United States preparedness against terrorist attacks from chemical, biological, radiological and nuclear (CBRN) agents includes prep and planning for the public, as well as for the first responders who will be on the front lines during a catastrophic emergency event.
Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), last week told Homeland Preparedness News that the Office of the ASPR is “driving multiple efforts to protect Americans from 21st century health security threats,” which could include the potential deployment of bio-weapons like intentionally released infectious diseases or some other bacteria, virus or toxin, or the release of chemical weapons such as chlorine or mustard gas.
Such threats to public health, according to Kadlec and other top federal officials, continue to rise in the United States and abroad.
“It is imperative for first responders to keep themselves safe, so that in turn, they can provide care to those who are injured or ill,” Dr. Kadlec wrote in email responses to several questions related to national preparedness and response.
For example, first responders should become familiar with the ASPR’s Primary Response Incident Scene Management (PRISM) series, which Kadlec said has been developed to provide evidence-based guidance on mass casualty disrobe and decontamination during a chemical incident.
The PRISM guidance is based on scientific evidence gathered under a research program sponsored by the Biomedical Advanced Research and Development Authority (BARDA), which is overseen by ASPR. What many first responders may not realize is that studies during the BARDA research showed that disrobing and wiping skin with a dry cloth removes 99 percent of decontamination, Kadlec said.
“Dousing someone fully clothed with a fire hose, which is a common practice, potentially pushes chemicals into the skin causing greater harm. Emergency planners and first responders need to know about the studies and the resulting PRISM guidance so they can incorporate the proven approach into their emergency plans and exercises,” he said.
Chemical threat responses
For people who are exposed to a chemical agent, the greatest challenge is speed of diagnosis and treatment, Kadlec said, and it doesn’t matter if you’re a bystander or a firefighter, police officer or emergency technician in an ambulance.
“Some chemicals can cause illness in hours or even minutes,” he said. “In the U.S., we have seen this on a small scale with industrial plant accidents and train derailments involving chemicals like chlorine.”
ASPR collaborated with the National Library of Medicine at the National Institutes of Health to create a site called Chemical Hazards Emergency Medical Management — or CHEMM — which first responders, doctors and nurses can use during an emergency to identify the substance based on symptoms and then quickly determine the appropriate treatment, he said.
“There is even a mobile app called WISER (Wireless Information System for Emergency Responders) so first responders would have this information at their fingertips during an emergency,” Kadlec added.
BARDA also has sponsored the development of medical countermeasures (MCMs) that should be of interest to first responders for treating thermal burns and other injuries potentially caused during a chemical attack.
“A large, emergency decontamination exercise held at the University of Rhode Island in August 2017 provided first responders and ASPR the opportunity to exchange information on the best way to decontaminate individuals potentially exposed to chemical agents,” the doctor said.
Specifically, the university hosted Operation Downpour, an emergency decontamination exercise requested by the ASPR, which partnered on the event with the United Kingdom’s University of Hertfordshire (UH), the Federal Emergency Management Agency, the Rhode Island Department of Health, the Rhode Island Department of Environmental Management, University of Rhode Island (URI) Emergency Medical Services, the Rhode Island Disaster Medical Assistance Team (RIDMAT), and several local and district fire departments.
The exercise was part of a research project to help improve U.S. emergency response decontamination practices and relied on a national planning guide published by BARDA and the U.S. Department of Homeland Security (DHS) in 2014 entitled, Patient Decontamination in a Mass Chemical Exposure Incident: National Planning Guidance for Communities.
Operation Downpour involved the evacuation and subsequent decontamination of volunteers who had been exposed to simulated chemicals during a CBRN incident, according to URI. Researchers then examined different emergency response procedures for decontaminating and cleaning large numbers of people exposed to those toxic materials, including first responders.
“Mass contamination is an ever-present public health threat,” a UH narrator says on a Jan. 11 YouTube video posted of Operation Downpour. “At the University of Hertfordshire, we believe that lives can be saved through continuous testing and improvement of best practice.”
The large-scale exercise in Rhode Island, according to UH, involved 400 professionals and volunteers. In the video, hundreds of volunteers, some with their dogs, strip down to their underwear or swimsuits outside a URI cafeteria and move through decontamination tents or other areas where first responders test emergency response practices. The responders, wearing full protective gear, went through “meticulous training” for six months prior to conducting Operation Downpour, according to UH.
The UH Toxicology Research Group then collected empirical data from the volunteers, such as DNA samples from their skin, in order to conduct scientific analysis on whether the response approaches were successful in removing simulated chemicals. Results from the UH research are scheduled to be published in PRISM II next month.
Protecting health care workers
It’s important to note, too, that ASPR’s Hospital Preparedness Program (HPP) “places great importance on the safety and health of health care and medical practitioners,” Kadlec said.
The HPP specifically emphasizes responder safety and health in the 2017–2022 Health Care Preparedness and Response Capabilities, which describes how the nation’s health care system should adequately prepare for disasters. Kadlec noted that the publication includes multiple objectives related to responder safety and health, including risk assessment and workforce training.
Under the HPP, ASPR provides funding and guidance for state, local and territorial health departments to support healthcare coalitions that bring together public and private healthcare entities from across a region to plan, train and respond to natural disasters, mass shootings, train derailments, and other crises. More than 31,000 healthcare entities participate in healthcare coalitions nationwide, including approximately 85 percent of all U.S. hospitals.
Kadlec advised that when local healthcare coalitions develop processes for protecting the safety and health of responders and health care workers, “these processes should include consideration for thermal burns in the event of a chemical attack.”
HPP also directs healthcare coalitions and their members to train and exercise the use of personal protective equipment; plan for the provision and dissemination of necessary MCMs and other resources to protect patients, emergency responders, and health care workers; and organize trainings, drills and exercises to promote workforce safety and health.
A new framework suggested
The ASPR is a mega-coordinator across the federal government for aligning the public health and medical response to disasters.
“In this role, we bring to bear all of the federal public health and medical resources available to augment state and local personnel, supplies and equipment,” Kadlec said, referring to its management of the National Disaster Medical System and its emergency deployment of personnel in the U.S. Public Health Service, among others.
But what he envisions is a regional disaster health response system to improve preparedness and response across the board in the United States.
“Building readiness and response capacity for these crises and other emerging threats is a priority for ASPR and is the catalyst for creating a regional disaster health response system,” Kadlec said.
This new framework would be built on a tiered regional system that utilized local healthcare coalitions and trauma centers and would integrate medical response capabilities, including federal facilities from the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and emergency medical services, he explained.
“This system would expand specialty care expertise in trauma and chemical, biological, radiological, nuclear, and explosive agents, and would coordinate medical response through mutual aid across states, tribal nations, local governments, territories and regional jurisdictions,” he said. “A regional disaster healthcare system also would incentivize the healthcare system to integrate measures of preparedness into daily standards of care.”
Naturally, such a framework requires funding, which Kadlec would like to see provided for in the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). Many of the law’s provisions are set to expire in September.
While he considers current funding of the ASPR and its related programs to be inadequate, Kadlec and others in the federal government received some unexpected good news last week when President Donald Trump on March 23 signed the Consolidated Appropriations Act of 2018, H.R. 1625, funding the federal government through Sept. 30.
The spending package includes additional funding for critical preparedness and response activities. For instance, under the omnibus spending package, the Public Health and Social Services Emergency Fund (PHSSEF) received $1.95 billion, an increase of $436 million above the fiscal year (FY) 2017 level, which includes:
- $250 million for pandemic influenza preparedness to maintain flu vaccine manufacturing facilities and develop flu vaccines, therapeutics, and diagnostics, an increase of $193 million over FY2017;
- $265 million for HPP grants, an increase of $10 million over FY2017;
- BARDA authority, which received $537 million for advanced research and development of MCMs for national preparedness efforts, $25 million above FY2017; and
- Project BioShield received $710 million to enhance national preparedness activities by procuring MCMs against CBRN threats, $200 million above FY2017. ASPR also oversees this project.
Additionally, under the measure, Public Health Emergency Preparedness (PHEP) garnered $670 million to help states to prepare, respond and recover from emerging threats such as natural disasters, disease outbreaks and CBRN threats, which is $10 million above FY2017 funding.
And the Strategic National Stockpile nabbed $610 million, $35 million above FY2017, while the National Disaster Medical System got $57 million, a $7.5-million increase over FY2017 funds.
Stockpiles of MCMs
In addition, through BARDA, Kadlec said ASPR collaborates with private industry to develop MCMs that first responders and physicians will need to prevent, diagnose or treat injuries from CBRN, pandemic and emerging infectious disease threats.
“To treat different aspects of thermal burns and other injuries, we have purchased some of these products for the Strategic National Stockpile or they are available on the commercial market,” he said.
For example, Silverlon, a metallic silver-based antimicrobial wound dressing from Argentum Medical LLC, has been approved by the U.S. Food and Drug Administration (FDA) and stockpiled. Kadlec said the silver-impregnated dressings indicated to manage infected wounds can be readily used in a field-care setting and care for a wide range of traumatic and burn wounds for up to seven days.
The Reactive Skin Decontamination Lotion (RSDL) Kit, an MCM by Emergent BioSolutions Inc. to remove or neutralize chemical warfare agents and T-2 toxins from the skin, also has been cleared by the FDA and has been procured by the U.S. military for more than a decade. RSDL became available for purchase by civilians last year.
“Such products build the country’s preparedness to save lives in a mass casualty event,” said Kadlec.
Other definitive care products are in various stages of development at BARDA for thermal burns, he added.
One example is StrataGraft, a regenerative skin substitute from Mallinckrodt plc. The product has been FDA-designated as a Regenerative Medicine Advanced Therapy under provisions of the 21st Century Cures Act that allow the FDA to grant accelerated review approval to products that meet certain criteria.
BARDA is evaluating StrataGraft to assess its “efficacy and safety in promoting autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements,” or deep partial thickness burns, according to Mallinckrodt. BARDA is supporting the development of StrataGraft tissue as a potential medical countermeasure for large-scale burn incidents.
“Some of the products are under clinical investigation, either in early feasibility studies or in proof of concept stage (for example, imaging systems). Other products are in late stage development undergoing evaluation in pivotal clinical studies, and the companies are in discussions with the FDA,” Kadlec explained.