OTC codeine death claims ‘must stop’


codeine tabsules spill from orange pill bottle

Pharmacy Guild NSW Branch president David Heffernan has hit out at recent claims about deaths associated with OTC codeine, saying they defame pharmacists

In a message to NSW Guild members, Mr Heffernan is highly critical of media statements including those made recently by federal Health Minister Greg Hunt, TGA officials and doctor group representatives on the issue of OTC codeine.

Of particular concern is the claim that OTC codeine combination medicines have caused 100 deaths a year, he says.

“I am not aware of any study or data which backs up this claim – which is misleading, defamatory to pharmacists and must stop,” Mr Heffernan writes.

“If there is any data to back up such an overblown claim, those making the claims should produce it – but I doubt that they can because I do not believe it exists.”

Mr Heffernan says that the Pharmacy Guild is not denying the harms caused by codeine, and that even one death is too many.

However, he says that citing codeine death statistics in the context of low-dose OTC preparations is “entirely perverse” because most such deaths are attributable to abuse of prescription codeine.

“In the circumstances, citing those deaths as a justification for removing over the counter codeine is not only false, but perverse,” he writes.

Mr Heffernan notes that the “vast majority” of drug deaths involving opioids occur in a polypharmacy setting, with victims ingesting drugs including morphine, oxycodone, fentanyl, benzodiazepines, ibuprofen, paracetamol, codeine and/or alcohol.

“In instances such as these, the death is caused by the collective action of many of the drugs the person has taken,” he says.

“Where codeine was thought to be the sole cause of the death, the number of people dying each year in Australia is under 25, and this number includes deaths from both over the counter and prescription codeine products.”

He also points out that on occasion data cited to support the upschedule predates MedsASSIST.

“The figures quoted appear to be data manipulated from National Coronial Information System for the period 2007 to 2011, and the Roxburgh study 2000-2013, where, for the majority of the time codeine was Schedule 2 and none of the data collected was with real-time monitoring.

“We understand that Greg Hunt is not a pharmacist, yet disturbingly he appears to be reliant on data manipulated from his bureaucracy.

 “Defamatory media implying pharmacy has been negligent in its responsibilities must be called out and stopped.”

Mr Heffernan told the AJP that “turf wars” between doctor groups and pharmacy were unproductive and called on GP groups to support real-time monitoring of codeine-containing medicines following the upschedule.

“In the real world, pharmacists and GPs have a constructive and friendly relationship with each other,” he says.

“These doctor groups are at risk of doing serious damage to that relationship with their continued false representation of pharmacy, and their continued lack of acknowledgement of the genuine approach by the Guild to work on the problem that we identified and paid for ourselves, with MedsASSIST.

“MedsASSIST not only identified problem users with OTC products but also problem users of prescription opioids.

“Pharmacists know that problem users of OTC codeine generally came from prescription opioid abuse, and after February 1 pharmacy will grapple with the challenges of helping patients with addiction problems without a real time monitoring system.”

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8 Comments

  1. Toby
    23/01/2018

    It’s a bit late to shut the gate, now the Codeine-Prescription-only horse has bolted? Where was the aggressive talk, or lawsuits, when it might have made the difference and stopped the change? The anti-pharmacy forces have hung pharmacy out to dry on this one. There won’t be anything meaningful left in the s2/s3 category if this keeps up. As usual, far too little, and far too late from the Guild. Window dressing. And yet the Guild-only bandwagon, with insurance-business profits and so much more, rolls on…and on.

    • Robert King
      24/01/2018

      I agree the anti-pharmacy forces have hung Pharmacy and pharmacists’ reputations out to dry on this. They certainly have used misinformation to paint pharmacists as self-interested, unprofessional, and incapable of assisting patient needs for mild to moderate pain. In reference to another article in todays’ AJP, Pharmacy in Australia leads the world in using technology to control and minimise harm in relation to OTC Pseudoephedrine and Codeine.
      However, I disagree with your rant at the Guild on the amount of effort that has gone into trying to prevent this scheduling change. Having been involved with the issue on a local basis, and having spoken with Guild leadership on numerous occasions, there has been an enormous amount of effort put into trying to secure a sensible, monitored, patient focused outcome. Lets also remember the significant efforts of the PSA (via Prof Peter Carroll), who has done a fantastic job in trying to defend the professional judgement and independence of Pharmacists.

  2. Tim Griffiths
    24/01/2018

    February 1 will mark the end of a more than two year process and it’s disappointing and cringeworthy to watch some branches of the PSA and the Guild continuing to argue and misdirect at the eleventh hour. Here is a link to the paper that most cite when referring to codeine deaths. https://www.mja.com.au/system/files/issues/203_07/10.5694mja15.00183.pdf

    The authors actually do state that there are limitations to what they can conclude when comparing OTC to Rx codeine linked to cause of death. But, codeine was the sole cause those more than 100 deaths. Look more closely and you will also see that paracetamol, ibuprofen and doxylamine were also toxicologically linked to more than half of the deaths in that period – almost 800. The authors state that this was indicative of the use of the combination products

    What is often missing from these arguments is the fact that more than 500,000 Australians misuse OTC codeine annually and it is the most misused opioid pharmaceutical by a long way. That misuse is driven solely by the codeine content and ready availability and that misuse contributes to the enormous toll of morbidity associated with chronic misuse of combination codeine-containing analgesics. Death is not the only measure of harm – far from it.

    What is also often missing is reference to the available evidence for low-dose codeine and it’s unsuitability for treating chronic pain as well as many presentations of acute pain. The evidence is flimsy and low-quality at best. The evidence for harm is significant.

    MedAssist? Well, we can only really take MedAssist seriously when the Guild releases ALL of the data for independent review, not the cherry-picked morsels. The lack of transparency is very telling.

    The best things pharmacists can do is talk to their patients about the actual reasoning behind the decision (not just spout the party narrative); discuss alternative chronic pain management, both pharmaceutical and non-pharmaceutical; and refer appropriately for uncontrolled chronic pain and for signs of dependency. The last is probably the single most important skill of a pharmacist – knowing when to refer.

    • Robert King
      25/01/2018

      HI Tim,
      the Guild and PSA are not denying the need to act on the abuse/misuse of Codeine. To suggest anything else is insulting. The arguments being put forward are designed to allow Pharmacists to have some professional discretion to treat mild to moderate pain, with the additional community safeguard of electronic monitoring.

      The paper you cite states clearly the source of Codeine is unknown.

      “Missing data on the origin of codeine products consumed prior to death (prescribed or OTC) limits inferences about the source of codeine in these deaths, and hence inferences about the extent to which the diversion of prescribed codeine contributed to these deaths. It also limits inferences that can be drawn about the likely impact of reducing OTC codeine availability on the prevalence of codeine-related mortality.”

      The scheduling changes single out OTC Codeine as the problem, whilst nothing is done to address what will happen when these patients present to surgeries. Historical evidence shows that the most likely outcome will be a prescription for Panadeine Forte or Oxycodone – unrecorded , monitored … and the real issue of addiction and overdose is shamefully kicked down the road. Pharmacy innovation ignored, Pharmacists professional judgement discarded.

      There are many implications of this decision, and it will be interesting to see how this plays out. But the fact is this decision is simplistic and based on selective use of the facts.

  3. Toby
    26/01/2018

    The Guild seems to be labouring under the delusion that it can win arguments with the AMA, the government and the media, with data and academic jargon alone. As though taking the high road will work, instead of fighting dirty like everyone else does. When will the Guild figure out that it is being trounced by opponents, that take grain-of-truth facts, and MAGNIFY them into anti-pharmacy soundbites which resonate brilliantly in the media? The Guild needs to first accept that the AMA, government and the media, are NOT academic or professional organisations, that discuss facts politely at tea parties or just-so conferences. They are virulently anti-pharmacy groups, similar to trade unions that aggressively present over-the-top claims in the hope of getting some of it. Trouble is, when these over-the-top anti-pharmacy claims are thrown at the Guild, the anti-pharmacy pharmacy forces get 90% of what they want, instead of the 40% they were hoping for. Because the Guild responds with boring, irrelevant requests to ‘discuss’ or ‘examine’, and with (rare) mealy-mouthed TV appearances by Guild bigwigs, that reinforce the public perception that pharmacists are merely yes-people. No dramatic, memorable assertions on prime-time TV, about how many lives pharmacists save each year, and how much medicine mishap pharmacists prevent. The Guild should be responding to aggressive anti-pharmacy gambits / decisions, with heaps of its own aggression. Instead of reserving its aggression, almost entirely for slapping down its own critics within the pharmacy profession. Codeine is a perfect example. I could go on. And on.

  4. Toby
    26/01/2018

    And lastly, I have read that Codeine has just been made available OTC in New Zealand, our NEAREST neighbour, and the country most similar to us. So much for the much-vaunted argument that Codeine needed to go script-only here, because that’s what overseas was doing, and we just HAD to copy it. So if you think a well-oiled, switched-on pharmacy lobby can’t win these battles, think again. Because just across the Tasman, the NZ pharmacy lobby has just won a major battle for it pharmacy profession. Why? Because they wanted to, and because they knew how to.

  5. Debbie Rigby
    29/01/2018

    NPS MedicineWise website has information on the evidence on codeine-related deaths – see
    https://www.nps.org.au/medical-info/clinical-topics/news/codeine-related-deaths-a-cause-for-concern

    Codeine-related deaths more than double in 10 years

    An Australian study examining codeine-related mortality in a 10-year period from 2000 to 2009 found that deaths where codeine was determined to be an underlying cause had more than doubled from 3.5 per million to 8.7 per million. This is about half the number of deaths related to Schedule 8 drugs and heroin.

    Accidental overdose was more common than intentional death (48.8% compared to 34.7%) and almost all deaths involved mixed drug toxicity (83.7%). People who died from accidental overdose were more likely to have also taken benzodiazepines, pharmaceutical opioids and illicit substances than those who died from intentional overdose. They were also more likely to have a history of substance use problems, injecting drug use and chronic pain.

    People who died from intentional overdose were more likely to have taken paracetamol, ibuprofen and/or doxylamine. They were also more likely to be older, female and have a history of mental health issues.

    The patterns of concomitant drug use and of comorbid conditions found in this study suggest that people who died from accidental overdose may have been using codeine in addition to prescribed pain medicines, engaging in dose escalation of codeine and developing codeine dependence.

    • Amandarose
      30/01/2018

      I think the big overlooked issue here is PRICE. The rise of discounting and the drop in price would surely have had a major impact on prescription and otc abuse.
      The 5 dollar packs of combination products makes them affordable to abuse where that were 15-20 dollars in smaller quantities in early 2000’s.

      We tax alcohol and tobacco to reduce abuse yet codeine and prescriptions are discounted insanely.

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