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5 A Decision-Aiding Framework As highlighted throughout this chapter, the benefits of prepositioning strategies will depend on the particular community in which they are imple- mented. Different communities differ in their likelihood of experiencing an anthrax attack; in their existing surveillance, detection, and dispensing infrastructure; in their population and geographic characteristics; in their values and preferences; and in their available resources. These differences affect which prepositioning strategy or combination of prepositioning strat- egies, if any, will be most effective in meeting a community’s prophylaxis goals. To assist state, local, and tribal jurisdictions in evaluating whether their community would benefit from implementing prepositioning, the committee has developed a decision-aiding framework. The key elements of this frame- work are presented in Box 5-1. The framework is intended to assist each community in evaluating the strategies described in detail in Chapter 4— forward-deployed, cached, and predispensed—according to its own needs, objectives, value trade-offs, and constraints. This chapter details the ele- ments of the framework listed in Box 5-1. It then presents a recommended modeling approach for communities to use in applying the quantitative elements of the framework (evaluation of potential health benefits versus likely costs) to make decisions about the use of prepositioning strategies. The final section presents the committee’s findings and recommendations on the benefits, costs, and sustainability of the various strategies. 153
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154 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX BOX 5 -1 Key Elements of the Decision-Aiding Framework Communities across the United States differ in their needs and capabilities. Different communities may benefit most from different strategies for prepositioning antibiotics for anthrax, or may not ben- efit from prepositioning strategies at all. The committee developed a decision-aiding framework to assist state, local, and tribal jurisdictions in deciding which prepositioning strategies, if any, to implement in their community. The key elements of this framework are: • A ssessment of risk and current capabilities — Consideration of the risk of an anthrax attack — Assessment of current capability for timely detection of an attack — Assessment of current dispensing capability, including (1) over- all dispensing capability, and (2) specific gaps in dispensing capability, such as particular subpopulations not well served by current plans • I ncorporation of ethical principles and community values • E valuation of potential prepositioning strategies for medical counter measures for anthrax — Evaluation of potential health benefits, including evaluation of potential effectiveness in reaching specific populations or filling other specific gaps in dispensing capability — Evaluation of potential health risks — Evaluation of likely costs — Consideration of practicality, including (1) communications needs and expected social behavior and adherence, (2) logistics, and (3) legal and regulatory issues ASSESSMENT OF RISK AND CURRENT CAPABILITIES To evaluate whether alternative prepositioning strategies would be appropriate for their communities, jurisdictions must consider the risk of an anthrax attack in their community and assess their current capability to detect such an attack in a timely manner and to distribute and dispense postexposure prophylactic antibiotics to their population. This section de- scribes these assessments. Risk of an Anthrax Attack A community’s risk assessment for an anthrax attack is important for prioritizing funding for dispensing capabilities within the context of
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155 A DECISION-AIDING FRAMEWORK overall public health needs, and it helps inform decisions about the specific dispensing strategies that would protect the community most effectively. For example, a community facing a low risk of an anthrax attack might decide to rely on the Strategic National Stockpile (SNS) and not assume the additional costs associated with implementing local prepositioning strategies. Conversely, a community facing a high risk of an anthrax attack might decide that the additional cost was a valuable use of public health resources. This section reviews the factors included in risk assessment, iden- tifies sources of risk information to which jurisdictions already have access and that can be used in decision making about prepositioning, and briefly addresses how this information can be used to inform prepositioning deci- sions (a topic discussed in greater detail below in the section on evaluation of potential prepositioning strategies). The Department of Homeland Security (DHS) outlines three compo- nents of risk: the threat (the likelihood of an attack), the vulnerability of a community to that attack, and the consequences of a successful attack (DHS, 2008a). For assessment of specific terrorism scenarios, factors that impact the assessment of threat may include intent and capability of ad- versary, weapon availability, attack simplicity, historical information, and intelligence information (FEMA, 2007). The following factors related to vulnerability and consequences are also taken into account in assessment of risk: “population and population density, the presence of critical infra- structure and key resources, location in high terrorist or high risk natural disaster areas, and capabilities to prevent, protect against, or mitigate a threat” (FEMA, 2007, p. 10). State, local, and tribal jurisdictions rely primarily on the federal gov- ernment to provide information about the threat of a terrorist attack. The Secretary of DHS has issued material threat determinations (MTDs) for anthrax and multi-drug-resistant anthrax (DHS, 2008b; GAO, 2009). Many public health officials, particularly those from states or larger cities, have access to additional classified intelligence information that, if avail- able, could be used to inform decisions about prepositioning. The committee has focused primarily on long-term planning for prepositioning and recognizes that the federal government and public health officials in jurisdictions may not have detailed, long-term information about specific anthrax threats to jurisdictions (beyond what is conveyed by the MTDs), including detailed information about the relative likelihood of specific attack scenarios. Nevertheless, jurisdictions should use this infor- mation if they have it (or can make reasonable assumptions about it) to inform policy and decision making about prepositioning. In contrast, the federal government may, on occasion, have specific information about an imminent credible threat to a specific jurisdiction(s). In such circumstances, the risk of an attack might be considered very high, and rapid decisions
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156 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX might be made to forward-deploy medical countermeasures (MCM) to that jurisdiction(s). The committee focused less on this type of prepositioning in response to a potentially imminent attack. Vulnerability and consequence are largely independent of specific in- telligence information about a threat. Jurisdictions do not need classified, detailed intelligence information about specific threats to consider their vulnerability to an anthrax attack and the potential consequences to the community. Jurisdictions already have access to several sources of information about risk in their community. Some are provided by the federal govern- ment, and jurisdictions generate others as part of the process for applying for federal funding. First, DHS funding allocations are based on DHS-developed risk assess- ments (FEMA, 2011). DHS’s Urban Areas Security Initiative (UASI) grant identifies 31 metropolitan areas at the highest risk of a terrorist attack (FEMA, 2011). A designation of UASI Tier 1, assigned to the 11 highest- risk areas, or Tier 2, assigned to the remaining 20 areas, is itself a general- ized risk assessment. DHS funding reflects this differential risk, assigning Tier 1 cities 81.6 percent of the program’s total funding. Jurisdictions funded by DHS’s UASI and State Homeland Security Program (SHSP) grants (another terrorism response-related grant pro- gram) have access to the information from their specific Threat and Hazard Identification and Risk Assessment (THIRA), a required part of their grant application (FEMA, 2011). THIRAs assess all threats and haz- ards facing the jurisdiction, including terrorism threats, and are submitted to DHS as part of the overall State Mitigation Plan, which is intended to foster collaboration among the disaster response plans of all jurisdictions within a state. Awardees of the Office of the Assistant Secretary for Preparedness and Response’s (ASPR’s) Hospital Preparedness Program (HPP) grant are required to use the results of a Hazard Vulnerability Analysis—which identifies, analyzes, and prioritizes potential threats to a jurisdiction—to inform their planning efforts (ASPR, 2011). This is another existing infor- mation source for state and local jurisdictions to use in assessing the value of prepositioning strategies in meeting their prophylaxis goals. The use of risk-related information in decision making about preposi- tioning is addressed in greater detail later in the chapter, including how a community’s relative risk of an anthrax attack and the likelihood of spe- cific attack scenarios impact the potential benefits and cost-effectiveness of different prepositioning strategies. The committee recognizes, however, that detailed information about threat and the likelihood of specific attack scenarios may not exist. Jurisdictions should use the best risk assessment information available to inform decision making about prepositioning.
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157 A DECISION-AIDING FRAMEWORK In the absence of such information, jurisdictions can also explore the potential benefits and costs of prepositioning given different assumptions about threat and specific attack scenarios. In some cases, jurisdictions may ultimately rely more heavily on the vulnerability and consequences aspects of risk assessment. For example, a remote county with low population density, no high-profile potential critical infrastructure targets, and a high risk of flooding may decide to rely on the SNS instead of implementing prepositioning strategies, instead devoting more public health resources to flood preparedness. On the other hand, a community with high population density and infrastructure that is thought to be a potential terrorism target might decide to implement several prepositioning strategies. These trade- offs are discussed in greater detail in a later section. Finally, in further recognition of the fact that some local jurisdictions may lack resources to conduct an in-depth assessment of the risk of an an- thrax attack, the committee recommends below partnerships among state, local, and tribal governments and with the federal government in work- ing through the key elements of the decision-aiding framework presented in this chapter. In many cases, federal and state governments may have greater access to classified information and resources for conducting risk assessment and could provide guidance on this element of the framework to local jurisdictions. Assessment of Current Capability for Timely Detection of an Attack Along with assessing the risk of an anthrax attack, jurisdictions need to assess their current surveillance and detection capability in order to evalu- ate their ability to meet prophylaxis goals and the potential usefulness of prepositioning in achieving those goals. The various mechanisms for detect- ing an attack were discussed in Chapter 2. Minimizing the time between the decision to dispense and antibiotic administration becomes increasingly crucial as the delay in detecting an attack increases. Therefore, preposi- tioning strategies may be particularly beneficial in jurisdictions that lack robust detection and surveillance systems. Jurisdictions should assess their community’s detection and surveillance capabilities and take into account the possibility of delayed detection of an attack when deciding whether prepositioning strategies would be beneficial. The committee does not intend to imply that if a jurisdiction’s capa- bility for rapid detection is low (for example, a rural jurisdiction without BioWatch sensors), this should automatically be addressed through the ad- dition of rapid detection technology; many considerations beyond the scope of this report are involved in such a determination. The point is simply that low detection capability is one potential indicator that prepositioning would be beneficial.
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158 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Assessment of Current Distribution and Dispensing Capability Jurisdictions also need to understand the capability of their current dis- tribution and dispensing system in order to evaluate whether preposition- ing strategies would benefit the community. If a community’s distribution and dispensing system is already capable of covering the entire population within an appropriate time window, the development of prepositioning strategies is unnecessary. Conversely, if a community has inadequate over- all capability or gaps in reaching particular subpopulations, preposition- ing strategies may be beneficial. The effort required to gain an accurate understanding of distribution and dispensing capability will likely be more resource-intensive than current practices are, but that understanding is necessary before decisions are made about developing and implementing expensive prepositioning strategies. Jurisdictions should assess their overall distribution and dispensing capability and determine whether there are any gaps. A gap analysis can re- veal whether certain portions of the population, by virtue of socioeconomic status and/or demographic characteristics, are at a systemically increased risk of reduced access to disaster mitigation response. Some people may not be well served by traditional points of dispensing (PODs)—for example, people with low incomes or limited transportation options, people with no or limited English proficiency, historically underserved ethnic/racial groups, people with disabilities (especially the vision impaired, hearing impaired, and mobility impaired), people who are homeless, and people who are homebound. Identifying such gaps is important in determining whether strategies are appropriate to augment current distribution and dispensing mechanisms and, if so, which strategies are likely to be most appropriate. It is difficult, however, to obtain an accurate assessment of jurisdictions’ current distribution and dispensing capability for three primary reasons. First, the full capability of the SNS has not been demonstrated. Second, the extent to which distribution and dispensing plans have been developed is used as a proxy for understanding how those plans will be implemented. Although this may be a useful first step, it does not capture the realities and potential obstacles associated with implementing a distribution and dispensing plan in a real emergency. Where performance metrics exist, they are scattered across different grant requirements and often simply measure whether a task was performed or not, rather than the quality of performance. Third, full-scale drills have not been required until now, so information on how distribution and dispensing systems function has been obtained from piecemeal exercises. These data cannot provide a complete and accurate picture of the overall capability of a jurisdiction’s distribution and dispensing system.
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159 A DECISION-AIDING FRAMEWORK Distribution from the Strategic National Stockpile Jurisdictions need to know how quickly SNS assets will reach them so they can calculate their capability to complete dispensing of initial prophy- lactic MCM to their population within the appropriate time window. SNS Push Packages (described in Chapter 3) are deployed rapidly in response to an ill-defined threat within no more than 12 hours of the federal decision to deploy and are unlikely to include the full quantity of MCM necessary for initial prophylaxis (CDC, 2011a). Current estimates of the time to deliver the initial Push Packages to the Tier 1 UASI cities after the deci- sion to dispense varies between approximately 4 and 8 hours for the first shipment to arrive (Burel, 2011). The committee is unaware of any large- scale exercise of the vendor-managed inventory (VMI) portion of the SNS, which is expected to begin arriving within 24-36 hours and contains the supplies needed beyond the original Push Package quantities. It is also un- known whether the SNS has the capability to distribute MCM to multiple locations simultaneously and over a sustained period of time (as would be necessary in the reload scenario envisioned by Danzig ). The gap in knowledge surrounding distribution from the SNS prevents jurisdictions from understanding the capability and capacity of the current prophylaxis system. If the current system can provide prophylaxis to the exposed popu- lation within the specified time window, the disadvantages of prepositioning discussed in Chapter 4 and later in this chapter (e.g., increased cost) may outweigh any marginal benefit from a decrease in time to prophylaxis. If, on the other hand, significant challenges exist in the centralized distribution system, prepositioning at the state and local levels may be highly beneficial. Existing Performance Measures and Metrics Four primary sources measure state and local MCM dispensing ca- pability and capacity: the Centers for Disease Control and Prevention’s (CDC’s) Public Health Preparedness Capabilities, the SNS Technical As- sistance Review (TAR) tool, the RAND-CDC Performance Metrics Project, and the CDC-administered Public Health Emergency Preparedness (PHEP) grant (CDC, 2009a,b, 2011b; Nelson et al., 2009). This section describes the performance metrics associated with each of these four sources, high- lighting the need for more and better measures and metrics for accurately assessing a dispensing system’s performance. Public Health Preparedness Capabilities: National Standards for State and Local Planning CDC’s Public Health Preparedness Capabilities (CDC, 2011b) catalogs the fundamental capabilities that all jurisdictions should
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160 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX have to mount a successful mass prophylaxis campaign. These capabilities are broken down into five core dispensing functions: • identify and initiate MCM dispensing strategies; • receive MCM; • activate dispensing modalities; • dispense MCM to identified populations; and • report adverse events. For each function, the document lists associated tasks, performance measure(s), and resource elements required. This effort is a significant step forward because it highlights the im- portance of performance measures for each MCM dispensing function and identifies gaps in existing measures. Those gaps remain substantial, however: three of the five core functions as yet have no associated per- formance measures. Performance measures for specific functions are part of the Medical Countermeasures Distribution and Dispensing (MCMDD) composite measure, introduced in the 2011 PHEP cooperative agreement grant guidance (CDC, 2011c). The composite measure, discussed in greater detail below, was designed to describe comprehensively the capability of a jurisdiction (state or Cities Readiness Initiative [CRI] area) to meet Public Health Preparedness Capability 8: MCM dispensing (CDC, 2011c). Technical Assistance Review (TAR) tool for states and localities The SNS TAR entails a detailed evaluation of state and local jurisdictions’ plan- ning efforts for receiving, distributing, and dispensing SNS MCM (CDC, 2009a,c). At both the state and local levels, the TAR assesses 12 core distri- bution and dispensing functions, similar to but more detailed than the five core functions of CDC’s Public Health Preparedness Capabilities (the state TAR measures the additional function of capability to repackage). The SNS TAR does not emphasize performance measures: of the local TAR tool’s 85 metrics, only 7 are performance measures. TAR scores are based primar- ily on an “all or nothing” scale: a full score is awarded if an item can be identified in the plan or if an exercise has been conducted. The score does not depend on the quality of performance during the exercise. The TAR, like Public Health Preparedness Capabilities, represents progress in assessing state and local preparedness to mount a mass pro- phylaxis campaign, but it evaluates jurisdictions primarily by how well they plan. Adding more performance metrics and measures of the ability to achieve preset prophylaxis goals to the SNS TAR would enable juris- dictions to chart their progress quantitatively and determine persistent weaknesses.
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161 A DECISION-AIDING FRAMEWORK RAND-CDC Performance Metrics Project (Nelson et al., 2009) The 2009 RAND report New Tools for Assessing State and Local Capabilities for Countermeasure Delivery is intended to provide detailed performance metrics that build on and are compatible with the TAR (Nelson et al., 2009). RAND’s ongoing project has yielded the most detailed performance metrics to date. They measure the capability of system elements to meet their goal, as well as the time required to complete various tasks. Because a primary motivation for prepositioning is to decrease the time to prophy- laxis, measurement of the time to completion is critical for determining the potential benefit of prepositioning strategies. If the current distribution and dispensing system were capable of providing prophylaxis to a popula- tion within the appropriate time frame, prepositioning strategies would be redundant. On the other hand, like the performance measures in the Public Health Preparedness Capabilities and the TAR, the RAND metrics are not com- prehensive. Specifically, they do not assess the distribution system (SNS to states), a potentially rate-limiting process in a mass prophylaxis campaign. There also are no performance metrics designed to collect data from real- istic full-scale exercises rather than piecemeal drills. Public Health Emergency Preparedness (PHEP) cooperative agreement program Beginning in fiscal year 2011, jurisdictions receiving funding through the CDC-administered 2011-2016 cooperative agreement program are required to report on the MCMDD composite measure described above and must achieve a minimum benchmark score that will increase gradually over time (CDC, 2011c). The measure is meant “to serve as a collective indicator of [MCM distribution and dispensing] preparedness and opera- tional capability” (CDC, 2011c, p. 24). In the first year (i.e., required by July 15, 2012), a jurisdiction’s composite score will comprise the state and local 2011 TAR scores and the results of a minimum of three different drills (from the eight described by previous PHEP guidance) (CDC, 2009b, 2011c). Within the 5-year grant cycle (by 2016), each jurisdiction must participate in a full-scale exercise, the results of which will then contribute to its composite score. These requirements apply to both states and CRI areas, with potentially different requirements for each (specific guidance on conducting and reporting the results of full-scale exercises is expected at a later date). Adoption of this composite measure will enhance intrastate planning and will represent a significant step toward standardizing perfor- mance measurement across jurisdictions. Beyond the composite measure, the 2011 PHEP grant will require funded jurisdictions to provide more detailed reporting on capability-based performance measures for MCM dispensing; those details are also forthcoming (CDC, 2011c).
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162 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Data from Full-Scale Exercises and Real Events Along with performance metrics, data on a distribution and dispensing system’s performance are needed to assess how the system will function during a real event. If the data identify system inadequacies, prepositioning of antibiotics may be a means to fill identified gaps. Performance data may be gathered in two ways: from exercises and drills and from real-world experiences. Data from full-scale exercises Full-scale exercises have been included as an acceptable method of collecting data for fulfilling PHEP reporting requirements in previous years, although these exercises often have not been performed. Instead, other acceptable exercises and drills have been used in their place, including tabletop exercises, drills, and functional ex- ercises (CDC, 2009b). As noted above, the most recent PHEP cooperative agreement (2011-2016) requires each state and CRI area to participate in at least one full-scale exercise over the course of the 5-year grant period (CDC, 2011c). While the details of the exercise requirements are forthcom- ing, current guidance explains that a CRI area’s full-scale exercises “must include all pertinent jurisdictional leadership and emergency support func- tion leads,” along with all planning and operational staff who will have a response role in a crisis (CDC, 2011c, p. 33). However, the cost and resources required to conduct a full-scale exer- cise remain significant barriers for public health departments, which already face limited funding. Full-scale exercises also require partnership and sig- nificant coordination with non–public health elements of the distribution and dispensing system, such as schools, community centers, and private businesses. These entities may not be willing or able to interrupt their daily operations to participate in such exercises. Yet without the data from full- scale exercises, jurisdictions are left to extrapolate how quickly the entire system would work in a real emergency, what obstacles they might face (e.g., logistics or communications), and what mechanisms could be used to circumvent those obstacles. In addition, the data collected in other types of exercises are not stan- dardized, limiting the ability to compare neighboring distribution and dis- pensing systems and, in turn, making it difficult to identify and apply best practices across a region. Recognizing these issues, CDC has continued to develop and refine templates and guidance, making significant strides with the 2011 PHEP grant requirements for collecting data and interpreting metrics more efficiently and cost-effectively at the state and local levels (Neff, 2011). Ongoing efforts by CDC to facilitate large-scale exercises, whether through funding or through technical support and guidance, will
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163 A DECISION-AIDING FRAMEWORK enable state and local jurisdictions to assess the performance of their MCM distribution and dispensing system. In addition to large-scale exercises conducted in the context of the PHEP program, other efforts to assess large-scale performance could be useful. DHS, for example, sponsors an annual nationwide exercise that could be a potentially useful venue for assessing the performance of the entire system—from the federal government to state and local entities. In addition, the use of computer simulations or models could be explored to assess a community’s ability to dispense MCM in a timely manner without having to conduct large-scale exercises in each high-risk jurisdiction. Such models would need to be anchored in real-world data to the maximum extent possible and be flexible enough to represent the unique attributes of a wide range of different communities with reasonable fidelity. Data from real events: the 2009 H1N1 vaccination campaign The 2009 H1N1 influenza pandemic was the most recent real-world test of emergency preparedness plans, offering insights into the working of the entire emer- gency response system (ASTHO, 2010; FICEMS, 2009; HHS and DHS, 2009; IOM, 2010; NACCHO, 2010). However, the differences between pandemic influenza and anthrax limit the utility of these data for inform- ing anthrax preparedness policy. A response to pandemic influenza takes place over many weeks or even months, whereas the current goal for initial antibiotic prophylaxis after an anthrax attack is 48 hours after the decision to begin dispensing is made (see Chapter 2). Additionally, the 2009 H1N1 influenza pandemic saw an ebb and flow of the number of patients seeking immediate treatment, whereas an anthrax attack could necessitate offering medication to an entire city at once, creating a sudden massive demand on the public health system. The performance of the distribution and dispens- ing system can also be assessed using more routine real-life distribution events, such as annual influenza vaccination campaigns. Finding 5-1: To determine the potential benefits of prepositioning strate- gies, it is critical that jurisdictions accurately assess their distribution and dispensing capability. The few performance measures available for assessing prophylaxis capability are still nascent in their development. Existing per- formance data often have come from small-scale drills rather than full-scale exercises because of limited financial resources and personnel and the infea- sibility of interrupting the functioning of non–public health entities such as schools, community centers, and private businesses. This fact, coupled with limited standardization and comparability of measurement across jurisdic- tions, makes it difficult to evaluate the current capability of a distribution and dispensing system and, in turn, the value of adopting prepositioning strategies to augment that capability.
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198 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX The concerns and risks described above for MedKits and personal stockpiles apply equally to the general population and to critical infrastruc- ture personnel, first responders, and their families. Therefore, the committee finds that, where feasible, workplace caches are likely to be a more effective strategy with fewer risks than personal stockpiles in homes. There may be some cases, however, in which workplace caches are not feasible or are not an effective strategy—for example, critical infrastructure personnel and first responders who do not muster at a workplace, and critical infrastructure personnel and first responders for whom it would be infeasible to bring antibiotics from workplace caches back to their families. For this reason, the committee recognizes that communities should retain the flexibility to select various prepositioning strategies, with the suggestion that they select workplace caches over personal stockpiling where possible. With regard to vulnerable individuals for whom predispensing might be appropriate because of their medical condition and/or social situation, this would likely involve predispensing of a personal stockpile, done through standard prescribing practices and depending on the usual relationship between physician and patient. In this situation, public health would not bear the cost of the predispensed MCM, but similar concerns about risks would exist. The discussion of ethical principles earlier in this chapter notes that there is no ethical argument against individuals pursuing purchase of per- sonal stockpiles (because these medications are not in short supply, so that purchase by some people does not impose a shortage on others or exacer- bate existing inequities in society), and doing so is allowed under current prescribing practices. However, that discussion adds that a final decision on whether individuals should maintain home stockpiles requires a full assessment of the other factors discussed in this report, such as the local risk of attack, the well-documented risks associated with taking antibiotics in inappropriate doses or for the wrong indication, cost, effectiveness, and flexibility. Given this ethical analysis and the findings presented above, the committee does not recommend that individuals pursue personal stock- piles (with the potential exception of those lacking other timely access to MCM). At the same time, with reference to the existing prescription practices, physician-patient relationships, and respect for individual liber- ties, the committee does not find it advisable to explicitly prohibit this practice either. Finding 5-7: The use of predispensing as a broad public health strategy for the general population is unlikely to be cost-effective and carries significant risks. Based on a community’s comprehensive risk assessment, however, targeted predispensing may sometimes prove to be an appropriate strategy, particularly for individuals or groups that would lack timely access to anti-
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199 A DECISION-AIDING FRAMEWORK biotics through the existing dispensing system. These might include, for example: • vulnerable individuals, such as homebound or medically vulner- able individuals for whom physicians and patients agree that pre- dispensing is an appropriate strategy; • critical infrastructure personnel and first responders who do not muster at a workplace; and • critical infrastructure personnel and first responders for whom it would be infeasible to bring antibiotics from workplace caches back to their families. Finding 5-8: The added safety features that might be provided by an FDA- approved MedKit relative to a personal stockpile obtained through regular prescribing practice are unlikely to justify the significant additional cost of developing and purchasing the MedKits. Personal stockpiling currently is allowed under normal prescribing practices, and it could be used to pre- dispense to those targeted groups and individuals for whom predispensing is an appropriate option. Factors Affecting the Appropriateness of Alternative Prepositioning Strategies The committee heard testimony from numerous individuals on factors that may affect the appropriateness of different prepositioning strategies, as well as potential health, economic, and other consequences of the strate- gies. Key aspects of this information are synthesized in Table 5-3, which presents, for a range of prepositioning strategies, qualitative characteristics that describe when each strategy would be most likely to be appropriate, along with a qualitative description of the consequences of each strategy. The first two columns of the table describe, for a continuum of MCM storage locations (first column), associated strategies to consider (second column). The prepositioning strategies are listed in the rows of the table according to increasing levels of forward deployment. The first row, no prepositioning, corresponds to the current situation of inventories held pri- marily in centralized SNS stockpiles, with no incremental prepositioning. The next row, forward-deployed MCM, corresponds to stockpiles held locally in warehouses, either as part of the SNS or other federal deployment (e.g., Department of Defense [DOD] or Department of Veterans Affairs [VA]) or in commercial warehouses. The next row, cached MCM, corresponds to stockpiles held in specific local caches, such as hospitals, pharmacies, or workplaces. Finally, the last row, predispensed MCM, corresponds to per- sonal stockpiles or home MedKits—the maximum level of prepositioning.
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TABLE 5-3 200 Appropriateness and Consequences of Alternative Prepositioning Strategies: Qualitative Summary Factors Affecting Appropriateness of Strategies Consequences of Strategies Continuum of MCM Public Health Gaps in Sub- Storage Strategies to Risk Dispensing populations Cost to Time to Inventory Potential for b c d e f g h a Status Capability Covered Public Health Prophylaxis Flexibility Misuse Locations Consider No Pre- – Centralized Low Adequate None Limited Baseline Greatest None positioning stockpiles (SNS, other) Forward- – SNS forward- High Adequate n/a Moderate Shorter Medium None Deployed deployed MCM – Other federal forward-deployed (e.g., DOD, VA) – Private forward- deployed Cached MCM – Hospital/ High Limited Some Moderate Shorter Less Some/little pharmacy caches – Workplace caches Predispensed – Personal stockpiles Extremely Inadequate Many Limited Shortest Least Moderate/ MCM High high – MedKits High NOTE: DOD = Department of Defense; MCM = medical countermeasures; workplaces (e.g., storage, training, and maintenance of workplace caches) n/a = not applicable; SNS = Strategic National Stockpile; VA = Department of and individuals or private insurers (e.g., personal stockpiles). Research and Veterans Affairs. development costs for MedKits may be borne by the federal government, by a private-sector company, or by some combination of these. a Combinations of strategies may be appropriate. f The time from the decision to dispense until MCM can be delivered to all b Likelihood of an attack and likelihood of an attack of a given type or size. exposed and potentially exposed individuals. c MCM dispensing capability in the event of a large attack. g Inventory flexibility includes the potential for use of multiple drugs, the d Subpopulations that may not be covered by MCM dispensing capacity in the potential for redeployment of inventories based on need, and the ease event of an attack. with which stockpiles can be rotated. e The cost incurred by public health authorities to store and maintain inventories h Potential for misuse of the prepositioned MCM (e.g., individuals taking the of MCM. Other costs may be borne by other entities, such as private-sector antibiotics for other conditions or not in the event of an anthrax attack).
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201 A DECISION-AIDING FRAMEWORK Factors related to the appropriateness of strategies (the middle columns of Table 5-3) include threat status (the likelihood of an attack and the likeli- hood of an attack of a given type or size), public health dispensing capacity (capacity to dispense MCM after an anthrax attack), and gaps in cover- age of subpopulations (subpopulations that may not be covered by public health MCM dispensing in the event of an attack). These factors would be determined through a local community’s assessment of its anthrax risk and its response capabilities in accordance with the decision-aiding framework presented in this chapter. In Table 5-3, these factors are expressed qualita- tively by level (e.g., low versus high versus extremely high threat status). Consequences of strategies (the rightmost columns of Table 5-3) include the cost to public health (the cost to store and maintain the inventories of MCM), time to prophylaxis (the time from the decision to dispense until MCM can be delivered to all exposed and potentially exposed individuals), inventory flexibility (potential for redeployment of inventories based on need), and potential for misuse (of the prepositioned MCM). Again, these consequences are expressed in Table 5-3 qualitatively (e.g., limited versus moderate versus high cost to public health). The table consists of a set of suggested “if-then” rules, stored in its rows: if a situation is well described by the entries in a row under “Factors Affecting Appropriateness of Strategies,” then the prepositioning strategy or strategies in the corresponding row might be appropriate to consider. For example, in a community with “some” gaps in covered populations, prepositioning in hospital, pharmacy, or workplace caches might be ap- propriate. On the other hand, in a community with “low” threat status, “adequate” dispensing capacity, and “no gaps” in covered subpopulations, no prepositioning may be most appropriate. Similar reasoning can be applied with respect to the consequences of implementing a strategy. As an example, the bottom row (for the MedKits strategy) will lead to the shortest time to prophylaxis, but with a high cost and the least flexibility and the greatest potential for misuse. This strategy is recommended for consideration only if the threat status is “extremely high” (which the committee leaves undefined) and public health dispensing capacity is “inadequate” (also left undefined, but meant to be suggestive). Other strategies in the table represent different trade-offs among cost, flex- ibility, time to prophylaxis, and potential for misuse, and they are recom- mended for consideration for different levels of threat status, public health dispensing capacity, and gaps in covered subpopulations. The rows in Table 5-3 are not meant to be exhaustive—for example, there is no row showing what strategies to consider if threat status is “low” but public health dispensing capacity is “inadequate”—but rather to sum- marize and synthesize the types of qualitative considerations and trade-offs suggested during discussions for this study of when each strategy most
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202 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX likely would be appropriate. Although such qualitative summaries can be misleading, as terms such as high and moderate have no precise definitions, and there may be exceptions to the general rules suggested, these summaries do illustrate the types of trade-offs that communities will probably face. The committee draws several key observations from Table 5-3. First, prepositioning becomes potentially more useful in communities with rela- tively high threat status, limitations on public health dispensing capacity, and/or gaps in covered subpopulations. Second, prepositioning of MCM is likely to decrease time to prophylaxis but will decrease flexibility, increase costs, and increase the potential for misuse of MCM. Finding 5-9: Table 5-3 summarizes qualitatively factors related to the appropriateness of various MCM prepositioning strategies and the con- sequences of implementing these strategies. Prepositioning is potentially useful in communities with relatively high risk status, limitations on public health dispensing capacity, and/or gaps in covered subpopulations. Preposi- tioning is likely to decrease time to prophylaxis but will decrease flexibility, increase costs, and increase the potential for misuse of MCM. Recommendations The above sections have presented an approach for evaluating the ben- efits and costs of alternative MCM prepositioning strategies, as well as the committee’s findings regarding the benefits, costs, and suitability of these strategies. These findings lead to the following recommendations. Recommendation 5-3: Consider the risk of attack, assess detection and dispensing capability, and evaluate the use of prepositioning strategies to complement points of dispensing. State, local, and tribal governments should, in partnership with each other and with the federal government, the private sector, and com- munity organizations: • C onsider their risk of a potential anthrax attack. • A ssess their current detection and surveillance capability. • A ssess the current capability of and gaps in their medical counter- measures dispensing system. • B ased on their risk and capability assessment, evaluate whether specific prepositioning strategies will fill identified gaps and/or im- prove effectiveness and efficiency. The decision-making framework should include, for a range of anthrax attack scenarios: — valuation of the potential health benefits and health risks of e alternative prepositioning strategies;
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203 A DECISION-AIDING FRAMEWORK — valuation of the relative economic costs of alternative preposi- e tioning strategies; — omparison of the strategies with respect to health benefits, c health risks, and costs, taking into account available resources; and — onsideration of ethical principles and incorporation of com- c munity values (see Recommendation 5-2). Recommendation 5-4: Give priority to improving dispensing capability and developing prepositioning strategies such as forward-deployed or cached medical countermeasures. In public health planning efforts, state, local, and tribal jurisdictions should give priority to improving the dispensing capability of points of dispensing and push strategies and to developing forward-deployed or cached prepositioning strategies. The committee does not recommend the development of public health strategies that involve broad use of predispensed medical countermeasures for the general population. In some cases, however, targeted predispensed medical countermeasures might be used to ad- dress specific gaps in jurisdictions’ dispensing plans for certain sub- populations that lack access to antibiotics via other timely dispensing mechanisms. These might include, for example, some first responders, health care providers, and other workers who support critical infra- structure, as well as their families. Personal stockpiling might also be used for certain individuals who lack access to antibiotics via other timely dispensing mechanisms (for example, because of their medical condition and/or social situation) and who decide—in conjunction with their physicians—that this is an appropriate personal strategy. This is allowed under current prescribing practice and would usually be done independently of a jurisdiction’s public health strategy for dispensing medical countermeasures. The following recommendation addresses the development of an FDA- approved MedKit. The committee found that among predispensing strate- gies, FDA-approved MedKits are likely to be more costly than personal antibiotic stockpiles and EUA-approved MedKits because of the additional costs associated with the rigorous process of FDA approval. Depending on how the MedKit was developed, these costs could be shared between the federal government and the private sector, but consumers and cash-strapped state and local public health agencies might also bear the brunt of these additional costs. There is limited evidence to suggest that FDA-approved MedKits would be less prone to inappropriate use than other forms of
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204 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX predispensing and, similar to other forms of predispensing, they cannot respond flexibly to different anthrax attack scenarios. The following recom- mendation does not preclude the use of an EUA MedKit, which would be less costly than an FDA-approved MedKit, but would be appropriate only for targeted use in specific contexts. Recommendation 5-5: Do not pursue development of a Food and Drug Administration-approved MedKit unless this is supported by additional safety and cost research. The committee does not recommend the development of a Food and Drug Administration-approved MedKit designed for prepositioning for an anthrax attack until and unless research demonstrates that MedKits are significantly less likely to be used inappropriately than a standard prescription and can be produced at costs comparable to those of stan- dard prescription antibiotics. REFERENCES ASPR (Assistant Secretary for Preparedness and Response). 2011. FY11 Hospital Preparedness Program (HPP) guidance. Washington, DC: HHS, http://www.phe.gov/Preparedness/ planning/hpp/Documents/fy2011-hpp-funding-guidance.pdf (accessed August 22, 2011). ASTHO (Association of State and Territorial Health Officials). 2010. Assessing policy barriers to effective public health response in the H1N1 influenza pandemic. Arlington, VA: ASTHO, http://www.astho.org/Display/AssetDisplay.aspx?id=4933 (accessed May 18, 2011). Baccam, P., and M. Boechler. 2007. Public health response to an anthrax attack: An evalu- ation of vaccination policy options. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 5(1):26-34. Bernier, R. 2011. The need for evidence-AND values-informed policy making on medi- cal countermeasures—the case for public engagement. Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Counter- measures for the Public, Washington, DC, http://iom.edu/~/media/Session%203-%20 Bernier_Public%20Engagement.pdf (accessed August 8, 2011). Brandeau, M. L., G. S. Zaric, J. Freiesleben, F. L. Edwards, and D. M. Bravata. 2008. An ounce of prevention is worth a pound of cure: Improving communication to reduce mor- tality during bioterrorism responses. American Journal of Disaster Medicine 3(2):65-78. Bravata, D. M., G. S. Zaric, J.-E. Cleophas Holty, M. L. Brandeau, E. R. Wilhelm, K. M. McDonald, and D. K. Owens. 2006. Reducing mortality from anthrax bioterrorism: Strategies for stockpiling and dispensing medical and pharmaceutical supplies. Bio- security and Bioterrorism: Biodefense Strategy, Practice, and Science 4(3):244-262. Brookmeyer, R., N. Blades, M. Hugh-Jones, and D. A. Henderson. 2001. The statistical analysis of truncated data: Application to the Sverdlovsk anthrax outbreak. Biostatistics 2(2):233-247. Brookmeyer, R., E. Johnson, and S. Barry. 2003. Modeling the optimum duration of antibiotic prophylaxis in an anthrax outbreak. Proceedings of the National Academy of Sciences 100(17):10129-10132. Brookmeyer, R., E. Johnson, and S. Barry. 2005. Modelling the incubation period of anthrax. Statistics in Medicine 24(4):531-542.
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