Codeine rescheduling decision delayed until at least 2017

The Therapeutic Goods Administration recently undertook public consultation in regard to a proposal that all medicines containing codeine currently available over-the-counter (OTC) be re-scheduled as S4 prescription-only medicines. The reasoning behind the proposal was that potential issues of morbidity, toxicity and dependence require restrictions. Most organisations lodging submissions opposing the proposal - including APMA, the Consumers Health Forum, Painaustralia, the Pharmacy Guild and the AMA - but the TGA initially announced an 'interim' decision to adopt the proposal.

In a move strongly welcomed by APMA, the TGA medicines scheduling delegate subsequently announced on 19 November (after a further round of consultations) that any rescheduling of codeine-based medicines will be delayed until at least 2017 because of the number of submissions received during the consultation process.

The deferral will allow more thorough consideration of the submissions and the subsequent information provided.

Prescription pills

This delay is an acknowledgement that such a misguided decision would create major difficulties for patients - and have serious implications for health care costs and doctors - as even the AMA acknowledged in its submission. 

APMA lodged a comprehensive submission arguing against the change.

This is not because we believe that OTC codeine medicines are the preferred medication for people living with chronic pain – often codeine is a poor choice of analgesic, with more effective medications available. However these medications are effective for a wide range of acute pain, including period pain and migraine. 

There is evidence that some people develop codeine dependency, and excessive use of codeine (particularly when taken in high doses over time in combination with ibuprofen or paracetamol) can cause significant harm and even death.

And it is not because APMA does not want people with chronic or persistent pain to get medical assessment and assistance - we continue to lobby strongly for a massive expansion of pain services, including better primary health services, uptake in training in pain and pain management for GPs and pain management education for consumers to be expanded so that services can be accessed quickly and without cost through the public system.

APMA has long argued that the prevalence and chronicity of persistent pain requires the availability of the widest possible range of effective medications at the cheapest price, in the best interest of effective pain management. In order not to disadvantage people with pain, the pharmacists who dispense these OTC medications are best-placed to identify and counsel people at risk of misusing these medications, rather than a blunt refusal to allow access without a GP prescription.

APMA CEO Elizabeth Carrigan criticised the initial TGA decision, pointing out that the vast majority of consumers use codeine products appropriately, and problems can and should be addressed alternately. "We need the prompt introduction of a real-time prescription monitoring program, a significant expansion of pain management services, and a comprehensive quality use of pain relieving medicines education campaign in the community" Ms Carrigan said. such measures alone were unlikely to address the problems of misuse.

In a submission which echoed APMA concerns, the AMA said such measures [rescheduling] alone were unlikely to address the problems of misuse. "Improved education about effective and safe pain management options for the public, pharmacists and general practitioners is also necessary," the AMA submission said.  Implementing the Electronic Recording and Reporting of Controlled Drugs system in each state and territory was also needed to curb the harms of opioid misuse.

You can pdfread APMA's submission here375.77 KB. You can also access a pdfmedia release from the Consumers' Health Forum (CHF)239.33 KB about the decision.

If you need information about accessing services for chronic pain or to assist codeine dependency, call the Pain Link help line service on 1300 340 357.


The Australian Pain Management Association Inc. (APMA) is a health promotion charity providing advocacy, information and practical support for people living with chronic (persistent) pain and their families. APMA is the consumer health organisation for all Australians who live with pain. APMA is your voice.


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