OFF-LABEL PRESCRIPTIONS IN DERMATOLOGY – CHALLENGES OF NEW ROUTES OF ADMINISTRATION FOR SOME OLD DRUGS
Abstract
"Off-label drug use" refers to prescription of medications for indications, dosage, dosage form, patient group or route of administration which are officially unapproved. Recently, new indications for some drugs emerged and few of them are being used off-label to treat topically a variety of dermatological conditions. Off-label use is more common in dermatology than in other medical specialties, and those drugs are basically available as compounded formulations, but the choice of a proper vehicle and safety of extemporaneous drug preparation intended for topical use are usually neglected in the case of systemic drugs. Moreover, bases commonly used as vehicles for extemporaneous dermatological preparations are stabilized with traditional surfactants known for their potential to irritate skin; while inflammatory dermatoses can worsen when exposed to irritants
In this paper, we have listed several systemic drugs which are being used in topical treatment of some frequent dermatological conditions, but not according to their officially approved indications. The choice of drugs was made according to the topical off-label dermatological prescriptions obtained from public pharmacies. The aim was also to review data related to, in our opinion, two major drawbacks of using off label topical drugs- safety data on the use of the final dermal preparation and scientific information relevant for choice of a proper topical vehicle for specific drug and proper stability evaluation.
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