Doctors fire salvo over codeine deaths

The PSA and Guild have expressed disappointment after an RACGP spokesperson said OTC codeine is “out of control”

Royal Australian College of General Practitioners president Bastian Seidel said in a statement over the weekend that “codeine addiction has become a serious problem for our community”.

“The consumption of these medications is currently running out of control with over 16 million items being sold over the counter in pharmacies every year,” he said.

“Up to 150 Australians are now dying from codeine-related overdoses each year – double the number ten years ago,” he said, citing Trends and characteristics of accidental and intentional codeine overdose deaths in Australia, which found that for every two Schedule 8 opioid-related deaths in 2009, there was one codeine-related death.

Dr Seidel said many more people were now seeking help for codeine addiction.

“While these sales represent a lucrative financial return of over $150 million a year for the pharmacy industry, patients are paying for this with their lives.

“The Therapeutic Goods Administration’s decision to reschedule over-the-counter codeine-based medications is being strongly endorsed by medical and community groups, and follows similar action in many other countries.

“The Pharmaceutical Society of Australia and the Pharmacy Guild’s efforts to lobby government to continue over-the-counter sales have undermined the collaborative work by governments and health professionals across Australia through the Nationally Coordinated Codeine Implementation Working Group—particularly its work to develop information and resources for GPs, pharmacists and patients in preparation for the change in February 2018.

“I’m calling on the PSA and the Pharmacy Guild to support the TGA’s decision to end over the counter sales—or remove themselves from the working group immediately.

“It’s time these pharmacy peak bodies committed to this much needed public safety initiative.”

PSA national president Dr Shane Jackson told the AJP that the comments were “not helpful” and ignored a key issue.

“What’s being lost in this whole debate, unfortunately, is that there’s this focus on codeine at the expense of the larger issue around prescription opioids,” Dr Jackson said.

“It’s being suggested that the upscheduling of codeine will solve the opioid issue that we have in this country. And that’s simply not correct.”

A spokesperson for the Pharmacy Guild agreed.

“Doctor groups need to address the absence of any real time recording for medicines containing codeine once they become S4 prescription medicines next year,” the spokesperson said.

“One need only read multiple coroners’ reports to know that making medicines prescription-only does not prevent their abuse.

“The majority of codeine-related deaths are a result of high-strength medicines that are prescribed by doctors and/or as a result of combination of medicines consumed by patients. 

“The statistics cited by the RACGP are eight years old – and they show one codeine-related death for every two opioid related Schedule 8 (controlled prescription drug) deaths. What does the RACGP propose to do about doctor shopping?”

A changed landscape

Dr Jackson also warned that it was quite possible that, as has been suggested by some stakeholders, doctors would prescribe codeine in higher strengths than those currently used by consumers who buy it over the counter.

“We just don’t know what’s going to happen post-February 1. And that’s why we need a considered approach about opioids in general, which considers mandatory real-time monitoring across the country, as we’ve advocated for a very long time.

“If all jurisdictions would mandate real time recording of all opioids, including codeine – as we’ve recommended, for example by using MedsASSIST – then we would almost eliminate the abuse of codeine-containing analgesics.”

He told the AJP that it was “frustrating” that the RACGP had chosen to discuss OTC codeine in the context of financial return for pharmacies.

“It’s a therapeutic issue,” he said. “When we’re trying to work together as health professionals to achieve an outcome of improving the health of patients, I don’t think turning the debate to economic issues, as a backhander to another professional group, is helpful – especially when I think health professionals on the ground think this debate, and issues between organisations, are not helpful to their cause.

“What we’ve advocated is that codeine-containing analgesics have a place for acute, short-term pain, when provided using a framework of real time monitoring, so that you can eliminate abuse and help people who are misusing the product for short-term pain by referring them to their GP – but making it available for acute short-term pain.”

The Guild and PSA say they will continue to advocate for access to low-dose codeine in certain situations of acute pain, with appropriate safeguards.

“We’re not trying to overturn an upscheduling process, but equally we recognise that patients should have access to this product for acute pain,” Dr Jackson said.

“So we’re trying to ensure some flexibility… pharmacists are appropriately trained to be able to provide it with the appropriate support mechanisms in place.”

He reminded stakeholders that the TGA decision to upschedule was made using data before MedsASSIST was rolled out and changes were made to pack sizes.

“So the landscape has changed since that decision was made, and we need to recognise that.”

“I think most people use it (low-dose codeine) appropriately, and the information through MedsASSIST would suggest that. We do have a gap in that 30% of pharmacies aren’t using MedsASSIST, and that’s why we’re calling on jurisdictions to make real time monitoring mandatory.”

The Guild spokesperson also highlighted data which showed MedsASSIST had had a significant impact on OTC codeine sales.

“In one group of pharmacies using MedsASSIST, over-the-counter sales of codeine products fell 31% compared to the same six month period the previous year.

“Community pharmacists are voluntarily continuing to use MedsASSIST as a clinical tool to support their patients and refer them where appropriate for more intensive pain management and addiction support, including to their GPs.”

The Guild has no plans to leave the working group, the spokesperson said.

“The TGA itself has recognised the strong and positive contribution of the Guild and the PSA in the working group, and is keen for us to continue that contribution.

“Community pharmacists will be on the frontline talking to people when these medicines are upscheduled, so they are crucial to the working group.

“GPs must work with pharmacists to ensure safe transition – especially for acute pain sufferers – and referral where necessary.

“The Pharmacy Guild of Australia will continue to press for a common sense exception to codeine up-scheduling so that patients can continue to access these medicines for the temporary relief of acute pain from their pharmacist in accordance with a strict protocol, which would include the mandatory use of real time recording.”

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  1. Amandarose

    otc codeine is a real problem and one I think would have been addressed better if everyone got on board with medassist. Unfortunately in the area I work many stopped using it as sales dropped because other pharmacies were not using it. Participating in locuming recently was a real eye opener at the volume of this stuff some pharmacies sell.
    I don’t refuse sales but I do engage in non judgemental discussions which has helped several people stop use- usually with subutex and our excellent addiction doctor.

    Others had genuine pain like misdiagnosed rheumatoid arthritis.

    I do worry about these people and what they will replace their addiction with.

  2. vixeyv

    Its enough to give you a headache!!

  3. Jarrod McMaugh

    There are a few important points to take away from the study that Dr Seidel has based his comments on:

    1) The rate of codeine-related deaths was around half that of deaths attributed to heroin and Schedule 8 opioids
    2) in the accidental deaths, there may be evidence of:
    (a) codeine being used to top up prescribed pain medication;
    (b) dose escalation of codeine; and
    (c) the development of codeine dependence.
    3) Those who had intentionally overdosed were more likely to be older, female and have a history of mental health problems;
    4) Those who had accidentally overdosed were more likely to have a history of substance use problems, chronic pain and injecting drug use.
    5) In cases where data were available, most deaths involved people who had been prescribed codeine products, although a significant minority (40.0%) had used OTC codeine products.

    Each of these are salient points, and while OTC codeine has been associated with 40% of deaths, these people were using OTC codeine to top up prescribed opioids.

    What is important to take from this, is that the proportion of death and harm caused by OTC codeine alone is both hard to define, and proportionally small compared to the overall issue.

    Why is this important? Because people like myself who have been criticising the TGA’s decision on scheduling of codeine are doing so because scheduling alone is not capable of addressing the issue. A significant majority of people who are being harmed by opioid addiction and overdose are being prescribed opioids.

    Currently, without any other measures in place, all that will happen in February is that 100% of all codeine-related harm and deaths will be from prescribed codeine. The actual number of people affected will not be reduced…. and I fear that it will increase due to an underwhelming response from TGA and medical colleges in addressing the issue of iatrogenic addiction, recognition of drug-seeking behaviour, recognition of legitimate pain behaviour (an issue due to the potential of some patients to be misidentified as drug-seeking patients), and poor referral pathways for addiction, pain, and concomitant pain/addiction.

    Prescribers are currently under-prepared and over-confident, and those harmed by this will have every right to be outraged at the lack of preparation leading up to February.

    The most frustrating thing is that some medical representative bodies are treating this issue like a political beacon – they see it as irrefutable proof that pharmacists are both ineffective as custodians of public safety with regards to medication; and that pharmacists that raise any concerns are only driven by greed derived from lost sales.

    When February comes around, and harms from codeine do not decrease, will those who haven’t listened finally see that the criticism has been justified all along?

    • Ronky

      Neither the RACGP nor anyone else has ever suggested that rescheduling alone is a complete panacea to all codeine problems. However it is now irrefutable on the evidence that rescheduling is an important part of addressing the issue. The Guild’s continuing campaign demanding a novel political “fix” to circumvent the rescheduling has now itself become the major issue. No, the vast majority of pharmacists who raise concerns about codeine are not driven by greed, but the Guild is sure as Hell giving everyone that impression, about ALL pharmacists, not just the small minority who are its members or the even smaller minority who are its members and agree with its underhand tactics on this issue.

      • Anthony Tassone


        The PSA are collaborating with the Guild and are supportive of the “Prescription only except when” concept. They’re also working with the Guild to help best prepare the pharmacy workforce for the upcoming changes.

        I feel your allegations of the proposal being motivated by greed rather than ensuring appropriate access for the significant number of patients who use it safely for acute pain are unfounded.

        Anthony Tassone
        President, Pharmacy Guild of Australia (Victoria Branch)

        • Ronky

          I can’t help what you feel, Anthony. I didn’t make the allegation. I said I’m not surprised that the RACGP and other outside observers conclude that your organisation is motivated by greed, because its actions are giving that impression.

  4. Ronky

    The pack sizes were reduced in 2010. MedsASSIST was rolled out in March 2016. The rescheduling decision was made in January 2017. The decision specifically gives as one reason for the rescheduling that data from MedsASSIST itself shows that (some) pharmacists are continuing to supply OTC codeine inappropriately and for chronic conditions.

    To assert such an obviously false statement that “the TGA decision to upschedule was made before MedsASSIST was rolled out and changes were made to pack sizes” does nothing but further demolish the Guild’s credibility.

    • Anthony Tassone


      I think you may be referring to the below passage from the article

      “He reminded stakeholders that the TGA decision to upschedule was made using data before MedsASSIST was rolled out and changes were made to pack sizes.”

      With respect I think you’ve paraphrased this passage to suit your claim “further demolish the Guilds credibility”.

      The reference is to the dataset that significantly influenced the TGA in their decision which predates up scheduling and MedsASSIST roll out, not when actual MedsASSIST was rolled out in relation to the upscheduling decision.

      Anthony Tassone
      President, Pharmacy Guild of Australia (Victoria Branch)

      • Ronky

        Brilliant deduction that I’m “referring to” or “paraphrasing” the statement which I quoted verbatim in my comment. The statement made no reference to any “dataset”, which (you claim) “significantly influenced” the decision.
        Really Anthony, just stop before you dig yourself even deeper in the mess you’ve created.

        • Anthony Tassone

          “He reminded stakeholders that the TGA decision to upschedule was made using data before MedsASSIST was rolled out and changes were made to pack sizes.”

          I’m pretty sure that
          a) this passage actually appeared in the article (not sure where your ‘verbatim’ comment did); and
          b) it refers to data.

          I’m going to stop now not for any ‘hole’ apparently being dug just that there really isn’t anything else to say about this point.

          Anthony Tassone
          President, Pharmacy Guild of Australia (Victoria Branch)

          • Ronky

            OK, so you’re now admitting that the decision was made long after the pack sizes were reduced and after MedsASSIST was rolled out, but that the decision was made based on a “dataset” that was produced BEFORE these things happened. Is that it? You’re claiming that the decision was made on evidence that was more than 7 years old! and ignoring more recent evidence (which you imply leads to the opposite conclusion)? Just read the decision document and it’s obvious this is false. The decision was made on the best and most recent evidence available, which if anything argues even more strongly for upscheduling than the older evidence did..

  5. Tony Lee

    Dr Shane Jackson sums the issue well.
    Instead of the RACGP attacking pharmacy they should concentrate on the abuse of opioid prescribing by their own members. Frankly, adding codeine to their armoury is frightening.

    • Amandarose

      I had a GP this week prescribing durogesic 25 to opiate nieve young patient with sore ribs. Wanted Naproxen which she ran out of got a very strong narcotic. I wouldn’t fill the script and as it was after hrs I left a colleague to sort it out with the GP the next day. GP argued that he had never heard of Durogesic be strong and that he did not believe it was not appropriate for acute pain. Said he just sat his exams and had never heard of it. Pile of references later girl got her Naproxen. Like to say this is not a common occurrence, but have seen it with many GP’s. One guy ordered 100mcg. Might have killed a patient. Sometimes I have heard about it after the event when patients at HMR stating they are allergic to Fentanyl when actually they were poisoned and lucky partners had pulled the patches off when they started being sick, hallucinating unconscious. Always check patients have taken these before and know what they are doing.

      • Jarrod McMaugh

        The doctor didn’t realise fentanyl was potent o_O

      • PharmOwner

        Opioid naive patients have died as a result of being commenced on Fentanyl patches. Patches are NOT suitable for acute pain as they can take around a week to reach steady state. If your GP had just sat his exams, maybe a bit of feedback to his/her university could be in order. I’ve also had a prescriber of many years experience try the “I’ve never heard of that before”, followed by “none of the Melbourne pharmacies have pulled me up on this” when I called him to find out why he’d neglected to write his Endone quantity in words and figures. He flat out refused to acknowledge he might have made a mistake. I subsequently notified AHPRA because I believed that if he continued neglecting his prescribing responsibilities he was putting patients at risk. I received a nice letter back from AHPRA saying that they’d investigated and the prescriber in question put our conversation down as a “misunderstanding”. At least they investigated. Maybe the prescriber learnt something.

  6. Jonesy

    The article states that codeine deaths are half that attributed to schedule 8 drugs.

    The likelihood follows that deaths from codeine will double once upscheduled.

    This will be a real problem add many doctors will simply prescribe double dose codeine products.

    • Ronky

      No, because most if not all of the OTC codeine deaths are due to overdose of the NSAID or paracetamol component which the deceased has consumed along with the codeine overdose he is seeking.. It’s unlikely that many doctors will prescribe these irrational dose combinations once they go to S4.

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