Change on the agenda

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Sildenafil, cannabidiol and ibuprofen among those to be considered for rescheduling 

Australia’s medicine scheduling body is to consider another request to have sildenafil (Viagra) rescheduled.

The June joint meeting of the TGA’s Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) will hear recommendations for the scheduling of a number of important medicines.

Among those is sildenafil, with a proposed changed to see a new Schedule 3 listing for the medicine in “divided preparations for oral use containing 50 mg of sildenafil per dosage unit in packs of not more than 4 dosage units in accordance with the requirements of Appendix M”.

“The availability of sildenafil in pharmacy after initial prescribing by a medical practitioner will be of particular benefit to men without ready access to medical facilities (e.g. shift workers or people in rural or remote areas),” the proposal states.

“Pharmacies are well distributed in urban and rural areas throughout Australia with wider, more flexible operating hours than physician practices. They offer direct and convenient access to professional health care and treatment advice”.

Another proposal to be heard at the June scheduling meeting is for a further downscheduling of ibuprofen. The proposal seeks to amend the S2 listing for ibuprofen “in divided preparations, each containing 400mg 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.”

The most recent attempt to reschedule sildenafil was rejected in 2018.

A further proposal seeks changes to the scheduling of cannabidiol, with a Schedule 4 listing.   

“The benefit/risk ratio is such that cannabidiol (CBD) formulations in which 98% or greater of the cannabinoid content is CBD and where the upper limit to THC content is 0.2% (by dry weight), should not be regulated as an unapproved medicine through its inclusion on Schedule 4 of the SUSMP, but instead, regulated as listed, assessed-listed or registered medicines (depending on the level of therapeutic claim) under the Australian Register of Therapeutic Goods (ARTG),” the proposal states.

“Given its clear evidence of benefits, good safety profile and low risk, it should be regulated as a complementary medicine in the same way that other plant medicines (herbal medicines) are regulated in Australia.”

The full listing of scheduling proposals can be viewed here.

Public notice of the interim decisions from the meeting are due to be released in early September.

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