HHS Offers Pandemic Guidance on Masks, Antivirals

[Shiloh]

Source: http://www.cidrap.umn.edu//cidrap/content/influenza/panflu/news/jun0308guidance-jw.html

HHS offers pandemic guidance on masks, antivirals

Robert Roos * News Editor

Jun 3, 2008 (CIDRAP News) ? Proposed pandemic preparedness guidance released by the federal government today recommends that people wear face masks if they have to go into crowds during an influenza pandemic and says critical infrastructure businesses should consider stockpiling antiviral drugs, among various other suggestions.

The guidance from the US Department of Health and Human Services (HHS) also spells out a role for preventive use of antiviral drugs in a pandemic but says that antivirals used preventively will have to come mainly from private stockpiles, because government stockpiles will be used mostly for treating the sick.

HHS released three draft guidance documents, covering the use of face masks and respirators by individuals and families, antiviral use during a pandemic, and considerations on antiviral drug stockpiling by employers. The agency is inviting public comments on all of them and says none as yet represents established policy.

Masks and respirators
The guidance on use of masks and respirators generally echoes advice issued by the Centers for Disease Control and Prevention in May 2007 but uses firmer language, changing "may" to "should" in several instances.

The document says the most important precautions for preventing flu are to limit close contact with others and use good hygiene. The specific recommendations on masks and respirators are as follows:

* Those who must go into crowded settings during a pandemic should wear a face mask to protect themselves from others' coughs and sneezes and to protect others from their own respiratory droplets. Even though most people out in public won't be sick, those who are infected can shed virus before they have symptoms, the guidance notes.
* Those who must have close contact with someone who has pandemic flu should wear an N-95 respirator certified by the National Institute of Occupational Safety and Health. N-95 respirators are devices that fit tightly to the face and are designed to stop 95 of small airborne particles.
* People sick with pandemic flu should wear a mask when they must be in contact with others.

The guidance suggests that it would be reasonable for each household to stockpile 20 respirators. In addition, people who have to commute on public transit might want to buy 100 face masks, plus some more for use in other crowded settings and at home. HHS estimates the cost of stockpiling the recommended number of respirators and masks at $35 to $70 per household.

The report notes that the Food and Drug Administration (FDA) has cleared many face masks, though none specifically for use by children. Also, the FDA recently cleared the first respirators intended for use by the public during a public health emergency such as a pandemic, it says. However, there are no respirators designed for children.

General guidance on antivirals
The proposed recommendations on use of antiviral drugs replace advice that was developed in 2005 as part of the HHS pandemic preparedness and response plan. The recommendations were prepared by an interagency group that included state, local, and tribal public health agencies as well as HHS.

Today's document comes a few weeks after the Institute of Medicine (IOM) said it was unclear whether the government's policy was to use antivirals only for treatment or for both treatment and prophylaxis. The IOM said the federal stockpile would have to be expanded if goals included providing preventive treatment for some people at risk in a pandemic.

The proposed guidance recommends prophylactic antivirals for several groups, but it says the supplies used for that purpose "will depend largely on private sector organizations and businesses purchasing and stockpiling antiviral drugs for their employees."

The document recommends that government antiviral supplies "be prioritized for treatment of all persons who may benefit from therapy," without attempting to put certain groups ahead of others. Further, it states, "Treatment is preferred to prophylaxis in settings of limited antiviral drug supply; targeting some antiviral drug supply for prophylaxis and prioritizing treatment for certain groups would raise significant ethical and logistical challenges."

The working group recommends that antivirals be used for:

* Containing initial pandemic outbreaks overseas and in the United States with treatment and post-exposure prophylaxis (PEP) for people exposed to the virus and those in areas where exposure may occur
* Reducing introduction of infection into the United States as part of control efforts at the borders
* Treating people with pandemic flu who seek care early in their illness and would benefit from treatment
* Prophylaxis for high-risk healthcare and emergency services workers
* Providing PEP for low-risk healthcare and emergency workers, immunocompromised people, and those living in group settings such as nursing homes and prisons

Further, the report says businesses that provide essential goods and services?critical infrastructure businesses?"should strongly consider antiviral prophylaxis for critical workers." Other employers may consider providing antivirals to protect their workers and maintain operations.

Employer stockpiling of antivirals
The guidance on antiviral stockpiling by employers underlines the recommendation that critical infrastructure employers should consider stockpiling, but it "does not establish the requirement or expectation that all employers stockpile antiviral drugs."

The document makes clear that employers generally won't be able to obtain antivirals from government stockpiles: "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."

The report says businesses may want to buy antivirals for the following purposes:

* To provide prophylaxis for frontline healthcare and emergency workers
* To protect workers who are needed to maintain essential community services
* To provide early treatment for workers who fall ill
* To protect overseas employees and operations in areas where federal pandemic response activities will not reach

See also:

HHS introduction page with links to guidance documents and comment options
http://aspe.hhs.gov/panflu/antiviral-n-masks.shtml

May 3, 2007, CIDRAP News story CDC offers advice on citizen use of masks, respirators""

Apr 25 CIDRAP News story IOM:US likely to need bigger antiviral stockpile" "

 

[tropical]

Re: HHS offers pandemic guidance on masks, antivirals

Re: HHS offers pandemic guidance on masks, antivirals

:applause:

 

[Shiloh]

Re: HHS offers pandemic guidance on masks, antivirals

Re: HHS offers pandemic guidance on masks, antivirals

Source: http://www.reuters.com/article/dome...04?feedType=RSS&feedName=domesticNews&sp=true

New bird flu plan suggests more drug stockpiles

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - New U.S. government pandemic guidelines propose stockpiling millions more doses of the antiviral drug Tamiflu to help protect people from infection, and recommend that each household store protective masks.

For the first time they propose using the drugs Tamiflu and Relenza to prevent infection, and give guidelines to businesses that may want to buy the drugs in advance to treat or protect employees.

They also spell out how many face masks -- up to 100 for some commuters -- Americans should have on hand.

The U.S. government now has 50 million courses of antiviral drugs, with 10 pills in each course in the case of Tamiflu. States can buy 31 million more courses under a federal contract that subsidizes the cost, for a total of 81 million courses.

The proposals being floated for public comment could bring this number up to 195 million courses, said Dr. Ben Schwartz, a pandemic planner at the Health and Human Services Department who wrote most of the new guidelines.

They include details on using drugs to prevent infections.

"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," Schwartz said in a telephone interview.

The federal government would buy drugs to prevent flu among federal health workers in the Indian Health Service and the Veterans Affairs Department, he said.

ENTRENCHED VIRUS

The biggest pandemic threat now is from H5N1 avian influenza, which is entrenched in chickens and ducks in much of Asia and has broken out in parts of Europe, the Middle East and Africa. Although rare in people, it has killed 241 out of 383 infected in 15 countries since 2003.

Tamiflu, made by Roche AG and Gilead Sciences and known generically as oseltamivir, and GlaxoSmithKline's and Biota's Relenza, known generically as zanamivir, can treat regular seasonal flu and bird flu and might also prevent infection.

Several companies are making vaccines against H5N1 but it is unclear if they would work against a mutated pandemic strain and if there would be enough. And some other strain of flu may cause a pandemic.

"For the first wave of a 1918-like pandemic, antiviral treatment could prevent about 144,000 deaths and about 1.85 million hospitalizations," read the proposals, available on the Internet here

A separate proposal suggests purchases of face masks and specialized masks known as respirators.

"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, so a stockpile of 20 respirators per household would be reasonable," reads the proposal, available here

"Pandemic outbreaks in communities may last 6 to 12 weeks," it added. "Persons who cannot avoid commuting on public transit may choose to purchase 100 facemasks for use when going to and from work."

A third proposal published here. advises employers who may want to buy drugs to protect workers. Roche said more than 300 companies have bought Tamiflu as part of their pandemic plans and hundreds more had contacted the company.

(Editing by Patricia Zengerle)

 

[Shiloh]

Re: HHS offers pandemic guidance on masks, antivirals

Re: HHS offers pandemic guidance on masks, antivirals

Source: http://www.pharmalive.com/News/index.cfm?articleid=546448&categoryid=10

PRODUCT MARKETING NEWS

Trust for America's Health on New HHS Influenza Pandemic Draft Guidance

WASHINGTON, June 04, 2008 /PRNewswire-USNewswire/ -- Trust for America's Health (TFAH) issued the following statement on the release of The U.S. Department of Health and Human Services(HHS) Draft Guidances to Assist in Preparation for an Influenza Pandemic (http://aspe.hhs.gov/panflu/antiviral-n-masks.shtml) today, emphasizing that the federal government must do all it can to ensure it protects every American from a potential pandemic flu outbreak, especially those who are employed by smaller businesses that may not have the ability or resources to fully prepare.

"Asking employers and families to take tangible steps to prepare in advance for a pandemic influenza outbreak is a step in the right direction. However, the federal government must assure that all Americans have access to the protections HHS recommends," said Jeff Levi, Director of the Trust for America's Health. "An employee of a small to mid-size company should not be penalized because the enterprise can not afford the costs of acquiring, storing and dispensing antiviral medications during a flu pandemic.

"Nor is it reasonable for every American family to stockpile the recommended 20 respirator masks per household or the up to 100 facemasks per family at a cost of $35.00 - $70.00. Even for the families that can afford to stockpile masks, children would likely be left unprotected. There is still no Federal Drug Administration-approved respirator mask for kids, despite the warning by the Centers for Disease Control and Prevention that children can be more susceptible than adults to infection, and compared to adults, children usually shed more influenza virus for a longer period of time.

"In the event of a pandemic outbreak, leaving the massive costs and logistical responsibilities to businesses and individuals, without the assurance of equal access to key prevention strategies, like antivirals and respirator masks, is not an option. The government must assure all Americans are protected, regardless of where they live or work."

www.healthyamericans.org

CONTACT: Liz Richardson of Trust for America's Health, +1-202-223-9870, lrichardson@tfah.org

Web site: http://www.healthyamericans.org/

Terms and conditions of use apply
Copyright ? 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company

 

[sharon sanders]

HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Notice of Availability of Draft Guidances to Assist in Preparation for an Influenza Pandemic


SUMMARY:

Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be easily passed between humans. Because humans have little immunity to the new virus, many people may become ill and a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the United States (US) each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1000 of those infected. It is projected that based on this historical experience and given the current US population, a pandemic today, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the US alone.
The US Government (USG) has developed a comprehensive strategy to prepare for and respond to an influenza pandemic, including developing and acquiring vaccine and antivirals to prevent and treat illness, planning for use of measures to reduce the spread of the disease by asking ill persons to stay home, voluntary quarantine of household members who live with an ill person, closure of child care facilities and dismissal of students from schools, decreasing the frequency and duration of close contact among people to slow transmission of infection (social distancing), recommending hygiene measures, and advising the use of personal protective equipment in certain situations. HHS has developed a number of guidances to assist government agencies, businesses, community organizations, and the public in their preparedness efforts, utilizing these strategies. The three guidance documents available for public comment are part of this series and should be reviewed as part of an overall approach to pandemic preparedness.
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) (PDF version - 2 pages)
  
• Read the Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness (html)
  (PDF version - 5 pages)
  
  Submit Comments on the Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness
  
• Read the Proposed Guidance on Antiviral Drug Use During an Influenza Pandemic (html)
  (PDF version - 26 pages)
  
  Submit Comments on the Proposed Guidance on Antiviral Drug Use During an Influenza Pandemic
  
• Read the Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic (html)
  (PDF version - 20 pages)
  
  Submit Comments on the Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic

<small>Documents in PDF format require the Adobe Acrobat Reader?. If you experience
problems with PDF documents, please download the latest version of the Reader?.</small>​

Note: Please see the Federal Register Notice for instructions and the deadline for submitting comments. Electronic comments submitted via email are preferred. Email attachments are permitted.

 

[sharon sanders]

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Prophylactic Antivirals For Health Care Workers



# 2054

http://afludiary.blogspot.com/


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 on Wednesday.


The two new guidance documents are called:

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

Both of these documents were released last week, and the HHS is seeking public comment 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.

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

 

[sharon sanders]

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

"...The working group encourages governments, healthcare organizations and other employers, and families and individuals as appropriate, to purchase and stockpile sufficient antiviral drug supply to support recommended antiviral drug use strategies and to plan for effective implementation at the time of a pandemic as part of comprehensive pandemic planning and preparedness..."

http://aspe.hhs.gov/panflu/antiviraluse.html


This is significant because this is the first time the U.S. government has recommended that families and individuals purchase and stockpile anti-virals.

AND

They are recommending a 12 week supply for those in high-risk groups - namely health care workers.

"...A regimen is defined as 10 drug doses: treatment, provided twice daily for 5 days, and post-exposure prophylaxis, provided once daily for 10 days both require a single regimen. By contrast, prophylaxis for the duration of a community outbreak may require up to 8 regimens for a 12-week outbreak...."


hat tip to Fla Medic for delineating the quotes for me.

 

[gsgs]

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

we were waiting for this since 2005.
Now they not only allow it but even recommend it.
But will doctors write prescriptions ?

The same logic should apply to prepandemic vaccine,
antibiotics for pneumonia and others.
Waiting for other countries to follow.

 

[Shiloh]

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Re: HHS - Draft Guidances to Assist in Preparation for an Influenza Pandemic

Source: http://www.ama-assn.org/amednews/2008/06/16/hlsc0616.htm

HEALTH & SCIENCE
Pandemic debate now steered to allotting antivirals
Preplanning is key to using these drugs effectively to reduce the illness' spread.

By Victoria Stagg Elliott, AMNews staff. June 16, 2008.

During an influenza pandemic, antiviral drugs will be in short supply, and a national discussion is needed to determine how these medications will be doled out to the population, particularly for prophylaxis care, says a recent Institute of Medicine report.

"We know [antivirals] have a role in treatment, but what does society feel about who should get the drugs for prevention?" asked Andrew T. Pavia, MD, a member of the committee convened by the IOM to create the document, released April 25. "Should it be the elderly? Should it be the children? Should it be the people who we depend on for our safety?"

Much of the debate over how a vaccine for a pandemic influenza virus strain would be used already has occurred. But, members of the IOM's Prophylactic Use of Antiviral Medications During an Influenza Pandemic committee say a similar conversation regarding antivirals is crucial. In the early days of the predicted pandemic, for instance, these medications may be the only tools available to help control the illness' spread. The pandemic vaccine may take months to start rolling out. During that time, health care workers and emergency personnel should be given first priority for these drugs, but who else should get them?

"Given that scarcity is almost a certainty, and this is not a society that knows much about scarcity, we need a lot of public buy-in," said June E. Osborn, MD, committee chair.

Many questions can't be nailed down beforehand. For example, it's unknown which influenza strain would be the pandemic trigger. Other questions include how effective the antivirals will be and how the virus will hit the elderly or the young. What mix of treatment and prophylaxis will protect the greatest number of people? How rapidly will the virus develop resistance? What are the best strategies to avoid that?

"It's very difficult to come down with hard and fast recommendations, because there's so much uncertainty as to how it's going to play out," said Patricia Quinlisk, MD, MPH, a panel member and state epidemiologist with the Iowa Dept. of Public Health.

But committee members hope that state and federal public health officials will use this report as a jumping-off point to tackle the questions that can be answered in advance. These include defining the goals of pandemic antiviral use that balance both ethical concerns and fiscal realities.

"What are the goals of an antiviral program going to be? Provide prophylaxis to the vast majority of the population? If so, how are you going to [do] that? Where are the resources going to come from?" said Dr. Pavia, who is also professor of pediatrics and chief of pediatric infectious disease at the University of Utah School of Medicine in Salt Lake City. "The resources that are being put into public health in general and pandemic preparedness are pretty limited."

Also, the role of stockpiles accumulated by the private sector needs to be determined. The committee is calling for memorandums of understanding and various other agreements between private and public entities to determine how best to use this resource. The federal government's Shelf Life Extension Program, which tests the efficacy of those drugs that are past their expiration dates but might be needed in a pandemic, should be expanded to cover antivirals held by the private sector.

Experts responded that this report was a good first step to help physicians deal with the ethical and logistical issues that may come with antiviral distribution in a pandemic.

"The idea of creating some sort of national ethical framework is really good," said Charles W. Mackett III, MD, executive vice chair of the Dept. of Family Medicine at the University of Pittsburgh Medical Center. He is also chair of his institution's pandemic influenza task force, which has held discussions with local community members about the allocation of its antiviral stockpile.

Health and Human Services issued its pandemic flu plan in November 2005, which included limited guidance on antiviral use. A plan specific to antivirals is under development. The American Medical Association is a consulting organization.

* Discuss on SermoDiscuss on Sermo
* Links
* See related content

 

[Sally Furniss]

Re: HHS Offers Pandemic Guidance on Masks, Antivirals

Comments from the Center for Biosecurity of UPMC on Draft Guidances for Pandemic Influenza Planning

Biosecurity and Bioterrorism. Volume 6, Number 3, 2008 © Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2008.0729

On May 23, 2008, the U.S. Department of Health and Human Services (HHS) proposed and requested public comment on 3 draft guidances for pandemic influenza planning (73 FR 31690-91):


(1) Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness;

(2) Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and

(3) Proposed Considerations for Antiviral Drug Stockpiling by Employers in Preparation for an Influenza Pandemic.

The documents are part of a series of HHS guidances to assist government agencies, businesses, community organizations, and the public in preparing for a pandemic. The Center for Biosecurity of UPMC reviewed the proposed draft guidances and submitted to HHS the following analyses of the antiviral use and employer stockpiling guidances as its official comments.


<hr style="width: 100%; height: 1px; color: rgb(152, 152, 152); background-color: rgb(152, 152, 152);">Comments on “Proposed Guidance on Antiviral Drug Use During an Influenza Pandemic”

Overview

The Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) agrees with the basic medical and scientific premise of the Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic: that antiviral drugs could mitigate the effects of an influenza pandemic if the circulating pandemic strain is susceptible to the medicine and if access to the drugs is timely and uniform.¹



We also support the proposed overall tiered strategy for use of these medicines (ie, the top priority for use of public stockpiles is for containment and suppression of initial outbreaks and for treatment, with prophylaxis only if the stockpile is sufficiently large).


However, while we applaud the U.S. Department of Health and Human Services’ (HHS) effort to address difficult antiviral use issues, it is our view that:


(1) it is unrealistic to expect the private sector to purchase sufficient supplies of antivirals for prophylaxis;


(2) serious consequences may arise if the private sector does not stockpile recommended quantities of antivirals;

(3) much of the perceived benefit outlined in the guidance is based on an optimistic set of assumptions that have large margins of error, including susceptibility of the influenza strain to the stockpiled antivirals;

(4) planning should better address issues associated with providing antivirals to workers and populations in “closed settings,” such as prisons, jails, and longterm care facilities.

Specific Issues



1. It is unrealistic to expect the private sector to create sufficient stockpiles of antiviral prophylaxis, and there is no reason to expect that the private sector will unilaterally accept this burden, especially with unsubsidized antiviral pricing. It is especially worrisome that segments of critical infrastructure are covered under voluntary participation by the private sector.

The proposed guidance notes that the “total number of antiviral drug regimens needed to fully implement the working group recommendations substantially exceeds current public sector stockpiling targets . . . [and that] . . . mplementing prophylactic antiviral drug strategies . . . will require the establishment of stockpiles in the private sector.”¹However, it is unrealistic to expect the private sector to create sufficient stockpiles of antiviral prophylaxis for healthcare and emergency service workers and for outbreak control for individuals in closed settings and people who are severely immunocompromised, who will need, respectively, an estimated 103 million, 5 million, and 2 million regimens. There is also no reason to expect that the private sector will unilaterally accept this burden and at prices that are not subsidized.


In addition, reliance on the private sector to purchase the antivirals necessary to implement the proposed policies is untenable given the number of “barriers to establishing such stockpiles” that were identified in the guidance. Barriers include the cost of antivirals, shelf-life maintenance, regulatory and logistical challenges, potential liability, and concerns that private sector stockpiles could be appropriated by the government in an emergency. These barriers preclude the full implementation of the proposed policies and are especially worrisome because segments of critical infrastructure would need to rely on voluntary participation by the private sector.


The document also states that “the public and private sectors should coordinate use of antiviral stockpiles so that available drug supplies most efficiently contribute to achieving national pandemic response goals.”¹ We concur with the principle that pandemic influenza preparedness is a “shared responsibility.” However, we would encourage language that assigns the federal government the responsibility of convening meetings with the private sector to establish a mechanism for facilitating such collaboration.




2. If the private sector fails to stockpile sufficient quantities of antivirals, serious consequences, including high rates of absenteeism among healthcare workers, might ensue.

We disagree that the creation and maintenance of antiviral stockpiles for such a critical public health event should be a shared responsibility, as this approach may lead to serious gaps in the availability of antivirals and other unintended consequences. For example, if healthcare workers are not offered antiviral prophylaxis by their employers in a pandemic, it is expected that many of those employees will not show up for work, which will add significant strain to what would already be an overburdened healthcare system. Although the proposed guidance notes that public sector stockpiles can be used for prophylaxis if supplies are sufficient, the conditions under which a determination would be made to shift policy are unclear given that public sector stockpiling targets are insufficient to meet prophylaxis requirements.


Serious consideration should be given to how public sector stockpiles will be used in the event that private sector stockpiles do not materialize or are insufficient to meet demand for prophylaxis. In addition, how will these recommendations change if public sector stockpiling targets are not reached? As of November 2007, only 18 states had purchased their full allocation of antivirals at federally subsidized prices to meet public sector stockpiling targets, while 25 states had made partial purchases and 7 states had not made any purchases.²

The federal government should instead request and encourage the private sector to develop and support other important policies that would assist in pandemic mitigation. For example, the private sector could advocate and make it possible for the workforce to comply with the principles of social distancing, provide workforce education, and assist with the distribution of medical countermeasures.




3. Much of the perceived benefit of the proposed guidance centers around an optimistic set of assumptions that have large margins of error, including the influenza strain’s susceptibility to the stockpiled antivirals and community mitigation strategies significantly lowering the attack rate.

The proposed guidance assumes that using antiviral drugs to treat and prevent infection will be an important component of a pandemic influenza response. However, this will be the case only if the circulating strain is susceptible to the stockpiled antivirals. This fact should be acknowledged in the guidance, because it changes the cost-benefit ratio of antiviral stockpiling. In addition, while it is assumed in the guidance that community mitigation strategies will lower the attack rate by 50%, the government should also delineate the circumstances under which the proposed guidance for antiviral use would not make sense.


The document further mentions the intention to use antiviral medications from the Strategic National Stockpile (SNS) at U.S. borders to “reduce the risk of infected persons entering the United States early in an influenza pandemic as part of a risk-based border.”¹ The proposed guidance should explain how this strategy will be implemented, outline the quantity of antiviral regimens that have been allocated for this use, and provide an estimate of reduced risk based on this approach.




4. Planning should address in greater detail the issues associated with providing antiviral medications to staff and populations in “closed settings,” such as prisons, jails, and long-term care facilities.

The recommendation for postexposure prophylaxis (PEP) of people living in “closed settings,” such as prisons and jails, is included among the proposed recommendations for the use of antiviral drugs in private sector stockpiles. However, because these populations are under the jurisdiction of federal, state, or local correctional authorities, providing antiviral medications to these populations may actually be the responsibility of public sector stockpiles. As of June 30, 2007, approximately 2.3 million inmates were in custody in the U.S. Of these, 196,804 were located in federal prisons, 1,321,731 in state prisons, and 780,581 in local jails.³ Of the federal prisoners, 166,425 were held in federal facilities, 22,354 in privately operated facilities, and 8,025 in community correction centers. The issue of who has the responsibility to provide antiviral medications to these individuals and whether the drugs should be allocated from public or private stockpiles should be clarified, and recommendations should then be adjusted accordingly.


The estimated number of people held in prisons or jails in the U.S. also does not include juveniles housed in residential placement. In 2003, which is the latest year for which we could find data, 96,665 juveniles were held in residential placement in the U.S., including 37,335 in state facilities, 28,875 in local facilities, 30,321 in private facilities, and 124 in tribal facilities.⁴ This population should be included to better estimate the number of antiviral regimens needed for stockpiling.


In addition, the assumption that there will be “one exposure per person . . . for outbreaks in closed and high-risk settings”¹ seems overly optimistic. It is likely that in “closed settings,” particularly prisons and jails because of “crowding and a limited ability to apply other measures to reduce transmission,”¹ more than one exposure per person will occur during a pandemic. Accordingly, the estimated need of one antiviral regimen per person is an underestimate. Given that it is impossible to estimate how many exposures per person will likely occur during a pandemic in closed and high-risk settings, consideration should be given to recommending pre-exposure prophylaxis to these populations instead of postexposure prophylaxis.


Furthermore, the estimated 500,000 correctional officers and 800,000 healthcare providers in long-term care facilities^5,6 should also be considered for inclusion in the group of individuals for whom pre-exposure prophylaxis is recommended. It is important to reduce potential absenteeism among these workers, who are at an increased risk for exposure, due to fear of being infected while at work.
Michael Mair and Ann Norwood
Submitted July 2, 2008

References

1. U.S. Department of Health and Human Services (HHS). Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic. 2008. http://aspe.hhs.gov/panflu/antiviraluse.pdf. Accessed June 16, 2008.
2. Trust for America’s Health. Ready or Not 2007. December 18, 2007. http://healthyamericans.org/reports/bioterror07/BioTerrorReport2007.pdf. Accessed June 16, 2008.
3. Sabol WJ, Couture H. Prison Inmates at Midyear 2007 (NCJ 221944). Washington, DC: U.S. Department of Justice; June 2008. http://www.ojp.usdoj.gov/bjs/pub/pdf/pim07.pdf. Accessed June 11, 2008.
4. OJJDP Statistical Briefing Book. March 27, 2006. http://ojjdp.ncjrs.gov/ojstatbb/corrections/qa08201.asp?qa-Date=2003. Accessed June 11, 2008.
5. Correctional Officers. Washington, DC: U.S. Department of Labor, Bureau of Labor Statistics; December 18, 2007. http://www.bls.gov/oco/ocos156.htm. Accessed June 11, 2008.
6. Federal Interagency Working Group. Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. October 17, 2007. http://www.pandemicflu.gov/vaccine/prioritization.pdf. Accessed June 11, 2008.

Comments on “Proposed Considerations for Antiviral Drug Stockpiling by Employers in Preparation for an Influenza Pandemic”

Overview

The Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) applauds the effort by the U.S. Department of Health and Human Services (HHS) to clarify federal roles and expectations regarding the stockpiling of antivirals during an influenza pandemic. We fully support public-private collaboration to address public health threats and agree that “our best chances of protecting health and maintaining community functioning during a pandemic rely on a coordinated response between public sector and private sector partners.”¹

We also recognize the importance of stockpiling medical countermeasures to prepare for public health emergencies, and we believe that the draft guidance is an appropriate first step in highlighting the many operational, legal, and ethical questions pertaining to the creation of private sector stockpiles.

However, it is our view that employer stockpiling, which will impose significant costs and implementation burdens on employers that choose to purchase the medicines, is not a viable strategy to ensure that the U.S. has the necessary supplies of antivirals for prophylaxis during a pandemic. In addition, the proposed considerations to encourage employer antiviral stockpiling do not offer sufficient guidance or incentives for employers to purchase the medicines and may actually discourage them from stockpiling. It is unrealistic to expect the private sector to create sufficient antiviral stockpiles or to unilaterally accept this burden, and it is especially troubling that segments of critical infrastructure are covered under the private sector’s voluntary participation. If the private sector does not stockpile sufficient supplies of antivirals, serious consequences, including higher than necessary absenteeism rates among healthcare providers during a pandemic, will likely result.

If this strategy is advanced, it is our view that several issues must first be addressed to ensure that employer antiviral stockpiling and dispensing activities are fairly, safely, and legally executed and that antiviral stockpiling is a feasible and appealing pandemic influenza planning strategy for employers. Individual employers should not be encouraged to stockpile antivirals until they are: (1) given the option to participate in a program to extend the shelf-life of the medicine; (2) assured that their stockpiles will not be taken or seized by the government to supplement deficiencies in public antiviral caches in the event of a pandemic, unless such an approach is mutually agreed upon; (3) provided with a detailed assessment of the legal and regulatory issues that they could face with stockpiling and dispensing antiviral drugs; and (4) provided with guidance for how, when, and to whom to distribute antivirals that is consistent with the best available medical and public health recommendations.

Specific Issues

1. Employers will likely be discouraged from stockpiling antivirals due to the limited shelf-life of the medicines and lack of available options for rotation or extending the shelf-life, such as through the federal Shelf-Life Extension Program (SLEP).

The proposed considerations do not take into account that the recommended antivirals for employer stockpiles—oseltamivir (Tamiflu^®) and zanamivir (Relenza^®)—have a shelf-life of 5 years from the date of manufacture. In addition, pharmacy dispensing laws in states often significantly shorten that time frame by giving an expiration date of 6 months to 1 year after dispensing the medicine to a patient.¹ The expiration date of oseltamivir capsules was reportedly extended recently from 5 to 7 years, but it appears that the 7-year dating does not apply to commercial product (eg, sold via commercial wholesalers or dispensed by pharmacists to individuals).²
Rotation does not appear to be an option for employer antiviral stockpiles, as the practice is not permitted for antivirals in the Strategic National Stockpile (SNS) and state stockpiles.² While Roche, the maker of oseltamivir, recently announced the introduction of a program to facilitate employer stockpiling by reserving, storing, and rotating the medicine, the plan does not appear to provide a rotation option for those employers that purchase the antivirals outright from the company.³ A similar plan does not currently appear to be available for zanamivir. Federal antiviral stockpiles are permitted to participate in the Shelf-Life Extension Program (SLEP), a program administered jointly by the U.S. Food and Drug Administration (FDA) and the Department of Defense (DoD) that extends the shelf-life of the medicines. However, employer, local, and state antiviral stockpiles are not permitted to participate in the program and do not have access to other options to extend the shelflife of their stockpile investment.
Allowing employer stockpiles to participate in SLEP or a similar program would likely provide businesses with a greater financial incentive to invest in antivirals. SLEP participation results in significant cost savings for the federal government. For example, one government report stated that “for every dollar spent on the SLEP testing of items the taxpayer has avoided the expenditure of 94 dollars for new, replacement materiel.”⁴ Given that employers will probably be paying more for antiviral regimens than the government does and that large amounts of stockpiled antivirals will have to be discarded if a pandemic does not occur during the shelf-life period, it is even more critical that the investments in employer stockpiles are maximized.

Expanding SLEP to nonfederal antiviral stockpiles has previously been considered at the national level. For example, the issue was considered in the 2006 National Strategy for Pandemic Influenza Implementation Plan⁵ but was determined, without a rationale provided, not to be feasible at the time.⁶ In April 2008, the Institute of Medicine’s (IOM) Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic recommended that SLEP be expanded to include other public and private sector entities that are stockpiling antivirals for use in an influenza pandemic.² The Committee also suggested that HHS develop a process to use the knowledge acquired by the FDA in the operation of SLEP to facilitate the use of properly stored, recently expired medications that exist in supplies outside of SLEP in the event these medications are needed in a shortage.²

The proposed considerations acknowledge that the shelflife issue is a barrier to employer stockpiling and that “everal Federal initiatives have been launched in an effort to reduce these barriers.”¹ However, information about these initiatives, including what the possible solutions might be and when employers can expect to be informed about them, is not included in the guidance and should be provided to employers.

We fully support and encourage continued efforts at HHS to share information about SLEP and to find solutions for employer stockpiles, as well as state and local antiviral stockpiles, to participate in SLEP or a similar program. Encouraging employers to consider purchasing antivirals without providing them with the same or a similar option that federal antiviral stockpiles have to extend the shelf-life of their investment is a critical barrier to employer stockpiling.




2. Without assurances that government will not take possession of privately held antivirals in response to a pandemic, little incentive exists for employers to invest the necessary effort and funds to purchase and stockpile antivirals or to share stockpile plans and information with state and local officials.

We agree with HHS that employers should communicate and coordinate their pandemic plans with relevant state and local health officials to better protect lives and preserve community function, and we applaud HHS for acknowledging in the proposed considerations the difficult issue of governments taking, or seizing, employer stockpiles to effectively respond to a pandemic. We also recognize that state leaders and health officials have significant powers, especially during times of emergency, and that these powers, when used appropriately, can have a significant and positive impact on the public’s health.

However, the considerations note that while the “Federal government . . . discourages the potential appropriation of privately held stockpiles of antiviral medications by governmental authorities . . . [it] acknowledges the responsibility of a State to coordinate all assets within its jurisdiction and within its legal authorities to effectively respond to emergencies such as a pandemic.”¹ This approach will likely discourage many employers from electing to make the significant investments in stockpiling antivirals in the first place, because they are not given sufficient reassurance or incentive to invest in medicines that could later be taken by the government to compensate for shortages in government stockpiles. The proposed considerations also do not provide information about possible penalties or sanctions for noncompliance by employers or about what compensation would be provided for the cost of antivirals and the time and effort spent on stockpiling if the government takes their medicines for public use.
For those employers that choose to assume the risk that their medicine could be taken and that purchase antivirals, what incentive is there for them to share and coordinate antiviral and pandemic influenza plans with state and local government officials? To encourage public-private information sharing and collaboration around pandemic planning and response, HHS should consider assuring employers that their stockpiles will not be taken for public use. If that is not a feasible option, then HHS, at a minimum, should consider developing, in close collaboration with employers, mechanisms (eg, legal agreements or protocols) that would better inform employers about possible takings by outlining the specific scenarios under which a taking might occur, the likelihood of a taking, the process by which the antivirals could be taken, and possible compensation plans if stockpiles are taken by government.




3. A more detailed assessment of the specific legal and regulatory issues that may be associated with employer antiviral purchasing, storage, and dispensing is required to enable employers to make better informed decisions about stockpiling the drugs and to ensure that all employers are acting on the same information.

The proposed considerations briefly mention that various legal and regulatory issues may arise with employer antiviral stockpiling and that employer purchasing and stockpiling of antivirals “must comply with applicable Federal and State laws and regulations.”¹ However, because of the complexity of such legal and regulatory issues, the federal government should provide employers with significantly more detailed information about the specific laws and regulations with which employers who choose to stockpile should be concerned. For example, stating that “Federal laws may also be implicated” is not sufficient.¹ Instead, HHS should consider assessing in detail which federal laws may be implicated and the likelihood of such laws being enforced during an influenza pandemic. The guidance should also address how compliance with and enforcement of the laws and regulations may change if a public health emergency is declared.
To further encourage and support employer stockpiling, HHS should also provide employers with more detailed guidance on the complex “ethical, logistical, and economic issues that will be encountered in ordering, storing, securing, and dispensing prescription medications” than outlined in the proposed considerations.¹ For example, what are some of the specific storage and logistical challenges that employers might confront in stockpiling?




4. Before issuing directive guidance, HHS needs to provide the private sector with a concept of operations plan for the use of antivirals during a pandemic that takes into account both the potential side effects of wide-scale antiviral use and the likely shortage of medical care and consultation during a pandemic.

We agree with HHS’s statement that “f antivirals are taken with less or no medical supervision, they also may be used incorrectly reducing their effectiveness and potentially contributing to the emergence of drug resistant viruses.”¹ However, we feel that this concern is not limited to prepandemic dispensing of antivirals, as indicated in the HHS guidance. Such concern may be an issue for private sector distribution of antivirals during a pandemic when access to medical professionals may be limited. It is unclear how the private sector, absent a sufficient occupational health staff to oversee antiviral dispensing, will know when to distribute antivirals and to whom without intensive consultation with medical professionals. Specifically, we are concerned that without more specific guidance for the use of private sector antiviral stockpiles:

• Difficulties in diagnosing pandemic influenza will lead to wide use of antivirals. During a pandemic, it will be difficult to rapidly differentiate between actual cases of influenza and people who are sick with other diseases, so antivirals will be distributed widely. Practically, unless effective rapid diagnostic tests for pandemic influenza are available, antivirals will be given out to many people who prove not to have pandemic influenza.
• Influenza viruses may develop a resistance to antiviral medications. Experience shows that it is possible that resistance may develop more frequently during times of widescale use, which could limit the effectiveness of the medicine for treatment.

Therefore, HHS should consider issuing more detailed guidance to ensure that overuse of antiviral medications, which both increases the potential for resistant strains to emerge and places undue burden on the healthcare sector, is minimized and that limited antiviral stockpiles are sufficiently effective for treatment.



Brooke Courtney and Jennifer B. Nuzzo
Submitted July 2, 2008
References

1. U.S. Department of Health and Human Services. Proposed Considerations for Antiviral Drug Stockpiling by Employers in Preparation for an Influenza Pandemic. Washington, DC: HHS; 2008. http://aspe.hhs.gov/panflu/stockpiling.html.
2. Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic, Institute of Medicine (IOM). Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. Washington, DC: National Academies Press; 2008.
3. Roche introduces program to facilitate corporate pandemic stockpiling of Tamiflu® [news release]. Roche U.S.A. June 26, 2008. http://www.rocheusa.com/newsroom/current/2008/pr2008062601.html. Accessed June 27, 2008.
4. Extending the Shelf Life of Critical “War Reserves” Medical Materiel Using the FDA/DOD Shelf Life Extension Program. March 2005. https://slep.dmsbfda.army.mil/slep/slep_info_paper_mar2005.doc. Accessed July 29, 2008.
5. Homeland Security Council. National Strategy for Pandemic Influenza Implementation Plan. May 2006. http://www.whitehouse.gov/homeland/nspi_implementation.pdf.
6. National Strategy for Pandemic Influenza Implementation Plan: Summary of Progress. December 2006. http://www.pandemicflu.gov/plan/federal/stratergyimplementationplan.html.

http://www.upmc-biosecurity.org/web...8-09-15-comments_drft_guide_pan_flu_plan.html

 

[mixin]

Re: HHS Offers Pandemic Guidance on Masks, Antivirals

4. Planning should address in greater detail the issues associated with providing antiviral medications to staff and populations in ?closed settings,? such as prisons, jails, and long-term care facilities.

Given that it is impossible to estimate how many exposures per person will likely occur during a pandemic in closed and high-risk settings, consideration should be given to recommending pre-exposure prophylaxis to these populations instead of postexposure prophylaxis.

If the tier scheme is the same for antivirals as it is for vax, then the majority of the prison population will be not be elligible.

I speculate they will be sequestered; no one in and no one out. Only guards and staff will receive prophylactic antivirals if there is enough stockpiled. If not, schedule supplies once a month and give postexposure prophylaxis.