Date: December 9, 2022
To: Enrolled Pharmacies
Re: Emergency Tamiflu and Oseltamivir Shortage Compounding Instructions
_____________________________________________________________________________________________________This notice informs providers that due to the shortage of generic Tamiflu (oseltamivir), the Department of Healthcare and Family Services (HFS) will temporarily reimburse providers dispensing brand name Tamiflu or when compounding suspensions with brand or generic Tamiflu, while the shortage exists.
The drugs will be added as preferred products on the Preferred Drug List and prior authorization will not be required under the Medicaid fee-for-service (FFS) program or by the managed care organizations (MCOs).
Since it is not known at this time when the FDA-approved, commercially manufactured oseltamivir or Tamiflu for oral suspension will become available again, HFS will distribute an updated provider notice when that availability in retail pharmacies is restored.
Emergency Compounding of an Oral Suspension from 75 mg Tamiflu or oseltamivir capsules (Final Concentration 6 mg/mL)
The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured oseltamivir or Tamiflu for oral suspension is readily available from wholesalers or the manufacturer.
Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
Commercially manufactured oseltamivir for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or when lower doses are needed. If oseltamivir for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from Tamiflu or oseltamivir capsules 75 mg using one of these vehicles: cherry syrup, Ora-Sweet SF, or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved oseltamivir for oral suspension is commercially available.
- Calculate the total volume of an oral suspension needed to be compounded and dispensed for each patient.
The total volume required is determined by the weight of the patient.
Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded
Based Upon the Patient's Body Weight:
|Weight (kg)||Weight (lbs)||Total Volume to Compound per Patient (mL)|
|15 kg or less||33 lbs or less||75 mL|
|16 kg - 23 kg||34 lbs - 51 lbs||100 mL|
|24 kg - 40 kg||52 lbs - 88 lbs||125 mL|
|41 kg or more||89 lbs or more||150 mL|
- Determine the number of capsules and the amount of water and vehicle (cherry syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL).
Number of Oseltamivir 75 mg Capsules and Amount of Vehicle
(Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the
Total Volume of a Compounded Oral Suspension (6 mg/mL).
|Total Volume of Compounded |
Oral Suspension to be Prepared
|75 mL||100 mL||125 mL|| ||150 mL|
|Number of Oseltamivir 75mg Capsules* |
| ||12 capsules|
|Amount of Water||5 mL||7 mL||8 mL|| ||10 mL|
|Volume of Vehicle |
Cherry Syrup OR
OR simple syrup
|69 mL||91 mL||115 mL|| ||137 mL|
*Includes overage to ensure all doses can be delivered
- Follow the procedure below for compounding the oral suspension (6 mg/mL) from Tamiflu or oseltamivir capsules 75 mg:
- Place the specified amount of water into a polyethylene terephthalate (PET) or glass bottle.
- Carefully separate the capsule body and cap and pour the contents of the required number of 75 mg capsules into the PET or glass bottle.
- Gently swirl the suspension to ensure adequate wetting of the oseltamivir powder for at least 2 minutes.
- Slowly add the specified amount of vehicle to the bottle.
- Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension.
Storage of the Emergency Compounded Suspension
Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F).
Room Temperature: Stable for 5 days when stored at room temperature, 25°C (77°F).
Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above-mentioned vehicles, which were placed in glass and PET bottles. Stability studies have not been conducted with other vehicles or bottle types.
Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information for compliance with all State and Federal pharmacy regulations.
Questions regarding this notice may be directed to a pharmacy consultant in the Bureau of Professional and Ancillary Services at 877-782-5565 for FFS claims, or the appropriate MCO.
Kelly Cunningham, Administrator
Division of Medical Programs