Do I Need to Consider Beyond Use Dating for Multi-dose Vial Medication?

The answer is YES! Multi-Dose Vials (MDV) for injection have Beyond Use Dates (BUD) that need to be followed. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer’s original expiration date. Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed.

The MDVs typically contain an antimicrobial preservative to help limit the growth of bacteria; however, over time, sterility can be impacted. All MDVs for injection will have a beyond use date – in some cases it is specifically identified in manufacturer labeling, in other cases it is not specified. If not specified, pharmacies will need to refer to The Joint Commission guidelines to assign BUD for multi-dose vials (explained below). Pharmacies should use the shorter date (beyond use OR days’ supply calculated per the instructions) when considering what days’ supply to submit (and corresponding refill intervals). Refer to the latest PAAS National® Insulin Medication chart for BUD information for various insulin vials. Remember that each insulin vial has its own BUD!

Example 1: Lantus® vial, 10 mL: Inject 20 units q HS = 1000 ÷ 20 = 50-day supply but should be discarded 28 days after opening (first needle puncture)

Example 2: Levemir®, 10 mL: Inject 20 units q HS = 1000 ÷ 20 = 50-day supply but should be discarded 42 days after opening (first needle puncture)

Here are a few common questions & answers that may assist your pharmacy in filling and billing MDVs accurately:

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Q: Do I have to bill the correct days’ supply if it pushes the patient into a 2-month copay?

A: Most likely yes; if you are contracted for an extended days’ supply plan you must bill an accurate days’ supply. If the patient isn’t happy about their copay, pharmacy staff, or the patient, could try to call customer service in an attempt to obtain a copay override (since they are not getting a full 2 months). The pharmacy must submit the days’ supply as supported by the instructions for use and beyond use dating unless given specific approval in advance from the PBM help desk. Don’t forget to document any help desk calls using the 4-element clinical note format on the prescription hardcopy.

Q: When should multi-dose vials be discarded?

A: Medication vials should always be discarded whenever stability or sterility is compromised or cannot be confirmed. In addition, The Joint Commission recommends the following for multi-dose vials of sterile pharmaceuticals:

  • If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial
  • If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer’s expiration date

PAAS Tips:

  • Always bill for the exact days’ supply as many plans have days’ supply overrides built in for certain medications
  • If no override is available, bill for the plan limit and document ILQ (Insurance Limits Quantity) – see Proactive Tips Can You Bill It as 30 Days on the PAAS Member Portalunder ‘Proactive Tips’
  • Document on hard copy – billed as 28-day supply due to The Joint Commission guidelines (when appropriate)
  • Counsel patient on the BUD – put BUD on patient label

Kristen Sterzinger
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