Codeine upscheduled

Codeine-containing OTC preparations will be upscheduled due to concerns about its abuse

Codeine upscheduling decision fails consumers, says the Guild, this morning following the announcement.

The decision to upschedule medicines containing codeine to be available only with a prescription will simply add to overall healthcare costs and do little to address the misuse of these products by some patients, it says.

Guild president George Tambassis says the reported decision to upschedule the medicines is short-sighted and ultimately will only add pressure to the already financially stressed health system while also increasing the burden on already overworked GPs.

“What this decision means is that patients will have to go to their GP and get a prescription for these products every time they need them,” Tambassis says.

“It will limit access to these medicines for people with genuine medical needs.

“The decision has purportedly been made to help stamp out abuse of these medicines by some people but in reality this measure will only encourage vulnerable patients to doctor shop and try to find ways around the system.

“To show how community pharmacies could help cut the misuse of codeine-containing medicines and avoid any need to upschedule them, the Pharmacy Guild developed and introduced a real time recording system called MedsASSIST.

“This clinical decision support tool enables pharmacists to refuse sales to people they believe could be misusing, or be in danger of misusing, these products.

“More than 4 million transactions have been recorded since March when the system was introduced across Australia.

“Of these transactions, pharmacists have denied sales to some 70,000 patient because of identified risk factors.

“Nearly 50% of patients denied a sale were referred to their doctor for more treatment.”

However, despite the success of this program, the decision reportedly has been made to reschedule from 2018.

“Making these medicines Schedule 4 will simply create a barrier to the majority of consumers who use these products safely,” says Tambassis.

“This decision will not address issues of misuse and abuse but rather will increase Government expenditure on the MBS and PBS with consumers forced to visit a GP to have a prescription written.

“Shifting it to prescription only without a mandated real time recording system or any screening program will simply bury the problem even deeper in the overwhelmed system and cost shift it to an already bursting MBS,” Tambassis says.

The Guild says onus will now be on the Federal Government to:

  • ensure that the 98%-plus of Australians who use these medicines safely will continue to have timely and affordable access to pain management medication, considering they will have to access a prescription from a GP; and
  • address issues of addiction to codeine containing medicines, particularly given the even larger societal problem of addiction to prescription-only medicines, the lack of any real time monitoring system, and the likelihood that patients who go to a doctor are likely to seek greater strength pain relief that is subsidised under the PBS. 

“As custodians of Australia’s medicines schedule, pharmacists will comply with the decision and ensure they are available to advise and counsel patients, many of whom will be disappointed and annoyed that their safe access to these medicines has been denied,” says Tambassis.

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  1. Josh Litchfield

    8.50am and already had one in looking for it after the news release. Could be a fun day.

  2. Nicholas Logan

    An illogical decision given that the majority of traceable codeine-related deaths are from prescribed codeine.

    • Ian Carr

      So it’s only DEATHS we’re overly concerned about???

      • chris

        Yep..seems so.

      • Nicholas Logan

        No but it’s the only indicator for where the problem lies (as far as I know)

  3. Amin-Reza Javanmard

    “Of note is that the MedsASSIST sales data from March to July 2016 represents only 10% of the total
    sales in 2015 when compared to IMS data. This lower than expected coverage could be a
    consequence of the 65% coverage of pharmacies generally, the rate of uptake over these five
    months, or it could be the result of patients selecting to go to pharmacies that did not use
    Given the instances of ‘pharmacy shopping’ to source codeine,9 questions have been raised whether
    the patient use of codeine is best monitored by GPs noting their ability to better diagnose, treat
    and manage patients in relation to chronic pain. GPs are familiar with the treatment options
    available for their patient, and can refer patients to pain management specialists or clinics for
    greater oversight and intervention, a formal referral system that is not available for pharmacists.
    While MedsASSIST aims to provide pharmacists with a purchasing history for codeine-containing
    medicines, reservations were expressed relating to the limited ability of pharmacists to actively
    engage with ‘challenging’ patients to manage the use of codeine in OTC medicines, noting that the
    pharmacy environment does not usually allow for private conversations in the way that doctors’
    rooms do.”
    Tl;dr – apparently the 35% of pharmacies not using medsassist were selling 90% of the otc codeine.

  4. Glen Bayer

    Will be interesting to hear what the RACGP/AMA has to say about this one in terms of the work it’s going to create for the GPs.
    Also interesting that dihydrocodeine doesn’t appear to be included in the scheduling delegate’s final decision, so users will just buy bottles of Rikodeine.

  5. jeff hu

    I find it funny that a proven program like project stop has worked for pseudoephedrine but yet they don’t want to make medsassist compulsory and just go for up scheduling?? Why don’t we make pseudo products prescription only as well then?????????

    • Andrew

      Sorry, which part of ProjectStop is proven? DId you miss the latest stats on methamphetamine? Year on year increases and the latest survey shows higher use than ever before.
      The only thing it has achieved is to impair public access to a useful treatment option.

        • jeff hu

          Sorry I should’ve been clearer. Project stop has assisted pharmacists in making a therapeutical decision when supplying someone with a pseudo product. I don’t believe making the codeine products go onto script will assist the pharmacist in making a better decision compared with using a program like medsassist. I suppose we could use a combination of both script and medsassist when making the sale…

          • Janis Williams

            I have a friend nearly died from pneumonia after seeing a pharmacist and being given pseudoepehdrine/phenylephrine for 3 weeks when he was struggling to breathe. So the “therapeutic decision assistance” is limited and the pharmacists need to use some basic common sense.

          • jeff hu

            yes I agree but I think that’s a different area to what we are talking about since projectstop doesn’t actually diagnose the patient for you neither does medsassist…

          • Janis Williams

            Family and friend anecdotal evidence is that common sense is far from common…

  6. Raymond Li

    Terrible decision by the TGA. If a patient has been overdosing on codeine, and all of the codeine products on S2/S3 are sold as combinations, surely these patients are overdosing on paracetamol or NSAIDs also

  7. David Haworth

    Two points about Medsassist… 30% of pharmacies did not use it. And a large percentage of those that used it allowed patients to treat chronic pain as long as they only purchased at 4-5 day intervals. It would be nice if the RACGP/AMA ran some extra training for GP’s so that they just don’t prescribe large amounts of whatever the patient has been buying. This is well on the cards.

  8. Felecia Hamilton

    When do people start taking responsibility for themselves, if they have an addiction they need to correct their choices and only when they want help will they ask for it. You can’t make people become clean if they don’t want to. Upscheduling means genuine users of codeine will now be limited and what care is the GP going to provide apart from meeting their medicare quota, it is not about health and wellbeing anymore it is a business. In 10-15mins they will correct an addiction and control it? Upscheduling is just going to make the black market more of an option for the abusers and the genuine have their rights taken away.

  9. Tony Pal

    So pharmacists cannot be trusted to prescribe anything stronger than NSAID/Paracetamol. Yet surely the majority of codeine seeking clients were initiated on prescribed opiates and not low-dose OTC codeine. How many opiate dependants can trace back their need to their first dose of 8mg codeine? There is the issue of the efficacy of any dose under 30 mg, but now a diagnostic tool has been removed from the pharmacists armoury for those where low-dose codeine was effective. Doctors will be happy as their appointment books fill up.

    • Drugby

      There is evidence of harm from OTC codeine and codeine combination products, but no evidence of efficacy.

      See the TGA updated review which was also released today.

      • Ron Batagol

        Yes, Debbie, a well set out and comprehensive review- well worth reading for anyone interested in an objective assessment of the data!

      • Greg Kyle

        I find it strange that the TGA produced a document that said there is no evidence of efficacy of a product, and then used the same document as justification to reschedule the product line to prescription only. If there is no evidence of efficacy, why didn’t the TGA remove the product registrations due to lack of evidence of efficacy? Or is this a way for the TGA to “keep face” with the Pharma companies by not directly killing off their products? Instead, make them S4 and the prescribers will use other products that actually work, thereby making the current low dose products unviable and therefore the companies will stop producing them … voila – how to kill off a product line by stealth!

  10. Peter McGregor

    I’ll be scheduling a day off on the 31st December 2017….

    • Josh Litchfield

      Doesn’t it change in Feb 2018?

  11. Michael Post

    Prescription codeine without real time monitoring and prescriber accountability will further the codeine burden.
    GPs are inadequately qualified to manage chronic pain despite having a full clinical picture. There is a perfect opportunity for pharmacist specialists in pain management presenting right now- I imagine another opportunity will slip through our fingers?

    • Drugby

      I think it’s unfair to say “GPs are inadequately qualified to manage chronic pain” and infer pharmacists are. Management of chronic pain is complex. What is needed is holistic multidisciplinary care, ie GPs and pharmacists working together, either in primary care or via cyberspace (electronic health records and real time monitoring).
      MedsASSIST appears to be effective as a policing tool, but not every pharmacy is using it; and it doesn’t include GPs or other prescribers like dentists and nurse practitioners. And it doesn’t address the issue of suboptimal pain management and self-management.

      • Michael Post

        Debbie the inference was yours alone. Pain specialists exist to manage chronic pain. There exists an opportunity for pharmacists to train further and specialise in pain management. We have a glut of pharmacists itching for real clinical intervention. These theoretical specialists could work independently of retail pharmacy and become qualified. A complete clinical hx and long appointments with clients supporting pain specialists would be practical – pain specialists are interventionalists as well as consultants . Adequate qualification for a role assessing and treating chronic pain requires a focus, continuing education and varied, continuous practice experience.

        • Debbie Rigby

          Totally agree Michael that pharmacists with further training, mentorship and experience can be ‘pain specialists’. The SHPA model of residencies could be adapted to primary care.

          I don’t think all pharmacists have those skills and knowledge now (including myself).

      • Jarrod McMaugh

        “it doesn’t include GPs or other prescribers like dentists and nurse practitioners. And it doesn’t address the issue of suboptimal pain management and self-management.”

        Neither does changing the schedule.

        My stance on this has always been that schedule change or not, there is no solution without RTPM as part of the strategy.

        This isn’t going to fix the issue, it will just transport the problem more directly into the doctor’s offices, while still maintaining the problem in pharmacy (since all supply must come through pharmacy).

        The decision on whether to schedule or not isn’t in itself a good or bad decision – the issue is that it doesn’t address the problem. This is a band-aid that will create large costs for Medicare.

  12. Kevin Hayward

    I have always followed the advice of the BNF (British National Formulary) ” Compound analgesic preparations containing paracetamol or aspirin with a low dose of an opioid analgesic (e.g. 8 mg of codeine phosphate per compound tablet) are commonly used, but the advantages have not been substantiated. The low dose of the opioid may be enough to cause opioid side-effects (in particular, constipation) and can complicate the treatment of overdosage”
    Bearing this in mind I have always been reluctant to supply a compound product where a monotherapy would be safer and may be just as effective. For example in dental pain the BNF says “Combining a non-opioid with an opioid analgesic can provide greater relief of pain than either analgesic given alone. However, this applies only when an adequate dose of each analgesic is used. Most combination analgesic preparations have not been shown to provide greater relief of pain than an adequate dose of the non-opioid component given alone. Moreover, combination preparations have the disadvantage of an increased number of side-effects.”

  13. Ron Batagol

    This decision by TGA is long overdue, and simply follows a worldwide trend to restrict the unrestricted availability of Codeine.
    As TGA quite correctly notes “Low dose codeine-containing medicines are not intended to treat long
    term conditions, however public consultation indicated that many consumers used
    these products to self-treat chronic pain. This meant that consumers frequently
    became addicted to codeine.”

    Let’s face it. It has been well established that, despite, I’m sure, lots of anecdotal evidence to the contrary, that you need 30mg plus of codeine, to obtain a reasonable analgesic effect. Yet, ultra-fast metabolisers may well be at risk from courses of codeine at that strength.

    Furthermore, with the best of intentions, and dedicated efforts, a proportion of pharmacists documenting the sales of codeine-containing products to their customers will only be of moderate assistance in curbing the community codeine addiction problem.

    Interestingly, in 2014, when I had a piece in the MJA, after I successfully had TGA add the cautionary label for childrens’ formulations of NSAIDs, warning against using these products when fluid-depleted, I did receive complimentary contact and emails from nephrologists, but in addition, some also commented that they were seeing an ever-increasing number of patients with drug-induced chronic kidney disease, including life-threatening electrolyte disorders and renal tubular acidosis from over-consumption of Codeine & NSAID combination products!

  14. Jane Palmer

    From a patient perspective, I thinkvthe new decision has positives and negatives. I personally see a pain specialist and use a norspan 5mg patch for psoriatic arthritis. I use nurofen plus as a top up when the pain is really bad. As I only see my pain specialist every 6 weeks (190 dollars a hit). It is hard to estimate how good or bad my health will be in between these six weeks. I cant afford to see the gp as well as I am currently studying full time. I think the current rules are ok where we have to provide our drivers license. I disagree with the new regulations of no sale at all. I cant afford pay anymore money to see anymore doctors every 6 weeks. I understand misuse is an issue but that will always be the case with anything. Thank god I am leaving this crapy country soon. Its definitely going downhill quick. I am sick of the over regulations!!

  15. Debbie Rigby

    This is clearly an emotive and divisive decision. Social media has gone crazy with comments from consumers as well as pharmacists, GPs, and professional organisations.

    One comment from a consumer : “I don’t want to go on to morphine base medication” highlights lack of public awareness about codeine.

    I think this ABC interview with Sarah Spagnardi from NPS Medicinewise states the clinical issue nicely. It’s all about risk and benefit, and the lack of evidence for efficacy for low dose codeine.

    There are alternatives available OTC, with proven efficacy (eg paracetamol, NSAIDs, combination paracetamol/ibuprofen) but still the potential to do harm if overused or misused. Hence community pharmacy still has an important role in supporting patients with their acute and chronic pain management.

  16. Debbie Rigby

    There is a real need for resources and education for pharmacists and GPs on how to deal with codeine addiction.

    This fact sheet may be useful to use with patients when talking about codeine harms and benefits.

  17. Beverley Baxter

    My concern is that as per changes to Cough mixtures for the < 6 year olds,many pharmacists feel the need to offer SOMETHING – so stock PROSPAN rather than loose the sale. Not sure where the Codeine seekers will end up- placebos apparently work 33% of the time, but, will this alleviate pain sufficiently to allow for moderate exercise or effective participation in the work force!
    Interesting, challenging times ahead – Time to improve my lawn bowling, as well as my pharmaceutical knowledge – read as CPE

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