Why upscheduling codeine won’t solve any problem

The rescheduling of OTC codeine-containing analgesics to prescription only won’t reduce misuse or increase patient safety, writes Professor Peter Carroll

I believe the TGA’s decision to upschedule OTC codeine-containing preparations will do nothing to identify or help those people who may be dependent on codeine.

It will merely force these people to visit a GP, where there is no Australia wide real time monitoring of prescriptions for codeine-containing analgesics.

This has the potential to allow people to “doctor shop” and visit numerous GP practices to obtain multiple prescriptions. In addition, the evidence relating to opioid misuse and death concludes that prescription opioids are contributing mostly to the problem1.

I also believe that the rescheduling is unnecessary and not justified as the vast majority of consumers who use OTC codeine-containing analgesics do so safely and appropriately for the short term treatment of acute pain, and are at negligible risk of becoming dependent on codeine.

If the proposed rescheduling goes ahead it will mean that the hundreds of thousands, if not millions of Australians who use OTC codeine containing analgesics appropriately and safely to treat acute, short term pain such as migraine, period pain, toothache and muscle aches and sprains will be forced to visit a GP to get a prescription in order to still use the products.

Clearly, many will not be able to get an immediate appointment and, because of the rescheduling, will be forced to suffer unnecessary pain. This will be particularly so in regional parts of Australia where there are already difficulties with GP access.

This will add significant costs to the health care system, and if the GP does not bulk bill, significant out of pocket expenses for patients. It also has the potential to significantly increase patient visits to already overcrowded hospital emergency departments.

There is also no evidence to support the claim that rescheduling codeine will reduce the potential for abuse or misuse, or do anything to support those individuals who may be dependent on codeine.

It will simply transfer the problem to GPs where there is no real-time monitoring of codeine prescriptions, and the likelihood is that the person will receive a prescription for a higher strength codeine product2.

Switching patients to an ibuprofen/paracetamol combination is not a solution.

The TGA document detailing the reasons for the rescheduling of OTC codeine containing products to Schedule 4 refers to a combination of ibuprofen and paracetamol and states “This combination would fill any gap left by the unavailability of codeine-containing analgesics over the counter”3.

I believe statements such as this to be incorrect and potentially dangerous. There are many people who should not take NSAIDS like ibuprofen. These may include those with high blood pressure, heart failure or renal impairment. NSAIDS such as ibuprofen can also precipitate asthmatic symptoms and acute asthmatic attacks in around 5-10% of patients with asthma.

In addition, patients taking anticoagulants, for example those with atrial fibrillation, and those taking low dose aspirin for cardiovascular protection should not take ibuprofen. Ibuprofen can also have significant drug interactions with angiotensin converting enzyme inhibitors, angiotensin 2 receptor blocking agents and diuretics.

Codeine and paracetamol combination medications are used by many of these people and to suggest that they can simply just switch to an ibuprofen and paracetamol combination is not just incorrect, it could lead to serious adverse health outcomes for these people.

I believe the TGA should reverse the decision.

If this is not done then I believe all State Governments should delay the decision to reschedule codeine-containing products to prescription only and mandate real-time monitoring of all OTC codeine requests in community pharmacies.

If this is done it will allow time for the extent of any problem relating to the OTC supply of codeine-containing products to be quantified (which to date has not been done), and allow for people who may be abusing or misusing the products to be identified by pharmacists and then counselled and referred to their GP, or other health care professional, for further assessment and care.

Professor Peter Carroll, of the Discipline of Pharmacology, University of Sydney and School of Medicine, University of Notre Dame, is the chair of AJP’s Editorial Board.

This is an edited extract from “The Codeine Dilemma,” which appears in the October edition of the Australian Journal of Pharmacy.


  1. Australia’s Annual Overdose Report, A Penington Institute Report, April 2017
  2. http://bit.ly/2fdqfEJ
  3. Department of Health, Therapeutic Goods Association. Final decisions and reasons for decisions by delegates of the Secretary to the Department of Health” dated 25th January 2017


Previous 10 Rising Stars: what you said
Next Q&A: Regina Cowie, Priceline Pharmacist

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.


  1. Jarrod McMaugh

    Reference 2 isn’t working

  2. Jane Hanrahan

    The link is OK, however the medicare statistics website which it links to, seems to be having a few problems generating reports this morning. I have managed to get it to work about 3 times out of 15 attempts. Hopefully, this will get sorted soon.

  3. Andrew

    >>>There is also no evidence to support the claim that rescheduling codeine will reduce the potential for abuse or misuse,

    Long-standing policy in Developed Countries to limit the availability of agents with the potential to cause harm in the consumer. As you’ve accurately concluded restricting availability won’t change the intrinsic abuse potential of the agent but rather makes it more difficult to access the agent with which to do so. And as evidenced and reported by the TGA document 75% of codeine packs were sold to the cohort of “chronic/regular” users. Restricting availability of OTC codeine will almost certainly reduce community harm as this (relatively smaller) cohort is already at significantly higher risk of misadventure than the rest of the community who are infrequent users.

    Also can the professor direct me towards any source of evidence that justifies/validates the use of OTC strengths of codeine?

    • Jarrod McMaugh

      Andrew, you’ve raised a point that is the crux of the problem.

      Where is the evidence that making these medications prescription only will make access more difficult for those in whom actual addiction or harm of addiction is an issue?

      I’m not asking this question to be belligerent – my opinion has been clear from the start that schedule change without RTPM implementation is not going to reduce harms in those who are at risk; while inconveniencing everyone else.

      Despite this, there has been very little movement on RTPM by any group other than pharmacy groups and governments…. and other than the Victorian government, progress has been slow (Vic wills till be implemented long after codeine is prescription only).

      There is no evidence whatsoever that making any medication prescription only reduces the risks or harms of addiction or misuse. This can clearly be seen in the rising numbers of people who have been harmed by current prescription-only medications; and the situation in the US demonstrates this situation extrapolated to ridiculous proportions.

      Your last question is also misdirected. If there is evidence of the effectiveness of OTC codeine, this shouldn’t impact on the decision to schedule this medication as 3 or 4…. it should impact on whether these strengths are available at all. If there is evidence, it should be available – schedule is determine by risk vs benefit. If there is no evidence, then products should be deleted, rather than rescheduled.

      Restricting availability of codeine can certainly reduce harm. Schedule change doesn’t restrict availability – it just alters the pathway to access.

      • Andrew

        The proposed scheduling exception is in the absence of the burden of proof required of every other agent, has the potential undermine the entire scheduling system and is deeply hypocritical. So many other agents with superior safety profiles (and potential applications in pharmacotherapies) remain heavily restricted yet an agent with demonstrable harm, abuse potential, and unpredictable clinical response with no evidence to support its use in the proposed indications wants an exception…..it’s not really a consistent drug policy is it? It’s not aligned with the National Medicines Policy either.

        And because I love my hat of cynicism I consulted the google – I can’t find any public record of guild RTPM advocacy until AFTER the upscheduling decision. Wonder why…

        • Amanda Galbraith

          Hi Andrew, I think if you look a little further, you’ll see that the guild was creating, and then using, our real time recording system, well before the upscheduling decision. In fact, we utilized our data from the system, in our submissions to the TGA, Government, Ministers etc


          • Andrew

            Prove it. And then re-read what I wrote.

            No evidence of guild advocacy for RTPM prior to the threat of descheduling, then lots of noise and media releases afterwards. Almost like it wasn’t really a priority until a potential revenue source was threatened.

Leave a reply