Four reasons codeine should be S4 – but Guild disagrees

A pain specialist and researcher says there’s no evidence of benefit from current codeine-containing OTC products – and that “we can’t have a drug of abuse available over the counter”.

Professor Stephan Schug, Director of Pain Medicine at Royal Perth Hospital and Chair of Anaesthesiology at the University of Western Australia, says there’s only evidence of harm, such as addiction and overuse, from the medicines’ OTC status.

But the Pharmacy Guild says that while dependence on opioid painkillers is a problem, the new real-time reporting support tool, MedsASSIST – developed by the Guild for the recording and monitoring of over-the-counter medicines containing codeine – is already proving to be an effective alternative to requiring patients to have to visit a doctor to get a prescription for them.

Much of the data on OTC codeine misuse not only predates MedsASSIST, but also the 2010 scheduling and pack size changes, it points out.

The TGA is currently considering whether or not to move over the counter codeine-containing products onto prescription-only, following an influx of submissions when it first decided to re-evaluate these medicines’ scheduling status.

Of 127 public submissions on the interim decision to upschedule codeine-containing analgesics and cold/flu medicines to prescription-only, 113 did not support the proposal.

Prof Schug says there are four significant problems with the OTC status of some codeine-containing products.

“Firstly, codeine is a poor painkiller; it’s unpredictable and there are risks associated even with its appropriate use,” he says.

“There are many people in the population who carry a gene which makes codeine quite dangerous.

“And it’s not a good pain reliever on its own. Even at the very high dose of 60mg, only one in 12 people achieve a 50% reduction in pain – in this case after an operation.”

Secondly, there’s “almost no evidence” of effectiveness of low dose codeine in combination with either paracetamol or ibuprofen, he says.

“And here’s where the risk escalates because it’s well documented that people who have a problem with codeine use increase the dose and can actually kill or harm themselves from the paracetamol or ibuprofen toxicity.”

He says a patient recently reported taking 80 tablets a day; they were visiting four pharmacies a day to obtain these amounts.

“With regard to ibuprofen, life threatening low potassium levels, acute kidney failure as well as non-healing gastric ulcers with significant risks of perforation and bleeding occur with overdoses.

“Again we see patients using up to 60-100 tablets/day; a patient with a life-threatening ulcer perforation from 60 tablets ibuprofen plus/day was on my round last week.”

Thirdly, dependence on opioid analgesics is a significant concern in Australia, says Prof Schug. 

“And OTC codeine contributes to this by providing unmonitored access to a drug, which in the body is metabolised to morphine.

“The number of overdose deaths in Australia related to codeine has increased from 3.5 per million in 2000 to 8.7 per million in 2009. It is in particular concerning that the ratio of strong opioids to codeine is now in a range of 2:1 for such overdose deaths.

“Fourthly, the rescheduling of codeine containing preparations to prescription-only will not reduce people’s access to effective pain relief.

“There is nearly no improvement of the effect of paracetamol and ibuprofen by adding low doses (<12 mg is permitted) of codeine, while combining paracetamol and ibuprofen is much better with significantly better pain relief and safety.”

Prof Schug says the “easy and widespread” availability of the medicines is not limited or monitored well at all.

“Surveys of pharmacists and codeine dependent people seeking OTC codeine illustrate a number of difficulties managing the safe supply of OTC codeine analgesics,” he says.

“It is unreasonable to expect a pharmacist will be able to detect codeine dependence based solely on a customer’s appearance.”

The MedsASSIST tool was piloted in Newcastle, NSW and North Queensland only in February 2016, and rolled out nationally from March.

A recent AJP poll demonstrated good takeup of the tool already. Earlier this month 68% of AJP readers said they were already using MedsASSIST and thought it was a great initiative; another 8% were using it despite some reservations. Another 5% said their pharmacy was planning to implement it.

A spokesperson for the Pharmacy Guild today said the Guild acknowledges dependence on opioid analgesics is a concern in Australia. This was why the Guild developed MedsASSIST, which focuses on patient care and patient pain management support pathways designed to help pharmacists identify patients who are at risk of codeine dependence.

It facilitates access to suitable referral pathways to support patients to better manage their pain and enhance health outcomes, the spokesperson says.

“In addition to mandating the recording of OTC codeine, the Guild also supports mandatory warning labels advising consumers of the potential for dependence from prolonged use of these products,” the spokesperson says.

“We also support other measures including reducing pack sizes for these products to a maximum of three days’ supply, ongoing education for pharmacists, and a consumer awareness campaign.”

The spokesperson says such measures will help to ensure patients who need these medicines are able to access them.

“Such access is important and an independent review commissioned by the Therapeutic Goods Administration investigating the safety and efficacy of low-dose codeine found there was high-quality evidence that combination-codeine medicines provide clinically important pain relief in the immediate term,” the spokesperson told the AJP.

“We also need to take into context the fact that many studies that investigate abuse/misuse of codeine look at periods before 2010, when OTC codeine was rescheduled from Schedule 2 to Schedule 3 and the maximum available pack size was greatly reduced. 

“Therefore, any conclusions made on OTC codeine based on data pre-2010 are not factoring in critical changes to the scheduling of these medicines.”

The spokesperson says the Guild has consistently argued that making all codeine medicines prescription only is a blunt instrument that would not only be ineffective at addressing concerns of abuse, but could also have potential unintended consequences such as increased use of higher strength pain medicines in larger packs, or more potent opioids.

“It could also lead to substantial increased costs to consumers and the health system in the form of additional doctor visits and PBS costs.”

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  1. Lauren

    The guild are rubbish they represent sales not duty of care. Most pharmacists I deal with hate that codeine is still S2 and S3

    • Troy

      Strange – I am a pharmacist, and I don’t know ANY pharmacists who want OTC Codeine to go script-only. Do you work for the TGA? And by the way, the Guild supports the right of members of the public to have reasonable (non-script) access to adequate pain relief from pharmacies, and the right to decide if those OTC Codeine products provide that adequate pain relief for them. In other words, the right not to be corralled like cattle towards the doctor’s surgeries, because members of the public are supposedly too stupid to decide on an analgesic themselves – or do not have the right to do so.

  2. Darrin Brown

    Here Here!

    The sooner Codeine is s4 the better, especially since Nuromol/ Magigesic provides significantly better pain relief than codeine combinations.

    Not all Pharmacies are using Medsassist so this tool is useless until it is mandatory anyway.

    FYI: Codeine addicts are already discussing (link provided below) how to get around this system.

    • Alf

      Why would they bother? There are already too many soft doctors around who will write scripts for Codeine with 30mg of Codeine per tablet, in larger than OTC-maximum-quantity,and double-strength what you can buy in the strongest OTC Codeine products at 15mg per tablet.

      • Ron Batagol

        Sorry guys, Prof. Shugg has summarised it very well and his summary merely reflects what has been reviewed many times by experts in the field previously, (eg. one of the many recent reviews, in The Australian Prescriber in 2011,”Cautions with Codeine”, Joel Iedema

        Aust Prescr 2011;34:133-51 Oct 2011DOI: 10.18773/austprescr.2011.070

        The key points are:

        1. The prevalence of both slow and ultrafast CYP2D6 metabolism in the population varies (approximately 2–20%),

        2. Many of the preparations available in Australia contain less codeine than the doses studied in most clinical trials (generally 60 mg codeine). It is questionable if these low-dose codeine combination products (containing 8–15 mg codeine per tablet) provide meaningful analgesia over simple non-opioid analgesics alone.

        3. The problem of misuse and dependence, with an increasing amount of evidence for harm from abuse. • Misuse of OTC codeine products including deaths resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression.
        And, yes, of course pharmacists can, and do, currently try to play a big part in monitoring “shoppers” who are misusing the drug.
        BUT there’s no getting away rom the fact that it’s a not very useful drug in the non-prescription forms available, with potential for severe toxic effects when taken in higher doses in “cocktail formulations containing other drugs which are potentially in overdose, namely NSAIDs and Paracetamol.

        • Alf

          Methinks that people like yourself would make the jelly-beans script only, if only you could. Regarding the codeine issue, you are wrong. Just wrong.

        • Willy the chemist

          Ron, I “applaud” your politically correct view.
          However to be completely objective, we have to take a wholistic view.
          Following extensive review, the following course of action should be taken based on minimising harm;

          a) Upschedule all paracetamol to prescription only. After all paracetamol toxicity is one of the most common causes of poisoning worldwide. It is the leading cause of acute liver failure.
          In addition to CYP2E1 and CYP1A2, as noted above, the CYP3A P450s have been implicated in the formation of NAPQI in human liver microsomes.
          So in the general population, we also have the “the prevalence of both slow and ultrafast” P450s metabolisers of paracetamol.

          b) All alcoholic beverages and food must be upscheduled to S8 prescription only. It is a substance of abuse and many alcoholics are simply addicted to it.
          Alcohol abuse is a leading form of self abuse and leading to many cases of catastrophic injuries to both the drinker and others.

          Again differences in genes affect alcohol metabolism, different people carry different variations of the ADH and ALDH enzymes. Cytochrome P-450 (CYP) 2E1 is the major ethanol-oxidising enzyme.

          So in the general population, we again have the “the prevalence of both slow and ultrafast” P450s metabolisers of alcohol.

          c) Tobacco products should be upscheduled to prescription only.
          Tobacco use is the single greatest cause of preventable death globally. The World Health Organization (WHO) estimates that each year tobacco causes about 6 million deaths (about 10% of all deaths) with 600,000 of these occurring in non smokers due to second hand smoke.
          The United States Centers for Disease Control and Prevention describes tobacco use as “the single most important preventable risk to human health in developed countries and an important cause of premature death worldwide.”

          d) Sugar should be upscheduled to pharmacy only.
          Sigh, I’m too tired to go on……

          OK you know where I’m going. All of these are REAL issues that is more pertinent and affect more people than some “sub-therapeutic” codeine doses. Jeez the nannying that is happening!

          And we haven’t touch on any scientific basis for upscheduling of codeine and potentially the increasing dose and strength of narcotics being prescribed as alternative!


  3. Isaac

    Here are 4 equally ‘valid’ reasons to make all Codeine products s4:
    1) Pharmacies will have a less effective OTC range – wonderful news for doctors and supermarkets.
    2) The author of the above article is very likely a doctor – by writing this ‘unbiased’ article, he can support his pro-doctor prejudice, and keep his doctor mates, including those at the TGA, happy.
    3) The public will have their right to decide for themselves, further eroded. Boffins always love that. Whenever they take away yet another right, they sell it as ‘closing a loophole’. Note that for authorities generally. How much of your freedom do YOU want to keep?
    4) The article is a gratuitous kick in the teeth for those pesky competitors of doctors, the pharmacists. This despite the fact that pharmacists have successfully monitored another problem OTC drug, Pseudoephedrine, for years – with a system doctors have never acknowledged, let alone copied, Project Stop. Nor the new system just for monitoring OTC Codeine, MedsAssist. But hey, if someone gets addicted to Codeine because of doctor-prescribed ultra-strength Codeine tablets, that seems to be far less of a concern to everyone because doctor MUST have known best. Go, the doctors!

  4. Russell Smith

    Here we go again – yet another “pain expert” getting unwarranted press and yet again quoting well out of date stats – yet again galvanising the pros and the antis. Has no-one bothered to run a study engaging ppl who DO find codeine-containg products useful for pain relief in their own circumstances? And for how much longer do we need nanny the populace over this that and any perceived issue? There’s a lot of hot air generated over unfortunate outcomes for a tiny minority – oh and there must be some money or influence involved as well – but really, whatever the “problem” is there’s someone talking it up these days. The VAST MAJORITY of codeine-containing products consume responsibly and as advised by pharmacists – so IF you, the reader-pharmacist are not advising then why not? You didnt have and never needed Medassist in the past – and nor did I – but as a result of the loud-mouthed antis the PGA got involved – merely to head of the pathetic nannyism that pervades our holier than thou society.
    So – pull your heads in and dont behave as unprofessional defeatists who have run out of other people to annoy

  5. Monnette

    The Pharmacy Guild should be ashamed of themselves if they think that reduced pack size, ongoing education of pharmacists and ‘a’ consumer awareness campaign will solve the codeine problem that plagues Australia.
    I feel very insulted for the Guild even suggesting I need further education on this issue- how many Pharmacists and Pain Specialists’ expert advice and opinions will it take for the Guild to realise that their pro-codeine sales stance on this matter is pathetic and unsupported?

    • Troy

      I support the Guild’s stance – it is you who are pathetic, not the Guild.

      • Monnette

        just re-read your comment and have a think about what you have written.
        I feel sorry for you.

        • Troy

          Keep your fake sympathy. Making such a false offer, does nothing to improve you.

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