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

Background     
  As of September 25, 2009 influenza  activity is increasing in the United States with 26 states reporting widespread influenza activity. So far, ninety-nine percent of all subtyped influenza  viruses being submitted to CDC are 2009 influenza A (H1N1) viruses.

        The current  situation will likely affect   pharmacies as a  greater number of people than usual seek to fill prescriptions for influenza antiviral drugs or antibiotics to treat  secondary bacterial infections, in addition to seeking  advice on over-the-counter flu medications. This may affect supplies and availability of antiviral medications  and other materials that may be needed to fill prescriptions.

        Pharmacists and physicians who care for  pediatric patients should be aware of two  issues: (1) the possible need to compound Tamiflu on site if commercially  manufactured pediatric oral suspension formulation is not available, and (2) the need to ensure that the units of measure on the dosing dispenser and the dosing instructions match.     

        These situations are addressed  in the updated interim recommendations issued by CDC on September 22, 2009 for the use of antivirals in the treatment and prevention of influenza which can be found at      http://www.cdc.gov/H1N1flu/recommendations.htm       and in the 2009-2010 Influenza Season:  Information for Pharmacists available at      http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm   .

          Alternatives to Tamiflu   Oral  Suspension for Pediatric Patients     
  If pediatric formulations of Tamiflu  are not available, pharmacists may compound Tamiflu 75 mg capsules into  an oral suspension onsite. For the FDA -approved instructions for the emergency compounding of an oral suspension from Tamiflu 75mg capsules, see the FDA approved manufacturer package insert for oseltamivir (Tamiflu), available on the FDA Web site at      http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM147992.pdf         

        Compounding an  oral suspension from Tamiflu   75mg capsules provides an alternative when  commercially manufactured oral suspension formulation is not readily available. Tamiflu   capsules 75 mg may be compounded using either of two  vehicles: Cherry Syrup (Humco ) or Ora-Sweet   SF (sugar-free) (Paddock  Laboratories). Other supplies needed to compound include mortar and pestle and amber glass or amber polyethyleneterephthalate (PET) bottle.
     
In addition, for  children who may not be able to swallow capsules, Tamiflu   (30mg, 45mg and  75mg)capsules may be opened and mixed with sweetened liquids, such as regular or sugar-free chocolate syrup, if oral suspension is not available.

          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.