Medicines containing 500mg of paracetamol and 200mg of ibuprofen will remain Pharmacist-Only after the TGA rejected a call to down-schedule the products when sold in units of 12 or less.
In October 2012, the TGA referred a proposal to down-schedule the combination to Pharmacy-Only to the Advisory Committee on Medicines Scheduling (ACMS), having rescheduled it from S2 to S3, when in packs of 30 dosage units or less, in June 2011.
However, the ACMS recommended that the current scheduling of paracetamol in combination with ibuprofen remained appropriate, which led the TGA to make an interim decision on 7 January to maintain the combination as S3.
The TGA confirmed the interim decision earlier this week after no public submissions or other evidence had been received to alter the interim decision.
Confirming the decision, the TGA said that safety concerns about the combination had been raised in 2009 and there had not been enough data provided to disprove them.
Concern about the lack of professional intervention in purchases of products containing 500mg of paracetamol and 200mg of ibuprofen, if scheduled as Pharmacy-Only, was also a factor in the decision.
The TGA also turned down an application to up-schedule chloramphenicol for ophthalmic use from S3 to S4, after a recommendation from the ACMS to keep the products as Pharmacist-Only.
Confirming its decision to keep chloramphenicol as an S3 product for ophthalmic use, the TGA said that quick and easy access to it was a vital issue for patients.
Meanwhile, the TGA backed a proposal to schedule products containing 140mg or less of diclofenac, using a transdermal delivery system, as S2.
Outlining the reasons for the decision to schedule the products as Pharmacy-Only, the TGA said similar patches were already available overseas, and while dermal preparations of diclofenac were unscheduled, it was felt that a consumer should be able to seek advice from a pharmacist to ensure the new product formulation is used correctly safely.
Following the TGA’s decision, patches containing 140mg or less of diclofenac will be available as Pharmacy-Only from 1 May 2013.