sharon sanders
Editor-in-Chief & President
National Discussion Needed on Antiviral Drug Distribution During a Flu Pandemic
<st1:state w:st="on">WASHINGTON</st1:state> -- Uncertainties about the availability and effectiveness of antiviral drugs during a flu pandemic require federal and state officials to begin a national discussion about the difficult choices they may be forced to make about the drugs' distribution, says a new report from the <st1
lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace>. Medications such as oseltamivir (Tamiflu<sup>?</sup>) and zanamivir (Relenza<sup>?</sup>) are expected to play a key role in the early stages of a pandemic, helping to treat illness and slow its spread during the several months it takes to develop a vaccine. But it is impossible to know in advance how severe the next pandemic will be and what mix of treatment and prophylaxis will be optimal.
"We need to engage the public in a discussion about the use and distribution of antiviral drugs in advance of a pandemic when there will be limited time for deliberations because large numbers of people will be getting sick," said committee chair June Osborn, president emerita, Josiah Macy Foundation, <st1lace w:st="on"><st1:city w:st="on">Falls Church</st1:city>, <st1:state w:st="on">Va.</st1:state></st1lace> "Through a similar public dialogue, state and federal officials already have effectively built broad understanding of how a pandemic vaccine would be allocated."
Federal and state agencies have been building stockpiles of antiviral medications, which would be one of the few tools available against the virus during the early stages of a pandemic. Public health officials expect to use them to treat infected people and to prevent illness in those at risk of infection during the several months it takes to develop a vaccine. However, it is difficult to know whether the specific pandemic strain could rapidly become resistant to the drugs. And the stockpiles may not contain sufficient doses to allow broad prophylaxis as well as treatment in the event of a particularly lethal or fast-spreading virus, the report notes. Officials therefore need to develop in advance a set of priorities outlining the order in which different groups of people should receive the drugs. Establishing the parameters of an ethical framework for making such decisions ahead of a crisis would help officials to better make tough choices at the onset.<o></o>
<o>
</o>The prioritization scheme should have the flexibility to adjust for the particular circumstances of an actual outbreak, including how quickly the virus spreads, which population groups it affects most severely, and how readily it responds to drugs, the report says. The committee recommended that a scientific advisory body be established now, to be ready to advise the government in the midst of a pandemic. <o></o>
<o>
</o>In addition to engaging the public in prioritization planning, government officials also should connect with the corporations and other private entities that are building stockpiles of antiviral drugs for their employees, the report says. Efforts to establish agreements and understanding between the public and private sectors could lead to collaboration in an actual outbreak and reduce confusion and inefficiencies during a pandemic.<o></o>
<o>
</o>The committee noted that the federal Shelf Life Extension Program that covers antiviral drugs in stockpiles managed by the <st1:country-region w:st="on"><st1lace w:st="on">U.S.</st1lace></st1:country-region> departments of Defense and Health and Human Services should include the antivirals in state and other stockpiles. Like all medications, antiviral drugs carry expiration dates. Under this program, drugs are tested periodically to see if they continue to show potency beyond the manufacturer's expiration date. Extending the program to cover additional stockpiles could prevent the discarding of viable medications.<o></o>
<o>
</o>The study was sponsored by the U.S. Department of Health and Human Services. Established in 1970 under the charter of the National Academy of Sciences, the <st1lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace> provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, <st1lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace>, and National Research Council make up the National Academies. A committee roster follows.<o></o>
<o>
</o>Pre-publication copies of Antivirals for Pandemic Influenza: Guidance for Developing a Distribution and Dispensing Program are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). <o></o>
<o> </o>
# # #<o></o>
<o> </o>
[ This news release and report are available at http://national-academies.org ]<o></o>
<o> </o>
Board on Population Health and Public Health Practice
<st1:state w:st="on">WASHINGTON</st1:state> -- Uncertainties about the availability and effectiveness of antiviral drugs during a flu pandemic require federal and state officials to begin a national discussion about the difficult choices they may be forced to make about the drugs' distribution, says a new report from the <st1
lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace>. Medications such as oseltamivir (Tamiflu<sup>?</sup>) and zanamivir (Relenza<sup>?</sup>) are expected to play a key role in the early stages of a pandemic, helping to treat illness and slow its spread during the several months it takes to develop a vaccine. But it is impossible to know in advance how severe the next pandemic will be and what mix of treatment and prophylaxis will be optimal."We need to engage the public in a discussion about the use and distribution of antiviral drugs in advance of a pandemic when there will be limited time for deliberations because large numbers of people will be getting sick," said committee chair June Osborn, president emerita, Josiah Macy Foundation, <st1
lace w:st="on"><st1:city w:st="on">Falls Church</st1:city>, <st1:state w:st="on">Va.</st1:state></st1lace> "Through a similar public dialogue, state and federal officials already have effectively built broad understanding of how a pandemic vaccine would be allocated." Federal and state agencies have been building stockpiles of antiviral medications, which would be one of the few tools available against the virus during the early stages of a pandemic. Public health officials expect to use them to treat infected people and to prevent illness in those at risk of infection during the several months it takes to develop a vaccine. However, it is difficult to know whether the specific pandemic strain could rapidly become resistant to the drugs. And the stockpiles may not contain sufficient doses to allow broad prophylaxis as well as treatment in the event of a particularly lethal or fast-spreading virus, the report notes. Officials therefore need to develop in advance a set of priorities outlining the order in which different groups of people should receive the drugs. Establishing the parameters of an ethical framework for making such decisions ahead of a crisis would help officials to better make tough choices at the onset.<o
></o><o
> </o
>The prioritization scheme should have the flexibility to adjust for the particular circumstances of an actual outbreak, including how quickly the virus spreads, which population groups it affects most severely, and how readily it responds to drugs, the report says. The committee recommended that a scientific advisory body be established now, to be ready to advise the government in the midst of a pandemic. <o></o><o
> </o
>In addition to engaging the public in prioritization planning, government officials also should connect with the corporations and other private entities that are building stockpiles of antiviral drugs for their employees, the report says. Efforts to establish agreements and understanding between the public and private sectors could lead to collaboration in an actual outbreak and reduce confusion and inefficiencies during a pandemic.<o></o><o
> </o
>The committee noted that the federal Shelf Life Extension Program that covers antiviral drugs in stockpiles managed by the <st1:country-region w:st="on"><st1lace w:st="on">U.S.</st1lace></st1:country-region> departments of Defense and Health and Human Services should include the antivirals in state and other stockpiles. Like all medications, antiviral drugs carry expiration dates. Under this program, drugs are tested periodically to see if they continue to show potency beyond the manufacturer's expiration date. Extending the program to cover additional stockpiles could prevent the discarding of viable medications.<o></o><o
> </o
>The study was sponsored by the U.S. Department of Health and Human Services. Established in 1970 under the charter of the National Academy of Sciences, the <st1lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace> provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, <st1lace w:st="on"><st1lacetype w:st="on">Institute</st1lacetype> of <st1lacename w:st="on">Medicine</st1lacename></st1lace>, and National Research Council make up the National Academies. A committee roster follows.<o></o><o
> </o
>Pre-publication copies of Antivirals for Pandemic Influenza: Guidance for Developing a Distribution and Dispensing Program are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). <o></o><o
> </o># # #<o
></o><o
> </o>[ This news release and report are available at http://national-academies.org ]<o
></o><o
> </o><st1lace w:st="on"><st1lacetype w:st="on">INSTITUTE</st1lacetype> OF <st1lacename w:st="on">MEDICINE</st1lacename></st1lace><o></o>
lace w:st="on"><st1lacetype w:st="on">INSTITUTE</st1lacetype> OF <st1lacename w:st="on">MEDICINE</st1lacename></st1lace><o></o>