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					 Antivirals in the Draft
 CDC Pandemic Plan
               David K. Shay
             Influenza Branch
  National Center for Infectious Diseases
Centers for Disease Control and Prevention

      CDC’s Pandemic Plan
• Public Health Guidance for Community-Level
  Pandemic Influenza Planning
• Goal is to help the public health and medical
  communities across the nation respond to a
• Augments information for state and local
  partners described in the DHHS Pandemic
  Influenza Preparedness and Response Plan,
  which provides the framework for coordinated
  federal and state-level planning
• Due to DHHS by August 1
      Purpose and aims I
• Provide guidance to public health
  agencies for the development of
  state-level pandemic influenza
  response plans, as recommended in
  Cross-Cutting Critical Benchmark #6
  of the CDC and HRSA cooperative
  agreements for Public Health and
  Hospital Bioterrorism             3
      Purpose and aims II
• Help healthcare partners address
  the medical challenges of pandemic
  influenza (e.g., large patient volume,
  occupational health risks, and
  targeting limited supplies of antiviral
  medications and vaccines)

       Purpose and aims III
• Define the public health role in healthcare
  planning and preparedness for pandemic
• Strengthen linkages between public health
  agencies and private sector partners --
  including healthcare facilities, community-
  based organizations, clinical laboratories, and
  first responders -- to protect health and
  preserve essential services during a pandemic
      CDC’s Federal Role in Pandemic
  Influenza Preparedness and Response
• CDC is lead agency in these areas:
  – Disease surveillance and laboratory diagnostics
  – Disease control and prevention strategies, including
    community containment measures, mitigation of
    travel-related transmission risk, and effective use of
    antiviral drugs and vaccines
  – Public health communication with the states,
    healthcare and public health organizations,
    ministries of health, and the World Health
  – Public health investigations and research            6
      11 Supplements in Plan
1. Disease Surveillance     7. Community Disease
2. Laboratory Diagnostics      Control and Prevention
3. Healthcare               8. Mitigation of Travel-
4. Infection Control           Related Transmission
5. Vaccine Use
                            9. Public Health
6. Antiviral Drug Use –        Communications
   draft reviewed with
   APHL, ASTHO,             10. Psychosocial Issues
   NACCHO, CSTE on          11. Clinical Guidelines
   Recommendations for the Inter-
Pandemic and Pandemic Alert Periods

A. Use of Antivirals in Management of
  Cases and Clusters of Novel Influenza
     Use of Antivirals for Treatment
     Use of Antivirals for Prophylaxis of
     Use of Antivirals for Containment of
  Disease Clusters

    Recommendations for the Inter-
 Pandemic and Pandemic Alert Periods
B. Preparedness and Planning for Use of Antivirals During a Pandemic
      National Recommendations on Use of Antivirals during a Pandemic
      State Level Planning
                  Distribution to Priority Groups
                  Monitoring and Data Collection
                            Supply and Distribution
                            Antiviral Effectiveness
                            Adverse Events
                            Antiviral Drug Resistance
                  Coordination with Bordering Jurisdictions
                  Legal Preparedness
                  Public Health Information

 Recommendations for the Pandemic

A. When Pandemic Influenza Is Reported
B. When There is Limited Transmission of
   Pandemic Influenza in the United
C. When There is Widespread
   Transmission of Pandemic Influenza in
   the United States


Antiviral Drugs with Activity Against
   Influenza: Pharmacology, Side
   Effects, Prophylaxis, Treatment,
• M2 Ion Channel Inhibitors:
     Amantadine and Rimantadine
• Neuriminidase Inhibitors: Oseltamivir
   and Zanamivir

Antiviral Drugs in the Strategic
       National Stockpile
As of May 2005, the Strategic National
Stockpile contains 2.26 million
treatment regimens of oseltamivir
(capsules and suspension), and 5
million treatment regimens of
rimantadine (tablets and syrup), with
additional purchases of antivirals
 National Recommendations on
        Use of Antivirals
…recommendations for optimal use of limited supplies
   of antivirals during a pandemic are under
   consideration by DHHS, in consultation with the
   National Vaccine Advisory Committee (NVAC),
   bioethicists, and other expert partners. During an
   actual pandemic these recommendations may be
   modified, based on the characteristics of the
   causative virus (e.g., drug susceptibilities, initial
   geographic distribution, fatality rate, age-specific
   morbidity and mortality rates)

       Recommendations will
•   Priority groups for treatment, based on predicted
    medical risk, and the goal to reduce morbidity and
•   Priority groups for short- and long-term prophylaxis,
    based on predicted medical and occupational risk,
    and the goal to preserve healthcare and other
    essential services
•   Effective antiviral use by healthcare providers,
     Strategies for administration to individual patients
     Strategies for retarding the development of drug resistance
•   Size of SNS stockpile

    Distribution to Priority Groups:
     recommendations for states
•     Estimating the size and needs of priority groups in local
•     Making arrangements for transport, receipt, storage, security,
      tracking, and delivery of:
      -- SNS antiviral stocks for use in treatment to hospitals,
      clinics, nursing homes, alternative care facilities, and other
      healthcare institutions
      -- SNS antiviral stocks for use in short-term prophylaxis (e.g.,
      for direct contacts of infected patients)
      -- SNS antiviral stocks for use in long-term prophylaxis (e.g.,
      for healthcare workers, public safety workers, and essential
      service providers).
•     Developing a communication plan to explain the rationale for
      establishing these target groups

    Questions about Distribution
•   Will states request antivirals from SNS, or will they be
    distributed to states after a federal decision?
•   What are the criteria for release of antivirals in SNS?
    -- What’s the process for requesting antivirals from SNS?
    -- How will requests be approved?
    -- Will there be a ‘reserve’? How large?
•   How will SNS assets be divided amongst the states? A pro
    rata scheme based on population?
•   How will states receive SNS assets? Will assets be delivered
    to SNS receipt, storage, staging (RSS) sites, to state health
    departments, or to local health departments and large
    integrated healthcare delivery systems?
•   How can states best prepare to:
    -- Deliver antivirals to institutions/health care facilities during a
    -- Use data management systems to track distribution?


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