Pandemics occur when an influenza virus mutates into a novel strain that is highly transmissible among humans, leading to outbreaks worldwide. Because there is little or no pre-existing immunity in the population, the strain is highly pathogenic, thus causing disease among those who become infected. Infected individuals may be capable of transmitting the virus strain for 1 to 2 days before developing symptoms. Pandemics arise periodically but unpredictably and can cause successive waves of disease lasting for up to 3 years. In recent years, the H5N1 strain and other strains of the influenza virus have emerged or re-emerged. Experts are concerned because of similarities between the H5N1 strain and the H1N1 strain, which caused the 1918-19 pandemic. For example, research suggests that both the H5N1 and H1N1 strains prompt an over-reaction of the inflammatory response in humans, causing rapid and severe damage to the lungs. Although the H5N1 strain has not been easily transmitted among humans, influenza experts believe that H5N1 or another new influenza strain may eventually mutate to become highly transmissible. Pharmaceutical interventions available during a pandemic include vaccines and antivirals. Pharmaceutical interventions are the primary methods used to prevent the spread of disease as well as to reduce morbidity and mortality caused by the influenza virus. See table 1. Vaccination is the primary method for preventing infection with the influenza virus. Vaccines reduce the severity of disease or provide immunity by causing the body to produce protective antibodies to fight off a particular virus strain. In order for a vaccine to be most effective, it needs to be well-matched to a particular strain of the influenza virus so that the antibodies formed in response to the vaccine protect against that strain. However, existing strains of the influenza virus can mutate into new strains; in part, this is why a new vaccine is created each year for the upcoming influenza season. Much of what is known about the anticipated effectiveness of a pandemic vaccine is based on evidence from the annual seasonal vaccine. During a pandemic, it may be necessary to use a vaccine that was developed prior to a pandemic and therefore may not be well-matched to the pandemic-causing strain. This vaccine, called a pre-pandemic vaccine, is developed using an influenza strain that experts believe is likely to cause the next pandemic. Research exploring the use of a pre-pandemic vaccine based on strains of the H5N1 virus suggests that it may provide some protection against serious illness and death. In contrast, a pandemic vaccine would be developed against an identified pandemic- causing strain and would likely provide better protection against the pandemic strain. It is likely that seasonal influenza vaccine manufacturers will produce the vaccine used during a pandemic. However, for the 2007-08 influenza season, only five vaccine manufacturers were licensed to produce seasonal influenza vaccine for the United States and only one manufacturer produced its vaccine from start to finish in facilities within U.S. borders. We also recently reported that experts are concerned that countries without domestic manufacturing capacity will not have access to vaccine in the event of a pandemic if the countries with manufacturing capacity prohibit the export of pandemic vaccine until their own needs are met. Antivirals can reduce symptoms and help prevent the spread of influenza by suppressing the growth of the influenza virus. Unlike the immune response triggered by a vaccine, antivirals target the virus itself. For example, some antivirals interfere with the virus’s ability to attach to cells, thereby preventing infection of human cells. Antivirals also differ from vaccines in that they do not need to be reformulated to match a specific influenza strain in order to be effective. In addition, antivirals can be manufactured and stockpiled in advance, making them potentially available at the beginning of a pandemic. HHS currently maintains a stockpile of antivirals in the SNS. However, as we have previously reported, there are limitations associated with relying on antivirals during a pandemic. For example, the effectiveness of antivirals during seasonal influenza has been limited if they are used more than 48 hours after the onset of symptoms in an infected individual. For prophylactic use against seasonal influenza in healthy individuals, antivirals may not be as effective if they are not taken throughout the entire time an outbreak is present in a community. Some influenza strains have become resistant to the antivirals currently approved for prevention and treatment, and thus, the antivirals may not always be effective in preventing disease. In addition, antivirals, like vaccines, take several months to produce, and the lead time needed to scale up production capacity may make it difficult to meet any large-scale, unanticipated demand immediately. As we recently reported, current antiviral production capacity is inadequate to meet expected demand during a pandemic. Further, antivirals can be expensive to stockpile and difficult to administer, depending on the form in which they are given. For example, Tamiflu is given as a capsule or liquid and is relatively easy to administer, whereas, Relenza, is more difficult to administer because it is a powder that must be inhaled using a special device. Since 2000, we and others have reported that federal, state, and local officials need to have information on target groups that have priority for receiving pharmaceutical interventions to know how, where, and to whom to distribute the interventions. We reported that having established target groups is particularly crucial in times of limited supply, such as during a pandemic, when a lack of specific guidance makes it difficult for federal, state, and local officials to plan. For example, in a prior report, we noted that health officials in one state did not know exactly how many individuals were considered a priority for receiving a vaccine. In that case we found that it took state officials nearly a month to compile data on high-risk individuals, to decide how many doses of vaccine were needed in local areas, and to receive and ship vaccine to counties. State and local officials rely on federal guidance when making decisions on which groups should be targeted first for vaccination. For example, in a prior report on the 2004-05 influenza season, when the United States lost approximately half of its seasonal vaccine supply because of manufacturing difficulties, we found that CDC quickly revised its recommendations on who should be prioritized for vaccine. CDC’s changes decreased the targeted population from approximately 188 million to 98 million. State and local officials we spoke with for this report told us that they quickly adopted CDC’s revised recommendations. Since the terrorist attacks on September 11, 2001, public health departments and hospitals have been considered vital elements of emergency preparedness and response efforts. Surge capacity in public health departments and hospitals will be critical to pandemic response given the large number of people expected to require medical care. During a pandemic, hospitals will need to provide care for influenza patients as well as continue providing care for other patients. A pandemic will put a severe strain on the health care system, which already is easily overwhelmed by seasonal influenza outbreaks. Seasonal influenza results in more than 200,000 hospital admissions and 36,000 deaths in the United States every year, and hospitals were stretched to capacity in some past seasonal influenza outbreaks. A severe pandemic would overwhelm hospitals in the United States. For example, using HHS’s planning assumptions, authors of one study estimated that influenza patients would need the equivalent of 191 percent of available staffed non- ICU beds and 461 percent of available staffed ICU beds. A pandemic would occur in the context of existing health care provider shortages. Shortages of health care providers, including physicians and nurses, have been reported for many years by GAO and others. For example, the Association of American Medical Colleges recently released a report summarizing studies issued by 15 states between 2000 and 2007 regarding physician shortages in the United States. That report found that many of these states reported shortages of physicians in specialties such as primary care, cardiology, and endocrinology. Similarly, a recent survey of chief executive officers by the American Hospital Association found that as of December 2006, hospitals across the country reported having an estimated 116,000 registered nurse vacancies. That survey also found that nearly half of emergency departments are operating at or above capacity. Partly in response to these workforce shortages, Congress passed the Pandemic and All-Hazards Preparedness Act (PAHPA) in December 2006. Among other things, the law requires the Secretary of HHS by 2009 to identify strategies to recruit, retain, and protect the public health workforce from workplace exposures during public health emergencies, which would include pandemics. In addition, PAHPA established the Office of the Assistant Secretary for Preparedness and Response to coordinate activities between HHS and other federal departments, agencies, and offices and state and local officials responsible for emergency preparedness. Nonpharmaceutical interventions are measures used to reduce the impact of a communitywide infectious disease outbreak without the use of pharmaceuticals. Examples of nonpharmaceutical interventions include isolation, quarantine, social distancing, and infection control (see table 2). Slowing the spread of disease during a pandemic will be particularly important given anticipated shortages of pharmaceutical interventions and the expectation that a severe pandemic will overwhelm the health care system. Experts have suggested that nonpharmaceutical interventions can help the health care system by reducing the anticipated influx of patients by limiting the rate of disease transmission (see fig. 1). In the past, nonpharmaceutical interventions have been used in some cases to successfully slow the spread of infectious disease outbreaks. For example, during the 1918-19 pandemic, local public health officials relied on nonpharmaceutical interventions—including rules forbidding overcrowding in streetcars and bans on public gatherings—to slow the spread of disease. More recently, during the global outbreak of severe acute respiratory syndrome (SARS) in 2003, nonpharmaceutical interventions were also implemented to slow the spread of disease. For example, we reported that nonpharmaceutical interventions, such as closing two hospitals to new admissions, appeared to be useful in Canada’s management of the SARS outbreak. Public health emergencies such as the SARS outbreak in 2003 and the anthrax incidents in 2001 have demonstrated that communication with the public about a public health emergency by federal officials is a critical component of national preparedness. In July 2003, we reported that effective communication between health care providers and the public reinforced the need to adhere to infectious disease control measures and that rapid and frequent communications regarding SARS helped slow its spread. In addition, in October 2003, we reported that the media and the public looked to CDC as the source for health-related information during the anthrax incidents, but that CDC was not always able to successfully convey the information that it had. As with the SARS outbreak and anthrax incidents, a pandemic will generate immediate, intense, and sustained demand for information. The public will want information quickly about the risks and status of the pandemic, what they can do to stay healthy, what is being done by the government to protect them, and where to go for medical services. Very technical points and sensitive political issues will need to be explained to the general public. If accurate and consistent information is not available and disseminated in a timely and efficient manner, rumors, myths, and misinformation may lead to unnecessary public anxiety and could result in mistrust of, and noncompliance with, the public health and medical measures that are recommended to save lives. Once a pandemic begins, HHS plans to make accessible to state and local jurisdictions federal stockpiles of antivirals and pre-pandemic vaccine until a pandemic vaccine becomes widely available. According to HHS, public-sector stockpiles of antivirals are intended to be used primarily for the treatment of sick individuals. HHS intends to oversee the distribution and administration of federally owned pre-pandemic vaccine to individuals identified as members of the critical workforce; that is, workers in sectors that are necessary for society to continue functioning. HHS also plans to provide jurisdictions with doses of the pandemic vaccine as they become available. HHS recommends that state and local jurisdictions follow its list of targeted groups in administering the pandemic vaccine. However, HHS faces challenges with implementing its strategy for using pharmaceutical interventions, such as the lack of vaccine manufacturing capacity within U.S. borders and the length of time experts anticipate will be needed to manufacture a pandemic vaccine. Additionally, we and others have reported since 2000 how problems can arise if potential target groups are not established in advance. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. Until a pandemic vaccine becomes widely available, one part of HHS’s strategy for using pharmaceutical interventions involves distributing antivirals in the SNS to state and local jurisdictions. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in public-sector stockpiles—meaning those in the SNS and in jurisdictional stockpiles. As of May 2008, HHS had stockpiled 44 million courses of antivirals for treatment in the SNS and is subsidizing the purchase of 31 million treatment courses by state and local jurisdictions for storage in their own stockpiles. As of May 2008, state and local jurisdictions had collectively stockpiled nearly 22 million treatment courses of antivirals. Of the federally stockpiled antivirals, HHS has reserved 6 million courses for containment of an initial outbreak. For example, these 6 million courses may be used to respond to initial outbreaks abroad and parts of the United States experiencing the earliest cases. Officials told us that after the department distributes these initial 6 million courses of antivirals, it plans to deliver the remaining antivirals in the SNS to all jurisdictions simultaneously for treatment of individuals sick with influenza. According to HHS’s guidance, state and local jurisdictions will receive their allotments of antivirals on a per-capita basis and should prepare to receive their share of antivirals when a pandemic begins, either in the United States or overseas. According to HHS officials, the decision to release antivirals from the SNS will be made by the Secretary of HHS in conjunction with the Director of CDC. HHS officials estimate that it will take between 7 days and 1 month for all antivirals to be distributed to jurisdictions. HHS officials also told us that they have conducted several exercises to test HHS’s plan to distribute antivirals to these jurisdictions during a pandemic. Antivirals from the SNS will be delivered to one location within each jurisdiction. According to HHS officials, state and local jurisdictions will distribute both the SNS antivirals and antivirals stored in their own stockpiles throughout their respective areas using pandemic-specific distribution plans. HHS officials told us that the stockpiles of antivirals owned by state and local jurisdictions will provide the jurisdictions with more immediate access to the drugs during the initial stages of a pandemic. Because these stockpiles will be entirely under each jurisdiction’s control, officials there may choose to use some of these antivirals as prophylaxis—as proposed in HHS’s draft guidance on antiviral use during a pandemic—in an attempt to slow the spread of the pandemic by providing them to healthy individuals who have been exposed to the pandemic-causing strain. However, to ensure that stockpiles are not rapidly depleted, HHS currently recommends that jurisdictions use antivirals only for treatment. HHS also advises jurisdictions to begin deploying their respective antiviral stockpiles immediately when a pandemic has been confirmed. In June 2008, HHS released draft guidance for the use of antivirals during a pandemic in the Federal Register for public comment. The draft guidance is consistent with HHS’s previous recommendation that public-sector stockpiles be used primarily for treatment of individuals sick with influenza. In its draft guidance, HHS also acknowledged that more antivirals will be needed than will be available in public-sector stockpiles particularly if antivirals are used for prophylaxis. HHS proposes in its draft guidance that the private sector stockpile 110 million additional courses. HHS also suggests that antivirals in the private-sector stockpile be targeted for prophylactic use for health care and emergency services personnel, and in some circumstances, for persons with compromised immune systems as well as those living in group settings. The purchasing, allocation, and distribution of private-sector stockpiles would be the responsibility of the owner of those stockpiles. HHS’s strategy also involves releasing federally owned pre-pandemic vaccine to specific locations in state and local jurisdictions for administration when it has been determined that sustained transmission of the pandemic virus has occurred. HHS intends to oversee distribution and administration of pre-pandemic to members of the critical workforce identified by a federal interagency group—the National Infrastructure Advisory Council. Workers considered critical consist of those necessary to maintain national or homeland security, economic survival, and the public health and welfare. These employees include emergency service providers, such as law enforcement, banking and financing personnel, and health care providers. The National Infrastructure Advisory Council estimates that the critical workforce includes about 20 million people. HHS has a goal of stockpiling enough pre-pandemic vaccine to cover this group. As of May 2008, HHS had purchased and stockpiled enough pre- pandemic vaccine for about 13 million people. HHS’s strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine becomes widely available. State and local jurisdictions will receive allotments of pre-pandemic vaccine on a per-capita basis. According to HHS officials, stockpiles of pre-pandemic vaccine will be released for simultaneous distribution to selected sites in each jurisdiction. Currently, each vaccine manufacturer stores the doses of pre-pandemic vaccine that it produces. According to HHS, each manufacturer is assigned to supply this vaccine to certain jurisdictions using its established distribution channels. HHS officials also told us that they have a longer-term plan to distribute vaccine using a single distributor, based on CDC’s Vaccine Management Business Improvement Project. According to HHS officials, this centralized distribution system would be incorporated with its existing Vaccine Ordering and Distribution System, which allows for federal tracking of vaccine distribution. HHS anticipates having a centralized distribution system in place around 2010. HHS officials told us that utilizing this type of system would be beneficial during the early stages of a pandemic, when it is expected that maintaining central control of and securing vaccine will be a high priority. HHS plans to provide pandemic vaccine as it becomes available to state and local jurisdictions for use among target groups. HHS has developed guidance for the prioritization system for administration of the pandemic vaccine. HHS has divided the entire U.S. population into four broad categories—homeland and national security, health care and community support services, critical infrastructure, and the general population. Within each category, groups are clustered into five tiers that correspond to the vaccination priority—or target group—for that specific category. (See table 3 for target groups for a severe pandemic.) These targeted groups were derived through consideration of four vaccination program objectives: (1) protecting those who are essential to the pandemic response and provide care for persons who are ill; (2) protecting those who maintain essential community services; (3) protecting children; and (4) protecting workers who are at greater risk of infection because of their job. In its guidance, HHS also proposed that not all targeted groups be vaccinated in every pandemic, depending on the severity of the pandemic. For a less severe pandemic, for example, individuals in tiers 2 and 3 in the category of critical infrastructure would not be targeted for vaccination. HHS also noted that the guidance will need to be reassessed periodically before a pandemic occurs to consider factors such as changes in vaccine production capacity. During a pandemic, guidance will also be modified based on additional factors that will not be known until a pandemic occurs, including the characteristics of pandemic illness. HHS officials told us that should a pandemic occur in the near future, pandemic vaccine will likely be distributed from vaccine manufacturers directly to state and local jurisdictions using the same distribution systems the manufacturers regularly use for seasonal influenza vaccine. As with pre-pandemic vaccine, HHS anticipates that eventually multiple manufacturers will produce pandemic vaccine. However, it anticipates utilizing a single, centralized distributor. HHS expects to have a centralized distribution system in place around 2010. HHS faces three challenges with implementing its strategy for using pharmaceutical interventions during a pandemic. The first challenge is associated with uncertainties about the effectiveness and clinical outcomes of the pharmaceutical interventions. For example, the uncertainty concerning which influenza strain will cause the next pandemic raises the possibility that the pre-pandemic vaccine currently being developed will not offer protection against the pandemic strain. Also, because the actual pandemic-causing strain has not yet surfaced, researchers can only estimate what amount of vaccine will actually be needed to stimulate a sufficient human immune response. Similarly, the appropriate dosage of antivirals or the exact length of the treatment course needed to make them effective will not be known until the actual pandemic-causing strain emerges. Further, the ability of influenza viruses to develop resistance to antivirals also raises questions about their effectiveness. In 2005, a group of global experts on antivirals noted that studies have suggested that different strains of the H5N1 avian influenza virus have developed resistance to different antivirals. There is also the potential for adverse outcomes that may result from large-scale administration of a newly developed vaccine, such as what occurred during the “swine flu” outbreak of 1976. The government’s success in vaccinating large numbers of the public with the swine flu vaccine was negated by the development of Guillain-Barré syndrome among hundreds of immunized individuals, leading to several deaths. This adverse event only became apparent when the vaccine had been administered to large numbers of people. A second challenge concerns difficulties with the production of pharmaceutical interventions, particularly vaccines. The United States lacks vaccine manufacturing capacity; for example, we found that for the 2007-08 influenza season only one influenza vaccine manufacturer had its production processes entirely within U.S. borders. Additionally, in 2007 we found that the lack of U.S. vaccine manufacturing capacity is cause for concern among experts because it is possible that countries without domestic manufacturing capacity will not have access to vaccine in the event of a pandemic if the countries with domestic manufacturing capacity prohibit the export of the pandemic vaccine until their own needs are met. According to HHS, exacerbating the lack of manufacturing capacity is the length of time experts anticipate will be needed to manufacture a pandemic vaccine. HHS estimates that it may take as long as 20 to 23 weeks after the start of the pandemic for the first doses of pandemic vaccine to become available. Figure 2 shows how pharmaceutical manufacturers would proceed to develop and produce pandemic vaccine as well as when initial batches of vaccine are likely to become available. In response to this lack of manufacturing capacity, HHS has established the long-term goal of domestically producing enough pandemic vaccine for 300 million people within 6 months of having a reference strain of the pandemic virus. HHS expects to reach this level of manufacturing capacity around 2010. The department is currently making large investments in domestic vaccine manufacturing capacity for this purpose. (See app. II for a description of these investments.) HHS is doing this in part by supporting vaccine research with contracts that require manufacturers to establish vaccine-producing facilities within U.S. borders. Through these contracts, one U.S. facility has expanded its manufacturing capacity and is expected to double its existing capacity by 2009 and triple its capacity by 2011. A second facility was recently established in the United States and is expected to manufacture a licensed product in 2010. HHS officials told us there had also been progress in expanding domestic manufacturing capacity for antivirals. The third challenge HHS faces involves difficulties in stockpiling and distributing pharmaceutical interventions. The high costs of purchasing and storing antivirals calls into question HHS’s plan to rely on state and local jurisdictions to acquire and store their own stockpiles of antivirals. For example, officials from one state we spoke with told us that the state was facing financial difficulty in determining how it will purchase its share of antivirals and in identifying and paying for adequate storage space. HHS officials have acknowledged that the cost of purchasing antivirals is high, but have also noted that the contract price HHS has negotiated for state and local jurisdictions is better than the retail price. No federal funding has been made available to aid state and local jurisdictions in building and maintaining storage capacity. In addition, should a pandemic occur in the near future, HHS plans to utilize multiple distributors for pre-pandemic and pandemic vaccines, allowing manufacturers to use existing processes with which they are familiar. However, HHS acknowledged that this process also has multiple weaknesses. For example, the current distribution plan requires extensive coordination between HHS and multiple manufacturers and distributors. It also requires that states and local jurisdictions manage vaccine shipments from multiple sources, which may complicate receipt and storage activities. In response, HHS is planning to centralize its distribution system through a single distributor. HHS has made progress on revising its 2005 guidance to state and local jurisdictions for identifying target groups for the use of pandemic vaccine, but has not finalized guidance for using antivirals and pre-pandemic vaccine. Since 2000, GAO and others have reported on the importance of having pre-established target groups for pharmaceutical interventions to avoid problems deciding who should receive these interventions. In addition, during times of shortage, state and local public health officials look to the federal government for guidance, including when making decisions on which groups should be targeted for prioritization. For example, during the seasonal influenza vaccine shortage of 2004-05, state and local officials immediately adopted the revised guidance on who should be targeted for vaccination as recommended by CDC. State and local public health officials and others have stressed that federal guidance on target groups is needed to aid in their pandemic planning efforts. HHS first published target groups for pandemic vaccine and antivirals in the HHS Pandemic Influenza Plan in November 2005. These initial groups were identified to support a goal of reducing morbidity and mortality among those at greatest risk for developing complications from influenza, such as the elderly. Since the publication of the HHS Pandemic Influenza Plan, there has been wide recognition that other factors should be considered, such as protecting those critical workers needed to keep society functioning, including health care and law enforcement personnel. In addition, recent expansion in the production of antivirals has increased the amount available. Thus, HHS, in consultation with other federal agencies, was tasked by the National Strategy for Pandemic Influenza Implementation Plan and the HHS Pandemic Influenza Implementation Plan to revise the groups outlined in the HHS Pandemic Influenza Plan. In July 2008, HHS released guidance on prioritizing target groups for pandemic vaccine. HHS released draft guidance for public comment in the Federal Register on how antivirals may be used during a pandemic in June 2008. However, HHS has not yet released draft guidance identifying target groups for pre-pandemic vaccine. HHS officials told us they are working on draft guidance for pre-pandemic vaccine in collaboration with other federal agencies, such as DHS. According to officials, target groups for pre-pandemic vaccine are likely to resemble those for pandemic vaccine, but with more of a focus on the critical workforce rather than on the general population. HHS officials said a tiered structure, such as that used for the pandemic vaccine, would only be needed if a pandemic occurs before HHS has reached its goal of stockpiling enough doses for 20 million people. HHS has initiated efforts to improve the surge capacity of health care providers, but these efforts will be challenged during a severe pandemic. Surge capacity of health care providers will be hindered by existing shortages of health care providers and by the potentially high absentee rates of providers during a pandemic. Inadequate staffing of health care facilities will be likely, and the ability to deliver health care consistent with established standards of care may be compromised. HHS’s efforts include plans to supplement the number of health care providers with medical and nursing students. Given the uncertain effectiveness of efforts to increase surge capacity, HHS has developed guidance to assist health care facilities in planning for altered standards of care; that is, for providing care while allocating scarce equipment, supplies, and personnel in a way that saves the largest number of lives in mass casualty events, such as pandemics. In a severe pandemic, existing health-care provider shortages would worsen as health care providers become infected through exposure to infected patients or reach exhaustion because of longer working hours. The federal government assumes absenteeism among all workers, including health care providers, could be as high as 40 percent. During the 2003 SARS outbreak (a disease that has a high mortality rate and poses a high risk for health care workers similar to a pandemic), health care workers accounted for more than 20 percent of the infected cases. During the epidemics in Toronto and Hong Kong, 51 percent and between 28 percent and 50 percent, respectively, of health care providers who treated SARS patients became infected with the SARS virus. Studies have shown that during extreme public health emergencies, such as a pandemic, some health care workers may be unable or unwilling to report to work. For example, a survey of public health department workers, including communicable disease staff, nurses, and physicians, at three public health departments in Maryland found that approximately 46 percent would be likely not to report to work during a pandemic outbreak. Similarly, in a survey of hospital personnel, including doctors and nurses, only half responded that they would be willing to report to work during a pandemic. Those who said they may be unlikely to report to work cited fear of contracting an illness as the reason. These potential workforce shortages during a pandemic will affect care for all patients, not just those with influenza. HHS has initiated many efforts to increase the number of health care workers during a public health emergency by supplementing the workforce with federal response teams and by encouraging mutual aid between states. However, HHS faces challenges in improving surge capacity during a severe pandemic because of the widespread effects of a pandemic and the existing shortages of health care providers. HHS has planned four types of efforts to improve surge capacity during a pandemic. First, the HHS Pandemic Influenza Plan recommends that health care facilities use personnel available locally to increase the number of health care providers during emergencies. These recommendations include using trainees (such as medical and nursing students), patients’ family members, and retired health care providers to provide support for essential patient care at times of severe staffing shortages. The plan recommends that hospital clinical administrators take on patient care responsibilities and that facilities recruit health care providers from other medical settings, such as medical offices and day surgery centers, to assist with patient care in the hospital setting. Additionally, the plan recommends that health care providers be cross- trained to provide support for essential patient care at times of severe staffing shortages. To assist with this effort, HHS’s Agency for Healthcare Research and Quality has developed a video to help train health care workers who are not respiratory care specialists to provide basic respiratory care and ventilator management to adult patients during mass casualty events. In addition, the HHS Pandemic Influenza Plan recommends deployment of federal medical responders, such as members of the National Disaster Medical System, during the early stages of a pandemic to supplement the number of health care providers. Second, the HHS Pandemic Influenza Plan encourages state and territory officials to use the Emergency System for Advance Registration of Volunteer Health Professionals program, which enables state and territory officials to quickly identify licensed volunteer professionals to work in areas with shortages. This program is state-based systems that provide advanced registration and the credentialing information of clinicians needed to augment health care facilities during a declared emergency. The program enables the sharing of pre-registered health care professionals across state lines. According to HHS, as of February 2008, 40 state and territorial jurisdictions had begun to implement the program; all states and territories are required to have this program fully operational by August 2008. Third, HHS has advised state officials to incorporate the Emergency Management Assistance Compact (EMAC) in their plans as another vehicle for obtaining medical assistance during a pandemic. Once a governor declares a state of emergency, a state can request that EMAC address its need for resources, such as health care providers. EMAC personnel will find states that have health care providers who can be deployed across state lines. EMAC was established in 1996 and is administered by the National Emergency Management Association. All 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands have enacted legislation providing authority to join EMAC. Fourth, HHS encourages state and local officials to use other mechanisms to expand surge capacity of health care providers for providing care to less severely ill patients during a pandemic. These mechanisms would encourage home care of less severely ill patients and include “telehealth” (also known as “telemedicine”), which allows health care providers in hospitals to care for and monitor patients at home with the use of electronic information and telecommunications technologies; and call centers (similar to nurse advice lines), which will allow patients at home to contact health care providers in hospitals in order to obtain medical advice regarding home care. HHS faces several challenges in its efforts to increase surge capacity of health care providers during a pandemic. There are concerns that the use of untrained personnel may reduce the capacity of trained health care providers to deliver needed care. For example, officials from one professional association told us that using such individuals would require training and supervision, which would actually increase the workload of the health care facilities’ staff. They also told us that cross-training personnel to provide support for essential patient care during a mass casualty event may be infeasible because health care providers will be busy caring for patients in their own areas of expertise. Cross-training of health care providers needs to be done in advance, but this may be infeasible because it would take providers away from their daily patient- care responsibilities, and this may be difficult to do given current workforce shortages. Furthermore, health care providers from other areas may not be available for deployment in a severe pandemic. Members of response teams, such as those of the National Disaster Medical System, already have full-time jobs in health care. Therefore, these teams would not necessarily add to the nation’s overall number of health care providers who would be available to treat influenza patients. We were told by HHS and FEMA officials that the National Disaster Medical System response teams will not likely be deployed during a pandemic outbreak because of the widespread nature of a pandemic and the need for those responders in their own regions. Similarly, while the EMACs make it easier for health care providers to work in states other than those in which they are licensed, given the widespread nature of pandemics, health care providers likely will be needed in their own home regions. During a severe pandemic, inadequate staffing of health care facilities will be likely despite efforts to improve surge capacity. Thus, the ability to deliver health care consistent with established standards of care for all patients may be compromised. HHS officials told us they believe that decisions on the allocation of scarce resources—such as equipment, supplies and personnel—are best made at the local level. Therefore, the HHS Pandemic Influenza Implementation Plan recommends that health care facilities plan ahead for providing altered standards of care; that is, for providing care while allocating scarce resources in a way that saves the largest number of lives in mass casualty events. With altered standards of care, instead of treating the sickest or most injured patients first, health care providers would identify and treat patients who have a critical need for treatment and would be likely to survive. Complicating conditions, such as an underlying chronic disease that may impact an individual’s ability to survive, would be considered in the decision-making process. Resources being used by current patients, such as those recovering from surgery, would also become part of the overall resource allocation decisions and might be re-allocated to patients with a more critical need for treatment and a higher likelihood to survive. Altered standards of care would be implemented on a temporary basis. Once the event wanes and more resources become available, provision of health care would return to established standards of care used in normal situations. HHS has issued two guidance documents, Altered Standards of Care in Mass Casualty Events and Mass Medical Care with Scarce Resources: A Community Planning Guide, to assist health care facilities to plan for providing altered standards of care. Altered Standards of Care in Mass Casualty Events provides health care facilities guiding principles for developing altered standards of care. Additionally, it includes a discussion of the authority to activate the use of altered standards of care and the associated legal and regulatory issues, including the possible need for liability protection for health care providers and facilities. Mass Medical Care with Scarce Resources expands on the Altered Standards of Care in Mass Casualty Events report. It provides a discussion of the circumstances that communities would face as a result of a mass casualty event, approaches and strategies that could be used to provide the most appropriate standards of care possible under the circumstances, examples of tools and resources available to help state and local officials in their planning process, ethical considerations in planning for a mass casualty event, and a pandemic case study. PAHPA calls for HHS’s Assistant Secretary for Preparedness and Response to lead and coordinate HHS emergency preparedness and response activities. Accordingly, the Assistant Secretary is engaged in efforts to increase the number and enhance the preparedness level of health care providers for public health emergencies. As part of this effort, HHS officials told us that they have begun to examine issues related to recruitment, retention, and protection of the public health workforce with the goal of identifying strategies to overcome workforce shortages. In addition, to encourage health professionals to enter employment in a state or local public health agency, PAHPA authorizes HHS to award grants to states to assist in operating public health workforce loan repayment programs for individuals who serve in health professional shortage areas or in areas at high risk of a public health emergency. PAHPA also authorized HHS to develop Centers of Public Health Preparedness at accredited schools of public health. HHS intends that these centers will help to train and educate health professionals to prepare for and respond to public health emergencies, including a pandemic. As part of this effort, CDC will develop core emergency preparedness and response curriculums, identify performance goals, and develop health systems research projects. HHS has already incorporated standardized benchmarks and performance measures into existing grant programs. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions to help slow the spread of disease and to lessen the burden on the nation’s health care system until a pandemic vaccine is widely available. HHS has developed guidance and is investing in research on the general use and effectiveness of nonpharmaceutical interventions, thereby helping jurisdictions make more informed decisions. According to HHS, the findings from this research will be used to update existing guidance. However, HHS faces difficulties in helping state and local jurisdictions overcome implementation challenges, such as identifying steps for ensuring community compliance. The authority to implement nonpharmaceutical interventions—such as decisions on school closures—to slow the spread of disease and lessen the burden on the nation’s health care system until a pandemic vaccine is available rests with state and local jurisdictions. To assist state and local authorities with their current planning efforts for using nonpharmaceutical interventions, HHS published a guidance document in February 2007—the Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States – Early, Targeted, Layered Use of Nonpharmaceutical Interventions. HHS officials told us that the recommendations in the guidance are for pre-pandemic contingency planning and are intended to provide state and local jurisdictions with a conceptual framework to guide their planning. In this guidance, HHS introduces its “community mitigation framework” that is based upon a targeted, layered strategy involving the direct application of multiple, partially-effective nonpharmaceutical interventions, initiated early and maintained consistently throughout a pandemic. Specifically, HHS’s guidance describes four interventions: (1) isolation (either at home or in a health care setting) and treatment (as appropriate) with antivirals of all individuals with confirmed or probable infections; (2) voluntary home quarantine of members of households exposed to the disease and consideration of combining this intervention with antivirals, provided sufficient amounts are available and can readily be distributed; (3) school closures (including public and private schools as well as colleges and universities) accompanied by closures of other public settings (e.g., shopping malls and movie theaters) to prevent out-of-school social contacts; and (4) adult social distancing to reduce contact among adults in the community and workplace. HHS officials and other experts have acknowledged the significance of implementing certain nonpharmaceutical interventions in order to maximize the available public health benefit while minimizing adverse secondary effects of the interventions. Thus, HHS recommends that state and local jurisdictions consider the severity of the pandemic when making decisions about how to respond to the outbreak. For example, for a less severe pandemic, HHS recommends voluntary home isolation of sick individuals, but generally does not recommend measures that may be more burdensome, such as voluntary quarantine of exposed household members, school closures, and adult social distancing. HHS recommends that state and local jurisdictions implement those additional measures and others in a more severe pandemic. Department officials and experts have also stressed the importance of balancing the need to intervene early enough for nonpharmaceutical measures to be effective, while at the same time not causing unnecessary hardship by implementing them too early. HHS and other federal agencies released guidance in March 2008—the Federal Guidance to Assist States in Improving State-Level Pandemic Influenza Operating Plans—that included information to assist state and local jurisdictions in determining when to implement certain nonpharmaceutical interventions. For example, this guidance recommends implementing voluntary quarantine and administering antivirals to individuals exposed to the pandemic virus when a case of novel influenza is detected in an area, including before sustained human-to-human transmission has been established. Once a pandemic is underway, HHS anticipates providing technical assistance to state and local jurisdictions on the implementation of nonpharmaceutical interventions. This technical assistance would include assessing the specific epidemiological characteristics of the pandemic, such as how the pandemic-causing strain is transmitted, and consulting with state and local jurisdictions on the effectiveness of the nonpharmaceutical interventions that had been implemented. Because it is not possible to accurately predict the severity of a pandemic, HHS officials told us the recommendations in the guidance may change significantly during an actual pandemic, based on data HHS gathered from providing technical assistance as well as from data from initial outbreak investigations or from routine surveillance systems. HHS officials acknowledge that the recommendations in its guidance are not specific because the scientific evidence on the use and effectiveness of nonpharmaceutical interventions is limited, and therefore inconclusive. The research to date using mathematical modeling and analysis of historical data of past pandemics suggests that utilizing multiple nonpharmaceutical interventions simultaneously and early in a pandemic may aid in slowing disease transmission. For example, historical studies of the 1918-19 pandemic describe how some cities reduced death rates by successfully implementing multiple nonpharmaceutical interventions, including social distancing, mandated mask wearing, and case isolation. However, because of incomplete historical records, researchers are not able to determine precisely, where, when, and for how long these interventions were implemented. HHS has supported several research initiatives to establish a stronger evidence base concerning the implementation and effectiveness of nonpharmaceutical interventions, thereby helping jurisdictions to make more informed decisions. For example, in October 2006, HHS awarded $5.2 million to support eight research projects on topics ranging from the role hand hygiene can play in reducing disease transmission to examining upper respiratory infections in families. According to HHS, the findings from this research will be used to update existing guidance. HHS and other experts have stressed the need for additional research to, for example, better inform the assumptions used in mathematical models. HHS listed other key areas for further research in its guidance, such as understanding fundamental questions regarding influenza transmission and the potential psychosocial effects of certain nonpharmaceutical interventions, such as prolonged voluntary home quarantine and social distancing. HHS faces difficulties in helping state and local jurisdictions implement nonpharmaceutical interventions. First, as HHS acknowledged in its guidance, there is the potential for state and local jurisdictions to implement these interventions in an uncoordinated, untimely, and inconsistent manner, thereby dramatically reducing their effectiveness. For example, if one jurisdiction implements a voluntary quarantine of sick individuals and a neighboring jurisdiction does not, the overall movement of sick individuals in the area may not be sufficiently reduced. HHS hopes that state and local jurisdictions will follow its guidance and act in concert, but HHS cannot compel jurisdictions to do so. Second, HHS faces the challenge of helping state and local jurisdictions identify specific thresholds for implementing and ending nonpharmaceutical interventions, such as at what point to close schools. The Federal Guidance to Assist States in Improving State-Level Pandemic Influenza Operating Plans provides general guidance to state and local jurisdictions on when to consider beginning to implement nonpharmaceutical interventions. However, this guidance does not provide details on when to implement specific interventions. For example, the guidance recommends state and local officials begin to consider closing schools when transmission of a pandemic virus occurs, but does not identify a specific absentee rate at which officials should take action. Experts have noted that determining specific triggers is difficult, partly because the data currently available are imperfect and sparse, requiring decision-makers to make assumptions regarding the transmission rate of the pandemic-causing strain as well as the effects of other community behaviors during the pandemic. In addition, state and local officials generally do not have the capabilities to collect the data that federal authorities will need to develop specific triggers during an actual pandemic. For example, one local official noted that one method of determining specific community triggers would be to use prevalence rates, which measure the percentage of the population infected with disease. However, state and local areas do not have surveillance systems capable of providing this level of detail in real-time. Third, HHS faces the challenge of helping state and local jurisdictions convince residents to comply with its requests regarding nonpharmaceutical interventions. This task is especially difficult because restrictions on public activities to combat a pandemic may need to be in place for several months. During the 1918-19 pandemic, nonpharmaceutical interventions were implemented for 2 to 8 weeks. However, researchers have suggested that such interventions would need to be implemented for a longer period for a future pandemic in order to prevent another increase in transmission after the interventions are discontinued. In the 1918-19 pandemic, nonpharmaceutical interventions were lifted. In some cases, the public became fatigued with the interventions, leading to public opposition and noncompliance when authorities found it necessary to reimpose the restrictions. A fourth challenge HHS faces is that these restrictions may have negative impacts on the nation’s economy and on the financial well-being of individual households. For example, nonpharmaceutical interventions may exacerbate worker absenteeism as parents stay home to care for their children when schools are closed. This could eventually result in disruptions in the provision of essential services, such as law enforcement. Similarly, lengthy nonpharmaceutical interventions could financially strain individuals and families. For example, while an HHS-sponsored study on public perceptions regarding a pandemic found a generally high willingness to comply with public health recommendations, it also found a decrease in reported ability to comply with recommended measures when financial constraints were considered. Thus, 57 percent of respondents said they would have problems complying with recommended measures because of financial difficulties if they had to be out of work for 1 month, with 76 percent reporting problems if they had to miss 3 months. A fifth challenge for HHS is the lack of trust by U.S. citizens of federal government public health authorities. A recent study found that only 40 percent of the U.S. population would trust federal government public health authorities as a source for accurate information. The authors of this study assert that this lack of trust may have been exacerbated by the public’s negative perceptions of the government’s response to Hurricane Katrina in 2005 and that the U.S. population may now be less willing to cooperate with some public health requirements in the future, including isolation of sick individuals. HHS has made progress by establishing roles, responsibilities, and procedures for communicating messages to the general public during a pandemic. HHS has also developed pandemic educational materials to communicate messages to the general public before and during a pandemic and has identified ways to disseminate these materials. In addition, HHS has engaged the general public on pandemic issues to better understand public perceptions and knowledge. Nonetheless, communicating sensitive and complex issues to the general public during a pandemic will be challenging. HHS has assigned roles and responsibilities, and developed procedures, for how HHS plans to communicate with the general public about a pandemic. Under the National Response Framework, HHS is the lead federal agency for public health and medical services, and as such, HHS is the federal agency responsible for communicating with the general public about the public health and medical aspects of a pandemic before and during an outbreak. In addition, the HHS Pandemic Influenza Plan identified activities that should be undertaken to prepare HHS to communicate with the general public before and during a pandemic. In November 2006, HHS completed the U.S. Department of Health and Human Services Pandemic Influenza Communications Plan which lays out detailed roles, responsibilities, and procedures to guide HHS communications with the general public. For example, this plan assigned HHS’s Office of the Assistant Secretary for Public Affairs responsibility for coordinating pandemic health messages across all HHS agencies and with state and local communications staff in order to ensure that all HHS agencies work closely together to make public statements that are timely, consistent, and accurate. HHS has named spokespersons within HHS to deliver messages to the public before and during an outbreak. HHS has trained federal, state, local, and private sector public affairs officials to communicate with the general public about a pandemic. The Crisis and Emergency Risk Communication training modules developed by HHS clarify the role of spokespersons, describe the psychology of communicating during a crisis, and provide best practices for working with the media during a crisis. HHS has held 10 Crisis and Emergency Risk Communication training sessions for nearly 500 senior federal officials and public affairs staff, and 11 regional training sessions for approximately 900 state and local leaders. Two additional trainings are scheduled in 2008. HHS also held Crisis and Emergency Risk Communication training sessions in June 2007 for Red Cross leaders and in January 2007 for stakeholders. Nearly 900 training sites participated in these sessions via the Internet. During a pandemic, the HHS communications effort will operate out of its Emergency Communications Center. The center’s capabilities include originating or accessing video feeds, news conferencing, posting mass electronic mailings, responding to media telephone inquiries, receiving, vetting, and clearing messages to be released by HHS. HHS will use a departmental public affairs conference line to provide telephone connections for public affairs staff throughout the department. These phone connections will allow HHS public affairs personnel to work from dispersed sites during the crisis, coordinate messages, receive guidance or direction, and provide information to those needing it. The DHS National Incident Communications Conference Line will also be used by HHS to exchange information with other federal agencies. In addition, the Office of the Assistant Secretary for Public Affairs conducts media outreach to strengthen the relationship between the media and HHS and to support pandemic planning and education. Periodic briefings are scheduled between senior department officials, including the HHS Secretary, and members of the press. For example, in early 2007 HHS held a series of roundtable discussions on pandemics with the major broadcast and cable television networks, wire services, and bloggers to raise awareness of pandemics; the secretaries of HHS and Department of Agriculture participated. HHS press-office staff members also talk to the media regularly to answer questions and provide updates on pandemic planning and related issues. In January 2007, HHS began holding a series of tabletop exercises with key media leaders and senior government officials in six major cities to facilitate effective communication to help insure the timely dissemination of accurate information to the general public through the use of media outlets during a pandemic. HHS has developed and disseminated educational materials for communicating critical information to the general public and is in the process of developing additional materials. HHS has identified some of the critical information that the general public will require during a pandemic and has developed message maps—communications tools used to help organize complex information—to convey that information in a concise format before an outbreak. HHS has developed 82 message maps. HHS’s message maps are each designed to distill three primary, easily understood messages on issues such as the differences between avian influenza, pandemic influenza, and seasonal influenza, as well as what HHS is doing to prepare for a pandemic. Each of these primary messages has three supporting messages that can be used as appropriate to provide context for the issue being mapped. HHS message maps take the form of a series of questions and answers and are made public so that spokespersons from across the government or from private organizations can use the maps to convey accurate and consistent background information to their constituents before an outbreak. Table 4 shows an example of an HHS message map. HHS has several means of disseminating information regarding a pandemic. HHS manages www.pandemicflu.gov, the official U.S. government Web site for disseminating information on pandemics to the public before and during a pandemic. The Web site is updated with new information as it becomes available and provides the public, public health and emergency preparedness officials, government and business leaders, school systems, and local communities with comprehensive governmentwide information on a pandemic. In addition, HHS will use a variety of other information systems to distribute pandemic information including telephone hotlines, such as 1-800-CDC-INFO; educational sessions through teleconferencing, such as the Clinician Outreach and Communication Activity to which the public can call-in; satellite informational broadcasts; and radio and television public service announcements. HHS has developed public service announcements for use on television and radio that urge the general public to learn about and prepare for a pandemic and has created an archive of materials—video footage, posters, and fact sheets—for conveying key pandemic messages to the general public. HHS also has developed planning checklists for specific audiences—such as medical providers, schools, and businesses—to raise awareness and to assist these audiences in preparing for a pandemic. For example, the planning checklists identify issues that should be considered, such as storing additional infection control supplies (such as hand cleansing products and tissues); establishing pandemic-specific policies, procedures, and roles and responsibilities; planning to maintain continuity of operations; coordinating activities with local stakeholders; practicing infection control; and developing communications plans. HHS officials told us that communicating messages to the general public during a pandemic will be challenging despite the department’s preparations. The first challenge is that a pandemic will create an immediate, intense, and sustained demand for information from both the general public and the groups to whom the public will be turning for information, such as the media and health care community. In addition, the general public will likely turn to numerous sources other than HHS for information, including other federal agencies, state and local authorities, the media, health care providers, the Internet, hotlines, employers, peers, family, and community leaders. HHS will not be able to ensure that messages delivered to the general public by non-HHS entities are coordinated and consistent with HHS messages, and the communications may cause confuse the general public. A second challenge concerns the public’s reception to HHS’s communications. HHS has found a low level of public understanding on pandemic issues, some unwillingness to comply under certain circumstances with the messages that HHS plans to deliver, and anxiety over particular messages (such as why pre-pandemic vaccines and some antivirals will not be made available to the general public). For example, a nationally representative survey on pandemic issues found that 58 percent of the general public in the United States did not know what a pandemic is. The survey also found that the public is less willing or is unable to follow some of the recommendations that HHS plans to communicate during a pandemic. For example, HHS plans to recommend that sick individuals who do not require hospital care observe voluntary home isolation and treatment; however, 24 percent of the people surveyed said that they did not have someone to take care of them in their homes. The same study also found that 35 percent of respondents would go to work if requested by their employer even if public health officials recommended that people stay at home during a pandemic. Furthermore, HHS tabletop exercises have identified several issues that will prove challenging when communicating with the public during a pandemic, particularly the sensitivity of certain messages, the use of specialized public health terms in the messages, and the inadequacy of HHS message maps to address the complexity of the issues being communicated. Discussions during these tabletop exercises will help HHS to develop plans to resolve these identified challenges. For example, HHS’s messages will have to communicate clearly the difference between specialized terms such as isolation and quarantine, and the meaning of the phrase “altered standards of care.” Because of the complexity of the issues in its message maps, HHS plans to develop additional educational materials to distribute to the public before a pandemic in order to make these complexities more comprehensible. Although HHS has made progress in identifying issues that need to be addressed and in funding research and vaccine production, significant challenges remain, many of which are beyond HHS’s control or which cannot be quickly addressed. Such challenges include coping with the potentially high absentee rate among health care providers during a pandemic and the length of time it will take to develop a pandemic vaccine once the virus is identified. One important activity, however, that is within HHS’s control that HHS could address before a pandemic is finalizing the guidance on how limited pharmaceutical interventions should be used during a pandemic. A severe pandemic, such as that of 1918-19, has the potential to result in widespread illness and death and is expected to overwhelm the nation’s ability to respond. According to HHS, initial batches of the most effective protective measure—a pandemic vaccine—may take as long as 20 to 23 weeks after the start of the pandemic to become available. Although the federal government has provided some guidance, final decisionmaking will fall on state and local officials who will have to decide how to allocate pharmaceutical interventions and whom interventions should go to first, and when. HHS, in consultation with other federal agencies, has been tasked with revising guidance to assist state and local jurisdictions in identifying groups that should be considered a priority for receiving limited pharmaceutical interventions. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance for public comment on how antivirals may be used during a pandemic. However, HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. We and others have reported since 2000 how problems related to pandemic planning—such as those problems with the distribution and administration of pharmaceutical interventions—can arise if target groups are not established in advance. This lack of essential information could slow the initial response at the state and local levels and complicate the general public’s understanding of the necessity for rationing these interventions. Additionally, the general public should continue to be engaged in the process of priority setting, as public participation is an essential component for acceptance of tough decisions that will be required unless and until greater capacity or a universal vaccine can be developed. To improve the nation’s preparedness for a pandemic, we are recommending that the Secretary of HHS expeditiously finalize guidance to assist state and local jurisdictions to determine how to effectively use limited supplies of antivirals and pre-pandemic vaccine in a pandemic, including prioritizing target groups for pre-pandemic vaccine. HHS provided written comments on a draft of this report which we have reproduced in appendix III. HHS also provided technical comments, which we have incorporated as appropriate. In its comments, HHS noted that it has taken and plans to take additional actions related to our recommendation since we provided the draft report to the department for its review. HHS indicated that the final guidance for pandemic vaccine allocation was released on July 23, 2008, and that this guidance describes the groups who should be targeted and prioritized for receiving pandemic vaccine. HHS also indicated that the department released draft guidance on how antivirals may be used during a pandemic in June 2008, and that HHS will release for public comment proposed draft guidance on pre-pandemic vaccine allocation in the near future. We updated the text of the report to reflect these developments. We also revised the wording of our recommendation in light of HHS’s comment that HHS recommends that antivirals in public-sector stockpiles should be used primarily for the treatment of individuals sick with influenza. We first identified the need for finalized guidance on how limited pharmaceutical interventions should be used during a pandemic, including target groups where appropriate, in 2000. We believe that finalizing guidance on the use of pharmaceutical interventions will be crucial for responding to a pandemic outbreak and that the necessary guidance documents should be finalized as soon as possible. Throughout its comments, HHS described aspects of its pandemic preparedness activities that it believed could be presented more clearly in our report and presented additional details about its activities. We have revised the language in the report to reflect HHS’s comments where it was necessary. In particular, we revised our discussion of pharmaceutical interventions to clarify our presentation of the three types of pharmaceuticals and how pre-pandemic vaccine will be distributed and administered during a pandemic. We also revised the report to reflect HHS’s objection to our statement that the use of antivirals early in a pandemic could slow the spread of the pandemic. HHS commented that the magnitude of the impact of pharmaceuticals on pandemic spread is uncertain given “…limited countermeasure supplies, unclear effectivenesss, and operational challenges…” Many of HHS’s comments addressed the scope of the department’s actions in relation to the responsibilities of states and local jurisdictions. For example, HHS noted that it will directly oversee the administration of pre- pandemic vaccine to members of the critical workforce, rather than fully delegate that task. For antivirals, HHS agreed that states are free to administer antivirals in their own stockpiles to anyone they like, but also noted that state plans have been reviewed by CDC to ensure that the plans reflect the national recommendation to use antivirals primarily for treatment of individuals sick with influenza. Thirdly, HHS emphasized that health care personnel surge capacity in a pandemic is a local responsibility. Although the 2005 HHS Pandemic Influenza Plan recommends deployment of federal medical responders to supplement the number of health care providers, HHS noted that the federal government does not have adequate health care personnel to provide surge capacity. On that topic, HHS also noted that its planning documents for allocating scarce health care resources were intended as “…planning documents for consideration by communities, not for the purposes of establishing definitive standards.” Finally, HHS proposed alternate terms for some of the concepts in our report (we have noted these instances in the report). For example, HHS disagreed with our use of the term “altered standards of care” and said that the more appropriate term is “standards of care appropriate to the situation.” Because we believe that “altered standards of care” is an accurate description of what may happen as the result of the allocation of scarce health care resources in a pandemic emergency and because HHS used this phrase in its guidance to state and local jurisdictions, we did not make this change. We are sending copies of this report to the Secretary of HHS and to interested congressional committees. We will also make copies available to others on request. In addition, the report will be available at no charge on GAO’s Web site at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or CrosseM@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made major contributions to this report are listed in appendix IV. The National Response Framework lays out, in part, the manner in which the federal government responds to domestic incidents. The plan is a guide for an all-hazards response, categorizing the types of federal assistance into specific emergency support functions. Primary and supporting agencies are listed for each emergency support function. “Emergency Support Function #8 – Public Health and Medical Services Annex” of the National Response Framework directs the Department of Health and Human Services (HHS) to provide support as the primary agency, with 16 other agencies, including the Departments of Homeland Security and Agriculture. The National Response Framework replaced the National Response Plan in March 2008, which, in turn, replaced the Federal Response Plan in April 2005. The Federal Response Plan, originally drafted in 1992 and revised in 1999, established the process and structure for the federal government’s provision of assistance in response to any major disaster or emergency declared under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act). The purpose of the Stafford Act is “to provide an orderly and continuing means of assistance by the federal government to state and local governments in carrying out their responsibilities to alleviate the suffering and damage which result” from disasters and emergencies. National Strategy for Pandemic Influenza On November 1, 2005, the President of the United States released the National Strategy for Pandemic Influenza, which provides a framework for future planning efforts for how the country will prepare for, detect, and respond to an influenza pandemic. The strategy reflects the federal government’s approach to the pandemic threat and is based on three main types of activities: (1) preparedness and communication, (2) surveillance and detection, and (3) response and containment. National Strategy for Pandemic Influenza Implementation Plan On May 3, 2006, the President of the United States released the National Strategy for Pandemic Influenza Implementation Plan, which further clarifies the roles and responsibilities of governmental and nongovernmental entities—including federal, state, local, and tribal authorities and regional, national, and international stakeholders—and provides preparedness guidance for all segments of society. This plan addresses the following topics: U.S. government planning and response; international efforts and transportation and borders; protecting human health; protecting animal health; law enforcement, public safety, and security; and institutional considerations. The federal government has identified approximately 300 action items to address the threat of a pandemic. These items include 199 action items led or co-led by HHS. As stated in the plan’s preface, the plan will be reviewed on a continuous basis and revised as appropriate to reflect changes in the understanding of the threat and the development of new technologies. Since the release of the implementation plan, the Homeland Security Council released the National Strategy for Pandemic Influenza Implementation Plan One Year Summary on July 17, 2007. This document summarizes the federal government’s efforts to prepare for an influenza pandemic. Because HHS has primary responsibility for coordinating the nation’s response to public health emergencies under “Emergency Support Function #8,” the department has developed the HHS Pandemic Influenza Plan. The first part of this plan provides HHS’s strategic plan for dealing with an influenza pandemic. This includes information on recommendations on the use of vaccines and antivirals, legal authorities, key HHS activities, HHS research activities, and international partnerships on avian and pandemic influenza. Preparing for and responding to a pandemic will not be purely a federal responsibility; it will primarily be a local response. And because a pandemic is likely to occur in multiple areas simultaneously, resources cannot be geographically shifted as is often done with other emergencies; every community will need to rely on its own planning and resources to respond to the outbreak. Therefore, the second part of the HHS Pandemic Influenza Plan consists of 11 supplements that provide guidance to state and local officials on response elements necessary for preparation for a pandemic (see table 5). The third part of the plan, which details the critical actions items for which HHS has the lead as described in the National Strategy for Pandemic Influenza Implementation Plan, was produced as a separate plan—the Pandemic Influenza Implementation Plan—and was released in November 2006. The Pandemic Influenza Implementation Plan also includes a second part that contains the HHS agencies’ operational plans. The HHS Pandemic Influenza Plan will be reviewed on a continuous basis and revised as appropriate to reflect changes in the understanding of the threat and new technologies. HHS has released five updates regarding the progress of the department’s preparedness efforts on March 13, 2006; June 29, 2006; November 13, 2006; July 18, 2007; and March 17, 2008, respectively. Homeland Security Presidential Directive-21: Public Health and Medical Preparedness On October 18, 2007, the President of the United States released the Homeland Security Presidential Directive-21: Public Health and Medical Preparedness, which provides a strategy for protecting the health of the U.S. population against all disasters, including a pandemic. This directive describes four critical components of public health and medical preparedness: biosurveillance, countermeasure distribution (including pharmaceuticals), mass casualty care, and community resilience. All four critical components will include coordination of efforts at the federal, state, and local levels, as well as with private sector, public health, and medical disaster response resources. Guidance on Allocating and Targeting Pandemic Influenza Vaccine On July 23, 2008, HHS, in coordination with DHS, released the Guidance on Allocating and Targeting Pandemic Influenza Vaccine. This guidance provides a framework to state and local jurisdictions on how to allocate limited supplies of pandemic vaccine to targeted groups, with the goal of providing this vaccine to all who choose to receive it. According to the guidance, groups targeted for vaccination varies depending on the severity of the pandemic. According to HHS officials, it is important to have a stockpile of pharmaceutical interventions, when possible, for use during the early stages of a pandemic. HHS allotted portions of its total fiscal year 2006 appropriation for pandemic-related purposes—$5.683 billion—to the acquisition and development of pharmaceutical interventions. Specifically, approximately $1.1 billion was targeted for investment in antivirals and approximately $3.2 billion was dedicated for vaccines. HHS has also established goals for amounts of pharmaceutical interventions to be stockpiled nationally (see table 6). HHS has invested millions of dollars into the stockpiling of antivirals to achieve its two goals for antivirals. Table 7 summarizes the approximate number of courses stockpiled as of May 2008. In addition, in March 2006, HHS allotted $200 million dollars to the development of additional antivirals, and in January 2007, the department awarded a 4-year contract of about $103 million for further development of the new antiviral peramivir. HHS has also awarded contracts to purchase pre-pandemic vaccines from manufacturers to add to the federal stockpile. See table 8 for HHS’s efforts to stockpile pre-pandemic vaccines. HHS officials told us that the greatest challenge to preparing for an influenza pandemic and implementing its plans for using pharmaceutical interventions is the lack of vaccine manufacturing capacity within the United States. We found in prior work that the lack of U.S. vaccine manufacturing capacity is cause for concern among experts because it is possible that countries without domestic manufacturing capacity will not have access to vaccines in the event of a pandemic if the countries with domestic manufacturing capacity prohibit the export of the pandemic vaccine until their own needs are met. Table 9 describes other HHS initiatives to establish domestic manufacturing infrastructure for vaccine production. Other HHS activities to enhance domestic vaccine manufacturing capacity include investing in vaccine development and research. For example, HHS has invested over $1 billion in development of a cell-based approach to influenza vaccine manufacturing, which it claims will modernize the current egg-based production process (see table 10). The current manufacturing process uses chicken eggs, and egg-based vaccines can easily become contaminated. Cell-based technology does not have these sterility issues and allows for faster development and greater production capacity. Although cell-based vaccine production has been used for other vaccines, it has not been approved for use in developing influenza vaccines. However, according to HHS, it anticipates that a licensed cell- based influenza vaccine will be manufactured in 2010. Also, in January 2007, HHS awarded contracts totaling approximately $133 million to vaccine manufacturers for development of pre-pandemic vaccines, containing adjuvants—substances that may be added to a vaccine to increase the body’s immune response, thereby necessitating a lower dose of vaccine. In addition to the contact named above, Martin T. Gahart, Assistant Director; George Bogart; Cathleen Hamann; Gay Hee Lee; and Deborah J. Miller made key contributions to this report. Influenza Pandemic: Federal Agencies Should Continue to Assist States to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.: June 19, 2008. Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources. GAO-08-668. Washington, D.C.: June 13, 2008. Influenza Pandemic: Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92. Washington, D.C.: December 21, 2007. Influenza Pandemic: Opportunities Exist to Address Critical Infrastructure Protection Challenges That Require Federal and Private Sector Coordination. GAO-08-36. Washington, D.C.: October 31, 2007. Influenza Vaccine: Issues Related to Production, Distribution, and Public Health Messages. GAO-08-27. Washington, D.C.: October 31, 2007. Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles and an Effective National Strategy. GAO-07-781. Washington, D.C.: August 14, 2007. Emergency Management Assistance Compact: Enhancing EMAC’s Collaborative and Administrative Capacity Should Improve National Disaster Response. GAO-07-854. Washington, D.C.: June 29, 2007. Influenza Pandemic: DOD Combatant Commands’ Preparedness Efforts Could Benefit from More Clearly Defined Roles, Resources, and Risk Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007. Influenza Pandemic: Efforts to Forestall Onset Are Under Way; Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604. Washington, D.C.: June 20, 2007. Emergency Management: Most School Districts Have Developed Emergency Management Plans, but Would Benefit from Additional Federal Guidance. GAO-07-609. Washington, D.C.: June 12, 2007. Avian Influenza: USDA Has Taken Important Steps to Prepare for Outbreaks, but Better Planning Could Improve Response. GAO-07-652. Washington, D.C.: June 11, 2007. The Federal Workforce: Additional Steps Needed to Take Advantage of Federal Executive Boards’ Ability to Contribute to Emergency Operations. GAO-07-515. Washington, D.C.: May 4, 2007. Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but Accountability, Funding, and Communications Need to be Clearer and Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21, 2006. Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4, 2005. Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005. Influenza Pandemic: Challenges in Preparedness and Response. GAO-05-863T. Washington, D.C.: June 30, 2005. Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T. Washington, D.C.: May 26, 2005. Infectious Disease Preparedness: Federal Challenges in Responding to Influenza Outbreak. GAO-04-1100T. Washington, D.C.: September 28, 2004. Bioterrorism: Public Health Response to Anthrax Incidents of 2001. GAO-04-152. Washington, D.C.: October 15, 2003. Infectious Diseases: Gaps Remain in Surveillance Capabilities of State and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003. SARS Outbreak: Improvements to Public Health Capacity Are Needed for Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03-769T. Washington, D.C.: May 7, 2003. Bioterrorism: Preparedness Varied across State and Local Jurisdictions. GAO-03-373. Washington, D.C.: April 7, 2003. Hospital Emergency Departments: Crowded Conditions Vary among Hospitals and Communities. GAO-03-460. Washington, D.C.: March 14, 2003. Nursing Workforce: Emerging Nurse Shortages Due to Multiple Factors. GAO-01-944. Washington. D.C.: July 10, 2001. Nursing Workforce: Recruitment and Retention of Nurses and Nurse Aides Is a Growing Concern. GAO-01-750T. Washington, D.C.: May 17, 2001. Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High- Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.

Summary: The emergence of the H5N1 avian influenza virus (also known as "bird flu") has raised concerns that it or another virus might mutate into a virulent strain that could lead to an influenza pandemic. Experts predict that a severe pandemic could overwhelm the nation's health care system, requiring the rationing of limited resources. GAO was asked to provide information on the progress of the Department of Health and Human Services's (HHS) plans for responding to a pandemic, including analyzing how HHS plans to (1) use pharmaceutical interventions to treat infected individuals and protect the critical workforce and (2) use nonpharmaceutical interventions to slow the spread of disease. To conduct this work, GAO reviewed government documents and scientific literature, and interviewed HHS officials, state and local public health officials, and subject-matter experts on pandemic response. HHS plans to make existing federal stockpiles of pharmaceutical interventions available for distribution once a pandemic begins. These interventions would include antivirals, which are drugs to prevent or reduce the severity of infection, and pre-pandemic vaccines, which are vaccines produced prior to a pandemic and developed from influenza strains that have the potential to cause a pandemic. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in the Strategic National Stockpile and in jurisdictional stockpiles. According to HHS, these public sector stockpiles are intended to be used primarily for the treatment of individuals sick with influenza. HHS intends to oversee the distribution and administration of pre-pandemic vaccine to individuals identified as members of the critical workforce. Members of the critical workforce--estimated to be about 20 million--include workers in sectors that are considered necessary to keep society functioning, such as health care and law enforcement personnel. HHS's strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine--a vaccine specific to the pandemic-causing strain--becomes widely available. HHS anticipates that initial batches of a pandemic vaccine may not be available until 20 to 23 weeks after the start of the pandemic. As batches of the pandemic vaccine become available, HHS plans for state and local jurisdictions to provide it to members of targeted groups based on factors such as occupation and age, instead of making it available to the general public. HHS faces challenges implementing its strategy for using pharmaceutical interventions during a pandemic, including the lack of vaccine manufacturing capacity in the United States. HHS is currently making large investments to expand domestic vaccine manufacturing capacity. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions, such as isolation of sick individuals and voluntary home quarantine of those exposed to the pandemic strain. To assist state and local jurisdictions with implementing nonpharmaceutical interventions, HHS has developed guidance that describes the department's "community mitigation framework." The framework involves the early initiation of multiple nonpharmaceutical interventions, each of which is expected to be partially effective and to be maintained consistently throughout a pandemic. HHS faces difficulties, including helping jurisdictions develop ways to ensure community compliance. HHS is investing in several initiatives to increase the nation's knowledge about the general use and effectiveness of nonpharmaceutical interventions. The findings from this research will be used to update existing guidance.