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Pandemic Planning Toolkit A resource to assist your organization in preparing for pandemic influenza

TAMIFLU® (oseltamivir phosphate) has been studied only in strains of influenza that were circulating at the time. The magnitude of effect of TAMIFLU in treating and preventing novel strains of influenza, such as those that may be involved in a pandemic, cannot be predicted.

How is the US government protecting the country?

A federal pandemic plan is in place

The National Strategy for Pandemic Influenza, issued by President Bush on November 1, 2005, guides our nation's preparedness and response to a flu pandemic with the intent of:21
  • Stopping, slowing, or otherwise limiting the spread of a pandemic to the US
  • Limiting the domestic spread of a pandemic and mitigating disease, suffering, and death
  • Sustaining infrastructure and mitigating impact on the economy and the functioning of society
The Strategy charges the US Department of Health & Human Services (HHS) with leading the federal pandemic preparedness.21
 
The HHS Pandemic Influenza Plan is a blueprint for pandemic flu preparation and response. In particular, the HHS Plan provides guidance to national, state, and local policy makers and health departments. The goal is for all involved to achieve a state of readiness and quick response. The HHS Plan is based on the knowledge that once a pandemic is triggered by the emergence of a novel influenza A virus subtype, it is a global event and all countries are at risk.
 
The US will work in concert with the WHO and other international partners on containment and response activities abroad that also will assist the planning and monitoring for disease outbreaks in the US.
 
To review the plan, go to: http://www.hhs.gov/pandemicflu/plan/.

Components of the HHS plan

The HHS Plan includes an overview of the threat of pandemic flu, a description of the relationship of this document to other federal plans, and an outline of key roles and responsibilities during a pandemic. In addition, the HHS Plan specifies needs and opportunities to build robust preparedness for and response to pandemic flu. The preparations made for a pandemic today will have lasting benefits for the future.

Antiviral stockpiling is crucial22

Major components of the critical preparedness and ready response actions include:
  • Intensifying surveillance and collaborating on containment measures - both international and domestic
  • Stockpiling antivirals and vaccines, and working with industry to expand capacity for production of these medical countermeasures
  • Creating a seamless network of federal, state and local preparedness, including increasing healthcare surge capacity
  • Developing the public education and communications efforts that will be critical to keeping the public informed

A plan based on known pandemic principles23

Strategies outlined in the HHS Plan are based on an understanding of pandemics and flu disease, and are guided by several overarching principles:
  • Preparedness will require coordination among federal, state, and local government and partners in the private sector
  • An informed and responsive public is essential to minimizing the health effects of a pandemic and the resulting consequences to society
  • Domestic vaccine and production capacity sufficient to provide vaccine for the entire US population is critical
  • Quantities of antiviral drugs sufficient to treat 25% of the US population should be stockpiled.
  • Sustained human-to-human transmission anywhere in the world will be the triggering event to initiate a pandemic response by the US
  • When possible and appropriate, basic public health measures will be employed to reduce person-to-person viral transmission and to prevent or delay influenza outbreaks
  • At the start of a pandemic, vaccine, which will initially be in short supply, will be procured and distributed to state and local health departments for immunization of predetermined priority groups
  • At the onset of a pandemic, antiviral drugs from public stockpiles will be distributed to predetermined priority groups
 
Learn about how much antiviral medicine the government is stockpiling.

 
FOOTNOTE
21. The White House. National strategy for pandemic influenza. November 1, 2005. Available at: http://www.whitehouse.gov/homeland/pandemic-influenza.html. Accessed April 13, 2006.
22. US Dept of Health and Human Services. Pandemic planning update: a report from Secretary Michael O. Leavitt (2006). Available at: http://www.pandemicflu.gov/plan/pdf/panflu20060313.pdf. Accessed April 13, 2006.
23. US Dept of Health and Human Services. HHS Pandemic Influenza Plan. Available at: http://www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf. Accessed April 13, 2006.
Indications

TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have been symptomatic for no more than 2 days.

TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.

TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).

Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

Safety Information

There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:

  • Treatment of adult and pediatric patients - nausea, vomiting.
  • Prophylaxis of adult and pediatric patients - nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

Please see TAMIFLU full Prescribing Information for additional safety information.
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