MR Paracetamol: Advisory Committee to consider upscheduling to S3

The TGA has 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.

MR paracetamol is used in Australia to treat chronic pain, especially in the elderly, and is currently an S2 ‘Pharmacy Only’ medicine. It is a separate product from the more widely used immediate release (IR) paracetamol available from pharmacies and supermarkets.

MR paracetamol contains a higher dosage of paracetamol than IR paracetamol, and it is released over a longer period, meaning the product can be taken three times a day, rather than four. IR paracetamol would be unaffected by any upscheduling decision.

The TGA has conducted a review of the safety of MR paracetamol in Australia, and sought the advice of the Advisory Committee on Medicines (ACM), following 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 IR paracetamol.

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 scheduling submission will be considered by ACMS in March 2019. Its recommendations will then be considered by the delegate of the Secretary of the Department of Health.

The TGA invites public submissions on the proposed upscheduling of MR paracetamol and these must be received by close of business 31 October 2018.