Mixed decisions from scheduling committee

Ranitidine set to remain an S3 medicine, while TGA decides to downschedule migraine and acne treatments

The Therapeutic Goods Administration (TGA) scheduling delegate has confirmed that the reflux treatment ranitidine (Zantac) will not be downscheduled, and has also knocked back a proposal for a Selective Serotonin Reuptake Inhibitors (SSRIs) class entry.

However, the migraine treatment Rizatriptan and acne medicine Adapalene will both be rescheduled to S3, the delegate said.

The final decisions on proposed amendments referred to the TGA’s Advisory Committee on Medicines Scheduling (ACMS) for its March 2020 meeting were released this week.

The delgate confirmed that ranitidine would remain Pharmacy Only (S2): “My view is that the current scheduling of ranitidine is appropriate,” they said.

“Pharmacist intervention, currently in place, is the critical mitigating factor to ensure the quality use of ranitidine. Increased pack sizes of ranitidine available at the general sales level and Schedule 2 would remove the opportunity for pharmacist interaction and increase the potential for harm to consumers,” the delegate said.

A proposal to have a group entry for Selective Serotonin Reuptake Inhibitors (SSRIs) was also rejected, with the delegate saying “I have not identified compelling evidence that establishes the provision of an SSRI group entry is required to be in place to protect health”.

Among the medicines that is to be downscheduled is rizatriptan, which will now have a new Schedule 4 listing “when in divided oral preparations containing 5 milligrams or less per dosage unit and when sold 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 migraine symptoms”.

“Rizatriptan is most effective when taken as soon as possible following the onset of a migraine, “the delegate said.

“It is my view that timely access to rizatriptan is a critical factor to improving patient outcomes. Removing the requirement for, patients with a confirmed diagnosis of migraine, to obtain a prescription from a GP will promote prompt access rizatriptan”.

Also moving to S3 is adapalene. It’s new Schedule 3 listing is for its use in “topical preparations containing 0.1 per cent or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age”.

“Adapalene is a topical retinoid indicated for comedo, papular or pustular acne of the face, chest and back,” the delegate said.

“It is a potent modulator of cellular differentiation, keratinisation and inflammatory processes, all of which are features in the pathology of acne vulgaris. I made a decision to restrict the indication to acne vulgaris to capture the current approved indication”.

“I consider 0.1% to be a relatively low cut off in the context of products currently available on the market. Consumer consultation with a pharmacist is necessary to reinforce and/or expand on aspects of the safe use of adapalene at the proposed concentration,” they said.

“I am satisfied that, with pharmacist intervention, supply single ingredient preparations, and the low strength combination preparation can be supplied without medical practitioner intervention”.

The delegate rejected a proposal to include cosmetic use in the Schedule 3 entry “because the safety and efficacy of adapalene for cosmetic use has not been demonstrated”.

As reported in AJP last week, the delegate deferred their final decision on melatonin and called for further public submissions on proposed changes.


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