1. 1 Antivirals in the Draft CDC Pandemic Plan David K. Shay Influenza Branch National Center for Infectious Diseases Centers for Disease Control and Prevention

2. 2 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 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

3. 3 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

4. 4 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)

5. 5 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

6. 6 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 Organization –Public health investigations and research

7. 7 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

8. 8 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 Recommendations for the Inter- Pandemic and Pandemic Alert Periods

9. 9 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 Recommendations for the Inter- Pandemic and Pandemic Alert Periods

10. 10 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 Recommendations for the Pandemic Period

11. 11 Antiviral Drugs with Activity Against Influenza: Pharmacology, Side Effects, Prophylaxis, Treatment, Resistance M2 Ion Channel Inhibitors: Amantadine and Rimantadine Neuriminidase Inhibitors: Oseltamivir and Zanamivir Appendix

12. 12 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

13. 13 …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) National Recommendations on Use of Antivirals

14. 14 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 Recommendations will include:

15. 15 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 Distribution to Priority Groups: recommendations for states

16. 16 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 pandemic? -- Use data management systems to track distribution? Questions about Distribution