Antivirals for Pandemic Influenza Guidance on Developing a Distribution and Dispensing Program (2008) / Chapter Skim
Currently Skimming:
Summary
Summary
Pages 1-10
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
The main antiviral drugs stockpiled by the federal and state governments are the neuraminidase inhibitors oseltamivir and zanamivir. These antivirals have been approved by the Food and Drug Administration (FDA)
|
From page 2... ...
With respect to treatment of cases and post-exposure prophylaxis of their household contacts, key planning issues include, but are not limited to, determining where drugs are dispensed; allocation and distribution of drugs to those sites; diagnostic approach for cases; strategy to enumerate house hold contacts and assess appropriateness of dispensing drugs for them; potential regulatory barriers to dispensing; and monitoring antiviral drug use and safety. With respect to prophylaxis for targeted health care and emergency services personnel, key issues include, but are not limited to, determining where drugs are dispensed; potential regulatory barriers to dispensing; labor issues that may arise from target ing some workers, but not others; and monitoring antiviral drug use and safety.
|
From page 3... ...
requires a process of national public and stakeholder engagement similar to that undertaken for pandemic influenza vaccine Theseinclude some documents that are available in draft form (the Department of Health and Human Services' November 6 and 20, 2007, draft guidance documents) or that have been developed as a basis for further discussion (the prioritization scheme for antiviral use developed by the National Vaccine Advisory Committee and included in the 2005 National Pandemic Influenza Plan)
|
From page 4... ...
In Chapter 4, the report recommends a first level of prioritization for prophylaxis, discusses characteristics of groups with occupational or household exposure that require consideration, describes advantages and disadvantages of a range of dispensing sites, and examines some legal issues relevant to planning and implementing antiviral dispensing strategies. The committee noted the planning assumptions made by federal government planners to address uncertainty.
|
From page 5... ...
, and the DHHS Secretary's Pandemic Influenza Update IV (DHHS, 2007c) refers to the stockpile as "81 million treatment courses," which "include 6 million treatment courses set aside for the early stages of an emerging pandemic." Recommendation 2-1: The committee recommends that the fed eral government clarify the national goals for antiviral use in an influenza pandemic.
|
From page 6... ...
(These may include prioritization schemes, guidelines for initial treatment of suspected cases, initial post-exposure pro phylaxis, reporting of adverse events concerning antivirals, and coordination with state, tribal, and local officials as to who has been given medication.) An influenza pandemic will require making difficult value-laden deci This could perhaps include antivirals in the federal stockpile, depending on the threshold for viability established by the Shelf-Life Extension Program and evidence-based decisions about the usefulness of these drugs.
|
From page 7... ...
Recommendation 3-1: The committee recommends that the federal government in collaboration with state, tribal, and local govern ments support the development of a national ethical framework to guide the allocation of antivirals (and other scarce health resources) during a severe influenza pandemic.
|
From page 8... ...
In order to use scarce antivirals sparingly and strategically, based on available epidemiologic data and local circumstances, the committee recommends the following: Recommendation 4-2: The committee recommends that pandemic influenza planners at all levels make outbreak prophylaxis for health care and emergency personnel who are in short supply and will have repeated and difficult-to-control exposure a first priority for prophylactic antiviral use. Post-exposure prophylaxis for other health care personnel and emergency responders should be a sec ond priority.
|
From page 9... ...
It may not be necessary or realistic to attempt to gather comprehensive information about each antiviral drug-related adverse event, but rather, to gather statistically accurate information. Recommendation 4-5: The committee recommends that the Depart ment of Health and Human Services consider options in addition to the Food and Drug Administration Adverse Event Reporting System to capture adverse events resulting from use of antiviral drugs to ensure active and timely reporting.
|
From page 10... ...
The committee understands that aspects of such activities may be used to meet the performance measures requirement in CDC guidance, but not the exercise requirement. Recommendation 4-6: The committee recommends that federal pandemic influenza grant guidance explicitly state that jurisdic tions receiving federal funding may fulfill the exercise requirement through the implementation of response to actual biologic emer gency situations or similar events, if the appropriate benchmarks are used, performance is evaluated, and necessary corrective action is taken.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.