Nats call to reverse or compromise codeine decision


David Heffernan and John Barilaro
David Heffernan and John Barilaro.

The NSW National Party has thrown its support behind the Guild’s “prescription – except when” concept

At the Harden Pharmacy in regional NSW, state Deputy Premier and Nationals Leader John Barilaro called upon Health Ministers around the country to take action on the codeine upschedule.

“We’ve made an announcement where the Nationals are calling on the Federal Government to reverse their decision in relation to the way customers can access codeine products over the counter,” he said.

“A reverse would be great, or a compromise position, which I know the Pharmacy Guild have been looking to.

Mr Barilaro is the Minister for Regional NSW, Skills and Small Business.

“Prescription – except when” would see pharmacists still able to dispense currently-OTC codeine-containing analgesics after the 1 February 2018 upschedule under certain circumstances, such as for dental pain relief when a dentist or GP cannot be accessed.

The Deputy Premier said such a measure is supported with the safeguard of a national real-time monitoring system to prevent misuse.

Mr Barilaro pointed out that the upschedule will have a bigger impact in rural and regional parts of the State, such as Harden, where timely access to doctors is often limited.

Harden is a designated district of workforce shortage for GPs.

New Pharmacy Guild NSW Branch president David Heffernan was on scene and explained how the Guild’s proposal, in conjunction with a real-time monitoring system, would help pharmacists identify and help people with drug misuse problems or poorly managed pain.

“We applaud the NSW Nationals for supporting our common sense proposal to allow safe and appropriate access to these medicines to occur without a prescription,” says the Pharmacy Guild’s national president, George Tambassis.

“We all know that simply making these medicines prescription only will not prevent their abuse through doctor-shopping.

“The Pharmacy Guild has already proactively put real time monitoring in place using its MedsASSIST program – yet no such national system exists for prescription medicines.

“We are certainly urging State and Territory Governments to put patients first and recognise the value of the system we are proposing – maintaining safe appropriate access, with safeguards and real time recording,” Mr Tambassis says.

 

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27 Comments

  1. Debbie Rigby
    05/10/2017

    See also the AMA media release in response. https://ama.com.au/media/pharmacy-guild-undermining-tga-over-codeine
    Some indisputable facts from this media release:
    – TGA makes evidence-based decisions about medicines, free from political interference and sectional interests
    – compelling evidence to support the decision to make codeine prescription only
    – Deaths and illness from codeine use have increased in Australia
    – 2016 survey showed that 75 per cent of recent painkiller or opioid misusers reported misusing an over the counter codeine product in the previous 12 months
    – patients who have short-term pain will still have access to alternative over-the-counter painkillers, which are more effective than low-dose codeine
    – better for patients with chronic pain to manage it with doctors’ advice on appropriate medicines and non-medicine treatments

    • Andrew
      06/10/2017

      The Nats, Guild, Barilaro, whoever else supports the “except when” option are effectively saying they’re comfortable trading >0 drug misadventure deaths in the community for this rule. No other way of putting it, really.

      I guess this is officially the point where pharmacy decided money was more important than patient outcomes.

    • Ron Batagol
      06/10/2017

      Yes Debbie- Couldn’t agree more! The evidence is in.! All those trying to keep “flogging the dead Codeine horse”- please focus on assisting your patients/clients instead of confusing them!
      It will be critical that pharmacists are active in providing the best advice to assist even more people who may opt to gravitate towards the inherent risks of supermarket self-selection of NSAIDs as their pain-relief option , instead of getting appropriate professional pain-relief guidance from their pharmacist in the post OTC -Codeine world!

      • Debbie Rigby
        06/10/2017

        It’s like tying yourself to the deckchairs on the Titanic

        • Stephen Roberts
          13/10/2017

          Never under-estimate the lobbying skills & dogged determination of the PGA.
          Never.

  2. Kishore Chand
    06/10/2017

    IT is a shame to see the politicians , who have no knowledge of effects of medication, call for reveversal of
    codeine decision
    They should focus on politics rather than health of people. Let experts do their job

  3. Debbie Rigby
    06/10/2017

    Topical analgesics should also be considered as an option – can be effective for acute and chronic musculoskeletal pain, and reduce the inherent safety issues associated with oral opioids including codeine.

    https://www.news-medical.net/news/20171005/Study-Topical-analgesics-may-provide-effective-safe-treatment-alternative-to-opioids.aspx

  4. Ron Batagol
    06/10/2017

    Another important consideration is that we are fortunate in the country to have a collaborative Nationally legislated uniform Poisons Code. I’d hate to see what sort of chaotic situation would arise with the National Poisons Code if various States decided to ignore changes to poisons schedules and devise their own rules for specific situations as it suited them!

  5. Pene Wood
    06/10/2017

    Couldn’t agree more with the comments already made. In most cases codeine isn’t appropriate or necessary above other analgesic options we already have in pharmacy. And correct me if I’m wrong isn’t that what the current S3 scheduling for codeine is? We can supply for short-term use for acute pain? On a whole pharmacists are currently not doing it very well (even with MedsAssist) so what makes them think anything is going to change….

  6. LOUISE MAXWELL
    06/10/2017

    As a pharmacist I feel embarrassed and most concerned to see the Pharmacy Guild push for codeine to remain OTC while ignoring all medical evidence which supports its upscheduling. The general public would not realise that the Pharmacy Guild represents pharmacy owners and not the profession as a whole. We should always put patient care ahead of profits!

  7. Andaroo
    06/10/2017

    I think every* medicine should be taken from OTC including all unscheduled and complementary medicines. We are pharmacists, not doctors, others should diagnose then under instruction, we can optimally provide that treatment.

    Diagnosing illness, monitoring conditions, minor aliments, sick certificates, certifying documents and administering immunizations are tasks that should not be apart of a working day for a pharmacist, that’s what doctors/nurses/JPs train for. The same principle principle would extend from regulated medicine to complementary medicine, with supply of natural medicines being constrained to prescriptions from naturopaths. Prescribing would be mutually exclusive to the respective fields unless the prescriber had completed both areas of study.

    This would solve a few problems, and fix any conflict of interest. We never wanted to give out free advice for most of the working day, and we shouldn’t be expected too. Hence, this way next time we are asked anything not specifically related to a patient’s dispensing history, we would be able to give a warm, friendly, advice less smile with a motion towards the closest surgery. Then we will have the time and energy to counsel the absolute sh#t out of that person when they come back with a script for Nuromol for, what can now only be described as, clinically dressed, scratch on their knee.

    *All sample medications included as these circumvent the professional oversight of pharmacists in their area of expertise.

  8. John Smith
    06/10/2017

    Just to be clear on this issue. The PGA has made it crystal clear that they only work for the interest of its members in different occasions and forums, and hence the PGA decisions, reports, and press releases only represents its members ( the owners ) and maybe some pharmacists who happen to be members too.

    So in regards to people who have migraine and get it all the time, which is better, to get codeine or go and seek prophylactic agents and rely on panadol, hydration, nurofen, or paracetamol/ibuprofen combo, or even old remedy aspirin, which if someone is on a prophylactic measure, shouldn’t be getting them too often.

    regarding toothache, which is better leave the patients relying on pain killers or by upscheduling, they will go to the dentist and solve the roots of the problem.

    Doctor and pharmacy shopping is a problem anyway, so let’s not mix the two problems together. monitoring Rx is a must either and criteria for prescribing and selling it is a must too. That is irrelevant to the upscheduling, it should have happened ages ago.

    The notion of common sense in pharmacy does not resonate with me at all as a pharmacist, because since when we rely on common sense in dealing with medicines? evidence to support is the way to go. That is why we have schedules, dispensing policies and procedures. We never ran before on common sense. For example, the regulations in NSW to keep the DDs repeats on premises. What if the customer is moving interstate, isn’t it common sense to give it back? regulations and rules are there for a reason, and we need to respect for the safety of patients.
    It is an opinion, some might agree and some might not… that is just life and have a good day everyone

  9. M M
    06/10/2017

    Maybe the PGA is asking us to forget about what we studied at uni and use our common sense in the 21 century.

    TGA, Doctors, and many Pharmacists will not allow this to happen.

  10. Anthony Tassone
    06/10/2017

    There has been previous mention of a consumers survey conducted through Community pharmacies regarding their potential behaviour and action once codeine is upscheduled to Prescription only from February 1st 2018.

    Below are some updated results since last mentioned:

    To the end of September there are 856 responses.

    In summary:

    The majority of consumers surveyed (71%) indicated they when codeine is upscheduled, their most likely course of action would be to visit a doctor to obtain a prescription for the codeine product they were using.

    The majority of this group (70%) indicated they will not even consider alternative analgesics that will remain available over-the-counter.

    A majority of consumers (63%) also believed they will visit a doctor more often as a result of this change.

    People currently using paracetamol and codeine combination are most likely to go to the doctor and less likely to use an alternative product.

    94% of consumers supported pharmacists being able to supply codeine without a prescription under strict conditions including monitoring usage in a real-time recording system. This highlights the trust and confidence patients have in their community pharmacists.

    Such sentiments at the grassroots level are important and should be considered as part of this ongoing debate and discussion.

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

    • Andrew
      07/10/2017

      Love it when you guys quote public surveys. Here’s another one from just last week;

      – 40% Australian public believe in angels and demons
      – 35% believe ghosts exert their will on the living
      – 33% believe that aliens have visited Earth
      – 16% “strongly” agree that vibrations from wind farms cause health problems.
      – 14% believe vaccines cause autism

      http://thenewdaily.com.au/news/national/2017/09/26/australians-believe-demons-aliens/

      How do you propose we address the problems this will cause the scheduling system, Anthony?

      • Anthony Tassone
        07/10/2017

        Andrew

        One thing I propose is to not be so dismissive of actual patients concerns about the impact on their own pain management by a decision that they had little control over.

        Looking past your clear and repeated anti Guild position for just a moment to acknowledge how patients have expressed they will respond to the schefuling change and their views on other available alternatives is important.

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

        • Andrew
          08/10/2017

          Or you could frame my anti-guild positions as pro-public health and evidence based practice. I’ve never argued against a good idea, or one backed by evidence. Surveys ain’t evidence.
          So rather than being snide maybe engage, and see the damage that this advocacy is causing the profession and our social contract. Why do doctors hate pharmacists? Stuff like this.

          Also, there is equivalency in this advocacy with legalizing drugs like cannabis and MDMA, you must support that too right?

        • John Smith
          08/10/2017

          Hi Anthony, I will give you some of the patients concerns that we hear everyday…
          Patient: Why don’t I get my repeats back?
          pharmacists: sorry the legislation states to keep the DDs repeats on premises in NSW…

          Patient: why can’t I get the 3 repeats on the clonazepam today?
          pharmacist: sorry have to confirm with Dr first

          patient: why can’t I get my repeat of lyrica today?
          pharmacist: because you just got it dispensed 2 days ago, why do you need more?

          Do you need more concerns to consider?

          are health professionals building their decisions based on patients concerns or based on evidence to protect patients from a danger that sometimes they don’t see. For example taking too much ibuprofen and on empty stomach, etc..

          surveys could be used to lobby and change legislation, but evidence are used in the favour of protecting health. It is as simple as

          • Big Pharma
            08/10/2017

            What’s wrong with ibuprofen on an empty stomach? It is more effective on an empty stomach.

          • Debbie Rigby
            14/10/2017

            Agree. Good evidence to show ibuprofen is absorbed quicker (and therefore acts faster than when taken with food) and more (higher AUC). The GI side effects of ibuprofen are systemic in action, so taking with food will not Prevent PUBs.

            Product information and AMH now states take with or without food for ibuprofen.

          • Anthony Tassone
            08/10/2017

            Hi John

            I’m not suggesting that Consumer surveys should be the determining factor in matters of medicine accessibility over and above evidence, safety and risk profile.

            The point I am trying to make is that there is a significant cohort of patients who have used low dose over the counter combined analgesics containing codeine for acute or short term pain and will be significantly inconvenienced and may endure greater out of pocket costs and added taxpayer expense to access a medicine they use safely and for them appropriately.

            The Prescription only except when proposal jointly developed by the Guild and the PSA is for acute pain in certain instances and not for long term use or for chronic pain management.

            As a profession we often and rightly speak of “patient centred care”. This has various tenets including; evidence, safety and relative risk but also should include understanding the impacts of their self care in this case of acute pain.

            Whilst the TGA undertook an extensive consultation regarding the proposed scheduling changes to codeine, the fact that many consumers (and even some health professionals) are only beginning to fully understand and appreciate the upcoming scheduling changes can make one soon realises that the experience and impact of the “everyday consumer” may not be fully understood.

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

          • Curious George
            19/10/2017

            Anthony, as a profession we also focus on quality use of medicine. Where is the evidence that codeine products at OTC doses are effective or appropriate choices for analgesia? Chris Hayes, Dean of the Faculty of Pain Medicine, Australia and New Zealand College of Anaesthetists, outlines reasons for their support of the TGA’s decision. In a nutshell, there is lack of evidence that the dosage of codeine in OTC combo products is effective analgesia; nor is it clinically significantly more beneficial than simple analgesia alone.

            https://www.tga.gov.au/sites/default/files/codeine-fpm-anzca-letter.pdf

            The “everyday consumer” may not fully understand the implications of this, and the job of pharmacists is to educate consumers on best practice.

      • Big Pharma
        08/10/2017

        Here’s a stat…100% of patients surveyed that were abusing OTC codeine supported the continuation of OTC accessibility.

        The most popular indication for request was migraine triggered by wind farm vibrations

  11. Jarrod McMaugh
    08/10/2017

    Its concerning that some prominent pharmacists who have commented here do not understand the nature of what The Guild and PSA are looking to create with “prescription except when” regulations. Either they don’t understand the concept, they haven’t availed themselves of the information that is readily available, or they are overlooking the information to suit their argument. Not sure which is worse.

    “PEW” is not the same as leaving codeine schedule 3. It will specifically be schedule 4. The regulation will create the capacity for pharmacists who have undertaken accreditation to have the clinical capacity to supply codeine within a specific criteria in a manner that requires RTPM.

    This will not be the same as current schedule 3.

    Not every pharmacist will be qualified. Not every patient will meet the requirements.

    It’s is disturbing the number of patients who see this as a move to preserve sales…. I can only assume that this belief is because the Guild is involved. Anyone who believes this is about money is forgetting three things:
    1) prescriptions have greater margins than OTC items.
    2) the volume of items sold as “PEW” cannot be anywhere near the volume sold now, just by the nature of the proposal & the number of products that will be deleted.
    3) the guild has invested more money into medsASSIST than any group (including governments) without reimbursement for monitoring codeine supply.

    Point three is also critical to the issue, because from February there won’t be any monitoring of codeine sales in Australia until RTPM arrives. Victoria is closest, with perhaps 12-18 months until it is in place. Other states are far behind. The federal system will not monitor codeine in any combination (only schedule 8, which doesn’t have the same harms)

    As has been pointed out many times before, and not addressed by any critics of PEW – moving codeine to schedule 4 does not actually make access safer… Only less convenient. Prescribers don’t have access to RTPM.

    The issue with safe access isn’t a component of the individual practitioners; it is a function of access to information about the patient’s history. Without this access, patients who are at risk of addiction or who are currently addicted will be at more risk, not less.

    Prescribers are no better than pharmacists at detecting drug-testing behavior. In addition, they have access to far more potent opioids, and regularly prescribe them. Last week I had a pethidine prescription presented for a known doctor shopper from a new GP who had no history and did not apply for a permit as they wanted to see if this helped their migraines first before getting the permit. No discussion with any other health professional about her history.

    I guess this is the elephant in the room – no one wants to point out to RACGP or AMA that amongst their great memebrs are some who are lax, lazy, inept, or even corrupt. Many of my colleagues in harm minimisation in Melbourne are very aware of specific doctors who create harm through their prescribing habits.

    PEW isn’t about preserving sales or money. It is about having a system in place where a small but significant number of patients will have access to treatment of acute pain where the remaining OTC items aren’t appropriate, via a system that is safer than current S3 or S4 supply.

    • John Smith
      08/10/2017

      Pick something that has evidence that it does actually work and does not have addictive features, which every single pharmacist in the world knows about the addiction problem that the codeine causes, to build up your case upon and lobby to change the legislation. Picking the codeine unfortunately will not give you the pharmacists’ support and I don’t think you need their support anyway, as PGA clearly works in the interests of their members i.e. owners and don’t consider the working conditions or pharmacists conditions at all… We can all agree to disagree but things are distinct clear now who is doing what and in who’s favour 🙂 Happy Sunday everyone

      • Jarrod McMaugh
        09/10/2017

        Ramez, you continue to overlook the issue that there will be no RTPM from February to prevent harm.

        This is the core of the problem that is continuing to be raised. It’s not about how the access is achieved (because prescription-only isn’t going to prevent access for those who are at risk). The issue is how does a clinician in the position of making a decision about appropriate supply know that there hasn’t been some kind of risky behavior prior to this instance?

        In February, people at risk will go to see a GP, who has zero capacity to see their usage, and a decision is made blindly. How is this in any way better than a system that currently utilises purchasing habits of an individual?

        I would like to see the evidence that changing codeine to prescription only WITHOUT REAL TIME MONITORING is safer than the current situation. What aspect of having a GP involved is inherently safer than the current system, if the problem is driven by doctor shopping (for which the GPs are not equipped to monitor).

        Evidence that we do have access to, shows us that iatrogenic addiction and overdose of prescribed medications are at an all time high, and increasing. The morbidity and mortality from prescription medications are now higher than those from traffic accidents. What about this situation tells us that access to codeine via prescription is inherently safer than the current system?

        You keep saying that evidence is not present for the proposal to set up PEW. I put it to you that evidence exists that prescription supply without RTPM is unsafe for people who are at risk. The issue isn’t about the form of access (since this can be easily overcome in all instances, include schedule 8). The issue is access to real time information that informs a clinician’s decision about the specific risk of this particular instance of supply.

        When anyone chooses to overlook this and accuse proponents of PEW as being driven by money, they not only display their ignorance of the real issues, but they do a major disservice to those people that we are trying to protect.

        RTPM is critical. Victoria is leading the way, but there is little sign that the other states are going to catch up any time soon (and the Tasmanian system is not fit for purpose).

        This has been the issue right from the start, and those who have been involved in the discussion for the last 3 years will be aware of this…. and many are distressed that the current changes are treated as if they will magically fix the issue, when they are incomplete.

        Without RTPM, changing schedule won’t fix a thing. Without an increase in workforce and referral pathways for chronic pain, acute pain, addiction, and addiction with pain, then we will continue to have patients inappropriately prescribed medications that continue to cause more harm than good.

        Evidence exists for codeine as a pain relieving agent – even if it is not the best option in all situations, it is the best option for a small number of situations due to other issues. The avenue of supply doesn’t alter how effective a medication is.

        It is not good enough to sit back and see the impending issue we are going to have (ie a large number of people inconvenienced, a small number of people who were at risk now at greater risk) and say “well, it’s going to be a shame, but we don’t have studies on PEW so we best just let the catastrophe happen”.

  12. M M
    08/10/2017

    Both PSA and PGA have failed to provide any evidence to prove their non-scientific argument.

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