The TGA has ignored the concerns of dermatologists and will allow over the counter sales of the topical retinoid adapalene from next year.
In an interim decision announced on 10 June, the TGA’s Advisory Committee on Medicines Scheduling approved an application for adapalene to be down-scheduled to Schedule 3 ‘Pharmacist Only Medicine’.
The decision means that from June 2021 the topical retinoid will be available from pharmacies in packs containing less than 0.1% adapalene without prescription for the treatment of acne in adults and children over the age of 12.
The proposal was strongly opposed by the Australasian College of Dermatologists and the AMA, who said there were serious risks of adverse health effects with adapalene if it is made available without prescription.
In a submission to the TGA the College warned that adapalene may be highly irritating to the skin and its appropriate use requires monitoring and instruction by a medical practitioner.
Pharmacists were not qualified to provide counselling on correct use of topical retinoids such as advising on the differences in absorption between anatomical locations, frequency and duration of use, and knowledge of adjunctive skin care treatments, the College said.
It also emphasised that an accurate diagnosis of acne is needed before using a topical retinoid, and it is not condition that should not be self treated by a consumer with advice from a pharmacist.
Acne could be mistaken for other skin conditions such as papular rosacea, for which adapalene may induce significant aggravation, the College submission said.
“There may also be a need to examine other areas of the body such as the back and chest and the pharmacy setting is not an appropriate setting to do so.
But in its decision the TGA said the only serious concern for adapalene was the teratogenicity, which was unlikely to occur with topical formulations that required 150 times the dose of oral preparation to induce birth defects.
“I am satisfied that pharmacists are suitably qualified to be able to assess and counsel patients to ensure the quality use of adapalene under a Schedule 3 classification,” the TGA assessor said. “I am additionally reassured that product labelling, implemented through other legislation, is a mitigating factor to protect against the risks to pregnancy.”
However the TGA did not allow a proposal to allow cosmetic use of adapalene.
Further submissions in relation to the interim decisions can be made to the TGA before 9 July 2020.