Preparing for the change

changes ahead sign

Reminder to be ready for Schedule 3 modified release paracetamol  

Pharmacists are being reminded to prepare for the change in classification of all modified release paracetamol products from Schedule 2 to Schedule 3, from 1 June.

In August 2019, a final decision was published that made Modified Release paracetamol a Schedule 3 medicine with an implementation date of 1 June 2020.

The final decision was confirmed, with a final amendment, at the Therapeutic Goods Administration Scheduling Committee’s May 2020 meeting.

The new Schedule 3 amended entry for these products is for paracetamol:

a) when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or

b) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or

c) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’.

GSK, manufacturer of the Panadol Osteo range says it has produced a range of information to help pharmacists and pharmacy assistants manage the change, including in-store display materials, fact sheets, information and a video series featuring John Bell, pharmacist, educator and former PSA President.

“Customers will now need to speak to their pharmacists to purchase MRP products. Ensuring customers have a clear understanding of the correct dosing for MRP is crucial. Understanding the patients’ whole treatment plan including exercise, weight management and any complementary medicines will help pharmacists give appropriate advice,” said Mr. Bell.

“Pharmacy assistants will often be the first point of contact for customers, so it’s essential pharmacists are educating their staff on the change in scheduling, and what it means for them and their customers. It will be important that customers be reassured they can still purchase their preferred product without a prescription, but they need to speak to the pharmacist first.

As reported recently in AJP, the the Therapeutic Goods Administration (TGA) scheduling delegate also confirmed their “final decision to schedule paracetamol in liquid preparations for oral use in Schedule 3 except when in Schedule 2 as liquid preparations for oral use containing a maximum of 10 g of paracetamol per container”.

The main points provided in support of the interim decision were:

• The scheduling proposal in the Delegate’s interim decision takes into consideration the
appropriate balance between patient access to medicines and safety.

• The Delegate’s interim decision on paracetamol (liquid formulations) is supported to the extent
that current marketed products will not be affected by the decision.

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