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Interim decisions and invitation for further comment on substances referred to the March 2019 ACMS/ACCS meetings
Scheduling of chemicals and poisons
1.4. Interim decision in relation to mometasone
1 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #26, March 2019)
1.4. Interim decision in relation to mometasone
For the reasons set out below, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision under regulation 42ZCZN to amend the current Poisons Standard in relation to mometasone as follows:
MOMETASONE except when included in Schedule 2.
MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms
Proposed date of effect of the proposed amendment: 1 October 2019
Reasons for the interim decision (including findings on material questions of fact):
I agree with the committee's finding that the relevant matters of section 52E of the Therapeutic Goods Act 1989 are unable to be addressed for the purposes of amending the Schedule 4 entry for mometasone without clarification of the risk mitigation measures to support a Schedule 3 entry via Appendix M.
I agree with the committee's finding that the Schedule 2 entry for inhaled mometasone be amended as proposed by the Applicant. In addition, I agree with the Secretariat's proposed editorial change in the schedule order of the index entry.
In my view, the relevant parts of the SPF, 2018 are the sections on the Scheduling Factors for Schedules 4, 3, 2 and the considerations for amending Appendix H and M.
Reasons for interim decision:
I have made the decision to retain the current Schedule 4 entry for mometasone, and to amend the Schedule 2 entry for mometasone for the reasons set out below.
The change to the Schedule 2 entry for mometasone in aqueous nasal sprays to add 'when packed in a primary pack containing 200 actuations or less' was supported because prior to this change, there was no limit on the number of actuations supplied for treatment of up to six months. Whereas this amendment means that the Schedule 2 supply will have a limit requiring return of the patient to a pharmacy for resupply and possible consultation with a pharmacist. For the treatment of adults, the usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total daily dose 200 micrograms). It is recommended that the dose is reduced to one spray in each nostril (total daily dose 100 micrograms) for maintenance treatment. A delivery device containing up to 200 actuations would permit fifty days of prophylaxis and treatment and/or 100 days of maintenance.
The basis on which I have decided to not down-schedule mometasone from Schedule 4 to Schedule 3 as proposed by the Applicant are as follows. Among other things, I consider the issues relevant to this matter include that the diagnosis, management or monitoring of the medical condition is such that it requires medical intervention before the mometasone is used:
- consumers and/or pharmacists are not best placed to perform a differential diagnosis in the supply of mometasone (e.g. fungal infections, herpes zoster, infection);
- retention of mometasone in Schedule 4 will support better patient outcomes as any failures in the treatment of conditions with existing mild to moderate potency over-the-counter corticosteroids will be a signal that medical intervention is required;
- mometasone is classified as a Class III (potent) topical corticosteroid and there are systemic adverse events associated with medically unsupervised and inappropriate use; and
- inappropriate application of topical mometasone to the face can lead to significant skin problems including corticosteroid induced rosacea on the face (perioral dermatitis) and skin atrophy.
After taking into account the matters stated above, I find that the Scheduling Factors under Schedule 4 are met and that the existing Schedule 4 entry remains appropriate.
I am not sufficiently persuaded that the down-scheduling of mometasone will necessarily offer any additional benefit to the community given that existing provisions allow for 3 days emergency supply for a previously diagnosed condition in the absence of a prescription at the time of supply. From my understanding of the data, the mild corticosteroids in Schedules 2 and 3 appear to be supplied and used appropriately. I have not identified evidence from either pharmacists or consumers of any demand for, or unmet need for, a higher potency corticosteroid to be available without prescription. While '0.1 per cent or less of mometasone in packs containing 15 g or less' may possibly meet the Scheduling Factors for a Schedule 3 medicine, on balance, I consider the caveats to be too substantial, especially in the absence of clarification of the risk mitigation measures, to support a Schedule 3 entry. For the reasons referred to above, I have decided to retain the current Schedule 4 entry for mometasone.
From my reading of the application it was unclear what additional conditions or controls would be included in Appendix M that would support the proposed down-scheduling to Schedule 3, as pharmacists are already familiar with corticosteroids. Clarification of the risk mitigation measures to support a Schedule 3 entry via Appendix M is required. In the absence of proposed additional controls or supply requirements which would support a Schedule 3 entry, I have decided that an entry for mometasone should not be included in Appendix M.
I have made the decision that mometasone should not be included in Appendix H of the Poisons Standard on the grounds that there is a long history of the over-the-counter availability of topical corticosteroids which the community is familiar with. In addition, it is my view that there may only be limited additional benefit from the advertising of a more potent option and the choice of agent is best managed through consultation with the pharmacist.