I’ve got 99 problems… and codeine is one

Results of a new study on the cost of OTC codeine informed the TGA in its upscheduling decision – but Guild says there is more to the story

Researchers from South Australia have conducted the largest known examination of hospital admissions relating to use of OTC combination analgesics containing codeine.

Admissions related to prescription codeine products were excluded from the study, as well as those related to polypharmacy overdose and intentional paracetamol/aspirin/ibuprofen overdose.

The researchers reviewed discharge summaries of more than 1000 patients admitted to Flinders Medical Centre in South Australia between June 2010 and June 2015 for specific drug-related conditions, and determined 99 hospital admissions across 30 individual patients were eligible for the study.

The mean consumption across the sample was 28 OTC codeine tablets per day, with the highest level of ingestion reaching 90 tablets per day.

Duration of patient-reported OTC codeine use ranged from a few days to 10 years, with a mean of 606 days prior to admission.

Among eligible patients, 70% reported use of ibuprofen/codeine products, 21% reported use of paracetamol/codeine products, and 9% used both.

No patient reported use of aspirin/codeine products.

The most commonly reported indication for OTC codeine use was musculoskeletal pain (26.7%), followed by headache/migraine (13.3%).

Altogether the 99 OTC codeine-related hospital admissions were estimated to cost the local healthcare system a total of $1,008,082 – leading to a mean of $10,183 per hospital admission.

The study authors point out that OTC use and dependence was poorly documented by clinicians, and where dependence had not been identified on admission, a mean of 4.8 days had elapsed before identification.

“This study was designed to help inform discussion around the costs of OTC vs prescription access to low-dose codeine containing analgesics,” says study co-author Jacinta Johnson, Senior Pharmacist and Clinical Educator at Flinders Medical Centre, SA Pharmacy and SA Health.

“Our findings were provided to the TGA prior to their decision late last year,” she tells AJP.

“As the rescheduling decision has now been made, we hope that by quantifying some of the costs associated with over-reliance on analgesics to manage chronic pain, this study will highlight the need to invest in greater comprehensive, multidisciplinary pain management services.

“Additionally, we hope that summarising the features of these presentations will help clinicians to identify patients who are overusing these products sooner.”

Dr Johnson says the results add to the body of evidence describing the harms associated with OTC codeine products.

“Given there is only limited evidence to show adding low-dose codeine to simple analgesics provides a benefit over simple analgesics alone, to me the overall harms outweigh the benefits,” she argues.

“Regardless of how such products are accessed – over the counter or via prescription – there will always be potential for misuse and pharmacists have a vital role to play in educating patients and monitoring pain management over time.”

“There needs to be some clarity”

Victorian pharmacist Jarrod McMaugh agrees but thinks there is more to the story.

“The impact of misuse of any medication (regardless of schedule) is a concern for all health professionals,” he says.

“Despite this, there needs to be some clarity on the way in which people are ending up in hospital with these serious outcomes.

“When an adverse outcome occurs in a patient who is taking OTC medication, a disproportionate weight of importance is put on this without due consideration of the impact of prescription-only medication, or whether the medication was accessed via a prescription.

“For instance, the TGA decision to alter the scheduling of codeine noted that there were significant harms associated with use of OTC codeine without discussion of concomitant opioids or whether any of the patients harmed by codeine use were regularly reviewed by a GP or pain specialist,” Mr McMaugh tells AJP.

“When I refer to my own dispensing records since August (all codeine dispensing is recorded in my pharmacy) for 163 patients, 60% had prescriptions for combination codeine products. Of the remaining 65 patients, 42 had a single purchase of OTC codeine, and the remaining 23 had both OTC and prescription-only codeine products. Interestingly, patients who had prescribed codeine included a large number of privately prescribed OTC-strength products.

“The $1 million over five years identified in the study may sound like a significant sum, but it pales alongside the estimated $266 million a year minimum … the codeine scheduling decision will cost our health system,” says the Guild.

“I think that the wider health community is not acknowledging that access to ‘OTC’ codeine occurs via prescriptions, and those patients who are consuming opioids in the volumes that lead to hospitalisation are not restricting their access to OTC purchases. They doctor-shop and obtain prescriptions for various opioids, including OTC-strength products.

“Given that the research discusses in some depth the impact of ‘open access’ to codeine, it is important that the research quantitatively determines the source of the opioids that lead to harm.

“These concepts are important to consider in the impact of the TGA’s decision on access to codeine, and whether the decision has lead to improved outcomes and reduced harms. It could certainly be argued that without real time monitoring, the impact of scheduling alone will not minimise harm, and may potentially increase it due to prescribing cascade and dose escalation.”

$1 million… or $266 million?

The Pharmacy Guild of Australia maintains that most codeine-related fatalities are not from OTC codeine medicines.

“The plight of patients who become addicted to medicines containing codeine is of serious concern to the Guild and to all health professionals,” says a spokesperson for the Pharmacy Guild.

“The Guild has for many years been at the forefront of advocating for and taking action to introduce tools that enable clinicians to identify and support patients at risk of dependence.

“The people who become addicted to over the counter codeine and cause self-harm through overuse are a very small minority of the Australian consumers who use these medicines safely and appropriately,” they tell AJP.

“Furthermore, most codeine-related fatalities are not from OTC codeine medicines. The majority are a result of high-strength medicines that are prescribed by doctors and/or as a result of combination of medicines consumed by patients. Nevertheless, it is imperative that better systems are put in place to try to prevent such abuse of over-the-counter products, and the associated harm and cost.

“With mandatory national real-time recording of sales of medicines containing codeine, the likelihood of a patient being able to purchase and consume up to 90 tablets a day would be vastly reduced.”

The Guild says that under its proposed mandatory real time monitoring system, it is more likely that a person overusing codeine medicines would be detected, counsellor and either referred to their GP or into drug addiction and pain management support.

“The upscheduling of these medicines alone will not prevent abuse, especially while there is no real time national recording mechanism in place for doctor prescriptions. Doctor shopping is a reality, which doctor groups appear helpless or disinclined to combat.

“As to cost – the $1 million over five years identified in the study may sound like a significant sum, but it pales alongside the estimated $266 million a year minimum in additional health system costs (including additional doctor visits) that the codeine scheduling decision will cost our health system,” says the Guild spokesperson, referring to a Cadence Economics report prepared for the Pharmacy Guild in November 2015.

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  1. Andrew

    >>>“The people who become addicted to over the counter codeine and cause self-harm through overuse are a very small minority of the Australian consumers who use these medicines safely and appropriately,” they tell AJP.

    If I remember the TGA report correctly this small cohort purchase close to 80% of the OTC codeine.

    • Willy the chemist

      Good article. It’s balanced reporting.

      I will support the scheduling of alcohol, and the listing of any alcoholic food as a drug. I’m serious too, the harm and cost to community is crazy.

    • Jarrod McMaugh

      Data that I have seen collected form the MedsAssist database show that more than 80% of all codeine-containing products sold were one-off.

      This means that if the numbers from the TGA document are correct, then these patients are obtaining the medication via prescribed pathways, not OTC sale.

      • Andrew

        Or more likely it’s an incomplete and unrepresentative dataset that can’t pick up the longitudinality of patient use? What was the duration of data collection and uptake of MedsAssist? I’m still not convinced by MedsAssist – too easy to trick and overcome – look online for how-to guides.

        Direct from the report, from MedsAssist data
        “66% of patients requested a codeine product once, while 12% requested a codeine
        product more than three times”

        That’s 12% using chronically – slightly lower than the 19% from the other dataset but still contrary to the OTC indication of “short term use”. We could argue the semantics of pack size and duration and definition of “short term” but I think we generally have a good idea on what these patients actually treating, and 12% of customers going through the MedsAssist system continue to (prima facie) receive the product on a chronic basis.

        • Anthony Tassone


          Some further information about the data collected from MedsASSIST that may be of assistance (up until August 2017, and is from implementation of the platform from March 2016);

          – 59.3% of ID numbers have appeared once (and 40.7% have appeared more than once). This could suggest the majority of consumers are using codeine containing medicines on an ad hoc or one off basis;
          – Almost 92% of the ID numbers recorded purchased an OTC containing medicine less than 8 times in a year, again suggesting that the majority of consumers are using these medicines on a period basis for acute pain.

          Currently approximately 70% of pharmacies are using the MedASSIST platform. The Guild has long advocated that real-time monitoring of combined analgesics containing codeine should be mandated and continue to do so.

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

          • Andrew

            Can I have access to or query the MedsAssist data too? I think we could find some interesting trends in there.

            If not, please don’t quote unpublished data it’s of no value.

          • Big Pharma

            Very difficult to draw conclusions from a program which is not used in 100% of pharmacies. What % of the 70% use the program 100% of the time? Plenty of gaps here.

            I can guarantee you operators knowingly supplying these products in excess are not going to document every sale.

            Whilst I appreciate the PGAs position on mandatory recording, diddly squat can be drawn from incomplete or heavily skewed data

          • Jarrod McMaugh

            I think it’s a bit disingenuous to say data is useless unless it contains all possible sources.

            That would make every survey or poll or even clinical trial unusable.

            It would also make most prescribing data in Australia useless, as it normally focussed on PBS supply (a particular issue when talking about pain relief given the high volume of private scripts used)

            This data exists. That is a useful resource.

          • Big Pharma

            Fair point… the data does exist. However it is heavily skewed and usefulness questionable at best. Conclusions cannot be made when indeed the oversupply problem is likely to exist among pharmacies not using the program. Most inappropriate codeine sales in the country would exist within the 30%.

            You can not possibly claim the vague data from noncompulsory codeine recording is more credible than the study above.

          • Jarrod McMaugh

            Do you not see the irony of your points in the first paragraph where you question the validity of data that exists by making vague criticisms and assumptions that you have no way of supporting?

            And no one is claiming that any data is more credible than this study. They are both important pieces of information that are needed to inform policy. What both pieces of information tell us is that compulsory monitoring of all opioids is needed to minimise harm. Between February & the national implementation of real time monitoring, there will be no way of monitoring individuals who intentionally purchase codeine from multiple sources. The result will be more harm, not less.

          • Andrew

            Well….there’s the published data (which I quoted)….and then there’s the unpublished, unverified, and unavailable data yourself and Anthony have quoted. Only one of these is worth anything.

          • Jarrod McMaugh

            I think you’re just picking and choosing the data you want to talk about because you don’t like the source.

            The data from the Adelaide study has been available unpublished for quite a while, discussed and considered valid for quite a while. Should it have been ignored up until it was published?

            When medsASSIST data is published, will you suddenly my have new respect for it, or have another reason to say it’s not valid?

          • Andrew

            I’d probably have a look at it first.

            Can only comment on the data that’s available – I’m just trying to unpack what’s going on, and it seems from the data that’s available that OTC codeine was (and maybe continues?) to be handled very poorly indeed. Most packs going to chronic users is what the data says yet some are still advocating for an exception. That will kill people.

          • Jarrod McMaugh

            Will suplly via an exception to schedule 4 by an accredited pharmacist and compulsory RTPM be more risky than prescription only without RTPM?

            What is it about prescribing medication without access to supply history that makes it safe?

            Yes there needs to be changes, but scheduling alone is inadequate. I’m really tired of having to point to out that scheduling change isn’t going to fix anything. It is like parents putting their alcohol in a cupboard before their teenage kids have a party…. Slightly more inconvenient but not safer.

            The problem we have is that good data is available about a problem; but the sution that we’ve been handed is incomplete, and will create more problems.

            We know that the medical system is stressed – this will be increased by more people waiting to see their doctor.

            We know that hospital EDs are utilised inefficiently – especially for pain – this will be increased. Look to the UK for a system at breaking point. This is where we are heading.

            We know that prescribing cascades occur for patients the longer they receive incomplete therapy (IE medication without physio/psychology/nutrition/etc) without resolution of their complaint.

            We know that iatrogenic addiction is real & causes significant harm. Look to the US for a system at breaking point. This is where we are heading.

            At the moment, we have a system that cannot actually change the issue, and a “solution” that is going to compound the issue for people who are at risk of addiction or harm, and it is going to punish and compound the issue for others who are not at risk.

            If scheduling medication was a solution to addiction or pharmaceutical injury, then there would never be a need for controlled supply arrangements or a market for diverted medications. Scheduling change needs to occur because codeine needs to be monitored; but this doesn’t reduce harm or exposure in any way at all.

          • Andrew

            >>>>Will suplly via an exception to schedule 4 by an accredited pharmacist and compulsory RTPM be more risky than prescription only without RTPM?

            Dunno.. With the MedsAssist data you’ve quoted at least 12% of patients (or 8% from Anthony’s figure) are receiving codeine on what looks like a chronic (or at very least, regular acute use) which by my reckoning is against the QuM of OTC codeine. It would be interesting to look further in to the 92% cohort who received eight supplies or less too – I think there would be a detectable amount of non-QuM use in those too – all supplied under the RTPM.

            Would you not agree that someone receiving eight packs of OTC codeine in one year requires referral beyond pharmacy? That’s 15% of the year where they need analgesia.

            And that’s before we even consider the questionable role of codiene in OTC pharmacotherapy where it has been shown to be no more effective and much more harmful than combination ibuprofen/paracetamol.

            Jarrod I think we (pharmacists and community) need to experience the consequences of this policy cluster*** to inform us of where things have gone wrong and where we can do better. There’s been almost no increase of capacity in any of the support services that will be needed – it’s a poorly thought out and implemented policy that has not been supported by those siloed organisations who are in a ethical position to do so, to the detriment of the community.

          • Andrew

            I’m also concerned about what looks like a push from the guild to support their RTPM platform over the DORA system that was successfully trialed in Tasmania.

          • Jarrod McMaugh

            Medsassist is currently the only RTPM in place in almost all jurisdictions until the other states, and the federal government get things in place.

            Victoria will be next – great for my practice. Not great elsewhere.

            Medsassist costs the Guild significant amounts of money, for which there is no remuneration or charge to guild members. prolonging its use isn’t a financial benefit for anyone. “Pushing” it as an ongoing model makes no sense, especially when the guild is involved at state & federal level in advocating for the state & federal systems to be introduced.

          • Anthony Tassone


            Whilst Tasmania should be applauded as a jurisdiction for having implemented a real time prescription monitoring system – unfortunately there will be difficulty in implementing that type of system in other larger states as it relies on human and manual intervention in the backend to alert the pharmacist at the point of dispensing.

            It is not fully automated at the point of dispensing to be able to inform the dispenser of recent and relevant supplies to impact on a dispensing decision. It relies upon a phonecall and correspondence from the Tasmanian department to the pharmacy.

            I’m happy to stand corrected on the above points but that is my understanding.

            There would be some challenges larger jurisdictions to make it scale-able with a higher volume of Schedule 8 substances (and other substances of interest) that would need to be monitored.

            The Guild and the PSA have been strong advocates for real time prescription monitoring and for it to have the minimum amount of disruption to the normal workflows of a pharmacist and for integration into existing platforms.

            The Victorian real time prescription monitoring system due to commence operation in 2018 will not be based on the Tasmanian DORA system. This is not from any undermining by an stakeholder but would have been a considered position by the Victorian government for what would be fit for purpose for its jurisdiction.

            Anthony Tassone
            President, Pharmacy Guild of Australia (Victoria Branch

          • Jarrod McMaugh

            Do you think that a 3-day supply every 1.5 months is a large amount of use? I don’t think that equated to 15% of the year – that is 6% of the year.

            I get where you are coming form with the last paragraph… but if I could see a hoon driving like an idiot and a collision was clearly going to happen, I would do what I could to warn them, despite them being responsible for their own injuries. We can’t sit back and wait for government policy or complacency from some sectors of health to end in disaster if we can see it is going to happen

          • Anthony Tassone


            Purchase of a low dose combined analgesic containing codeine up to eight times in a year does not necessarily infer overuse or inappropriate use. If you consider if it is being used for period pain or headache where other treatments may not be suitable or not considered as effective.

            Headaches and migraines have been recorded as two of the top 3 reasons for use on the MedsASSIST platform (headaches 17.5% and migraine 12.9%).

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

      • Big Pharma

        That’s a long bow to draw.

        MedsAssist data is useless unless it is compulsory for ALL sales at ALL pharmacies. More than likely those misusing OTC codeine are sourcing it from the 30% of pharmacies who cannot be bothered contributing to community healthcare or are excited by the profit opportunity now all OTC sales have been funnelled their way.

        Pharmacists are more than capable of assessing and treating pain and I do believe they need a little more in their armoury than a nice expensive paracetamol/ibuprofen combination product.

        However like everything, HMRs, Medschecks, OTC substances of abuse and complementary medicines…..it’s the lack of accountability and regulation in the profession that has ruined Pharmacy’s involvement in every aspect of healthcare.

        As a result we have Nuromol@.

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