Changes to diclofenac, fluticasone and cannabis schedules confirmed by TGA
The TGA’s Advisory Committee on Medicines Scheduling has confirmed earlier decisions to alter the scheduling of a number of widely used medicines.
A provisional amendment to the entry for diclofenac, made earlier this year, was confirmed by the ACMS. The revised Schedule 2 entry for diclofenac will increase the amount for exempt preparations for dermal use ‘except when labelled for the treatment of solar keratosis’ from 1% to 2% or less of diclofenac.
“Serious adverse events are rare and the likelihood of adverse effects with the topical product is lower than with oral products and is no greater than for the same daily dose using the 1% product,” the ACMS delegate states in their reasoning for the change.
Another confirmed amendment sees the removal of the limit of 200 actuations previously required under the Schedule 2 entry for fluticasone.
The decision sees the S2 entry for fluticasone read that it is available in “aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms , for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over”, and takes out the added requirement “when packed in a primary pack containing 200 actuations or less”.
“The benefit:risk profile of the fluticasone is highly favourable,” the committee found.
“Extensive post-marketing experience has established that the likelihood of off-label use is extremely low and that abuse or misuse of the fluticasone in this treatment setting is unlikely to be a significant problem”.
Meanwhile, amendments have also been made to the Schedule 4, Schedule 8 and Appendix K entries for cannabidiol, cannabis and tetrahydrocannabinols “to ensure that the cannabidiol entry is clearly understood”, the TAG said.
There had been queries “at both Commonwealth and state/territory level on the meaning of the cannabidiol entry and how it affects products,” the TGA said, prompting the reconsideration and rewording agreed to by the ACMS at its March meeting.
The S4 entry now specifies it is for Cannabidiol in preparations for therapeutic use in which:
- cannabidiol comprises at least 98 per cent of the total cannabinoid content of the preparation; and
- any other cannabinoids present are only those naturally found in cannabis, and are present only as unavoidable impurities in the cannabidiol component of the preparation.
The Appendix K entry specifics it includes Cannabis and Tetrahydrocannabinols except when included in Schedule 4.
The S8 entry covering Tetrahydrocannabinols has been adjusted to identify that it is not included in S8 when in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols.