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10/30/2001

National Pharmaceutical Stockpile Aids Homeland Health Security

Donna Young

In 1998, Congress directed the Centers for Disease Control and Prevention (CDC) to develop a national stockpile of pharmaceuticals and vaccines as part of the nation's medical readiness response plan to terrorism. Federal lawmakers appropriated $51 million in fiscal year 1999 to create the stockpile and provided an additional $52 million each year in 2000 and 2001, according to congressional records.

The National Pharmaceutical Stockpile is a repository of anti-infectives, chemical antidotes, antitoxins, life-support medications, i.v. administration and airway maintenance supplies, surgical items, and other medical supplies, according to CDC.

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.

CDC does not consider the stockpile a "first-response" tool. Rather, the stockpile’s purpose is to "bolster" a state or city government’s response to a biological or chemical attack.

Purchases of pharmaceuticals and medical supplies for the federal stockpile are made by the Department of Veterans Affairs (VA), according to the General Accounting Office (GAO), which has been issuing reports on the stockpile since 1999. VA also manages the contracts for storage, rotation, security, and transportation of the stockpile.

A portion of the federal stockpile is managed by vendors.

First use. Supplies from the stockpile were first deployed September 11 after terrorists attacked the United States by destroying the World Trade Center in New York and damaging the Pentagon near Washington, D.C.

CDC dispatched one of its eight 12-hour push packages—a 50-ton preassembled package of supplies, pharmaceuticals, and medical equipment—to the city of New York.

"Each package," according to the Department of Health and Human Services (HHS), "involves several truckloads of materials and is intended to be sufficient to respond to an emergency involving mass casualties."

Logistics. The push packages are kept in environmentally controlled, secured warehouses in secret locations around the country and are ready for deployment to reach any affected area within 12 hours of a federal decision to release the supplies, according to CDC.

If an incident requires a larger or multiphased response, the vendor-managed inventory packages can be shipped to arrive at the site within 24 to 36 hours, according to CDC.

Llelwyn Grant, CDC spokesman, said, for national security reasons, he could not divulge whether pharmaceuticals dispatched from the stockpile are supplied in bulk form or ready-to-dispense containers.

But CDC’s Web site indicates that state and local authorities repackage bulk medicines and label them and other medical supplies in accordance with the state’s terrorism contingency plans.

CDC transfers authority for the stockpile materials to state and local authorities once it arrives, the Web site notes. The agency also provides technical advisers to assist state and local officials when stockpiled supplies are deployed.

Preparedness. Stephen V. Cantrill, Denver Health Medical Center’s emergency medicine associate director, testifying before Congress, said that "the packaging of the drug items in the stockpile is oriented towards fiscally advantageous stock rotation, not efficient distribution once the stockpile arrives at the locale of the terrorist attack."

Cantrill had participated in the planning and execution of Operation TopOff, a Congressionally mandated, no-notice, multi-site disaster exercise held in May 2000 to evaluate the nation’s ability to deal with simultaneous disasters from weapons of mass destruction.

He testified before Congress this past May and again in October about his experience dealing with the stockpile during the disaster exercise.

In a National Public Radio (NPR) interview in October, Cantrill described the push packages as large aluminum and plastic containers measuring 6 feet high and 5 feet wide.

He said the bulk containers of thousands of tablets and capsules are a problem when emergency workers try to dispense drugs to patients in an emergency situation.

In his congressional testimony, Cantrill said local officials should give significant thought to increasing their communities’ stocks of several drugs and rely less heavily on the federal stockpile. "A 12 to 24 [hour] wait would render most of the utility of the treatments for a chemical attack unhelpful as most of the severely afflicted patients would be dead."

In addition, he said, the stockpile should include more of the antidotes that are widely used in Europe, such as hydroxocobalamin, or vitamin B12b, a treatment for cyanide poisoning.

Second use. On October 8, CDC again tapped the stockpile to air ship 100 cases of anti-infectives to Florida’s Palm Beach County Health Department in Boca Raton after exposure to Bacillus anthracis, the bacterium that causes anthrax, was confirmed in two men.

Bob Stevens, a 63-year-old editor employed by American Media Inc. of Boca Raton, died of inhalational anthrax on October 5. Two days later, one of his coworkers, Ernesto Blanco, tested positive for exposure to anthrax spores. State health officials announced on October 15 that Blanco had an anthrax infection. By that time, anthrax exposure—but not infection—had been diagnosed in six more American Media employees, according to CDC.

Within days of confirmation of the initial anthrax cases in Florida, health officials announced that B. anthracis spores had been found in letters in New York and on Capitol Hill in Washington.

On October 12, New York’s Mayor Rudolph Giuliani announced that an NBC News employee had tested positive for cutaneous anthrax after handling a letter that also tested positive for B. anthracis spores. Later, it was reported that cutaneous anthrax had been diagnosed in the 7-month-old son of an ABC News producer, a CBS employee, a New York Post employee, and two New Jersey Postal workers.

On October 21, it was reported that inhalational anthrax had been diagnosed in a Washington, D.C., postal worker. The next day, two other D.C. postal workers died of what was later confirmed as anthrax.

At press time, anthrax infection had been diagnosed in nine people. Twenty-eight staffers on Capitol Hill had tested positive for anthrax exposure. And in New York, a police officer and two laboratory workers also tested positive for exposure.

CDC’s Grant said the government supplied Palm Beach County with enough anti-infectives, primarily doxycycline and fluoroquinolones, to treat thousands of people, if necessary.

According to HHS Secretary Tommy G. Thompson, CDC has enough anti-infectives to treat 2 million people for anthrax exposure for 60 days.

Thompson, testifying before Congress on October 3, said HHS has "taken steps to improve our pharmaceutical stockpiles and made investments in research and our public health infrastructure." In addition, he said HHS has accelerated the production of a new smallpox vaccine (see November 1 AJHP).

On October 17, Thompson asked Congress for $1.5 billion to expand the stockpile—including increasing the number of push packages and boosting the supply of anti-infectives to treat up to 12 million people for anthrax exposure—and to speed the development and acquisition of smallpox vaccine. The funds would also be used to increase state and local readiness.

Grant said CDC deployed the anti-infectives to Florida on the basis of recommendations from state and local public health officials and an onsite team of CDC investigators following the second diagnosed exposure to anthrax.

States can directly ask CDC’s director to deploy stockpile supplies, according to CDC’s Web site. The director has the authority, in consultation with the surgeon general and the HHS secretary, to order the deployment.

Nearly 1000 people, including American Media employees and other people who had visited the Boca Raton building since August 1, were tested for anthrax and received anti-infectives at the county’s Delray Beach Health Care Center, according to CDC.

NPR reported that the American Media employees received blister packs of anti-infectives. In addition, the New York Times reported that several people left the health center with a 15-day supply of ciprofloxacin and instructions to seek prescriptions from their physician to cover 45 more days of therapy.

Leftover supplies. Grant would not divulge whether the unused supplies from the push package sent to New York on September 11 were returned to CDC’s stockpile or are being warehoused by the city for future use.

According to Grant, CDC expects leftover stockpile supplies to be absorbed by the local health care system and used by community and state medical personnel, rather than shipped back to their point of origin.

But, he said, unused push-package supplies could be returned to CDC if the materials have not been compromised and were stored properly.

"Materials are assessed on a case-by-case basis," Grant said. "The materials that are sent are meticulously packaged and configured in a certain manner. If that configuration is compromised in any way or if any of the boxes are unsealed, those materials are not returned to the stockpile."

Grant said CDC resells to vendors unused medical supplies and pharmaceuticals as long as they are at least six months from their expiration date and still in the sealed, original packages. Vendors then resell the supplies to their customers, he added.

CDC is ultimately responsible for ensuring that the medical materials and pharmaceuticals in the stockpile are rotated and kept within their shelf-life limit.

But GAO, in two separate reports—October 1999 and March 2001—scolded CDC and VA for a lack of internal controls and poor management of the stockpile.

GAO said that, although CDC had identified physical security as a risk, stockpile supplies were placed at four locations before fences were erected to separate the government’s stock from the wholesale distributor’s stock.

For nearly four months, GAO reported, fences did not separate the supplies and management was unable to control access to the supplies.

Problems. In its March 2001 report, GAO expressed concerns about a lack of written agreements among CDC, VA, and wholesale distributors regarding the distributors’ responsibilities.

CDC also lacked standard operating procedures or signed agreements regarding the use of private air cargo and land transport to move the stockpiles in the event of a terrorist incident, GAO found.

"Without formal agreements, there is no guarantee the stockpiles will make it to the destination."

The March GAO report also noted that CDC had not finalized agreements with a private-sector partner to implement a method to rotate soon-to-expire pharmaceuticals into the commercial marketplace and replace them with fresh stock.

According to a briefing memorandum for a May 1 congressional hearing on bioterrorism, GAO reported that CDC and VA had "significantly improved accountability" over the stockpile but "further progress needs to be made."

GAO listed 13 recommendations to improve stockpile management. The memorandum also stated that the agencies concurred with the overall conclusion of the March GAO report and with 12 of the 13 recommendations. However, in some instances, the memorandum noted, the agencies disagreed with the related risk that GAO noted. For instance, HHS did not agree with GAO’s assessment of the security need for CDC to install fencing before placing inventories at storage locations.