EMERGENCY contraception pill ulipristal acetate (EllaOne 30mg by MS Health) was included on the Australian Register of Therapeutic Goods (ARTG) on 06 Mar 15, but is now slated for an over the counter (OTC) schedule 3 listing effective 01 Feb 18, as a one of the final decisions by the Health Department delegate in line with recommendations by the Advisory Committee on Medicines Scheduling (ACMS #20).
Ulipristal inhibits or delays ovulation by stopping the surge in lutenising hormone prior to ovulation.
The amended listing supports the sponsor's submission for the drug to be scheduled "for emergency post-coital contraception" as an Appendix H New Entry meaning it can be advertised to consumers.
The ACMS determined that S3 scheduling and allowing advertising together with the drug's "low toxicity and low potential for abuse" would benefit public health "since increased community knowledge may improve access to this product, which will likely reduce the incidence of unplanned pregnancies".
Pharmacist counselling and supply was also cited as reducing the risk of misuse and ulipristal is also "not an abortifacient, therefore risk of 'abuse' is minimal".
The delayed start date will "give some lead time for pharmacists to gain experience with the relatively new Schedule 3 listing," the TGA announcement said.
Ibuprofen is also now approved by the ACMS for marketing from 01 Oct 17 in a modified release dosage form containing 600 mg per dosage unit in packs of 32 or less dosage units when labelled with a recommended daily dose of 1200 mg or less and not for the treatment of children under 12 years of age.
The new extended release form will be schedule 3 which the committee saw as comparable with the scheduling status of naproxen 600 mg modified release, diclofenac 25 mg immediate release and paracetamol 665 mg sustained release.
Advertising of this schedule 3 product is also permitted, with an Appendix H entry on the basis that "there is a public health interest to inform consumers about pain relief options through advertising".
In addition this listing "will give consumers access to a product for pain relief that is longer-lasting than currently available products" and "the potential for abuse and toxicity are low and in line with existing ibuprofen products".
Pharmacist intervention will also help consumers manage any risks, the TGA noted.
The above article was sent to subscribers in Pharmacy Daily's issue from 30 Jun 17
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 30 Jun 17