Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions

Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions

Commercially manufactured Tamiflu for Oral Suspension (12 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules. However, preparation of an oral suspension from the 75 mg Tamiflu Capsules, as described in the FDA-approved labeling resulting in a concentration of 15 mg/ml, may be necessary when the commercial suspension, Tamiflu for Oral Suspension (12 mg/ml), is not readily available in a timely manner because of an actual shortage of the product. If demand is high, it may make sense for pharmacies to compound the suspension (15 mg/ml) in advance of receiving prescriptions. FDA will not object if pharmacies compound the suspension from Tamiflu Capsules in advance of receiving prescriptions, if the amount compounded is commensurate with the number of valid prescriptions that the pharmacy can reasonably anticipate receiving within the next 24 hours. Based on mixing and stability considerations it is reasonable for pharmacists to compound the suspension (15 mg/ml) using up to 100 capsules at a time, to meet the number of anticipated prescriptions for the next day. Pharmacies should carefully review the instructions provided in the Tamiflu Capsule labeling for compounding the suspension (below). When compounding the suspension (15 mg/ml) for more than one patient, pharmacists need to:

Assure that the suspension is thoroughly mixed and stable, which includes emptying the correct number of capsules, assuring that suspension vehicles identified in the labeling are used (other vehicles have not been studied, and certain sugars in the suspension may lead to a decrease in potency), and assuring that any mixer used is well maintained and cleaned.
If a sufficient number of amber bottles are not available it is acceptable to use other types of glass or PET bottles.
Pharmacists need to refrigerate the compounded product, assure that the product is stirred thoroughly before dispensing, and ensure that patients are advised to continue refrigerating the product at home.
Patients should also be advised to gently shake the product before administration to ensure proper mixing of the suspension.
Pharmacists and health care providers should also ensure that an appropriate dispensing device (i.e., one that measures volume in mL) is provided with the compounded suspension.
Directions for Emergency Compounding of an Oral Suspension from TAMIFLU Capsules (Final Concentration 15 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 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 TAMIFLU for Oral Suspension (12 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for Oral Suspension is not available, the pharmacist may compound a suspension (15 mg/mL) from TAMIFLU (oseltamivir phosphate) Capsules 75 mg using either of two vehicles: Cherry Syrup (Humco®) or Ora-Sweet® SF (sugar-free) (Paddock Laboratories). Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for Oral Suspension is commercially available.

First, 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 each patient. Refer to Table 7.

Table 7 Volume of an Oral Suspension (15 mg/mL) Needed to be Compounded Based Upon the Patient's Weight

abrir aquí para acceder al documento FDA completo (muy extenso):
Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions