Pharmacy Daily | Scheduling decisions confirmed

DECISIONS to down-schedule certain preparations of migraine treatment, eletriptan, and anti-inflammatory, ibuprofen, from 01 Feb 2021 have been confirmed by the Therapeutic Goods Administration (TGA) (PD 10 Sep).

However, a third bid to make erectile dysfunction treatment, sildenafil, Pharmacist-Only, has again come up short.

In the TGA's Notice of final decisions to amend (or not amend) the current Poisons Standard, released this morning, the Delegate of the Secretary of the Department of Health announced a new Schedule 3 Appendix H entry for eletriptan tablets containing 40mg or less per tablet, when in a pack containing not more than two dosage units.

"[Eletriptan] satisfies the Schedule 3 scheduling factors on the basis that the risk profile of eletriptan is well defined and the risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist," the Delegate said in its interim decision.

"I have decided to include a pack size limit in the new S3 entry to mitigate the risks of medication overuse headache, unintentional and intentional overdose."

The Delegate also confirmed the decision to amend the S2 entry for ibuprofen in divided immediate release preparations containing 400mg or less of ibuprofen in a primary pack with a maximum of 12 dosage units, when labelled "not for the treatment of children under 12 years of age".

Announcing its decision not to amend the current Poisons Standard for sildenafil to S3, the Delegate noted the Pharmaceutical Society of Australia (PSA) had issued a submission supporting calls to down-schedule the medication.

However, the Delegate said, "no new information has been provided to mitigate my concerns that the down-scheduling of sildenafil may lead to risk for consumers accessing sildenafil without medical intervention and lack of follow-up".

The delegate also decided against amending the scheduling of oxymetazoline and clotrimazole.

It also confirmed that decisions relating to amendments to the current Poisons Standard for nicotine and cannabidiol will be made in mid and late Dec respectively.