.

Gain of Function and Loss of Control: Genetic Modification of Microbial Agents - Viruses "On Steroids".

Gain of Function refers to genetic modification to enhance certain properties of a biological agent. "Dual use research" refers to experiments which have a primary goal of benefitting humanity, but which could produce harm if misapplied. So, for example, a virus which was being genetically modified (GM) for altruistic reasons might become more transmissible or resistant to vaccines or antimicrobial medications. Such a GM virus has bioterrorism potential. The UN Biological Weapons Convention has not been universally approved and 10 States are not signatories to the Convention. The control of such experiments is variously controlled in certain jurisdictions but in Australia these experiments are well regulated through the Gene Technology Act 2000 (Cth), the National Health Security Act 2007 (Cth) and the Crimes (Biological Weapons) Act 1976 (Cth). The controls on such experiments in Europe and the United States are less precise. There are examples in the United States and Europe where the security provisions to contain microorganisms undergoing research including genetic modification have been breached. This threatens the health and safety of laboratory workers and the wider community.

The PRISMA 2020 Statement: A System Review of Hospital Preparedness for Bioterrorism Events.

Hospitals are an important part of a nation's response to bioterrorism events. At present, research in this field is still in the initial stage. The number of related studies is small, the research direction is relatively concentrated, and a comprehensive analysis and standard evaluation system are lacking. This literature survey was conducted using PRISMA methodology. Collective information was gathered from PubMed, Web of Science, Scopus, and available grey literature sourced through Google and relevant websites. The studies were screened according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flowchart. Analysis and summary of the extracted data was performed according to the World Health Organization (WHO) Rapid Hospital Readiness Checklist (2020). Twenty-three articles were selected for review, data extraction, and data analysis. Referring to the WHO rapid hospital readiness checklist, six main indicator categories were determined, including emergency management, medical service capacity, surge capacity, laboratories, regional coordination, and logistical support, and fifty-two subcategories were finally identified. The study summarizes and analyzes the relevant literature on hospital disaster preparedness and extracts relevant capability elements, providing a reference for the preparation of hospitals against bioterrorism events and a basis for the design and development of hospital preparedness assessment indicators.

Construção e validação de instrumento para avaliação das medidas de biossegurança em bioterrorismo pelos bombeiros / Construction and validation of and assessment tool for biosafety measures in bioterrorism for firefighters / Construcción y validación de un instrumento para evaluar las medidas de bioseguridad en el bioterrorismo de los bomberos

Objetivo: Este estudo teve como objetivo desenvolver e validar um instrumento de avaliação das medidas de Biossegurança adotadas pelos bombeiros militares, para a contenção dos agentes biológicos frente a um evento de bioterrorismo. Métodos: Tratou-se de um estudo descritivo de abordagem quantitativa, de desenvolvimento metodológico e do tipo de validação de conteúdo de um instrumento de avaliação. O estudo foi dividido nas fases de desenvolvimento e validação do instrumento. Para o desenvolvimento do instrumento foram feitas revisões da literatura e para a validação do instrumento foi utilizado o método Delphi. Para o estudo foram incluídos 6 juízes que avaliaram o instrumento através da escala numérica tipo Likert. Resultados: Os juízes avaliaram que o instrumento proposto está bem estruturado, possuindo boa clareza e coesão de escrita, com aplicabilidade no campo de estudo e de grande relevância, principalmente em vista a ausência desse tipo de instrumento para a população de bombeiros militares. Para avaliar a concordância entre os juízes foi utilizado o índice de Validade de Conteúdo, que alcançou 98% de concordância e o Índice de Fidedignidade Interavaliadores, que alcançou os conceitos bom e muito bom, mostrando baixa variância das respostas dos juízes, sendo estatisticamente válido. Conclusão: O estudo descreveu o processo de construção e validação do instrumento, provando ser apropriado e confiável para ser utilizado.

Objective: This study aimed to develop and validate an instrument to assess the Biosafety measures adopted by firefighters, for the containment of biological agents in the face of a bioterrorism event. Methods: This is a descriptive study with a quantitative approach, methodological development, and the type of content validation of an assessment instrument. The study was divided into instrument development and validation phases. For the development of the instrument, literature reviews were conducted and for the instrument validation, the Delphi method was used. For the study, 6 judges were included who evaluated the instrument using the Likert-type numerical scale. Results: The judges evaluated that the proposed instrument is well structured, with good clarity and cohesion of writing, with applicability in the field of study and of great relevance, especially considering the absence of this type of instrument for the military firefighter population. To evaluate the agreement between the judges, we used the Content Validity Index which reached 98% of agreement and the Interrate agreement, which reached the concepts good and very good, showing low variance of the judges' answers, being statistically valid. Conclusion: The study described the process of construction and validation of the instrument, proving to be appropriate and reliable to be used.

Objetivo: Este estudio tenía como objetivo desarrollar y validar un instrumento para evaluar las medidas de bioseguridad adoptadas por los bomberos militares para contener los agentes biológicos durante un evento de bioterrorismo. Métodos: Se trata de un estudio descriptivo de abordaje cuantitativo, de desarrollo metodológico y del tipo de validación de contenido de un instrumento de evaluación. El estudio se dividió en las fases de desarrollo y validación del instrumento. Para la elaboración del instrumento se realizaron revisiones bibliográficas y para la validación del mismo se utilizó el método Delphi. Para el estudio se incluyeron 6 jueces que evaluaron el instrumento mediante una escala numérica tipo Likert. Resultados: Los jueces evaluaron que el instrumento propuesto está bien estructurado, poseyendo buena claridad y cohesión de redacción, con aplicabilidad en el campo de estudio y de gran relevancia, especialmente en vista de la ausencia de este tipo de instrumento para la población de bomberos militares. Se utilizó el Índice de Validez de Contenido para evaluar la concordancia entre los jueces, alcanzando un 98% de acuerdo y el Índice de Fiabilidad Inter-registrador, que alcanzó conceptos buenos y muy buenos, mostrando una baja varianza en las respuestas de los jueces, siendo estadísticamente válido. Conclusión: El estudio describió el proceso de construcción y validación del instrumento, demostrando ser apropiado y confiable para ser utilizado.

Assessing dual use research of concern (DURC)-lessons learned from the United States government institutional DURC policy.

Life science research was analyzed for potential misuse in the 2004 report "Biotechnology Research in an Age of Bioterrorism". However, it was not until 2015 that the United States Government (USG) Institutional Dual Use Research of Concern (DURC) policy went into effect. Institutions receiving USG funding for life science research are required to scan their research portfolios for research involving one of 15 agents and subsequent 7 experimental effects described in the policy. In practice, this policy was implemented in a variety of ways with varying outcomes and lessons learned. First and foremost, reviewing research for potential DURC is a highly subjective process that differs depending on the risk tolerance, experience, and training of the individuals charged with reviewing research for an institution as well as the review process itself. The information being reviewed also lends to the subjectivity of the process, that is, the experimental data provided. It is difficult to determine whether research is potential DURC without experimental data. Any review process is hypothetical until there is data. Lastly, reviewers of the research should look beyond the research proposals, like how compounding existing research information can create new risks, potential use in other organisms or systems, or the creation of a roadmap that, for example, shows how to create a concerning organism or could be used in a pathogen.

Smallpox as a Bioagent: A Refresher and Update for the SOF Provider.

Smallpox plagued humans for millennia until its eradication in 1980 following a successful global campaign led by the World Health Organization (WHO). It is the first known biological weapon to be used in war and has been weaponized in the past by the former Soviet Union. To date, smallpox remains a Category A Bioagent and is assessed to be a relevant threat to US military personnel. Given that the last natural case of smallpox occurred more than 40 years ago, a high level of suspicion along with a substantial understanding of the disease process are required to recognize potential future cases. While available countermeasures are limited, several new agents have recently become available for the prevention and treatment of smallpox and have been added to the strategic national stockpile. This review serves as a refresher and update for the clinical disease, to include its epidemiology and management with updated FDA-approved countermeasures.

Surveillance of emerging infectious diseases for biosecurity.

Emerging infectious diseases, such as COVID-19, continue to pose significant threats to human beings and their surroundings. In addition, biological warfare, bioterrorism, biological accidents, and harmful consequences arising from dual-use biotechnology also pose a challenge for global biosecurity. Improving the early surveillance capabilities is necessary for building a common biosecurity shield for the global community of health for all. Furthermore, surveillance could provide early warning and situational awareness of biosecurity risks. However, current surveillance systems face enormous challenges, including technical shortages, fragmented management, and limited international cooperation. Detecting emerging biological risks caused by unknown or novel pathogens is of particular concern. Surveillance systems must be enhanced to effectively mitigate biosecurity risks. Thus, a global strategy of meaningful cooperation based on efficient integration of surveillance at all levels, including interdisciplinary integration of techniques and interdepartmental integration for effective management, is urgently needed. In this paper, we review the biosecurity risks by analyzing potential factors at all levels globally. In addition to describing biosecurity risks and their impact on global security, we also focus on analyzing the challenges to traditional surveillance and propose suggestions on how to integrate current technologies and resources to conduct effective global surveillance.

Agricultural Crop Security: Exploring US Federal Readiness and Response Capabilities.

A large-scale agroterrorism attack on the United States would likely have severe economic and social consequences. In particular, the destruction of crops with pests or pathogens could cause substantial damage to food, economic, and social stability, with relatively little health risk to the perpetrators. The tools of engineering biology could enable a well-trained, nefarious actor to amplify their desired impacts through the development of disease-intensifying traits. In the United States, plant health emergencies are handled first at the local and state levels, then escalated to include the support and leadership of the US Department of Agriculture (USDA) and other federal agencies. We used publicly available documents and interviews across government, academia, and industry to explore the strategic and tactical approaches of the US federal government to detect and respond to plant agroterrorism. In this article, we discuss the agroterrorism preparedness and response capabilities at 3 levels of federal response: (1) within the Plant Protection and Quarantine program of the Animal and Plant Health Inspection Service at the USDA, (2) between USDA components, and (3) between federal agencies. We outline the approaches currently taken and identify opportunities to strengthen these approaches.

The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic.

The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products. EUAs proved vital for the first group of COVID-19 vaccines, including the temporary pause of one vaccine while emergency safety issues were evaluated. Although this review on the EUA is primarily focused on the USA, distinctions were made with other jurisdictions such as Europe and Canada with respect to the emergency authorizations of the vaccines. Finally, we discuss some important differences following EUA and formal new drug/vaccine application (NDA/BLA) approvals.