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.
What type of framework can we use in designing our pandemic
planning process?
Many approaches have been used by different corporations to address planning for the next
pandemic. The following framework ties many of these approaches together and should help create
a roadmap for an organization beginning the planning process as well as assist the more advanced
planner in doing a gap analysis on their existing plan.
Phase 1: Build a Pandemic Response Planning Effort
The following actions are critical to successfully launching your pandemic response planning effort:
Educate executives so that company leadership has a clear, consistent, fact-based understanding of a pandemic’s range of likely impacts, appropriate pandemic planning assumptions, possible mitigation strategies and useful trigger points51
Create an enterprise-wide planning group that examines pandemic issues from a broad perspective within the organization52
Collect and review existing business continuity plans. In developing pandemic plans, companies should leverage their existing Crisis Management Plans and be sure that pandemic plans are aligned with other planning efforts52
Evaluate the potential risks and vulnerabilities specific to your enterprise based on an assessment of pandemic flu’s ability to disrupt the functioning of people, processes, and technology and determine appropriate strategies to mitigate these disruptions50
Use “scenario-driven” planning as a tool to facilitate the disaster planning process. This important step involves envisioning and exercising business plans and conducting operations within assumed circumstances that represent a real-world disaster situation. Many businesses utilize scenario-driven planning to produce formal continuity-of-operations plans for all known significant business disruptions. Click here to go to the Department of Homeland Security (DHS) planning scenarios
Identify products or services that will be essential or in increased demand during a pandemic53
Identify the company’s most critical operating processes and devise a way to conduct those critical processes in the face of extremely challenging conditions. One method to organize these processes is to divide them into three categories51
Processes that can be suspended
Processes that can be maintained with remote access
Processes that require human interaction in an office or plant environment
Tie important elements of the plan to predetermined trigger points.50 Many businesses use the WHO Pandemic Phases and/or the US Government Pandemic Response Stages as their trigger points
Document in detail the actions necessary to prepare for each increased pandemic threat level, as well as eventual stabilization and recovery after the threat subsides50
Monitor the progress of the influenza threat, using the classification systems determined by the World Health Organization (WHO) and/or the US Government Response Stages
Ensure that executive management is aware of the current pandemic conditions and potential impacts
Track government and health organizations’ responses and advisories
Track employee absenteeism trends
Phase 4: Activate Plan and Manage Problems50
Activate the pandemic planning actions appropriate to the current conditions or trigger points
Assess the changing impacts and conduct ongoing incident management measures specific to your organization’s people, processes and technology
FOOTNOTE
50. Pandemic Response Checklist. SUNGARD Information Availability Services, LP: Wayne, PA.
June 2006. Available at: http://www.availability.sungard.com/NR/rdonlyres/B95868B7-A2DC-49B4-B40C-
BBDED3C5FCFE/0/SunGardpandemicResponseChecklist.pdf. Accessed February 21, 2007.
51. Krell E. A best-case scenario for pandemic planning. Business Finance. December 2006:22.
52. Center for Infectious Disease Research & Policy (CIDRAP), University of Minnesota. 10-Point Framework for Pandemic Influenza Business Contingency Planning. Available at: www.cidrap.umn.edu/10points. Accessed February 21, 2007.
53. US Department of Homeland Security Web site. Pandemic Influenza: Preparedness, Response, and Recovery Guide for critical infrastructure and key resources. September 2006:1-84. Available at: http://www.pandemicflu.gov/plan/pdf/cikrpandemicinfluenzaguide.pdf. Accessed February 21, 2007.
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.