TGA hits back on codeine controversy

tug of war vector

The TGA has responded to RMIT ABC’s Fact Check article, reaffirming its stance that OTC codeine sales have been responsible for more than 100 deaths per year

Last week, RMIT ABC Fact Check investigated the evidence behind Health Minister Greg Hunt’s claim that making codeine prescription-only would save 100 lives a year.

“Mr Hunt’s claim doesn’t stack up,” the Fact Check team concluded.

“There has not been any recent data to suggest that 100 Australians are dying every year from over-the-counter codeine products.”

See ABC Fact Check’s full breakdown of the figures here.

While the Fact Check team suggested the figures were overestimated, the TGA says it actually regards its numbers as an “underestimate” of the annual number of deaths related to OTC codeine.

And despite calls from some leaders in the pharmacy sector that Minister Hunt and the TGA should “publicly admit that they were using outdated data”, the TGA is not backing down.

In a statement released over the weekend, the TGA and the Department of Health “reaffirm” their advice that OTC codeine sales have been responsible for more than 100 deaths per year.

“This has been previously calculated through reference to coronial advice and statistics as well as research into the levels of abuse and harms associated with OTC codeine,” the TGA said in its statement.

“Indeed, the TGA and the Department regard this as an underestimate of the annual number of deaths.

“While an exact number of those who may have died from over the counter codeine is difficult to determine, the TGA has used the best available evidence to estimate this number.”

The TGA says it estimated that OTC codeine factored in at least 100 deaths per year in the following way:

  1. The TGA took into consideration the Roxburgh research (Roxburgh, A. et al, Trends and characteristics of accidental and intentional codeine overdose deaths in Australia, October 5, 2015) as well as noting other articles that highlight that OTC codeine misuse has increased:
    1. The rate of all codeine related deaths increased during the period 2000 -2009 by 0.5 deaths per million persons per year, from 3.5 deaths per million in 2000 to 8.7 per million in 2009.
    2. In 59.9% of cases (861), there was no information about whether the codeine consumed before death was prescribed or obtained over the counter. Where the name or specific details of the codeine product were available, a prescription codeine product (most commonly Panadeine forte) was recorded in 59.9% of cases (343 of 572), and OTC codeine products were recorded in the remaining 229 cases [40%].
  2. In noting the increased rate of deaths of 0.5 per million persons per year we calculated that in 2017 (eight years later) this rate would be 12.7 per million persons a year. Taking the Australian population at 24.45 million people in 2017 an estimate of 310.5 deaths due to codeine (both prescription and OTC) was calculated.
  3. The research also stated that where the name or specific details of the codeine product was available 40% were recorded as OTC. Given this we have calculated 310.5 x 40% = 124.2 deaths per year where OTC codeine was consumed. The TGA took a conservative approach and revised this figure down to 100 deaths that could be attributed to OTC codeine containing products.

Professor Peter Carroll from the University of Sydney stated that he has serious concerns regarding the TGA’s calculations.

He says the TGA noted that Roxburgh et al (2015) reported that the rate of all codeine-related deaths increased during the period 2000-2009 by 0.5 deaths per million persons per year, and then used this figure to calculate the figure for 2017 (eight years later).

“I believe that for an extrapolation like that to be valid, it is imperative that one compares apples with apples and like with like, and I do not believe this is the case with the TGA’s calculations,” Professor Carroll tells AJP.

For example, he says the codeine products were rescheduled to Schedule 3 in May 2010, and MedsASSIST was introduced in March 2016.

“The TGA’s calculations do not take into account these significant changes to the availability of the products which were not operational for the period 2000-2009,” he says.

“One could equally make a similar calculation for 2018, even though codeine products are no longer available OTC.

“To me the TGA’s calculations are just not valid. I believe it is clearly wrong to claim that OTC codeine-containing products were responsible for the deaths of 100 Australians in 2017 when the data used to calculate this figure was collected a decade or more ago, and under different circumstances”.

Professor Carroll also said it was important to note that the vast majority of deaths reported by Roxburgh et al (2015) involved multiple drug use, not just codeine.

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  1. Debbie Rigby

    The important discussion is not about debating the number and using best available evidence to calculate this number; it’s about how we can better help consumers with acute and chronic pain. Recognizing the paradigm shift in the management of chronic pain. Acknowledging the growing use of opioids including codeine and the potential for harm including overdose, dependence, addiction and diversion. Helping patients to understand drugs are not the only solution to their pain. Understanding the biopsychosocial model of chronic pain management ourselves and supporting patients to access non-drug options.

    This persistent argument about the OTC availability of codeine is damaging the reputation of the Pharmacy profession and our role in multidisciplinary care of people with pain.

    • Couldn’t agree more! “Continuously “raking over the entrails” of scheduling decisions that were done in line with similar decisions in other international jurisdictions, based on the best objective evidence doesn’t help anyone!
      For heaven’s sake, let it go, get positive and start focussing on the best way the undoubted skills and expertise of pharmacists can be fully utilised to assist people who need advice in dealing with their pain problems!

    • Jarrod McMaugh

      Debbie, you can’t be serious with that last line.

      Basically, you are saying that it is OK to use the interpretation of the data on codeine deaths to achieve schedule change, but once there are questions about the validity of this interpretation, then we should just move past it.

      This is unacceptable, and it is unacceptable to say that challenging this position is damaging the reputation of pharmacists.

      There are individuals who have had their professionalism and personal reputation called in to question publicly for questioning the veracity of these interpretations. Now that a very well-respected mechanism for examining the legitimacy of publicly claimed statements and public policy (RMIT Fact Check) has supported the position that these figures can’t be backed up by the evidence, it is now decided that this should no longer be the focus – we should just move on, forget about it.

      This isn’t appropriate. Not only because ad hominem methods have been used against people who would dare challenge the TGA position or the position of doctors; it is unacceptable because we can’t have this kind of attitude about evidence – either it is robust and reliable and supports a position that should lead to policy change, or it isn’t and should be challenged for not being these things.

      This entire issue has centered completely around the reputation of pharmacists – the number of assumptions that have been made, and accusations leveled at pharmacists in general, has been appalling…. and now you say that this is affecting the reputation of pharmacy?

      If you really feel that this issue is damaging the reputation of pharmacists, why haven’t you been calling for those damaging comments to cease?

      When people have said that pharmacists have been causing the deaths by “not supervising” codeine sales, did you say then that this is an unfair attack on the reputation of pharmacists?

      When people claimed that pharmacists who challenged the idea of re-scheduling codeine were driven by “financial considerations”, did you say then that this is an unfair attack on the reputation of pharmacists?

      The facts remain that OTC codeine is a drop in the bucket for access to opioids. Prescribed volumes have been growing year on year; deaths along with it. The greatest contributor to overdose death has been benzodiazepines… outstripping the effects of codeine 10 to 1….. haven’t heard a single call for restrictions to BZDs…..

      • Debbie Rigby

        The decision to upschedule codeine combination products is based on patient safety and quality use of medicines, not the reputation of pharmacists.

        Extrapolation and assumptions from the best available evidence is appropriate in the absence of real-time current data – that’s what evidence-based medicine is: using the best available evidence, in the context of clinical experience and the patient’s values and expectations.

        It is important to understand the rationale used to support conclusions that underpin policy decisions. And to critically evaluate the evidence. I have not suggested at any time that this should not be done. As have many others, I have spent time critically looking at the evidence and public statements by organisations and expert opinion leaders.

        My point was that continued public argument about a **number** is not in the best interests of consumer health and safety.

        I think the quote from Dr Cairns in the Fact Check story needs to be highlighted:

        “The impact of the rescheduling of over-the-counter codeine products from February 1 remains to be seen.”

        Dr Cairns told Fact Check the recent rescheduling of codeine would bring Australia in line with most other countries, where codeine is available only with a prescription.

        “Over-the-counter codeine is only intended to be used for the management of acute pain,” Dr Cairns said.

        “Up-scheduling will assist people with chronic injuries and illnesses in receiving appropriate and more effective treatment, based on advice from their GP.”

        It is time to shift from debate about a number (one avoidable death is one too many) and focus on helping patients living with pain as part of a integrated patient-centred biopsychosocial approach. Pharmacists have the skills and knowledge to be part of the solution.

        • Jarrod McMaugh

          The decision was certainly based on QUM, but you clearly understand that the reputation of pharmacists (both individuals and the profession as a whole) was a major part of this discussion – you raised it here yourself.

          The discussion about the number is actually intrinsic to the discussion – if deaths attributed to OTC supply do not reduce, then we know that there has been a huge investment of money and time in something that is basically a waste. It’s all well and good to say that codeine causes deaths, so OTC codeine must be a bad thing, but this is not how epidemiology or harm minimisation works.

          I’m not sure if you have much experience with harm minimisation, but there is a basic concept that harm reduction doesn’t come solely from supply reduction – and if you only implement supply reduction, you actually INCREASE harm.

          This is seen with alcohol prohibition, and it is seen with prohibition of other drugs as well – this includes the use of opioids for purposes other than therapeutic…. The point is, attempts to reduce supply alone – especially when the source of that supply is unclear – does not have the intended impact of reducing deaths.

          You might say that it is time to move past this and not focus on numbers, but what I hear is an inability to admit that the data may not have been interpreted correctly. Evidence-based medicine requires the reassessment of data when there is doubt about it’s veracity – an inability to accept that data may have been interpreted incorrectly is not Evidence-Based, and any attempts to downplay the importance of this is also not evidence-based…. it is opinion based. Ironic, given that you have been calling for evidence over opinion.

          As per usual, the entire point is being missed. There has been no assessment of the prescribing habits with respect to codeine – all OTC strengths were assumed to be sold by pharmacists, when there is good evidence that large numbers have been dispensed from prescription.

          There has been no investment in harm reduction principles such as opioid replacement therapy, counselling, AoD, or even safe injection practices.

          There has been no investment in the infrastructure for chronic pain – especially important given this is one area where pharmacists have received significant criticism…. yet the performance of prescribers in the area of chronic pain has never been addressed or even questioned.

          The only area that has had progress has been RTPM, and unfortunately this is being used more as a political point-scoring activity rather than being driven by the practical needs of clinicians. I am very glad that Victoria is getting their own system, because the federal option is not adequate.

        • Jarrod McMaugh

          Debbie, I assume you have read this article too?

          Yet again, the issue is prescribed opioids & benzodiazepines. Not diverted; not illicit; not OTC.

          Based on your position above, I expect you’ll be calling for greater restrictions on these items as the solution? Since the current method of access doesn’t prevent harm, we better restrict it further, yeah?

  2. Andrew

    At the very least critics of the decision should loudly and regularly declare their financial interest in the debate. Yet to see that.

    • Jarrod McMaugh

      On both sides of the debate Andrew.

  3. Brian Lee

    I really want to ask Government why Medassist, which had national recording system which all pharmacies nationwide could see was left as “optional” and not forced as a mandatory recording system which could had helped patients who genuinely need and actually benefit from low dose codeine product??

    Quite frustrating that without closer look or thorough examination of data and practical strategies eg what Medassist could do about codeine related deaths, government illogically jumping to an invalid conclusion saying OTC codeine alone is to blame and must see a doctor. Also if that out dated statistic was what government used to give as a support statement for their decision, it is seriously concerning.

    I really wonder what really is the best for patients. Is it just restricting the supply and forcing them to go and see a doctor? Well, maybe, but I don’t think it is the best solution. Patients need more guidance and education so that they can choose to use correctly and us, as pharmacists, are the ones who will direct to doctor if need more help.

  4. Toby

    Love it: one comment says ‘in line with similar decisions in other international jurisisdictions’ – obviously is ignoring our nearest, most similar neighbour New Zealand, which declared an intent to make Codeine OTC just before Codeine went script-only in Australia. But hey, just ignore any facts that don’t fit your prejudice. At least the Kiwis can still think for themselves, unlike Australia, which has traded colonial master Britain, for a colonial master called ‘Rest-of-World’.

    • Jarrod McMaugh

      It’s also not evidence based – this is consensus. By its very nature consensus is not evidence based… It is doing what others are doing because you think it’s better, not because it IS better.

      Yet again, showing that evidence has been interpreted to suit the desired outcome, not the other way around.

    • Andrew

      NZ have done exactly the same as Australia – upscheduled combination codeine products which is in line with similar markets pretty much everywhere.

      They have downscheduled single-ingredient codeine (as per linky), which I believe is them going it alone.

      Opioid-related harm is growing exponentially world-wide – this is a poorly considered decision in terms of public health. It will cause deaths.

      Australia has done the right thing. IMO NZ has not. The decision will not be reversed, which is a relief.

      Declaration – this poster has no financial interest in the sale or promotion of codeine products in this or any other market.

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