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5 A Decision-Aiding Framework
Pages 153-208

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From page 153...
... This chapter details the elements 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)
From page 154...
... 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)
From page 155...
... 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.
From page 156...
... The use of risk-related information in decision making about prepositioning is addressed in greater detail later in the chapter, including how a community's relative risk of an anthrax attack and the likelihood of specific 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.
From page 157...
... 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 evaluate their ability to meet prophylaxis goals and the potential usefulness of prepositioning in achieving those goals.
From page 158...
... 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.
From page 159...
... Public Health Preparedness Capabilities, the SNS Technical Assistance Review (TAR) tool, the RAND-CDC Performance Metrics Project, and the CDC-administered Public Health Emergency Preparedness (PHEP)
From page 160...
... The TAR, like Public Health Preparedness Capabilities, represents progress in assessing state and local preparedness to mount a mass prophylaxis 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 jurisdictions to chart their progress quantitatively and determine persistent weaknesses.
From page 161...
... If the current distribution and dispensing system were capable of providing prophylaxis to a population 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 comprehensive.
From page 162...
... . As noted above, the most recent PHEP cooperative agreement (2011-2016)
From page 163...
... 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)
From page 164...
... 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. INCORPORATION OF ETHICAL PRINCIPLES AND COMMUNITY VALUES Many authors have addressed the question of which values and principles ought properly to serve as the basis for policies in public health, both in general and for the prevention of and response to disasters (Childress et al., 2002)
From page 165...
... • Proportionality -- Use burdensome measures, such as those that restrict liberty, only when they offer a commensurate gain in pub lic health, and no less onerous alternatives are both available and feasible. • Community engagement -- Engage the public in the development of ethically robust MCM dispensing plans, including plans for prepositioning antibiotics, to ensure the incorporation of commu nity values.
From page 166...
... Ethically sound public health policies must provide equivalent benefits to different groups within the population, while harms such as the inconvenience and risk of picking up MCM at a distant site should not be borne disproportionately by vulnerable groups. The next element addresses the reciprocal obligations of professionals and those they serve.
From page 167...
... Any limit to individual freedom that is imposed must be the only viable means of promoting an important public health goal. The final element of the ethical framework calls for community engagement.
From page 168...
... Since inhalational anthrax is noncommunicable, isolation is not a useful response and thus is not a relevant ethical challenge in this context. In the case of an anthrax attack involving a well-defined area of known contamination with anthrax spores, public health and public safety authorities might consider quarantining the area or confining people to their homes so they would not come in contact with the contaminated area.
From page 169...
... . At the same time, while there is no strong ethical argument to prevent community members from obtaining MCM in advance of an anthrax attack, neither is there an ethical basis for public authorities relying on this method in lieu of other modes of distribution, particularly if individuals, not public health entities, are intended to bear the costs.
From page 170...
... 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: • 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.
From page 171...
... It describes a general approach that can be taken by local communities to estimate these factors and explains how the results could be used to support informed decision making. In particular, this section presents a modeling approach that is recommended for use in evaluating potential health benefits and the likely economic costs of alternative prepositioning strategies.
From page 172...
... The value of any health benefit, of course, depends strongly on both the size and the type of the affected community and the attack scenario. For example, in the case of a small anthrax attack with known exposure (e.g., a known attack in a specific building)
From page 173...
... For groups and individuals lacking timely access to MCM through other dispensing mechanisms, however, the risk of not receiving postexposure prophylaxis following an anthrax attack may outweigh the potential health risks associated with inappropriate use. In addition, with a more focused strategy targeting vulnerable subpopulations, it might be easier to develop systems to decrease inappropriate use.
From page 174...
... Compared with the base case of no incremental prepositioning. A range of potential attack scenarios should be considered in evaluating any potential prepositioning strategy.
From page 175...
... The final section describes how these estimates of benefits and costs can be used to inform decisions about prepositioning strategies. Modeling to Evaluate Health Benefits A first-order model This section presents a simplified first-order mathematical model that can be used to estimate health benefits for a given anthrax attack scenario in a given community.
From page 176...
... To determine the health benefits that might accrue from a particular prepositioning strategy, the committee posits some likely parameters describing release/exposure scenarios and then develops a model for computing and comparing estimates of health outcomes for that strategy. The model is described briefly here; full details are provided in Appendix C
From page 177...
... . Finally, define S as the expected fraction of the population that will be saved for any prepositioning strategy and any assumed time δ after release at which the decision to dispense is made.
From page 178...
... SCENARIO 1 SCENARIO 2 SCENARIO 3 SCENARIO 4 Time Between Decision to Dispense Prophylaxis Starts Prophylaxis Starts at Prophylaxis Starts After Prophylaxis Starts and Completion at BioWatch Time of First Clinical Laboratory Confirmation Ater Delayed Detection Prepositioning of Prophylaxis Actionable Result Positive Diagnosis of First Positive Diagnosis and Diagnosis* (d = 24 hours)
From page 179...
... If data are available that allow calculating the percent effectiveness for a particular MCM and target population, the numbers in Table 5-1 can simply be multiplied by that percentage. This provides the opportunity to introduce into the assessment of the value of a prepositioning strategy the possibility that the prepositioned MCM might have a lower percent efficacy due to such factors as improper storage, wrong dosage, or lower patient adherence.
From page 180...
... is the same as that given in the example above; then the health benefits of any prepositioning strategy will essentially be those shown in Table 5-1. In other words, the health benefits depend more on the shape of the survival function than on the minimum incubation period.
From page 181...
... . The model can be used to evaluate changes in these factors and, thus, to evaluate the potential health benefits of prepositioning strategies in light of different assumptions about the behavior of the public, as well as strategies of public health and other officials for communicating with the public.
From page 182...
... Evaluating prepositioning strategies for given attack scenarios Given estimates of the health benefits and economic costs of alternative prepositioning strategies, one can consider several measures of cost-benefit. In general, the cost-benefit ratio of an intervention strategy is defined as follows: Cost-benefit ratio = Incremental cost of a strategy Incremental benefit of a strategy Similarly, if both costs and benefits of strategies are monetized, their difference provides a monetary estimate of the net benefit (positive or negative)
From page 183...
... . For the case of response to an anthrax attack, an intuitive measure of health benefits is deaths averted.
From page 184...
... (If costs are variable as well, No Prepositioning Prepositioning in Local Prepositioning Time to Prophylaxis Estimated Average Warehouses in Closed PODs Home MedKits Incremental Cost (a) Incremental costs and estimated average time to prophylaxis No Prepositioning Prepositioning in Local Prepositioning Estimated Deaths Warehouses in Closed PODs Home MedKits Incremental Cost (b)
From page 185...
... Incremental costs and changes in average time to prophylaxis Deaths Averted Home MedKits Prepositioning in Local Warehouses No Prepositioning Incremental Cost (b) Incremental costs and deaths averted FIGURE 5-2 Envisioned model output: incremental costs and incremental benefits, assuming the occurrence of a given attack scenario.
From page 186...
... Evaluating expected costs and benefits of prepositioning strategies The expected cost-benefit ratio for any prepositioning strategy (measured either as cost per death averted or cost per hour of decrease in average time to prophylaxis) depends not only on the attack scenario (e.g., size, diffusion, time to detect)
From page 187...
... The analyses of Bravata and colleagues showed that local dispensing capability, not local anthrax antibiotic inventories, is likely to be the ratelimiting factor in response to an anthrax attack: "because of the reportedly rapid availability of regional inventories, the critical determinant of mortality following anthrax bioterrorism is local dispensing capacity. Bioterrorism preparedness efforts directed at improving local dispensing capacity are required before benefits can be reaped from enhancing local inventories" (Bravata et al., 2006, p.
From page 188...
... . Finding 5-3: Behavior of the public is an important factor affecting dispensing capacity and must be considered in evaluating a community's likely dispensing capability and thus in evaluating the potential benefits of prepositioned MCM for anthrax.
From page 189...
... , local dispensing capacity (e.g., 20 public PODs that could each provide prophylaxis for 1,000 people per hour) , and local dispensing strategy (e.g., one household member could obtain antibiotics for all members of his/her household at a public POD)
From page 190...
... show that predispensing (e.g., using home MedKits) would reduce time to prophylaxis not only for individuals who had the MedKits but also for other exposed individuals in the population by reducing demand on public PODs, assuming that the capacity of public PODs would not be reduced in light of the availability of MedKits.
From page 191...
... . These results occur because of the distribution of the incubation period of anthrax across exposed individuals: reducing time to prophylaxis from 48 to 24 hours after exposure, for example, will likely have little impact on the fraction saved because few individuals will develop prodromal anthrax within that period.
From page 192...
... Prepositioning in 718,000 0 6,000 895,000 0 1,298,000 77,000 hospital/pharmacy caches that would serve 20 percent of the population Prepositioning in 723,000 726,000 6,000 895,000 3,683,000 1,298,000 307,000 workplace caches that would serve 20 percent of the population Prepositioning in 16,542,000 14,154,000 0 0 0 0 0 all homes NOTES: A population of 1.7 million individuals in 745,000 households is assumed. All estimates are rounded to the nearest $1,000; MCM = medical countermeasures; POD = point of dispensing; RSS = receiving, staging, and storing; SNS = Strategic National Stockpile.
From page 193...
... ; on a per capita basis, the estimated replacement cost for MedKits is more than four times higher than that for workplace caches. Note that these estimated annual replacement costs do not include the cost of returning and disposing of expired antibiotics -- costs that may be particularly relevant for the case of home MedKits.
From page 194...
... . The PRTM analysis estimates that annual inventory management costs would be zero for the case of home MedKits and that hospital, pharmacy, and workplace caches would incur very small annual storage/ management costs of approximately $6,000 (based on the assumption that storing/managing a pallet of 10,000 bottles of antibiotics would cost $14/month)
From page 195...
... For the case of workplace prepositioning, the cost of dispensing from public PODs is estimated to be $1.3 million (the workplace caches are assumed to serve 20 percent of the population) , and the cost of dispensing from workplace PODs is estimated to be $307,000 (slightly less than the cost of dispensing an equivalent amount of MCM from public PODs)
From page 196...
... However, because MedKits would have different packaging and instructions and be dispensed pre-exposure for long-term storage by the ultimate user, FDA approval would be needed for the indication of a prepositioned MCM (NBSB, 2008)
From page 197...
... Therefore, prepositioning strategies will provide the greatest value in responding to a large-scale attack in high-risk areas with limited dispensing through the POD system and/or other specific characteristics that would be addressed effectively using prepositioning. Prepositioning strategies may have little added value in areas in which the risk of an attack is low and/or dispensing capacity is sufficient.
From page 198...
... 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.
From page 199...
... Finding 5-8: The added safety features that might be provided by an FDAapproved 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 predispense to those targeted groups and individuals for whom predispensing is an appropriate option.
From page 200...
... – 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)
From page 201...
... , public health dispensing capacity (capacity to dispense MCM after an anthrax attack) , and gaps in coverage of subpopulations (subpopulations that may not be covered by public health MCM dispensing in the event of an attack)
From page 202...
... • 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;
From page 203...
... 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.
From page 204...
... 2007. Public health response to an anthrax attack: An evalu ation of vaccination policy options.
From page 205...
... Slides presented at the third meeting of the Institute of Medi cine Committee on Prepositioned Medical Countermeasures for the Public, Irvine, CA, http://www.iom.edu/~/media/Files/Activity%20Files/PublicHealth/PrepositionedCounter measures/Meeting%203/2%20-%20Carlin%20-%20At-Risk%20Populations.pdf. CDC (Centers for Disease Control and Prevention)
From page 206...
... 2011. Mitigating the risk of an anthrax attack by placing pre-event pharmaceuticals.
From page 207...
... . SNS-related medical countermeasures drills and exercises.


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