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Workshop Summary INTRODUCTION 1 Medical countermeasures are vital to protect the public against acts of terrorism and other public health emergencies. The need for an effec- tive system of dispensing medical countermeasures gained recognition in 1979 after the accidental release of radionuclides from the Three Mile Island nuclear power plant in Pennsylvania. If emissions had been higher, widespread dispensing of the countermeasure potassium iodide would have been necessary to prevent future cases of thyroid cancer among those living nearby or downwind. More than two decades later, in the fall of 2001, America witnessed its first bioterrorist attack of Bacillus anthracis (anthrax), spread by the bacterium’s spores on contaminated mail. Although the death toll from the 2001 anthrax attack was limited, 2 with only five deaths across six locations nationwide, more than 32,000 potentially exposed people received prophylaxis with oral antibiotics. Since 2004, the Cities Readiness Initiative (CRI) has addressed the threat potential of an outdoor anthrax dissemination in a large metropoli- tan area, including the countermeasure distribution and dispensing re- quirements of states and certain metropolitan jurisdictions. In addition, the program, operated through the Centers for Disease Control and Pre- vention (CDC), has provided guidance, funding, technical support, and program advisory for 72 jurisdictions to date. The CRI aims to improve the capacity of state and local jurisdictions to deliver medication and 1 The planning committee’s role was limited to planning the workshop, and the workshop sum- mary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. 2 Of 22 documented anthrax cases across the nation, 11 were by inhalation and 11 were by cutane- ous exposure. 1

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2 DISPENSING MEDICAL COUNTERMEASURES medical supplies during any large-scale public health emergency. The CRI acknowledges, and aims to address, the requirements associated with a window of only 48 hours from the time the decision is made to start countermeasures to the time they are actually dispensed. Respond- ing to an anthrax attack is one of the most demanding of all of the vast public health emergencies in both scope and task. Although it is just one of the many threats facing public health, anthrax was the primary focus of the workshop discussion. WORKSHOP DEFINITIONS, GOALS, AND OBJECTIVES With the threat of an anthrax attack as the case study, on March 3–4, 2008, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted a workshop titled “Medical Countermeasures Dispensing.” The workshop was organized by an independent planning committee. The following is a summary of the presentations and discussion that transpired during the workshop. 3 Any opinions, conclusions, or recommendations discussed in this work- shop summary are solely those of the individual persons or participants at the workshop and are not necessarily adopted, endorsed, or verified by the Forum or the National Academies. The overall workshop objective was to review a range of solutions to provide medical countermeasures rapidly to large numbers of people to protect them before or during a public health emergency, such as a bioterrorist attack or infectious dis- ease outbreak. In particular, the workshop goals were to: identify and discuss the most promising methods for dispensing medical countermea- sures as well as their inherent strengths and challenges; identify near- term opportunities for promoting efficient and effective dispensing mechanisms at the state and local level; and to bring invested stake- holders (including local, state, federal, nonprofit, and corporate represen- tatives) together to discuss these methods, opportunities, and challenges. Dispensing refers to the delivery of medical countermeasures to the population. Distribution, on the other hand, refers to transporting Strate- gic National Stockpile (SNS) assets (including vendor managed inven- tory) from its original location to the state receiving, staging, and 3 To download presentations or listen to audio archives, please visit http://www.iom.edu/CMS/ 3740/42532/50909/52001.aspx.

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3 WORKSHOP SUMMARY storing (RSS) warehouses, as well as the receipt, staging, storage, and transportation of materiel from the RSS warehouses to dispensing sites (see Box 1 for a glossary of key terms). Dispensing methods under discussion at the workshop were aimed at prophylaxis (prevention of illness), rather than at treatment (medical ef- forts to treat symptomatic individuals). Prophylaxis was described as one way to prevent mass casualties and to avoid overburdening and incapaci- tating a health care system that is ill equipped for treating mass casual- ties. Under the broad objective of prophylaxis, workshop participants were specifically asked to: (1) highlight challenges that arise in the cur- rent programs of dispensing of medical countermeasures, especially anti- biotics against anthrax, which must be given within 48 hours of the BOX 1 Glossary of Key Terms Distribution: The activity associated with the delivery of federal SNS assets from their original location to the state receiving, staging, and storing (RSS) ware- houses, as well as from the RSS warehouses to dispensing sites, alternate care facilities, and regional distribution sites/nodes. Dispensing: The activity associated with providing prophylaxis and other related medical materiel to an affected population in response to a threat or incident. This activity, which is conducted on the local level, is the final interface between provider and public. Points of dispensing (PODs): Locations where medical countermeasures are dispensed to the affected population. PODs may be open; that is, they are pub- lic sites visited by the at-risk population who have been directed to report to that site to pick up medical countermeasures. PODs may be closed; that is, they dispense medications to a select or pre-defined population, not the general pub- lic. Closed PODs dispense countermeasures to identified staff, family members, patients, contacts, and/or specific groups outlined in the provider’s mass pro- phylaxis dispensing plan. Independent of a closed or open POD, a POD may also be “medical” or “nonmedical.” A medical POD would mostly be staffed by medical personnel, who would primarily be responsible for dispensing medica- tion and conducting medical exams and triage procedures to determine whether cases are in the incubation stage or in need of hospitalization. In contrast, a nonmedical POD would be staffed by trained but nonmedical personnel, who would dispense medication and triage as appropriate, but would not conduct individualized medical assessments.

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4 DISPENSING MEDICAL COUNTERMEASURES decision to so in order to minimize casualties; (2) discuss potential inno- vations, tools, technologies, and frameworks available from sectors out- side the traditional public health system; and (3) explore potential public–private partnerships that are indispensable for expanding the ca- pacity to dispense countermeasures in a short time frame. The scenario used for discussions during the workshop was an an- thrax attack because such an attack already occurred in the United States, and it thus provides valuable empirical data on what measures worked and what challenges arose. The anthrax attack also presents public health planners with extreme logistical challenges, including the short time line essential for effective prophylaxis and the size of the potentially exposed population (tens of thousands). For these reasons, the lessons learned from and extrapolated to a widespread dissemination of anthrax— deemed by CDC to be among the most perilous types of bioterrorist agents—may be applicable to other types of bioterrorist attacks or public health emergencies. CURRENT CHALLENGES AND THREATS Public health emergencies such as an intentional anthrax release, or infectious disease threats such as severe acute respiratory syndrome (SARS) and pandemic influenza, highlight the ever-changing threats posed by acts of terrorism and other public health emergencies, while also underscoring the pressing reality of these events. However, these events present different stresses on the public health community. As dis- cussed during the workshop, a bioterrorist event such an anthrax attack represents a deliberate attack that threatens our national security and our public health. A naturally occurring event such as an influenza pandemic is a public health crisis with national security implications (due to the numbers who might become ill—armed forces, public safety workers, etc.). Therefore, the key is for the nation to plan aggressively to counter- act the threat of future public health emergencies, said Dr. Gerald Parker, the principal deputy assistant secretary in the Office of the Assistant Sec- retary for Preparedness and Response at the Department of Health and Human Services (HHS). However, he asserted, the United States is un- prepared to confront the full range of threats. Another presenter noted that one of the main criticisms leveled at the federal government by the 9/11 Commission was a “failure of imagina- tion,” underscoring the point that the government did not anticipate the

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5 WORKSHOP SUMMARY nature of the threat and thus had no systems in place to counteract it. Many other presenters sounded the alarm that the public health system has been beleaguered since the 1980s (IOM, 1988) and is inadequately staffed for a widespread attack. Issues presented at the workshop as im- pediments to successful, comprehensive antibiotic countermeasure deliv- ery to the population included labor, physical facility capacity, security, liability, and financial sustainability. The anthrax example, Parker said, dramatically brings to light the seriousness of the threat and the nation’s lack of preparedness in two major ways. The first is the need to dispense countermeasures within an extremely short time window to minimize morbidity and mortality from anthrax. The second is the allure of anthrax or other biological toxins (e.g., ricin) to terrorist groups because of their relatively low cost and ease of production and dispersal. Many existing technologies can be used to disperse aerosolized forms of these agents over massive and heavily populated areas, posing a risk to hundreds of thousands of people (Baccam and Boechler, 2007). Distribution of Medical Countermeasures: The Strategic National Stockpile The magnitude of the challenge facing America requires experience in the logistics of wide-scale distribution and dispensing of countermea- sures by all levels of government, and the private sector’s assistance is also crucial. The SNS, which was first established in 1998 as the Na- tional Pharmaceutical Stockpile, is a national repository of medicine and medical supplies. The stockpiles are strategically located around the United States to ensure that once federal and local authorities agree that SNS deployment is needed, “12-hour push packs” of medications and/or supplies can be delivered to any designated receiving and storage site within 12 hours, while other managed inventory can be in place within 24 hours of the decision to deploy. Once the SNS materiel arrive at the designated site, state and local authorities assume responsibility for the materiel and oversee storage, distribution, and dispensing (CDC, 2008). Under this division of responsibility, the largest challenges and gaps are at the local level. It is widely believed that upon activation, the federal government would be able to distribute the necessary SNS materiel to state and local agencies within 12 to 24 hours. Public health officials could then begin dispensing from local caches, thus meeting the ideal

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6 DISPENSING MEDICAL COUNTERMEASURES dispensing time frame of 12 to 36 hours from SNS activation. However, most communities still lack adequate mechanisms and capacity to expe- ditiously dispense countermeasures to all of the exposed and potentially exposed populations, Parker said. Dispensing Medical Countermeasures The demands on local governments are extensive, and local officials may benefit from partnering with other sectors to develop solutions, noted Gregory Burel, the Senior Executive Service Director, Division of Strategic National Stockpile, CDC. A joint government–private partner- ship or a “community” response with government leadership is necessary to ensure the most positive outcome. The CRI, for example, provides federal pre-event or planning leadership through a federal program aimed at providing selected cities with technical assistance to expand their ca- pacity to dispense countermeasures within this 48-hour window. Even so, it is important to acknowledge that the actual operational requirement still rests with state and local entities, and that is where the intergovern- mental and nongovernment liaison is paramount. As will be highlighted throughout this document, public–private partnerships may be leveraged to assist in these efforts. Challenges and Moving Forward Countermeasure dispensing must harness all types of imaginative partnerships between public and private institutions, working together in ways tailored to individual community needs, Parker asserted. The chal- lenge requires incentives for and commitments from the private sector to enter into innovative partnerships with government agencies, with bene- fits to each partner. Several presenters emphasized that community-level planning, capacity, training, and response would be improved by collabo- ration between public and private sectors. Countermeasure dispensing at the local level depends on new and creative types of local partnerships, Parker said. Whatever their configu- ration, partnerships must be geared to each community’s needs. The pub- lic health system as a whole must also address the major gaps and obstacles to local dispensing of countermeasures, such as liability protec- tion for participation by private partners, communication with the public,

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7 WORKSHOP SUMMARY and security around dispensing sites. The task ahead is fundamentally important to national security and public health, Parker concluded. CURRENT PLANS AND GAPS REGARDING MEDICAL COUNTERMEASURE DISPENSING Under the current system, the dispensing of medical countermeasures at the local level is the final step in a complex and interactive process starting with federal, state, and local public health programs. For the sys- tem to work effectively, participants must understand the urgent nature of the public health threats, such as anthrax. For example, anthrax pro- duces spores that enter the body through the lungs, mouth, or skin. After the initiation of symptoms, death can occur as quickly as two or three days, with a high percentage of mortality among those infected, said Dr. Sid Baccam of Innovative Emergency Management. Consequently, an- thrax exposure requires prophylaxis by oral antibiotics promptly after exposure, optimally within 48 hours, and before symptoms arise. Once someone becomes symptomatic, he or she must be treated because if the individual becomes ill and does not receive timely treatment, the fatality rate approaches 100 percent. Even with supportive care in the hospital, symptomatic inhalational anthrax cases are approximately 50 to 75 per- cent fatal (CDC, 2003; Inglesby et al., 1999). Therefore, due to the sig- nificant risk, standard public health procedures call for erring on the side of prudence and administering antibiotics to everyone who might have been exposed, even before symptoms are apparent. The short time window for preventing illness after anthrax exposure compels the public health system to respond as swiftly as possible to de- liver post-exposure prophylaxis (PEP). As described by Baccam, optimal management of the health effects from a bioterrorist attack includes rapid action, progressing in stages known as the four “Ds”: detect, decide, dis- tribute, and dispense. The ability to rapidly detect an anthrax exposure, decide on deployment of the SNS, distribute countermeasures to state and local health authorities, and dispense to affected populations within 48 hours of the decision to do so requires herculean efforts. In the anthrax scenario, the federal government is responsible for procuring and stockpiling the antibiotics (among other countermeasures), according to legislation requiring CDC to establish SNSs of medical countermeasures throughout the country. Once the attack is detected and the decision is made to transfer stockpiled antibiotics to the states, state

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8 DISPENSING MEDICAL COUNTERMEASURES governments distribute antibiotics within their borders to pre-designated sites established primarily by local governments as “points of dispens- ing” (PODs). Most local governments, their partners, or other organiza- tions expect to dispense the majority of countermeasures from PODs to large groups of people. Each locally designated POD, in other words, receives its countermeasures from state authorities, which in turn have received them from the SNS (CDC, 2008). This workshop focused on the final step in the process: medical countermeasure dispensing from PODs and via alternative mechanisms to their populations. Public health planners have used PODs as the major framework for planning countermeasures dispensing, yet PODs pose some of the greatest challenges, including their location, design, opera- tions, capacity, workforce, and a host of other factors. Dispensing Medical Countermeasures: Time Considerations The foremost problems arise from delays in starting and completing the initial dispensing of prophylaxis. Speaker Baccam illustrated that even short delays have striking effects on morbidity and mortality, ac- cording to various models (Baccam and Boechler, 2007). At the local level, where dispensing occurs, the degree of morbidity and mortality is impacted by at least three factors: (1) the time of onset of a post- exposure prophylaxis campaign (i.e., the time to deliver the initial pill), (2) the capability in completing the campaign (i.e., the time to deliver the last pill), and (3) the capacity of nearby hospitals to treat symptomatic patients. Symptomatic people need to be treated in hospitals. A commu- nity with limited hospital bed capacity will be completely overwhelmed with a high caseload and thereby experience greater mortality. The three local factors were modeled by Baccam in hypothetical scenarios shown in Figure 1. In Case A, which is the most effective case, the prophylaxis campaign starts on Day 1 and is completed by Day 2. In Case B, the campaign starts on Day 2.5 and is less efficient, taking 4 days to complete. The unmarked black line in Figure 1 illustrates the time frame over which infected people, if there is no prophylaxis cam- paign, will progress from the incubation period to becoming sympto- matic. In the absence of PEP, all infected people become symptomatic (Inglesby et al., 1999). In Case A, 100 percent of infected people are still in the incubation stage when they receive prophylaxis; they are prevented

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9 WORKSHOP SUMMARY from becoming symptomatic and thus do not need hospital care. In Case B, nearly 100 percent of infected people are still in the incubation period when the campaign is started, but they become symptomatic due to the inefficiency of the PEP campaign. This lack of efficiency is, in other words, linked to how many people are served by the PODs and other methods over a set period of time, that is, the throughput. The conse- quence of delays in starting the PEP campaign—and the longer duration of initiation of the PEP campaign in Case B—is that more than 50 per- cent of infected persons become symptomatic and thus need hospital care, noted Baccam. Whether their lives will be saved depends on the community’s hospital capacity and availability of treatment. The end result of these two hypothetical scenarios is that a delay of a mere 1–2 days in start-up time has profound effects on the efficacy of the cam- paign, with up to 50 percent more morbidity and mortality in the hypo- thetical cases depicted here (see also Baccam and Boechler, 2007). However, degeneration of the hospital capability is not fully represented in its impact. Another speaker, Dr. Nathaniel Hupert of Weill Cornell Medical College, discussed the relationship between the expected surge in hospi- tal admissions after an anthrax attack and the tactics used in POD-based antibiotic dispensing campaigns. His model, the Regional Hospital Caseload Calculator, uses two factors to determine outcomes: the delay until starting dispensing (or “time to first pill”) and the duration of the campaign once started (or “time to last pill”). Within the first week after an anthrax attack, shortening the “time to last pill” can be expected to decrease hospitalizations by 2 to 6 percent for each day saved. Using the Caseload Calculator in conjunction with another Cornell model, the Bioterrorism and Epidemic Outbreak Response Model, he calculated that achieving these reductions in hospitalization may require up to a 33 per- cent increase in POD throughput, which will have important human re- source implications for preparedness planning.

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10 DISPENSING MEDICAL COUNTERMEASURES Timelines for: Detect Decide Distribute Dispense Avoid Can Save with Oral Antibiotics 100 Percentage of Prophylaxed People Who Percent WeBecoming Symptomatic 80 Case A 60 40 Case B 20 0 0 1 2 3 4 5 6 7 8 Time after Attack (days) Time After Attack (Days) FIGURE 1 Timelines for the 4 Ds—detect, decide, distribute, and dispense— in two hypothetical scenarios. The 4Ds are critical in determining how well we mitigate an intentional release of anthrax through mass prophylaxis. SOURCE: Baccam (2008). POD Models Cities Readiness Initiative The focus of the federal efforts to dispense medical countermeasures has been through the Strategic National Stockpile, as described by Burel. “12-hour push packs” are in place near major population centers. One of CDC’s core functions related to stockpiling is to advance the CRI. 4 As recently as 2003, there were few PODs and no alternative dispensing sites, which are crucial to enhancing dispensing capacity. The goal of the CRI is to provide, in concert with responsible jurisdictions, mass prophy- laxis to 100 percent of an exposed or potentially exposed population 4 For more information about the CRI, visit http://www.bt.cdc.gov/CRI/.

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11 WORKSHOP SUMMARY within 48 hours of the decision to do so. Today, the CRI has extended its reach to 72 locations covering 57 percent of the U.S. population, Burel said. Those cities have already designated 3,500 PODs. The CRI is strengthening POD infrastructure with state and local partners through technical assistance, including training, electronic mailing lists (listservs), management practices, education of the public via satellite broadcasts, and advice on security to enforce public safety around PODs. The CRI is experimenting with POD structures of many types, including “pull” and “push” mechanisms. Pull mechanisms require the general public to come pick up the countermeasure from open PODs, e.g., drive- through clinics or clinics established at schools, where as push mecha- nisms involve state and local officials pushing the countermeasures out to entities that are then responsible for delivering the countermeasure to specific populations. For example “push” mechanisms through which countermeasures are delivered to residences through social services, such as Meals on Wheels and home health care, or using the U.S. Postal Ser- vice to deliver countermeasures to individual residences. Several of these concepts, including pull and push mechanisms are discussed in greater detail in the next section. Medical and Nonmedical PODs In addition to the time of initiation and the duration of the campaign, there are a host of other features for localities to consider in the design and operation of their PODs, as discussed by a number of speakers in- cluding Baccam, Burel, and Hupert. One is the location of the POD. Lo- calities are expected to position their PODs at accessible sites (typically sites used for voting), such as high schools, large auditoriums, or elemen- tary schools, in ways that best serve the local community. Another key question is who staffs a POD and how many PODs and staff will be re- quired. There are two types of POD designs, medical and nonmedical. A medical POD would mostly be staffed by medical personnel who would primarily be responsible for dispensing medication and conducting medi- cal exams and triage procedures to determine whether cases are in the incubation stage or in need of hospitalization. In contrast, a nonmedical POD would be staffed by trained but nonmedical personnel, who would dispense medication and triage as appropriate, but would not conduct individualized medical assessments.

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22 DISPENSING MEDICAL COUNTERMEASURES BOX 6 Ideas for Improving Current Planning Efforts • Create innovative frameworks, models, and partnerships for the public and private sectors to meet the massive challenge of dispensing countermeasures to affected populations within 48 hours of the deci- sion to do so. • Streamline the design of points of dispensing (PODs) to vastly in- crease the number of people who receive countermeasures in the quickest possible time. • Cultivate novel alternative POD designs, especially through public– private partnerships for numerous functions, including reduced pres- sure on public PODs. • Harness technology systems to track and register people who receive medicines and their medicine lot numbers. • Identify in advance those at risk for adverse effects from a given coun- termeasure. • Ensure liability protection for private-sector partners to distribute and dispense countermeasures. • Recruit a large workforce, train them, and ensure back-up to fill in if the regular workforce is inadequate or unavailable during an emer- gency. • Perform actual planning exercises that permit and encourage impro- vised decision making. • Identify the best methods of communication during a public health emergency as well as where and how to obtain medical countermea- sures. • Provide security at PODs and other dispensing sites. The use of “pre-positioning,” however, is controversial and it was sug- gested by a workshop participant that perhaps prior placement of coun- termeasures should be restricted to public health personnel and other first responders, as opposed to the general public. Pre-positioning for first responders could mean that critical personnel and/or volunteers would be issued antibiotics after being identified and trained. Another possibility is that local pharmacists, through public–private partnerships, could help to screen individuals who may need assistance, clinical evaluation, access to pharmaceutical records, and knowledge of drug–drug interactions, said presenter Mike Simko of Walgreens, a pharmaceutical chain with 6,000 U.S. pharmacies. Moreover, pharma- cists have the added advantage of being able to perform immunizations in many states. Immunizations may be critical in a public health emer-

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23 WORKSHOP SUMMARY gency and pharmacists may be able to offer their expertise to expand the workforce needed in an emergency. Similar points about the multiple clinical roles played by pharmacists were reiterated by Greg Sciarra of CVS Caremark. Carter Mecher from the White House Homeland Security Council reinforced the idea that a combination of several partially effective ac- tions, such as a layered strategy, would be needed to address the goal of rapidly dispensing countermeasures to a large population. Another prin- ciple is that the field is not starting from scratch. Many local govern- ments, some described below, have already entered into partnerships with the private sector. Those partnerships are beginning to spring up in many localities and are tailored to meet precise local needs, according to speakers Teresa Bates of the Department of Public Health of Tarrant County, Texas, and Robert Mauskapf of the Virginia Department of Health. Bruce Baker, the SNS coordinator for the Maryland Department of Health and Mental Hygiene, described his experience working with a variety of private-sector partners including a major trucking company, Maryland public television, newspapers, and big-box retail stores. A final and interrelated principle is that no single approach will work for every community. Local governments say they are seeking a menu of options from which they can pick and choose to meet their specific needs, sev- eral speakers noted. Any private establishment that can rapidly serve large numbers of customers represents a potential opportunity for a public–private partner- ship. Potential dispensing sites for open PODs could even include sites such as McDonald’s, Starbucks, and Wal-Mart, noted several panelists. Other sites might include restaurants, special pharmaceutical vending machines, retail stores, pharmacies, grocery stores, banks, automatic teller machines, and any other venue with drive-through facilities, Koonin said. She noted that McDonald’s serves thousands of customers a day at a single location. By entering into agreements with local govern- ments, these organizations could be innovatively adapted to become pre- designated as open PODs. Agreements typically require the private party to provide security, staffing, and recordkeeping (on recipients of the countermeasure and/or the number and nature of any adverse events), among other elements. Developing model agreements (Memorandum of Agreement) for use by state and local governments and HHS would ex- plore Public Readiness and Emergency Preparedness (PREP) Act provi- sions for liability and emergency protection allowances.

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24 DISPENSING MEDICAL COUNTERMEASURES Lynne Kidder of the Business Executives for National Security high- lighted the importance of establishing public–private partnerships at the local level, where personal relationships are more easily established and later maintained during an event. Jason Jackson, the Director of Emer- gency Management for Wal-Mart Stores, Inc., echoed the sentiment that experience has shown that public and private partners are able to work together extremely well during a disaster to solve problems, particularly if the groundwork has been laid in advance to establish a trusting rela- tionship. Jack Herrmann, Project Director of Public Health Preparedness at the National Association of County and City Health Officials (NACCHO), also noted that it is important for local public health de- partments to reach out to and stay in touch with their current and poten- tial business partners; frequent communication and collaboration can help to reduce the language and cultural differences between the public and private sectors. The CDC may also develop a template Memorandum of Agreement (MOA) to assist local governments and organizations in their efforts to create public–private partnerships, suggested Dulin. Closed PODs Closed PODs, which are not open to the public and instead focus on one particular group (such as a company’s employees and their families), may be an ideal means for large employers to partner with the public sec- tor. The benefits to each partner are numerous. For the public partner, fewer people would need to be served at nearby open PODs. Pamela Blackwell, Director of the Center for Emergency Preparedness and Re- sponse for the Cobb and Douglas Boards of Health in Marietta, Georgia, estimated that the currently planned closed PODs in the metro Atlanta area might reduce the number of people who need access to open PODS in case of an event by 40 to 50 percent, allowing public health to focus on at-risk populations in places such as jails and nursing homes. There is even a multiplier effect, as the household members of the employee may also receive countermeasures at the closed POD. Panelist Shortal noted that, in the case of a 10,000-person corporate headquarters, the total served when their families are included might easily reach 50,000 peo- ple, or more. For the employer, a large benefit is that their employees feel more secure that they and their families are protected. Employee security may foster greater loyalty to the company, reduce turnover, and promote swifter return to commercial operations after the emergency,

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25 WORKSHOP SUMMARY thereby restoring the company’s and possibly the local community’s economic viability (Lindner, 2006). However, employer concerns regard- ing potential liability from dispensing medications would need to be ad- dressed, emphasized Shortal, Mugno, Jackson, Kidder, and other participants from the private sector. Other benefits of closed PODs were articulated by speaker Karen Drenkard, chief nurse executive of Inova Health Systems in Virginia. Her health system has already become a closed POD by entering into a partnership with the government. That designation enabled her to pur- chase a cache of medications large enough to cover Inova Health Sys- tems’ 17,000 employees. Ensuring coverage for hospital personnel (and their families) is imperative to ensure readiness of critical hospital staff and to minimize absenteeism from staff who may become ill or reluctant to come to work if they do not have countermeasures available to them early in the event. Drenkard said Inova hospitals’ closed PODs have a dispensing ca- pacity of 1,200 people an hour. For staffing at the closed PODs, her or- ganization brought in nonclinical volunteers and trained them in groups of 10 to 20. To recruit more volunteers, Drenkard began a program that taps into nursing, pharmacy, and social work students. She and her staff also developed an “incident command system” with a clear chain of command. As part of a preregistration process, Drenkard set up a layered approach to distribute in advance a 3-day supply of countermeasures to homes of staff and family. The rest of the doses would be dispensed around the time of the emergency. However, provisions and guidance for the dispensing of countermeasures from closed POD had not been com- pletely formulated. Closed PODs have already proved to be appealing to large employ- ers in Tarrant County in Texas. Panelist Teresa Bates reported that since 2006, she has been partnering with several local businesses and universi- ties to create closed PODs. Her department requires the private-sector partner to have at least 600 employees to participate. As part of the signed agreements between the employer and the health department, the employer is required to provide medical staff and armed security during the event. Her department trains the employers’ POD staff as Medical Reserve Corps volunteers.

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26 DISPENSING MEDICAL COUNTERMEASURES Preregistration and Prescreening of Individuals For the broader problems of increasing efficiency and detecting ad- verse effects of countermeasures, regardless of whether PODs serve the public or private sector, Drenkard recommended a type of preregistration system akin to an E-ZPass, 7 which is used on many highways to facili- tate traffic flow by collecting tolls through advance registration. By gath- ering medical information in advance—with confidentiality protected— an individual could receive medical countermeasures more quickly, and be flagged ahead of time as at risk of suffering a drug–drug interaction or serious adverse effects (and thus receive a possible alternative drug). Medical recordkeeping is important not only to identify adverse effects in individuals, but it is also is an essential means to track whether a par- ticular batch of a given countermeasure is contaminated. By tracing epi- demiological patterns of adverse effects, in other words, epidemiologists will be able to determine whether an adverse event is an isolated case or whether it is tied to a contaminated lot of the countermeasure, for which a recall might be necessary. PODs of any configuration can use information technology to dis- pense countermeasures in an efficient and swift manner. One potential way to achieve that was suggested by speaker Noah Glass, chief execu- tive officer of GoMobo, Inc., a company that uses innovative mobile technologies to allow consumers to preorder food from restaurants online or via text message. Based on his experience, he outlined a similar sys- tem that could rely on cell phones and text messages to help individuals avoid long lines at PODs. Within less than 2 years, a system could be developed to pre-register individuals and families, acquire pertinent medical information, and provide detailed educational materials. At the time of an emergency, a text message or automated call to the owner of the cell phone would be used to assign a location and time at which the head of household (or other household member) should arrive at the POD. Once there the individual would identify the last four digits of a cell phone number or other code in order to obtain a prepackaged set of countermeasures in the amount necessary for the size of his or her household. However, as suggested by a participant, questions remain 7 E-ZPass is an electronic toll collection system used throughout the northeast United States that allows participants in the program to preregister accounts so that tolls may be deducted from prepayments made by the users. A small, removable sign attached to the middle of the upper windshield allows participants to pass through tolls without stopping, which ultimately improves the flow rates at toll booths.

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27 WORKSHOP SUMMARY about the availability of cell phones during an event, so research may need to be conducted to determine how such a system could be devel- oped to ensure it were operational during an event. Despite the promise of preregistration and prescreening as a way to increase the efficiency of medical countermeasures dispensing in the case of an event, many important questions remain regarding the feasibil- ity of this approach, including how to address privacy concerns as well as the technical challenges of creating, maintaining, and updating such a system. Staffing Requirements Public–private partnerships can be used to ensure coverage of addi- tional essential functions at PODs or alternative sites of delivery, the foremost being extra staffing, communication, health education, and se- curity. If insufficient staff are available, private partners that specialize in these areas or temporary agencies may be able to assist by recruiting ex- tra staff as needed. For example, one option that was highlighted by speakers was the possibility of using the knowledge and expertise of pharmacists to help screen and triage persons arriving at PODs. Another example of using existing resources, noted speaker Henry, is to harness a large range of public employees currently serving the public, such as first responders, firefighters, and other types of public employees, including the National Guard. In the Washington, DC, metropolitan area, many jurisdictions already mandate service by public employees in case of an emergency. In addition, individuals serving in the Medical Reserve Corps and Community Emergency Response Teams may also be called upon to assist in these efforts. To describe the opportunities offered by temporary agencies, the workshop heard from Jonathan Means, senior vice president and general manager of central operations and businesses for Kelly Services. Temporary employment agencies have the expertise and systems to recruit staff within a short period of time and have the capacity to set up call centers, for example, to assist in the dissemination of important information. However, although public–private partnerships offer a mechanism to strengthen capacity, many questions raised were left unanswered. For example, it was suggested that the POD model may require more than double the current public health staffing to implement, but is this an ac- curate estimate? Another question that remains unanswered is how re-

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28 DISPENSING MEDICAL COUNTERMEASURES peated and/or multiple attacks would be handled, and how many staff and resources would be needed to do so. Security In many communities, the availability of public-sector security per- sonnel to provide services during countermeasures dispensing is a rate- limiting step. Potential partnerships with private security firms specifi- cally devoted to maintaining public safety and security to provide addi- tional security resources may be a feasible solution to the shortage of public-sector security personnel. Christopher Hetherington, a crisis man- ager at Citigroup, noted that there are 1.8 million trained private security officers in the United States. The distribution of these private officers is widespread because they are employed at banks and other establishments throughout the country. Just as the Office of Homeland Security already foresees that these officers are a component of their plan to respond to catastrophic events, it is reasonable to anticipate partnerships for protect- ing the public at PODs and any other alternative sites. Issues regarding recruiting, credentialing, and training of these security personnel would need to be resolved, as would the matter of liability and compensation. Communication Systems Finally, communication with the public is a vital function long be- fore, as well as during, a public health emergency. In the case of anthrax exposure, pressure on public and private PODs will be alleviated if ex- posed individuals know where to go to get medical countermeasures and how to seek medical attention if they are ill. All public health depart- ments, for example, have pre-scripted messages that are ready to be sent out during a public health emergency; yet a multi-layered communica- tion strategy is necessary to reach the greatest number of people. Devel- oping excellent communication systems is an important goal for public– private partnerships, given the multiple avenues through which people now receive their news and education. One speaker observed that the more the public knows, the less likely they are to panic. Speaker Mauskapf spoke of his experience with maintaining strong working part- nerships with the media serving his state, Virginia, including the Na- tional Association of Broadcasters and local and national newspapers.

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29 WORKSHOP SUMMARY Mauskapf indicated that his organization is publishing information about and descriptions of anthrax in four languages. Speaker Neff also pointed out the challenge of communicating with and meeting the needs of non- English-speakers, and subsequently the necessity of developing appro- priate communication strategies for non-English speakers. Other speak- ers pointed out the key role of the Internet for obtaining and updating information during a highly fluid crisis. Paul Freibert, a public health planner from the Kentucky Public Health Department, noted that one of his subcommittees routinely invites the television stations serving his state to be part of the planning process. LIABILITY PROTECTION FOR CORPORATIONS AND NONPROFIT PARTNERS During public health emergencies, both corporations and nonprofit organizations are concerned about the extent of their liability protection if they participate in countermeasures dispensing. Fear of liability has been a major deterrent to expansion of public–private partnerships, in- cluding research and development, according to Margaret Binzer, a part- ner at McKenna Long & Aldridge, LLP. She explained that under current federal and state laws, individual volunteers (e.g., “Good Samaritans”) and government agencies (including their employees) have strong legal protections in dispensing during national emergencies, yet corporations and other entities lack immunity from liability in these circumstances. Recognition of the problem led to passage of new federal legislation, the Public Readiness and Emergency Preparedness Act of 2005 (Public Law 109-148), also known as the PREP Act. At the time of passage, the PREP Act was hailed as a far-reaching piece of tort reform, giving liability protections to manufacturers willing to sell countermeasures during national emergencies. It protects manu- facturers when selling pandemic products, security countermeasures, drugs, devices, and biological products. It also extends immunity to dis- tributors and program planners, as well as to health care professionals who dispense medical countermeasures (Hoffman, 2008). The trigger for these liability protections is a declaration by the Health and Human Ser- vices Secretary that a public health emergency exists or is likely to exist. A Secretarial public health emergency declaration, if appropriately drafted, could provide additional liability protection to the private sector for assisting in the dispensing of medical countermeasures.

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30 DISPENSING MEDICAL COUNTERMEASURES Although the PREP Act at the time of its passage seemed proactive to ensure coverage for future emergencies, it has only been used once. What was unforeseen was that the legal process to trigger a Secretarial declaration of a public health emergency has proved cumbersome and time consuming, Binzer said. Since passage of the Act, there has been only one declaration by the Secretary for sale and distribution of a vac- cine against the avian flu H5N1, as well as supplements for H7 and H9 influenza vaccines. That so few declarations have been issued has been yet another signal to the private sector to remain deeply concerned about liability exposure, said Binzer and several other participants. A panelist mentioned that a large-scale anthrax attack would undoubtedly trigger a PREP declaration as well as a Presidential Disaster Declaration. Another significant problem exists at the state level; few state stat- utes furnish immunity from liability to corporations and other entities when they act as Good Samaritans. In other words, private-sector entities such as hospitals, hotels, retail outlets, stadiums, and other organizations that donate time, space, supplies, and resources to emergency prepared- ness rarely enjoy liability protection (Hoffman, 2008). Iowa became the first state to extend its statutory Good Samaritan liability protection to corporations and nonprofit entities acting in good faith to provide emer- gency aid during a public health disaster. Georgia also recently passed similar innovative legislation—the Georgia Corporate Good Samaritan Act of 2008—to extend Good Samaritan protections to other entities be- sides individuals. Its basic features, which are described in Box 7, could serve as a model for other states. Liability protections are necessary to enlist support of the private sector in public–private partnerships, such as dispensing countermeasures to their employees (“closed PODs”). Similar efforts are under way in other states to explore ways to work within ex- isting state laws to ensure that emergency volunteers and entities have broader immunity from liability during emergency response activities or to establish formal Good Samaritan entity liability protection for busi- nesses.

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31 WORKSHOP SUMMARY BOX 7 The Georgia Corporate Good Samaritan Act of 2008 The Georgia Corporate Good Samaritan Act of 2008 provides that: • Any natural person, association, organization, or private entity (direc- tors, employees, and agents of such organization); • Working in coordination with and under the direction of an appropriate state agency; • Who voluntarily without the expectation or receipt of compensation; • Provides services or goods to another to prevent or minimize harm re- sulting from an emergency or disaster for which an emergency is de- clared by the Governor or federal agency; • Shall not be civilly liable to any natural person receiving such assistance as a result of a good faith act or omission unless the damage was caused by willful wanton negligence or misconduct of such natural per- son, association, organization, or entity. SOURCE: Public/Private Legal Preparedness Initiative (2008). CONCLUSION In concluding the workshop, Parker’s presentation summarized many of the comments made throughout the workshop, that planning and pro- viding for countermeasures dispensing is not just the concern of govern- ment, but is a shared public–private responsibility to protect lives in a community. A new civil defense for the 21st century is needed, charac- terized by a set of shared responsibilities among all levels of government, individuals, and communities. Public health cannot do this job alone— collaboration from the private sector will be necessary to rapidly provide life-saving countermeasures to large numbers of people in a community. Combining multiple strategies to create a layered approach may afford the most resilient and effective system to accomplish this goal. Parker noted that the United States is just about to reach the goal of having stockpiled sufficient antibiotics to provide post-exposure prophy- laxis for 60 million people for 60 days in the event of an anthrax attack. However, Parker continued, if we do not have the mechanisms to get these lifesaving medicines in the hands of Americans after such an attack or multiple attacks within a very short timeframe, we have squandered an opportunity to save lives. Parker noted that an analogy can be found in

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32 DISPENSING MEDICAL COUNTERMEASURES the school buses that ended up underwater in New Orleans after Hurri- cane Katrina. Those school buses, if harnessed early, could have been used to evacuate thousands of New Orleans citizens out of harm’s way. Instead, this valuable resource was rendered useless. We must ensure that the same does not happen to the resources in our stockpile, said Parker. When a strategist considers the potential threats against this nation in the arena of terrorism, two scenarios stand out as “strategic” in their im- pact: the first is a nuclear attack and the second is a bioterrorist anthrax attack on a large metropolitan area, noted Parker. The effects on this so- ciety in terms of loss of life and productivity of life, economic and psy- chological impact, and sustainability of a way of life would be unparalleled and unprecedented in American history. The efforts of fed- eral, state, and local government have been considerable in preparing for the response to a widespread anthrax incident. It has been the focus of countless hours and untold industry, yet as evidence by the presentations made during the workshop there are a number of efforts underway to improve a communities efforts. However, the nation is not comprehen- sively prepared to mount the greatest possible defense. One other fact has emerged from the attempt to address this great charge, continued Parker. In a country where the government is a concept of, by, and for the peo- ple, its defense, resiliency, and best chance at sustainability depends on the willingness and ability of the people to work with government through a “shared responsibility,” and it is imperative that the need for shared responsibility be understood. Parker said that throughout the workshop he and other speakers, in- cluding Minson, Shortal, and Robert Holman from Dallas County Health and Human Services, had discussed this new concept of “Civil Defense for the 21st Century,” and suggested the need for partnership between the government and the other key stakeholders—including corporate entities, nonprofits, other organizations, and individuals—is strongly seen in countermeasures response. If we are to save the greatest number of lives, then we must act to ensure that a complementary array of response capa- bilities are robust, vigorous, and ready, concluded Parker. The work of the IOM Forum, its members, and the workshop panel has been to move forward that principle.