History

The vulnerability of human populations to diseases has been extensively documented by many authors and does not need to be addressed in this article. Following the emergence of HIV/AIDS and, more recently, the dual threats of a man-made incident, exemplified by the anthrax attacks of fall 2001, and the threat from a naturally occurring disease, exemplified by the 2003 SARS and West Nile virus outbreaks, response to a medical crisis has become a topic of significant concern. Particular attention was paid to the reliance of local and state health responders on support from Federal agencies. The response of the Federal agencies to emerging threats has likewise become an issue for discussion and has prompted new and innovative solutions to a massive influx of funds over the past five years. In 1999, the United States Congress tasked the Department of Health and Human Services (HHS) and its Centers for Disease Control and Prevention (CDC) with establishing a National Pharmaceutical Stockpile (NPS) that could resupply large quantities of essential medical materiel to states and communities during an emergency within 12 hours of a Federal decision to deploy. 1 The specific mission described under the congressional mandate required that the CDC address the NPS to:

“An act of terrorism (or a large scale natural disaster) targeting the U.S. civilian population [that] will require rapid access to large quantities of pharmaceuticals and medical supplies.” The CDC responded by developing both a stockpile of materiel and a means of rapid deployment that could meet the stated requirements. Within two years, the response capability was tested.

First Deployment

Immediately after the September 11, 2001 terrorist attacks, the CDC dispatched a 50-ton, preassembled push package of supplies, pharmaceuticals, and medical equipment to New York City. "Each package," according to HHS, "involved several truckloads of materials and was intended to be sufficient to respond to an emergency involving mass casualties." The push package arrived within 7 hours of HHS Secretary Tommy Thompson’s order to deploy. Three of the four airplanes in American airspace the night of September 11 supported the SNS program; the fourth was Air Force One.

Figure 1 – A single “push package” weighs 94,424 pounds and fills either one wide-body aircraft or seven tractor trailers. The Strategic National Stockpile program pledges to deliver the pre-packaged supplies within 12 hours of the Federal (DHS) decision to deploy. Source: Centers for Disease Control and Prevention, Atlanta, GA.

Second Deployment

On October 8, 2001, the CDC again tapped the stockpile to ship 100 cases of anti-infectives by air to Florida’s Palm Beach County Health Department in Boca Raton. Exposure to Bacillus anthracis, the bacterium that causes anthrax, had been confirmed in two men. On the recommendations of state and local public health officials and an onsite team of CDC investigators, the CDC supplied Palm Beach County enough anti-infectives, primarily doxycycline and fluoroquinolones, to treat thousands of people, if necessary. The CDC deployed the anti-infectives to Florida without enlisting one of the assembled push packages. The Palm Beach County scare showcased the utility of the stockpile’s vendor managed inventory; by October 10, more than 700 people had been evaluated at a local health clinic, and antibiotics had been distributed.

Expansion Since 2001

Since these initial uses, the stockpile has grown to become a repository of anti-infectives, chemical antidotes, antitoxins, life-support medications, IV administration and airway maintenance supplies, surgical items, and other medical supplies. 2

The DHS defines the function of the SNS as providing a means “To ensure availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents.”

Funding for the SNS reflects the critical role it has in the planning of responses to any future incident. In fiscal years 1999-2002, funding for the stockpile hovered just above $50 million; following the attacks of fall 2001, the funding grew more than ten-fold—the stockpile was now truly a national resource. 3

Role of the SNS

The stockpile is designed to supplement state and local public health agencies in the event of a biological or chemical terrorism incident anywhere and at anytime in the United States or its territories; it is not a first-response tool. Rather, its purpose is to bolster the response of a state or city government to a biological or chemical attack or other medical emergency where additional resources are required. 4 This augmentation approach has obvious implications for the choice of products included in the push packages and the vendor managed inventory. The stockpile focuses on providing resources relevant to an incident that has progressed beyond the initial medical resources of a locality or state. Clearly, this is not ideal for all incidents, especially those that require very rapid responses, such as release of a chemical agent. This has led to some revisions of the content and deployment of the stockpile. One future initiative is the proposed Chempack Program, the HHS plan to supply local fire departments and emergency medical services with antidotes for organophosphates and cyanide prior to deployment, rather than as part of a push package. This means that the antidotes can be sent aboard responding ambulances and fire trucks to be used within the short time frame after exposure to hazardous material. 5

With the creation of the Department of Homeland Security, the role of the NPS and its management was revisited. The Homeland Security Act of 2002 charged the DHS with defining the program’s goals and gave the department responsibility for stockpile funding and deployment. In March 2003, the NPS became the Strategic National Stockpile under joint management of the DHS and HHS. (The evolution of the SNS and VMI is depicted in Figure 2.)

With the Nation’s threat level constantly elevated, the SNS has become critically important. As new drugs are developed, HHS evaluates whether they are vital to national security and, together with the DHS determines whether they should be added to the stockpile.

Vendor Managed Inventory

The SNS has been supplemented by a second tier of medical products that are under the control and management of selected, pre-qualified vendors. The so-called vendor managed inventory (VMI) is designed to arrive 24-36 hours after SNS deployment, and to provide for specific medical requirements such as targeted antibiotics. VMI offers significant value if the threat is well-defined, because the pharmaceuticals and supplies can be tailored specific to the suspected or confirmed agent or agents. In this instance, the DHS may decide to ship only VMI and not a push package, as was the case for the October 2001 Palm Beach County shipment. VMI supplies are considered a component of the SNS and do not require separate request or consent dialogues. Pharmaceuticals in both the push packages and VMI are rotated so that the inventories never reach their expiration dates and always remain within their extended shelf life.

Figure 2 – The stockpile’s history includes a substantial upgrade in funding following the events of September 11, 2001.

1. See CDC website: http://www.bt.cdc.gov/stockpile/. Accessed February 2004.
2. Some of these components, for example medical countermeasures against chemical warfare agents, were included in the stockpile prior to September 2001.
3. FY’99-$51M, FY’00-$52M, FY’01-$52M, FY’02-$645M, FY’03-$300M.
4. SNS supplies also are available in the event of naturally occurring incidents, such as hurricanes, floods, and natural disease outbreaks
5. "Many of us felt that there was no point in having kits in the stockpile when they need to be used in the first minutes and hours after exposure and the stockpile is not designed to get to a city for six to twelve hours, [so] we gave those out to communities all over the country," said Dr. Jerry Hauer, former director of the HHS Office of Emergency Preparedness, in the September 2003 issue of U.S. Medicine Newspaper (“HHS Office Directs Agency’s Anti-Bioterrorism Efforts” by Stephen Spotswood).