6

Recommended Actions for Moving Forward

The committee concludes this report by offering a summary of its recommendations for moving forward, which include actions recommended for state, local, and tribal public health officials and those recommended at the federal/national level, as well as research needed to provide a evidence base for decision making on prepositioning. Although these actions are proposed in the context of the selection, development, and implementation of prepositioning strategies, many would also help enhance the nation’s overall ability to distribute and dispense antibiotics rapidly following an anthrax attack, regardless of the specific decisions made about prepositioning.

ACTIONS FOR STATE, LOCAL, AND TRIBAL PUBLIC HEALTH OFFICIALS

The following recommendations are intended to assist state, local, and tribal public health officials in evaluating the potential benefits, health risks, and costs of developing prepositioning strategies in their community.

Recommendation 5-2: Integrate ethical principles and public engagement into the development of prepositioning strategies within the overall context of public health planning for bioterrorism response. State, local, and tribal governments should use the following principles as an ethical framework for public health planning of prepositioning strategies:



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6 Recommended Actions for Moving Forward The committee concludes this report by offering a summary of its rec- ommendations for moving forward, which include actions recommended for state, local, and tribal public health officials and those recommended at the federal/national level, as well as research needed to provide a stronger evidence base for decision making on prepositioning. Although these ac- tions are proposed in the context of the selection, development, and imple- mentation of prepositioning strategies, many would also help enhance the nation’s overall ability to distribute and dispense antibiotics rapidly fol- lowing an anthrax attack, regardless of the specific decisions made about prepositioning. ACTIONS FOR STATE, LOCAL, AND TRIBAL PUBLIC HEALTH OFFICIALS The following recommendations are intended to assist state, local, and tribal public health officials in evaluating the potential benefits, health risks, and costs of developing prepositioning strategies in their community. Recommendation 5-2: Integrate ethical principles and public engage- ment into the development of prepositioning strategies within the overall context of public health planning for bioterrorism response. State, local, and tribal governments should use the following principles as an ethical framework for public health planning of prepositioning strategies: 209

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210 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX • P romotion of public health—Strive for the most favorable balance of public health benefits and harms based on the best available research and data. • S tewardship—Demonstrate stewardship of public health resources. • D istributive justice—Distribute benefits and harms fairly, without unduly imposing burdens on any one population group. • R eciprocal obligations—Recognize the professional’s duty to serve and the reciprocal obligation to protect those who serve. • T ransparency and accountability—Maintain public accountability and transparency so that community members grasp relevant poli- cies and know from whom they may request explanation, informa- tion, or revision. • P roportionality—Use burdensome measures, such as those that restrict liberty, only when they offer a commensurate gain in public health and when no less onerous alternatives are both available and feasible. • C ommunity engagement—Engage the public in the development of ethically sound dispensing plans for medical countermeasures, including plans to preposition antibiotics, so as to ensure the in- corporation of community values. 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; — 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

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211 RECOMMENDED ACTIONS FOR MOVING FORWARD — onsideration of ethical principles and incorporation of com- c munity values (see Recommendation 5-2). Recommendation 5-4: Give priority to improving dispensing capabil- ity 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. FEDERAL/NATIONAL-LEVEL ACTIONS The following are federal/national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recommendation 4-1: Develop national guidance for public-private coordination in the prepositioning, distribution, and dispensing of medical countermeasures. The Department of Health and Human Services should convene state, local, and tribal governments and private-sector organizations to de- velop national guidance that will facilitate and ensure consistency for public-private cooperation in the prepositioning, distribution, and dis- pensing of medical countermeasures and help leverage existing private- sector systems and networks.

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212 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Recommendation 5-1: Enhance assessment of performance in imple- menting distribution and dispensing plans for medical countermeasures. The Centers for Disease Control and Prevention should continue to fa- cilitate assessment of state, local, and tribal jurisdictions’ performance in implementing dispensing plans for medical countermeasures, in ad- dition to assessing planning efforts. More specifically, the Centers for Disease Control and Prevention, in collaboration with state, local, and tribal jurisdictions, should facilitate assessment of the entire distribu- tion and dispensing system by: • d emonstrating Strategic National Stockpile distribution capabilities to high-risk jurisdictions; • f acilitating large-scale, realistic exercises in high-risk jurisdictions to test dispensing capability; and • c ontinuing efforts to identify objective criteria and metrics for evaluating the performance of jurisdictions in implementing mass dispensing. 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. RESEARCH NEEDS The significant costs of establishing and maintaining a distribution and dispensing system warrant a thorough understanding of the most efficient and effective mass prophylaxis strategies for a community. Throughout this report, the committee has highlighted areas in which additional research is needed to better characterize the risk of an anthrax attack, the distribution and dispensing capability needed to provide prophylaxis for a population within an appropriate time period, what that time period is, and the role of prepositioning in an overall bioterrorism preparedness and response system. The remaining evidence gaps in each of these areas, as well as others identified below (see Table 6-1), need to be filled in a systematic and rigorous manner by quantitative and qualitative research. Any and all data from real-world events should be used to guide the formulation of research questions. The committee does not intend that decision making should

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213 RECOMMENDED ACTIONS FOR MOVING FORWARD TABLE 6-1 Evidence to Inform Prepositioning Decision Making: Research Needs General Category Specific Research Areas Epidemiological – Further understanding of the distribution of incubation and Medical Issues periods across a range of plausible exposures, and to Regarding Anthrax what degree exposure influences the incubation period and Postexposure – Efficacy of prophylaxis by host factors and timing Prophylaxis (PEP) of initiation for Anthrax – Alternative agents for drug-resistant anthrax – Development of appropriate pediatric formulation for PEP and impact on home stockpiling – Improvement of early detection through environmental sensors, clinical diagnostics, and other means Operations and – Evaluation of an operational target (time window) Logistics for dispensing initial doses of prophylaxis to the entire at-risk population – Exploration of a logistics model to assess the effectiveness of current distribution strategies for different jurisdictions and the cost-effectiveness of various alternative distribution strategies for filling gaps in capability – Demonstration of the current time to receive medical countermeasures (MCM) from the Strategic National Stockpile (SNS) in a target community – Assessment of costs and effectiveness of alternative means to improve SNS distribution time – Accurate assessment of local dispensing capacity, including existing closed points of dispensing (PODs) – Assessment of populations not adequately served by PODs – Further assessment of existing prepositioning models, including the MedKit component of the postal model – Potential impact of behavior of the public on a dispensing system (e.g., if individuals with home stock- piles also attempt to receive MCM from a public POD) – Potential impact of antibiotic prepositioning strategies on time to initiation of anthrax vaccine – Logistics and costs of replacement and appropriate disposal of prepositioned antibiotics continued

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214 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX TABLE 6-1 Continued General Category Specific Research Areas Behavior and Attitudes and behavior related to different Communications prepositioning strategies – Acceptability of a given strategy in the absence of a perceived acute threat – Trust and perceived inequities regarding availability of antibiotic prophylaxis, use of different antibiotics, and potential need to change public health recommenda- tions after an attack – Prescriber behavior around personal stockpiling Effectiveness of communications – Compliance with public health messaging – Directions for storage, preparation for pediatric dosage, saving drug for attack, direction for use during attack Adherence – Assessment of the risk for inappropriate use among varied populations: willingness to take drugs only upon notification – Behavior of the public in response to other disasters (e.g., U.S. use of potassium iodide after Japanese nuclear disaster) Safety – Adverse events and impact on adherence – Impact on general community antimicrobial resistance patterns – Influence of packaging of predispensed antibiotics on inappropriate use Cost-Effectiveness – Further assessment of the likely total costs of alternative prepositioning strategies in different communities – Further assessment of health benefits of alternative prepositioning strategies in different communities – Further assessment of cost-effectiveness of alternative prepositioning strategies in different communities await the research results, but those results should be used to refine plans in the future. Recommendation 6-1: Perform additional research to better inform decision making about prepositioning strategies. Results of such research would strengthen the decision-aiding frame- work proposed in this report for determining whether prepositioning strategies would be beneficial within a community. The Department of

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215 RECOMMENDED ACTIONS FOR MOVING FORWARD BOX 6-1 P riority Research Needs • F urther understanding of the anthrax incubation period, i.e., the minimum time before symptom onset and the distribution of the incubation period for a set of exposed individuals (e.g., what sub- population factors affect anthrax incubation periods); • E valuation of a standard goal for the time within which jurisdictions must administer an initial dose of prophylaxis to the entire at-risk population; • A ssessment of costs and effectiveness of alternative means of im- proving Strategic National Stockpile (SNS) distribution time; • A ssessment of factors related to behavior and communication, in- cluding acceptability of, trust in, and adherence to recommended medical countermeasures (MCM); • E stimate of rate of misuse of antibiotics in a home stockpiling con- text; and • A ssessment of the likely efficacy, costs, cost­effectiveness, and safety of a Food and Drug Administration (FDA)–approved home MedKit. Health and Human Services should conduct additional research in the following broad areas: epidemiological and medical issues regarding anthrax and postexposure prophylaxis for anthrax, operations and logistics, behavior and communications, safety, and cost-effectiveness. In recognition of limited public health resources, Box 6-1 summarizes the research needs that are most critical. CONCLUDING REMARKS Prepositioning is just one potential component of a larger endeavor to enhance the nation’s capability to prevent illness and death from an anthrax attack. Other components include national security efforts to prevent an attack or mitigate its effects; efforts to enhance detection and surveillance capability; further development of strategies for anthrax prevention (e.g., anthrax vaccine) and treatment (e.g., anthrax antitoxin); continuous re- finement of the current medical countermeasures (MCM) distribution and dispensing system; and efforts to engage the private sector in both the development and the delivery of MCM. To best protect the public’s health and to make optimal use of resources, decision making about preposition- ing must take place within the context of the entire system.

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