Audit Alert: Topical Nail Treatments

Manufacturer guidelines for Jublia^® indicate a patient should use one drop per toenail with the big toe requiring a second drop. A representative from the manufacturer responded to an inquiry from PAAS National^® stating there are approximately 200 applications per 4 mL bottle. Confirm with the prescriber’s office how many nails are being treated (including if any big toes are affected), document with a clinical note, and update the patient’s label to include the clarification. If there is no indication of a big toe being treated, it will be assumed that it is not. Penlac^® is similar to Jublia^®; however, the manufacturer does not indicate how many applications are in each bottle. PAAS recommends using the same calculations as you would for Jublia^®.

Jublia^® example:

• “Apply to 4 affected toenails including both big toes once daily”
• 2 small toes + 2 big toes = (1 application x 2 small toes) + (2 applications x 2 big toes) = 6 applications/day
• 4 mL = 200 applications ÷ 6 applications/day = 33 days’ supply
• 8 mL = 400 applications ÷ 6 applications/day = 66 days’ supply

Penlac^® example:

• “Apply to 4 affected toenails including both big toes once daily”
• 6.6 mL = approximately 330 applications ÷ 6 applications/day = 55 days’ supply

Kerydin^® comes packaged in a 4 mL or 10 mL bottle. A representative from the manufacturer responded to an inquiry from PAAS stating each mL of the product contains 60 drops, therefore the 4 mL bottle has 240 drops and the 10 mL bottle has 600 drops. The representative went on to state patients should use 1-2 drops per treatment of the toe, with big toes requiring 3-4 drops per treatment. Kerydin^® has the same clinical note documentation requirements as Jublia^® and Penlac^® regarding which toes are affected, and the clarification being added to the patient’s label.

Kerydin^® example:

• “Apply to 4 affected toenails including both big toes once daily”
• 2 small toes + 2 big toes = (2 drops x 2 small toes) + (4 drops x 2 big toes) = max 12 drops/day
• 4 mL = 240 drops ÷ 12 drops/day = 20 days’ supply
• 10 mL = 600 drops ÷ 12 drops/day = 50 days’ supply

PAAS Tips:

• Clinical notes should contain four elements:
  • Date
  • Name and title of who you spoke with
  • What was discussed
  • Your initials
• Do not use PBM “drops per mL” general estimates to determine days’ supply
• Clarify number of toes being treated, including whether the big toe is being treated
• Update the patient label to include the clarification
• If patients are requesting early refills, confirm they are applying correctly
• Refer Jublia^® patients to the manufacturer website for an instructional video