Scheduling decisions see migraine treatments move to Pharmacist Only status, while liquid paracetamol S2 sales to be restricted from mid-year
Proposed medicines scheduling changes will see the migraine treatments Sumatriptan and Zolmatriptan move to Schedule 3 (Pharmacist Only) from early next year.
Also, there will be significant changes to sales of liquid paracetamol preparation scheduling from mid-2020.
The interim resolutions from the November 2019 meeting of the Advisory Committee on Medicines Scheduling (ACMS) were released late last week by the Therapeutic Goods Administration, and they reveal a number of significant changes.
From 1 February 2021 there will be a new S3 entry for Sumatriptan “for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets”.
Similarly, the S3 entry for Zolmitriptan is “for oral use when in tablets containing 2.5 milligrams or less per tablet and when in a pack containing not more than 2 tablets”.
Both products have been added to Appendix H and to Appendix M.
The Appendix M entry for Sumatriptan states it is to “be dispensed by a registered pharmacist who has assessed a patient’s symptoms to be consistent with an acute, episodic migraine attack; and that assessment and supply is consistent with expected professional standards of practice and specifically related clinical support tools and resources; and that a history of migraine or acute migraine treatment has ideally been verified e.g. via the patient’s My Health Record, or through previous prescribing/dispensing.
The pharmacist will record the supply of this medicine in their dispensary software, and include the patient’s name, address, date of birth and gender. The pharmacist will label product with patient’s name and directions for use and date of supply”.
Meanwhile, the ACMS also elected to restrict Schedule 2 sales of paracetamol in liquid formulations from 1 June 2020 to:
- Liquid preparations for oral use containing a maximum of 10 g of paracetamol per container;
- when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack
- in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules
The products will now be listed in Schedule 3:
- when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2
- in modified release tablets or capsules containing 665 mg or less paracetamol
- in liquid preparations for oral use except when in Schedule 2
The committee rejected the applicant’s request for these products to move into Schedule 4, saying the application appeared to contain a “mathematical error that will have a significant but unnecessary impact on existing liquid paracetamol products currently available in Schedule 2”.
“I am satisfied that potential risks associated with preparations containing greater than 10 g paracetamol per pack can be adequately controlled through pharmacist counselling via a Schedule 3 listing unless otherwise scheduled (e.g. for veterinary use),” the scheduling delegate concluded.
The delegate rejected a proposal to increase the S3 pack size of combined paracetamol + ibuprofen products from 30 to 50 dosage units.
In a note attached to the latest decisions, the ACMS said it was “reconsidering” its previous interim decision to not downschedule Mometasone from S4 to S3, and a new decision based on further advice would be published in April.