Not satisfied with the February 1 upschedule of low-dose codeine, one stakeholder has applied to upschedule some codeine-containing products to S8

A proposed amendment to the scheduling of codeine has been referred to the June 2018 meeting of the Advisory Committee on Medicines Scheduling which could make it even tougher for consumers to access codeine-containing preparations.

The private applicant has asked the ACMS to amend the Schedule 4 and 8 entries for codeine to:

  • up-schedule codeine from Schedule 4 to Schedule 8 when in divided preparations containing more than 12mg of codeine per dosage unit;
  • up-schedule codeine from Schedule 4 to Schedule 8 when in undivided preparations containing more than 0.25% of codeine; and
  • amend both Schedule 4 and 8 entries for codeine to reflect these changes.

This means that codeine-containing preparations in Schedule 4 could only contain 12mg or less of codeine per dosage unit, down from 30mg.

Panadeine Forte contains 30mg (in combination with paracetamol) and would thus be captured into the S8 schedule.

The reasons listed for the proposal include the aim of addressing “scheduling inconsistencies” highlighted in the Regulation Impact Statement (RIS).

“This will be achieved by moving high dose codeine-containing medicines and single ingredient 30mg codeine into Schedule 8 where, as suggested by the RIS, these products belong,” the amendments consultation reads.

The change would also ensure that by moving these products to S8, they would be subject to monitoring by State and Territory Real Time Monitoring Systems, which differ across jurisdictions as to whether they examine S4 drugs.

Meanwhile, another proposal before the ACMS seeks to amend the Schedule 3 entry for paracetamol to allow the S3 primary pack size, when combined with ibuprofen, to be increased from 30 to 50 dosage units.

Reasons listed for this proposal include the long-standing availability of both medicines without prescription in Australia and the fact that fixed dose combinations of the two “offer greater analgesic efficacy at a lower dose while maintaining the acceptable safety profile of each active alone”.

The larger pack sizes could allow pharmacists to exercise greater discretion in assisting patients with acute intermittent strong pain, and offer a safer, more economical and convenient alternative to the stronger analgesics available through medical practitioners, the applicant says.

Submissions regarding the proposed changes must be received by close of business Thursday 10 May 2018.