TGA recommends downscheduling products, while a new listing is added for an emergency contraceptive
A couple of well-known medicines will be downscheduled following the latest meeting of the Advisory Committee on medicines Scheduling (ACMS).
The recently released notes form the March meeting of the ACMS reveal that the TGA delegate recommended deleting the S2 entry for penciclovir in preparations “containing 1% or less of penciclovir for the treatment of herpes labialis in packs containing 10g or less”.
The change of schedule will come into effect from 1 October 2017.
The delegate agreed with the committee’s view that penciclovir in this preparation had low toxicity, with public health benefit from increased access, and it had a similar safety profile and precautions as unscheduled topical acyclovir.
All other penciclovir preparations will remain as Schedule 4 entries.
Meanwhile, the delegate also recommended to exempt the antihistamine loratadine from scheduling in preparations “containing loratadine 10mg or less in divided preparations for oral use in packs containing not more than 10 dosage units when used in children 6 years of age and over for the treatment of seasonal allergic rhinitis”.
The ACMS said loratadine for children has been available at the general sales level in both UK and USA since 2002, without increased adverse events.
“Adults should be able to identify seasonal allergic rhinitis based on symptoms,” the committee had advised. “Symptoms in children are no different to symptoms in adolescents or adults, for whom loratadine is already exempt from scheduling”.
In addition it found there are risks of delay in correct diagnosis in the younger age group, however “risk of adverse outcomes as a result are relatively low, and there is a public health benefit in wider availability of a first line treatment for allergic rhinitis in children”.
The risks could be limited by placing restrictions on the number of days of supply or number of units to an appropriate pack size and appropriate labelling, the delegate stated.
Other changes from the meeting were:
- Adding a new Appendix H listing for Ulipristal for emergency post-coital contraception, an amendment to the S3 listing from 1 February 2018. “Public health is likely to be improved, since increased community knowledge may improve access to this product, which will likely reduce the incidence of unplanned pregnancies,” the delegate said, adding that risk of misuse may be mitigated through “need for pharmacist counselling and supply”.
- Amending the S3 entry for ibuprofen to include a modified release dosage form of 600mg of ibuprofen per dosage unit in packs of 32 or less dosage units, when labelled with a recommended daily dose of 1200mg or less of ibuprofen; and not for the treatment of children under 12 years of age.