# 2109
This month of June has been relatively quiet when it comes to reports of bird flu around the world. How much of that is genuine quiescence of the virus, and how much is simply a lack of governmental reporting, is hard to know.
There has been bird flu news, however. Big news.
Here in the United States the government has publicly put the preparedness ball in our court.
Us; American citizens - individuals, families and business owners
We, the people.
While the message has always been that the government can't do it all in a pandemic, and that people need to prepare - over the past month the HHS has become far more specific in their recommendations.
Next week (July 3rd) will end the public comment period for three important proposed pandemic guidelines directed at individuals and business owners.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Availability of Draft Guidances To Assist in Preparation for an Influenza Pandemic
AGENCY: Office of the Secretary, Health and Human Services.
ACTION: Notice of Availability.
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SUMMARY: The Department of Health and Human Services (HHS) is seeking public comment on three draft guidances:
- Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness;
- Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic
- Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic.
The draft Guidances are now available on the HHS Web site
http://aspe.hhs.gov/panflu/antiviral-n-masks.htmDATES: Submit comments on or before July 3, 2008.
If you have not yet read these interim guidance documents, you really should. And you still have a few days left in which you can send your comments to the HHS.
The first guideline listed Interim guidance on the use and purchase of facemasks and respirators by individuals and families for pandemic influenza preparedness has a much stronger recommendation for the home stockpiling, and use, of facemasks and respirators than we've seen before.
Key messages:
- The first and most important steps in reducing one’s risk of pandemic influenza are to limit close contact with others as much as possible and to practice good hygiene. These measures should be used at all times, regardless of whether a facemask or respirator is worn.
- When a person cannot avoid being in a crowd during an influenza pandemic – for example, because they must commute to work on public transit – but has no specific expectation of encountering a sick person, they should use a facemask.
- When it is necessary to have close contact with someone who is ill with pandemic influenza – for example, to give care to a family member – one should use an N95 respirator or equivalent certified by the National Institute of Occupational Health and Safety (NIOSH) and consider specifically using a respirator model that also is cleared by the U.S. Food and Drug Administration (FDA) for use by the general public in public health medical emergencies.
- Ill persons should use a facemask when they must be in contact with others.
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Settings where respirators and facemasks should be used will depend on the potential for exposure to infectious persons:
- A facemask is recommended when exposure in a crowded setting occurs with persons not known to be ill. An example would be exposure on a crowded bus or subway while commuting to work during a pandemic. Because ill persons are advised to stay home during a pandemic, contacts in most public settings will be with persons who are not ill. However, it is prudent to wear a facemask because one may encounter people who are infectious but not yet ill.
- A facemask also is recommended for use by ill persons when they must be in close contact with others. The facemask will trap the wearer’s secretions and reduce the risk to other persons. Close contact between ill persons and others should be limited as much as possible. However, such contact will occur when the ill person is being cared for at home or if they need to leave home to access medical care or manage other necessities. Ill persons do not need to wear a facemask when they are not in close contact with others
- A respirator is recommended for use in settings that involve close contact (less than about 6 feet) with someone who has known or suspected influenza illness. In non-occupational settings, the most common use for a respirator would be in a household where someone has influenza. One person should be responsible for taking care of the ill individual and that person should wear a respirator during those contacts. The Centers for Disease Control and Prevention (CDC) will be issuing guidance on home care of an ill person, which will be posted on the internet at www.pandemicflu.gov.
Families can use this guidance as the basis for making decisions about purchasing respirators and facemasks as part of household pandemic preparedness. Although not all households will have someone who becomes ill with influenza during a pandemic, because one cannot predict in which households an infection will occur, it would be reasonable for each household to stockpile some respirators that can be used, if needed, when caring for an ill family member.
With proper precautions, a single caregiver can use the same respirator several times over a day for brief care visits with the same ill person in the household,[2] so a stockpile of 20 respirators per household would be reasonable. Decisions on stockpiling facemasks and the number to obtain would depend on a family’s situation and their expectation of the need for close contact in crowded settings during a pandemic.
Pandemic outbreaks in communities may last 6 to 12 weeks.[3] Persons who cannot avoid commuting on public transit may choose to purchase 100 facemasks for use when going to and from work. An additional supply of facemasks also could be purchased for other times when exposure in a crowded setting is unavoidable or for use by an ill person in the home when they come in close contact with others.[4]
The cost of a box of 20 N95 respirators is about $15 - $30 and the cost of a box of 50 facemasks is about $10 - $20. Therefore, the total cost to a family to purchase the recommended number of respirators and facemasks would be about $35 - $70.
Strong recommendations, but ones that I support.
I've long advocated that private individuals have masks (see Who Was That Masked Man? and Any Mask In A Viral Storm), even if the science wasn't clear as to how effective they would be (it still isn't).
Masks make sense as a part of system of `layered' levels of protection, which will also include social distancing, covering coughs, having the sick stay home, and frequent handwashing, among others.
* * * *
The second document is the HHS's Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic. Here the working group has determined that the number of courses of antivirals the United States needs on hand for a pandemic would be at least 195 million.
Roughly 2.4 times more than the government intends to purchase.
They urge that the private sector, mostly businesses - but `families and individuals as appropriate' - stockpile the rest.
This would provide:
- 6M doses for deployment overseas to try to stop an outbreak
- 79M treatment courses for the infected here in the United States
- 103M courses to provide prophylaxis for healthcare and emergency service workers
- 5M courses for outbreak control in Nursing homes, prisons, and other closed settings
- 2M courses for people who are severely immuno-compromised
With an anticipated Federal and State Stockpile (currently lagging behind the goal) of 81 million courses, this means that the private sector would have to make up the 114 million course shortfall.
A `course' is defined as 10 pills, which currently sells for about $60 when purchased wholesale, or nearly $100 when purchased retail.
If that sounds like a lot of Tamiflu, well . . it is. Nearly 7 Billion dollars worth at wholesale prices.
But wait. There's more.
In addition to the 195 million courses outlined in this document, the authors point out that more than 150,000 American lives could be saved if households had antivirals available for PEP, or Post Exposure Prophylaxis.
There are basically three uses for antivirals:
- Treatment of those infected
- Outbreak Prophylaxis for people who are likely to be exposed
- PEP (Post Exposure Prophylaxis) - giving antivirals to those exposed, but not yet symptomatic to prevent infection.
The idea behind PEP is that if one household member is stricken by pandemic flu, the rest of the household is at greatly increased risk of catching, and spreading the virus. By giving each of them a 10-day prophylactic course of Tamiflu, it is believed that many of these infections can be prevented.
The working group falls short of actually recommending household PEP, explaining:
Despite these potential benefits, however, further work is needed to assess the feasibility of this strategy and identify approaches for purchasing and stockpiling the antiviral drugs to support its implementation. Therefore, the working group makes no recommendation for household antiviral PEP at this time.
To implement household PEP would require another 106 million courses of antivirals, bringing the total needed to just over 300 million courses.
Obviously the costs of such preparations would be very steep, but not as steep as the cost of going into a severe pandemic ill prepared. Whether that is enough to motivate employers and individuals to act, before a pandemic erupts, is unknown.
Certainly the Federal government could do things to encourage this stockpiling, including relaxing the rules for prescriptions, and finding ways to lower the price so that individuals can buy at wholesale prices.
Roche's announcement yesterday of their RAPP (Roche Antiviral Protection Program) may help some large companies acquire antivirals for their employees, but does nothing for individuals and small to medium sized businesses.
* * * *
The third guidance document, Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic , strongly recommends that certain employers provided Outbreak Prophylaxis for their employees.
Outbreak Prophylaxis is defined as a daily preventative dose of an antiviral for the duration of exposure. Assuming a 12 week pandemic wave, then each employee would need in excess of 80 doses.
Prime among the candidates for Outbreak Prophylaxis are health care workers, as they are atop OSHA's (Occupational Safety and Health Administration) risk pyramid.
Occupational Risk Pyramid for Pandemic Influenza
Very High Exposure Risk:
High Exposure Risk:
- Healthcare employees (for example, doctors, nurses, dentists) performing aerosol-generating procedures on known or suspected pandemic patients (for example, cough induction procedures, bronchoscopies, some dental procedures, or invasive specimen collection).
- Healthcare or laboratory personnel collecting or handling specimens from known or suspected pandemic patients (for example, manipulating cultures from known or suspected pandemic influenza patients).
Medium Exposure Risk:
- Healthcare delivery and support staff exposed to known or suspected pandemic patients (for example, doctors, nurses, and other hospital staff that must enter patients' rooms).
- Medical transport of known or suspected pandemic patients in enclosed vehicles (for example, emergency medical technicians).
- Performing autopsies on known or suspected pandemic patients (for example, morgue and mortuary employees).
Lower Exposure Risk (Caution):
- Employees with high-frequency contact with the general population (such as schools, high population density work environments, and some high volume retail).
- Employees who have minimal occupational contact with the general public and other coworkers (for example, office employees)
To assist employers in deciding if their employees need antiviral outbreak prophylaxis, the HHS has created this chart:
Appendix 2
The CDC recommends outbreak prophylaxis for Very High, or High risk employees. This includes nearly all caregivers and emergency response personnel.
They also recommend that employers of essential employees working in critical infrastructure `strongly consider' outbreak prophylaxis.
While this is certain to be expensive, it is only right that the people who we expect to take the highest risks during a pandemic get the best protection we can afford them.
Hospitals unprepared to protect their very high and high risk employees with PPE's and antiviral outbreak prophylaxis during a pandemic may find that many of these workers won't be willing to work under those conditions.
It's not as if they can claim they weren't warned.
* * * *
While these are all proposed guidances, they signal a significant sea change in the government's policy. An admission that the private sector must shoulder a larger share of the preparedness burden than we've heard previously.
The responsibility for preparing for a pandemic is not the government's alone, it is a shared responsibility between government and the private sector - including individuals.
Like it or not, the ball has been placed squarely in our court.
What we do with it may well determine how well our nation comes out of the next pandemic.
