03/15/2010 (10:45 am)
AFD - HHS, Facemasks, Antiviral - HHS Seeking Public Comment On Pandemic Guidance Documents
# 2045
http://afludiary.blogspot.com/
The HHS has just published 3 interim guidance documents on pandemic influenza and is asking for public comment on them between now and July 3rd, 2008.
Here is the announcement. (slightly reformatted for readability). Follow the link for complete submission rules.
DEPARTMENT OF HEALTH AND HUMAN SERVICES (http://edocket.access.gpo.gov/2008/E8-12357.htm)
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.
-----------------------------------------------------------------------
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.htm (http://aspe.hhs.gov/panflu/antiviral-n-masks.htm)
DATES: Submit comments on or before July 3, 2008.
A hat tip goes to Crof, on Crofsblog (http://crofsblogs.typepad.com/h5n1/), for alerting me to this request.
Since I'm leaving for the Orlando Conference in the morning, and will be gone most of the next 3 days, I probably won't have time to read and blog on these documents until the weekend at the earliest.
The documents in question are available in PDF form from the links below.
Notice of Availability of Draft Guidances to Assist in Preparation for an Influenza (http://aspe.hhs.gov/panflu/antiviral-n-masks.shtml)
The USG is requesting comment from the public and interested stakeholders 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; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic.
Read the Federal Register Notice: Notice of Availability of Draft Guidances to Assist in Preparation for an Influenza Pandemic (html) (http://edocket.access.gpo.gov/2008/E8-12357.htm) (PDF version - 2 pages) (http://edocket.access.gpo.gov/2008/pdf/E8-12357.pdf)
Read the Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness (html) (http://aspe.hhs.gov/panflu/facemasks.html)
(PDF version - 5 pages) (http://aspe.hhs.gov/panflu/facemasks.pdf)
Submit Comments on the Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness (PANFLUCOMMENTS1@hhs.gov)
Read the Proposed Guidance on Antiviral Drug Use During an Influenza Pandemic (html) (http://aspe.hhs.gov/panflu/antiviraluse.html)
(PDF version - 26 pages) (http://aspe.hhs.gov/panflu/antiviraluse.pdf)
Submit Comments on the Proposed Guidance on Antiviral Drug Use During an Influenza Pandemic (PANFLUCOMMENTS2@hhs.gov)
Read the Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic (html) (http://aspe.hhs.gov/panflu/stockpiling.html)
(PDF version - 20 pages) (http://aspe.hhs.gov/panflu/stockpiling.pdf)
Submit Comments on the Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic (PANFLUCOMMENTS3@hhs.gov)
posted by FLA_MEDIC @ 4:59 PM (http://afludiary.blogspot.com/2008/06/hhs-seeking-public-comment-on-pandemic.html)
# 2054
Since I was away at the ACHA convention for much of last week, I haven't have an opportunity to read and comment on the newly released proposed guidance on the use of Antivirals by the HHS until today. I covered the new facemask and respirator recommendations (http://afludiary.blogspot.com/2008/06/hhs-revised-mask-recommendations.html) on Wednesday.
The two new guidance documents are called:
Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic (http://aspe.hhs.gov/panflu/antiviraluse.html)
and
Proposed considerations for antiviral drug stockpiling by employers in preparation for an influenza pandemic (http://aspe.hhs.gov/panflu/stockpiling.html)
Both of these documents were released last week, and the HHS is seeking public comment (http://afludiary.blogspot.com/2008/06/hhs-seeking-public-comment-on-pandemic.html) on these new recommendations through the first week of July.
While there is much to ponder in these new documents (and it will require more than one blog to cover), the most striking change is the recommendation that private sector employers consider stockpiling prophylactic antiviral medications, particularly if their employees will be at high risk of exposure.
That means Hospitals, EMS units, Fire Departments, and Law Enforcement Agencies, among others.
http://aspe.hhs.gov/panflu/s_image1.jpg
These new guidelines divide antiviral use into four categories.
Overseas Containment
Treatment
Outbreak Prophylaxis
PEP (Post Exposure Prophylaxis)
Outbreak Prophylaxis, as defined by these documents, would require up to 8 courses (80 pills) of Tamiflu per employee to cover a pandemic wave.
PEP (Post Exposure Prophylaxis) would require 1 course (10 pills).
The federal and state stockpiles, which currently fall short of the 81 million courses originally planned, are generally reserved for overseas containment (6 million courses), and treatment of infected patients (75 million courses).
Little or none of the state and federal stockpile is expected to be available for outbreak prophylaxis or PEP. Employers are put on notice that they cannot expect any of the federal stockpile to be allocated to them for protecting their employees.
"Despite expanding recommendations for antiviral drug use, there are no current plans for a commensurate expansion of public sector stockpiles, and employers will have to take the lead role for protection of their workforce if these recommendations are to be implemented."
While this guidance is quick to say "This guidance does not establish a requirement or expectation that all employers stockpile antiviral drugs.", it makes it pretty clear that certain classes of employers should stockpile prophylactic antivirals.
Quoting from the guidance again:
Antiviral strategies may be most useful for employers that have employees who will have frequent exposure to persons with pandemic illness, in critical infrastructure sectors, and those that have overseas locations and operations.
Outbreak prophylaxis of front-line healthcare and emergency services workers (fire, law enforcement, and emergency medical services [EMS]) is recommended because of their important role in providing critical healthcare services, preserving health and safety in communities, the lack of surge capacity in these sectors and the importance of reducing absenteeism when demands for services are likely to be increased.
There you have it in black (well, blue) and white.
A strong recommendation that hospitals and emergency services provide 12 weeks of prophylactic antivirals to all employees who will have direct exposure to infected patients.
Employees who are not routinely exposed to infected patients should be offered PEP (Post Exposure Prophylaxis) if they happen to come in contact with an infected patient.
And of course, all of this is on top of the requirements for PPE's, or personal protective equipment (masks, gowns, gloves) for HCW's (Health Care Workers).
The burden of protecting their employees has now been squarely laid on the shoulders of employers, particularly those in healthcare and critical infrastructure sectors.
There will be resistance to this idea, I'm sure.
Antivirals are expensive. They have a limited shelf life. Safe and secure storage of antivirals may be problematic. And there is always the possibility that antivirals could lose their effectiveness if a pandemic virus acquires resistance.
All true.
But none of these arguments are going to carry much weight if a pandemic breaks out, and employees discover that their health and safety have been secondary considerations.
If hospitals want nurses, doctors, and technicians to work, they'd better have adequate PPE's and prophylactic antivirals.
If EMS, fire, and police departments expect their first responders to respond, they'd better do the same.
The time for waffling, or making excuses, or simply saying that there is no guidance to suggesting they stockpile antivirals is over. Health Care Workers, and first responders, along with other critical infrastructure employees need to make it very clear to their employers that they expect to be protected.
And now, for the first time, they have some federally issued ammunition to use in their argument.
posted by FLA_MEDIC @ 7:46 AM (http://afludiary.blogspot.com/2008/06/prophylactic-antivirals-for-health-care.html)
# 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 (http://afludiary.blogspot.com/2008/06/hhs-revised-mask-recommendations.html), and yesterday on the Proposed considerations for antiviral drug stockpiling by employers in preparation for an influenza pandemic (http://afludiary.blogspot.com/2008/06/prophylactic-antivirals-for-health-care.html)
Today we'll take a closer look at Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic (http://aspe.hhs.gov/panflu/antiviraluse.html) 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 (http://aspe.hhs.gov/panflu/antiviraluse.html) 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 (http://content.nejm.org/cgi/content/full/353/25/2636) 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 (http://aspe.hhs.gov/panflu/antiviraluse.html#_Toc199842571) 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 (http://aspe.hhs.gov/panflu/antiviraluse.html#_Toc199842571).
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.
posted by FLA_MEDIC @ 10:07 AM (http://afludiary.blogspot.com/2008/06/household-post-exposure-prophylaxis-pep.html)
# 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 (http://edocket.access.gpo.gov/2008/E8-12357.htm)
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.
-----------------------------------------------------------------------
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.htm (http://aspe.hhs.gov/panflu/antiviral-n-masks.htm)
DATES: 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 (http://aspe.hhs.gov/panflu/facemasks.html) 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.
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 (http://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] (http://aspe.hhs.gov/panflu/facemasks.html#_ftn2) 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] (http://aspe.hhs.gov/panflu/facemasks.html#_ftn3) 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] (http://aspe.hhs.gov/panflu/facemasks.html#_ftn4)
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 (http://afludiary.blogspot.com/2007/04/who-was-that-masked-man.html)? and Any Mask In A Viral Storm (http://afludiary.blogspot.com/2007/02/any-mask-in-viral-storm.html)), 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 (http://aspe.hhs.gov/panflu/antiviraluse.html). 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 (http://afludiary.blogspot.com/2008/06/roche-offers-companies-option-to.html) 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 (http://aspe.hhs.gov/panflu/stockpiling.html) , 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 (http://www.osha.gov/Publications/influenza_pandemic.html)
http://www.osha.gov/images/risk_pyramid_288.jpg
Very 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). High 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). Medium Exposure Risk:
Employees with high-frequency contact with the general population (such as schools, high population density work environments, and some high volume retail). Lower Exposure Risk (Caution):
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 (http://aspe.hhs.gov/panflu/stockpiling.html)
http://aspe.hhs.gov/panflu/s_image1.jpg
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.
posted by FLA_MEDIC @ 9:33 AM (http://afludiary.blogspot.com/2008/06/ball-is-in-our-court.html)
___
The federal and state stockpiles, which currently fall short of the 81 million courses originally planned, are generally reserved for overseas containment (6 million courses), and treatment of infected patients (75 million courses).
Little or none of the state and federal stockpile is expected to be available for outbreak prophylaxis or PEP. Employers are put on notice that they cannot expect any of the federal stockpile to be allocated to them for protecting their employees.
___
Because the rest of the stockpilling are marked reccomended only, the next problems will be:
- induct the employees directors to decide a stockpile buying (now)
- reaching these enormous needed antivirals (and other) quantity on the market after the above decision
# 2062
The release of the Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic (http://aspe.hhs.gov/panflu/antiviraluse.html) and Proposed considerations for antiviral drug stockpiling by employers in preparation for an influenza pandemic (http://afludiary.blogspot.com/2008/06/prophylactic-antivirals-for-health-care.html) last week was intended elicit public comment prior to adoption of these guidelines.
Today we have one very long response from Dr. Graeme Laver of Australia, who believes that outbreak prophylaxis, and personal stockpiling of tamiflu are bad ideas.
Needless to say, the doctor and I differ on several points, although I applaud his call for making Tamiflu available without prescription.
This is just a snippet of a much longer article, follow the link to read the whole thing.
Prophylactic Use of Tamiflu Bad Idea, Leading Virologist Says (http://hstoday.us/content/view/3741/150/)
by Anthony L. Kimery
Tuesday, 10 June 2008
‘Early treatment is the only way to go’
The US government’s new proposal (http://aspe.hhs.gov/panflu/antiviral-n-masks.shtml) to use drugs like Tamiflu and Relenza as a prophylaxis to prevent infection by a pandemic strain of influenza is wrongheaded, says Dr. Graeme Laver, a former professor of biochemistry and molecular biology at the John Curtin School of Medical Research at the Australian National University in Canberra.
Laver, who played a key role (http://www.math.nyu.edu/faculty/greengar/coursepages/tamiflu_laver.pdf) in the development of both drugs, has been studying influenza viruses for nearly 40 years. He and Dr. Robert Webster (another world-renowned virologist at St. Jude Children’s Research Hospital) are credited with having first found the link between human flu and bird flu. In the 1960's, both received world acclaim when they developed a new and innovative generation of vaccines for flu viruses.
Laver told HSToday.us that “prophylaxis with Tamiflu in a pandemic is wrong. Early treatment is the only way to go.”
But the US government proposes to use Tamiflu and Relenza prophylactically to prevent infection, including giving guidelines to businesses that may want to buy the drugs in advance to treat or protect employees.
The Department of Health and Human Services’s (HSS) pandemic plan calls for “targeted antiviral prophylaxis … of disease clusters, administration of antiviral treatment to persons with confirmed or suspected cases of pandemic influenza, and provision of drug prophylaxis to all persons in [an] affected community.”
Similarly, should clusters of humans be found infected with a virulent strain of influenza like H5N1, the World Health Organization's plan of attack is to flood the regions with Tamiflu in the hope that it will quell further spread of the virus.
Dr. Ben Schwartz, a pandemic planner at HHS who wrote most of the new guidelines, told Reuters that "for prophylaxis of health care and emergency services workers, the responsibility for purchasing and stockpiling the drugs would primarily be on the health care organizations ... or on the emergency organizations that would be protecting their workforce.”
Meanwhile, HSToday.us has learned that there also are discussions within HHS about making Tamiflu and Relenza “push packets” available to people to have on hand in the event of a pandemic.
Laver also has problems with that notion.
“Personal stockpiles of Tamiflu or Relenza are not a good idea,” Laver told HSToday.us, explaining, “personal stockpiles are wrong for two reasons. First, nothing might happen and the stockpiles will be wasted and, second, if the stockpiles are used, it will be on the basis of self-diagnosis, and that is not a great idea.”
(Cont.) (http://hstoday.us/content/view/3741/150/)
Health care workers who will be in direct contact with infectious patients run a terrible risk of contracting the virus. Dr. Laver seems to have a good deal of faith that early treatment with Tamiflu can quickly end an infection.
Here is another quote from the article.
Laver also said “using a rapid flu test to assist this would be a good idea, so that people who think they have the flu can be properly diagnosed quickly and take the drugs very soon after symptom onset. This rapid procedure of ‘test and treat’ would mean that the infection should be immediately terminated and the flu victim experience a quick recovery. Seems quite simple, really!”
Perhaps, but we haven't seen very many `quick recoveries' thus far.
One could argue that up until now most bird flu patients haven't received the drug early enough - and that might well be true - but we don't have a lot of evidence that Tamiflu administered early will be a panacea for pandemic influenza.
Health Care workers, particularly those with families, are going to have a difficult choice deciding whether to work during a pandemic. Roughly half of those polled (http://afludiary.blogspot.com/2008/05/hcw-debate-update.html) have indicated they might not risk exposure.
Making prophylactic antivirals available, along with adequate PPE's (masks, gowns, gloves) would go a long way in convincing many HCW's to work.
We've no idea, of course, how effective outbreak prophylaxis will be. It has been a rare occurrence that cullers, taking prophylactic Tamiflu, have contracted the virus. That would seem to be a good sign.
As far as individual stockpiling of antivirals is concerned, Dr. Laver admits that the critical time period to begin treatment once symptoms appear is short.
To work, Tamiflu must be taken in proper doses within 6 to 12 hours after onset of symptoms.
"Forty-eight hours is about the limit the drug is effective," Laver said.
One would have to have a good deal of confidence that governments can get antivirals into the hands of those infected within 12 hours of the first symptoms appearing to reject the notion of personal stockpiling.
In a mild, or even moderate pandemic, that might be possible.
No one knows how our infrastructure will handle a severe pandemic. There are genuine concerns (http://www.pandemicflu.gov/plan/individual/index.html) about supply chain failures, social disruptions, and even temporary outages of essential services.
How efficiently antivirals can be distributed to individuals under those circumstances is an open question.
This debate over the use of antivirals during a pandemic is long overdue.
The concerns raised by Dr. Lever are not without merit, and his call to make Tamiflu an O-T-C med is laudable. But I strongly disagree with his stand against prophylactic antivirals for HCW's and first responders.
They will be on the front line, and deserve all the protection they can get.
Hopefully others will weigh in on this issue over the next few weeks. The public is encouraged to comment on the proposed guidelines for antivirals and for face masks and respirators.
Information on how to do so is presented here (http://afludiary.blogspot.com/2008/06/hhs-seeking-public-comment-on-pandemic.html).
posted by FLA_MEDIC @ 8:45 AM (http://afludiary.blogspot.com/2008/06/virologist-disagrees-with-hhs-proposed.html)
#If you have any other info about this subject , Please add it free.# |