1. Advisory Committee on Medicines Scheduling (ACMS #24)
Delegate's final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is not to amend the Poisons Standard in relation to ibuprofen combined with paracetamol.
Reasons:
The delegate notes the public submission opposing the interim decision. The reasons for the final decision align with the reasons for the interim decision. Additional reasons for the final decision are the following:
- Increasing pack size from 10 days' supply (30 tablets) to 17 days' supply (50 tablets) may encourage self-treatment of chronic pain. Treatment of chronic pain is outside the approved acute short term pain indication (e.g. migraine headache, tension headache) for S3 paracetamol ibuprofen combinations. This could result in the consumer delaying seeking further advice from a health practitioner. This may result in delayed diagnosis of a chronic condition, a longer recovery period, and potential long term morbidity, which will have an increased impact on the healthcare system. The availability of larger quantities of any analgesic increases the likelihood of misadventure. Consumers should only have access to clinically appropriate quantities.
On balance, I consider that the perceived benefits of larger pack sizes from a convenience perspective are outweighed by the risks.
Public submissions on the interim decision
One (1) public submission was received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations. The submission was in opposition of the interim decision.
The main point provided in opposition of the amendment was:
- The Schedule 3 and Schedule 4 entries should have been revised as proposed by the applicant. Such revisions would have better reflected the current scheduling principles and would have been a move towards closer alignment with the New Zealand scheduling of the combination.
Interim decision
The interim decision was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACMS, September 2018 – 1.6 Paracetamol combined with ibuprofen.
Scheduling proposal
The pre-meeting scheduling proposal for ibuprofen combined with paracetamol was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.