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On September 30, 2009, the Center for Disease Control and Prevention (CDC) sent a message to the states that the FDA and Roche (maker of Tamiflu®) acknowledge limited commercial and stockpiled supplies of Tamiflu® oral suspension.
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.
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.
The Delaware Division of Public Health (DPH) remains committed in our support of the on-going H1N1 response efforts. This includes ensuring that those who need antiviral treatment have access to the appropriate medication. The Division of Public Health (DPH) surveyed pharmacies throughout Delaware and concluded there is a shortage of Tamiflu® oral suspension in the market at both pharmacies and distributors. Given this finding, the Division of Public Health (DPH) is working directly with the pharmaceutical community to release from its limited in-state stockpile of Tamiflu® oral suspension to some pharmacies and hospitals in Delaware.
Medical providers prescribing antiviral medications are encouraged to following the CDC’s Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season at http://www.cdc.gov/h1n1flu/recommendations.htm.
If you have questions regarding this Health Alert contact the Delaware Division Public Health at (302) 223-1720.
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