What the new codeine laws mean for Australia

Medicines containing codeine will require a prescription from the start of February 2018, following increased concern over addiction, overuse and abuse of the painkiller. In this article, we take a look at what the new laws mean and how they are set to impact the medical and pharmaceutical industries.

Codeine now only available by prescription

Following an extensive consultation by the Therapeutic Goods Administration (TGA), products containing codeine will no longer be available over-the-counter, and patients will require a prescription if they require access to the painkiller. The move by the Australian regulator follows a decision by the United States, most of Europe, Hong Kong, Japan and United Arab Emirates who have already stopped the sale of codeine products without a prescription.

Key points

• From 1 February 2018, medicines that contain low-dose codeine will no longer be available without a prescription in pharmacies.
• Codeine-containing combination analgesics such as such as Panadeine, Nurofen Plus and Mersyndol, as well as a range of codeine-containing cough, cold and flu medicines will no longer be available without a prescription.
• Research shows that current over-the-counter low-dose (< 30 mg) codeine-containing products offer little additional pain relief when compared to similar medicines without codeine.
• There is evidence to suggest that paracetamol/ibuprofen combinations available as a single pill can be offered as an alternative to codeine-based analgesics for short-term management of pain in patients able to take NSAIDs and for whom paracetamol alone is not sufficient.

Meanwhile any person dealing with therapeutic goods must comply with all Commonwealth and state and territory laws. The TGA says stakeholders should review the relevant state and territory laws carefully, as in some states and territories it is a criminal offence to supply therapeutic goods by retail unless the goods are included in the ARTG.

Tighter opioid dispensing laws as misuse soars

According to the International Narcotics Control Board, the use of common, opioid-based painkillers such as codeine, morphine and oxycodone has increased by four times over the past decade – and Australian is among a handful of countries consuming the bulk of the world’s opioid medication supply. On top of this, in recent years there has been a worrying increase in the number of opioids being prescribed for ongoing chronic pain conditions. The latest general practice data shows that an opioid was prescribed in almost three in four (72.7%) occasions of general multisite pain management. Between 1992 and 2012, opioid dispensing increased 15-fold (500,000 to 7.5 million) and the corresponding cost to the Australian Government increased 32-fold ($8.5 million to $271 million), while opioid-related harms, hospitalisations and accidental deaths also increased. And according to the Australian Bureau of Statistics, in 2017 opioids were associated with the largest number of drug-induced deaths since the 1990s. People with unmanaged or poorly managed chronic pain are at risk of drug dependence and misuse, as well as accidental overdose – despite opioids being ineffective for ongoing pain.

Best-practice pain management

While doctor’s groups have previously welcomed the move by the TGA, the Pharmacy Guild of Australia opposes it, saying it would clog up GP clinics and increase health costs, without effectively identifying addicts. But Painaustralia has welcomed the new reform for pain management, with Painaustralia’s CEO Carol Bennett saying many consumers have unfortunately been led to believe that opioids are effective for management of ongoing chronic pain.

“Better awareness of the ineffectiveness of opioids for chronic pain as well as pathways for best-practice pain management are important to address these misunderstandings,” she said. “We also need sound alternative treatments and supports other than medication for people with chronic pain.

“A public awareness and education campaign is needed to compliment this new guide for doctors and ensure that the community understands best-practice pain management.”