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.
Distribute antivirals to employees
The method and timing of TAMIFLU distribution to employees who have a prescription for TAMIFLU is specific to
each organization's pandemic plan. Consider the merits/challenges of
various options before making a final determination. Similar to the
employee consultation process, the choices made in prior steps may
influence your distribution plan. Answering these questions will help
guide your decisions regarding TAMIFLU distribution.
How will the organization use TAMIFLU?
The company should define the role of TAMIFLU during a pandemic. Here are the three most likely roles:
Keep a cache of TAMIFLU for treatment of on-site employees when they appear to have flu symptoms or for prevention when on-site employees may have been exposed to someone with flu symptoms
Distribute TAMIFLU in advance to employees at home so they can use it as needed in the event of a pandemic
Distribute TAMIFLU in advance to employees at their homes so that they can use it as needed in the event of a pandemic AND maintain a cache of TAMIFLU for on-site employees
Should distribution to employees be centralized or direct? Centralized distribution
Product can be dispensed to employees from a central distribution point (e.g., On-site clinic) during a pandemic or at any other predetermined trigger point.
May be an optimal distribution strategy if ONLY on-site employees will receive TAMIFLU
Issues to consider
Number of eligible employees: Large numbers of employees eligible to receive TAMIFLU could make dispensing logistically impractical in a time of crisis.
Number of sites: Organizations with multiple sites will require clinics & staff at all sites during a pandemic
Storage of Product: If product is stored at an off-site location it may complicate distribution logistics
Security: Organizations may require increased security
Infection Control: Centralized distribution may increase the risk of transmitting infection
Access: Gaining access to the corporate campus or office building may be challenging during a pandemic
Remember that federal law requires each employee to obtain a valid prescription before receiving the drug
Direct distribution to employees
TAMIFLU can be shipped directly to an employee at their home to ensure that they have product available during a pandemic. The organization can coordinate the distribution of TAMIFLU at a predetermined pandemic event phase with the assistance of a distribution partner.
May be an optimal distribution strategy for organizations with large numbers of employees, a distributed workforce or organizations that do not have on-site clinical services or storage capacity available.
Issues to consider
Lost or Damaged Product: Employees that receive TAMIFLU in advance may be at a greater risk of misplacing or damaging the product.
Inappropriate Usage: Employees that receive TAMIFLU in advance may be at a greater risk for misuse of TAMIFLU. The organization should ensure appropriate education, resources, and a means for employees to contact a health care professional prior to administration.
Remember that federal law requires each employee to obtain a valid prescription before receiving the drug.
Who will help your organization with distribution?
Identify a distribution partner
Prescription Benefit Managers
Pharmaceutical Wholesalers
Specialty Distributors
When will you distribute TAMIFLU to employees?
The decision as to when to distribute is specific to your company's pandemic plan. Consider the following possible options:
Immediately upon receipt of the organization's TAMIFLU order
When public health officials declare that a specific phase of the pandemic has been reached (Please refer to www.who.int for the current pandemic phase)
When certain event-triggers are met in accordance with your organization's pandemic plan.
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.
How will the organization use TAMIFLU?
