INTRODUCTION1

The negative health impact of many large-scale public health emergencies, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or the recent 2009 H1N1 influenza pandemic, can be mitigated significantly by medical countermeasures such as antimicrobials, antivirals, and vaccines. To be effective, these countermeasures generally must be delivered in very large quantities in a short period of time. For example, in the event of an outdoor release of aerosolized anthrax over a wide geographic area, hundreds of thousands to millions of people would need prophylactic antibiotics within 48 hours of exposure to prevent deadly inhalational anthrax. In the event of an influenza pandemic, the timing is less urgent (although to be most effective antiviral medications should be taken by patients who have been symptomatic for no more than 2 days), but the entire population could be affected and extremely large quantities of antiviral medications would need to be dispensed.

Adding to these challenges, an extensive array of different medical countermeasures are needed to protect the public against the large number of known and unforeseen chemical, biological, radiological, and nuclear threats. Despite ongoing efforts to develop existing and new countermeasures from discovery through approval by the Food and Drug Administration (FDA), when a public health emergency occurs, the best

1

The workshop series was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshops. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Forum or The National Academies, and should not be construed as reflecting any group consensus.



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INTRODUCTION 1 The negative health impact of many large-scale public health emer- gencies, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or the recent 2009 H1N1 influenza pandemic, can be mitigated significantly by medical countermeasures such as antimicrobi- als, antivirals, and vaccines. To be effective, these countermeasures gen- erally must be delivered in very large quantities in a short period of time. For example, in the event of an outdoor release of aerosolized anthrax over a wide geographic area, hundreds of thousands to millions of people would need prophylactic antibiotics within 48 hours of exposure to pre- vent deadly inhalational anthrax. In the event of an influenza pandemic, the timing is less urgent (although to be most effective antiviral medica- tions should be taken by patients who have been symptomatic for no more than 2 days), but the entire population could be affected and ex- tremely large quantities of antiviral medications would need to be dispensed. Adding to these challenges, an extensive array of different medical countermeasures are needed to protect the public against the large num- ber of known and unforeseen chemical, biological, radiological, and nu- clear threats. Despite ongoing efforts to develop existing and new countermeasures from discovery through approval by the Food and Drug Administration (FDA), when a public health emergency occurs, the best 1 The workshop series was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshops. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Forum or The National Academies, and should not be construed as reflect- ing any group consensus. 1

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2 MEDICAL COUNTERMEASURES DISPENSING countermeasure available to detect, prevent, or treat the disease or injury may be unapproved or approved for different indications. The restricted time frame of a response is unlikely to allow sufficient time to receive FDA approval. Because of the scope of these programs and the tremendous chal- lenges involved in implementing and executing them, the delivery of medical countermeasures during a public health emergency has been identified as one of the major challenges facing the medical and public health community. In November 2009, the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events con- vened a meeting to discuss recent progress made in the nation’s ability to rapidly and effectively deploy medical countermeasures in response to public health threats, along with remaining challenges and vulnerabili- ties, and strategies to address these challenges in future work. About the Preparedness Forum The IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events was established to foster dialogue among a broad range of stakeholders—practitioners, policy makers, community mem- bers, academics, and others—and provide ongoing opportunities to con- front issues of mutual interest and concern. The Preparedness Forum provides a neutral venue for broad-ranging policy discussions that aid in the coordination and cooperation of public and private stakeholders in developing and enhancing the nation’s medical and public health prepar- edness. Members include representatives and leaders from local, state, and federal governments; leaders of health professional and business as- sociations; and other stakeholders and key decision makers. The Preparedness Forum has a long-standing interest in medical countermeasures and has hosted several other workshops on this issue. The first workshop focused largely on opportunities to improve dispens- ing strategies, especially through public–private partnerships, and associ- ated liability protections for corporations and nonprofit partners (IOM, 2008). A more recent workshop, held in February 2010, examined the Public Health Emergency Medical Countermeasures Enterprise and aimed to identify innovative strategies to enhance products from discov- ery through approval (IOM, 2010a). Finally, in the spring of 2010 the Forum hosted a series of three regional workshops to examine successes

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3 WORKSHOP SUMMARY and lessons learned from the 2009 H1N1 influenza vaccination campaign (IOM, 2010b). 2 Workshop Objectives and Overview The workshop described in this document was held in Washington, DC, on November 18, 2009. It aimed to provide an overview of the cur- rent threats, progress made, and remaining vulnerabilities in the public health system with regard to dispensing medical countermeasures. Work- shop presentations and discussions focused in depth on two areas in which important advances have recently been made: Emergency Use Au- thorization (EUA) and the pilot of a U.S. Postal Service (USPS) medical countermeasures dispensing model in Minneapolis–St. Paul, Minnesota. These topics are introduced briefly here, and discussed in much greater detail in their respective sections (see Box 1 for a glossary of key terms). Workshop attendees included representatives from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and others within the Department of Health and Human Services (HHS), as well as state and local health departments, the private sector, and others. The workshop agenda is in Appendix B and biographical sketches of planning committee members, speakers, and panelists are in Appendix C. Due to the timing of the meeting, the response to the 2009 H1N1 influenza pandemic was at the forefront of participants’ minds. The first section of this summary describes efforts—which, at the time of the workshop, were ongoing—to distribute and dispense medical counter- measures for 2009 H1N1, including antivirals, vaccine, and personal pro- tective equipment, such as N95 respirators. This was a new kind of response; prior to 2009 H1N1, most mass dispensing planning efforts had been done through the Cities Readiness Initiative, discussed in more detail below, and focused primarily on rapidly dispensing antibiotics through points of dispensing (PODs). At the workshop, participants dis- cussed lessons learned and opportunities for enhancing future medical countermeasures dispensing efforts based on their experiences during the response to 2009 H1N1. Nevertheless, they also noted that pandemic influenza is just one of the many threats facing public health, and empha- 2 Summaries of these workshops and workshop audio files and slides are available for download via the Preparedness Forum’s website, http://www.iom.edu/preparedness forum.

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4 MEDICAL COUNTERMEASURES DISPENSING sized that many of the other potential threats would require an even more rapid response. The Project BioShield Act of 2004 (Public Law 108-276), among other measures, amended Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) to establish the EUA program. EUA permits the FDA Commissioner to authorize the use of an unapproved medical product, or an unapproved use of an approved medical product, during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security (FDA, 2007). The EUA program is designed to strengthen pub- lic health protections against biological, chemical, radiological, and nu- clear agents by enabling access to the best available medical countermeasures when there are no adequate, approved, and available alternatives. Although the Project BioShield Act granted the authority for EUA in 2004, only two EUAs had been issued prior to 2009. In response to the 2009 H1N1 influenza pandemic, in 2009 and 2010 EUAs were issued for 22 products, covering pandemic vaccine, antivirals, N95 respi- rators, and diagnostic tests. Because of this, those involved in issuing, interpreting, and using EUAs gained much deeper experience during the year leading up to the workshop, and many new developments emerged. Workshop participants discussed policy implications of EUAs, strategies to limit potential logistical challenges that could delay the dispensing of medical countermeasures, and other challenges and outstanding issues. The Postal Model for dispensing medical countermeasures uses postal carriers to rapidly deliver the countermeasures to residents for self-administration. A pilot of this model was undertaken recently in Minneapolis–St. Paul. Workshop participants from Minnesota, USPS, FDA, and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) described the process of developing the pilot pro- gram. The process included developing a logistical plan, meeting USPS carrier union and management requirements, and obtaining an EUA for the placement of MedKits in the homes of the postal carriers who volun- teer to participate in the program. Since the workshop, President Barack Obama has issued an Executive Order that, among other provisions, or- ders the federal government to pursue a national U.S. Postal Service medical countermeasures dispensing model to respond to a large-scale biological attack (The White House, 2009).

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5 WORKSHOP SUMMARY About This Summary This document highlights and summarizes the workshop presenta- tions and discussions, including recent developments, success stories, and lessons learned regarding distributing and dispensing medical coun- termeasures, EUA, and the pilot of the Postal Model. The summary also highlights opportunities and areas for future work, as identified by work- shop participants. Whenever possible, unique ideas or concepts presented at the workshop are attributed to the individual who first advanced those concepts. In situations where many participants made similar points, the recurring themes are identified. Any opinions, conclusions, or recom- mendations discussed in this workshop summary are solely those of the individual participants and should not be construed as reflecting consen- sus or endorsement by the workshop, the Forum on Medical and Public Health Preparedness for Catastrophic Events, or The National Academies. BOX 1 Glossary of Key Terms Cities Readiness Initiative (CRI): The Centers for Disease Control and Prevention’s Cities Readiness Initiative is a federally funded program designed to enhance preparedness in the nation’s largest cities and metropolitan statistical areas, home to more than half of the U.S. population. Through CRI, state and large metropolitan public health departments develop plans to respond to a large-scale bioterrorist event by dispensing antibiotics to the entire population of an identified city or metropolitan statistical area with 48 hours (CDC, 2010a). a Dispensing : Dispensing is the activity associated with providing prophylaxis and other related medical material to an affected population in response to a threat or incident. This activity, which is conducted at the local level, is the final interface between provider and public. Distribution: Distribution is the activity associated with the delivery of federal Strategic Na- tional Stockpile assets from their original location to the state receiving, staging, and storing (RSS) warehouses as well as from the RSS warehouses to dispensing sites, alternate care facilities, and regional distribution sites/nodes. Emergency Use Authorization (EUA): EUA is an authorization issued by the Food and Drug Administration (FDA) for the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national secu- rity (FDA, 2007). Medical Countermeasure (MCM): MCM is a drug, biological product, or device that treats, identifies, or prevents harm from a biological, chemical, radiological, or nuclear agent that may cause a public health emergency.

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6 MEDICAL COUNTERMEASURES DISPENSING Points of Dispensing (PODs): PODs are locations where medical countermeasures are dispensed to affected populations. Pre-Emergency Use Authorization (pre-EUA): A pre-EUA is a submission sent to the FDA for review prior to the determination of an actual or potential emergency in order to reduce the time needed during an emergency to review the submission and consider authorization of the product (FDA, 2005). Project BioShield Act (Public Law 108-276): Passed in 2004, Project BioShield was de- signed to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear agents. The legislation instituted a secure funding source for the purchase of critical medical coun- termeasures, took steps to facilitate research and development, and facilitated the use of medical countermeasures in an emergency by establishing the Emergency Use Authoriza- tion (HHS, 2010a). Public Readiness and Emergency Preparedness Act (PREP Act) (Public Law 109-148): Passed as part of the Department of Defense Appropriations Act in 2005, the PREP Act authorizes the Secretary of the Department of Health and Human Services (“Secretary”) to issue a declaration (“PREP Act declaration”) that provides immunity from tort liability (ex- cept for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats, and conditions deter- mined by the Secretary to constitute a present or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures (HHS, 2010b). Strategic National Stockpile (SNS): SNS is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration and airway maintenance supplies, and medical/surgical items. The SNS is designed to supplement and resupply state and local public health agencies in the event of a national emergency anywhere and at anytime within the United States or its territories (CDC, 2010b). a The above definition describes the use of the term dispensing in the field of preparedness and response. The profession of pharmacy defines dispensing as “the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container appropri- ately labeled for subsequent administration to, or use by, a patient” (NABP, 2010, p. 7). MEDICAL COUNTERMEASURES DISTRIBUTION AND DISPENSING IN RESPONSE TO THE 2009 H1N1 INFLUENZA PANDEMIC Since the anthrax attack in 2001, many new programs, tools, and policies have been developed to enhance the nation’s ability to use medi- cal countermeasures to protect the public against acts of terrorism and other public health emergencies. These include the Cities Readiness Ini- tiative (CRI), Project BioShield, the Public Readiness and Emergency Preparedness Act (PREP Act), and EUA. Despite these advances, the enormous scope and tremendous challenges involved in implementing and executing medical countermeasures programs leave much work to be

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7 WORKSHOP SUMMARY done. The threat may emerge anywhere or everywhere across the coun- try, there are many different known and yet-unknown threats, and the time frame is always tight. The response to the 2009 H1N1 influenza pandemic, which was ongoing as of the date of the workshop, provided an important opportunity to assess the strengths and vulnerabilities of the medical countermeasures distribution and dispensing system, and, under the significant pressure associated with a real-world event, to develop new programs, tools, and policies that addressed needs as they arose. At the workshop, representatives from several of the primary entities involved in the response—federal agencies, state and local public health departments, and the private sector—discussed their roles in distributing and dispensing countermeasures in response to the 2009 H1N1 influenza pandemic. While by no means a comprehensive review of medical coun- termeasures dispensing in the response to 2009 H1N1, workshop presen- tations and discussions did highlight some successes, pressing issues of concern, and areas for future work. This section begins by describing the activation and response of the CDC’s Strategic National Stockpile (SNS), which supplied antiviral medications and other countermeasures to locations across the country. The section then briefly describes some of the challenges that state and local public health departments faced dur- ing the 2009 H1N1 response. Following that, it highlights two innovative public–private partnerships that were formed during the response: the Commercial Supply Chain Dashboard and the unprecedented level of involvement of pharmacies and pharmacists in countermeasures dispens- ing. Finally, the section mentions remaining issues to be addressed in order to enhance public–private partnerships, and outlines efforts re- cently made to provide liability protection for those involved in medical countermeasures dispensing. The use of EUAs during the 2009 H1N1 response was a central focus of the workshop and will be discussed in greater detail in the next main section. Many of these issues were examined in more depth, and with the benefit of additional time for reflection, in a series of regional workshops hosted by the Preparedness Forum in April and May 2010. Participants examined the 2009 H1N1 vaccination campaign and identified strategies to improve future emergency vaccination programs and other medical countermeasures dispensing campaigns. A summary of these workshops is forthcoming (IOM, 2010b). At the workshop described in this document, several participants noted that the 2009 H1N1 response provided an important opportunity to learn and enhance systems for medical countermeasures distribution and

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8 MEDICAL COUNTERMEASURES DISPENSING dispensing. However, they also cautioned that lessons learned from the 2009 H1N1 response may not apply directly to responses to other threats because the specific nature of a threat imposes particular constraints on the response. For example, in the case of an anthrax release, the time for response is extremely short, but the affected geographic area may be more restricted than other threats. In response to these particular chal- lenges, the CRI and the Postal Model, discussed in detail later in this summary, focus on dispensing antibiotics to the entire population of the nation’s largest cities and metropolitan statistical areas within 48 hours, using mechanisms such as PODs and delivery by postal carriers. By contrast, responding to an influenza pandemic involves different constraints, which will vary depending on the characteristics of the influ- enza strain. The pandemic may affect a very large geographic area, per- haps reaching most parts of the country, and different kinds of countermeasures may be required, including antivirals, vaccine, N95 res- pirators, and diagnostics. Unlike the anthrax scenario, the time for re- sponse will be longer than 48 hours, although time pressures exist in all situations in which medical countermeasures are needed. Because of dif- ferences in timing and in the kinds of countermeasures required, the mechanisms used to distribute and dispense countermeasures for an in- fluenza pandemic are likely to be different than for an anthrax attack, and may focus more heavily on delivering the countermeasures to healthcare providers for administration to their patients. Regardless of the scenario contemplated, workshop participants em- phasized the importance of developing layered, multifaceted approaches to medical countermeasures distribution and dispensing. This could in- clude “push mechanisms” that drive medical supplies directly out into the community immediately following an incident, forward preposition- ing of materials so initial supplies are available locally, and MedKits prepositioned in individual residences, among other possible approaches. “No single strategy is going to work in being successful,” said Matthew Minson, then-senior medical officer for strategic initiatives at HHS/ASPR. “It is going to have to be a combined effort.”

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9 WORKSHOP SUMMARY Distribution from the Strategic National Stockpile (SNS) Responding to an influenza pandemic is a major focus of medical countermeasures distribution and dispensing plans. Pandemics have oc- curred throughout history, and although a pandemic is declared based solely on the ease and speed of disease transmission (as opposed to the lethality of the disease), pandemic flu can have a high toll on health. Each year in the United States, between 5 and 20 percent of the popula- tion is infected with influenza A (the seasonal flu) and approximately 24,000 people die (range 3,300 to 48,600) (CDC, 2010c). In a pandemic, the infection rate can be much higher, and the death toll rises accord- ingly. The pandemic of 1918 killed an estimated 50 million people worldwide (about 3 percent of the global population), including ap- proximately 675,000 people in the United States (CDC, 2010d). Pandem- ics also occurred in 1957 and 1968, but they were less severe. With this as the backdrop, the first news of a new strain of Influenza A—2009 H1N1—in the United States and Mexico triggered surveillance for an emerging pandemic. It also triggered a nationwide plan for medi- cal countermeasures distribution and dispensing. At the federal level, a major component of the response plan was the release of stockpiled countermeasures (e.g., antivirals) from the SNS. The SNS response released the largest quantity of countermeasures yet, in a more accelerated time frame than ever, demonstrating the SNS capa- bility to respond to influenza. Nevertheless, the situation also highlights the challenges of responding to a scenario such as the one involving an- thrax; despite the speed of the 2009 H1N1 response relative to previous efforts, it would not be fast enough to protect the nation from an anthrax attack. This subsection outlines the time line and logistical considerations of the SNS’s response to 2009 H1N1, describes the development of a new public–private partnership designed to improve situational awareness of the commercial supply chain in order to enhance decision making and streamline information sharing, and highlights some areas that partici- pants identified for additional work to enhance future responses. Time Line and Logistics In early spring, the CDC confirmed two cases of H1N1 in humans in California, the same virus determined to be circulating in Mexico (Box 2). Cases were also seen in Texas, Kansas, and New York. The flu was

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10 MEDICAL COUNTERMEASURES DISPENSING BOX 2 Timeline of Division of SNS Activities in Response to the 2009 H1N1 Influenza Pandemic Spring Timeline • April 21, 2009: Centers for Disease control and Prevention (CDC) confirms five U.S. cases in California and Texas. • April 23, 2009: Mexican officials announce the same virus is circulating in their country. • April 25, 2009: CDC confirms more cases in Kansas and New York City. • April 26, 2009: Department of Health and Human Services declares a public health emergency and HHS/CDC decide to push 25 percent of flu countermeasures contained in the Strategic National Stockpile. Trucks are on the road by 10 p.m. the same night. • May 3, 2009: All but two target areas have influenza countermeasures. • May 7, 2009: All product delivered to the 62 target areas. Fall Timeline • August 25, 2009: Commercial Supply Chain Dashboard initial meeting with commercial partners. • October 1, 2009: Deployment of 300,000 Tamiflu oral suspension regimens. • October 21, 2009: Deployment of 59.5 million N95 respirators. • October 23, 2009: Commercial Supply Chain Dashboard launched. • October 24, 2009: IV Peraminvir web portal launched; 1,200 5-day treatment courses available. • November 2, 2009: Deployment of remaining 240,000 Tamiflu oral suspensions regimens. • November 6, 2009: Receipt of additional 10,000 5-day courses of IV peramivir totaling 11,200 5-day courses. occurring at an unusual time of year and was killing young, healthy pa- tients, who are not usually at risk of death from influenza. At the workshop, Greg Burel, director of the CDC’s Division of Stra- tegic National Stockpile (DSNS), described the time line of the DSNS response and the intense activity during the months following identifica- tion of the first cases. Within 5 days of the initial diagnosis, the CDC decided to release a quarter of the antiviral countermeasures from the SNS and push them out across the country to any states that chose to re- ceive them. It was the first time that medical countermeasures had been released from the stockpile in such a massive effort to address an imme- diate threat.

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11 WORKSHOP SUMMARY To facilitate distribution of products, the United States and its protec- torates are divided into 62 “project areas,” or centers of population. Trucks began transporting materials out from the strategic stockpiles and toward project areas by 10 p.m. of the day the decision was made to be- gin releasing materials. Within 9 hours, the first trucks began to arrive in New York City. Within 7 days, all project areas except the two in the Pacific Island territories had received stockpiles of antiviral countermea- sures. The last two project areas received countermeasures 4 days later. To accomplish this task, two 12-hour shifts of 31 people loaded 363 trucks and 18 aircraft. A total of $265 million worth of product was moved at a rate of 60 pallets per hour. In October and November, an additional 540,000 Tamiflu oral sus- pension regimens were deployed from the SNS as public health officials geared up for the reappearance of 2009 H1N1 during the traditional flu season. In addition, 59.5 million N95 respirators—personal protective equipment that protects against the transmission of virus—were distrib- uted to state and local health departments. While these preventive measures were happening, the SNS took on a second mission of a different character—the distribution of peramivir IV, an intravenous antiviral medication for hospitalized patients with com- plicated disease. The peramivir deployment brought two complicating factors to the process. First, peramivir IV had not yet been approved by the FDA for any use, and could only be deployed through an EUA. The EUA for peramivir will be discussed in additional detail in the next sec- tion. Second, its inventory was “vendor managed,” meaning that the stockpiles did not physically reside in the SNS warehouses. Instead, phy- sicians requested the treatment regimen through a web portal developed by the CDC. Once the order was received and approved, it was filled in- dividually at the manufacturer, with shipments completed within 24 hours of order and delivered directly to the hospital where the patient and his/her physician were located. Commercial Supply Chain Dashboard During the crisis it became clear to federal and state health officials that there was limited visibility into the commercial supply chain for critical supplies such as antiviral drugs and N95 respirators. This made the task of responding to situations on the ground much more difficult. To address this issue, government and commercial partners came to-

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44 MEDICAL COUNTERMEASURES DISPENSING MedKits To successfully complete a mission of this magnitude, volunteers themselves need to have rapid access to antimicrobials and personal pro- tective equipment so they are protected as they deliver medication to the community. Families of the volunteers should have access to antimicro- bials as well so that the volunteers would know that their families were protected. “They would not have to worry about seeing those family members into a POD or clinic and then get in to effect the mission,” Plessas said. In fact, the union leadership of the postal carriers and man- agement at the USPS required, as a condition of participation in the pro- gram, that their members be provided with antibiotics in advance of an incident. “They felt they wouldn’t be able to respond minuteman-like if they didn’t have that stuff already in hand. The challenge then fell to the federal government to try and help in making that happen,” said Minson of HHS. In response to this concern, postal carriers who volunteer have re- ceived MedKits to keep in their homes. MedKits are medical kits con- taining supplies of needed prescription pharmaceuticals for use by members of the household only as directed during a declared public health emergency. In this case, the kits contain doxycycline hyclate tab- lets. The kits are also known as Household Antibiotic Kits (HAKs). Qualified healthcare providers, under the auspices of the public health authorities, screened and cleared the postal carriers to receive the Med- Kits. Postal carriers who had a contraindication for doxycycline were not permitted to volunteer to participate in the postal program. The use of MedKits has been controversial because of concerns re- garding the ability of households to properly store and maintain the kits and to reserve them for emergency use, as well as safety concerns about the self-administration of prescription medications without medical su- pervision. A pilot study was conducted in St. Louis to evaluate the use of MedKits in households (CDC, 2007). They were provided to approxi- mately 4,000 households. The study looked at the ability of households to maintain MedKits in the home as directed and reserve them for emer- gency use, and attitudes and perceptions regarding the MedKits. Partici- pants included corporation employees, first responders, and clients and staff of a community health clinic. At the workshop, Laura Eiklenborg, formerly deputy director of emergency preparedness for the City of Min- neapolis and now director of public-sector solutions at OptumHealth, pointed to this study as an example of what has worked in the pre-event

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45 WORKSHOP SUMMARY placement of post-exposure prophylaxis. At the end of the study, 97 per- cent of participants were able to return their MedKits intact. However, despite the promising results of the pilot study, others have noted that additional studies should be conducted to ensure safety and prevent misuse before the MedKit program is implemented on a wide scale (IOM, 2008). In particular, the pilot study was not able to test whether participants were able to accurately and safely prepare and use the medication by following the enclosed instructions during an actual emergency. Nor did the study test the effects of the conditions under which the MedKits were stored in participants’ households. At the work- shop, Erin Mullen of PhRMA’s Rx Response noted that the bathroom medicine cabinet is one of the worst places to keep medications because it tends to be warm and humid. Before MedKits could be provided to the postal carriers, however, the planners had to overcome a legal restriction. Specifically, given the materials and instructions in the volunteer kits, the FDA deemed the MedKit to constitute an off-label use, thus requiring an EUA. Following standard emergency protocol, the individual MedKits contain a 10-day regimen of doxycycline instead of the usual 60-day treatment regimen for anthrax exposure. The household kits included doxycycline and in- structions for use to cover anyone in that household for 10 days—adults and children of all ages, including people with medical conditions, preg- nant women; they even have preparation instructions for dysphagic adults. Because of both the 10-day regimen and the written information that would accompany the medication, the kits were identified as involv- ing the unapproved use of an approved product, thus requiring an EUA. Postal Model EUA As noted above, a key feature of the postal model is that the postal carriers who volunteer are provided with MedKits to keep in their homes before an emergency occurs. This complicated the effort to obtain an EUA to cover the MedKits because an EUA can only be issued following the determination of a threat and declaration of an emergency, as dis- cussed earlier. For all other EUAs that have been issued, the threat de- termination and declaration of an emergency were made after the emergency had been detected. In the case of the MedKits for the postal model, however, the Secretary of the Department of Homeland Security made the threat determination in advance of an actual event. He stated

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46 MEDICAL COUNTERMEASURES DISPENSING that there is a significant potential for a domestic emergency involving a heightened risk of attack with Bacillus anthracis (DHS, 2008). On the basis of this threat determination, the Secretary of HHS declared an emergency justifying an EUA for the MedKit. Based on the threat deter- mination and the emergency declaration, the FDA was able to review the request and issue the EUA. Additional details, including the conditions of authorization, can be found in the letter of authorization (FDA, 2008). Because the EUA is dependent on the emergency declaration, the EUA is valid until the emergency is declared over. The emergency decla- ration justifying the EUA was renewed in 2009, and continued to be ef- fective as of the date of the workshop. With the EUA in place, home MedKits were packaged and provi- sioned to the volunteers. Supplies for the delivery units were pre- positioned and fit tests for N95 masks have been completed. In addition to the 10-day MedKits for placement in their households, Plessas said that individual-dose MedKits will be provided to the volunteers so they can be activated on the day of the emergency. These have also been called individual Household Antibiotic Kits (iHAKs). “Literally, if [the postal carriers] are there in the morning, or if they are coming off the street, we can send them back out,” Plessas said. This EUA is the only EUA to have been issued before an actual event, and it was only the second EUA of any kind issued by the FDA. Therefore, those involved gained much experience and insight into the process. The lessons learned, as reported by the workshop participants, are detailed below. Lessons Learned During the EUA Process Negotiations and discussions about the EUA request were drawn out because, as Plessas explained, “The urgency of [an] attack already suf- fered didn’t exist.” Throughout the process, several issues came to light: 1. End-user needs: Targeted end-users should brief the FDA directly on issues such as operational response requirements, Plessas said. In the case of the postal model, many operational considerations needed to be addressed because volunteers were going to act as medical countermeasures responders. For exam- ple, the plan needed to address what happens if someone has the day off. Everything needs to be properly understood for the EUA

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47 WORKSHOP SUMMARY to effectively and efficiently support the end-users in their mis- sion. Plessas noted that direct dialog with the FDA might have helped smooth things along during the process. 2. Forms: There was a huge disconnect between state and federal authorities about what basic forms, such as anthrax screening forms and patient information sheets, needed to look like. “Keep in mind that by this time in history, the states had spent at least 6 years developing their own screening form for things like an- thrax; we already had those tools in place,” said Sell of the Min- nesota Department of Health. “And then I was given a federal form that didn’t jibe with, for instance, our state epidemiologist, who has to sign off on these kinds of things.” Negotiating these types of differences was time consuming and difficult, especially because there was little clarity on what could be changed and what could not. The people who needed to be at the table dis- cussing these issues weren’t present at the beginning, meaning that these issues had to be worked out late in the process. 3. Roles and responsibilities: Roles and responsibilities need to be explicitly articulated in the EUA request, or amendments may be necessary after the EUA is released, Plessas said. This occurred with the postal EUA. After the EUA was released in October 2008, amendments were made that went into effect in February 2009. Two additional minor changes were being pursued as of the date of the workshop. 4. Communication: Specific to the postal EUA, an HHS press re- lease went out to the general public about the program before the volunteers had received the final word from postal management. This resulted in some internal consternation. The take-home les- son is that internal partners and stakeholders should be kept up to date before anything is released to the public. 5. Medication expiration dates and annual renewal requirements: As currently stated in the EUA, MedKits have an annual expira- tion date, with an annual renewal process in place. Eiklenborg noted that it requires significant effort from both USPS and pub- lic health authorities to manage the logistics related to the expiration of drugs, redispensing medications, and rescreening volunteers.

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48 MEDICAL COUNTERMEASURES DISPENSING Security and Workforce Protection The Postal Model relies heavily on law enforcement to protect the USPS workers and the stockpile. The postal carriers who volunteer need to feel safe to complete their mission, and the delivery units (post offices and delivery annexes) need to be secure areas for the medications to be processed for delivery. In developing the pilot, the Minneapolis Department of Health de- termined what was needed to complete the plan, and then presented the findings and the mission to the local and state law enforcement agencies in the area to seek their collaboration. They began by determining what the law enforcement requirements would be for the postal model, com- pared with what would be needed to provide security for a plan that was based solely on PODs. It became clear quickly that, while the demand on local law enforcement in the first 12–24 hours of the postal model is slightly higher, demand remained much more intensive with the PODs, requiring multiple shifts over multiple days. “It became readily apparent to the law enforcement partners that the postal model actually provides the best opportunity for the optimization of law enforcement use in get- ting meds into people’s mouths,” Plessas said. Nevertheless, the law en- forcement requirement—one law enforcement officer to accompany each postal carrier—continues to be considered one of the more challenging aspects of the postal model. Despite these concerns, by taking advantage of existing memoran- dums of understanding among the Minneapolis Police Department, the St. Paul Police Department, and the Minnesota State Patrol, there are now commitments well in excess of what is actually needed to execute the postal model as it currently stands. It is important to note that the postal EUA is specific to postal em- ployees, so it does not cover the law enforcement partners. Therefore, these partners are not able to have MedKits pre-positioned in their homes. Instead, Plessas explained, “They have a cache program for pro- phylaxis whereby there is a cache dedicated for emergency responders within the Twin City areas.” Programs to supply emergency responders with protective equipment such as N95 respirators are also in place within the different departments. Although much of the workshop discussion focused on the security requirements of the postal model, FedEx’s Mugno also emphasized that security is a concern throughout the countermeasures dispensing system. He mentioned an example of a hospital emergency department being

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49 WORKSHOP SUMMARY overrun in Memphis when 2009 H1N1 vaccine was first available. “Se- curity is definitely still an issue and [it] needs to be resolved and talked about a lot more,” he said. Areas for Future Work Workshop participants discussed areas for future work arising from the issues seen in the Minneapolis–St. Paul pilot of the Postal Model for dispensing medical countermeasures. The key areas were an EUA to cover first responders, as well as issues surrounding expiration dates and which medications are included in the model. EUA for First Responders Workshop participants discussed the idea of creating an EUA for first responders that would be similar to the one for the USPS postal car- riers who volunteered to participate in the countermeasures delivery plan. This would enable the law enforcement officers who accompany the postal carriers on their routes to also have MedKits in their homes. Sev- eral workshop participants noted that these law enforcement officers would have the same safety concerns for themselves and their families as the postal carriers who have been provided with MedKits. Providing MedKits only to the postal carrier could raise questions of equity. Fur- thermore, because the model calls for each postal carrier to be accompa- nied by a law enforcement officer, these first responders must be available to begin the dispensing route as quickly as possible. However, there are a number of challenges associated with developing such as EUA, including lack of familiarity with EUAs and the complexity of the first-responder community. Tim Conley, director of preparedness and planning for the Village of Western Springs Department of Fire/EMS Services and Emergency Man- agement in Illinois noted that most first responders have never heard of EUAs. “In general there is a huge lack of understanding and training in the first responder community when it comes to public health. They do not know what they are facing,” he said. “We would run into a fire, point, go. They will go. They will chase the bad guys down the street, getting shot at. They will run at them, they will go. [But] they do not un- derstand a biological event.”

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50 MEDICAL COUNTERMEASURES DISPENSING The second, more difficult challenge is that the first responder com- munity has a very complex structure that varies across jurisdictions. Even within one metropolitan area, there are multiple law enforcement agencies operating. By contrast, the USPS is one federal entity—a postal carrier in one city has the same paycheck, reporting structure, mandate, job responsibilities, and even uniform as a postal carrier in another city. In fact, the postal model and its associated EUA are not specific to Min- neapolis–St. Paul, but can be applied to any CRI location where the par- ticipating public health authority is willing to take on the roles and responsibilities spelled out in the postal model and the EUA. In order to have an EUA for first responders, there would need to be some type of umbrella structure that can create the ability for the fragmented commu- nity of first responders to act together. As Minson explained, “EUA requires [that] you have some element of medical direction, an accountable measure, a reporting structure and ultimately the ability to recoup the kits if the EUA comes to determine this. When you start to talk about the very complex interplay with emer- gency service districts and EMS and fire departments and shared person- nel . . . it begins to look like you really want to get . . . not so much an EUA, but an approved kit if that is where you are going to go.” Although EUAs are extremely helpful, Plessas said, “EUA is not the desired end-state. It exists to bridge to some kind of FDA-endorsed Med- Kit. At some point we need them move out what’s an emergency use— recognize that this threat continues to exist and move toward being able to have a MedKit available.” He suggested that a future MedKit could go beyond just treating for anthrax, perhaps expanding to include materials that could be deployed for multiple threats. Mullen of PhRMA and Rothholz of the American Pharmacists Asso- ciation also noted that restricting MedKits to first responders (as well as postal carriers) may raise issues of equity. They noted that many other people may be considered “essential personnel” and provide critical ser- vices during an emergency. Rothholz noted that if pharmacists are not available to handle their regular patient needs, then the healthcare system may become overloaded. Mullen said many companies had told her that all of their personnel are essential to their operations, and they were not willing to categorize their employees in this way. When asked whether she advocated that everyone receive a MedKit, Mullen replied that it should at least be considered.

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51 WORKSHOP SUMMARY Expiration and Annual Renewal Process Workshop participants discussed various issues surrounding drug expiration and the annual renewal process, in order to avoid having to collect MedKits annually from each household and reissue new ones. Suggestions ranged from stocking medications with longer expiration dates to including more shelf-life potency testing and data collection in the drug development process. In fact, Gorman stated that stability and potency testing for a 10-year period has already been added to some of the new contracts for products that are not yet FDA approved, in order to avoid going through the Shelf-Life Extension Program. Mullen reminded participants that regardless of the conditions of the EUA, many state dis- pensing laws are stricter than federal laws, and most limit prescriptions to one year, thus necessitating annual renewal. Choice of Medication Workshop participants brought up the fact that the Postal EUA only covers the placement of doxycycline, while Ciprofloxacin is also indi- cated in the clinical guidelines for the prophylaxis and treatment of inha- lational anthrax. The SNS and local caches include both drugs. Eiklenborg noted, “First responders and mission-critical personnel out- side of the postal workers will actually have access to either indicated antibiotic, Cipro or doxy.” She noted that while 98 percent of the popula- tion is indicated for doxycycline, “The discrepancy between the available types of antibiotics for postal really is inconsistent and it is confusing.” Workshop participants noted that, during the anthrax attacks in 2001, people in certain areas were given doxycycline, and people in other areas were given Ciprofloxacin. Even though both are indicated for the treat- ment of anthrax, Ciprofloxacin costs more than doxycycline, and was therefore perceived as better. Regarding the postal model, there has been no pushback on the use of the cheaper doxycycline because the postal workers are volunteers who were told at the onset that doxycycline would be used, and to qualify for the program, they could not be contra- indicated for doxycycline.

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52 MEDICAL COUNTERMEASURES DISPENSING CONCLUSION Since the anthrax attack in 2001, many new plans, programs, and tools have been developed to enable rapid and effective medical coun- termeasures dispensing, including EUA, the PREP Act, Project BioShield, the Cities Readiness Initiative, and a pilot of the Postal Model. These activities have been directed toward countermeasures dis- tribution and dispensing for public health emergencies such as a rapidly emerging anthrax attack or widespread influenza pandemic. The response to 2009 H1N1 provided many workshop participants and their respective organizations with extensive practical experience; insight into how tools, legislation, and plans function during an actual response; and the opportunity to refine procedures and develop stronger partnerships among stakeholders. In particular, participants described two public–private partnerships that significantly enhanced the effective- ness and efficiency of the countermeasures dispensing system: one pro- ject improved situational awareness of the supply chain and the other enabled pharmacies and pharmacists to administer 2009 H1N1 vaccine. At the same time, participants noted several areas where additional dis- cussions and work could further enhance these partnerships, including issues related to payment, communication, documentation and data col- lection, working with multiple jurisdictions, and liability. Among the developments that occurred during the 2009 H1N1 re- sponse was the issuance of an unprecedented number of EUAs that al- lowed the use of approved countermeasures for unapproved uses, and in one case, the use of a medication that has not yet been approved by the FDA for any use. Workshop participants discussed how this provided stakeholders with much greater experience and understanding of the process involved in issuing EUAs, and also resulted in improvements to these processes. Nevertheless, participants identified a number of areas in which further work would be beneficial, including education and communication about EUAs, fact sheets and documentation, SLEP, la- beling, EUAs and state dispensing laws, data collection, and streamlining and standardizing the EUA process. Several participants emphasized that although EUA is an important tool for disaster response, it is not always the ideal end solution, particularly for high-risk scenarios in which coun- termeasures already exist and the response needs can be anticipated. They said that the end goal for these kinds of countermeasures should be an approved product. Over the course of the workshop, participants also

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53 WORKSHOP SUMMARY discussed other potential solutions that could help move beyond reliance on large numbers of EUAs during disaster responses. Despite the progress made during the 2009 H1N1 response, many workshop participants noted that the next public health threat may be even more challenging. The next threat could be more lethal and fast moving; there may not be any approved medications to treat or contain the problem; legal concerns could prevent healthcare provider and pri- vate-sector organizations from fully supporting response efforts; and communication gaps could lead to public confusion and suppress accep- tance of the medical countermeasure. The Cities Readiness Initiative, including the recent pilot of the Postal Model, is designed to specifically address a fast-moving threat that requires countermeasures dispensing within a short period of time. Workshop participants involved in the pilot in Minneapolis–St. Paul de- scribed the features of this program, outlined the challenges they had faced in developing and implementing it, and shared the solutions they had found to address these challenges. These insights should be particu- larly useful as the pilot is extended into a national model, as required by President Obama’s Executive Order. Participants also mentioned several areas for future work, including an EUA to allow first responders to have MedKits in their homes and issues about expiration and the annual re- newal process. Overall, a recurring theme of the workshop was that much progress has been made in the area of medical countermeasures dispensing, but much work remains to protect the health of the public in the face of bio- logical, chemical, radiological, and nuclear threats.

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