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Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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Page 90
Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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Page 91
Suggested Citation:"References." Institute of Medicine. 2008. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: The National Academies Press. doi: 10.17226/12170.
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88 ANTIVIRALS FOR PANDEMIC INFLUENZA Biedrzycki, P. 2007. Antiviral distribution during an influenza pandemic—LPHA planning con- siderations. Presentation at Meeting One of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Wash- ington, DC. Call, S. A., M. A. Vollenweider, C. A. Hornung, D. L. Simel, and W. P. McKinney. 2005. Does this patient have influenza? Journal of the American Medical Association 293:987-997. Carpenter, M., J. Hodge, and R. Pepe. 2008. Deploying and using volunteer health practitio- ners in response to emergencies: Proposed uniform state legislation provides liability protections and workers’ compensation coverage. American Journal of Disaster Medicine 3(1):17-24. CDC (Centers for Disease Control and Prevention). 2006a. CDC Health Alert: CDC recom- mends against the use of amantadine and rimantadine for the treatment or prophylaxis of influenza in the United States during the 2005–2006 influenza season. http://www.cdc. gov/flu/han011406.htm (accessed April 9, 2008). CDC. 2006b. Pandemic influenza guidance supplement to the 2006 public health emergency prepared- ness cooperative agreement phase II (July 10, 2006). http://www.bt.cdc.gov/planning/ coopagreement/pdf/phase2-panflu-guidance.pdf (accessed April 9, 2008). CDC. 2006c. Rapid diagnostic testing for influenza: Information for clinical laboratory directors. http://www.cdc.gov/flu/professionals/diagnosis/pdf/flu-rapid-test-lab-director.pdf (accessed April 9, 2008). CDC. 2006d, April 8. Public health emergency preparedness cooperative agreement supplement. Washington, DC: DHHS. CDC. 2007a. Interim pre-pandemic planning guidance: Community strategy for pandemic influenza mitigation in the United States—early, targeted, layered use of nonpharmaceutical interven- tions. http://www.pandemicflu.gov/plan/community/community-mitigation.pdf (accessed April 9, 2008). CDC. 2007b. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP) 56(rr06):1-54. http://www.cdc.gov/mmwr/preview/ mmwrhtml/rr5606a1.htm (accessed March 31, 2008). CDC. 2008. Pandemic influenza funding announcement for competitive proposals (activities) (DCD-RFA-TP08-802). http://www.bt.cdc.gov/planning/coopagreement/pdf/panflu- funding-opportunity-tp08-802.pdf (accessed April 4, 2008). Denver Health. 2007. Adapting community call centers for crisis support: A model for home-based care and monitoring. Denver, CO: Denver Health. DHHS (Department of Health and Human Services). 2005. DHHS pandemic influenza plan. Washington, DC: DHHS. http://www.hhs.gov/pandemicflu/plan/pdf/HHS PandemicInfluenzaPlan.pdf (accessed April 29, 2008). DHHS. 2007a. Draft proposed guidance on antiviral drug use strategies during an influenza pandem- ic. Washington, DC: DHHS. http://www.asisonline.org/newsroom/crisisResponse/ Antiviral_overview_11-6-07.doc (accessed April 29, 2008). DHHS. 2007b. Revised summary of proposed guidance on antiviral drug use strategies for an influ- enza pandemic. DHHS. Washington, DC: DHHS. DHHS. 2007c. Pandemic planning update IV. Washington, DC: DHHS. http://www. pandemicflu.gov/plan/panflureport4.pdf (accessed April 9, 2008). DoD (Department of Defense). 2007. The DoD/FDA shelf-life extension program to extend the shelf life of critical stockpiles of medical material for the federal government. Washington, DC: DoD. Duffy, E. 2007. Letter to Hoffman la-Roche, Inc., December 3, 2007. EMEA (European Medicines Agency). 2005. Summary report: Review on influenza antiviral medicinal products for potential use during pandemic. London, UK: EMEA.

REFERENCES 89 EMEA. 2008. Emergence of resistance to oseltamivir among influenza A(H1N1) viruses in Europe. http://www.eurosurveillance.org/edition/v13n05/080131_2.asp (accessed March 31, 2008). FDA (Food and Drug Administration). 2005. Tamiflu pediatric adverse events: Questions and answers. http://www.fda.gov/Cder/Drug/infopage/tamiflu/QA20051117.htm (ac- cessed April 9, 2008). FDA. 2007a. FY 2008 Congressional justification for Food and Drug Administration. http://www. fda.gov/oc/oms/ofm/budget/2008/8-FieldNarrative.pdf (accessed April 9, 2008). FDA. 2007b. Pediatric Advisory Committee meeting transcripts (November 27, 2007). http:// www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4325t1_transcript.pdf (ac- cessed April 9, 2008). Friedman, M. J., and M. W. Attia. 2004. Clinical predictors of influenza in children. Archives of Pediatric Adolescent Medicine 158:391-394. GAO (Government Accountability Office). 2000. Influenza pandemic: Plan needed for federal and state response. Washington, DC: GAO. Glass, T., and M. Schoch-Spana. 2002. Bioterrorism and the people: How to vaccinate a city against panic. Clinical Infectious Diseases 34(2):217-223. GlaxoSmithKline. 2007. Pandemic planning. http://www.pandemicplan.gsk.com (accessed March 31, 2008). Gostin, L. O., J. W. Sapsin, S. P. Teret, S. Burris, J. S. Mair, J. G. Hodge, Jr., and J. S. Vernick. 2002. The model state emergency health powers act: Planning for and response to bio- terrorism and naturally occurring infectious diseases. JAMA 288(5):622-628. Griffin, M. 2007. Influenza diagnostic options: Issues and concerns. Presentation at Meeting One of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. ��������������� Washington, DC. Grijalva, C. G., K. A. Poehling, K. M. Edwards, G. A. Weinberg, M. A. Staat, M. K. Iwane, W. Schaffner, and M. R. Griffin. 2007. Accuracy and interpretation of rapid influenza ����������������������������������������������������� tests in children. Pediatrics 119:e6-e11. Hannan, C. 2008. 2004–2005 influenza vaccine shortage: Immunization program lessons learned. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Hayden, F. G., and A. T. Pavia. 2006. Antiviral management of seasonal and pandemic in- fluenza. Journal of Infectious Diseases 194(Suppl 2):S119-S126. Hoard, M., and R. Tosatto. 2005. Medical reserve corps: Strengthening public health and improving preparedness. Disaster Management and Response 3:48. Hodge, J. 2004. Health information privacy and public health. Journal of Law, Medicine, and Ethics 31(1):663-671. Hodge, J. 2006a. Legal issues concerning volunteer health professionals and the hurri- cane-related emergencies in the Gulf Coast region. Public Health Reports March-April (121):205-207. Hodge, J. G., Jr. 2006b. Legal triage during public health emergencies and disasters. Admin- istrative Law Review 58(3):627-644. Hodge, J. 2007. Legal issues in an influenza pandemic. Presentation at Meeting One of the In- stitute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Hodge, J. G., Jr., L. Gable, and S. Calves. 2005. Volunteer health professionals and emergen- cies: Assessing and transforming the legal environment. Biosecurity and Bioterrorism 3(3):216-223. Hodge, J., D. Bhattacharya, and A. Garcia. 2006. Assessing criminal liability of volunteer healthcare workers in emergencies. American Journal of Disaster Medicine 1(1):12-17.

90 ANTIVIRALS FOR PANDEMIC INFLUENZA Hodge, J., R. Pepe, and W. Henning. 2007. Voluntarism in the wake of hurricane Katrina: The uniform emergency volunteer health practitioners act. Disaster Medicine and Public Health Preparedness 1(1):44-50. Homeland Security Council. 2006. National strategy for pandemic influenza implementation plan. Washington, DC: HSC. HRSA (Health Resources and Services Administration). 2005. Emergency system for advance registration of volunteer health professionals (ESAR-VHP)—interim technical and policy guidelines, standards, and definitions (June 2005). Washington, DC: DHHS. HRSA. 2006. Emergency system for advance registration of volunteer health professionals (ESAR- VHP)—legal and regulatory issues (May 2006). Washington, DC: DHHS. IDSA (Infectious Diseases Society of America) and D. Poretz. 2007a. IDSA comments on DHHS draft pandemic antiviral drug strategies guidance. http://idsociety.org/WorkArea/ downloadasset.aspx?id=9250 (accessed April 9, 2008). IDSA and D. Poretz. 2007b. IDSA on OSHA draft respirators and facemasks guidance. http:// idsociety.org/WorkArea/downloadasset.aspx?id=9250 (accessed April 9, 2008). IOM (Institute of Medicine). 2003. The future of the public’s health in the 21st century. Washing- ton, DC: The National Academies Press. IOM. 2006. Modeling community containment for pandemic influenza: A letter report. Washington, DC: The National Academies Press. IOM. 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare work- ers. Washington, DC: The National Academies Press. Janssen, A. P., R. R. Tardif, S. R. Landry, and J. E. Warner. 2006. “Why tell me now?” The public and healthcare providers weigh in on pandemic influenza messages. Journal of Public Health Management and Practice 12(4):388-394. Kass, N. E. 2005. An ethics framework for public health and avian influenza pandemic pre- paredness. Yale Journal of Biology and Medicine 78(5):239-254. Kass, N. 2008. Ethics, public health, and antiviral medication strategies in pandemic influenza. Pre- sentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. The Keystone Center. 2007. Final report: The public engagement project on community control measures for pandemic influenza. Keystone, CO: The Keystone Center. Khan, S. 2008. Multi-attribute decision analysis in public health—analyzing effectiveness of al- ternate modes of dispensing. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Klimov, A. 2008. Influenza antivirals: Surveillance and resistance. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Koh, H. K., L. J. Elqura, C. M. Judge, J. P. Jacob, A. E. Williams, M. S. Crowther, R. A. Serino, and J. M. Auerbach. 2008. Implementing the cities readiness initiative: Lessons learned from Boston. Disaster Medicine and Public Health Preparedness 2(1):40-49. Lackenby, A., O. Hungnes, S. G. Dudman, A. Meijer, W. J. Paget, A. J. Hay, and M. Z. Zambon. 2008. Emergence of resistance to Oseltamivir among influenza A(H1N1) viruses in Eu- rope. Eurosurveillance 13(5). Lanard, J., and P. M. Sandman. 2005. Superb flu pandemic risk communication: A role model from Australia. http://www.psandman.com/col/abbott.htm (accessed April 11, 2008). Lipsitch, M., T. Cohen, M. Murray, and B. R. Levin. 2007. Antiviral resistance and the control of pandemic influenza. PLoS Medicine 4(1):e15. Mahoney, M. 2008. Presentation at Meeting Two of the Institute of Medicine Committee on Imple- mentation of Antiviral Medication Strategies for an Influenza Pandemic. ��������������� Washington, DC. McCaw, J., and J. McVernon. 2006. Prophylaxis or treatment? Optimal use of an antiviral stockpile during an influenza pandemic. Parkville Victoria, Australia: Royal Children’s Hospital.

REFERENCES 91 McCormick, D. 2006. Iowa responds to mumps outbreak. http://www.idph.state.ia.us/adper/ common/pdf/focus/may2006.pdf (accessed April 4, 2008). McGeer, A., K. Green, and A. Plevneshi. 2007. Antiviral therapy and outcomes of influenza requiring hospitalization in Ontario, Canada. Clinical Infectious Diseases 45(12):1568- 1575. M’Ikanatha, N. M., K. G. Julian, A. R. Kunselman, R. C. Aber, J. T. Rankin, and E. Lauten- bach. ����������������������������������������������������������������������������� 2005. Patients‘ request for and emergency physicians’ prescription of antimi- crobial prophylaxis for anthrax during the 2001 bioterrorism-related outbreak. BMC Public Health 5:2. Monto, A. S., S. Gravenstein, M. Elliott, M. Colopy, and J. Schweinle. 2000. Clinical signs and symptoms predicting influenza infection. Archive of Internal Medicine 160(NOV 27):3243-3247. Moscona, A. 2005. Neuraminidase inhibitors for influenza. New England Journal of Medicine 353:1363-1373. National Conference of Commissioners on Uniform State Laws. 2006. Uniform Emergency Volunteer Health Practitioners Act in Annual conference: Meeting in its one-hundred-and- fifteenth year. Hilton Head, SC: National Conference of Commissioners on Uniform State Laws. New Zealand National Ethics Advisory Committee. 2007. Getting through together: Ethical value for a pandemic. Wellington, New Zealand: Ministry of Health. Ohmit, S. E., and A. S. Monto. 2006. Symptomatic predictors of influenza virus positivity in children during the influenza season. Clinical Infectious Diseases 2006(43):564-568. Otake, T. 2007. Tragedy swirls around tamiflu. The Japan Times, March 20. Patel, A. 2007. CDC/DSNS pandemic influenza update. Presentation at Meeting One of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Reuters. 2008. Australia, Hong Kong report tamiflu-resistant flu. http://www.reuters.com/ article/healthNews/idUSL0754411220080207?pageNumber=2&virtualBrandChannel =0&sp=true/ (accessed February 7, 2008). Roche Pharmaceuticals. 2006. U.S.-based supply chain for tamiflu fully operational. http:// www.rocheusa.com/newsroom/current/2006/pr2006091401.html (accessed March 31, 2008). Roche Pharmaceuticals. 2008. Tamiflu® (oseltamivir phosphate) capsules and for oral suspen- sion. http://www.fda.gov/medwatch/safety/2008/Tamiflu_PI.pdf (accessed April 9, 2008). Skivington, S., and E. Koscove. 2008. Pandemic influenza planning at Kaiser Permanente. Pre- sentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Stergachis, A., C. M. Wetmore, M. Pennylegion, R. D. Beaton, B. T. Karras, D. Webb, D. Young, and M. Loehr. 2007. Evaluation of a mass dispensing exercise in a cities readiness initia- tive setting. American Journal of Health-System Pharmacy 64(3):285-293. Thomas, J. C., N. Dasgupta, and A. Martinot. 2007. Ethics in a pandemic: A survey of the state pandemic influenza plans. American Journal of Public Health 97(Suppl 1):S26-S31. Tufts, S. 2003. SARS and new normals: Health and hospitality workers fight back. Our Times Aug/Sep 2003. UK (United Kingdom) Department of Health. 2007. Pandemic Flu News June(4):1-14. United States code annotated. 2005. Eagan, MN: West Publishing. University of North Carolina Institute for Public Health. 2008. Good Samaritan entity liabil- ity protection issue brief. http://nciph.sph.unc.edu/law/tools/IssueBrief.pdf (accessed April 9, 2008).

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Planning for an influenza pandemic, whether it occurs in the near or distant future, will need to take into account many constantly evolving factors. The Institute of Medicine (IOM) Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic was asked by the Department of Health and Human Services, (DHHS) to consider best practices and policies for providing antiviral treatment and prophylaxis during a pandemic event. The committee's report, entitled Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program, calls for a national and public process of creating an ethical framework for antiviral use within the context of uncertainty and scarcity. It is unclear whether antivirals will work against a pandemic strain as well as they work against seasonal influenza. Also, government stockpiles may not be sufficient for all possible uses in part because antivirals are costly and public health agencies must invest in other important activities, including other medical resources for pandemic influenza. Furthermore, the report identifies the lack of a science-based advisory body to guide decision making during the pandemic, including guidance on all dimensions of antiviral dispensing (for example, prioritization, drug safety, and antiviral resistance). The report also acknowledges the need for diverse methods and sites of dispensing, and discusses their advantages and disadvantages.

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