Antivirals in the Draft CDC Pandemic Plan

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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

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CDCs 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
  pandemic
• 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

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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

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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)

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Purpose and aims III

• Define the public health role in healthcare
  planning and preparedness for pandemic influenza
• 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

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CDCs 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
  Organization
• Public health investigations and research

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11 Supplements in Plan

• 1. Disease Surveillance
• 2. Laboratory Diagnostics
• 3. Healthcare
• 4. Infection Control
• 5. Vaccine Use
• 6. Antiviral Drug Use draft reviewed with APHL,
  ASTHO, NACCHO, CSTE on 5/27

• 7. Community Disease Control and Prevention
• 8. Mitigation of Travel-Related Transmission
  Risk
• 9. Public Health Communications
• 10. Psychosocial Issues
• 11. Clinical Guidelines

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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 Contacts
• Use of Antivirals for Containment of Disease
  Clusters

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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
• Procurement
• Distribution to Priority Groups
• Monitoring and Data Collection
• Supply and Distribution
• Antiviral Effectiveness
• Adverse Events
• Antiviral Drug Resistance Coordination
  with Bordering Jurisdictions
• Legal Preparedness
• Training
• Public Health Information

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Recommendations for the Pandemic Period

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

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Appendix

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

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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 pending

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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)

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Recommendations will include

• Priority groups for treatment, based on predicted
  medical risk, and the goal to reduce morbidity
  and mortality
• 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,
  including
• Strategies for administration to individual
  patients
• Strategies for retarding the development of
  drug resistance
• Size of SNS stockpile

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Distribution to Priority Groups recommendations
for states

• Estimating the size and needs of priority groups
  in local jurisdictions
• 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

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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?
• -- Whats 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 pandemic?
• -- Use data management systems to track
  distribution?