FDA Public Health Alert: Tamiflu Dosing Errors
- By admin aapc
- In Industry News
- October 19, 2009
- Comments Off on FDA Public Health Alert: Tamiflu Dosing Errors
Prescribers and pharmacists should be alert for potential dosing errors with Tamiflu for oral suspension. The dosing dispenser packaged with Tamiflu has markings only in 30, 45, and 60 mg, whereas health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons. The U.S. Food and Drug Administration (FDA) has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.
Specific considerations for Tamiflu dosing for children over 1 years old:
- Dosing should be prescribed in mg according to information provided in the table below. Caregivers for children should use the dosing dispenser packaged with the medication, unless otherwise directed by a health care provider.
- If the dosing dispenser packaged with Tamiflu oral suspension is lost or damaged, or if the prescriber wishes to use volume-based dosing, appropriate dosages in mL are also provided in the table. In these cases the prescriber and pharmacist should ensure that a dosing dispenser, such as an oral syringe calibrated in mL, is given to the patient or caregiver with instructions for use. The dosing dispenser packaged with the product should be discarded.
- Prescribers should avoid prescribing Tamiflu oral suspension in teaspoons. This can lead to inaccurate dosing. If a prescription is written in teaspoons, the pharmacist should convert the volume to mL and ensure that an appropriate measuring device, such as an oral syringe calibrated in mL, is provided. The dosing dispenser packaged with the product should be discarded.
Dose of Tamiflu for Oral Suspension (12 mg/mL) for Treatment of Influenza
|
Body Weight (kg) |
Body Weight (lbs) |
Recommended Dose |
Dose (mL) |
Number of Bottles of Tamiflu needed to Obtain the Recommended Doses for a 5 Day Regimen |
|
< 15 kg |
< 33 lbs |
30 mg twice daily |
2.5 mL |
1 |
|
>15 kg to 23 kg |
>33 lbs to 51 lbs |
45 mg twice daily |
3.8 mL |
2 |
|
>23 kg to 40 kg |
>51 lbs to 88 lbs |
60 mg twice daily |
5.0 mL |
2 |
|
>40 kg |
>88 lbs |
75 mg twice daily |
6.2 mL |
3 |
The following links provide additional information on the emergency compounding of an oral suspension from Tamiflu 75 mg capsules (HCPCS Level II code G9019 Oseltamivir phosphate, oral, per 75 mg (Tamiflu®)) and the emergency use of Tamiflu in infants less than 1 year of age:
- Emergency Use of Tamiflu in Infants Less than 1 Year of Age
- Emergency Compounding of an Oral Suspension from Tamiflu 75 mg Capsules (Final Concentration 15 mg/mL).
On Oct. 15, the FDA also posted a news release warning anyone purchasing products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus to use extreme caution. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu, which may pose risks to patients.
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