FDA Produces 2009H1N1 Frequently Asked Quesations

FDA Press Release

2009 H1N1 Flu Virus and Antivirals Questions and Answers

Q: Do the FDA’s Emergency Use Authorizations for antiviral drugs (Tamiflu and Relenza) cover their use for both prevention and treatment?
The EUAs for Tamiflu and Relenza cover the emergency use of the drugs, subject to the terms and conditions of the EUAs. Tamiflu and Relenza are also approved by the FDA for treatment and prevention under certain circumstances. Specifically:

Tamiflu is approved:

to treat uncomplicated acute illness due to influenza infections in patients 1 year of age and older who have been symptomatic for no more than 2 days, and
to prevent influenza in patients 1 year and older.

Relenza is approved:

to treat uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than two days, and
to prevent influenza in adults and pediatric patients 5 years of age and older.

The EUA for Tamiflu authorizes, under certain circumstances, Tamiflu to be used to treat and prevent influenza in children under 1 year of age, and provides alternative dosing recommendations for children older than 1 year (based on age instead of weight). (We note that because of limited experience, use of Tamiflu for prevention of 2009 H1N1 flu in infants less than 3 months of age is not routinely recommended but may be considered if the need is considered critical.) The EUA also authorizes distribution of Tamiflu deployed from the Strategic National Stockpile and that has had its expiration date extended under the federal government’s Shelf Life Extension Program (SLEP).

The EUA for Tamiflu and Relenza authorize the drugs to be used at later time points (i.e., in patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have “uncomplicated acute illness” per se). The EUAs for Tamiflu and Relenza authorize the drugs to be distributed or dispensed without all of the FDA-required prescription label information. The EUAs for Tamiflu and Relenza authorize the drugs to be accompanied by certain written emergency use information. The EUAs also note that public health officials or other volunteers may distribute Tamiflu and Relenza to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.

Q: Do the Emergency Use Authorizations for the antiviral drug products Relenza and Tamiflu cover only products in the Strategic National Stockpile (SNS) or do they cover the state and local stockpiles and private sector stockpiles?
The EUAs for Relenza and Tamiflu are not limited to Tamiflu and Relenza held in the Strategic National Stockpile. However, the EUAs are limited to Tamiflu and Relenza distributed under the authority of the Centers for Disease Control and Prevention (CDC) and/or the appropriate local state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that private entities are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs. However, private entities simply distributing product outside of the emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals) would not be within the scope of the EUAs.

Q: Do the Emergency Use Authorizations for Tamiflu and Relenza cover regular pharmacy prescriptions?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that pharmacies are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Do the Emergency Use Authorizations for antivirals allow hospitals without outpatient pharmacies to dispense Tamiflu and Relenza?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that hospitals without outpatient pharmacies are part of state and local emergency response plans for dispensing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what information should be given to a patient?
The Fact Sheet for Patients and Parents authorized under the Tamiflu and Relenza EUAs must be made available to the patient or recipient of the product through appropriate means, which may include distribution of the Fact Sheets with the product.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what does it mean to make available medication information “through appropriate means?”
A condition of the EUAs for Tamiflu and Relenza provides that state and/or local health authorities make available “through appropriate means” fact sheets developed for recipients and for health care providers for this emergency use. Making these fact sheets available “through appropriate means” can include (but is not limited to) handing that information to the recipient with the product, or otherwise making it available for reference at the location where medications are being distributed, depending on the circumstances of the emergency.

Q: In the Emergency Use Authorizations for Tamiflu and Relenza, what kind of “additional information,” which is consistent with the fact sheets, can be provided by the CDC and state or local authorities?
Examples of “additional information” include direct translations of the fact sheets into other languages, a poster display, and DVD or television announcements that relay the information contained in the fact sheets.

Q: Why does the Emergency Use Authorization for Tamiflu state that it covers Strategic National Stockpile assets and those authorized under SLEP, but the EUA for Relenza does not make the same statement?
The EUAs for Tamiflu and Relenza cover all Tamiflu and Relenza that is being distributed as part of a government (federal, state or local) emergency response as specified under the EUAs. This can include Tamiflu and Relenza from the Strategic National Stockpile (SNS), but can also include state or local stockpiles of Tamiflu and Relenza, provided it is distributed in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals), subject to the terms and conditions of the EUAs. In addition, it should be noted that while Tamiflu is part of the federal Shelf Life Extension Program (SLEP), Relenza is not. For this reason, reference to SLEP in the Relenza EUA was unnecessary.

Q: Does a physician need a confirmed diagnosis before prescribing Tamiflu?
Tamiflu is approved for both the treatment and prevention of influenza. Health care providers should use their best judgment given the circumstances and extent of exposure when deciding whether prophylaxis and/or treatment is warranted.

Depending on the characteristics of an outbreak, public health officials may provide additional recommendations for prioritization and identification of appropriate recipients. Because testing may require a few days and might have variable accuracy, and the antiviral drugs are most effective when used early in the course of illness, health care providers may choose to begin treatment based on determination of a suspected or probable case. Published CDC recommendations and case definitions should be consulted as appropriate.

Q: Do the Emergency Use Authorizations override state guidelines regarding dispensing and storage of Tamiflu and Relenza in a public health emergency?
Distribution and administration of Tamiflu and Relenza under the EUAs are subject to the terms and conditions of the EUAs. The EUAs require Tamiflu and Relenza to be distributed in accordance with state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals).

Tamiflu and Relenza should be stored consistent with the manufacturer’s storage instructions in the approved labeling. The EUA includes a waiver of good manufacturing practice requirements with respect to the holding of authorized Tamiflu and Relenza by CDC and other public health authority(ies) for a period of 90 days. If a public health authority believes that improper storage of their Tamiflu and Relenza may have occurred, please contact the FDA.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.