1 Advisory Committee on Medicines Scheduling (ACMS #26) - Final decisions made pursuant to regulation 42ZCZR
Final decision in relation to paracetamol (modified release)
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to paracetamol (modified release) as follows:
Schedule 4 - Amend Entry
PARACETAMOL:
- when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
- when combined with ibuprofen in a primary pack containing more than 30 dosage units;
- in
slowmodified release tablets or capsules containing more than 665 mg paracetamol; - in non-
slowmodified release tablets or capsules containing more than 500 mg paracetamol; - in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in Schedule 2;
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
- for injection.
Schedule 3 - Amend Entry
PARACETAMOL:
- when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
- in modified release tablets or capsules containing 665 mg or less paracetamol.
Date of effect of the decision
1 June 2020
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision insofar as it relates to the up-scheduling of paracetamol in modified release (MR) tablets or capsules containing 665 mg or less of paracetamol to Schedule 3 and the reasons for this decision. In making my final decision, I have taken into account the public submissions received before the second closing date in response to the call for further submissions published on 6 June 2019 under regulation 42ZCZP of the Regulations.
I have given consideration to the view that Schedule 3 will not provide sufficient control to reduce the frequency of deliberate self-poisoning with MR paracetamol. Specifically, there was a concern expressed that pharmacists will be unable exert sufficient controls against the purchase of MR paracetamol for suspected problematic or inappropriate use, in view of the experience with codeine and other Schedule 3 products. Notwithstanding the important role of the direct involvement of pharmacists in consumer education, in making my decision, I took into account that up-scheduling to Schedule 3 may also act to reduce some impulsive intentional overdose due to placing additional barriers to sales. Among other things, I have relied on evidence that restriction to access will likely reduce method specific attempts, and may reduce overall attempts. On balance, I am satisfied that a Schedule 3 entry for MR paracetamol is appropriate, it provides additional oversight by pharmacists, and may provide a barrier to impulsive purchasing associated with intentional overdose.
I have not made a decision on the request for labelling exemptions from each state and territory health authority as raised in the public submissions, as these matters are considered under other legislation at the time of making my decision.
I have taken into account the compelling evidence in the public submissions that a 1 October 2019 implementation date provides insufficient time for sponsors of MR paracetamol medicines to carry out all of the regulatory, manufacturing, transportation and distribution steps necessary to comply with the proposed changes. In recognition of the concerns raised in the public submissions on the practicality of the implementation date for businesses affected by the proposed changes I have decided on a 1 June 2020 implementation date.
I note that this deferred implementation date for the rescheduling to take effect will allow more time for industry to carry out a communication plan for consumers and healthcare professionals, and this would be in the interest of promoting public health.