Antivirals for Pandemic Influenza Guidance on Developing a Distribution and Dispensing Program (2008) / Chapter Skim
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2 Antiviral Effectiveness, Safety, and Supply
2 Antiviral Effectiveness, Safety, and Supply
Pages 19-38
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From page 19... ...
. In this chapter, the committee examines current information about the effectiveness and safety of neuraminidase inhibitors, and implications of supply issues, and emergent effectiveness and safety data for planning and implementation of an antivirals program.
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From page 20... ...
Neuraminidase inhibitors are effective in treating influenza and are currently used to prevent some cases during seasonal influenza outbreaks. Randomized trials, conducted primarily among relatively healthy children and adults, have demonstrated decreased duration of symptoms, disability, antibiotic use, and decreased time to return to normal function after treatment (Moscona, 2005)
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From page 21... ...
It is not known if the effectiveness of neuraminidase inhibitors against the pandemic strain will be similar to their effectiveness when used during seasonal influenza outbreaks. Wide-scale use, as well as overuse or misuse, could lead to both increased resistance and the emergence of newly identified, or at least greater numbers of known, adverse events.
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From page 22... ...
. Resistance The effectiveness of adamantanes, which have been marketed for three decades, has become so limited by the spread of resistant viruses that federal and international public health authorities advise against their use in treating seasonal influenza (CDC, 2006a)
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From page 23... ...
The factors influencing the rate of antiviral resistance are complex. Based on what is known about the emergence of antiviral resistance in HIV, potential factors driving the emergence of neuraminidase inhibitor– resistant influenza include the structure of the circulating neuraminidase, the relationship of the susceptibility of the pandemic strain and the drug levels among the patients, and the degree of inappropriate use or partial prophylaxis in the presence of circulating resistant virus.
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From page 24... ...
Prophylactic use of antiviral medications will be reserved for initial containment efforts and other highly select circumstances" (Homeland Security Coun TABLE 2-1 Strategic National Stockpile Antiviral Goal and Status Status Status March Goal July 2007 2008 Federal Strategic 50 million courses (6 million 36 million 49.9 National Stockpile of these are intended for million domestic containment) Federally subsidized, 31 million courses 12 million 21.7 state-purchased state million stockpiles Total 81 million courses 48 million 71.6 million SOURCES: DHHS, 2007a,c; A
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From page 25... ...
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." Clearly, the stockpile of 75 or 81 million courses is not suf BOX 2-1 Priority Groups to Receive Antiviral Treatment and Prophylaxis Identified in the 2005 DHHS Pandemic Influenza Plan (based on the recommendation of the National Vaccine Advisory Committee) • Patients admitted to hospital • Health care workers (HCWs)
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From page 26... ...
Adequacy of Supply In thinking about the available public stockpile (at federal, state, and to a lesser extent, local levels) and the important issues listed above, the committee used three simple potential scenarios to think about antiviral dispensing.
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From page 27... ...
Reserving the antivirals for treatment alone is not an option as it would leave a vast proportion of health care and emergency services personnel with certain exposure unprotected and vulnerable to becoming incapacitated by illness. Even if the intent was to provide only postexposure prophylaxis to 10.7 million health care workers and emergency services personnel (using figures from the DHHS draft proposed guidance, which estimates that one-third of health care workers would not have direct contact with infected individuals)
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From page 28... ...
. A pandemic of any level of severity greater than seasonal influenza would cause some level of social and economic disruption due to higher than usual hospitalization and death rates, but a severe pandemic in this scenario of a modest antiviral stockpile would involve making the most difficult decisions, and thus, present the greatest need for a pre-developed, widely understood ethical framework.
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From page 29... ...
would total 85.6 million courses. The draft proposed guidance also estimates needing approximately 4 courses of post-exposure prophylaxis for each of the remaining 4.3 million health care workers not identified as needing outbreak prophylaxis, for a total of 17.2 million courses.
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From page 30... ...
, based on the estimates provided in the DHHS draft proposed guidance. An even higher total would ensure one course of treatment is available for all people in the United States at the time of the pandemic, a combination of post-exposure or seasonal prophylaxis for all health care workers and emergency services personnel, and prophylaxis for a large number of exposed household contacts (again using DHHS 2007 estimates)
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From page 31... ...
Even so, there is reason to believe that additional demands will be placed on the antiviral supply. The 2005 DHHS Pandemic Influenza Plan includes patients hospitalized with pandemic influenza on the list of priority groups to receive antivirals, and acknowledges that hospitalized patients would include individuals presenting for care late after falling ill.
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From page 32... ...
Aside from the change in expiration dating of oseltamivir, it is important to note that federal antiviral stockpiles are included in an FDAoverseen Shelf-Life Extension Program (SLEP)
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From page 33... ...
Rotating stocks of antivirals may pose logistic challenges, and the amount of drug used in the United States for treatment during seasonal influenza outbreaks may be too small to enable complete rotating of stocks. Despite these issues, the fact that rotating stocks is not allowed precludes the possibility of considering alternatives that could have economic and preparedness benefits.
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From page 34... ...
. The collective effort of many public- and private-sector entities will be needed to support the response to a pandemic. The goal of this coordination will be to maximize optimal distribution of limited antiviral stock consistent with key public health strategies for pandemic containment and mitigation, including a recommendation regarding prioritization.
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From page 35... ...
The committee understands that in a pandemic resulting in declarations of emergency or public health emergency, federal, state, or local public health authorities have the authority to take private stockpiles of antivirals to meet critical societal needs, notwithstanding such agreements. Other potential areas of public–private collaboration include conducting joint drills and exercises, using businesses as points-of-dispensing (Khan, 2008)
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From page 36... ...
, ���������������������������������������������� antivirals would have the potential to affect ����������������������������������� the course of the pandemic. They could lower mortality rates across a diverse population and could help preserve critical infrastructures by protecting key personnel and lessening the strain on the health care delivery system.
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From page 37... ...
does not risk over-use and misuse to the same extent. For the same reasons as the broad prophylaxis associated with scenario C, and because of its������������������������������������ ��������������������������������������� focus on��������������������������� health care and emergency services personnel, scenario B promises health care, public safety, and ��������������������������������������������������������������� social order benefits for the population as a whole.
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