Australia to consider change for paracetamol

7 September 2018 - Deborah Wilkes

Australia's Therapeutic Goods Administration (TGA) is seeking comments on a proposal to reverse switch modified-release paracetamol from pharmacy-only to pharmacist-only status.

The regulatory agency has asked the Advisory Committee on Medicines Scheduling (ACMS) to consider the proposed upscheduling at its meeting in March 2019.

The TGA is seeking comments on the proposed upscheduling by close of business on 31 October 2018.

The move follows regulatory action in the European Union to suspend modified-release paracetamol products from the market due to the complexity of managing overdose with such products.

The European Medicines Agency (EMA) said in December 2017 that the medicines would remain suspended unless the companies that held the marketing authorisations could provide “evidence of appropriate and practical European Union-wide measures to help prevent overdose with the products and adequately reduce its risks”.

The TGA said any decision to upschedule modified-release paracetamol 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".

New Zealand's Medicines Classification Committee (MCC) recently recommended that modified-release paracetamol medicines be reverse-switched from pharmacy-only to restricted status. The latter is also known as a pharmacist-only medicine.

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