September 25, 2009

9/25/2009 Updated Pediatric Antiviral Dosing Syringe and Compounding Information for 2009 H1N1 and Seasonal Flu

Filed under: Uncategorized — kkaneshi @ 4:26 pm

IHAN - Indiana State Department of Health - Advisory - 654 - Updated Pediatric Antiviral Dosing Syringe and Compounding Information for 2009 H1N1 and Seasonal Flu

 Note on Tamiflu Oral Suspension Syringe

The second issue that pharmacists and physicians may face is the need to ensure that the units of measure on the dosing dispenser and the dosing instructions match.  An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations of Tamilfu is provided in the packaging for the manufacturer’s product rather than graduations in milliliters (mL) or teaspoons (tsp).  This can lead to patient or caregiver confusion and dosing errors.  When dispensing commercially manufactured Tamiflu,  oral suspension, pharmacists should ensure the units of measure on the dosing instructions match the dosing device provided.   If prescription instructions specify administration using mL or tsp, then the device included in the Tamiflu product package should be removed and replaced with an appropriate measuring device, such as an oral syringe if the prescribed dose is in milliliters (mL).

When dispensing Tamiflu oral suspension for children younger than 1 year of age, the oral dosing dispenser that is included in the product package should always be removed. Pharmacists and health care providers should provide an oral syringe that is capable of accurately measuring the prescribed milliliter (mL) dose, and counsel the caregiver how to administer the prescribed dose. Oseltamivir is authorized for emergency use in children younger than 1 year of age under an Emergency Use Authorization (EUA) issued by FDA. For the EUA, see http://www.cdc.gov/h1n1flu/eua/pdf/tamiflu-hcp.pdf.

For More Information:
2009-2010 Influenza Season: Information for Pharmacists: http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm

Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season: http://www.cdc.gov/H1N1flu/recommendations.htm

Questions & Answers: Antiviral Drugs, 2009-2010 Flu Season:  http://www.cdc.gov/h1n1flu/antiviral.htm

Updated Interim Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season: http://www.cdc.gov/H1N1flu/pregnancy/antiviral_messages.htm

Antiviral Drugs: Summary of Side Effects: http://www.cdc.gov/flu/protect/antiviral/sideeffects.htm

For the FDA page on antiviral influenza drugs:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm

For the FDA-approved package insert with instructions for the emergency compounding of an oral suspension from Tamiflu 75mg capsules see http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM147992.pdf

For the FDA public health alert regarding Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm.

For additional information, you can also call CDC’s toll-free hotline, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day.