Consumers from early 2018 will no longer be able to purchase codeine-based painkillers, but will rather, require a prescription from their GP or healthcare provider. This follows ongoing concerns about the overuse and abuse of commonly known OTC (over the counter) Schedule 2/3 medicine painkillers to schedule 4 prescription medicines.

After years of consideration and numerous submissions on the proposal from various stakeholders, Australia’s medical regulator, the Therapeutic Goods Administration (TGA) today (December 20, 2016) announced its long-awaited decision to regulate the sale in pharmacies nation-wide “based on the effects of medicines containing codeine on people’s health and wellbeing.”

In an official statement released by the TGA today, the organisation referred to various regulations across the world, including the USA, Hong Kong, Japan and the United Arab Emirates (UAE), whereby codeine-containing products require a prescription. The TGA also expressed their concerns about the addictive nature of the drug, following compelling evidence of harm caused by overuse and abuse of codeine-based medicines.

“Misuse of OTC codeine products contributes to severe health outcomes, including liver damage, stomach ulceration, respiratory depression and death,” said the TGA, further citing a study that revealed the risk of addiction “seems to increase with higher ‘morphine equivalent’ doses”, and respiratory depression can occur after brief exposure to standard codeine doses [not defined] in ultrarapid metabolises.

Meanwhile, public consultations reveal consumers unintentionally use low-dose codeine-containing medicines to self-treat chronic pain, but many subsequently become addicted to the medicines, long-after the need for their intended use.

The changes will take effect from February 1, 2018.