Restrictions imposed on bulk paracetamol sales, but naproxen stays S2
Regulators have chosen to impose restrictions on the open selling of bulk packs of paracetamol.
Transcripts from the March meeting of the TGAs Advisory Committee on Medicines Scheduling (ACMS), released today, show that the Department of Health delegate has decided to amend the S2 entry for paracetamol to packs containing 100 tablets or less, among a series of other changes.
The full list of recommendations includes restricting paracetamol for therapeutic use:
- when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
- in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or if these packs are labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’.
The proposed implementation date of the changes is 1 October 2016.
There are also minor changes to the S3 and S4 entries for paracetamol, which can be viewed here.
The delegate highlighted the upper limit to dosage of paracetamol of generally 4 g or eight 500mg tablets per day. and the use of paracetamol in combination products as contributing to the decision.
Meanwhile the delegate rejected a proposal to amend the S2 naproxen entry to exclude naproxen (i.e. make it available for sale outside pharmacy) when containing 200 mg or less of naproxen per dosage unit in packs of 12 or less dosage units when not labelled for the treatment of children under 12 years of age.
Current naproxen scheduling remains appropriate, the delegate commented.
The meeting also saw the confirmation of an interim decision to amend the S2 and S4 entries for loratadine to increase the unscheduled loratidine dosage from 5 dosage units to 10 dosage units in divided oral preparations when used in adults and children 12 years of age and over for the treatment of seasonal allergic rhinitis.