Paracetamol on the move


De-listing of paracetamol from PBS is pure speculation

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″. 

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2 Comments

  1. Ron Batagol
    07/06/2019

    Having submitted my comments to the TGA public consultation on this issue, I agree with the decision of the TGA Delegate, because of the significance of the unpredictable pharmacokinetic profile of modified release paracetamol in managing overdoses. Incorporating the pharmacist’s guidance to prospective purchasers adds an important extra layer of protection for the consumer.

  2. Anthony Tassone
    11/06/2019

    Before Dr. Nespolon unloads on (another) poorly informed critical comment about pharmacist’s practice, it would be well worth reading the interim decision by the TGA from its March 2019 meeting considering the scheduling change for modified release paracetamol.

    It can be found via the below link:

    https://www.tga.gov.au/book-page/15-interim-decision-relation-paracetamol-modified-release

    Below is an excerpt from the delegate’s reasons for the interim decision:

    “I consider that 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.”

    It then goes on:

    “Having considered the evidence for harm, my view is that greater direct involvement of pharmacists in the sale of MR paracetamol if it were included in Schedule 3 may prevent unintentional overdose through consumer education. Up-scheduling is likely to reduce the risk of either inadvertent overdose (through consumers not understanding that the products are intended for a specific chronic condition, have a lower limit of number of tablets per day and do not exert their full effect as soon after dosing as immediate release paracetamol) and the more common deliberate overdose due to greater oversight of sales. Pharmacists would be able to exert some control over purchase for suspected problematic or inappropriate use.”

    These passages in the reasons for the interim decision display an understanding of the role of pharmacists as medicine experts and highly accessible health professionals that the public trust in.

    Pharmacists and doctors work well together each and every day at the local level and respect each other’s skills and role in patient care. Dr. Nespolon’s repeated attacks do not acknowledge or comprehend this important collaborative relationship.

    Anthony Tassone
    President, Pharmacy Guild of Australia (Victoria Branch)

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