4

Prepositioning Strategies

Policy makers are considering prepositioning to complement existing more centralized strategies because prepositioning strategies may serve to:

• increase the number of potentially exposed people who are able to access antibiotics within an appropriate time frame following an anthrax attack;

• decrease the burden on existing strategies for dispensing medical countermeasures (MCM), especially the use of points of dispensing (PODs), and reduce surge demand on the health care system; and

• enhance fairness and equitability in access to antibiotics.

As discussed in this chapter and further in Chapter 5, however, these strategies also can be associated with higher levels of inappropriate use and health risks, higher costs, and additional practical burdens relative to existing strategies.

Antibiotics may be prepositioned in many different venues using many different strategies, including:

• forward-deployed MCM—MCM stored near the locations from which they will be dispensed,

• cached MCM—MCM stored at the locations from which they will be dispensed,1 and

image

1The term cache often is used broadly to describe stockpiles of MCM held by state or local jurisdictions, health care facilities, and private-sector organizations, among others. For the



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4 Prepositioning Strategies Policy makers are considering prepositioning to complement existing more centralized strategies because prepositioning strategies may serve to: • increase the number of potentially exposed people who are able to access antibiotics within an appropriate time frame following an anthrax attack; • decrease the burden on existing strategies for dispensing medical countermeasures (MCM), especially the use of points of dispensing (PODs), and reduce surge demand on the health care system; and • enhance fairness and equitability in access to antibiotics. As discussed in this chapter and further in Chapter 5, however, these strategies also can be associated with higher levels of inappropriate use and health risks, higher costs, and additional practical burdens relative to existing strategies. Antibiotics may be prepositioned in many different venues using many different strategies, including: • forward-deployed MCM—MCM stored near the locations from which they will be dispensed, • cached MCM—MCM stored at the locations from which they will be dispensed,1 and 1 The term cache often is used broadly to describe stockpiles of MCM held by state or local jurisdictions, health care facilities, and private-sector organizations, among others. For the 93

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94 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX • predispensed MCM—MCM stored by the intended users or by heads of households or other nonmedical caregivers for use by those in their care. This chapter describes these three categories of prepositioning strategies. For each category, several example strategies, the potential roles for those strategies within a jurisdiction’s overall dispensing strategy, and potential health risks, if any, are discussed. Also discussed for each category are practical considerations, including logistics, communication needs, expected behavior and adherence, and legal and regulatory issues. Table 4-1 summa- rizes key features of the three categories of prepositioning strategies. This table is not intended to be comprehensive; other push and pull strategies (such as those described in Chapter 3) also could be employed to enhance distribution and dispensing. In this chapter, the committee discusses the individual properties of dif- ferent prepositioning strategies to highlight the specific uses of each and the associated advantages, disadvantages, and other considerations. However, these strategies are likely to be used in combination not only during initial prophylaxis, but also later when it is necessary to provide the exposed population with vaccine and a prolonged antibiotic course. This chapter focuses primarily on the qualitative considerations that should factor into jurisdictions’ decisions about whether to develop strategies for preposi- tioning prophylactic antibiotics in their communities. Chapter 5 outlines a decision-aiding framework and a model for quantifying and comparing health benefits and economic costs across the various prepositioning strate- gies and presents the committee’s recommendations on this topic. FORWARD-DEPLOYED MEDICAL COUNTERMEASURES Forward-deployed MCM are stored near the locations where they will be dispensed. The primary purpose of forward-deploying MCM is to de- crease the transportation time associated with distributing the MCM from stockpiles to PODs. Several entities could potentially maintain forward- deployed stockpiles of antibiotics, including the Centers for Disease Control and Prevention (CDC)/Strategic National Stockpile (SNS); other federal agencies, such as the Department of Veteran Affairs (VA) and Department of Defense (DOD); state and local authorities; and commercial pharmaceu- tical distributors. These strategies are described below. purposes of this report, and to enable clear discussion of the different properties associated with different types of prepositioning, the committee defines cache more specifically to denote storage of MCM in the locations from which they will be dispensed and uses the term stockpile to cover federal, state, and local stockpiles.

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TABLE 4-1 Practical Considerations for Developing Prepositioning Strategies Example Primary Entities Infrastructure and Prepositioning Potential Uses Involved and Other Practical Related Strategies Strategies for Strategy Partnerships Needed* Requirements to Consider/Notes Forward- SNS forward-deployed Decrease time to CDC To benefit from An issue is how Deployed initiate dispensing, forward-deployed far along the con- MCM Other federal forward- and hence increase CDC; VA and/or DOD; strategies, PODs tinuum (centralized → deployed (VA, DOD) the overall number state/local/tribal public must be capable of forward-deployed) to of people receiving health authorities being set up quickly place prophylaxis within enough to take the MCM stockpiles State, local, tribal an appropriate time State/local/tribal pub- advantage of the time forward-deployed frame following lic health authorities savings associated exposure with distribution from Commercial forward- Commercial pharma- forward-deployed deployed to supply ceutical distributor(s); stockpiles public health open state/local/tribal public PODs health authorities Commercial forward- Commercial pharma- deployed to supply ceutical distributor(s); private-sector closed private-sector entities PODs with closed PODs Cached MCM Caches in hospitals and – Protect health care – Health systems, Infrastructure and staff other health care facili- workers expected hospitals, and other needed to store and ties—for example, com- to work during the health care facilities* dispense MCM already munity health centers, response and their exist in health care – ASPR, through clinics, skilled nursing families facilities the Hospital facilities, subacute care – Maintain functioning Preparedness facilities of the health care Program system – Protect patients and long-term residents from anthrax 95 continued

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TABLE 4-1 Continued 96 Example Primary Entities Infrastructure and Prepositioning Potential Uses Involved and Other Practical Related Strategies Strategies for Strategy Partnerships Needed* Requirements to Consider/Notes Cached MCM Retail pharmacy Protect pharmacy staff Pharmacies* Infrastructure and staff Pharmacies may caches expected to work dur- to store and dispense serve as open PODs ing the response and MCM already exist in dispensing MCM their families retail pharmacies delivered postevent General private-sector – Enhance dispensing Private-sector entities* Most workplaces do Private-sector work- workplace caches capability for the not already have the places may serve as general population by infrastructure and staff closed PODs dispens- off-loading demand to store and dispense ing MCM delivered from the public health MCM; this capacity postevent distribution and would have to be de- dispensing system veloped or alternative arrangements made – Help ensure business continuity and the well-being of employ- ees and their families Workplace caches Protect first responders, Private and public Predispensed MCM for those who will critical infrastructure employers with could be used for be expected to work workers, and other employees who are those for whom during a response groups of workers expected to work workplace caches expected to work during a response* are not a feasible during a response; option (see below) workers’ families may also be included

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Caches in agencies Most agencies do not Agencies may be Enhance access for Agencies serving serving vulnerable have the infrastructure better suited to serve vulnerable populations vulnerable populations, populations and staff to store and as PODs, to use including community- dispense MCM other existing service and faith-based delivery systems to organizations, such as dispense MCM food banks and home delivered postevent, health care providers* or to help enable and encourage their clients to go to open PODs Workplace caches Predispensed Individual supplies – Protect first respond- Certain employers with Employers would work might be used; see MCM for those expected to ers and critical employees who are ex- with employees to above work during a response infrastructure work- pected to work during develop plans to store, ers who lack access a response, as well as screen, dispense, and to antibiotics via their health plans replace MCM when other timely dispens- expired; employ- ing mechanisms (e.g., ers should consult workplace caches); with their health plan workers’ families may administrator to assess also be included whether the medica- tion will be covered – Help ensure business continuity and the well-being of employ- ees and their families continued 97

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TABLE 4-1 Continued 98 Example Primary Entities Infrastructure and Prepositioning Potential Uses Involved and Other Practical Related Strategies Strategies for Strategy Partnerships Needed* Requirements to Consider/Notes Predispensed Individual supplies for Enhance access for These individuals Prescribers would MCM selected patients selected patients who should work with their work with patients to lack access to antibiot- prescribers to deter- develop plans to store, ics via other timely dis- mine ability to safely screen, dispense, and pensing mechanisms store and appropriately replace MCM when use antibiotics expired NOTES: ASPR = Office of the Assistant Secretary for Preparedness *Private and other nongovernmental entities could implement prepositioning and Response; CDC = Centers for Disease Control and Prevention; strategies independently, but in many cases, federal, state, local, and tribal DOD = Department of Defense; MCM = medical countermeasures; governments will play a key role in facilitating the adoption of such strategies POD = point of dispensing; SNS = Strategic National Stockpile; through initiatives, planning assistance, financial and other incentives, and/or VA = Department of Veterans Affairs. efforts to address legal and other barriers.

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99 PREPOSITIONING STRATEGIES Forward-Deployed by the Strategic National Stockpile SNS stockpiles currently are held in large, strategically placed ware- houses throughout the nation. For security reasons, the locations of SNS stockpiles are not disclosed. Therefore, it is possible—and perhaps likely—that certain SNS warehouses are located near high-risk areas, such as major cities, and therefore would already be considered forward-deployed. The SNS could be further forward-deployed by establishing additional SNS warehouses. This might be done, for example, by prepositioning MCM in SNS-managed warehouses in the 11 Tier 1 cities of the Urban Areas Security Initiative, which are the metropolitan areas that the Department of Homeland Security (DHS) has determined to be at highest risk of a terrorist attack (Burel, 2011; DHS, 2011). The primary motivation for forward-deploying SNS stockpiles is to decrease the time associated with transportation from the SNS warehouse to state receiving, staging, and storing (RSS) warehouses, which then redis- tribute the MCM to the jurisdictions’ PODs. This strategy would enable PODs to begin dispensing antibiotics more quickly, thereby increasing the number of people receiving prophylactic antibiotics within the time window in which they can prevent anthrax. Decreasing the transportation time from SNS warehouses to state RSS sites will be effective, however, only if the RSS sites and PODs can be set up and staffed quickly enough to take advantage of the reduced delivery time (Burel, 2011). If MCM are delivered from the SNS before the RSS sites are ready to redistribute them or are redistributed from RSS sites to PODs before the PODs are ready to begin dispensing, the reduced delivery time from SNS warehouses will have no impact on the time at which dispensing of the MCM begins. Although data are sparse on the time currently required for state and local authorities to commence POD operations, and this time is likely to show great variability across jurisdic- tions, the limited data available suggest that 8 hours or more may be needed (Burel, 2011). Therefore, decreasing the SNS transportation time to under 8 hours is unlikely to be cost-effective unless jurisdictions can set up PODs more quickly. For those states and localities that already have the ability to set up RSS sites and PODs rapidly, reducing the SNS delivery time to 8 hours or less might induce some state and local entities to consider eliminating or reducing the quantity of antibiotics in their caches as a cost-saving measure. Forward-deploying MCM that remain under the control of the SNS (rather than transferring them to state, local, or private entities) would decrease transportation time while still enabling central coordination by the SNS; some flexibility to use the SNS infrastructure to redeploy MCM to other areas of need; and the use of the Shelf Life Extension Program (SLEP, described in Chapter 3), which is available only to selected federal stockpiles (Courtney et al., 2009).

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100 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Forward-deploying SNS stockpiles would require storing MCM in more locations compared with storage in fewer, more centralized ware- houses; therefore, forward-deployment would impose a higher management burden and require a greater quantity of medication, with associated costs. This strategy also would decrease flexibility to reallocate antibiotics if an attack occurred in a location with lower perceived risk. CDC’s CHEMPACK project is an example of forward-deployed SNS materiel (Box 4-1). The most significant difference between an attack with B OX 4-1 C HEMPACK: Forward-Deployed Strategic National Stockpile (SNS) Antidotes for Nerve Agents • N erve agents (e.g., ricin, sarin gas) can be absorbed through the eyes or skin, ingested by eating or drinking contaminated food or water, and inhaled; they can cause death by disrupting normal cel- lular mechanisms, causing muscles to tire, which results in cessation of breathing (CDC, 2006). • A ntidotes for nerve agents can prevent death, but are most likely to do so only when administered immediately after exposure (CDC, 2006). • D uring the 1991 Gulf War, the Israelis distributed the nerve agent antidote atropine to all citizens based on the potential threat of a chemical attack; an order to administer the antidote never was given, and the program has since been discontinued for budgetary reasons (Stoil, 2010). • T he only known attack using a nerve agent was carried out by members of the Aum Shinrikyo cult in 1995 in the Tokyo subway system; the sarin gas attack injured approximately 3,800 people and killed 12 (Danzig et al., 2011; Olson, 1999). • S ince 2004, the Centers for Disease Control and Prevention (CDC) has stockpiled nerve agent antidotes as a part of the SNS, forward-deploying them in volunteer states because of the speed with which the antidotes must be administered postexposure to be effective (HHS, 2009). • C DC has partnered with at least 39 states to stockpile nerve agent antidotes at locations in state (e.g., warehouses, hospitals) as part of the CHEMPACK project (CDC, 2007a; Delaware Health and Social Services, 2009). • C DC retains control of the CHEMPACK stockpiles, monitors the proper storage of the materiel at all times, and collects and re- places expired antidote (HHS, 2009). • P articipating states are responsible for CHEMPACK security, the storage facility, and distribution after an attack (HHS, 2009).

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101 PREPOSITIONING STRATEGIES a nerve agent and anthrax is the time frame postexposure within which MCM are effective: antidotes for nerve agents must be administered within minutes to hours, compared with several days for anthrax antibiotics. CDC also forward-deploys DTPA (diethylene triamine pentaacetic acid) in states to reduce response time in the event of a radiological incident. In 2010, CDC reported that “as of March 2010, 89% of the 62 [Department of Health and Human Services–funded] state, locality, and U.S. insular area public health departments received 78,880 doses of [DTPA] from CDC’s [SNS]” (CDC, 2010d, p. 28). Forward-Deployed by Other Federal Agencies MCM also could be forward-deployed at VA hospitals or DOD medi- cal treatment facilities, which are located throughout the country. Although these activities are beyond the normal scope of the VA and DOD mandates, the potential to use this health system infrastructure should not be over- looked. These facilities already maintain pharmaceutical caches for their staff and patients and have the medical staff and infrastructure required to monitor and store medications properly (VA, 2010; see Appendix D). The SNS already partners with the VA and DOD, and the VA currently provides the SNS with acquisition support (CDC, 2010a; VA, 2011). Therefore, instead of using resources to establish new SNS warehouses, it might be possible to expand VA or DOD caches to include antibiotics for the public. These MCM would be distributed to open PODs for dispensing; VA or DOD facilities would be unlikely to serve as open PODs since they would be occupied with providing health care following an attack. Stockpiles at VA or DOD facilities would allow use of the SLEP to minimize costs associ- ated with expiration, and potentially could even be cycled through regular health care uses to avoid expiration entirely. Forward-Deployed by State Authorities MCM could be forward-deployed by states to locations at high risk instead of being kept in a single central location within the state. For example, Minnesota maintains 11 caches of MCM throughout the state, distributed according to population density and proximity to major cities (Minnesota Department of Health, 2006). In 2005, the New York State Department of Health’s Office of Health Emergency Preparedness established all-hazard medical emergency response caches (MERCs) in multiple locations throughout the state (NYSOHS, 2007). The MERCs contain pharmaceuticals and devices (e.g., doxycycline and ciprofloxacin, Mark I Autoinjector Kits with antidotes to nerve agents) and other medical supplies and equipment that can be deployed rapidly in

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102 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX an emergency, reaching any area in the state within 4 hours (compared with 12 hours in the case of SNS Push Packages). The state-owned assets in the MERCs are the first supplies available to move into an affected area. De- pending on the incident, if these state supplies are committed or expended, the state requests assistance from the SNS. The MERCs also eliminate the need for multiple local stockpiles that are not cost-effective. The MERCs are intended to bridge the supply gap between the time of an incident and the arrival and distribution of SNS resources. Like the SNS forward-deployed strategy, this strategy offers the ad- vantage of decreased transportation time to POD sites. It also has simi- lar drawbacks, including increased costs associated with supporting more facilities and potentially greater quantities of MCM, and decreased flex- ibility to reassign MCM should an attack occur at a location other than those predicted. Unlike forward-deploying at SNS warehouses or in VA or DOD facilities, however, state stockpiles cannot take advantage of the SLEP (Courtney et al., 2009). Although this is a limitation for centralized state stockpiles as well, it could have a greater impact on disbursed forward- deployed stockpiles since they would likely require a greater quantity of antibiotics overall, and the administrative burden of monitoring, discard- ing, replacing, or cycling medications through regular health care uses would increase as the number of stockpile locations increased. In the past, states attempting to contract with pharmaceutical distributors to rotate the antibiotics in their stockpiles have faced the challenge of a low market demand for the MCM, and thus little benefit in terms of decreasing replace- ment costs due to expiring medications (Courtney et al., 2009). This might be an area for which national guidance would be beneficial, as discussed in detail later in this chapter. Several studies have suggested that state and local planning efforts should focus first on increasing dispensing capacity because increasing local inventory is cost-effective and effective in reducing mortality if the commu- nity already has a highly robust dispensing capacity (Bravata et al., 2006; Zaric et al., 2008). This issue is examined further in Chapter 5. Forward-Deployed by Commercial Entities MCM could be forward-deployed by commercial pharmaceutical dis- tributors, including both companies that specialize primarily in supply chain management and pharmaceutical distribution (e.g., McKesson, Cardinal Health, AmerisourceBergen) and companies that distribute pharmaceuticals to supply their retail stores (e.g., Target, Walmart). Commercial pharma- ceutical distributors could forward-deploy MCM on behalf of either public health authorities to supply open PODs or private-sector entities to sup- ply closed PODs for employees and their families. Under this strategy, a

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103 PREPOSITIONING STRATEGIES jurisdiction or private-sector entity would contract with a pharmaceutical distributor to maintain stockpiles of antibiotics in a warehouse near the anticipated POD location(s). This strategy would limit the time needed for transportation (relative to relying on pharmaceutical warehouses located far away) and would take advantage of these distributors’ expertise in supply chain management and medication storage. The challenge for public health authorities would be to identify pharmaceutical distributors that were inter- ested in participating in such a program and would find it worthwhile from a business perspective. While distributors may be willing to store MCM in bulk, they are likely to find it more challenging to store MCM in prelabeled unit-of-use quantities because of storage space requirements and costs. CDC currently is exploring the use of pharmaceutical distributors to distribute antiviral drugs from the SNS (CDC, 2011a). During the 2009 H1N1 influenza pandemic, the state of Virginia em- ployed this model, contracting with a private vendor (AmerisourceBergen) to store and distribute its supply of antivirals at the direction of the state health commissioner (Virginia Department of Health, 2009). Virginia is pursuing additional partnerships with chains and pharmacies based on the system set up in response to the 2009 pandemic. CACHED MEDICAL COUNTERMEASURES Cached MCM are positioned in the locations from which they will be dispensed. The caches may be located in health care facilities (e.g., hospitals and pharmacies) or non–health care facilities (e.g., non–health care work- places) and may be maintained by public or private entities. The specific purposes, advantages, and challenges involved depend on the type of cache and are described below. Caches in Health Care Settings The primary purpose of MCM caches in health care settings is to dis- tribute the MCM to health care workers and their families. Health care workers, considered critical infrastructure personnel, are then available to treat victims of a terrorist attack and maintain the level of medical support needed for a community. In addition to the benefits to patients needing care, communities may be more resilient if health care systems remain intact in the face of an attack. This prepositioning strategy also enhances equitable access to MCM by providing an alternative dispensing method for health care workers who will be expected to report to and stay at work during the course of the response to an attack, and who therefore will be unable to stand in line at PODs to receive MCM for themselves and their families. MCM caches in health care settings also could be designated to protect

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142 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX ing an FDA-approved MedKit would be worthwhile. The costs associated with developing an approved MedKit are touched on below. As an intermediate solution, it might be possible to use a MedKit authorized under an EUA (as was done in Minneapolis-St. Paul), although accomplishing this may not be straightforward. During a discussion at a 2009 IOM workshop, it was noted that although an EUA could be obtained for postal workers who volunteered to participate in the postal pilot, ob- taining similar consideration for the first responders who would accompany the postal workers as they delivered MCM postattack was challenging (and has to date not been accomplished) (IOM, 2010b). In particular, speakers observed that all postal workers have a single employer (the USPS), whereas first responders are employed by jurisdictions at many different levels and privately. Adding critical infrastructure workers to the mix would only in- crease the challenges. Selected Patients Certain patients may have social situations and/or medical conditions that preclude them (or are a significant barrier) from accessing medications through the public health system. For example, some patients might be un- able to travel to PODs or might have a compromised immune system that would make it unadvisable to stand in line with a crowd. In many cases, such patients could rely on another household adult or a neighbor to obtain MCM, and some jurisdictions might develop plans through which home health care workers or other service delivery agencies would deliver MCM. For patients without access via these mechanisms, the potential risk of not having antibiotics following an anthrax attack may outweigh concerns about health risks from inappropriate use, lack of flexibility, and cost. Kent Sepkowitz, Vice Chairman of Clinical Affairs at Memorial Sloan- Kettering Cancer Center, suggested to the committee that oncology patients and possibly HIV patients might appropriately receive predispensed antibi- otics. These patients would not be well suited to standing in POD lines, and they have a long history with prepositioned antibiotics and their use with appropriate physician control (Sepkowitz, 2011). Little available published evidence exists on whether patients with complex medical conditions are less likely to misuse antibiotics relative to the general population, and there is likely to be a great deal of individual variation in this regard. Physicians considering prescribing antibiotics for protection against anthrax would need to take into account individual patients and their demonstrated level of adherence to medication instructions. For such patients, predispensing also would make it possible to adapt to their individual needs. For example, alternatives to doxycycline could be provided for those allergic to that drug,

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143 PREPOSITIONING STRATEGIES and the time would be available to provide thoughtful solutions to those at risk of drug interactions or with complex physiology. Predispensing for these selected patients is most likely to entail per- sonal stockpiling through normal physician-patient contact and prescrip- tion routes, as an independent activity. Thus it would be done on an ad hoc basis and would likely be covered by health insurers. The committee is not recommending predispensing for those who have other ways of obtaining access to postexposure prophylactic antibiotics given the concerns discussed above about potential health risks, lack of flex- ibility, and cost. Predispensing is warranted only if the alternative (i.e., no access to antibiotics postevent) is worse. Specifically, the committee is not recommending predispensing for those who are anxious about an anthrax attack but who could, for example, obtain MCM at a POD, although the committee recognizes that this is currently allowed legally under normal prescription laws. The committee acknowledges that public health officials have not done a very good job at communicating what plans are in place, and therefore it may be challenging for physicians and their patients to determine whether and how a patient would access antibiotics in case of an anthrax attack. Improving communication on existing dispensing plans may be a safer and more effective means of decreasing anxiety than pro- moting widespread availability of predispensed MCM. Table 4-3 provides a summary and comparison of the different potential forms of predispensing of MCM: the general safety-related advantages, the potential for inappro- priate use among the general population and target subpopulations, and associated costs.

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TABLE 4-3 144 Comparison of Potential for Inappropriate Use Among Different Potential Forms of Predispensed Antibiotics Potential for Inappropriate Use General Population Target Subpopulation(s) Form Advantages Costs (to whom) Personal Physician screening for Misuse is likely to be high Unknown whether they Baseline for predispensed Stockpile contraindications, allergies, differ from general MCM and drug interactions population a EUA MedKit Include screening out of Extremely limited data Two studies, with substan- Administrative costs at FDA; people allergic to the MCM; restricted to families of tial limitations, that used cost to assemble packages specific instructions and postal workers suggest target subpopulations show (customized to household); tamper-evident packaging; that misuse is decreased decreased misuse relative to limited economies of scale provision of instructions relative to historical historical prescription data on how to prepare for prescription data (no head-to-head com- children and adults who parison) (CDC, 2008b; IOM, cannot swallow pills; special 2010b) packaging to distinguish from routine prescriptions FDA-approved Same as above, but broader Very limited evidence Two studies, with substan- Most expensive b MedKit availability than EUA MedKit, to suggest it would be tial limitations, that used (requires approved MedKit, and screening by physician different from prescription target subpopulations show physician screening, or pharmacist medications decreased misuse relative to pharmacist dispensing) historical prescription data (no head-to-head com- parison) (CDC, 2008b; IOM, 2010b) NOTE: EUA = Emergency Use Authorization; FDA = Food and Drug Administration; MCM = medical countermeasures. a Screening currently is performed by nonmedical personnel. b Could be prescribed during normal patient-physician contact. Another possibility is that a public health professional or occupational health physician could write a standing order and set up a screening system.

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147 PREPOSITIONING STRATEGIES DHS (Department of Homeland Security). 2011. Fiscal year 2011 Homeland Security Grant Program: Guidance and application kit. Washington, DC: DHS, http://www.fema.gov/ pdf/government/grant/2011/fy11_hsgp_kit.pdf (accessed July 6, 2011). FDA (Food and Drug Administration). 2009. Letter to Biomedical Advanced Research and De- velopment Authority (BARDA) regarding BARDA request for emergency use authoriza- tion of postal worker Medkits. Silver Spring, MD: FDA, http://www.fda.gov/downloads/ Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/UCM107309.pdf (ac- cessed February 23, 2011). FDA. 2011. Medication guide: CIPRO. Silver Spring, MD: FDA, http://www.fda.gov/ downloads/Drugs/DrugSafety/UCM246794.pdf (accessed April 7, 2011). Frush, K. S., X. Luo, P .Hutchinson, and J. N. Higgins. 2004. Evaluation of a method to reduce over-the-counter medication dosing error. Archives of Pediatric & Adolescent Medicine 158:620-624. GAO (Government Accountability Office). 2008. States are planning for medical surge, but could benefit from shared guidance for allocating scarce medical resources. GAO-08- 668. Washington, DC: GAO, http://www.gao.gov/htext/d08668.html (accessed July 21, 2011). Get Smart Colorado. 2011. About Get Smart Colorado. http://www.getsmartcolorado.com/ (accessed June 21, 2011). Gostin, L. O., J. W. Sapsin, S. P. Teret, S. Burris, J. S. Mair, J. G. Hodge, and J. S. Vernick. 2002. The Model State Emergency Health Powers Act: Planning for and response to bioterrorism and naturally occurring infectious diseases. Journal of the American Medical Association 288(5):622-628. Griffith, J. 2011 (February 28). Postal plan antibiotic kits: A Minnesota perspective. Slides pre- sented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom.edu/~/media/ Session%204-%20Griffith_Other%20Examples%20of%20Prepositioning.pdf (accessed March 23, 2011). HHS (Department of Health and Human Services). 2009 (December). CDC’s CHEMPACK Project: Nerve agent antidote storage. Washington, DC: HHS, http://oig.hhs.gov/oei/ reports/oei-04-08-00040.pdf (accessed July 15, 2011). HHS, DHS (Department of Homeland Security), DOD (Department of Defense), DOJ (De- partment of Justice), and USPS (U.S. Postal Service). 2011. National postal model for the delivery of medical countermeasures. Washington, DC: HHS, http://www.phe.gov/ Preparedness/planning/postal/Documents/eo13527-section2.pdf (accessed July 8, 2011). HRSA (Health Resources and Services Administration). 2004. National Bioterrorism Hospital Preparedness Program: FY 2004 continuation guidance. Rockville, MD: HRSA, www. gnyha.org/eprc/general/funding/2004_BioT_Hospital.pdf (accessed June 18, 2011). HRSA. 2005. National Bioterrorism Hospital Preparedness Program: FY 2005 continuation guidance. Rockville, MD: HRSA, http://info.kyha.com/documents/NBTHPP.pdf (accessed June 18, 2011). HRSA. 2006. National Bioterrorism Hospital Preparedness Program: Program guidance fiscal year 2006. Rockville, MD: HRSA, https://grants.hrsa.gov/webExternal/DisplayAttachment. asp?ID=1C655E9F-924B-41A9-8539-FA022BF91DFE (accessed July 21, 2011). IAEA (International Atomic Energy Agency). 2011. IAEA International fact finding expert mission of the Fukushima Dai-Ichi NPP accident following the great East Japan earth- quake and tsunami. Vienna, Austria: IAEA, http://www-pub.iaea.org/MTCD/Meetings/ PDFplus/2011/cn200/documentation/cn200_Final-Fukushima-Mission_Report.pdf (ac- cessed July 10, 2011).

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148 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX IDSA (Infectious Diseases Society of America). 2008. Preliminary statement of the Infectious Diseases Society of America on the U.S. Department of Health and Human Service’s pro- posed informational guidance on home stockpiling of doxycycline for anthrax. Arlington, VA: IDSA, www.idsociety.org/WorkArea/downloadasset.aspx?id=11572 (accessed Febru- ary 23, 2011). Injac, R., V. Djordjevic-Milic, and B. Srdjenovic. 2007. Thermostability testing and degrada- tion profiles of doxycycline in bulk, tablets, and capsules by HPLC. Journal of chromato- graphic science 45(9):623-628. IOM (Institute of Medicine). 2008. Dispensing medical countermeasures for public health emergencies: Workshop summary. Washington, DC: The National Academies Press. IOM. 2010a. The 2009 H1N1 influenza vaccination campaign: Summary of a workshop series. Washington, DC: The National Academies Press. IOM. 2010b. Medical countermeasures dispensing: Emergency use authorization and the postal model: Workshop summary. Washington, DC: The National Academies Press. Janis, M. 2011 (April 20). Prepositioning for at-risk populations. Slides presented at the Insti- tute of Medicine Committee on Prepositioned Medical Countermeasures for the Public Meeting Three, Irvine, CA, http://iom.edu/~/media/Files/Activity%20Files/PublicHealth/ PrepositionedCountermeasures/Meeting%203/2%20-%20Janis%20-%20At-Risk%20 Populations.pdf (accessed September 15, 2011). Jernigan, D. B., P. L. Raghunathan, B. P. Bell, R. Brechner, E. A. Bresnitz, J. C. Butler, M. Cetron, M. Cohen, T. Doyle, M. Fischer, C. Greene, K. S. Griffith, J. Guarner, J. L. Hadler, J. A. Hayslett, R. Meyer, L. R. Petersen, M. Phillips, R. Pinner, T. Popovic, C. P. Quinn, J. Reefhuis, D. Reissman, N. Rosenstein, A. Schuchat, W.-J. Shieh, L. Siegal, D. L. Swerdlow, F. C. Tenover, M. Traeger, J. W. Ward, I. Weisfuse, S. Wiersma, K. Yeskey, S. Zaki, D. A. Ashford, B. A. Perkins, S. Ostroff, J. Hughes, D. Fleming, J. P. Koplan, J. L. Gerberding, and the National Anthrax Epidemiologic Investigation Team. 2002. Inves- tigation of bioterrorism-related anthrax, United States, 2001: Epidemiologic findings. Emerging Infectious Diseases 8(10):1019-1028. Kardas, P., S. Devine, A. Golembesky, and C. Roberts. 2005. A systemic review and meta- analysis of misuse of antibiotic therapies in the community. International Journal of Antimicrobial Agents 26(2):106-113. Karthikeyan, K. G., and M. T. Meyer. 2005. Occurrence of antibiotics in wastewater treatment facilities in Wisconsin, USA. Science of the Total Environment 361:196-207. Larson, E., S. X. Lin, and C. Gomez-Duarte. 2003. Antibiotic use in Hispanic households, New York City. Emerging Infectious Diseases 9(9):1096-1102. Lazaruk, S. 2011 (March 19). Radiation fear prompts run on iodine pills in B.C. The Vancouver Sun. http://www.vancouversun.com/Radiation+fear+prompts+iodine+pills/4473503/story. html (accessed March 21, 2011). Levy, S. B. 2001. Antibiotic resistance: Consequences of inaction. Clinical Infectious Diseases 33(Suppl. 3):S124-S129. Lien, O., B. Maldin, C. Franco, and G. K. Gronvall. 2006. Getting medicine to millions: New strategies for mass distribution. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 4(2):176-182. Live Process. 2011. Joint commission crosswalk: The standards 2011. Verona, NJ: Live Process, http://www.liveprocess.com/images/stories/liveprocess/downloadsandtools/joint_ commission_em_crosswalk_2010_to_2011.pdf (accessed August 12, 2011). Lurie, N. 2011 (July 21). Statement on bioterrorism, controlled substances and public health issues before the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health. Washington, DC, U.S. Congress, http://www.hhs.gov/asl/ testify/2011/07/t20110721b.html (accessed August 31, 2011).

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149 PREPOSITIONING STRATEGIES Mathias, A. 2011. State and local perspectives. Remarks presented to the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC. M’ikanatha, N. M., K. G. Julian, A. R. Kunselman, R. C. Aber, J. T. Rankin, and E. Lautenback. 2005. Patients’ request for and emergency physicians’ prescription of anti- microbial prophylaxis for anthrax during the 2001 bioterrorism-related outbreak. BMC Public Health 5(2). Minnesota Department of Health. 2006. Regional pharmaceutical cache system. St. Paul, MN: Minnesota Department of Health, www.health.state.mn.us/oep/responsesystems/ sns/snscache.pdf (accessed June 17, 2011). Missouri Department of Health and Senior Services. 2008. Pallet size and equipment require- ments. Jefferson City, MO: Missouri Department of Health and Senior Services, http:// health.mo.gov/emergencies/sns/pdf/LoadingDock.pdf (accessed August 5, 2011). Muccio, A. A. 2011 (March 1). Prepositioned medical countermeasures for the public: Com- munity health centers. Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Wash- ington, DC, http://www.iom.edu/~/media/Session%2010%20MuccioHospital%20%20 CHC%20Caches.pdf (accessed June 18, 2011). NABP (National Association of Boards of Pharmacy). 2010. Model pharmacy act/rules. Mount Prospect, IL: National Association of Boards of Pharmacy, http://www.nabp.net/ government-affairs/model-actrules/ (accessed August 12, 2011). Navas, E. 2002. Problems associated with potential massive use of antimicrobial agents as prophylaxis or therapy of a bioterrorist attack. Clinical Microbiology and Infection 8(8):534-539. NBSB (National Biodefense Science Board). 2008. Personal preparedness discussion: Ex- cerpted from the summary report of the National Biodefense Science Board June 18, 2008. Washington, DC: NBSB, http://www.phe.gov/Preparedness/legal/boards/nbsb/ Documents/nbsb-excrpt-pp-080618.pdf (accessed February 23, 2011). NLM (National Library of Medicine). 2008 (1 September). Doxycycline. Bethesda, MD: National Institutes of Health, http://www.ncbi.nlm.nih.gov/pubmedhealth/ PMH0000563/#a682063-storageConditions (accessed April 7, 2011). NRC (Nuclear Regulatory Commission). 2009. Backgrounder on emergency preparedness at nu- clear power plants. Washington, DC: NRC, http://www.nrc.gov/reading-rm/doc-collections/ fact-sheets/emerg-plan-prep-nuc-power-bg.html (accessed February 20, 2011). NYSOHS (New York State Office of Homeland Security). 2007. Annual report 2007. Al- bany, NY: NYSOHS, http://www.security.state.ny.us/publications/OHS%20Annual%20 Report%20Final%2007.pdf (accessed February 18, 2011). Olson, K. B. 1999. Aum Shinrikyo: Once and future threat? Emerging Infectious Diseases 5(4):513-516. Pfizer. 2011. Vibramycin [doxycycline formula] labeling. New York: Pfizer, http://labeling. pfizer.com/ShowLabeling.aspx?id=611 (accessed July 2, 2011). Public Health Law Network. 2011a. Legal issues relevant to private entities serving as closed points of dispensing (closed PODs) in emergencies. St. Paul, MN: Public Health Law Network-Robert Wood Johnson Foundation, http://www.publichealthlawnetwork.org/ wp-content/uploads/Closed-PODS-legal-issue.pdf (accessed June 20, 2011). Public Health Law Network. 2011b. Public Readiness and Emergency Preparedness (PREP) Act—liability protections for covered persons. St. Paul, MN: Public Health Law Network-Robert Wood Johnson Foundation. Rambhia, K. J., and G. K. Gronvall. 2009. Science for policymakers: Antibiotics resistance. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 7(4):371-377.

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150 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX RFDS (Royal Flying Doctor Service). 2011a. In focus—medical chests. Sydney, Australia: RFDS, http://www.flyingdoctor.org.au/Contact-Us/General-Enquiries/ (accessed July 27, 2011). RFDS. 2011b. Frequently asked questions. Sydney, Australia: RFDS, http://www.flyingdoctor. org.au/Search/Frequently-Asked-Questions-FAQs.html (accessed July 27, 2011). Richman, P. B., G. Garra, B. Eskin, A. Nashed, and R. Cody. 2001. Oral antibiotic use without consulting a physician: A survey of ED patients. American Journal of Emerging Medicine 19(1):57-60. Robbins, M. 2011 (March 1). Remarks presented to the Institute of Medicine Public Work- shop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC. Schillie, S. F., N. Shehab, K. E. Thomas, and D. S. Budnitz. 2009. Medication overdoses lead- ing to emergency department visits among children. American Journal of Preventative Medicine 37(3):181-187. Sepkowitz, K. A. 2011 (February 28). Immunocompromised hosts [and] drug resistance. Slides presented at the Institute of Medicine Public Workshop for the Committee on Preposi- tioned Medical Countermeasures for the Public, Washington, DC, http://www.iom.edu/~/ media/Session%207-%20Sepkowitz_Safety%20Issues.pdf (accessed June 19, 2011). Shehab, N. 2011 (March 1). Safety considerations for prepositioned antibiotics in the com- munity: A public health perspective. Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom.edu/~/media/Session%207-%20Shehab_Safety%20Issues. pdf (accessed March 13, 2011). Shehab, N., P. R. Patel, A. Srinivasan, and D. S. Budnitz. 2008. Emergency department visits for antibiotic-associated adverse events. Clinical Infectious Diseases 47(6):735-743. Shepard, C. W., M. Soriano-Gabarro, E. R. Zell, J. Hayslett, S. Lukacs, S. Goldstein, S. Factor, J. Jones, R. Ridzon, I. Williams, N. Rosenstein, and the CDC Adverse Events Working Group. 2002. Antimicrobial postexposure prophylaxis for anthrax: Adverse events and adherence. Emerging Infectious Diseases 8(10):1124-1132. Shulman, A. 2011 (March 1). Private sector perspectives and workplace caches. Remarks presented to the IOM’s Committee on Prepositioning Medical Countermeasures for the Public, Public Workshop, Washington, DC. Silver, A. 2011 (March 1). Home Care Association of New York State. Homebound popula- tion. Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom. edu/~/media/Session%208-%20Silver_Vulnerable%20Populations.pdf (accessed July 21, 2011). Smith, K. 2011 (March 1). Florida Division of The Salvation Army. Panel on Vulnerable Populations and Ethics. Remarks presented to the IOM’s Committee on Prepositioning Medical Countermeasures for the Public, Public Workshop, Washington, DC. Smith, K., and J. J. Leyden. 2005. Safety of doxycycline and minocycline: A systematic review. Clinical Therapeutics 27(9):1329-1342. Stargel, J. 2011 (March 1). Private sector perspective and workplace caches. Remarks pre- sented to the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC. Stergachis, A., C. M. Wetmore, M. Pennylegion, R. D. Beaton, B. T. Karras, D. Webb, D. Young, and M. Loehr. 2007. Evaluation of a mass dispensing exercise in a Cities Readi- ness Initiative setting. American Journal of Health-System Pharmacy 64(3):285-293. Stoil, R. A. 2010 (August 4). Lack of funds may mean having to buy your own gas mask. The Jerusalem Post, http://www.jpost.com/Israel/Article.aspx?id=183579 (accessed November 2010).

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151 PREPOSITIONING STRATEGIES Toner, E., R. Waldhorn, C. Franco, B. Courtney, K. Rambhia, A. Norwood, T. V. Inglesby, and T. O’Toole. 2009. Hospitals rising to the challenge: The first five years of the U.S. Hospital Preparedness Program and priorities going forward. Prepared for HHS, con- tract number HHSO100200700038C. Baltimore, MD: Center for Biosecurity of UPMC. Turnbull, P. 2011 (March 1). Private sector perspectives and workplace caches. Remarks presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC. Turner, J. 2011 (March 1). Prepositioning strategies: Colleges and universities. Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom.edu/~/media/Session%20 11B-%20Turner_Colleges%20-%20Other%20Strategies.pdf (accessed July 21, 2011). VA (Department of Veterans Affairs). 2010. Emergency management: Pharmaceutical cache program. Washington, DC: VA, http://www.publichealth.va.gov/emergencymanagement/ cemp_programs/pharm_cache.asp (accessed June 16, 2011). VA. 2011. Office of Acquisition and Logistics—National Acquisition Center—Business Resource Services. Washington, DC: VA, http://www.va.gov/oamm/oa/nac/brs/index.cfm (accessed July 26, 2011). Virginia Department of Health. 2009. Antiviral distribution plan: Attachment pandemic influenza. Richmond, VA: Virginia Department of Public Health, http://www.google. com/url?sa=t&source=web&cd=1&ved=0CBoQFjAA&url=http%3A%2F%2Fwww. vdh.state.va.us%2Foep%2Fdocuments%2F2009%2Fdocs%2FVDH%2520PanFlu%25 20Plan%2520Supplement%25207%2520-%2520Antiviral%2520Dist%2520%26%25 20Use%25209-24-2009.doc&rct=j&q=VDH%20Pandemic%20Influenza%20Plan%20 %E2%80%93%20Supplement%207%3A%20Antiviral%20Drug%20Distribution%20 and%20Use%20&ei=QG1fTpm4B5OdgQf5nfj8AQ&usg=AFQjCNEzcxFS_a_ gKW9FJvRIUKGCSa5c-g&cad=rja (accessed September 1, 2011). Yin, H. S., A. L. Mendelsohn, M. S. Wolf, R. M. Parker, A. Fierman, L. van Schaick, I. S. Bazan, M. D. Kline, and B. P. Dreyer. 2010. Parents’ medication administration errors: Role of dosing instruments and health literacy. Archives of Pediatrics & Adolescent Medicine 164(2):181-186. Zaric, G. S., D. M. Bravata, J.-E. Cleophas Holty, K. M. McDonald, D. K. Owens, and M. L. Brandeau. 2008. Modeling the logistics of response to anthrax bioterrorism. Medical Decision Making 28(3):332-350.

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