Important Information About Influenza/H1N1
TUESDAY, DECEMBER 15, 2009
CDC ANSWERS QUESTIONS REGARDING NON-SAFETY-RELATED VOLUNTARY RECALL OF CERTAIN LOTS OF SANOFI-AVENTIS PEDIATRIC H1N1 VACCINE: http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
MONDAY, NOVEMBER 2, 2009
PERAMIVIR AVAILABLE VIA EMERGENCY USE AUTHORIZATION
Peramivir, a neuraminidase inhibitor (http://www.cdc.gov/h1n1flu/eua/EUA%20Peramivir%20Letter%20-%20Frieden.pdf), is an intravenous (IV) drug authorized for emergency use for the treatment of certain hospitalized patients with known or suspected 2009 H1N1 influenza.
Peramivir IV is an unapproved drug and is still being evaluated in phase 3 clinical trials. Limited phase 2 and 3 safety and efficacy data for Peramivir IV are available, but not sufficient to constitute an adequate basis to establish safety and efficacy that is required for full marketing approval. The data are sufficient to allow approval for emergency use of Peramivir IV in certain patients as described herein.
Additional information is available at http://www.cdc.gov/H1N1flu/EUA/Peramivir_recommendations.htm
IV Peramivir may be appropriate for certain hospitalized and critically ill patients with suspected or confirmed 2009 H1N1 influenza, such as patients not responding to either an oral or inhaled antiviral therapy and patients without a dependable oral or inhaled route of drug delivery (e.g. patients unable or unlikely to absorb oseltamivir due to ileus or high nasogastric tube output).
Clinicians should carefully review the healthcare provider fact sheet on Peramivir at (http://www.cdc.gov/h1n1flu/eua/Final%20HCP%20Fact%20sheet%20Peramivir%20IV_CDC.pdf). This fact sheet also includes the terms and conditions of the EUA and safety and efficacy data on Peramivir.
To request Peramivir IV (licensed clinicians with prescribing privileges ONLY), http://emergency.cdc.gov/h1n1antivirals/. For any questions, call 1-800-CDC-INFO (1-800-232-4636).
WEDNESDAY, OCTOBER 21, 2009
FDA Authorizes Dispensing of Certain Lots of Tamiflu and Tamiflu Oral Suspension Beyond the Labeled Expiration Date. In response to ongoing shortages of Tamiflu and Tamiflu Oral Suspension, the FDA has authorized dispensing of certain lots of those products beyond their labeled expiration date. More information, including the method to determine whether a lot of the product has been approved for beyond-date dispensing, is found here: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
DrugSafetyInformationforHeathcareProfessionals/ucm184770.htm
And here: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm
THURSDAY, OCTOBER 1, 2009
EFFECTIVE OCTOBER 9, 2009, PHARMACISTS WILL HAVE TEMPORARY AUTHORITY TO ADMINISTER SEASONAL AND H1N1 FLU VACCINE TO PATIENTS AGE 14 AND OLDER. Pursuant to a request from Dr. Jeffrey Engel, State Health Director, the Pharmacy and Medical Boards have passed an emergency amendment to the pharmacist vaccination rule authorizing pharmacists to administer seasonal and H1N1 influenza vaccine to patients age 14 and older. The effective date of this amendment is Friday, October 9, 2009.
This authority is, at present, temporary, and it is expected that the authorization will extend through July 2010, unless a permanent rulemaking is begun prior to that date. Dr. Engel’s request to the Pharmacy and Medical Boards stated that the North Carolina Division of Public Health (DPH) “has concluded . . . that the age restriction contained in the pharmacist vaccination rules will impair DPH’s ability to fulfill its mission to protect the public health and safety of North Carolina’s citizens. Indeed, pediatric patients are among the members of the North Carolina public most susceptible to particularly serious complications from novel H1N1 infection.” DPH intends to “enlist the aid of pharmacist vaccinators across the state to meet this serious, urgent need.”
TUESDAY, SEPTEMBER 29, 2009
ADDITIONAL GUIDANCE FOR PHARMACIST COMPOUNDING OF TAMIFLU ORAL SUSPENSION: As health-care providers continue to combat seasonal and H1N1 flu, there have been some reports of shortages of commercially available Tamiflu oral suspension. The following guidance documents – which are based on instructions provided in the Tamiflu package insert -- may be useful for pharmacists who find themselves without access to commercially available Tamiflu oral suspension or in need of preparing patient-specific doses that would be difficult to administer using commercially available Tamiflu oral suspension:
TAMIFLU COMPOUNDING INSTRUCTIONS
WEDNESDAY, AUGUST 26, 2009
H1N1 FLU VIRUS. See links below for important information about the 2009 H1N1 influenza virus:
- Letter to public health professionals from Secretary Lanier M. Cansler
- "What Do I Need to Know and Do?" informational flyer for the public in English
- "What Do I Need to Know and Do?" informational flyer for the public in Spanish
or visit www.flu.nc.gov.
MONDAY, AUGUST 24, 2009