Downscheduling welcomed


time for change clock

Guild applauds downscheduling of migraine treatments as latest medicines scheduling decisions are revealed

The Pharmacy Guild of Australia has welcomed the confirmed decision to down-schedule the migraine treatments sumatriptan and zolmitriptan to S3, or pharmacist-only, medicines.

In a decision released on Thursday 7 May, the Therapeutic Goods Administration (TGA) scheduling committee decided Sumatriptan would be in Scheudle 3 “when in divided oral preparations containing 50 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 symptoms”.

Similarly, Zolmitriptan would be in S3 “when in divided oral preparations containing 2.5 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 symptoms”.

Both decisions would come into effect from 1 February 2021. 

Guild national president George Tambassis said the decision to down-schedule the medicines was a good outcome for patients.

“Patients don’t know when a migraine is coming on and so have had to try to manage their medicines by having a prescription on hand in case they needed to fill it,” he said.

“This very sensible decision by the delegate means that patients who have a stable, well-established pattern of symptoms, will be able to access sumatriptan and zolmitriptan for the acute relief of migraine when and where they need it”.

“Importantly, being pharmacist-only medicines will ensure that patients receive the counselling and advice to ensure they are taking the medicine appropriately,” Mr Tambassis said.

“In its decision the TGA pointed to the fact that the ‘access controls in place for a Schedule 3 medicine are appropriate and sufficient to mitigate the misuse’ of these medicines.”

Meanwhile, the TGA scheduling delegate confirmed their “final decision to schedule paracetamol in liquid preparations for oral use in Schedule 3 except when in Schedule 2 as liquid preparations for oral use containing a maximum of 10 g of paracetamol per container”.

The main points provided in support of the interim decision were:

• The scheduling proposal in the Delegate’s interim decision takes into consideration the
appropriate balance between patient access to medicines and safety.

• The Delegate’s interim decision on paracetamol (liquid formulations) is supported to the extent
that current marketed products will not be affected by the decision.

This change comes into effect on 1 June 2020.

The delegate also confirmed “the reasons for my final decision to create new Schedule 4 and Schedule 6 entries for caffeine,” also from 1 June.

The delegate did, however, decide to vary the interim decision not to down-schedule mometasone for dermal use from Schedule 4 to Schedule 3, and introduce an actuation limit for mometasone.

“I find that mometasone for dermal use meets the Scheduling Factors for Schedule 3 without the requirement for an Appendix M entry; that the introduction of an actuation limit for intranasal mometasone in Schedule 2 is not required; and that in the interests of public safety, mometasone should not be
included in Appendix H,” the delegate said.

The new S3 listing is for Mometasone “as the only therapeutically active substance in preparations for dermal use containing 0.1 percent or less of mometasone in packs containing 15 g or less”.

 

 

Previous Allergic rhinitis: more than a sniffle & a sneeze
Next The week in review

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.