Changes to the way modified release paracetamol products are supplied: questions and answers

Modified release paracetamol (sometimes labelled as sustained release, slow release or extend release) is formulated with a higher dose of paracetamol per tablet (665 mg) compared to immediate release paracetamol at 500 mg per tablet. In modified release formulations, paracetamol is released into the body more slowly and has a more convenient 8-hourly dosing regimen compared to the immediate release products (usually taken 4-6-hourly).

The TGA's review of modified release paracetamol was initiated in August 2018 following the decision by the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee to suspend all modified release paracetamol products in the European Union in September 2017. The EMA decision was based on increased risks to people who overdosed on modified release paracetamol compared to immediate release paracetamol. Rather than taking the same approach as the EMA, the TGA decided to take a more measured approach and initiate the scheduling review.

The TGA's review has now been completed and a decision has been made to change way that you will access products that contain modified release paracetamol from 1 June 2020. Information on these changes and a summary of reasons for the changes were published on the TGA website on 22 August 2019.

Currently, you can purchase modified release paracetamol products from a pharmacy without talking to a pharmacist. From 1 June 2020, you will be required to speak to a pharmacist before purchasing these products. This is to ensure that consumers receive the appropriate advice on the use of these products.

You will not be required to have a prescription from your doctor to buy modified release paracetamol.

These changes will not affect the wide range of immediate release paracetamol products that are available on the market, including from supermarket and convenience store outlets.

The changes mean that you will need to speak to a pharmacist to ensure the medicine is appropriate for them and will be used safely and correctly. If a pharmacist thinks that a particular medicine is not suitable for the condition, is unsafe for the person or is being misused, they may suggest another treatment, refuse the sale of a product and/or refer you to a doctor.^[1]

There are significant health risks associated with the misuse of modified release paracetamol. Overdose with modified release paracetamol, whether intentional or accidental, is common in Australia and many other countries. The complex and unpredictable pharmacokinetics (i.e. concentrations of the medicine in the blood) of modified release paracetamol following an overdose makes it very difficult to treat in emergency situations using the standard antidote for immediate release paracetamol overdoses.

The change comes into effect from 1 June 2020. This will allow both consumers and suppliers time to prepare for the change.

You will still be able to purchase modified release paracetamol products from a pharmacy, however, from 1 June 2020 you will need to discuss your needs with a pharmacist. It is important to talk to your healthcare provider about the best treatment options available to you for ongoing pain.

Once the change is implemented on 1 June 2020, the following modified release paracetamol products will only be able to be purchased after consultation with a pharmacist:

• APO-OSTEO RELIEF modified release tablets, 665 mg, 100 pack

• APO-OSTEO RELIEF modified release tablets, 665 mg, 96 pack

• CHEMISTS OWN OSTEO RELIEF PARACETAMOL modified release tablets, 665 mg, 96 pack

• OSTEOMOL modified release tablets, 665 mg, 96 blister pack

• OSTEOMOL modified release tablets, 665 mg, 96 bottle

• OSTEOMOL slow-release tablets, 665 mg, 192 pack

• PANADOL OSTEO caplets, 665 mg, 96 pack

• PARACETAMOL OSTEO SR tablets, 665 mg, 1000 pack

• PARACETAMOL OSTEO SR tablets, 665 mg, 96 pack

• PARACETAMOL OSTEO SR tablets, 665 mg, 96 bottle

• PHARMACY ACTION PARACETAMOL OSTEO tablets, 665 mg, 96 pack

The decision, and the reasons or the decision, can be found at 1.4. Final decision in relation to paracetamol (modified release).

In Australia, medicines and chemicals are classified into Schedules according to the level of regulatory control required over the access to (availability of) the substance to protect public health and safety.

The Schedules are published in the Poisons Standard and are given legal effect through state and territory legislation. Decisions on scheduling of medicines are made by a senior medical officer within the TGA.

Medicines in Schedule 4 (Prescription Only Medicine) and Schedule 8 (Controlled Drug) require a prescription from a medical practitioner, whereas medicines in Schedule 2 (Pharmacy Medicine) and Schedule 3 (Pharmacist Only Medicine) can be obtained from a pharmacy without a prescription.