Pharmaceuticals and the Strategic National Stockpile Program

This article discusses current stockpile practices after exploring a history of the use of biologic agents as weapons, the preventive measures that the federal government has used in the past, and the establishment of a Strategic National Stockpile Program in 2003. The article also describes the additional medical supplies from the managed inventory and the federal medical stations. The issues (financial burden, personnel, and materiel selection) for local asset development are also discussed. Critical is the cost to local communities of the development and maintenance of a therapeutic agent stockpile and the need for personnel to staff clinics and medical stations. Finally, the important role of the dental profession for dispensing medication and providing mass immunization in the event of a disaster is described.

In September and October 2001, two waves of attacks from anthrax ( Bacillus anthracis ) contained in mailed letters were conducted on the East Coast of the United States. Twenty-two people were infected with inhalation anthrax as a result, and of those 22, 5 died . Two of the letters, which were apparently sent from a mail box in Princeton, NJ, were addressed to Senators Tom Daschle of South Dakota and Patrick Leahy of Vermont. Within one of the envelopes was a note with a pharmaceutical direction “Take Penacilin [sic] Now.” The earlier group of five letters contained a brown granular form of anthrax and caused lesions of cutaneous anthrax. The other two letters contained approximately 1 g of more potent, white, refined anthrax spores that subsequently caused inhalation anthrax. Both samples originated from the same strain (Ames), and were derived from the original-type strain studied by the United States Army Medical Research Institute of Infectious Diseases at Fort Detrick, MD. The level of sophistication and technology to produce the second batch of anthrax spores is significant, but the laboratory that originated this material has yet to be found. Despite more than 9000 interviews on six continents, no one has been held responsible. It is estimated that more than $1 billion was spent on providing prophylactic medications and clean-up operations at various federal locations as a result of the attacks .

This was not the first attack on the United States using a biologic weapon. A significant number (at least 239) of mock “attacks” took place in the late 1940s and into the 1960s as the US government live-tested various bacteria over San Francisco from a Navy ship and dropped biologic agents over New York, Washington, DC, and Panama City, FL to determine the spread of the particles and how easy it would be to conduct such an attack . Until Senate hearings in 1977, these tests were not general public knowledge. One such attack—on the New York subway system in midtown Manhattan—involved dropping light bulbs filled with Bacillus subtilis var. niger on the train tracks. The Army report on the incident concluded, “Similar covert attacks with a pathogenic agent during peak traffic periods could be expected to expose large numbers of people to infection and subsequent illness or death” .

Biologic warfare, in the form of clay pots filled with rotting “serpents of every kind,” was probably instigated by Hannibal as a key element of his victory over King Eumenes of Perganum in 184 bc . In the Middle Ages, the Tartars propelled plague-ridden bodies over the walls of Caffa to cause plague in the enemy, and similar tactics were used by the Russians against Sweden in 1710. Smallpox was used in the fifteenth and eighteenth centuries as a weapon through the distribution of contaminated clothing. For example, during the French and Indian wars, smallpox-laden blankets were supplied by the English to Native Americans. Similar incidents of biologic weapon use involving cholera and the plague also may have occurred during World War I in Italy and Russia, respectively . Chemical weapons use (chlorine gas) was initiated in Ypres, Belgium by German forces in 1915.

In June 1925, the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases and of Bacteriological Methods of Warfare was developed and is known as the Geneva Protocol . Unfortunately, it contained no provision for monitoring and inspection regarding compliance. In 1932, the Japanese government began a substantial biologic weapons program that was subsequently inflicted on China and resulted in untold deaths from bubonic plague. In 1940, on Gruinard Island in Scotland, the British developed anthrax “bombs” that demonstrated effectiveness against sheep. At the conclusion of the tests, the island was so dangerous that it remained off limits (and classified) until decontaminated with formaldehyde in 1986. Subsequently, anthrax was described as being “100-1000 times more potent than any chemical agent” .

It was in 1953 that research was initiated in the United States on the defensive aspects of biologic weapons, including vaccines, chemoprophylaxes, and therapeutic regimens. Subsequently, in 1969, President Richard Nixon signed an executive order that the US offensive program would be terminated and only small research quantities of biologic agents would be retained for the development of biologic protective measures, diagnostic procedures, and therapeutic regimens. The 1972 Biological Weapons Convention (implemented in 1975) was signed by 140 countries and was supposed to halt the proliferation of biologic agents and eliminate current offensive weapon stockpiles. The use of such agents in “defensive” research was not subject to direct oversight. Based on an incident of inhalation anthrax, in which 66 people died in Sverdlovsk, Russia in April 1979, it became clear (from President Yeltsin in 1992) that the Soviet Union had at least one secret biologic warfare facility. In actuality, the program had more than 40 such facilities and at its peak employed more than 50,000 scientists and technicians. The dispersal of these scientific personnel and their associated knowledge and materiel after the 1989 dissolution of the Soviet Union is of grave and continuing concern . The Japanese religious cult Aum Shinrikyo, which attacked the Tokyo subway with sarin gas in March 1995 and killed 12 people, also had a biologic weapons program and was attempting to develop B anthracis , Clostridium botulinum , and Coxiella burentii in weaponized forms . A chemical weapons convention was signed in 1993 to provide a comprehensive ban on the development, production, stockpiling, and use of chemical weapons with guidelines for destruction of existing weapons. It came into force in 1997.

Vulnerability

The assessment of threat has been described as being a combination of the “perceived adversary’s capability to produce and effectively disseminate biological agents, his intent to do so, and our own vulnerability to such an action” . In practice, however, we can only assess our own vulnerabilities. The focus at federal and local levels is on using our existing and emerging technologies to develop preventive and therapeutic measures for deployment. At the same time, we know that recombinant DNA techniques could produce modified organisms against which no preventive and therapeutic strategy could be developed. These organisms and known lethal strains of existing organisms and synthetic and natural chemical agents are regarded as “asymmetric threats.” They represent weapons for which developing strategies to detect and respond to them to protect public health is substantially more difficult, particularly in the hands of terrorist groups that do not represent a particular sovereign nation.

An underlying assumption in planning for chemical and biologic threats also focuses on people as the principal point of attack. In reality, biologic and chemical attacks easily could be directed toward crops (eg, the use of Agent Orange in the Vietnam War), food animals, or biologically degradable plastics and rubber. In considering the use of available natural, chemical, and biologic toxins, a plethora of such agents is beyond the classic agents that cause anthrax, smallpox, or the plague. The Centers for Disease Control and Prevention’s (CDC) list of critical biological agents (categories A, B, and C) does not include many of these agents because they are viewed as not being capable of development as threats.

From a response-planning perspective, what is the potential local impact of such an attack? A 1997 study published by the CDC estimated that an attack with B anthracis on a town of 100,000 people would result in 50,000 cases of illness and 32,875 deaths . Only through environmental surveillance and the early administration of appropriate antibiotics could such a disaster of mortality be modulated. Any act of terrorism (or a large-scale natural disaster) targeting the US civilian population will require rapid access to large quantities of pharmaceutical agents and medical supplies. Such quantities of medication and medical supplies may not be readily available locally, and quantities available will be depleted quickly. Preparedness for biologic or chemical attack and natural disasters requires consideration of the accumulation (stockpiling) of adequate pharmaceutical and associated medical supplies.

History of federal government pharmaceutical response

The first federally mandated stockpiles were overseen by the CDC, which is 1 of 13 major operating components of the Department of Health and Human Services. From 1974 until 1998, the primary focus of these programs was on naturally occurring infectious diseases, such as smallpox.

The Aum Shinrikyo sarin attack in 1995 raised legitimate concerns as to how a major city in the United States would respond pharmaceutically to such an attack from a chemical or biologic agent. In addition to the known cultivation of biologic agents by Aum Shinrikyo, intelligence exists to support that Iran, Syria, Libya, China, North Korea, Russia, Israel, Taiwan, and possibly Sudan, India, Pakistan, and Kazakhstan support offensive biologic weapons programs . As a result, in 1999, the US Congress mandated the formation of the national pharmaceutical stockpile program. The program was appropriated $51 million to acquire and oversee the stockpile of pharmaceutical interventions, medical supplies, and equipment for immediate availability to a state or local authority making a request . In March 2003, the national pharmaceutical stockpile program was shifted under the auspices of the US Department of Homeland Security and was renamed the Strategic National Stockpile (SNS) program . With the signing of the BioShield legislation, the SNS program was returned to US Department of Health and Human Services for oversight and guidance.

History of federal government pharmaceutical response

The first federally mandated stockpiles were overseen by the CDC, which is 1 of 13 major operating components of the Department of Health and Human Services. From 1974 until 1998, the primary focus of these programs was on naturally occurring infectious diseases, such as smallpox.

The Aum Shinrikyo sarin attack in 1995 raised legitimate concerns as to how a major city in the United States would respond pharmaceutically to such an attack from a chemical or biologic agent. In addition to the known cultivation of biologic agents by Aum Shinrikyo, intelligence exists to support that Iran, Syria, Libya, China, North Korea, Russia, Israel, Taiwan, and possibly Sudan, India, Pakistan, and Kazakhstan support offensive biologic weapons programs . As a result, in 1999, the US Congress mandated the formation of the national pharmaceutical stockpile program. The program was appropriated $51 million to acquire and oversee the stockpile of pharmaceutical interventions, medical supplies, and equipment for immediate availability to a state or local authority making a request . In March 2003, the national pharmaceutical stockpile program was shifted under the auspices of the US Department of Homeland Security and was renamed the Strategic National Stockpile (SNS) program . With the signing of the BioShield legislation, the SNS program was returned to US Department of Health and Human Services for oversight and guidance.

Current stockpiling practices

The SNS program works with governmental and nongovernmental partners to upgrade the nation’s public health capacity to respond to a national emergency. Critical to the success of this initiative is ensuring that capacity is developed at federal, state, and local levels to receive, stage, distribute, and dispense SNS assets. SNS past responses include the World Trade Center response on September 11, 2001, the anthrax response in October 2001, and the Hurricane Katrina and Rita responses in August and September 2005.

Strategic National Stockpile deployment

The goal of SNS is to transport a first wave of critically needed supplies to a requesting state within hours of the federal decision to deploy . The deployed materiel may consist of a 12-hour push package, vendor-managed inventory, or other various needed medical materials. After the initial push package deployment, event-specific shipments are organized and released to state and local agencies in need.

The 12-hour push package

Twelve-hour push packages strategically located throughout the United States provide a broad-spectrum support that enables assets to be received within 12 hours after a federal decision has been made, and it will be deployed. Each push package is composed of large quantities of pharmaceutical agents, equipment, and medical supplies to begin individual 10-day regimens for more than 300,000 people. The push package is composed of more than 100 containers and weighs approximately 50 tons. It is designed to be transported either via cargo plane or trailer unit and requires more than 12,000 sq ft of space at the receiving site for full implementation. Because the package is preassembled before an event, the supplies are broad in scope. Each package contains unit dose and bulk oral antibiotics, oral antibiotic suspensions and syrups, intravenous and intramuscular injection medications, a selection of analgesic agents, and other emergency medications. There is equipment to be used in a mass-casualty event for tablet counting, volume counting, and automated packaging and medical supplies for intravenous administration and trauma care . Push packages do not contain antitoxins and vaccines for category A biologic threat agents, such as anthrax, botulism, plague, smallpox, and tularemia. The SNS maintains separate stockpiles of these interventions and provides them in a separate shipment within the same time frame.

In support of the push package there is a five- to seven-person Technical Advisory Response Unit that deploys—ideally before the push package arrives at the site—to assist state and local authorities in receiving, managing, distributing, dispensing, and replenishing the push package. The unit also assists in providing packaging expertise and postevent recovery of assets to the push package site of origin. States are responsible for the development of their own plans for managing and distributing these assets and organizing teams of health care professionals to use them .

Managed inventory

Managed inventory is composed of federally owned inventory at vendor sites that can be deployed when needed as a follow-up to a push package or when an event is not large enough to justify a full 12-hour push package. Managed inventory is used to provide needed medications, as was evidenced after Hurricane Katrina, when badly needed medications were used for chronically ill patients. These supplies are tailored to the specific event and are intended for delivery within 12 hours or less when intended as a replacement for a push package or within 24 to 36 hours when intended as a secondary asset .

Federal Medical Station

A newly developed SNS asset that was deployed for the first time after Hurricane Katrina is the Federal Medical Station (FMS) . The FMS is a medical asset that is designed to support regional, state, and local health care agencies that respond to catastrophic events that have damaged, incapacitated, or overwhelmed existing medical facilities. The basic type III FMS is a low- to mid-acuity of care and has supplies and pharmaceutical agents to treat approximately 250 people for approximately 3 days. The asset provides the following critical capabilities: (1) inpatient, nonacute treatment capability for areas in which hospital bed capacity has been exceeded, (2) a special needs shelter for displaced persons with chronic diseases, limited mobility, or behavioral health requirements, and (3) support to quarantine missions that isolate persons suspected of being exposed to or affected by a highly contagious disease. Type I FMSs are for critical care settings and Type II FMSs are specialized critical care units. The FMS provides shelter and medical supplies; however, a professional staff is required to implement and augment the station . A local team of trained medical professionals, such as dentists and dental hygienists, would be an important adjunct to assist with the FMS deployment on site.

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Jun 15, 2016 | Posted by in General Dentistry | Comments Off on Pharmaceuticals and the Strategic National Stockpile Program
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