The Therapeutic Goods Administration’s (TGA) Advisory Committee on Medicines Scheduling has made an interim recommendation to reschedule codeine-containing products from S3 (Pharmacist Only Medicine) to S4 (Prescription Only Medicine) from June 2016.

The decision is predicated on risk dependence and the adverse effects of codeine-based products compared to newly released forms of ibuprofen and paracetamol combination medicines.

According to Macquarie University’s ‘The Value of OTC Medicines in Australia’ report, consumer preference for analgesics containing codeine in 2014 constituted “22 per cent of the volume of analgesics sold in pharmacies”1.

Following the news, both the Australian Self Medication Industry (ASMI) and the Pharmacy Guild have expressed concern over the proposal, with ASMI stating, “the vast majority of consumers use OTC codeine-containing products appropriately”.

While codeine has the potential to cause addiction, TGA findings reveal it was the opioid drug of dependence for 1,038 opioid substitution pharmacotherapy patients in 2013.

Father of the late Oscar winning actor, Heath Ledger, Mr Kim Ledger has spoken publicly about Australia’s prescription drug epidemic, and his bid to heighten public awareness, understanding and action with regard to the topic in his role as Patron for Scriptwise – a not-for-profit that aims to curb Australia’s prescription drug crisis. Mr Ledger has publicly advocated for “moving towards some form of live monitoring for prescription medications”.

As the Federal Government is yet to weigh in on the issue, Macquarie University’s Centre for Health Economy research reveals the Australian economy could accrue up to an estimated $675 million each year, should S3 analgesics be re-scheduled as S4 medicines.

A final decisionwill be announced in late November, 2015, with doctors, pharmacists, industry and consumers urged to make submissions to the Therapeutic Goods Administration up until October 15, 2015.


1 –Macquarie University. The Value of OTC Medicines in Australia. March, 2015.