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| THE CSTE WASHINGTON REPORT Marcia S. Mabee, MPH, PhD Editor 11479 Waterview Reston, Virginia 20190 mmabee@ix.netcom.com 703-709-3001 MAY 17, 2001 Volume 5, Number 10 EDITOR'S NOTE: Senate hearings last week in Washington provided an opportunity for federal officials to outline the specifics of planning for terrorist attacks on U.S. populations, including nuclear, chemical or bioterrorism. The President selected the Federal Emergency Management Agency (FEMA) as the lead agency for response efforts, with HHS designated for handling health issues. HHS Secretary Tommy Thompson provided detailed testimony on the progress made over past several years within his agency for bioterrorism and the agency's aggressive plans to build on that progress. Recognition of the importance of bioterrorism preparations within HHS is an important milestone, and this Washington Report is devoted to a summary of that progress. The CSTE Washington Report is provided as a information resource for members of the Council of State and Territorial Epidemiologists on federal legislation and regulation affecting public health and epidemiology in the U.S. Regulations cited can be accessed via http: www.gpo.gov. BUDGET UPDATE: Last minute disputes and a copy machine jam that resulted in two missing pages delayed passage of the Budget Resolution nearly one more week. The final outcome is essentially the same as reported here 5/3/01, but the treatment of a $5.6 billion emergency fund has technically lowered the discretionary spending total available for programs by 1 percentage point - from an expected $667 billion and a 5 percent increase over FY 2001 to $661.3 billion and 4.1 percent more than FY 2001. The $5.6 billion emergency fund was eliminated, but the money was then pooled with an additional $700 million in funding that the Budget Resolution Conferees agreed to provide, for a total of $6.3 billion -- nearly all of which ($6.2 billion) will be provided for domestic discretionary spending, and made available to the Appropriations Committees. This amounts, essentially, to a total of about $667.5 billion for discretionary spending, but does not appear in the usual places. A separate contingency fund has been set aside in the Budget Resolution to fund the expected multi-billion supplemental request for additional defense spending. The Budget Resolution passed the House on May 9th by a vote of 221-207 and it passed the Senate by a vote of 53-47. Work is rapidly proceeding on the $1.35 trillion tax cut that the Budget Resolution provided for. The Leadership in both Houses of Congress hope to pass a bill providing the biggest tax cut in a generation by the Memorial Day recess which begins May 25th. ANTIMICROBIAL BILL INTRODUCED -- Rep. Sherrod Brown, ranking Democrat on the House Subcommittee on Health of the Energy and Commerce Committee, introduced legislation on May 9th that authorizes funding to implement the top 13 action items developed by the Interagency Task Force on Antimicrobial Resistance. The Task Force issued its final report entitled, A Public Health Action Plan to Combat Antimicrobial Resistance, earlier this year and was reported here at that time. You can read the report at: http://www.cdc.gov/drugresistance/actionplan/html/index.htm Rep. Brown's bill, entitled, Antibiotic Resistance Prevention Act of 2001 (HR 1771) would provide whatever additional funding to other funding that is already authorized for combating antimicrobial resistance is needed for FY 2002-2006 to fully implement the Action Plan items. The funding would be confined to the Department of Health and Human Services, however, due to Congressional jurisdictional concerns. The top priority action items include four areas: surveillance, prevention and control, research, and product development. There are 20 surveillance action items in the full report, but the top two authorized for funding in Rep. Brown's bill are: a) Action item #2, "With partners, design and implement a national AR surveillance plan that defines national, regional, state, and local surveillance activities and the roles of clinical, reference, public health, and veterinary laboratories. The plan should be consistent with local and national surveillance methodology and infrastructure that currently exist or are being developed;" b) Action item #5, "Develop and implement procedures for monitoring patterns of antimicrobial drug use in human medicine, agriculture, veterinary medicine, and consumer products. CSTE consultants participated in a brain-storming session with Rep. Brown during March in preparation for the legislation. CSTE consultants have been asked to review the bill for comments and CSTE's support. HHS ASSIGNED PRIMARY HEALTH ROLE IN BIOTERRORISM RESPONSE, NEDSS TO PLAY KEY ROLE -- Last week, the Senate began a series of hearings intended to examine the efforts of more than forty different federal agencies with responsibility for combating domestic terrorism. Over the past decade, counter and antiterrorism programs have grown and proliferated without the benefit of a comprehensive national strategy. Moreover, this growth has occurred without critical assessments of threats and needs, according to Senate documents released prior to the hearings. Concurrent with the Senate hearings, President Bush announced the assignment of overall responsibility for domestic terrorism response to the Federal Management Agency (FEMA), setting the stage for cabinet level preparations for overall federal response to nuclear, chemical and bioterrorism threats to the American public. HHS Secretary Tommy Thompson outlined his agency's priorities for terrorism response in testimony before the Senate. "Bioterrorism presents unique challenges since it differs dramatically from other forms of terrorism and national emergencies. While explosions or chemical attacks cause immediate and visible casualties, an intentional release of a biological weapon would unfold over the course of days or weeks, culminating potentially in a major epidemic. Until sufficient numbers of people arrive in emergency rooms, doctors' offices and health clinics with similar illnesses, there may be no sign that a bioterrorist attack has taken place. Individuals with symptoms may be at considerable distance from the site of initial exposure, both in terms of onset of disease and geographic location. Moreover, the bioweapons most likely to be used are pathogens not routinely seen by health care providers. Medical providers generally are not familiar with the diagnosis and treatment of these disorders and may even fail initially to recognize symptoms. These scenarios underscore the importance of preparing for the possibility of bioterrorism. " Our efforts include preparing the medical and public health response to mass casualty events, working to improve our infectious disease surveillance capabilities, managing and securing the National Pharmaceutical Stockpile and investing in necessary research and development to improve our capability to respond to an emergency. "In order to advance an orderly and comprehensive approach to the many issues involved in such preparation, I will appoint a special assistant within the Immediate Office of the Secretary to lead the department's bioterrorism initiative. This person will report to me directly. I plan to call a national meeting of HHS agencies to evaluate the status of bioterrorism activities and report back to Congress on our efforts. In addition, the new special assistant will support the Surgeon General's efforts to revitalize the Public Health Service Commissioned Corps and its Readiness Force. Let me assure you that this is a top priority for me and for my entire department. "Because of the potential for widespread damage a bioterrorist attack could bring, I will focus on what I consider HHS's main priorities as the coordinator of medical assistance and the surveillance efforts CDC would undertake to identify the pathogen used. Coordinating the Medical and Public Health Response to Mass Casualty "As you know, much of the initial burden and responsibility for providing an effective response by medical and public health professionals to a terrorist attack rests with local governments, which would receive supplemental support from state and federal agencies. However, if the disease outbreak reaches any significant magnitude, local resources will be overwhelmed and the federal government will be required to provide protective and responsive measures for the affected populations that may include any or all of the following: Mass Patient Care -- including the establishment of auxiliary, temporary treatment facilities or procedures for the movement of overflow patients to other geographic areas for care; in the case of a bioterrorist event, mass immunization or prophylactic drug treatment for groups known to be exposed, groups that may have been exposed and populations not already exposed but at risk for exposure from secondary transmission and/or a contaminated environment; Deployment of Material from the National Pharmaceutical Stockpile; Mass Fatality Management to provide respectful and safe disposition of the deceased, including animals; Infection Control; and Assessment of the extent of contamination to the environment and identification of risk management steps to assure safe re-entry of the potentially contaminated areas. "Within my agency, the Office of Emergency Preparedness (OEP) is the primary agency responding to requests for assistance and resources. OEP's primary function is to manage the National Disaster Medical System (NDMS) as well as the Public Health Service Commissioned Corps Readiness Force, which could be called into action depending upon the severity of the event. "The National Disaster Medical System is a group of more than 7000 volunteer health professionals who can be deployed anywhere in the country to assist communities in which local response systems are overwhelmed or incapacitated. Organized into 44 Disaster Medical Response Teams, these volunteers would provide on-site medical triage, patient care and transport to medical facilities. Four National Medical Response Teams (NMRTs), which travel with their own caches of pharmaceuticals, have capabilities to detect illness-causing agents, decontaminate victims, provide medical care and remove victims from the scene. Three of the our NMRTs can be mobilized and deployed anywhere in the nation; the fourth is permanently stationed in the Washington, D.C. area. The NDMS also includes Disaster Mortuary Operations Response Teams that handle the disposition of the remains of victims of major disasters. "NDMS response teams can, upon request, be in an area to supplement local responders within 12 hours of a request. The system capability includes providing in-hospital care for up to 100,000 victims. Other activities that OEP has undertaken to help states and local communities develop their preparedness for mass casualties include but are not limited to: --development of competency standards for physicians, nurses and paramedics that focus on the emergency care and definitive treatment of mass casualties from nuclear, biological or chemical incidents --guidelines for hospital mass casualty procedures that focus on in-hospital decontamination and --medical practices for mass contaminated patients who arrive in hospital emergency rooms; and mass casualty treatment protocol reviews/updates that will provide clinical guidelines for the treatment of patients exposed to a nuclear, biological or chemical weapon of mass destruction. Improving Surveillance "If a terrorist used a biological or chemical weapon against the civilian population, how quickly the outbreak is detected, analyzed, understood and addressed would be the responsibility of state and local public health jurisdictions and the Centers for Disease Control and Prevention. "The CDC has used fund provided by the past several congresses to begin the process of improving the expertise, facilities and procedures of state and local health departments and within CDC itself related to bioterrorism. CDC has established a Bioterrorism Preparedness and Response Program within its National Center for Infectious Diseases to direct and coordinate their activities. CDC has a dedicated anti-bioterrorism staff of more than 100 full-time professionals comprising expertise in epidemiology, surveillance and laboratory diagnostics. "Over the last two years, the agency has awarded more than $80 million in cooperative agreements to 50 states, one territory and four major metropolitan health departments to support (1) preparedness and readiness assessment; (2) epidemiology and surveillance; (3) laboratory capacity for biological or chemical agents; and (4) the Health Alert Network (a nationwide, integrated, electronic communications system). "CDC has launched an effort to improve public health laboratories that likely would be called upon to identify a biological or chemical attack. The Laboratory Response Network (LRN), in collaboration with the Association of Public Health Laboratories, will help ensure that the highest level of containment and expertise in the identification of rare and lethal biological agents is available in an emergency event. The LRN also includes the Rapid Response and Advanced Technology Laboratory at CDC, which has the sole responsibility of providing rapid and accurate triage and subsequent analysis of biological agents, suspected of being terrorist weapons. "The CDC is also working to provide coordinated communications in the public health system, between federal agencies and between public health officials and the public itself. To this end, CDC has launched several initiatives. It has developed the National Electronic Disease Surveillance System (NEDSS), which will collect health data automatically from a variety of sources on a real-time basis to assist in the ongoing analysis of trends and detection of emerging public health problems. "CDC has also instituted the <em>Epidemic Information Exchange (EPI-X)</em>, a secure, Web-based communications network that will enhance bioterrorism preparedness efforts by facilitating the sharing of preliminary information about disease outbreaks and other health events among officials across jurisdictions and provide experience in the use of a secure Communications System. "CDC supports the Health Alert Network (HAN), a nationwide system that, when completed, will distribute health advisories, prevention guidelines, distance learning, national disease surveillance information, laboratory findings and other information relevant to state and local readiness for handling disease outbreaks. HAN will provide high-speed Internet connections for local health officials; rapid communications with first responder agencies and others; transmission of surveillance, laboratory and other sensitive data; and on-line, Internet- and satellite-based distance learning. CDC has provided HAN funding and technical assistance to 37 state health agencies, three metropolitan health departments and three Centers for Public Health Preparedness. "Because of food is a likely medium for spreading infectious diseases, FDA as well as CDC are enhancing their surveillance activities with respect to diseases caused by foodborne pathogens. Through FoodNet, an active surveillance system for diseases caused by foodborne pathogens, FDA, CDC and the Department of Agriculture (USDA), in conjunction with state health departments, are able to conduct investigations to map out the epidemiology of illnesses caused by contaminated foods. PulseNet, a national network of public health laboratories created, administered and coordinated by CDC in collaboration with FDA and USDA, enables the comparison of bacteria isolated from patients from widespread locations, from foods and from food production facilities. This type of rapid comparison allows public health officials to connect what may appear to be unrelated clusters of illnesses, thus facilitating the identification of the source of an outbreak caused by international or accidental contamination of foods. Managing and Securing the National Pharmaceutical Stockpile "The purpose of the National Pharmaceutical Stockpile (NPS) is to be able to rapidly respond to a domestic biological or chemical terrorist event with antibiotics, antidotes, vaccines and medical materiel to help save lives and prevent further spread of disease resulting from the terrorist threat agent. Operated by the CDC, the NPS Program would provide an initial, broad-based response within 12 hours of the federal authorization to deploy, followed by a prompt and more targeted response as dictated by the specific nature of the biological or chemical agent that is used. The first NPS "12-hour Push Package" was brought to operational status on December 27, 1999. "Since then, CDC has deployed six additional 12-hour Push Packages to various regions of the United States. One more Push Package awaits transport to its storage site. Each of these Push Packages is maintained in secure, climate-controlled facilities near a population center or at a transport hub from which they can be sent rapidly to any site in the country. "This fiscal year CDC will move into the next phase of its pharmaceutical response preparedness by finalizing contracts with pharmaceutical manufacturers and vendors for additional products that would be called for in case of a major event. Called Vendor Managed Inventory or "VMI, this portion of the NPS relies on products that are stored and managed by the manufacturers that produced them and/or the distributors through which they work to supply the nation's health care delivery system. VMI will be stored in facilities around the country where it can be efficiently rotated and from where it can be promptly transported. To the extent possible, pharmaceuticals in both the Push Packages and the VMI will be rotated so that the inventories always stay within their expiration dates or their extended shelf life. CDC has interim agreements with United Parcel Service and Federal Express Corporation to meet the transport needs of the NPS Program. "In order to ensure the quality of the products in the stockpile and the ability of the stockpile to deploy at a moment's notice, CDC will conduct periodic "no notice" inspections of facilities storing both the eight 12-hour Push Packages and the VMI and of the companies that are the NPS' cargo transport partners. FDA must also inspect drug and vaccine manufacturers whose products are stockpiled. In the spirit of vigilant oversight, CDC has mounted a program of training, exercises and technical assistance that will enhance the NPS Program's ability to receive, manage, repackage and distribute stockpile materiel on site. The Program, in cooperation with OEP, has engaged in an effort to develop a template for receipt, breakdown, repackaging and distribution of a Push Package. Because failure is not an option for the deployment of the stockpile, CDC must test its various components in advance. These exercises will produce an assessment of how each system partner performs and what aspects of their performance might need to be strengthened." Donna Knutson Executive Director Council of State and Territorial Epidemiologists 770-458-3811 770-458-8516 dknutson@cste.org |
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Council of State and Territorial Epidemiologist |