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.
Determine the number of individuals to protect
To determine which and how many individuals to plan to protect, your
organization must first establish clearly its mission or objectives during
a pandemic. NOTE: Your corporate mission during a pandemic will almost
certainly differ from your standard operating mission; however, it needs to
be equally clear.
As an example, a retail manufacturer may have dual objectives during a
pandemic:
Protect its employees
Continue to produce vital products for its customer base
Use the mission/objectives during a pandemic to determine the number of
individuals you will need to protect. The following checklist should prove
helpful in this determination.
Establish mission/objectives in a pandemic
Obtain agreement from senior management on the organization's
mission during a pandemic (business continuity, employee
protection, both, other).
If business continuity is the sole objective:
Identify which products and/or services must continue during a pandemic to fulfill the corporate mission
Specify the critical activities that are required inputs for those products and/or services
Identify job roles that are essential to support those critical activities
Distinguish job roles that can be performed only on-site from those that can be performed off-site
Identify employees that fill the "essential" roles & employees that can provide back-up
Identify functional areas that may need to increase the number of employees, (e.g., security)
If business continuity and employee protection are dual objectives,
determine which employees to cover beyond the "essential employees".
Consider internal and external groups you need to protect
The following internal groups may be considered for coverage:
Senior management
Employees that interact with the public
Employees at headquarters locations
% of All Employees
All Employees
The following external groups may be considered for coverage:
Key contractors and suppliers
Family members of employees
Members of the surrounding community
Estimate the number of new employees that may need to be hired to maintain business continuity
Arrive at the total number of individuals that your organization will need to protect
Total no. to protect = [# internal] + [# external] + [# new hires]
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.
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.
Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
Efficacy of TAMIFLU has not been established in immunocompromised patients.
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.
Establish mission/objectives in a pandemic
