HHS Pandemic Influenza Implementation Plan
Overview
STATEMENT BY SECRETARY LEAVITT
When the U.S. Department of Health & Human Services released the Pandemic Influenza Strategic Plan Part I, a year ago, I noted: “We are better prepared today than we were yesterday, and we will be better prepared tomorrow than we are today.” Indeed, we are better prepared this year than we were one year ago – and, by continuing to implement the plans we have outlined, we will continue to improve our readiness into the future.
Since the release of our report last November, Congress has allotted $5.5 billion to support our preparation efforts, and our progress has been unprecedented. HHS, for example, has conducted pandemic flu summits in every state and territory, engaging state, local and tribal leaders and community representatives in preparation for an effective response to a pandemic. We are building our vaccine production capacity by investing in new technology, while continuing to grow our stockpile of medical interventions and supplies needed for response. We launched www.pandemicflu.gov, a cross-governmental internet resource used by millions of Americans seeking planning and guidance tools to increase their personal and community preparedness. In addition, we facilitated and subsidized state purchase of antiviral drugs and provided millions of dollars to states to enhance their efforts to develop an exercise preparedness plan.
This substantial commitment and investment has taken us a long way down the path of preparedness – but this should not make us complacent. Though it has not yet achieved sustained transmission between humans, the H5N1 strain of avian influenza has reached dozens of countries and claimed more than one hundred-fifty lives. A pandemic remains a serious local and global threat, and there is more work to be done to prepare for it.
Preparation is a continuum. We remain fortunate that we have not yet been faced with a pandemic and can use this time to prepare. If we continue to be vigilant in our commitment to preparedness, we will be better prepared to limit the severity and duration of a pandemic. We have an opportunity to be the first generation in history to be prepared for a pandemic and to save millions of lives in this country and around the world as a result. We must renew our commitment to seize this opportunity.
Sincerely,
Michael O. Leavitt
PREFACE
An influenza pandemic has the capacity to affect individuals and disrupt
society on multiple levels. Pandemic influenza preparedness is a public health
priority and a shared responsibility of the U.S. Department of Health and Human
Services (HHS), the World Health Organization (WHO), and other Federal and
non-Federal stakeholders across the country and abroad. The global nature of an
influenza pandemic compels Federal, State, local, and tribal governments,
communities, corporations, institutions, families, and individuals to learn
about, prepare for, and collaborate in efforts to slow, mitigate, and recover
from a pandemic. The development, refinement, integration, exercise, and
communication of pandemic influenza plans by all stakeholders are critical
components of preparedness. To this end, the Federal Government has developed
the following documents to guide the Nation's pandemic influenza preparedness
planning and response activities:
- National Strategy for Pandemic Influenza: On
November 1, 2005, the President released the National Strategy for Pandemic
Influenza, which provides a framework for the U.S. Government's pandemic
influenza preparedness and response efforts. (See
http://www.whitehouse.gov/homeland/pandemic-influenza.html.)
- The National Strategy for Pandemic Influenza Implementation
Plan: The White House Homeland Security Council (HSC) released the
National Strategy for Pandemic Influenza Implementation Plan in May 2006. This
Implementation Plan provides a common frame of reference for understanding the
pandemic threat and summarizes key planning assumptions to set a framework for
effective action. It also proposes that Federal Departments and Agencies take
specific coordinated steps to achieve the goals of the National Strategy, and
outlines expectations for Federal and non-Federal stakeholders in the U.S. and
abroad. This plan directs all Federal Departments to develop a pandemic
influenza plan. (See
http://www.whitehouse.gov/homeland/pandemic-influenza-implementation.html.)
- HHS Pandemic Influenza Plan: On November 2, 2005,
HHS released Parts 1 and 2 of the HHS Pandemic Influenza Plan, which serves as
a strategic blueprint for all HHS pandemic influenza preparedness planning and
response activities. (See http://www.hhs.gov/pandemicflu/plan/.)
The Plan builds on the actions and expectations set out in the National
Strategy and its Implementation Plan, and updates the August 2004 draft HHS
Pandemic Influenza Preparedness and Response Plan. The Plan integrates the
changes made in the 2005 WHO classification of pandemic phases and its
concomitant expansion of international guidance. It also is consistent with the
National Response Plan (NRP) published in December 2004. It includes:
- The HHS Strategic Plan (Part 1): Part 1 outlines
Federal plans and preparation for public health and medical support in the
event of a pandemic. It identifies the key roles of HHS and its agencies during
a pandemic, and provides planning assumptions for Federal, State, and local
health and public health operations plans.
- Public Health Guidance for State and Local Partners (Part
2): Part 2 provides detailed guidance to State and local health
departments in 11 key areas. Parts 1 and 2 will be regularly updated and
refined, and will serve as tools for continued engagement with all
stakeholders, including State and local partners.
- HHS Implementation Plan (Part 3): This document
implements the strategy laid out in Parts 1 and 2 and itemizes the specific
roles and responsibilities of each of HHS' operational and staff divisions in
planning for and responding to a pandemic. This document identifies specific
steps that operationalize and implement the actions and expectations outlined
for HHS in the HSC National Strategy for Pandemic Influenza
Implementation Plan. In addition, it identifies additional actions
that are required for successfully accomplishing the activities laid out in
both the National Strategy and the HHS Strategic Plan. This plan itemizes the
specific roles and responsibilities of each HHS operational and staff division
in preparing for a pandemic, not necessarily responding to one. The HHS
Implementation Plan is divided into two parts as follows:
- Part I discusses Department-wide issues such
as international activities, international and domestic surveillance, public
health interventions, the medical response, vaccines, antiviral drugs,
diagnostic devices and personal protective equipment (PPE), communications, and
State and local preparedness, all of which require coordination of efforts
across HHS operational divisions. It details the specific steps needed to meet
the challenges of a pandemic response and the critical capabilities as
identified in both the National Strategy Implementation Plan and the HHS
Strategic Plan.
- Part II includes detailed continuity of
operations plans that ensure that the essential functions of each HHS operating
division are identified and maintained in the presence of an expected decrease
in staffing levels during a pandemic event.
The HHS Implementation Plan is a dynamic document that
will be reviewed and revised as needed as HHS efforts in pandemic preparedness
mature. The plan will be tested to identify preparedness weaknesses and to
promote effective implementation. Throughout this process, the pandemic
influenza response will be optimized by effectively engaging partners and
stakeholders during all phases of pandemic planning and response.
EXECUTIVE SUMMARY
An influenza pandemic has the potential to cause more death and illness
than any other public health threat. Although the timing, nature, and severity
of the next pandemic cannot be predicted with any certainty, preparedness
planning is imperative to lessen the impact of a pandemic. The unique
characteristics and events of a pandemic will strain local, State, and Federal
resources. For example, it is unlikely that there will be sufficient personnel,
equipment, and supplies to simultaneously respond adequately in multiple areas
of the country for a sustained period of time. Therefore, the minimization of
social and economic disruption will require a coordinated response by the whole
country. All governments, communities, and public- and private-sector
stakeholders will need to anticipate and prepare for a pandemic by defining
their roles and responsibilities, and developing continuity-of-operations
plans. To this end, the President directed the Secretary of HHS to initiate a
State and local preparedness process. HHS is actively working to help States,
tribes, cities, schools, businesses, churches, individuals, and families across
the country plan for a pandemic. HHS is collaborating with Governors' offices
in every State to hold pandemic summits and exercises. HHS/Centers for Disease
Control and Prevention (CDC) have developed checklists to aid in pandemic
influenza preparations. These checklists provide specific guidance for State
and local planning, businesses, health care providers, community organizations,
individuals, and families. (See http://www.pandemicflu.gov.)
During a pandemic, and consistent with the National Response
Plan (NRP, see
http://www.dhs.gov/xlibrary/assets/NRP_FullText.pdf),
as head of Emergency Support Function (ESF) #8, Public Health and Medical
Services, the Secretary of HHS will lead the Federal public health and medical
response efforts. The HHS Pandemic Influenza Plan serves as a
blueprint for all HHS pandemic influenza preparedness and response planning.
Part 1, the Strategic Plan, describes a coordinated public
health and medical care strategy to prepare for, and begin responding to, an
influenza pandemic. Part 2, Public Health Guidance for State, Local,
and Tribal Partners, provides guidance on specific aspects of pandemic
influenza planning and response for the development of State, local, and tribal
preparedness plans.
This document, Part 3, the HHS Implementation Plan,
operationalizes the strategy described in the White House Homeland Security
Council (HSC) National Strategy for Pandemic Implementation
Plan by detailing Department-wide HHS pandemic preparedness actions
and steps (Part I) and by outlining Agencies' continuity-of-business plans
(Part II).
Part I
Part I of the HHS Implementation Plan identifies eight
cross-cutting issues that encompass many of the themes noted in the HHS
Strategic Plan and Guidance for State and Local Partners. These themes
include infection control, laboratory diagnostics, surveillance, health care
planning, and workforce support. Each chapter outlines actions and specific
steps the Department will undertake to fulfill the directives of the HSC and
accomplish pandemic preparedness. The eight cross-cutting issue chapters
are:
- International Activities
- Domestic Surveillance
- Public Health Interventions
- Federal Medical Response
- Vaccines
- Antiviral Drugs
- Communications
- State, Local, and Tribal Preparedness
The action steps in these eight chapters are organized by the three
pillars identified in the National Strategy for Pandemic
Influenza: preparedness and communication; surveillance and detection;
and response and containment. The implementation of the HHS action steps is
contingent upon the availability of resources.
International Activities
While a novel influenza virus could emerge anywhere in the world at any
time, current concern focuses on the continued spread of avian influenza
A/(H5N1), which is highly pathogenic in poultry and has caused sporadic cases
of severe disease in humans.1,2,3 The emergence and
intercontinental spread of avian influenza A/(H5N1) in birds underscores the
interrelatedness of all countries and communities with respect to public health
emergencies. Chapter 1 emphasizes the need to work in partnership with
countries and provide technical assistance to enhance surveillance and response
activities in low-resourced countries. International disease-surveillance
efforts could permit the identification of the earliest stages of an evolution
of avian or animal influenza virus into a human pathogen that is capable of
human-to-human spread. The early detection of a pandemic virus will facilitate
a rapid and well-orchestrated global public health containment response whose
goal is the slowing or limiting of the spread of influenza. Slowing the spread
of a pandemic overseas may also allow the United States to implement public
health measures that might mitigate the impact of the disease when it arrives
on U.S. shores. Continued surveillance, once a pandemic is underway, is
important for monitoring and documenting changes in viral characteristics and
pathogenesis. The HHS plan focuses on strengthening global surveillance and
timely response capacity. It also emphasizes education of, and risk
communication to, all stakeholders and partners.
Domestic Surveillance
Continuous surveillance, both domestic and abroad, will provide data on
trends in disease activity and virus subtype circulation, and will inform
policy and public health decisionmaking in the pre-pandemic and pandemic
periods. Initially, domestic surveillance efforts are designed to detect
influenza virus types and subtypes, including pandemic strains, circulating in
the United States, and will focus on detecting initial cases and clusters of
human illness. Early detection of initial cases ensures timely investigation
and implementation of public health interventions to limit further spread of
disease. Detection of early cases and appropriate laboratory investigation will
facilitate the prompt identification of viral characteristics (antiviral
susceptibility, antigenicity, transmissibility, and virulence) that can affect
medical case management as well as public health response measures. It will
also facilitate the development of both pre-pandemic and pandemic vaccines.
Early delineation of viral characteristics will increase the likelihood that a
vaccine could be available in a timely manner. Early identification of cases
will also maximize the chances of delaying the spread of the pandemic across
the country.
Surveillance requires that laboratory systems are in place to
characterize viral subtypes, enable detection and investigation of suspected
cases in a community, and detect sentinel increases in disease activity.
Surveillance data will direct decisions on vaccine development, antiviral drug
use, and the implementation and continuation of public health interventions,
including diagnostic devices and personal protection equipment (PPE) use, to
limit the spread of disease. Ongoing surveillance and the generation of
real-time data can also help monitor the progression of a pandemic and the
effectiveness of various interventions. Surveillance data may be used by
researchers to model and project the trajectory of a pandemic.
HHS activities concentrate initially on continuing to build laboratory
and epidemiologic capacity for surveillance and response; and on establishing
comprehensive, integrated, timely, and sensitive surveillance systems; by
building on existing systems and by initiating new systems where gaps currently
exist. In addition, current HHS activities will support the faster development
and deployment of new virus detection products. These rapid diagnostics may cut
the time needed to confirm a human infection. If used at the point of care,
rapid diagnostics could allow early recognition of infected individuals and
promote the timely institution of appropriate medical care and public health
measures.
Public Health Interventions
At the start of a pandemic, a vaccine may not be widely available, and
the supply of antiviral drugs may be limited. Public health interventions, such
as containment strategies (isolation of infected individuals and social
distancing measures), could delay the introduction and/or spread of a novel,
pandemic influenza virus in the United States. In the absence of available
drugs, and before a pandemic vaccine is produced, public health interventions
are the main defense mechanism against viral infection. The specific
interventions implemented will depend on the pandemic phase. For example, early
in a pandemic that emerges overseas—before the virus is detected in the
United States—local containment strategies and travel-related actions
(travel advisories and precautions, including entry and exit screening of
persons arriving from infected countries or regions) could impede the
establishment of the pandemic virus in this country. Later, after the virus is
widespread in the United States, public health interventions such as closing
schools, restricting public gatherings, quarantining exposed persons, isolating
infected persons, and telecommuting or working from home could reduce the
number of people infected with the virus. During this time, public health
interventions that retard the spread of infection could mitigate the disruptive
impact of a pandemic until such medical interventions became available. The HHS
Plan outlines steps to develop recommendation protocols to implement and
evaluate public health interventions throughout a pandemic cycle.
Federal Medical Response
An influenza pandemic will place extraordinary demands on the U.S.
health care system. Efficient use of existing medical resources and expedient
deployment of Federal medical assets, including personnel, are crucial in
addressing the medical surge requirements imposed by a pandemic. Because the
provision of health care is almost entirely a local responsibility, planning at
the State and local level is essential for pandemic preparedness. Integration
of the medical response across the local, State, and Federal levels becomes
critical to optimize the use of scarce medical resources. HHS is working with
its State, local, and tribal partners to increase surge capacity of medical
materiel and personnel.
For the most efficient use of medical resources, effective response
plans must be developed and tested at all levels. Plans must include a
functional command structure consistent with the National Incident Management
System (NIMS), a regional approach to the stockpiling and distribution of
medical materiel, and a schedule of exercises for evaluating the effectiveness
of the plans. Guidelines must be developed and disseminated to all partners.
These guidelines should offer approaches for the allocation of scarce resources
and the altering of medical care such that scarce resources are applied to
benefit the greatest number of those in need. The success of the medical
response to an influenza pandemic will be determined by how medical providers
and facilities can implement interventions that enable them to meet the
increased medical demands that result from a pandemic.
The HHS Implementation Plan describes specific steps to
develop deployment strategies for Federal medical resources, including
personnel, and steps to develop guidelines for the health care system to
augment surge capacity, distribute medical resources, institute appropriate
infection control measures, and review/modify standards of care without
compromising clinical outcome.
Chapter 4, Federal Medical Response, primarily addresses the Federal
medical response, and also addresses integrated planning across all
jurisdictions. For additional preparedness guidance for State and local
partners, see Part 2 of the HHS Pandemic Influenza Plan (Public Health
Guidance for State and Local Partners) and Chapter 8, State, Local,
and Tribal Preparedness, of this plan.
Vaccines
Historically, vaccination has been the most effective measure for
minimizing the morbidity and mortality associated with influenza. Vaccines may
also limit virus spread, and thus, the course of a pandemic. Since a pandemic
vaccine can only be made once a pandemic virus is identified and isolated, it
cannot be available during the early phases of a pandemic. Therefore, a
pre-pandemic vaccine based on novel influenza viruses with pandemic potential
that are known to be in circulation, and for which a vaccine has already been
developed and stockpiled, may provide partial protection or immunologic priming
of persons at high risk during the early phases of a pandemic.
When a pandemic is declared and a specific vaccine against the pandemic
virus becomes available, its distribution and delivery will be a major focus of
the pandemic response. Vaccines produced for a pandemic virus must be safe,
produced in large quantities, delivered quickly, and be effective for the
largest number of individuals possible to minimize mortality and morbidity.
Thus, the rapid production and clinical evaluation of a pandemic vaccine and
the tracking of its use and distribution, particularly if two or more doses are
required, is an urgent priority of HHS pandemic planning and response
preparations. HHS is currently working with private industry to increase the
U.S. vaccine production capacity. The HHS Plan describes specific action steps
HHS will take to facilitate vaccine development, production, and distribution.
The Plan also identifies steps HHS will take to track vaccine efficacy and
adverse events.
Antiviral Drugs
If used appropriately, antiviral drugs may limit the spread of
influenza, reduce its morbidity and mortality, and thereby diminish the demands
placed on the U.S. health care system during a pandemic. However, the
susceptibility of the pandemic influenza virus strain to antiviral agents
cannot be determined until the pandemic virus strain emerges. Assuming
susceptibility, antivirals may also be used in attempts to contain small
disease clusters and potentially slow the introduction and spread of the
infection in and between communities. Indiscriminate use of antiviral drugs in
a pandemic could deplete national and local supplies. Therefore, a
comprehensive approach for the appropriate distribution and use of antiviral
stocks is an essential component of HHS pandemic preparedness. The HHS
Implementation Plan outlines the steps to facilitate the development,
licensure/approval, production, and availability of pandemic influenza
countermeasures. It also provides guidance for evaluating antiviral efficacy
and developing prioritization, allocation, and distribution strategies for
antiviral stockpiles.
Communications
Another critical component of HHS preparedness for an influenza pandemic
is a clear communications strategy and campaign that informs the public and
other stakeholders about this potential threat and provides a solid foundation
of information upon which future actions can be based. To be effective, this
strategy should be based on scientifically derived risk-communications
principles that are developed before, during, and after an influenza pandemic.
The HHS Plan outlines a communications strategy and campaign that effectively
provides reliable information and guides the public—including individuals
and families, the news media, health care providers, and other groups—in
responding to outbreak situations appropriately by adhering to public health
measures and undertaking actions that protect individuals and family members.
HHS is currently developing communications and outreach materials,
messages, and procedures for implementing communications plans. In addition,
HHS is developing strategies for health care providers and the public to
address any psychosocial concerns. During a pandemic, HHS will provide accurate
and timely information on the pandemic to the public. It will also monitor and
evaluate its interventions, and will communicate lessons learned to health care
providers and public health agencies on the effectiveness of clinical and
public health responses.
State, Local, and Tribal Preparedness
An effective pandemic response requires planning and coordination among
all levels of Government and all stakeholders. The country's success in
responding to and recovering from a pandemic necessarily depends on
preparedness by the State, local and tribal jurisdictions. State, local and
tribal leaders will be responsible for conducting surveillance, epidemiologic
investigation, disseminating information, implementing containment measures,
and distributing countermeasures (vaccine and antiviral drugs). In addition,
the provision of health care is almost entirely a local responsibility that is
shared by both private and public sector entities. Planning for the
preservation of societal functioning is also a critical local function.
Moreover, for pandemic influenza preparedness to be effective, it must
be a multidisciplinary effort, engaging all stakeholders, including traditional
public health and health care partners, as well as other sector partners, such
as the business community, public safety and law enforcement, emergency
management, education, transportation, social services, mental health and
substance abuse services, public utilities, and community- and faith-based
organizations. The duration, scope, and scale of the event will challenge
infrastructure across most, if not all, sectors. Multi-sectored mutual aid
agreements among local jurisdictions may aid in addressing the duration, scope,
and scale of the pandemic.
In FY06, the U.S. Congress appropriated $350 million as part of an
emergency supplemental appropriation to fund local and State preparedness. HHS
is currently working with its State, local, and tribal partners to increase the
health care surge capacity of medical materiel and personnel. With State
Governors, HHS is co-hosting pandemic summits and exercises in every State. In
addition, HHS has developed checklists to aid in community-level pandemic
influenza preparations. These checklists provide specific guidance for State
and local planning authorities, businesses, health care providers, community
organizations, and individuals and families.
The HHS Implementation Plan addresses cross-cutting
preparedness issues for which the Department will provide further assistance
for State, local and tribal pandemic preparedness. This assistance includes the
development of guidelines and operational plans for the distribution of
available supplies of pandemic vaccine and antiviral drugs.
Part II
HHS provides and operates many essential services and programs for
individuals across the United States. Disruption of business and community
operations by a pandemic can seriously jeopardize the health and well-being of
many Americans. Part II provides detailed continuity of operations plans for
the Office of the Secretary (OS) and HHS agencies, including:
- The Administration for Children and Families (ACF)
- The Agency for Health care Research and Quality (AHRQ)
- The Agency for Toxic Substances and Disease Registry (ATSDR)
- The Administration on Aging (AOA)
- The Centers for Disease Control and Prevention (CDC)
- The Centers for Medicare and Medicaid Services (CMS)
- The Food and Drug Administration (FDA)
- The Health Resources and Services Administration (HRSA)
- The Indian Health Service (IHS)
- The National Institutes of Health (NIH)
- The Substance Abuse and Mental Health Services Administration
(SAMHSA)
In Part II, each HHS agency and the OS identify essential activities,
programs, and personnel, and provide strategies to continue departmental
operations in the face of significant absenteeism during a pandemic. Agencies'
plans also include leadership succession, plans for the delegation of
authority, and options and procedures for alternate worksites. In addition,
each plan includes steps to protect the workforce (and the agency's customers)
during a pandemic. Finally, each agency outlines its role and responsibilities
in a coordinated inter-agency/departmental response to a pandemic.
Given its critical mission, HHS will occupy a central position in any
Federal pandemic influenza response. However, a robust, comprehensive response
consistent with the National Response Plan requires coordination across Federal
Departments and with international partners of the United States. Moreover, an
effective pandemic response that preserves human lives and societal
infrastructure requires collaboration with all State, local, and tribal
partners. This HHS Implementation Plan provides definitive
guidance and action steps to maximize our collective efforts in preparing for
and responding to pandemic influenza.
Footnotes
1 Chotpitayasunondh T, Ungchusak K,
Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S,
Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S,
Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M,
Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human
disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005
Feb;11(2):201–9.
2 Beigel JH, Farrar J, Han AM,
Hayden FG, Hyer R, de Jong MD, Lochindarat S, Nguyen TK, Nguyen TH, Tran TH,
Nicoll A, Touch S, Yuen KY; Writing Committee of the World Health Organization
(WHO) Consultation on Human Influenza A/H5. Avian influenza A (H5N1) infection
in humans. N Engl J Med. 2005 Sep 29;353(13):1374–85. Review.
3 Hien TT, de Jong M, Farrar J.
Avian influenza—a challenge to global health care structures. N Engl J
Med. 2004 Dec 2;351(23):2363–5.
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