Scheduling changes on the agenda


changes ahead sign

New proposals may see pharmacists dispensing downscheduled allergic rhinitis, migraine treatments, while caffeine powders are to be effectively banned

The TGA’s medicine scheduling committee is set to rule on proposals to downschedule the migraine treatment Zolmitriptan and the allergic rhinitis drug Mometasone.

Both medicines will move largely to Schedule 3 (Pharmacist Only) if the changes are accepted, with the proposal using the new Appendix M category. 

The proposals will be considered at the November meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS).

The proposed scheduling for Mometasone would see it placed in S3 when Mometasone was “the only therapeutically active substance in preparations for dermal use containing 0.1 percent or less of Mometasone in packs containing 15g or less except when included in Schedule 2.

S2 Mometasone would remain available in lower dose packs containing 200 actuations or less for short-term use.

Specific pharmacist training would be required for provision of S3 Mometasone and it would only be supplied if the patient had a formal diagnosis by a medical practitioner (or periodic review of the condition) within the last 6 months, and specifically recommended mometasone.

Similar requirements would be in place for the acute migraine treatment Zolmitriptan, which has been proposed to move to S3 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 2.5 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets”.

The Appendix M requirements for this medicine would see it “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”.

Appendix M is intended to include substances that have “formerly been scheduled as Schedule 4 (S4) and have required a prescription by a medical practitioner, but if rescheduled to S3 could be dispensed by a pharmacist with specific controls in place that help to ensure appropriate use”.

Meanwhile, the same hearings will also review a proposal to schedule Caffeine Powders – a matter of current attention due to the recent death of a user. 

The move will see caffeine powders effectively banned from general sale by being added to the Poisons schedule (S6), except when moved prescribed to Schedule 4 except: 

  • in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
  • in undivided preparations with a concentration of 4 per cent or less of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine. 

“A recent fatality associated with inadvertent caffeine overdose suggests the current availability of pure or highly-concentrated caffeine powder presents a risk of poisoning,” the proposal states.

“Caffeine powder is readily available for sale and consumption on the Australian market via the internet and numerous pure or highly concentrated (>98%) caffeine powders have been advertised for sale online either on Australian websites or international websites that are available to the Australian public.

Appropriate labelling and control of all concentrated caffeine products would reduce the risk of inadvertent overdose”.

 

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