Modified release paracetamol upscheduled to S3, but GP groups express concern about the move
Modified release paracetamol are set to be re-scheduled as S3 (Pharmacist Only) products according to the latest recommendations from the TGA’s scheduling advisory committee.
The Advisory Committee on Medicines Scheduling (ACMS) recommended at its March meeting that paracetamol in modified release capsules containing 665 mg or less of paracetamol would move to S3 from 1 October 2019.
“This will enable MR paracetamol-containing products to be available to the public from a pharmacist, without a prescription,” the ACMS delegate said.
Paracetamol would remain S4 in modified release tablets or capsules containing more that 665 mg paracetamol, or in non-modified release tablets or capsules containing more than 500 mg paracetamol.
The delegate said that in making the decision they took into account arguments made in public submissions in opposition of the proposed up-scheduling that;
- Australian overdose rates appear to be lower than those overseas;
- there will be disadvantage to those who use MR paracetamol at the moment for the management of osteoarthritis; and
- up-scheduling could divert people to opioids or other medicines.
“Among other things I find that the complex and unpredictable pharmacokinetic profile of MR paracetamol following an overdose poses an unacceptable risk to the Australian population and that my concerns regarding the potential for abuse outweigh the arguments to retain the Schedule 2 entry,” the delegate said.
“I consider MR paracetamol is substantially safe with pharmacist advice available to ensure quality use under a Schedule 3 classification”.
“My view is that there is the potential for harm if it is used inappropriately, and on balance, I find that up-scheduling MR paracetamol products to Schedule 3 would allow for additional pharmacist oversight while retaining public access”.
The Pharmacy Guild of Australia had backed the move, saying in its submission that:
“We have no objection to the proposed changes to the scheduling of this particular paracetamol
formulation. We agree that consumers would benefit from pharmacist counselling on the correct dose and the risks of this particular formulation”.
However, the Royal Australian College of General Practitioners (RACGP) said a change from Schedule 2 to Schedule 3 was “unlikely to protect children from accidental ingestion or protect adults from intentional overdose.”
Its president, Dr Harry Nespolon, said RACGP believed “there is a lack of evidence to suggest that oversight by pharmacists will lead to improved patient outcomes, especially improved drug safety”.
“Experience with mystery shoppers demonstrates significant variability in pharmacists’ advice. Hence, any decision to upschedule should be accompanied by a commitment to monitor its effect”.
Both PSA and the Consumers Health Forum backed the move to S3, and PSA added that it believed “consideration should be given to the possibility of up-scheduling paracetamol
currently exempt from scheduling to S2″.