Could codeine upschedule be pharmacy’s doing?

Could demotivated pharmacists have ultimately caused the codeine upschedule? asks David Paulmert

From the first of February 2018, all over-the-counter codeine-containing products will be removed from their current schedule, and placed into schedule 4: prescription only medications.

After intently listening to discussions about the schedule of codeine, and hearing so many pharmacists voice their opinions that, “the up-schedule will never happen”, it is disheartening to learn that this is the truth.

NAPSA believes codeine should not have been rescheduled and that MedsASSIST was doing more to solve the problem, and would do more to solve the problem of codeine addiction, than a reschedule.

It is important to reflect on why an issue like abuse of codeine may have arisen. Many are ready to blame the misinformed consumer, many are equally eager to blame the system.

However, as we cannot know for sure, the only relevant information we can add is that there is a group that certainly showed fault in this field: demotivated professionals.

The pharmacy industry is crowded with people who have lost their initial motivation since leaving university, and have settled into a routine that is rarely exciting nor challenging.

No longer motivated to succeed or to excel like they once were, a demotivated pharmacist might reject a non-compulsory program like MedsASSIST, as so many did, and not properly counsel a patient requesting a codeine product.

So what problem does that leave students?

On one hand, it is disheartening to see that demotivated health professionals are out there, and that they are influencing bodies like the Therapeutic Goods Administration to discredit the capabilities of pharmacists in ways like rescheduling S3 products.

On the other hand, if students can learn that remaining motivated and involved in their profession will do more to push the profession forward than complacency, they can be conscious about maintaining their standards further into their career.

We have witnessed a loss in this case; pharmacists argued for something well within their level of expertise and were denied.

NAPSA implores the current cohort of pharmacists to maintain their professional standards well into the future, right up until the end of their careers. A united and motivated profession will do wonders for issues like medicine rescheduling, remuneration, and CPA agreements.

It is our response to defeats, not successes, that shows the true character of our profession.

David Paulmert is the director of Media and Publications at NAPSA, the National Australian Pharmacy Students’ Association.

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  1. Andrew

    I think the problem lies with drug policy in this country.

    “You can’t have this” has never worked yet we keep trying it. It only ever leads to worse health outcomes.

  2. Drugby

    Great comments David and spot-on about motivation of pharmacists in a system that is currently financially challenged.
    I think the up-scheduling of codeine products should now be seen as an opportunity, to better support patients in their acute and chronic pain management. There are numerous OTC analgesics that have similar or greater efficacy than codeine combos, as well as non-drug alternatives or additions.
    Combination products containing paracetamol and ibuprofen (especially Nuromol) are more effective than paracetamol/codeine, so it’s not as if there are no OTC alternatives to offer consumers.
    For patients with migraines, metoclopramide/paracetamol may be appropriate.
    We need to be confident identifying and managing medication overuse headache.
    We will still be faced with doctors writing prescriptions for codeine products, so we can still have a role in dispensing them (and earning income) and having a conversation about safety and appropriateness of the script.

    • geoff

      I’m a bit lost with this topic so someone may be able to help me- ‘there is some evidence less than 30mg codeine 6 hourly is no more effective than simple analgesia’ so 2x 15mg codeine/paracetamol four hourly is more effective than simple analgesia?
      If 8mg/10mg codeine is sub therapeutic what difference does it make if a percentage of the population are ultra metabolisers of a sub therapeutic dose and aren’t they more at risk from 2x30mg prescription strength or will Drs always do liver function tests before prescribing to identify those at risk?
      I use 1x 10mg Codeine overnight infrequently to loosen neck muscles to prevent headache- it works but am I wrong according to the literature? Now I will need to see a Dr and break tablets into a third.
      The study on Ibuprofen + Paracetamol when first released was on a tiny sample, from memory sample in the 20s- are there better large studies since? Asking about analgesia is v fuzzy.
      For those who cannot take NSAIDs and need stronger pain relief than paracetamol alone’ are we likely to see an increased paracetamol overdose rate? 2 qid is not working so I’ll try 4 qid and they are cheap.
      The original concern about codeine related to an increased number of overdoses but 60% of overdoses were with PRESCRIBED codeine, only 40% OTC or other- logically making codeine script only should increase the overdose rate. How does this achieve the aim? The study seemed to assume that people in pain would just be happy with simple analgesia instead of going to a Dr.
      Codeine has never been useful in migraine and paracetamol is less effective than early treatment with aspirin or NSAIDs so metoclop/paracetamol may help with nausea/vomiting and GI motility but isn’t relevant in a discussion about codeine upsheduling.
      Overuse headaches are relevant to practice but were not a reason given by the Govt for upsheduling.
      There are various reasons claimed why it is good to upshedule codeine but as far as I know it is purely cost/benefit related to overdose for the Govt….am I missing something? Demotivation can also come from putting effort in (to MedsAssist in this case) and then being told to forget about it, someone else will do it better.
      My comments may seem flippant but queries are genuine

      • Drugby

        “I’m a bit lost with this topic so someone may be able to help me- ‘there is some evidence less than 30mg codeine 6 hourly is no more effective than simple analgesia’ so 2x 15mg codeine/paracetamol four hourly is more effective than simple analgesia”

        Yes, best available evidence suggests that the minimum effective analgesic dose for codeine is 25-30mg. Evidence also shows it is more effective than paracetamol 2 x 500mg dose in adults.

        • Owner

          Can you kindly provide the reference source for this minimum effective dose of Codeine study?

          With all the variance in sensitivity to opioids its peculiar to think that everyone would share this MED….

          • Drugby

            The TGA report has a lot of info and references

            Therapeutic Guidelines also states 30mg

          • Ron Batagol

            Debbie Rigby has summarised it well.

            Btw– the case referred to where the baby died after the mother had codeine
            post-natally was reported by Motherisk in Canada in 2004, “Safety of codeine
            during breastfeeding. Madadi P”. Link:

            Also, an excellent short summary article worth a read on the overall therapeutic concerns regarding Codeine use, in The Australian Prescriber 2011- Iedema J. “Cautions with codeine”,
            Aust Prescr 2011;34:133-5 | 1 October 2011 |


            And, yes,the TGA report referred to by Debbie is well-referenced.

            And, let’s face it, the Drug Companies are very practical in adapting and certainly not backward in coming forward, so to speak, and are already heavily promoting paracetamol/ibuprofen combination analgesic OTC products. If they become the mainstay of OTC analgesia, obviously there will be an ongoing need for pharmacist counselling ( eg. paracetamol dosage range, NSAID G-I, cardiac, and the often-overlooked renal toxicity potential in situations of renal compromise or fluid depletion).

          • Owner

            All I could find in the TGA document is there is an evidence gap in low dose codeine products in terms of efficacy. Further more there appears to be evidence that some OTC preparations of codeine would have hit the dose required to have evidence supportive of analgesic effect.

            Granted there is potential for harm in OTC codeine however unless there is a monitoring function on s4 codeine I done think the risk is resolved.

            I also wonder what % of patients will go on to get Panadeine forte tramadol etc. who were happy on a low dose combination product.

            Convince me.

        • geoff

          other posters said they did not use MedsAssist and agreed with upsheduling because OTC codeine was subtherapeutic so should not be sold , but you agree that 2x15mg strengthOTC is effective and superior to paracetamol alone, so this is not a valid reason. I still have problems with upsheduling achieving the TGA’s stated aim to decrease overdoses and many of the other purported reasons but all your information is greatly appreciated

      • Drugby

        “If 8mg/10mg codeine is sub therapeutic what difference does it make if a percentage of the population are ultra metabolisers of a sub therapeutic dose and aren’t they more at risk from 2x30mg prescription strength or will Drs always do liver function tests before prescribing to identify those at risk.”

        Ultrafast metabolisers due to CYP2D6 gene duplication (3 or more copies of the gene) may experience exaggerated and potentially dangerous opioidergic effects, resulting in about 50% higher plasma concentrations. Even low doses can result in toxic levels of morphine. So I think you are correct in saying ultrafast metabolisers of CYP2D6 are less likely to experience adverse effects with low doses of codeine.

        But it may be clinically relevant in breastfeeding. There was a well publicised case where a baby died after the mum had a “normal” dose of codeine.

        The hepatic CYP2D6 enzyme is not measured by liver function tests. Gene testing is available for many of the variant CYP2D6 alleles.

        • geoff

          Codeine is contraindicated in breastfeeding so not a reason to remove low dose codeine/paracetamol.

      • Drugby

        “The study on Ibuprofen + Paracetamol when first released was on a tiny sample, from memory sample in the 20s- are there better large studies since? Asking about analgesia is v fuzzy.”

        The studies on paracetamol/ibuprofen combination were conducted on patients who had 3rd molar extractions, which is relatively consistent strong pain and inflammation.

        In the Daniels study, 1 or 2 tablets of ibuprofen/paracetamol 200/500mg, 2 tabs of ibuprofen/codeine 200/12.8mg, 2 tabs of paracetamol/codeine 500/15mg or placebo were compared ie a double-blind, 5 arm parallel-group, placebo-controlled randomised, single-dose study – good study design. 1 or 2 tablets of ibuprofen/paracetamol 200/500mg provided highly effective analgesia comparable to or superior to the other combos.

        The other study was by Mehlisch, again in severe post-op dental pain. This compared paracetamol/ibuprofen with comparable doses of ibuprofen, paracetamol or placebo in over 700 patients. Again ibuprofen/paracetamol 200/500mg was superior.

        These two studies used doses as in Nuromol.

        A third study by Merry compared Maxigesic (paracetamol 500mg/ibuprofen 150mg) to paracetamol 500mg and ibuprofen 150mg alone, showing the combination was superior for wisdom teeth extraction analgesia than either drug alone. 122 patients were included.

        My issue with this combination is that it uses full doses four times daily whereas Nuromol is a lower dose three times daily with equal or superior efficacy.

        So as I said in my original post, there are other OTC alternatives to paracetamol/codeine or ibuprofen/codeine that are equally or more effective for acute pain. Of course NSAIDs carry their own risks, which should be considered when recommending it to patients.

        • geoff

          many thanks, I’ll have a look at those and also the TGA website but with a quick look at 100 pages of info largely in tables it may take a while to sort thru. I rely on the AMH and TGuidelines (rather than the impossible task of reading every study on every drug) so hopefully the guidelines can be updated to include the combination.

  3. Slim Jim

    Firstly, let me clarify and confirm that I am NOT a demotivated professional by any professional or personal standard.

    Now consider if the bulk of “pharmacies” ceased looking and trading like garish $5.99 “shops” and if “pharmacists” stopped acting like shop-keepers; would the medical profession, regulators (the guv’ment) and customers/clients/patients start taking us seriously as professionals?

    But it’s a bit too late for all that now… the irreversible damage to professional “image” and the practice of the profession has been self-inflicted from within when supermarket-style shelving, retailing “practice” and large format stores (white, red, yellow, purple, orange, red and blue) first started to appear in the early 80’s?

    I actively encourage all my Year 10 work experience placements to seriously consider NOT doing pharmacy, with great success. I have shown these motivated youngsters that professions such as medicine and its specialities, dentistry, psychology, physiotherapy and even engineering and IT are better professional options than pharmacy. I have no apologies for doing this, as many have returned to thank me.

    And if you thought that codeine was NOT going to be up scheduled, you must have been “dreaming” of a world where Australia leads rather than follows!

    The decision is not a defeat, but reality.

    • Paul's

      To right sj. Do not forget our head office overlords who have never worked in pharmacy yet continue to dictate to a professional how they should practice.

  4. Ian Carr

    This argument hangs very much on the concept of the patient’s alleged “right” to use codeine “appropriately and responsibly.” Personally, I was unable to use MedsAssist because it required me to sign the following
    “I have … determined a product containing codeine is therapeutically appropriate for the patient.”
    The recommendations of the evidence base (e.g. the AMH) do not allow any of us pharmacists to make such a determination. (AMH 2016: “Codeine is not recommended.” p.50)

    Therefore the TGA correctly determined: very small, if any, benefit — but a HUGE and increasing risk.

    My observation has been that the raising of the dose from 8-10 mg to 15mg per tablet has, in the past decade, resulted in the number of dependent OTC purchasers increasing by a multiple of at least 5 to 10.
    I am sure sales figures of the various strengths would reveal a major shift to max-codeine!

    The biggest issue is not whether we can force the codeine abuser to stick to a “safe dosage” — no matter how therapeutically inappropriate that may be — but the fact that there is a total disconnect between the OTC purchaser and their doctor. I am certain that few GPs are aware of codeine abuse by their patients.

    And the limited number of codeine purchasers who acknowledge or seek help or referral for their problem is minimal, implying that it will be the Emergency Department where the problem patient will eventually be presenting.

    • Jarrod McMaugh

      So does that mean you didn’t sell any? Or just didn’t use the MedsASSIST program to aid you in making clinical decisions?

      Every medication you supply, your professional and ethical standards require you to be able to make the same statement as the one you list here. In this instance, the supply of the medication would be the binding act (as opposed to a signature).

      • georgespiggott

        ( aka Ian Carr — computer has used another sign-in ) I was just about to edit my post to say: As I wanted to help those who were possibly codeine dependent, rather than send them to pharmacies who might not care, I had a campaign whereby every codeine requester was given an explanatory pamphlet explaining the issues and encouraging personal contact and referral to various Drug and Alcohol services. If that makes me any less professional than those who weakly justify poor pain management in the name of profit, I do apologize.

        • Jarrod McMaugh

          Clearly it doesnt make you less professional

          But in instances where codeine was still supplied, was it recorded so that pharmacists elsewhere can make a clinical decision with the best information available to them

          medsASSIST isn’t about whether the evidence is adequate or not….It is about access to information for pharmacists to aid in a decision. Operating in isolation where the ability exists to work together makes no sense.

          • georgespiggott

            Yes, we were recording sales as a S3R item on our dispense system. I have no desire to keep data from anyone, but MedsAssist looks like a last minute attempt to keep codeine OTC in the face of real and rising risks of harm. It’s quite simple: Codeine as pain reliever: POOR; Codeine as dependence risk: VERY HIGH; Compound codeine harms: all the way up to FATAL.

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