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INFLUENZA PANDEMIC - HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions [US GAO]
United States Government Accountability Office - GAO Report to Congressional Requesters
INFLUENZA PANDEMIC - HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
September 2008
INFLUENZA PANDEMIC - HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
What GAO Found
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In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic.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.
(...)
United States Government Accountability Office - Washington, DC 20548 - September 30, 2008
The Honorable Edward M. Kennedy Chairman
The Honorable Michael B. Enzi Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate
The Honorable Bennie G. Thompson Chairman Committee on Homeland Security House of Representatives
The emergence of the H5N1 avian influenza virus (also known as ?bird flu?) has raised concerns that it or another influenza virus might mutate into a novel and virulent strain that could lead to a human influenza pandemic(1) that would pose a grave threat to global public health.
Pandemics occur when an influenza strain to which humans have little or no immunity begins to cause serious illness and spreads easily from person to person.
In the United States alone, at least 675,000 people died during the 1918-19 pandemic, the deadliest pandemic in the twentieth century.
The Department of Health and Human Services (HHS) has estimated that a pandemic similar to the severe 1918-19 pandemic would sicken 90 million people in the United States (30 percent of the population), of whom nearly 10 million would require hospitalization and almost 2 million would die.(2)
Given that as of 2005 there were approximately 950,000 staffed hospital beds(3) in the United States, HHS?s estimates indicate that the effects of a severe pandemic would far exceed the capacity of U.S. hospitals.(4)
HHS has made substantial progress in its preparedness for pandemic influenza.
For example, since 2000, we had been urging HHS to complete its pandemic plan.(5)
HHS released the HHS Pandemic Influenza Plan in November 2005. (See app. I for summaries of select federal pandemic documents.) We recently reported that HHS has improved its influenza surveillance and diagnostic testing capabilities.(6)
Prompted by concerns regarding H5N1, HHS and its international partner organizations have increased efforts to enhance animal and human surveillance systems overseas.
Additionally, in February 2006, the Food and Drug Administration (FDA)?an agency within HHS?approved a diagnostic test developed by the Centers for Disease Control and Prevention (CDC)?another agency within HHS?that recognizes H5 influenza viruses within 4 hours of testing; it previously would have taken 2 to 3 days.
Despite this progress, a severe pandemic would pose formidable challenges to the federal government?s efforts to minimize damage to the public?s health and the nation?s economy.
The single most important pharmaceutical intervention during a pandemic?a pandemic vaccine that is well-matched to the pandemic-causing strain?will not be available in large quantities in the initial stages of a pandemic.
Other pharmaceutical interventions,(7) such as antivirals(8) and pre-pandemic vaccines (possibly less effective vaccines produced prior to the pandemic and based on strains experts believe may cause a pandemic) are also expected to be in limited supply and unavailable to the population at large.(9)
In addition, although the ability to quickly increase the number of health care providers, called surge capacity, will be vital for treating the potentially large numbers of infected individuals, efforts to do so must overcome existing shortages of health care workers in the United States.(10)
Similarly, because they are rarely used on a large scale, the effectiveness of large-scale implementation of nonpharmaceutical interventions, including closing schools and voluntary home quarantine, is uncertain.
In addition, throughout the initial stages of a pandemic, crucial information?such as when and where to access medical care, and how to reduce the chances of infection?will need to be communicated to the public in a way that does not incite panic.
Given these obstacles and the possible risk that the best-made plans may still be ineffective in a severe pandemic, the federal government is taking steps to prepare the nation for a potential pandemic in hopes of lessening its overall impact.
The National Response Framework charges the Secretary of the Department of Homeland Security (DHS) with responsibility for overall management and federal coordination of domestic incidents when needed,(11) the Federal Emergency Management Agency (FEMA) Administrator with responsibility as principal advisor to the President regarding emergency management, and the Secretary of HHS with responsibility for public health and medical response.(12)
On November 2, 2005, the Secretary of HHS released the HHS Pandemic Influenza Plan, which provides HHS?s plans for responding to a pandemic.(13)
The document also provides pandemic response guidance to officials in state and local jurisdictions(14) and to health care facility officials.
Since then, HHS has released five updates regarding the department?s preparedness efforts and has released its Pandemic Influenza Implementation Plan. Despite these efforts, influenza and public health preparedness experts have raised concerns about the adequacy of HHS?s plans and guidance to state and local officials and to health care facility officials.
Because of your interest in pandemic preparedness, we are providing information on the progress of HHS?s plans and its guidance to state and local officials, and to health care facility officials, for responding to a pandemic outbreak.
The focus of our work is on 4 key components taken from 5 of the 11 response elements critical for preparedness as described in the HHS Pandemic Influenza Plan (see table 5 in app. I for a list of all the response elements).
Three components that we examined?pharmaceutical interventions (vaccines and antivirals), surge capacity of health care providers, and public communications?have repeatedly been found to need improvement by GAO and outside experts.
In prior work, we reported on potential problems with pharmaceutical interventions during a pandemic, including vaccine shortages and the need for identifying target groups in advance.(15)
Health care provider shortages, including nurses and physicians, have been reported for many years by GAO.(16)
We reported that during the anthrax incidents of 2001, the media and the general public looked to CDC as the source for health-related information. However, CDC was not always able to successfully convey the information that it had.(17)
We also reported on the significance of communicating clearly on response efforts during a pandemic.(18)
The fourth component we focus on in our work?guidance for nonpharmaceutical interventions?is based on limited scientific evidence.
Specifically, for this report we analyzed how HHS plans to
(1) use pharmaceutical interventions for treatment of infected individuals and to protect the critical workforce,
(2) improve surge capacity of health care providers,
(3) prepare state and local authorities to use nonpharmaceutical interventions for slowing the spread of disease, and
(4) prepare to communicate with the public during a pandemic.
To determine how HHS plans to implement the four key components, we reviewed government documents related to a pandemic response. (See app. I for a description of each document.) In addition, to learn more about the elements needed for an effective public health emergency response, we reviewed related reports issued by GAO and HHS agencies, independent studies (including those from the Institute of Medicine, Congressional Research Service, and World Health Organization), and peer-reviewed journals.
We interviewed officials from HHS offices, including the Office of the Assistant Secretary for Preparedness and Response, Office of the Assistant Secretary for Public Affairs, CDC, National Vaccine Program Office, National Institutes of Health, Agency for Healthcare Research and Quality, Health Resources and Services Administration, and FDA to learn more about their planning efforts. In addition, we interviewed state and local public health officials and members of the National Association of County and City Health Officials and the Association of State and Territorial Health Officials.
We also interviewed officials from the American Hospital Association, American Medical Association, American Society For Microbiology, Council of State and Territorial Epidemiologists, Infectious Diseases Society of America, and Association of Public Health Laboratories.
We also interviewed subject-matter experts to get their perspectives on HHS?s planning efforts. We participated in relevant public meetings on pandemic preparedness, such as those sponsored by the Institute of Medicine, to gain knowledge of new scientific evidence on the effectiveness of planning efforts.
U.S. pandemic preparedness work is an ongoing process.
The data in this report were last updated on August 2008.
However, changes have continued to occur since completion of our data collection, and this report may not reflect all these changes. We conducted our work from April 2006 through September 2008 in accordance with generally accepted government auditing standards.
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Original PDF document at: http://www.gao.gov/new.items/d08671.pdf
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References:
1) In this report, the term ?pandemic? will refer to a human influenza pandemic.
2) Department of Health and Human Services, HHS Pandemic Influenza Plan (Washington, D.C.: November 2005). HHS also estimated that 1,485,000 people would require care in an intensive care unit (ICU) and 742,500 people would require mechanical ventilation.
3) The term ?staffed bed? means that there are health care staffs available to attend to a patient occupying the bed.
4) HHS estimates show that the effects of even a moderate pandemic would exceed the capacity of U.S. hospitals, with 865,000 people requiring hospitalization, 128,750 people requiring care in an ICU, 64,875 people requiring mechanical ventilation, and 209,000 deaths.
5) GAO, Influenza Pandemic: Plan Needed for Federal and State Response, GAO-01-4 (Washington, D.C.: Oct. 27, 2000), 27 and GAO, Influenza Pandemic: Challenges Remain in Preparedness, GAO-05-760T (Washington, D.C.: May 26, 2005), 17.
6) GAO, Influenza Pandemic: Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic, GAO-08-92 (Washington, D.C.: Dec. 21, 2007), 30-32, 36.
7) HHS refers to pharmaceutical interventions as medical countermeasures.
8) Antivirals are drugs designed to prevent or reduce the severity of a viral infection, such as influenza. Vaccines are drugs used to stimulate the response of the human immune system to help protect the body from disease.
9) For more detailed information on the use of antivirals and vaccines in a pandemic, see GAO-08-92, 4.
10) Surge capacity may also include the ability to acquire other resources such as hospital beds, pharmaceuticals, and equipment, and to allocate scarce resources and provide care outside of the normal health care delivery system and infrastructure. For the purpose of this report, we refer to surge capacity in the context of the ability to increase the number of health care providers.
11) Federal assistance can be provided to state, local, and tribal jurisdictions through mechanisms and authorities that do not require coordination of federal response activities and can be provided without a Presidential declaration of a major disaster or emergency. For example, federal assistance can be provided through the National Search and Rescue Plan and the Maritime Security Plan.
12) Department of Homeland Security, National Response Framework (Washington, D.C.: 2008). The National Response Framework replaced the National Response Plan in March 2008. See app. I for details regarding the genesis of the plan.
13) This is only part of the federal government?s planning efforts for responding to a pandemic. The President of the United States released two documents for a broader response: (1) 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 a pandemic and (2) the National Strategy for Pandemic Influenza Implementation Plan, which further clarifies the roles and responsibilities of governmental and non-governmental entities and provides preparedness guidance for all segments of society. See app. I for general descriptions of these documents.
14) For this report, we use the term ?state and local jurisdictions? to refer to state, local, territorial, and tribal areas. For the allocation of pharmaceutical interventions during a pandemic, ?state and local jurisdictions? refers to state, local, and territorial areas. Tribal populations are included in states? populations. HHS uses the term ?Project Areas? when discussing the allocation of antivirals and points of distribution when discussing pre-pandemic and pandemic vaccines.
15) See GAO-08-92, 4; GAO, Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage, GAO-06-221T (Washington, D.C.: Nov. 4, 2005), 2, 10; GAO, Influenza Pandemic: Challenges in Preparedness and Response, GAO-05-863T (Washington, D.C.: June 30, 2005), 6-9, 11-12; and GAO, Influenza Pandemic: Challenges Remain in Preparedness, GAO-05-760T (Washington, D.C.: May 26, 2005), 12-15. For additional information, see Related GAO Products at the end of this report.
16) See GAO-05-863T, 13; GAO-05-760T, 16-17; GAO, Infectious Diseases: Gaps Remain in Surveillance Capabilities of State and Local Agencies, GAO-03-1176T (Washington, D.C.: Sept. 24, 2003), 9-10; GAO, Bioterrorism: Preparedness Varied across State and Local Jurisdictions, GAO-03-373 (Washington, D.C.: Apr. 7, 2003), 17-18, 21-22; GAO, Nursing Workforce: Emerging Nurse Shortages Due to Multiple Factors, GAO-01-944 (Washington, D.C.: July 10, 2001), 6-12; and GAO, Nursing Workforce: Recruitment and Retention of Nurses and Nurse Aides Is a Growing Concern, GAO-01-750T (Washington, D.C.: May 17, 2001), 4-14.
17) GAO, Bioterrorism: Public Health Response to Anthrax Incidents of 2001, GAO-04-152 (Washington, D.C.: Oct. 15, 2003), 24.
18) GAO-05-863T, 9-11.
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United States Government Accountability Office - GAO Report to Congressional Requesters
INFLUENZA PANDEMIC - HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
September 2008
INFLUENZA PANDEMIC - HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
What GAO Found
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.
(...)
United States Government Accountability Office - Washington, DC 20548 - September 30, 2008
The Honorable Edward M. Kennedy Chairman
The Honorable Michael B. Enzi Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate
The Honorable Bennie G. Thompson Chairman Committee on Homeland Security House of Representatives
The emergence of the H5N1 avian influenza virus (also known as ?bird flu?) has raised concerns that it or another influenza virus might mutate into a novel and virulent strain that could lead to a human influenza pandemic(1) that would pose a grave threat to global public health.
Pandemics occur when an influenza strain to which humans have little or no immunity begins to cause serious illness and spreads easily from person to person.
In the United States alone, at least 675,000 people died during the 1918-19 pandemic, the deadliest pandemic in the twentieth century.
The Department of Health and Human Services (HHS) has estimated that a pandemic similar to the severe 1918-19 pandemic would sicken 90 million people in the United States (30 percent of the population), of whom nearly 10 million would require hospitalization and almost 2 million would die.(2)
Given that as of 2005 there were approximately 950,000 staffed hospital beds(3) in the United States, HHS?s estimates indicate that the effects of a severe pandemic would far exceed the capacity of U.S. hospitals.(4)
HHS has made substantial progress in its preparedness for pandemic influenza.
For example, since 2000, we had been urging HHS to complete its pandemic plan.(5)
HHS released the HHS Pandemic Influenza Plan in November 2005. (See app. I for summaries of select federal pandemic documents.) We recently reported that HHS has improved its influenza surveillance and diagnostic testing capabilities.(6)
Prompted by concerns regarding H5N1, HHS and its international partner organizations have increased efforts to enhance animal and human surveillance systems overseas.
Additionally, in February 2006, the Food and Drug Administration (FDA)?an agency within HHS?approved a diagnostic test developed by the Centers for Disease Control and Prevention (CDC)?another agency within HHS?that recognizes H5 influenza viruses within 4 hours of testing; it previously would have taken 2 to 3 days.
Despite this progress, a severe pandemic would pose formidable challenges to the federal government?s efforts to minimize damage to the public?s health and the nation?s economy.
The single most important pharmaceutical intervention during a pandemic?a pandemic vaccine that is well-matched to the pandemic-causing strain?will not be available in large quantities in the initial stages of a pandemic.
Other pharmaceutical interventions,(7) such as antivirals(8) and pre-pandemic vaccines (possibly less effective vaccines produced prior to the pandemic and based on strains experts believe may cause a pandemic) are also expected to be in limited supply and unavailable to the population at large.(9)
In addition, although the ability to quickly increase the number of health care providers, called surge capacity, will be vital for treating the potentially large numbers of infected individuals, efforts to do so must overcome existing shortages of health care workers in the United States.(10)
Similarly, because they are rarely used on a large scale, the effectiveness of large-scale implementation of nonpharmaceutical interventions, including closing schools and voluntary home quarantine, is uncertain.
In addition, throughout the initial stages of a pandemic, crucial information?such as when and where to access medical care, and how to reduce the chances of infection?will need to be communicated to the public in a way that does not incite panic.
Given these obstacles and the possible risk that the best-made plans may still be ineffective in a severe pandemic, the federal government is taking steps to prepare the nation for a potential pandemic in hopes of lessening its overall impact.
The National Response Framework charges the Secretary of the Department of Homeland Security (DHS) with responsibility for overall management and federal coordination of domestic incidents when needed,(11) the Federal Emergency Management Agency (FEMA) Administrator with responsibility as principal advisor to the President regarding emergency management, and the Secretary of HHS with responsibility for public health and medical response.(12)
On November 2, 2005, the Secretary of HHS released the HHS Pandemic Influenza Plan, which provides HHS?s plans for responding to a pandemic.(13)
The document also provides pandemic response guidance to officials in state and local jurisdictions(14) and to health care facility officials.
Since then, HHS has released five updates regarding the department?s preparedness efforts and has released its Pandemic Influenza Implementation Plan. Despite these efforts, influenza and public health preparedness experts have raised concerns about the adequacy of HHS?s plans and guidance to state and local officials and to health care facility officials.
Because of your interest in pandemic preparedness, we are providing information on the progress of HHS?s plans and its guidance to state and local officials, and to health care facility officials, for responding to a pandemic outbreak.
The focus of our work is on 4 key components taken from 5 of the 11 response elements critical for preparedness as described in the HHS Pandemic Influenza Plan (see table 5 in app. I for a list of all the response elements).
Three components that we examined?pharmaceutical interventions (vaccines and antivirals), surge capacity of health care providers, and public communications?have repeatedly been found to need improvement by GAO and outside experts.
In prior work, we reported on potential problems with pharmaceutical interventions during a pandemic, including vaccine shortages and the need for identifying target groups in advance.(15)
Health care provider shortages, including nurses and physicians, have been reported for many years by GAO.(16)
We reported that during the anthrax incidents of 2001, the media and the general public looked to CDC as the source for health-related information. However, CDC was not always able to successfully convey the information that it had.(17)
We also reported on the significance of communicating clearly on response efforts during a pandemic.(18)
The fourth component we focus on in our work?guidance for nonpharmaceutical interventions?is based on limited scientific evidence.
Specifically, for this report we analyzed how HHS plans to
(1) use pharmaceutical interventions for treatment of infected individuals and to protect the critical workforce,
(2) improve surge capacity of health care providers,
(3) prepare state and local authorities to use nonpharmaceutical interventions for slowing the spread of disease, and
(4) prepare to communicate with the public during a pandemic.
To determine how HHS plans to implement the four key components, we reviewed government documents related to a pandemic response. (See app. I for a description of each document.) In addition, to learn more about the elements needed for an effective public health emergency response, we reviewed related reports issued by GAO and HHS agencies, independent studies (including those from the Institute of Medicine, Congressional Research Service, and World Health Organization), and peer-reviewed journals.
We interviewed officials from HHS offices, including the Office of the Assistant Secretary for Preparedness and Response, Office of the Assistant Secretary for Public Affairs, CDC, National Vaccine Program Office, National Institutes of Health, Agency for Healthcare Research and Quality, Health Resources and Services Administration, and FDA to learn more about their planning efforts. In addition, we interviewed state and local public health officials and members of the National Association of County and City Health Officials and the Association of State and Territorial Health Officials.
We also interviewed officials from the American Hospital Association, American Medical Association, American Society For Microbiology, Council of State and Territorial Epidemiologists, Infectious Diseases Society of America, and Association of Public Health Laboratories.
We also interviewed subject-matter experts to get their perspectives on HHS?s planning efforts. We participated in relevant public meetings on pandemic preparedness, such as those sponsored by the Institute of Medicine, to gain knowledge of new scientific evidence on the effectiveness of planning efforts.
U.S. pandemic preparedness work is an ongoing process.
The data in this report were last updated on August 2008.
However, changes have continued to occur since completion of our data collection, and this report may not reflect all these changes. We conducted our work from April 2006 through September 2008 in accordance with generally accepted government auditing standards.
--
Original PDF document at: http://www.gao.gov/new.items/d08671.pdf
--
References:
1) In this report, the term ?pandemic? will refer to a human influenza pandemic.
2) Department of Health and Human Services, HHS Pandemic Influenza Plan (Washington, D.C.: November 2005). HHS also estimated that 1,485,000 people would require care in an intensive care unit (ICU) and 742,500 people would require mechanical ventilation.
3) The term ?staffed bed? means that there are health care staffs available to attend to a patient occupying the bed.
4) HHS estimates show that the effects of even a moderate pandemic would exceed the capacity of U.S. hospitals, with 865,000 people requiring hospitalization, 128,750 people requiring care in an ICU, 64,875 people requiring mechanical ventilation, and 209,000 deaths.
5) GAO, Influenza Pandemic: Plan Needed for Federal and State Response, GAO-01-4 (Washington, D.C.: Oct. 27, 2000), 27 and GAO, Influenza Pandemic: Challenges Remain in Preparedness, GAO-05-760T (Washington, D.C.: May 26, 2005), 17.
6) GAO, Influenza Pandemic: Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic, GAO-08-92 (Washington, D.C.: Dec. 21, 2007), 30-32, 36.
7) HHS refers to pharmaceutical interventions as medical countermeasures.
8) Antivirals are drugs designed to prevent or reduce the severity of a viral infection, such as influenza. Vaccines are drugs used to stimulate the response of the human immune system to help protect the body from disease.
9) For more detailed information on the use of antivirals and vaccines in a pandemic, see GAO-08-92, 4.
10) Surge capacity may also include the ability to acquire other resources such as hospital beds, pharmaceuticals, and equipment, and to allocate scarce resources and provide care outside of the normal health care delivery system and infrastructure. For the purpose of this report, we refer to surge capacity in the context of the ability to increase the number of health care providers.
11) Federal assistance can be provided to state, local, and tribal jurisdictions through mechanisms and authorities that do not require coordination of federal response activities and can be provided without a Presidential declaration of a major disaster or emergency. For example, federal assistance can be provided through the National Search and Rescue Plan and the Maritime Security Plan.
12) Department of Homeland Security, National Response Framework (Washington, D.C.: 2008). The National Response Framework replaced the National Response Plan in March 2008. See app. I for details regarding the genesis of the plan.
13) This is only part of the federal government?s planning efforts for responding to a pandemic. The President of the United States released two documents for a broader response: (1) 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 a pandemic and (2) the National Strategy for Pandemic Influenza Implementation Plan, which further clarifies the roles and responsibilities of governmental and non-governmental entities and provides preparedness guidance for all segments of society. See app. I for general descriptions of these documents.
14) For this report, we use the term ?state and local jurisdictions? to refer to state, local, territorial, and tribal areas. For the allocation of pharmaceutical interventions during a pandemic, ?state and local jurisdictions? refers to state, local, and territorial areas. Tribal populations are included in states? populations. HHS uses the term ?Project Areas? when discussing the allocation of antivirals and points of distribution when discussing pre-pandemic and pandemic vaccines.
15) See GAO-08-92, 4; GAO, Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage, GAO-06-221T (Washington, D.C.: Nov. 4, 2005), 2, 10; GAO, Influenza Pandemic: Challenges in Preparedness and Response, GAO-05-863T (Washington, D.C.: June 30, 2005), 6-9, 11-12; and GAO, Influenza Pandemic: Challenges Remain in Preparedness, GAO-05-760T (Washington, D.C.: May 26, 2005), 12-15. For additional information, see Related GAO Products at the end of this report.
16) See GAO-05-863T, 13; GAO-05-760T, 16-17; GAO, Infectious Diseases: Gaps Remain in Surveillance Capabilities of State and Local Agencies, GAO-03-1176T (Washington, D.C.: Sept. 24, 2003), 9-10; GAO, Bioterrorism: Preparedness Varied across State and Local Jurisdictions, GAO-03-373 (Washington, D.C.: Apr. 7, 2003), 17-18, 21-22; GAO, Nursing Workforce: Emerging Nurse Shortages Due to Multiple Factors, GAO-01-944 (Washington, D.C.: July 10, 2001), 6-12; and GAO, Nursing Workforce: Recruitment and Retention of Nurses and Nurse Aides Is a Growing Concern, GAO-01-750T (Washington, D.C.: May 17, 2001), 4-14.
17) GAO, Bioterrorism: Public Health Response to Anthrax Incidents of 2001, GAO-04-152 (Washington, D.C.: Oct. 15, 2003), 24.
18) GAO-05-863T, 9-11.
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