At the February 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
Gleolan is an oral powder for reconstitution, once reconstituted is meant as a single dose. The label reads, “Dissolve contents of 1 vial in 50ml of drinking water” but there is no stated final volume. However, the concentration after reconstitution is listed on the label as 30mg/ml—if the vial contains 1500mg, that would be a total of 50ml
Why Needed:
To determine which rule most applies:
5.1.8 Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as “eaches”, not the number of boxes, packages, grams, or milliliters.
Or 5.2.3 Reconstitutable Non-injectable Products must be billed as the total number of milliliters (ML) dispensed after reconstitution;
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Anticipated Outcome:
Discussed vial email among Prod Review & Exception TG members: outcome was “ML”. Discussed again during Prod Review & Exception TG in Jan: “Each” was the outcome
TG Discussion (1/22/19):
* This product is similar to ZMAX which is listed as 1 each.
* For consistent application of the BUS, recommend using the same for Gleolan.
* Gleolan is single dose.
* Label states 1 vial; in tiny print it does mention the 50 mL
* On DailyMed, in section 3 of the drug label it does mention the result of the reconstitution but have to hunt for this information. It would not be readily available to the pharmacy.
* Recommend BU= EACH with PS=1 per section 5.1.8 of Billing Unit Standard so there is consistent application of the BUS. (Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as “eaches”,
not the number of boxes, packages, grams, or milliliters). The task group agreed.
WG Discussion (2/7/19):
At this meeting, a motion was made and seconded to classify BU=EA and PS=1 per section 5.1.8 of the Billing Unit Standard. The motion carried.