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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