# 2056
The Department of Health and Human Services has released, for public comment, proposed guidelines on antiviral use during a pandemic.
While these guidelines have not yet been adopted, they do give us a pretty good understanding of how the HHS is thinking about these issues.
Last week I wrote on the new proposed facemask and respirator guidance, and yesterday on the Proposed considerations for antiviral drug stockpiling by employers in preparation for an influenza pandemic
Today we'll take a closer look at Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic and Household Post Exposure Prophylaxis (PEP) in particular.
The SNS (Strategic National Stockpile) of antiviral drugs, with a target of 81 million 10-pill courses of antivirals, will likely be insufficient in the face of a severe pandemic - particularly if any antiviral prophylaxis is anticipated.
The working group that created this new guidance puts it this way (reformatted for readability):
The total number of antiviral drug regimens needed to fully implement the working group recommendations substantially exceeds current public sector stockpiling targets.
Because of this, implementation will require governments, healthcare organizations and other employers, and families and individuals as appropriate, to purchase and stockpile sufficient antiviral drug supply to support these strategies, and plan for effective implementation at the time of a pandemic as part of comprehensive pandemic planning and preparedness.
Public sector stockpiles should be targeted for containment, delaying a U.S. pandemic, and treatment. Guidance from the Strategic National Stockpile recommends that antiviral drugs distributed from the SNS to the States be used for treatment.
Implementing prophylactic antiviral drug strategies, therefore, will require the establishment of stockpiles in the private sector. This approach is consistent with the role employers play in protecting their workers and operations against other types of risk.
Up until now, the private stockpiling of antivirals has been discouraged by the Federal government. Even the NEJM ran an editorial (12/22/05) urging doctors not to prescribe antivirals for patients to have on hand in case of a pandemic.
Of course, in 2005 our government was trying desperately to create their own stockpile, and Tamiflu was in short supply. It made sense, I suppose, to restrict private acquisitions of antivirals until the Federal stockpile could be filled.
Today Roche is cutting back on production because most governments have filled their orders. It now makes sense to encourage the private sector to stockpile the drug.
As the guidance says, implementing prophylactic antiviral drug strategies will require that "governments, healthcare organizations and other employers, and families and individuals (as appropriate)" purchase and maintain their own stockpile.
It is recommended that employers of high and very high risk employees (Health Care workers, EMS, Fire, Police) stockpile sufficient antivirals to provide outbreak prophylaxis to their staff, and PEP (Post Exposure Prophylaxis) to medium and low risk employees who may come in contact with an infected patient.
The inclusion of families and individuals is a bold, but welcome, addition.
Influenza is highly contagious, and with a novel virus, the assumption is that we won't have any built in immunity. The attack rate assumptions of 30% are guesses, based on the 1918 pandemic. Frankly, we won't know what the attack rate of the next pandemic will be until it is well underway.
But it is a pretty good guess that if a family member contracts the virus, that the rest of the household will be at substantial risk of getting sick.
It is here that PEP (Post Exposure Prophylaxis) can save lives and lessen morbidity during a pandemic.
Here is how the guidance document addresses PEP for household contacts of persons with Pandemic Illness.
PEP of household contacts will have the direct benefit of preventing infection, illness, and its consequences within the household – a setting where about one-third of all influenza transmission is estimated to occur.
In addition, because persons in the house of a case-patient are less likely to become infected when PEP is given, they will not transmit infection to others in the community, reducing the overall spread and burden of influenza disease. Antiviral treatment is likely to have little impact on the overall rate of illness in communities.
By contrast, household PEP may be more effective because it is given before people become ill and are infectious to others. The magnitude of this “indirect” benefit depends on the proportion of households that receive prophylaxis, how soon they receive the antiviral medication, and the effectiveness of prophylaxis.
If everyone in the affected household can be placed on a 10-day regimen of antivirals (and they stay home and not risk spreading the virus to the community) then we stand a very good chance of limiting the impact of a pandemic.
Of course, for that to happen, doctors need a green light and encouragement to begin prescribing prophylactic antivirals.
And given that the price of antivirals is currently prohibitive for many people, it would certainly be helpful if the Federal government could negotiate a special price for its citizens.
Studies indicate that the use of household PEP could save more than 150,000 lives and reduce hospitalizations by hundreds of thousands. Again, quoting from the guidance document.
Assuming a 15% attack rate with community mitigation and antiviral treatment, the model predicts a reduction in attack rate to 12.5% with the addition of antiviral PEP.
This corresponds to about 155,000 fewer deaths and about 838,000 fewer hospitalizations.
Overall, the combination of treatment and household PEP is estimated to reduce pandemic deaths by about 288,000 and hospitalizations by about 2.4 million.
To achieve these outcomes, based on the assumptions used in the model, would require a total of about 167 million antiviral regimens.
The incremental antiviral requirement for PEP compared with a treatment strategy alone is 88 million regimens.
In other words, the private sector will need to make up 88 million courses of antivirals just for household PEP.
For that to happen, the government needs to find ways to facilitate the purchase of antivirals by businesses, families, and individuals.
Preventing the deaths of 155,000 Americans (many of which will be children and young adults), and the hospitalization of 838,000 more is a genuine national security issue.
The acknowledgement that individuals and families need to have antivirals for PEP (post exposure prophylactic) use is an important first step.
Now we need to find ways to make it happen.
Addendum 06/10/08
A loyal reader has pointed out (correctly) that the working group, while extolling the benefits of household PEP, stopped short of making it a recommendation at this time.
This is a point I should have highlighted, and I erred in not doing so. Mea Culpa.
And thanks Paul.
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