National Academies Press: OpenBook

Prepositioning Antibiotics for Anthrax (2012)

Chapter: 6 Recommended Actions for Moving Forward

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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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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:

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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• Promotion of public health—Strive for the most favorable balance of public health benefits and harms based on the best available research and data.

• Stewardship—Demonstrate stewardship of public health resources.

• Distributive justice—Distribute benefits and harms fairly, without unduly imposing burdens on any one population group.

• Reciprocal obligations—Recognize the professional’s duty to serve and the reciprocal obligation to protect those who serve.

• Transparency and accountability—Maintain public accountability and transparency so that community members grasp relevant policies and know from whom they may request explanation, information, or revision.

• Proportionality—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.

• Community 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 incorporation 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 community organizations:

• Consider their risk of a potential anthrax attack.

• Assess their current detection and surveillance capability.

• Assess the current capability of and gaps in their medical countermeasures dispensing system.

• Based on their risk and capability assessment, evaluate whether specific prepositioning strategies will fill identified gaps and/or improve effectiveness and efficiency. The decision-making framework should include, for a range of anthrax attack scenarios:

— evaluation of the potential health benefits and health risks of alternative prepositioning strategies;

— evaluation of the relative economic costs of alternative prepositioning strategies;

— comparison of the strategies with respect to health benefits, health risks, and costs, taking into account available resources; and

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×

— consideration of ethical principles and incorporation of community 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 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 address specific gaps in jurisdictions’ dispensing plans for certain subpopulations 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 infrastructure, 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 develop national guidance that will facilitate and ensure consistency for public-private cooperation in the prepositioning, distribution, and dispensing of medical countermeasures and help leverage existing private-sector systems and networks.

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×

Recommendation 5-1: Enhance assessment of performance in implementing distribution and dispensing plans for medical countermeasures. The Centers for Disease Control and Prevention should continue to facilitate assessment of state, local, and tribal jurisdictions’ performance in implementing dispensing plans for medical countermeasures, in addition 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 distribution and dispensing system by:

• demonstrating Strategic National Stockpile distribution capabilities to high-risk jurisdictions;

• facilitating large-scale, realistic exercises in high-risk jurisdictions to test dispensing capability; and

• continuing 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 standard 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

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×

TABLE 6-1

Evidence to Inform Prepositioning Decision Making: Research Needs

General Category Specific Research Areas
Epidemiological and Medical Issues Regarding Anthrax and Postexposure Prophylaxis (PEP) for Anthrax

- Further understanding of the distribution of incubation periods across a range of plausible exposures, and to what degree exposure influences the incubation period

- Efficacy of prophylaxis by host factors and timing of initiation

- 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 Logistics

- Evaluation of an operational target (time window) 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 stockpiles 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

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×
General Category Specific Research Areas
Behavior and Communications Attitudes and behavior related to different 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 recommendations 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 framework proposed in this report for determining whether prepositioning strategies would be beneficial within a community. The Department of

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×

BOX 6-1
Priority Research Needs

• Further 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 subpopulation factors affect anthrax incubation periods);

• Evaluation of a standard goal for the time within which jurisdictions must administer an initial dose of prophylaxis to the entire at-risk population;

• Assessment of costs and effectiveness of alternative means of improving Strategic National Stockpile (SNS) distribution time;

• Assessment of factors related to behavior and communication, including acceptability of, trust in, and adherence to recommended medical countermeasures (MCM);

• Estimate of rate of misuse of antibiotics in a home stockpiling context; and

• Assessment of the likely efficacy, costs, cost-effectiveness, 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 refinement 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 prepositioning must take place within the context of the entire system.

Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×

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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×
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Suggested Citation:"6 Recommended Actions for Moving Forward." Institute of Medicine. 2012. Prepositioning Antibiotics for Anthrax. Washington, DC: The National Academies Press. doi: 10.17226/13218.
×
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If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur.

Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies.

Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.

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