Question: Given the current constraints of 503A & 503B, how would a Dermatologist legally order a bottle of compounded Cantharidin for in-office treatment of warts for his patients? How could the pharmacist legally dispense it? The amount of Cantharidin used is so small, it is impractical and not economical to provide this medication on a per-patient unit-dose basis. Also, Cantharidin, while a widely accepted treatment option by Dermatologists, is extremely caustic and would be best for the patient not to handle medication for their own safety.
Cantharidin should not be used to treat common warts due to paradoxical spread. The agent was proposed for the bulks list under the original FDAMA, and dermatologists recommend use for molluskum. There are important safety concerns with the active that require in-office application, and crystals are available for patient-specific in-office compounding. Even better if a drug company would sponsor development--I believe there are a few products that are patented and commercialized, but somehow avoiding the approval process (the non-self-insured may not be covered for unapproved drug use). Here's a great Pediatric Annals case challenge which includes a preliminary benefit-risk review:
http://www.childrensmercy.org/Content/uploadedFiles/Departments/Contact_Center/Referral_Forms/Dermatology/Mulluscum%20Contagiosum%20Cantharone%20Article.pdf?origin=publication_detail
Need to underscore VERY preliminary (limited) benefit-risk assessment--I'm not sure the cancer signal from animal studies has been adequately vetted re mitochondrial damage--doctors may not be following patients long enough or in enough numbers to observe/identify through clinical observation alone.
See:
http://cancerres.aacrjournals.org/content/32/7/1463.full.pdf
No comments:
Post a Comment