Dermatologists and the AMA are opposing a TGA proposal to down-schedule topical mometasone products (0.1% or less in packs of 15g or less) from a Schedule 4 to a Schedule 3 drug.
In a submission to the TGA Advisory Committee on Medicines Scheduling (ACMS), the AMA said dermatologist and GP members were unanimous that the risks to patients of misuse and prolonged use were high with no apparent advantages to patients.
The submission highlighted a number of safety issues with the topical corticosteroid including suppression of adrenal function and skin atrophy.
“Used appropriately, in the context of an established diagnosis and management plan, these are invaluable and safe products; but the key is accurate diagnosis. Pharmacists do not have the competency to accurately diagnose skin disease,” the submission said.
“Consequences of incorrect diagnosis can be significant if, for example, a potent steroid is used on an infective condition such as impetigo or a fungal infection.”
The AMA said treatment of chronic dermatoses requires a clear management plan, which may include, but not solely, the appropriate use of appropriately selected topical corticosteroids.
“The provision of a single increased potency agent would not encourage appropriate usage by pharmacists since many other choices are not available as S3.”
Melbourne dermatologist Professor Rod Sinclair told the limbic that just because doctors prescribe it safely, did not mean that mometasone was without safety issues.
“In particular it should not be used on the face due to the risk of aggravating acne and rosacea and it can actually induce perioral dermatitis. It should not be used in the flexures as it can induce stretch marks.”
“I think we will have to watch very carefully as to how it is used and document the surge in complications related to misuse and inappropriate use.”
The proposal to downschedule mometasone topical products is based on claim that it has “superior efficacy and comparable side effect profile to other OTC topical corticosteroids, such as hydrocortisone and clobetasone”
“The switching of mometasone 0.1% to Schedule 3 is expected to result in considerable cost savings to the government and the consumer through awareness and access to an effective topical corticosteroid with an acceptable risk-benefit profile,” a consultation document states.
The proposal is to be considered at the ACMS March 2019 meeting.