Effective public health response to a bioterrorist attack or other disease outbreak hinges on the ability to recognize the outbreak, mobilize supplies of needed materials to affected populations in a timely manner, and provide ongoing medical care for affected individuals.14,15 There are 5 distinct components of this response:
Surveillance activities may range from use of passive systems for detecting specific pathogenic microbes in the environment to development of syndromic surveillance programs to mine existing emergency medicine, primary care, or pharmaceutical databases to rapidly identify unusual clusters of suspicious symptoms.16-19 Determination of appropriate trigger or action levels in these surveillance systems is an ongoing challenge for medical and public health personnel that will not be considered here.20
Response capacity to a large-scale bioterrorist attack may be limited by the ready availability of antibiotics and/or vaccines.21 For this reason, the Federal Government has created the Strategic National Stockpile (SNS), composed of a number of ready-to-deploy "Push Packs" containing medical supplies to treat thousands of patients affected by the highest-priority disease-causing agents (the CDC Category A agents), as well as pre-designated pharmaceutical supply caches and production arrangements that may be used for large-scale ongoing prophylaxis and/or vaccination campaigns (Vendor Managed Inventory, VMI).5,22 Some large municipalities and medical facilities across the country also have developed smaller stockpiles and secure supply chains for critical antibiotics and medical materiel for use in terrorism response.23-27
In the context of a mass prophylaxis response to bioterrorism, distribution refers to the logistics of transporting materiel such as antibiotics and vaccines from stockpile locations (e.g., the airhead where the SNS has been deposited) to dispensing centers where they are given to affected populations.22
Dispensing operations are the final step in getting prophylactic medications and vaccines to affected populations.28 Dispensing center functions (described more fully in Section Two) include mass triage, medical evaluation of symptomatic individuals, pharmacotherapeutic consultation for drug or dosage adjustment if needed, and provision of antibiotics or vaccination.29 Additional functions may include data collection, patient briefings, mental health or pharmacist consultations, and emergency transportation for patients requiring medical care.
Followup may include monitoring patients for antibiotic effectiveness or vaccine immunoresponse, identifying patients who require dose modification, and arranging alternative treatment for patients who have adverse effects from the prophylactic treatment.30 As demonstrated after the 2001 anthrax prophylaxis campaigns, followup data gathering is also essential for determining compliance with recommended treatment regimens.31-33
Dispensing of antibiotics and/or vaccines is a cornerstone of any mass prophylaxis campaign against outbreaks of preventable disease.12,21,34-43 Without the ability to safely dispense large volumes of medications or vaccines to community-based individuals, efforts to improve surveillance, stockpiling, or distribution capacity will not translate into improved public health response.44 Conversely, dispensing operations are critically dependent on these surveillance, stockpiling, and distribution functions for defining the prophylaxis mission to be accomplished and for supplying the medical materiel necessary for its successful completion.
There are 2 conceptual approaches to mass prophylaxis: "push" and "pull." The "push" approach, exemplified by the recent Memorandum of Agreement between the Department of Health and Human Services (HHS) and the U.S. Postal Service, consists of bringing medicine directly to individuals or homes in an affected community.45 The "pull" approach, in contrast, requires that individuals leave their homes or places of work in order to travel to specially designated centers where they can receive medications or vaccinations.28,39,43 Each approach has strengths and weaknesses. The "push" approach may enable faster and more widespread coverage of an affected community, but it has little flexibility to handle medical evaluation for contraindications or dosage adjustment and may be infeasible for vaccination campaigns.31 The "pull" approach may increase efficient use of scarce health care providers and resources, enable medical evaluation of potential victims, and provide opportunities for centralized data collection and law enforcement investigation (in the setting of a known or suspected bioterrorism event).46,47 However, these advantages must be weighed against the delays and logistical challenges of setting up sufficient dispensing centers to handle high patient volumes.48,49
It is likely that in large-scale outbreak response, elements of both "push" and "pull" strategies will be utilized. For example, in addressing the needs of homebound or institutionalized individuals in a community, a "push" approach may be preferred to avoid complex transportation requirements in the midst of a public health crisis. Alternatively, even if a "push" approach is used to provide the majority of community residents with antibiotic prophylaxis, a small number of dispensing centers may be established to handle specific sub-populations (e.g., first responders and their families, tourists, etc.).50
As of this writing, "push" approaches to mass prophylaxis remain at an early planning stage. For that reason, this planning guide will focus on "pull" strategies using specialized dispensing centers. In local and national planning documents, these centers have been given a variety of names and acronyms. We use the term Dispensing/Vaccination Center (DVC), though a competing (and perfectly acceptable) alternative name is Point of Dispensing (POD).5,43 We have chosen not to use POD due to potential confusion with the term Point of Distribution, which refers to the local or regional site for unloading and breaking down antibiotic stockpiles shipped from the Strategic National Stockpile or other sources (this is also called the Receipt, Store, and Stage (RSS) site).
In the "pull" model of mass prophylaxis, the Dispensing/Vaccination Center is the principal operational unit of the dispensing function of community-wide disease outbreak response.40 A DVC is a single dispensing site that can be free-standing or located in a pre-existing building such as a school. Any mass prophylaxis plan involving the use of DVCs must have at least these two components:
Factors such as the size and nature of the release of disease-causing agents and the availability of local and Federal resources and personnel will determine whether the initial response to a bioterrorist attack or natural disease epidemic consists of the establishment of one, several, or many dozen DVCs. The stockpiling and distribution components of a public health emergency response plan need to be similarly scalable to maintain a reliable and adequate supply of antibiotics, vaccines, and other medical materiel to these DVCs.
CDC maintains the Strategic National Stockpile (SNS) and provides technical assistance on dispensing operations to local public health and emergency management planners throughout the United States. However, the SNS and its support staff do not constitute a stand-alone first response operation.5 Similarly, the National Disaster Medical System (NDMS) has been established by the Department of Health and Human Services to provide rapid response capability for medical disasters throughout the United States, but this system as well is not designed to supplant comprehensive local planning and operations for mass prophylaxis campaigns.51
Instead, these Federal assets and resources are intended to build on the local and regional first response infrastructure (that is, personnel and planning, but not necessarily stockpiles) for carrying out mass prophylaxis. The basic rule of community-wide mass prophylaxis is:
Every public health jurisdiction in the country has the responsibility to develop and maintain the capability to carry out first response and ongoing (Federally assisted) mass antibiotic dispensing and vaccination campaigns tailored to its local population.
There are at least four separate reasons underlying this rule:
The purpose of this section is to survey the major issues that factor into the creation of a successful mass prophylaxis plan. This information will provide readers with a general understanding of the complex issues involved in designing community-based dispensing operations. It also serves as a primer for Sections Two and Three, which are written for a more technical audience involved in development of local DVC plans.
Select Figure 1 for an outline of this section.
Many significant stakeholders should be included in planning for civilian bioterrorism response.9 We focus here on the nine local stake-holding groups who are essential to the planning and operation of a mass prophylaxis plan in an emergency setting.
Planning starts with an understanding of the covered community.52,53 Demographic, medical, and ethnographic information is critical to developing DVC floor plans (e.g., taking into account accessibility issues and typical family size), drug dosing schedules (e.g., age distribution), and information dissemination activities (e.g., translation services for non-English-speaking populations). Population density may be the chief determinant of choice of DVC sites (Item C). Since DVC operation would require population-wide cooperation with directives to proceed to specific sites for triage and prophylaxis, community representatives should be involved at the earliest planning stages in order to increase the likelihood of community buy-in to DVC plans (Number 6). Prophylaxis for home- or institution-bound individuals (e.g., nursing home residents, jail and prison inmates) requires specific additional planning that is not covered in these guidelines. The prophylaxis needs of these populations may be best addressed through pre-existing delivery systems (e.g., U.S. Postal Service, visiting nurse services, prison health systems) operating within a "push"-style mass prophylaxis framework but separately from community DVC activities.45
The Federal Government is working collaboratively with State and local public health officials to develop mass prophylaxis plans for bioterrorism response. The Strategic National Stockpile (SNS) Program was developed to assist States and communities in responding to public health emergencies. The SNS Program ensures the availability of medicines, antidotes, medical supplies, and medical equipment necessary for States and communities to counter the effects of biological pathogens and chemical nerve agents. The SNS Program stands ready for deployment and will arrive within twelve hours to any location across the nation to augment medical resources, treat symptomatic individuals, and provide prophylaxis therapy in support of efforts at the State and local level.
The CDC's cooperative agreement on public health preparedness and response for bioterrorism provides funding to upgrade State and local public health jurisdictions' preparedness for and response to bioterrorism, other outbreaks of infectious disease, and other public health threats and emergencies. Funding through this cooperative agreement is also being used to implement the Cities Readiness Initiative (CRI), which will help save lives through timely delivery of medicines and medical supplies during a large-scale public health emergency. Twenty cities and the National Capital Region (District of Columbia) have been chosen to participate in this pilot program. These cities have been chosen based on their population and geographic location.
The CRI will provide direct assistance to cities to help them increase their abilities to receive and dispense medicine and medical supplies from the Strategic National Stockpile. As a result of this pilot program, plans from all levels of government (Federal, State and local) will be unified to ensure a consistent, effective and timely response in the event of a large-scale public health emergency. CRI will help ensure that cities are able to use all the resources available to them for emergency response and preparedness efficiently and effectively.
Continued collaborations between the Federal Government and local and State public health officials are essential for developing mass prophylaxis plans for bioterrorism response. Public health practitioners bring a diverse skill set to mass prophylaxis and DVC planning, including expertise in epidemiology, health policy and law, health and risk communication, and diagnosis and treatment of medical and psychiatric disease.
Emergency management officials bring expertise in emergency response and operational command structures to public health planning.54 They also bring a broad perspective on incident management and have an understanding of existing infrastructure and resources in the community.55 In addition, these professionals may have experience in directing interagency response operations.
Health care professionals, including nurses, pharmacists, emergency service providers, and physicians, have detailed technical knowledge that can inform planning at numerous stages along the prophylaxis pathway (e.g., triage, materiel storage and packaging, medical evaluation, drug dosing).11,56-58 Additionally, since DVCs may be intended to supplant normal health care venues in the setting of a bioterrorist attack (at least initially during the prophylaxis stage), an important aspect of DVC planning involves determining the optimal role for community health professionals during the mass prophylaxis response.59 If these professionals are expected to participate directly in triage, evaluation, and dispensing activities, planning should include development of educational material and in-service training sessions directed at health care providers. Even if community health professionals are not expected to have direct patient care responsibilities in DVC operations, their cooperation is essential for educating patients about mass prophylaxis, providing appropriate directions to prophylaxis sites during an event, and providing followup care after an attack.
A bioterrorist attack would be both a public health emergency and a crime, so law enforcement would have three distinct tasks in a mass prophylaxis response: maintaining the safety and security of both patients and medical stockpiles during the prophylaxis response, maintaining public order generally, and carrying out a criminal investigation of the attack.46 These three tasks may need to occur simultaneously at each DVC, requiring extensive pre-planning and coordination between law enforcement and public health authorities to ensure proper resource allocation. Additionally, many aspects of DVC planning and operation will involve legal issues that should be carefully evaluated prior to any event (e.g., pharmaceutical dispensing waivers, memoranda of understanding, emergency declarations, etc.).60
Effective planning can make the public a valuable asset during disease outbreak response.61 Mass prophylaxis would require the rapid and coordinated mobilization not only of persons living in affected communities but also of ancillary service staff (e.g., food preparation and janitorial personnel) to support DVC activities. Community outreach should:
Health Care System Representatives
Traditional health care facilities such as hospitals and medical clinics may not be optimal sites for DVC activities because of the need to maximize space in these facilities for the treatment of mass casualties.55 Nevertheless, each DVC must have direct communication and transportation linkages with health care facilities capable of evaluating and treating both severe attack-related illnesses and adverse reactions to the antibiotics or vaccines administered in the DVCs.23,62 For that reason, representatives of local and regional health care delivery systems (hospitals, multi-specialty clinics, rehabilitation facilities, long-term care facilities) may provide important assistance with certain aspects of mass prophylaxis planning and should be included in the development of DVC plans.63 Additionally, communities may want to prioritize prophylaxis of hospital staff and their family members in order to maintain maximum operating capacity in the early days of an attack.64
Effective collaboration with local media is essential for community preparedness.65 Harnessing multiple modalities for information dissemination (e.g., radio, television, Internet) in the early hours of a bioterrorist attack or other disease outbreak may greatly improve the chances of effective community mobilization.4 This requires not only close collaboration between public health and emergency management officials and the media in the (pre-event) planning stages, but also the creation of ready-to-air response scripts for immediate distribution to media outlets.53
Mass prophylaxis will constitute one of many response activities initiated by local, regional, State, and Federal Government agencies in the setting of a bioterrorist attack or major disease outbreak.66 Interagency coordination in these activities will prevent unnecessary duplication or unexpected absence of services (e.g., in transportation and security details for DVCs), and inter-regional coordination will minimize competing claims for scarce resources (e.g., for SNS materiel in adjacent counties affected by an attack).4,67,68
Each DVC site requires, at minimum, the following:
Setting up and operating a DVC requires a range of generic office and medical supplies in addition to specialized items like signage and medications. Over the last year, several U.S. communities have developed checklists and even pre-stocked trailers for rapid deployment of one or multiple DVCs.
Once requested, assets from the Strategic National Stockpile are likely to arrive in less time than it takes to set up a network of fully functional DVCs.69 Each DVC must have a well-defined supply route linking it to the Receipt, Store, Stage (RSS) site for these SNS materials as well as to any local stockpiles. Most local stockpiles are pre-designated for use by local first responder, hospital, and emergency management personnel to ensure that they are ready to work with the public as soon as or before Federal assets arrive.
On-site stockpile management requires ability to ensure proper storage (e.g., coolers), inventory management, and security of supplies. If the DVC is dispensing antibiotics or vaccines under Investigational New Drug (IND) protocols, local staff may have to track patients to whom those supplies are distributed. However, recent legislative proposals call for the creation of Emergency Use Authorizations to facilitate rapid dispensing of "off-label" or investigational medicines and vaccines in the setting of mass prophylaxis (e.g., Project BioShield, press release at www.whitehouse.gov/news/releases/2003/02/20030203.html).
DVC staff fall into two categories:
Details of the DVC core and support staff are covered in Section Two, Part 3.B, while DVC command structure is covered in Section Four.
Core staff may operate in one of three areas:
EMS staff may be needed to stabilize seriously ill patients who are direct casualties of an attack or outbreak, patients with exacerbations of chronic medical conditions like asthma or cardiac disease, or patients who experience severe adverse reactions to dispensed medicines or vaccines. These patients may require transfer to health care facilities, as described in Item 6. Support functions include DVC security, communications, custodial services, and site management.
All DVC activities should be protocol-driven to the greatest extent possible to achieve maximum efficiency and standardization. At least four protocols are needed for DVC operation: triage, medical evaluation, pharmacotherapeutic evaluation, and mental health evaluation.29,56,70-72 Of these, the first three may change depending on the attack agent(s), with corresponding changes in pharmacotherapeutic or vaccination response strategies. The last, focusing on assessment and management of anxiety, grief, and panic reactions, will be applicable to most, if not all, bioterrorism and epidemic outbreak scenarios.
The DVC plan should include a basic floor plan and description of station-to-station patient flow under normal operation (e.g., precisely how patients are supposed to proceed from triage to dispensing). Optimally, all DVCs in a community should share the same basic layout, thereby streamlining related agency planning activities (e.g., law enforcement) and ensuring interoperability of staff between different DVCs. This will simplify training and improve the operational flexibility of staff. As detailed in Section Two of this Guide, DVC planners will need to design patient flow patterns to minimize bottlenecks and optimize staff allocation.
Since DVCs may be open 24 hours a day for many days in a row, planners need to consider support services for staff including food preparation, rest areas, toilet facilities, and counseling.5 Additionally, toilet facilities should be identified for the public and staff both inside and outside each DVC. Since clinic operation will likely include a variety of minor medical procedures that may produce biohazardous waste (e.g., initiation of intravenous lines for patients requiring transport to health care facilities), clinic services should include medical waste disposal.
Each DVC should have access to vehicles to transport casualties and patients with acute illnesses identified through the DVC triage process and for people who have immediate adverse reactions to the medications or vaccinations administered in the DVC. Transportation capability for transferring subacute patients to health care facilities (e.g., by municipal bus) may minimize crowding at the DVC site.
Choice of DVC sites should be guided by knowledge of local population density and proposed location of stockpile staging and distribution sites (called the Receipt, Store, and Stage [RSS] or Point of Distribution [POD] sites). In the absence of complicating factors (e.g., environmental contamination preventing DVC set-up in a given locale), DVCs should be situated so as to minimize transportation required for both people and medical materiel. Ideally, these locations will be familiar to local populations and can be rapidly demobilized and returned to their original use after the event.73 Locations that may have unintended stigma attached to them (e.g., STD treatment facilities) or that have special cultural significance (e.g., religious institutions) may pose challenges as sites for mass prophylaxis efforts. Contingency (secondary or tertiary) sites should be identified in the event of unavailability of primary sites.
Optimal DVC size will vary, depending on a number of population-, outbreak-, and staff-related factors (go to Section Two for detailed discussion of these factors and their impact on DVC design). To simplify selection of DVC sites, planners may begin by cataloging all sites that meet a set of requirements, such as a recognizable physical dimension (e.g., area of a basketball court).38
DVC sites should have both an outer and an inner perimeter that can prevent wholesale movement of crowds into the dispensing area. Additionally, the inner perimeter should have only a limited number of controlled entry and exit portals. DVC sites also must have internal storage and drug or vaccine preparation areas that can be secured during clinic operational hours (go to Section Two, 3.B.8 for more information).
DVCs should be accessible by forms of transportation that are common to the community (e.g., automobile for rural and suburban settings, mass transportation for urban settings). When scouting for potential DVC sites, planners should consider handicapped accessibility issues to provide coverage for people with impaired mobility.
DVC sites should have facilities for controlled storage of antibiotics and vaccines, including electrical outlets for cold storage containers requiring external power supplies.5 In addition, these sites should have separate areas for storage of medical supplies, communication equipment, and information dissemination material, which may require different levels of security.
Proposed DVC locations should have space for safe removal and temporary storage of medical waste, on-site potable water supply, electrical wiring capable of supporting multiple electrical and electronic appliances (e.g., coolers, computers), and restrooms. Food preparation facilities are not necessary, but additional securable space for this function is desirable in order to provide respite to staff.
In light of recent large-scale disruptions of electrical grids on both the east and west coasts of the United States and the possibility that future terrorist attacks may involve multiple (biological and non-biological) threats, it is critical to ensure that proposed dispensing sites have both backup power generation capacity and backup fuel delivery arrangements for those generators. This applies especially to DVCs that are intended for 24-hour operation.
DVC locations should have land-line phone capability to supplement cellular, radio, and satellite communications, which may be unavailable or overloaded during a terrorist event.74 Additionally, preexisting video and audio equipment (e.g., school audio-visual equipment) may reduce logistical burdens when planning staff training and public briefings at the DVC sites.
Local public health and emergency management officials may initiate the rollout of full community-wide or more targeted mass prophylaxis plans using DVCs in response to local triggers such as the isolation of an unusual disease-causing organism in multiple patients (for example, in an outbreak of meningococcal meningitis).16,19 If SNS assets are not requested, initiation of a local DVC plan does not require specific State or Federal authorization. However, SNS requisition must follow the chain of command established by CDC. Furthermore, any event involving suspicion or confirmation of bioterrorism will trigger a Federal criminal investigation.4
Local response capacity may be limited by the amount of local pharmaceutical supplies (e.g., of prophylaxis caches for hospital staff and their families in the setting of an infectious disease outbreak).
Local DVC plans may be activated by regional, State, or Federal authorities in response either to perceived threats to public health or to actual release of pathogenic material.75 While activation may be triggered at higher levels of government, DVC deployment and operation will remain under local control. Local planners need to establish clear procedures for confirmation of and response to such activations.
Mass prophylaxis planning involves the identification of stakeholders, resources, sites, and triggers for DVC activation (items A-D above). DVC planners are responsible for developing complete operational plans for individual DVCs as well as plans to integrate multiple DVCs in a large-scale response (select Figure 2). The full spectrum of activities to achieve activation, maintenance, and demobilization of each DVC should be addressed. It is important that plans have inherent flexibility to adapt to unexpected changes in the unfolding events. Finally, these plans should incorporate an incident command system which in turn should be an extension of the community emergency management structure (for a description of incident command systems, go to Section Four).
DVC management and command structure should be addressed during the early stages of planning. An effective DVC command structure should have the following characteristics:
The Incident Command System (ICS) and Incident Management System (IMS) serve as widely-recognized and time-tested command systems upon which to base DVC management.74,76 Section Four of this Guide presents a detailed IC/MS-based management outline for DVC operation that addresses these requirements.
To promote community buy-in of a mass prophylaxis campaign, the public must be fully informed of the reasons for such a campaign as well as the community's role in ensuring its success.65,77,78 The public should be made aware of key procedures and responsibilities for community bioterrorism response prior to the initiation of a mass prophylaxis campaign.79 This may include publicizing the ways in which the public would be assigned to DVCs (e.g., organized by ZIP code, last name, etc.), the expected DVC processes (e.g., education followed by prophylaxis), and post-DVC responsibilities (e.g., followup with a local health provider). Local print, radio, television, and Internet media representatives should be included in this planning process to develop uniform public messages. Finally, training materials for DVC staff and the general public should be developed early in the planning process in order to minimize DVC operational start-up time in the event of activation.
Many emergency management experts recommend against pre-publicizing the proposed locations of DVCs, since this information may change prior to or during a mass prophylaxis event, thus precipitating confusion. Emphasis instead should be placed on ensuring that planners have robust means of communicating exact clinic locations in an emergency setting.