Dermatologist concerns rejected: topical mometasone to be available OTC from June


By Michael Woodhead

18 May 2020

The TGA has rejected safety concerns from dermatologists about rescheduling of topical mometasone and has confirmed it will be made available over the counter in pharmacies from 1 June.

In 2019 the Australasian College of Dermatologists strongly opposed an interim decision by the TGA’s Advisory Committee on Medicines Schedule (ACMS) to permit OTC sale of 15g packs of topical mometasone 0.1% for skin conditions such as atopic dermatitis.

However the concerns raised by the ACD – such as the adverse event risks of a potent corticosteroid and the ability of pharmacists to diagnose skin conditions – were not considered valid reasons by the TGA Committee to prevent OTC sales of topical mometasone.

In its final decision the ACMS downplayed the risks of mometasone saying that “potency does not equate to toxicity” and noted that mometasone had lower systemic toxicity than other topical steroids. The Committee said the available evidence does not support a significant risk of skin atrophy with mometasone, and the risk could be managed by including labels and warnings that the product should not be used on the face or for more than four weeks without medical advice.

It also said there would be minimal risk of HPA suppression with topical mometasone, because of its  low systemic bioavailability.

“In addition, the 15 g pack size limitation will also mean that patients with extensive disease requiring access to large quantities will continue to be appropriately managed by a general practitioner or dermatologist,” it said.

The Committee also believed pharmacists had the ability to perform a differential diagnosis in the supply of mometasone for conditions such as fungal infections and herpes zoster infection.

“Pharmacists are already able to initiate treatment with Schedule 2 and Schedule 3 steroids based on their differential assessment of a patient’s condition. There is no evidence to suggest that pharmacists are unable to recommend appropriate treatments and therefore, I do not consider this to present a barrier to down-scheduling.”

The TGA therefore confirmed its earlier decision to approve the sale of mometasone without prescription on the grounds that “poorly controlled skin conditions can result in significant impairment of quality of life … [and] easier access to limited amounts of a potent topical corticosteroid can assist suitable patients in managing these conditions.”

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