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Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic -HHS

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  • Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic -HHS

    (1.1) Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic
    (1.2) Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic
    (1.3) Interim guidance on the use and purchase of facemasks and respirators by individuals and families for pandemic influenza preparedness
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    (1.1) [PANDEMIC PREPAREDNESS, ANTIVIRALS, USA] Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic

    Summary
    Optimal planning and preparation for an influenza pandemic requires coordinated efforts by every part of society including individuals and families, communities, employers in public and private sectors, and all levels of government.

    Federal, State, and local governments will implement strategies to protect the public in an influenza pandemic.

    Employers also will play a key role in protecting employees' health and safety, thereby limiting pandemic impacts on health, the economy, and society.

    As part of their comprehensive pandemic planning, some employers (from public and private sectors) have asked for guidance about whether they should stockpile or otherwise arrange for influenza antiviral drugs to be available for their employees during a pandemic.

    Private stockpiles, in coordination with public health stockpiles, would extend protection more broadly than could be achieved through the public sector alone and improve the ability to achieve the national pandemic response goals of mitigating disease, suffering, and death, and minimizing impacts on the economy and functioning of society.[1]

    The Federal Government strongly encourages employers of all sizes to plan for a pandemic, to protect the health of employees and assure continuity of operations.[2]

    Influenza antiviral drugs (antivirals) are one of several approaches to protecting people during a pandemic and can serve as an important part of a layered approach to pandemic mitigation.

    In some cases, employees whose jobs would normally involve very high or high exposure risk to known/suspected pandemic patients may reduce or eliminate exposure through engineering, administrative and work practice strategies.

    Non-pharmaceutical measures should also be used as a critical component of an employer?s plan to protect employees during a pandemic.

    Employers that provide frontline healthcare and emergency services must plan to protect their employees who will be exposed to ill persons during a pandemic.

    This guidance recommends providing antiviral prophylaxis to these very high risk and high risk employees[3] for the duration of community pandemic outbreaks to prevent illness.

    Businesses that provide goods or services essential to community health, safety, or well-being have an obligation to plan and prepare for continued operations in the event of a pandemic.

    These critical infrastructure[4] employers should strongly consider providing antiviral prophylaxis for the small number of employees who are critical to essential operations as part of comprehensive pandemic preparedness planning.

    In addition, other employers may consider antiviral prophylaxis for workers in order to maintain business continuity.

    If an employer is considering stockpiling antiviral drugs, it should do so with a clear understanding of the legal, regulatory, ethical, logistical, and economic issues that will be encountered in ordering, storing, securing and dispensing prescription medications.

    Employers should work with their company or contracted occupational health providers/services to plan for stockpiling antivirals.

    This guidance does not establish the requirement or expectation that all employers stockpile antiviral drugs.

    Any employer that chooses to stockpile antivirals should do so as part of comprehensive pandemic preparedness and response activities in coordination with State and local pandemic preparedness plans and in conjunction with other measures to protect workers and maintain continuity of operations.

    Antiviral drug stockpiles have been established at the Federal level and many States have also established stockpiles.

    Current recommendations focus on using up to 6 million courses of the Federally stockpiled antiviral drugs as part of a comprehensive public health response to contain the initial pandemic outbreak, wherever in the world it occurs, to reduce transmission when cases first appear in the United States, and to use the majority of stockpiled antiviral drugs to treat persons who have pandemic illness and may benefit from therapy.

    Newly developed proposed Federal guidance[5] recommends expanding antiviral drug use to include prophylaxis (i.e., antiviral use to prevent infection in persons either before or after they are exposed to pandemic influenza) in healthcare and emergency services occupations, for people whose immunity is compromised by an underlying medical condition or treatment, and for people living in group settings (e.g., nursing homes) if an outbreak of pandemic disease occurs at the facility.

    Household contacts of ill persons also may benefit from prophylaxis.[6]

    However, further work is needed to assess the feasibility of this strategy and identify approaches to purchase and stockpiling the antiviral drugs to support its implementation.

    The proposed Federal guidance on antiviral use also suggests a potential benefit of prophylaxis for workers who are critical to providing essential community services but leaves decisions on how to best protect key functions and critical workforces to employers.

    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.

    Employers may choose to purchase antiviral drugs for stockpiling for several reasons:

    (1) to provide prophylaxis for front-line healthcare and emergency services workers (fire, law enforcement, and emergency medical services [EMS]) whose occupations put them at greater risk of exposure and infection;

    (2) to provide prophylaxis for workers who are critical to essential operations in critical infrastructure businesses to sustain provision of essential community services;

    (3) to assure early treatment to employees who become ill7; and

    (4) to protect overseas employees and operations where U.S. government pandemic response activities will not reach.

    In addition to defining an employer?s antiviral drug strategy and which workers may be targeted, employers may also consider protecting workers who must travel during the pandemic and non-employees such as contractors or volunteers.

    Decisions on stockpiling should be made in the context of pandemic planning and preparedness, broadly, in which a range of protective measures are used to minimize employee infections during a pandemic, particularly for those employees at high risk for exposure to or severe diseases from complications of pandemic influenza.[7]

    Nonpharmaceutical interventions such as isolation of ill persons, quarantine of household members, and social distancing will be the first line of defense for employers during a pandemic.

    Antiviral drugs are only one tool that should be counted on to help mitigate a pandemic influenza, as their ultimate effectiveness in treating pandemic illnesses cannot be predicted in advance. In addition, it is important that employers be aware of the potential impacts and potential side effects of antiviral medications, the legal requirements and strategies for stockpiling and dispensing, ethical considerations in providing antiviral medications to some portion or all of the workforce, as well as the current public sector stockpile strategies. (...)
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    (1.2) [PANDEMIC PREPAREDNESS, ANTIVIRALS, USA] Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic

    Summary
    The use of prescription antiviral drugs to treat and prevent infection will be an important component of a pandemic influenza response.

    While current antiviral drug use strategies and publicly maintained stockpiles are targeted primarily for treatment of persons with pandemic illness, expanded antiviral drug production has allowed additional strategies to be considered.

    An interagency working group, with input from representatives of State, local and tribal public health agencies, considered scientific issues, ethics and values, and perspectives of stakeholders in developing draft guidance on antiviral use strategies and stockpiling.

    The antiviral drug use guidance in this document replaces the recommendations developed in 2005 which are published as part of the Department of Health and Human Service?s (HHS) pandemic preparedness and response plan.

    The proposed guidance on antiviral use is based on the national pandemic response goals of slowing the spread of pandemic disease, reducing impacts on health, and minimizing societal and economic disruption. The working group recommends the following strategies and settings for antiviral use to meet these goals:
    • Containing or suppressing initial pandemic outbreaks overseas and in the United States with treatment and post-exposure prophylaxis (PEP) among individuals identified as exposed to pandemic influenza and/or geographically targeted prophylaxis in areas where exposure may occur;
    • Reducing introduction of infection into the United States early in an influenza pandemic as part of a risk-based policy at U.S. borders [1];
    • Treatment of persons with pandemic illness who present for care early during their illness and would benefit from such treatment;
    • Prophylaxis of high-risk healthcare workers and emergency services personnel for the duration of community pandemic outbreaks;
    • Post-exposure prophylaxis of workers in the healthcare and emergency services sectors who are not at high exposure risk, persons with compromised immune systems who are less likely to be protected by pandemic vaccination, and persons living in group settings such as nursing homes and prisons if a pandemic outbreak occurs at that facility.
    Antiviral drugs are being stockpiled by HHS as part of the Strategic National Stockpile, (SNS) and by States.

    The current public sector stockpile target is 81 million drug regimens: 6 million regimens for containment and for slowing the entry of pandemic disease into the United States, and 75 million regimens for treatment.

    Implementation of recommendations for prophylaxis of healthcare and emergency services workers who have high-risk exposures and for PEP in recommended settings will depend largely on private sector organizations and businesses purchasing and stockpiling antiviral drugs for their employees.

    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.

    In addition to the proposed national recommendations on treatment and prophylaxis, businesses that provide goods or services essential to community health, safety, or well-being (?critical infrastructure? sectors) should strongly consider antiviral prophylaxis for critical workers as part of comprehensive pandemic preparedness planning, especially those workers who are individually critical and whose absence would jeopardize provision of essential services.

    Other employers may consider antiviral prophylaxis for workers to maintain business continuity or protect employees.[2]

    PEP for household contacts of persons with pandemic illness will reduce their risk of infection and may decrease overall rates of pandemic disease in communities.

    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.

    Antiviral medications from the SNS, other than those targeted for containment and use at U.S. borders, will be allocated pro rata and delivered to Public Health Emergency Preparedness Project Areas (includes 50 States, 4 major metropolitan areas, and 8 U.S. territories) when a pandemic occurs.

    The working group recommends that public sector antiviral drug supply be prioritized for treatment of all persons who may benefit from therapy based on assessment of medical need.

    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.

    Effective implementation of community mitigation strategies to reduce rates of illness and greater accuracy in diagnosing pandemic influenza illness would reduce antiviral drug needs, potentially leading to an ability to provide some prophylaxis while maintaining a treatment policy.

    Among prophylactic antiviral drug uses, protecting front-line healthcare and emergency services personnel is the top priority.

    Ongoing discussions with stakeholders and the public are important as part of a transparent process and to move forward in addressing implementation issues.

    Rapid implementation of these strategies during a pandemic will pose substantial challenges.

    Periodic reassessment of national antiviral drug guidance will be important based on scientific and technological advances.

    Strategies also should be reassessed when a pandemic occurs to take into account the characteristics of the virus, epidemiology of disease, and impacts on society. (...)
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    (1.3) [PANDEMIC PREPAREDNESS, MASKS, USA] Interim guidance on the use and purchase of facemasks and respirators by individuals and families for pandemic influenza preparedness

    This document provides interim guidance for the use of respirators and facemasks by individuals and families during an influenza pandemic.

    It was developed from existing U.S. Department of Health and Human Services guidance for the use of these devices in non-occupational community settings, posted on the internet at http://www.pandemicflu.gov/plan/community/maskguidancecommunity.html.

    While we do not have sufficient data to make science-based recommendations regarding every aspect of facemask and respirator use, individuals and families have requested additional information to assist in their pandemic influenza preparedness plans.

    During an influenza pandemic, one may become ill following close contact with someone who is infected at home, in the community, at work, or at school.

    The best ways to reduce the chance of illness are to avoid crowded settings, reduce close contact with others (within about 6 feet), and practice good hygiene (handwashing and covering coughs and sneezes).

    Using protective measures in workplaces, reducing contacts among children by closing schools, and canceling public gatherings also are likely to further reduce the risk of infection if these measures are used in the event of a severe pandemic.

    Facemasks and respirators may further decrease, but will not eliminate the chance of becoming infected, so their use does not lessen the importance of reducing close contacts and improving hygiene: the best protection can be achieved by combining several measures, each of which will partially protect against pandemic influenza.

    A facemask or respirator, if used correctly, may reduce the risk of acquiring or transmitting pandemic influenza illness in certain situations.

    Although the actual benefit of facemasks or respirators in preventing influenza transmission is unknown, use in certain situations may be warranted during a pandemic.

    If entry into a crowded setting is unavoidable (e.g., mass transit or going to a crowded store to purchase essentials such as medications), a facemask should be used, both to protect the wearer?s nose and mouth from other people?s coughs and sneezes, and to reduce the wearer?s likelihood of coughing or sneezing on others.

    A respirator should be used by individuals for whom close contact with an infectious person is unavoidable, such as when caring for a sick household member.

    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.
    • A facemask (for example, a surgical mask) is a disposable mask that covers the nose and mouth.
    • When used properly, facemasks may help protect against influenza by blocking droplets ? created when someone coughs or sneezes nearby ? from reaching the wearer?s nose or mouth.
    • If someone who is infected with influenza wears a facemask, it will trap their own secretions and may help protect others who are nearby.
    • A facemask also may help keep an uninfected wearer from touching their nose or mouth and potentially infecting themselves with influenza virus that is on their hands.
    • Facemasks are inexpensive and are relatively comfortable to wear.
    • Some small facemasks may fit larger children but children may have trouble wearing them correctly and consistently.
    The FDA has cleared many facemasks.
    These facemasks have been tested to show that they can trap germs and resist fluids, and will not cause skin reactions or breathing difficulties.

    FDA-cleared facemasks are labeled to be used by healthcare professionals and generally marketed as medical products sold ?over the counter? by medical supply companies.

    They may be labeled as surgical masks, procedure masks, isolation masks, dental masks, or laser masks.

    FDA has not cleared any facemasks specifically for use by children.

    Disposable masks that are not labeled for medical uses are not subject to FDA oversight and their quality is not known.

    Even if they look similar to facemasks, disposable masks not labeled for medical use, such as those commonly sold at hardware stores, may not provide the same protection against infection. Questions about a brand or type of facemask may be answered by a pharmacist or healthcare provider.

    General information on buying or wearing facemasks may be found on the FDA website, http://www.fda.gov/cdrh/ppe/masksrespirators.html.

    Instructions on how to correctly put on and take off a facemask are included with the packaging of some products.

    Correctly removing a facemask so that one is not exposed to contaminated mask surfaces is very important; good handwashing or use of a waterless hand-hygiene product before putting on and after taking off a facemask is critical.

    An N95 filtering facepiece respirator is a disposable respirator that covers the nose and mouth. Like a facemask, a respirator will trap infected droplets. In addition, if worn correctly, it will protect against breathing in small particles that may contain viruses.
    Respirators, which generally are worn in healthcare and other occupational settings, are tested and certified by NIOSH. NIOSH-certified disposable N95 respirators are marked with the manufacturer?s name, the part number (P/N), the level of protection provided by the filter (e.g. an N95 respirator is certified to filter out 95 percent of the most penetrating particulates), and ?NIOSH.?[1]

    Non-certified respirators are available but their effectiveness has not been tested by NIOSH. For questions about a brand or type of respirator, consult the NIOSH website, http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/.

    Instructions for correctly putting on and taking off a respirator are included in the package. As with facemasks, correctly removing and disposing of the respirator to avoid becoming infected from secretions that may be on the device is important; it is critical that hands be washed or decontaminated with a waterless hand-hygiene product before putting on and after taking off a respirator.

    A respirator works by fitting snugly against the face, forcing inhaled air to come through the filtering material. In workplaces where most N95 respirators are used, they are ?fit tested? to assure that air does not leak around the sides of the respirator.

    Although fit testing programs generally are not available for the public, selecting an appropriate respirator, carefully following instructions for its use, and making sure that it fits tightly against the face are critical to ensuring the respirator provides protection. Facial hair or other items that interfere with a close fit will diminish effectiveness.

    FDA recently cleared the first respirators specifically intended for use by the general public during a public health medical emergency such as a pandemic.

    These respirators, which also are NIOSH-certified, have directions that are written for untrained users and were tested to show that adult users with a variety of facial sizes could obtain a protective fit using those instructions.

    Their labeling instructions address the other precautions also needed for the safe use of respirators during an influenza pandemic such as handwashing, proper storage before use, and proper disposal after use.
    Where these are available, they may be the best option for users without access to fit testing.

    No respirator, however, will fit all users and one may want to purchase several sizes or models to see which fits best (i.e., fits snugly against the contours of the face) before purchasing a larger quantity.

    There are no respirators designed for use by children. Because the material used to make respirators is denser than that used in facemasks, it may be more difficult to breathe through a respirator. Persons who have heart or lung disease or other illnesses that affect their breathing should consult a healthcare provider before using a respirator.

    The effectiveness of both facemasks and respirators is reduced after they are worn for a long time and become saturated with moisture, or if they are torn or disfigured.

    At such times, they should be replaced.

    They can also become less comfortable to wear and may be more difficult to breathe through after extended use. Because the best ways to prevent influenza infection are to avoid crowds and reduce close contacts with others, there should not be a need to wear facemasks and respirators for long periods of time. In addition the facemasks and respirators should be removed when the wearer is no longer in a setting where close contact will occur. Never wash or disinfect disposable facemasks or respirators and never share used facemasks or respirators 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.
    Families can use this guidance as the basis for making decisions about purchasing respirators and facemasks as part of household pandemic preparedness. Although not all households will have someone who becomes ill with influenza during a pandemic, because one cannot predict in which households an infection will occur, it would be reasonable for each household to stockpile some respirators that can be used, if needed, when caring for an ill family member.

    With proper precautions, a single caregiver can use the same respirator several times over a day for brief care visits with the same ill person in the household,[2] so a stockpile of 20 respirators per household would be reasonable.

    Decisions on stockpiling facemasks and the number to obtain would depend on a family?s situation and their expectation of the need for close contact in crowded settings during a pandemic. Pandemic outbreaks in communities may last 6 to 12 weeks.[3]

    Persons who cannot avoid commuting on public transit may choose to purchase 100 facemasks for use when going to and from work. An additional supply of facemasks also could be purchased for other times when exposure in a crowded setting is unavoidable or for use by an ill person in the home when they come in close contact with others.[4]

    The cost of a box of 20 N95 respirators is about $15 - $30 and the cost of a box of 50 facemasks is about $10 - $20. Therefore, the total cost to a family to purchase the recommended number of respirators and facemasks would be about $35 - $70.

    Because the supply of respirators and facemasks is limited, stockpiling only the amounts that may be useful during a pandemic and using them only when necessary will help assure that supplies are sufficient for all settings where they are needed: on a daily basis in healthcare and other workplace settings, and for pandemic preparedness among healthcare workers, emergency responders, and others who provide essential services in communities.

    Stockpiling respirators and facemasks can contribute to pandemic preparedness in households but is not the only action that can be taken to prepare.

    Education on other measures to reduce the risk of being exposed and becoming ill, practicing good habits in handwashing and covering coughs and sneezes, as well as purchasing stockpiles of food and water all are recommended.

    Several scientific studies currently are being done to investigate the level
    of protection against influenza that may be provided by respirators and facemasks and the ability of persons to correctly and consistently use these devices.

    This interim guidance may be modified based on the results from these studies. Additional information on protecting oneself and one?s family in a pandemic is available at http://www.pandemicflu.gov/plan/individual/index.html.
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    [1] It is important to note that other NIOSH-certified N-, R-, or P- filtering facepiece respirators (e.g., N99, R95, and P100) provide an equal or greater level of exposure reduction to airborne particulates as an N95 and can be used if N95s are not available.
    [2] If a respirator is used several times by a single caregiver for brief care visits with the same ill person, the outside of the respirator may become contaminated with secretions from the ill person; therefore care should be taken to keep the respirator away from other household members between uses and to wash hands well after putting the respirator on.
    [3]In previous pandemics, community outbreaks generally have lasted 6 to 8 weeks. Effective public health measures to reduce the spread of infection in communities (?community mitigation?) may reduce the overall severity of the pandemic outbreak but could lengthen its duration, potentially to 12 weeks.
    [4] Facemasks and respirators should be stored in a dry, cool location, and protected from moisture, insects, dirt and extremes of temperature.
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