Keeping it in pharmacy


De-listing of paracetamol from PBS is pure speculation

Scheduling committee to decide on making some paracetamol products Pharmacist Only

The TGA has requested that its scheduling committee examine whether a certain category of paracetamol medicine be upscheduled to ‘Pharmacist-Only’ (S3).

In a release issued late last week, the TGA said it had asked the Advisory Committee on Medicines Scheduling (ACMS) to “consider whether one form of paracetamol – modified release (MR) paracetamol – should become a ‘Pharmacist Only’ medicine”.

“Any decision to upschedule MR paracetamol to S3 ‘Pharmacist Only Medicine’ would maintain access to these products in pharmacies, but give pharmacists the opportunity to check that patients are using the medicine correctly and counsel them on the importance of not exceeding the recommended dose,” the TGA said.

The moved follows a decision by the European Medicines Agency (EMA) to suspend marketing of MR paracetamol products in the European Union. The EMA’s decision was based on increased risks to people who overdosed on MR paracetamol compared to immediate release paracetamol.

A spokesperson for the Pharmacy Guild of Australia said the proposal would ensure patients are receiving appropriate counselling and support. 

“Upscheduling modified release paracetamol to the pharmacist only medicine category will ensure that patients can receive advice and counselling about the correct and appropriate use of these medicines by a medicines expert – their community pharmacist,” the spokesperson said.

“It is important that these medicines are taken correctly and in the recommended doses, and that any possible interactions with other medicines are identified by the pharmacist. Upscheduling these medicines also enables the patient to receive greater scrutiny and care with the aim of improving their health outcomes”.

Public submissions on the proposal are being called for, and must be received by close of business 31 October 2018.

The scheduling submission will be considered by ACMS in March 2019. 

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1 Comment

  1. Ron Batagol
    11/09/2018

    This article provides a good summary of the initiative submitted by the TGA Delegate to the A.CM.S Committee..
    I will be submitting comments, underTGA’s “Invitation for public submissions.”.
    My submission will emphasise the following points,(the first three of which have been summarised in this article):
    1.The European Medicines Agency suspended the sale of MR paracetamol in EU member countries altogether, and New Zealand’s Medsafe New Zealand’s Medsafe, at its Meeting on 26th. April resolved that “modified release paracetamol be reclassified from a pharmacy-only medicine to a restricted medicine”.(equivalent to our S3 Poisons Classification”).
    2.The complex and unpredictable pharmacokinetic profile of MR paracetamol following an overdose means that the continued availability of MR paracetamol in pack sizes of 96 caplets as a Schedule 2 medicine poses an unacceptable to risk to the Australian population.
    3 .Up-scheduling MR paracetamol to Schedule 3 will provide an opportunity for pharmacists to utilise their expertise to counsel patients on the importance of not exceeding a dose of 6 tablets per day, whilst still preserving OTC access to these products, as well as advice regarding the use of paracetamol with other analgesic products, including potential drug interactions and all other relevant aspects of analgesic medication management.
    4. Given appropriate pharmacy counselling, I am not in favour of reducing the pack size, as I believe this would unnecessarily limit consumer availability of the current range of the non-prescription medications, for the responsible and informed use of analgesics by patients for pain relief, especially in the light of the recent up-scheduling to Schedule 4 of Codeine products.
    5. Updates to the Product Information, with appropriate advice to health practitioners, need to be made by the manufacturers of modified release Paracetamol products, which incorporate the clinically agreed appropriate method for managing overdoses of MR Paracetamol Tablets.
    6. An additional emphasis in bold letters needs to be added to the CMI for MR Paracetamol products, for the wording in the section: “How much to use”, where it currently states:”
    Adults and children aged 12 years and over:
    *Do not take more than 6 caplets in 24 hours.
    *Not recommended in children under 12 years.
    * i.e. My suggestion is that these two statements need to be in bold letters.
    7. The Poisons Schedule change should be followed by appropriate updated practice guidelines by medical and pharmacy post-graduate educational groups, in addition to a widely-distributed summary by NPS Medicine Wise on dosage recommendations and agreed management of overdosage of, MR Paracetamol.
    (References cited)

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