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SISPAT 4 with CBMTS, 4-10 December 2004, will feature an exceptionally important pre-meeting Pharmaceutical / Medical Supply Workshop for medical and other professionals on 4 and 5 December 2004. The below article outlines several areas of coverage that are being prepared for this Workshop.
Establishing a Stockpile of Essential Medical Supplies: Actions and Issues
by Richard Nolan 1
Murray Hamilton 2
1 US Strategic National Stockpile (SNS), Atlanta
2 Rocky Mountain Center for Homeland Defense, Denver Research Center
Executive Summary
If a bioterrorism attack, a natural disaster, or a technological accident occurred today, would we, would you be ready? Would you have enough pharmaceuticals, vaccines, chemical antidotes, antitoxins, medical equipment, and other medical supplies to protect your citizens? Sadly, the answer is likely to be no. Today hospitals, manufacturers, and distributors hold just enough inventory to satisfy routine requirements. A large-scale national or regional emergency would quickly deplete their stocks.
Faced with this reality, many countries have begun to consider stockpiling medical supplies. They’ve discovered that the creation and operation of a stockpile is a complex effort that requires detailed planning, preparation, and effort. While the methods for creating a stockpile will be unique for each country, the issues that it needs to consider will be basically the same for all countries. The items in the stockpile must be identified and purchased, facilities established to hold the items, transportation planned for the delivery of the items, and local officials trained to use the items.
This paper discusses the reasons that a country may decide to establish a stockpile and the actions it may take to create and maintain one. For each action, it explains issues that a country should consider before it decides to act. It expands on many of the issues by noting the experience and methods of the US Strategic National Stockpile.
The remainder of the paper is organized in the following sections:
•• Background: the United States Strategic National Stockpile (SNS) to provide a context for references to the SNS
•• Reasons to stockpile medical supplies - why a country may need a stockpile
•• Establishing and maintaining a stockpile
•• Working with local communities to ensure effective local distribution of stockpile materiel
•• Regional, multinational stockpile issues
The United States’ Strategic National Stockpile
The U.S. Congress created the Strategic National Stockpile (initially the National Pharmaceutical Stockpile) in 1999 to create a national repository of pharmaceuticals, medical equipment, and other medical supplies that would quickly augment the resources of state and local communities for responding to terrorist attacks. In its early days, the SNS set a goal of being able to deliver large quantities of medical supplies anywhere in the U.S. or its territories in 12 hours or less following the federal order to deploy. Terrorist attacks in the fall of 2001, first on September 11 after the attack on the World Trade Centers and later for anthrax attacks, the SNS demonstrated that ability.
The SNS stocks pharmaceuticals, vaccines, chemical antidotes, antitoxins, medical equipment, and other medical supplies valued at approximately $1 billion. It stores a portion of its inventory in specialized air cargo containers in secure locations near transportation hubs around the country. The majority of its material, however, is held by vendors that constantly rotate the materiel to keep it fresh but are able to deploy it quickly. The SNS refers to these materials as vendor managed inventory.
The materiel that the SNS deploys depends on the incident. In the early hours of an emergency when people get sick from an ill-defined threat, the SNS will ship 50 tons of supplies in a wide bodied cargo jet or 8, 53 foot tractor trailers. Called a 12 Hour Push Package, this shipment is so named because it arrives in 12 hours or less and because it is simply pushed to the affected state without a specific request for help. Later when the threat is known, the SNS will ship large quantities of specific items to augment the local response to the threat. If the SNS does not stock an item that is needed, it will attempt to find, purchase, and rapidly deliver it. On 9/11, for instance, it purchased large quantities of breathing assistance devices and delivered them within 24 hours to help rescue personnel deal with dust at ground zero in New York City. The cost of the materiel that the SNS provides is borne by the federal government.
The SNS also works closely with state planners around the nation before an emergency to help them create and then test their plans for using the SNS during an emergency. This action is crucial to ensure the effective distribution of SNS materiel to victims
When an emergency occurs, the SNS deploys a team of five to seven technical advisors ahead of its materiel shipment to assist a state. The advisors and the materiel arrive at a safe location that the state specifies. Once the state accepts custody of the materiel, it is responsible for delivering it to its dispensing and treatment sites, ordering more when needed, dispensing medicines, and, after the emergency, returning unused SNS materiel and equipment.
Reasons for a Stockpile
In today’s technological and political world, nations must be ready to respond to a myriad of events that could endanger their citizens. A bioterrorism attack could affect from hundreds to hundreds of thousands of people and require large quantities of antibiotics, vaccines, and other items. As has been noted so many times in the recent past, every country is vulnerable. With international travel an outbreak in one country may quickly spread to another country - disease recognizes no border.
But there are other less sinister events that may require large quantities of medical supplies. A devastating hurricane or typhoon or an earthquake could pollute water supplies which could quickly cause diseases such as cholera if antibiotics are not available. Outbreaks of naturally occurring disease such as measles require vaccination of affected populations to contain the outbreak. The inadvertent release of toxic chemicals such as those in Bhopal, India and Chernobyl, Soviet Union have the potential for killing thousands if chemical antidotes and other items are not available.
All of these events may require rapid delivery of large quantities of medical supplies to protect and treat the public. These supplies may not be available from manufacturers, distributors, and hospitals unless a country stockpiles them ahead of time.
Establishing and Maintaining a Stockpile
In this section, we discuss key actions that a country should consider to establish and maintain a stockpile.
-- Items to stock
Deciding what and how much to stockpile is a complicated question that requires the identification of:
• The likelihood of specific threats from terrorism, nature, and technology;
• The projected casualties from each threat;
• The pharmaceuticals and other medical supplies that casualties from each threat would require for protection and treatment;
• The speed with which the supplies will have to arrive to respond to the threats;
• The amount of supplies that are available quickly from hospitals, distributors, and perhaps manufacturers;
• The cost of purchasing and holding medical supplies that are not available from other sources.
The SNS combines information from various intelligence sources on possible threats with information from medical and public health experts inside and outside of the government to identify the types of items that it could stock and the quantities, given projected casualties from each identified threat, which it should stock. Its science team (initially a pharmacist but now expanded to include a doctor and several nurses) use that information to work with its logistics team to identify specific products that manufacturers can provide in sufficient quantities and that have affordable costs over the life cycle of the products. Life cycle cost includes the cost of purchasing an item and other costs such as storage, shelf life extension, rotation, quality assurance, and delivery. Examples of factors that affect life cycle costs include:
• A product that has a shorter expiration date but a lower purchase cost than an equivalent may have a higher life cycle cost because of the frequency with which it must be replaced.
• Products that testing indicates are still effective when they are due to expire will have a lower life cycle cost if the extension of their shelf life defers replacement.
• A product that comes in single dose vials will cost more to store than the same product that comes in multi-dose vials because they occupy more space.
In the past, the SNS has rejected some items because they were not available in sufficient quantities and others because their life cycle costs were too high.
Recent natural disease outbreaks may affect the items that the SNS stocks in the future. The Centers for Disease Control and Prevention (CDC) in Atlanta has historically had manufacturers hold stockpiles of some childhood vaccines to preclude problems from manufacturing shortages. It has begun to recognize the value of the SNS’ ability to hold and quickly deliver vaccines as an effective way to respond to a natural disease outbreak. The unexpected high demand for influenza vaccine in 2003, for instance, caused significant shortages, which may result in the SNS holding additional flu vaccine and perhaps antiviral medications in the future.
Staffing a Stockpile Program
The staff that creates and maintains a stockpile must have a broad range of skills.
• Science personnel must understand the threats that a nation faces and the public health response to those threats to also understand the pharmaceuticals and other the medical products that will be needed.
• Logistics personnel must understand the acquisition, storage, and transport requirements of the products to plan and maintain facilities to store, rotate, and deliver them.
• Operations must understand how manage their rapid delivery to local communities.
• Public health specialists must have a broad understanding of the products and how the stockpile would deploy them to help local personnel plan for and use the product during an emergency.
• Finance personnel must ensure that sufficient funds exist to finance the operation of all aspects of the stockpile.
When the SNS started in 1999, it had a very small cadre of personnel. Over time, its staff has increased as the amount and complexity of the materiel that we stocked and the locations in which we stocked it has increased. Its staff includes a mixture of government employees and contractors. When the SNS started, it knew that commercial transportation and distribution companies were much better in their fields than the government could ever hope to be. Instead of creating its own capabilities, a time consuming task that would have delayed implementation, the SNS decided to partner with several commercial firms. Two of the firms are able to provide individuals quickly with specific skills that the SNS only needs for a short period for specific tasks. This capability has allowed the SNS to respond quickly to new requirements. Within this framework, the SNS functions as the managing partner to coordinate the efforts of its commercial partners.
Identifying Requirements for and Acquiring Stockpile Materiel
To decide whether to stock a particular product, a stockpile needs to determine if it is effective against anticipated threats, available in sufficient quantities, and affordable over the life time of the product. If the stockpile supports more than one country, it will also need to consider the political, cultural, legal, regulatory, religious, healthcare, and transport requirements of member countries.
Possible actions for reducing the cost of products stocked
Working with other organizations that already buy materiel at a substantial discount. A general rule in the purchase of most products is that the unit cost of a product will decrease as the volume bought increases. When the SNS started, it knew that it would be purchasing a lot of materiel and wanted to find a way to buy the materiel at the lowest possible cost. We also knew that the departments of Defense and Veterans Affairs (VA) purchased large quantities of pharmaceuticals and medical supplies to support their own operations. We asked each for a proposal to act as our acquisition agent. We choose the Department of Veterans Affairs, which buys huge quantities of medical supplies to support its network of 163 hospitals.
• Purchasing products with maximum expiration dates whenever possible.
• Maintaining products under proper environmental conditions (e.g. temperature and humidity) to increase the possibility of extending their shelf life past the manufacturer’s initial expiration date.
• Finding a way to rotate products into the commercial sector to keep stockpile material fresh and costs for replacement low. In some cases, the SNS has manufacturers hold materiel that it owns, replace it with fresh materiel as it comes off their production lines, and sell the replaced materiel to their commercial customers.
Storage and Configuration of Materiel
The locations where a country stores its stockpile and the way that it containerizes and configures stockpile materiel in storage will have a major impact on reducing the time to get the materiel to those who need them during an emergency. Considerations include:
• Storing stockpile materiel in the same containers in which they are shipped to minimize the time to handle the materiel while it is in transit to an emergency;
• Designing containers in which materiel is stored so that they can be moved easily and are compatible with all modes of transportation.
• Storing stockpile materiel in locations with loading docks and materiel handling equipment allows rapid loading of delivery vehicles. Storing the materiel on a single level instead of stacking it also reduces the time to load delivery vehicles.
• Storing stockpile materiel in multiple locations reduces the time to arrive on site by allowing deployment from the closest facility. It also allows deployment from another site if weather, sabotage, or other factors cause delays;
• Locating storage sites near the source of transportation reduces the time to get material from where it is stored to boats, trucks, or aircraft that deliver it;
• Configuring and identifying materiel in containers so that local officials can find and use different items (e.g. antibiotics) immediately after arrival reduces the time to get stockpile materiel to victims.
• Storing pharmaceuticals in unit of use quantities dramatically reduces the time to issue protective medicines to victims, but significantly increases the cost to repackage bulk medicines from manufacturers and store the repackaged medicines.
Managing Inventory
Managing stockpile inventories involves several considerations, some that I’ve already mentioned. Others include:
• Protecting products that are sensitive to temperature and humidity during storage and transit is essential to ensure that they remain effective. Some products may have to be frozen and others refrigerated. Most can be kept at controlled room temperatures between 15°C and 30°C (59°–86°F). In tropical environments, the control of humidity will have a major effect on product effectiveness and expiration.
• Rotating older stock out and replacing it with newer stock keeps the stockpile fresh.
• Tracking the amount, lot, and expiration dates of products in inventory and products on order is important to ensure that you have what is necessary to respond to an event.
• Controlling access to stockpile materiel, particularly to products such as morphine, will prevent pilferage, and ensure they are available when needed.
• Ensuring a continuous source of power to storage facilities to prevent destruction of inventory.
Transportation to an Event
The time that it takes to provide life saving medicines to victims will greatly influence the amount of suffering and death that occurs. Transportation to an event will be a major portion of that time. Considerations include:
• Ensuring that shipping containers are compatible with all expected methods of transport (water, air, and ground). The containers that the SNS uses will fit onto the aircraft of all commercial carriers that fly wide bodied aircraft in the United States. They will also fit onto tractor trailers.
• Having transportation assets available when an event occurs. When the SNS started, it asked the military if it could provide transportation but found that commercial carriers could respond faster. It formed partnerships with several carriers that were very good at loading their aircraft quickly, tracking their movement during transit, and flying to anywhere in the United States within six hours.
• Loading aircraft or other transport quickly. Casters on SNS shipping containers allow an individual to push them onto a truck even though they may weigh more than 1,000 pounds. They can also be moved by forklift. Initially, SNS containers had to be strapped and netted to a platform that air carriers used to load their aircraft. That process consumed a lot of time. The SNS modified its containers so that they snap to the carriers’ loading platform, a change that has significantly reduced the time to get an aircraft into the air.
• Providing priority movement of transport vehicles. SNS aircraft have special call signs that get them priority routing to their destination. SNS trucks are escorted by U.S. Marshals to ensure rapid, unimpaired movement.
• Maintaining multiple storage locations precludes problems from weather, traffic, road conditions, or sabotage and allow deployment from the location closest to the event.
Dispensing Stockpile Materiel
Dispensing is the process of giving protective medicines or vaccines to those who have been exposed to a threat or think they may have been exposed. By the time local officials know they have a problem because people are getting sick, others will be on the verge of getting sick because of the incubation period of the threat. Protecting those who are not yet sick must occur within days, which will be a tremendous effort in a large city. Local officials must mobilize staff to run dispensing centers day and night, tell the public where to go to get their medicines, identify individuals who must have specific types of medicines, and get medicines to those who are unable to go to a dispensing center. Considerations that will speed the dispensing process include:
• Defining the number and location of dispensing centers ahead of time to ensure they are conveniently located, adequately staffed, and properly supported with supplies, electricity, and security;
• Arranging staffing of dispensing centers so that the centers can run 24 hours a day until everyone gets their medicines;
• Storing medicines in units of use (for instance a 10 day regimen) that can be handed to victims directly without the time consuming effort of repackaging bulk medicines from manufacturers;
• Having waivers to existing regulations for dispensing medicines ready for signature that will allow others to hand out medicines. In the U.S., states typically require that pharmacists dispense medicines, but in a crisis there may not be enough pharmacists;
• Ensuring public health’s need for patient information is balanced with the need to dispense protective medicines quickly;
• Planning for a worst case event including the graceful degradation in the standards of medical care as the size of an event grows. If an event is not as bad as planned, it will be easier to change plans for a worst case than adjusting plans for a minor event to deal with a major event.
• Arranging security for dispensing centers to protect dispensing center staff, facilities, and materiel and provide crowd and traffic control.
• Creating public information messages (ideally before an event) so the public knows what the threat is, where to go for help, how to get their, and what to expect.
Security and Communications
During an emergency, those who were exposed to an agent or think they were exposed may become very impatient if they do not receive protective medicines quickly. If there isn’t enough security to protect dispensing and treatment centers, it may limit the number of sites that can hand out medicines, thus, limiting the speed with which the public can be protected.
Making sure that stockpile staff can communicate during an event with one another and with local officials will also be important for the effective distribution of stockpile materiel.
The SNS uses U.S. Marshals to protect its storage sites, the materiel and staff that it deploys, and the location at the emergency from which materiel is distributed to local officials. Marshals work with local law enforcement before and during deployment. States are responsible for providing security to protect delivery vehicles and at dispensing centers to protect staff, control crowds, and direct traffic.
Working with Local Officials
Getting stockpile materiel to local officials quickly does not ensure that victims will receive it quickly. Local officials must plan for and be ready to use stockpile materiel when it is delivered. In the United States, many state and local officials have never had to consider how to quickly dispense medicines to large numbers of people. SNS staff have had to make frequent on site visits to help them create a plan and later to test the plan with an exercise.
The functions that local officials may need help planning will depend upon how a country organizes its response. The SNS, for instance, tells state officials that it will deliver SNS materiel to the warehouse where the state will receive and stage it for delivery to local users. Once the state accepts custody of the materiel at the warehouse, it is responsible for delivering it to dispensing/ immunization and treatment sites, ordering more when it is needed, and dispensing medicines or providing vaccinations. The SNS provides the following help to states for creating a plan and testing it:
-- A written guide that describes each of the functions that must occur to get life saving medicines to victims
-- A 20 minute video that visually shows much of what is in the guide.
-- On site visits that work closely with states to help them plan their own methods for using SNS materiel.
-- Self evaluation check lists sent before an on site visit
-- Feedback to a state after every on site visit of the NS’ evaluation of the state’s readiness to use the NS
-- Support for local exercises to test state plans with a smaller version of a 12 hour push package.
Regional Stockpiles - Special Issues
For countries with limited funding to establish their own individual stockpile, participation in a regional stockpile that supports several countries may be the the best option. However, Regional stockpiles by their very nature must accommodate the requirements of all member states and considerations could include:
• Customs becoming a potential problem when stockpile materiel is transported over national borders.
• Agreement about and compatibility of items to ensure that public health staff in each country is familiar with the materiel and knows how to use it.
• Transportation that crosses national borders becoming a problem that could delay delivery of stockpile materiel.
• Language, culture, politics, religion, and laws that need to be considered to ensure that materiel is licensed, handled, packaged, described, documented, delivered, and administered properly by all countries that share a stockpile. In one country, for instance, a particular product may be acceptable for treating a specific threat while the same product may not be acceptable in another country for the same threat.
• Equitable distribution of resources and costs need to be considered so that each member agrees to pay its fair share and understands how materiel will be fairly allocated if an emergency occurs.
• Authority to deploy and coordinate deployment is crucial for rapid response to an emergency. Failure of the country where a stockpile is located to deploy quickly enough may destroy trust and cooperation between other members.
• Exercises that test deployment and the deployment plans of each country and their local communities are particularly important because of the wide range of language, cultural, political, religious, and legal issues involved.
Summary
In today’s world, every nation is vulnerable to threats from terrorism, nature, and technology. When a nation judges its threats to be significant and substantial, it may conclude that a stockpile is only way that it will have the large supplies of medical materiel that it needs to respond to a national emergency. Nations that plan a stockpile will each consider the same basic issues of what to stock, how to stock, how to deliver, and how to train local communities. This paper has used examples from the United States’ Strategic National Stockpile to illustrate how the SNS solved those basic issues. To the degree its experience is relevant; that experience may help others save precious time or money in developing and implementing their own programs. Ultimately, however, every nation will have its own unique approach to stockpiling.
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