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Biosecurity BriefingHHS Releases Pandemic Flu Draft Guidances for Public Comment By Crystal Franco, June 6, 2008 On May 28, 2008, the U.S. Department of Health and Human Services (HHS) issued a Notice of Availability of Draft Guidances to Assist in Preparation for an Influenza Pandemic. HHS has released these documents “to assist government agencies, businesses, community organizations, and the public in their preparedness efforts,” as part of a “comprehensive strategy to prepare for and respond to an influenza pandemic.”1 According to the May 28, 2008 release, HHS has made available three new draft guidance documents for review and comment by the public and “interested stakeholders”:
The Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness was developed by HHS as a guide for the use of respirators at home during a pandemic. Families are advised to “use this guidance as the basis for making decisions about purchasing respirators and facemasks as part of household pandemic preparedness.” The guidance provides the following key takeaways:
The guidance estimates that it would cost a family approximately $35-$70 to stockpile masks and N95 respirators for a pandemic. The Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic was developed by an interagency government working group that “considered scientific issues, ethics and values, and perspectives of stakeholders in developing draft guidance on antiviral use strategies and stockpiling.” This proposed guidance would replace the 2005 antiviral use recommendations which are currently part of the HHS pandemic preparedness and response plan.3 The proposed antiviral guidance is “based on the national pandemic response goals of slowing the spread of pandemic disease, reducing impacts on health, and minimizing societal and economic disruption.” To meet these goals, the guidance recommends the following with regards to antiviral use:
The working group recommends that next steps for the antiviral guidance includes continued scientific study of antivirals and their effectiveness in treatment and prophylaxis of influenza (specifically the H5N1 influenza and other strains with “pandemic potential”); increased government coordination to stockpile and maintain antiviral drugs; continued development of distribution and treatment protocols in the event of a pandemic; and surveillance for antiviral resistance and adverse events in treatment. The Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic guidance was drafted in response to employer requests for direction “about whether they should stockpile or otherwise arrange for influenza antiviral drugs to be available for their employees during a pandemic.” According to the guidance, employer and other “private stockpiles” would “extend protection more broadly than could be achieved through the public sector alone and improve the ability to achieve the national pandemic response goals of mitigating disease, suffering, and death, and minimizing impacts on the economy and functioning of society.”4 The guidance stipulates that should an employer choose to stockpile antiviral drugs, “it should do so with a clear understanding of the legal, regulatory, ethical, logistical, and economic issues that will be encountered in ordering, storing, securing and dispensing prescription medications.” Additionally, the feasibility and benefits of prophylaxis in a pandemic are still under consideration. However, HHS is clear that employers will likely “have to take the lead role for protection of their workforce” if federal guidance which recommends expanding antiviral use to include prophylaxis is to be implemented.4 Further information and instructions for submitting public comment on the guidance documents can be found online: http://aspe.hhs.gov/panflu/antiviral-n-masks.shtml. References
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