Mixed results on scheduling


tug of war vector

Migraine treatment and immediate release ibuprofen set to be downscheduled, but no change to status of another high profile medicine 

The migraine treatment eletriptan is to move to Schedule 3 (Pharmacist Only), the TGA has announced today. 

The TGA’s Advisory Committee on Medicines Scheduling (ACMS) decided at its June 2020 meeting to create a new S3 listing for “Eletriptan for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms”.

“I find that the eletriptan satisfies the Schedule 3 scheduling factors on the basis that the risk profile of eletriptan is well defined and the risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist,” the TGA delegate said.

“I am satisfied that the risk of adverse events, including cardiovascular events, can be minimised through
pharmacist-consumer consultation.

Pharmacists will exercise profession judgment on the migraine pattern of the presenting patient and if necessary, refer the patient for verification of diagnosis by a medical practitioner.”

The move is set to take place on 1 February 2021.

There was not such good news for those seeking greater accessibility for sildenafil, with a decision made to reject a downscheduling of the ED medication, which will remain Schedule 4 (Prescription Only).

“I have made an interim decision not to amend the current Poisons Standard in relation [to] sildenafil, specifically not to down-schedule certain preparations of sildenafil from Schedule 4 to Schedule 3,” the TGA delegate said.

A lack of oversight and follow-up in the pharmacy sector were among the reasons given by the delegate for the decision.

“I have considered the views expressed in the public submissions and those of the applicant, suggesting that down-scheduling sildenafil to Schedule 3 would create ease of access, increase awareness of ED and enable early engagement with the healthcare system. However, no data has been provided to substantiate these claims or clearly articulate how these benefits would apply to men’s health in general,” the delegate said.

“Having considered the need for medical practitioner oversight and the risks to consumers with the lack of patient follow up in a pharmacy setting, I am of the firm view that the current scheduling of sildenafil under Schedule 4 is appropriate.”

An application to broaden public access to immediate release ibuprofen has been more successful, with the ACMS amending the Schedule 2 entry to add ibuprofen “in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled: not for the treatment of children under 12 years of age”, from 1 February 2021.

“It is my view that the net benefits of broadening the availability of immediate release ibuprofen
with restrictions placed on age, dosage form and pack size, combined with warning labels,
outweighs the potential risks associated with improper use,” the TGA delegate said.

“I have made the decision to limit the new entry to immediate release formulations, as modified release ibuprofen has limited clinical experience and a very different use profile. Ibuprofen modified release is designed to help manage recurrent or chronic pain and therefore requires pharmacist intervention to ensure the quality use of the medicine.

For this reason, modified release ibuprofen should remain in Schedule 3 and has been excluded from this amendment”.

In good news for pharmacy, the ACMS decided against open sales for oxymetazoline, used for symptomatic relief of nasal congestion.

“In my view, access to oxymetazoline in a pharmacy allows for the provision of pharmacist advice to mitigate the risk of inappropriate use,” the delegate said.

“I am concerned that access to oxymetazoline at the general sales level, without pharmacist input, will lead to adverse effects from overuse and rebound congestion from prolonged use.”

The delegate also decided not to amend the current Poisons Standard in relation to clotrimazole, “specifically not to down-scheduling clotrimazole in vaginal preparations from Schedule 3 to Schedule 2”.

“It is my view that pharmacist intervention, currently in place, is the critical mitigating factor to ensure the quality use of clotrimazole 1% in preparations for vaginal use. Increased consumer availability as a Schedule 2 medicine would remove the opportunity for direct pharmacist consultation and increase the potential for harm to consumers”.

Meanwhile, stakeholders have welcomed an interim TGA decision to downschedule low-dose cannabidiol to S3 – but the peak pharmacist body warns that evidence and therapeutic purpose are key. Read more here

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1 Comment

  1. Jarrod McMaugh
    10/09/2020

    there was some interesting decisions around CBD as well….

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