Proposal to increase pack sizes for general sale of ranitidine rejected

Pharmacist intervention for the drug is “critical”, says delegate, while further interim decisions were made to downschedule rizatriptan, modified release melatonin and topical adapalene

An interim decision has been made to reject a proposal to increase the pack sizes available for general sale and in pharmacies for ranitidine, based on ACMS advice that the current scheduling for the drug “remains appropriate”.

“It is my view that pharmacist intervention, currently in place, is the critical mitigating factor to ensure the quality use of ranitidine,” said the Delegate of the Secretary of the Commonwealth Department of Health.

“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,” they said.

“Whilst ranitidine has a favourable safety profile, there is no compelling evidence to suggest that current access is inadequate. In my view, the benefit of convenience does not sufficiently outweigh the risk of harm associated ranitidine use set out above.”

The Delegate also considered a proposed group entry for Selective Serotonin Reuptake Inhibitors (SSRIs) in the Poisons Standard.

While there are a number of individual SSRIs captured in Schedule 4 of the Poisons Standard, including citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline, the Poisons Standard does not currently contain a group entry for SSRIs.

It has been argued that emerging SSRIs that are not derivatives of specifically scheduled SSRIs are effectively unscheduled, and therefore an SSRI group entry would automatically capture future unnamed or unscheduled SSRI variants in Schedule 4.

In its public submission to the committee, the PSA said it has “no objections to the creation of a new S4 group entry for SSRIs”.

The Pharmacy Guild of Australia added: “We believe that it would be reasonable for a group entry for SSRIs to be included in the Poison Standard as this would capture emerging SSRIs that are not derivatives of specifically schedule SSRIs.”

However based on advice from the Advisory Committee on Medicines Scheduling (ACMS), which did not recommend a SRRI class entry, a Delegate of the Secretary made an interim decision against the proposal.

“I find it problematic that the group entry, as proposed, is ambiguous in its intended capture,” said the Delegate.

“I have considered a scenario where a substance that satisfies the risk profile for Schedule 4 may not be captured by the proposed group entry.

“I have also considered an alternative scenario whereby lower risk substances may be inadvertently captured by the group entry. In addition, the group entry, as proposed, is likely to create uncertainty with respect to herbal extracts with potentially SSRI-like action e.g. St John’s Wort.”

They added: “I have not identified compelling evidence that establishes the provision of an SSRI group entry is required to be in place to protect health.”

Meanwhile interim decisions were made to amend entries for several medicines:

  • Downscheduling of rizatriptan from Schedule 4 to Schedule 3, 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.
  • Downscheduling of melatonin from Schedule 4 to Schedule 3, in modified release tablets containing up to 2 mg of melatonin for the treatment of primary insomnia for adults aged 55 or over, in packs containing not more than 30 tablets.
  • Downscheduling of adapalene from Schedule 4 to Schedule 3, in topical preparations containing 0.1% or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age.
  • Broadening availability of fexofenadine to general sale in 180mg tablets (5 day supply) for people aged over 12 years. The Guild stated that it does not believe it is in the public interest to further increase the scheduling exemption to allow increased quantities and strengths of fexofenadine to be available in general retail where there is no access to health professional advice.
  • Broadening availability of flurbiprofen to the general sale level with restrictions placed on age and dosage form combined with warning labels. The Guild said it believes the current scheduling remains appropriate.

Interested persons are invited to make submissions to the Secretary in relation to the interim decisions on or before 9 July 2020.

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