Why upscheduling codeine combination products is a really bad idea

white pills - look like codeine combination OTCs

Professor Peter Carroll, Dr Rebekah Moles, Dr Slade Matthews, Stuart Nankivell and Nick Logan (Members of the NSW Poisons Advisory Committee) on why they think upscheduling combination codeine products is a really bad idea…

The Australian Committee for Medicines Scheduling (ACMS) has made an interim decision to up-schedule all codeine-containing products (CCPs) to Schedule 4.

If ratified, this will mean that all cold and flu products containing codeine, as well as CCPs for acute pain, will only be available on prescription.

While we agree there is abuse of codeine by a very small minority of the population, we believe that the vast majority of consumers use these products appropriately and legitimately for the short-term treatment of acute pain. We believe any decision to up-schedule is counterproductive to the solution.


Our reasons are…

If CCPs are up-scheduled it will mean that consumers who wish to continue to use these products will be forced to visit GPs to obtain a prescription. This will add a cost burden to Medicare, and if the GP does not bulk bill, significant out-of-pocket costs to consumers.

RPBS data for the year ending 30 June 2015 shows that when GPs are given the choice of prescribing 8mg, 15mg or 30mg codeine with 500mg paracetamol, 92.3% of prescriptions are for a product containing 30mg codeine.

This means that if consumers are forced to get a prescription for CCPs they are more likely to be prescribed codeine at the higher strength.

Medicare data for the year ending 30 June 2015 shows that 64.4% of paracetamol 500mg and codeine 30mg tablets are prescribed on PBS Authority scripts in quantities greater than 60 tablets.

The data also shows that of the total number of tablets of CCPs prescribed, 99.7% are for the 30mg strength meaning that if consumers are forced to get a prescription for CCPs they are more likely to be prescribed codeine in larger quantities.

We thus believe that the evidence indicates that if a consumer is forced to go to the GP to obtain a CCP that was previously available OTC, they will be given a higher strength product in greater volume.

The inconvenience of supply by prescription may also result in CCPs being stockpiled by consumers in their home, which contradicts QUM guidelines and increases potential for self-harm.

A recent study in the Medical Journal of Australia (Roxburgh A et al, MJA 203 (7) 5 October 2015) reported that of the deaths involving codeine in the period from 2000-2013, where the source of the codeine could be identified, in 59.9% of cases the codeine was obtained on prescription.

Consumers prescribed CCPs may thus be at a greater risk.

A further concern is that when consumers find out that they can no longer get codeine-containing products OTC, they will turn to other OTC analgesics rather than go to the GP.

This could lead to the use of higher doses of single ingredient preparations of paracetamol and NSAIDS such as ibuprofen, and to the inappropriate use of NSAIDS with a resultant increase in drug interactions and adverse drug reactions.

We must remember that ibuprofen and paracetamol can be purchased in supermarkets and other non-pharmacy outlets without any professional advice.

We believe pharmacists are ideally positioned to manage the OTC supply of CCPs and, with a few tweaks, codeine abuse could be handled much more effectively.

Proposed improvements to the safe OTC supply of CCPs include:

  • up-scheduling all cold and flu CCPs to Schedule 3 to guarantee a professional interaction with a pharmacist;
  • reducing pack sizes;
  • clear warnings on labels regarding addictive potential; and
  • implementation of a national real time monitoring system.


This is a prime opportunity for our profession to develop an evidence-based, digital, professional service to manage acute pain at the coalface of primary healthcare in Australia.

Ideally the Federal Government would recognise its worth and remunerate it appropriately.

An ill-conceived knee-jerk reaction to limit CCP supply to prescription-only will not only mean that we never see it happen, we also believe that it will potentially create more problems.


Professor Peter Carroll, Dr Rebekah Moles, Dr Slade Matthews, Stuart Nankivell and Nick Logan are Members of the NSW Poisons Advisory Committee.

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  1. Country Pharmacist

    I agree with most of this however, reduced pack sizes is a bit silly. The packs are already limited to 5 days at maximum dose. The benefit of these products clearly outweighs the harm.
    Also, for anyone quoting studies saying that low dose codeine is ineffective, remember that there are multiple metaboliser types so population studies will not be accurate for everybody.

    • Dr Phil 42

      5 days??? they patients who ‘hit’ 5 pharmacies a day for “Nurofen plus”, then 5 others, she reckons 2 weeks between pharmacies covers her 72 tablets a day…

  2. Jarrod McMaugh

    The expected trend to prescribe higher dose codeine-containing analgesics is guaranteed.

    The supporters of this recommendation continually cite small studies that “prove” that OTC codeine is ineffective as an analgesic.

    For those doctors who are not aware of this discussion, they will be presented with patients seeking pain relief. A cursory google search (which may look something like “why are patients coming to me for minor acute pain issues all of a sudden”) will bring up results that champion this “ineffective dose” argument.

    For the doctor in this scenario, this presents a fate accompli – “low dose codeine is so ineffective that the scheduling was changed – best use a dose that will actually be effective”

    The end result is as this article predicts – higher use of 30mg dose codeine containing analgesics.

    • Tania

      This would probably be true but then wouldn’t legitimate patients get better pain control and drug addicted people get the help they need ? Right now I’m tired of nearly every 2nd or 3rd person asking me for codeine products . The legitimate get annoyed with my questioning and the drug addicted get abbusive and tell you to your face that they’ll just go somewhere else – no pain intervention or help for them – this is another reason I’m so tired of pharmacy and its limitations

      • Jarrod McMaugh

        Perhaps…. but what is your experience with the prescribing patterns of doctors and drug-seeking patients?

        The issue I have is that the rescheduling will cost a significant amount of money, but won’t actually fix the problem…. it will transfer it to another location…. and we will STILL have to deal with it!

        Unless the underlying issue is addressed, including the failure of GPs (as an industry) to take up harm minimisation, then this is not going away at all.

        • Dr Phil 42

          As a GP – taking up harm minimisation got me a “Reprimand” from the Medical Board

          • Jarrod McMaugh

            would you mind telling me about that? part of the victorian harm minimisation group’s aim is to increase uptake.

            if there are issues causing doctors to remove themselves from the programme, thats relevant

          • Dr Phil 42

            I would if the star chamber didn’t prevent me, on threat of being deregistered…. PM me if you don’t believe me

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