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.
Facilitate consultations for your employees
TAMIFLU is a prescription medication and according to federal law requires
a written prescription by a licensed physiciana or other qualified
healthcare professional (HCP)b. Consequently, for each individual the
corporation intends to receive TAMIFLU, a physician or HCP MUST verify
that the employee's health meets appropriate prescribing criteria
(see Prescribing Information, Package Insert) by conducting a consultation,
and then issue a prescription. The following checklist will help you to
select the optimal model for conducting consultations.
Assess your organization's needs and on-site resources.
Does your organization have employee health or clinical services located on-site?
How many employees will require physician consultations?
Will your organization require consultations at a single location or multiple geographic locations?
Identify entities able to conduct employee consultations and write prescriptions
Employee Health Services/On-site Clinic
Local/community clinic or physician group
Corporate healthcare providers (Not all corporate healthcare providers offer a program )
Determine which type of entity is right for your organization.
Consider the following:
An employee health or clinical services group located on-site may be able to handle employee consultations in-house, contingent upon:
Number of employees receiving consultations
Desired program timeline
Number of qualified and dedicated staff available
Large numbers of employees receiving physician consultations could challenge on-site clinical services as well as a local clinic or physician group, resulting in disruption of the normal corporate clinical services
Organizations with multiple work sites may find it challenging to internally coordinate a program. As well, it may be challenging to find affiliated clinics or physician groups across multiple work sites.
Corporate healthcare providers may be suited for large organizations that lack on-site clinical services or have multiple work sites or a geographically distributed workforce (e.g., a sales force) since they often have dedicated medical staff as well as networks of affiliated clinics and providers.
Discuss employee consultation issues with candidate entities to make your decision. Consider: Program Duration
How long will the program be offered?
How many consults can be conducted in a given day?
How will new employees or employees that missed a consult be serviced?
Program Logistics
Can the entity handle organizations with multiple work sites or a geographically distributed workforce?
How will consultations translate into prescriptions? Where will the prescriptions be stored? After a prescription has been written, the information can be stored in a database for use when your companies determine when to distribute the product. This information can also be used to verify who has completed required educational training prior to distributing TAMIFLU to employees.
Does the entity have the ability to provide a turnkey solution (i.e., a solution that encompasses consultations, storage and distribution)?
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.
FOOTNOTE: aIncludes dentists, podiatrists, and veterinarians. In some states, licensed physicians may need to sign off on prescriptions.
Dispensing licenses are governed by the State Board of Pharmacy for pharmacies and the State Board of Medical Examiners
for physicians. Please consult your state pharmacy laws for local
requirements. bIncludes midlevel practitioners (e.g., registered nurses,
physicians assistants) meeting certain state requirements
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.
Assess your organization's needs and on-site resources.
