Codeine decision expected within weeks


Will the success of MedsASSIST be enough to prevent the upscheduling of OTC codeine products?

At the ASMI conference in October, Health Minister Sussan Ley suggested a final decision on the scheduling of codeine will likely be delivered before the end of the year.

Currently the Department of Health is completing a regulatory impact statement on the proposals and a decision will be made public before the next round of scheduling decisions are announced.

News Corp publications have also been reporting that a decision will be passed down within weeks.

NSW pharmacist Nick Logan is eagerly awaiting the decision, and hopes the outcome will be based on evidence that shows pharmacists are capable of responsibly managing OTC codeine products.

“I feel very strongly about it. I think upscheduling is an illogical solution because, of the codeine-related deaths that are traceable, 60% of them involved codeine that was actually prescribed [by a doctor]. Also data from Medicare shows us that if a consumer is forced to see a GP for a codeine-containing analgesic they are likely to receive a higher strength and a higher quantity of tablets on prescription,” argues Logan.

“Accessibility should be a cornerstone when considering the supply of medicines for acute pain. Upscheduling these products would strip accessibility for acute pain and likely result in stockpiling prescribed medicine and a greater risk of misadventure.”

The Pharmacy Guild earlier this year set up MedsASSIST, its real-time recording system for codeine sales, to identify consumers at risk and refer them to doctors or support services.

Logan says real-time monitoring has shown itself to be an effective system.

“I was impressed at the speed at which the Pharmacy Guild of Australia responded to this problem with the delivery of MedsASSIST software,” he says.

“[My pharmacy] uses MedsASSIST for all OTC codeine analgesic sales as part of our store policy. It breaks down barriers and consumers enjoy the professional interaction. MedsASSIST gives us a chance to have really meaningful conversations with our customers about their pain, discuss management and refer if required.”

Since its national rollout in March, 65% of pharmacies are now taking part in MedsASSIST, with over 3.6 million transactions recorded.

In addition, 72,000 requests to purchase codeine medicines have so far been denied because of concerns about dependency issues, and 86% of consumers who made five or more purchases have been recommended to take follow-up action in managing pain and addiction.

There are some very clear steps the government can take to curb codeine misuse, says Logan.

“I believe that legislating the use of MedsASSIST nationally, reducing the pack sizes to a maximum of three days with very clear ‘Do not use for more than three days’ labelling is the answer to OTC codeine abuse. It might even provide an evolving, digital professional service that could attract federal government remuneration. The savings to the MBS would also be huge.”

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8 Comments

  1. IToldYouMyHeadHurt
    15/11/2016

    Further restricting access to effective pain medications is lazy policy and shows a systemic disinterest in the health outcomes of many people who live with chronic pain. One in five Australians live with chronic pain, our medical profession needs to pull its socks up and invest in better outcomes for patients through better patient care, diagnosis and treatment. Simply restricting and monitoring the access to medications (that for many of us mean we can go to work, be a parent, a community member, and a little closer to happy and healthy) ignores the elephant in the room – chronic pain sufferers don’t get effective treatment from their GPs and Specialists. Invest in health care, don’t restrict management regimes.

  2. IToldYouMyHeadHurt
    15/11/2016

    Further restricting access to effective pain medications is lazy policy and shows a systemic disinterest in the health outcomes of many people who live with chronic pain. One in five Australians live with chronic pain, our medical profession needs to pull its socks up and invest in better outcomes for patients through better patient care, diagnosis and treatment. Simply restricting and monitoring the access to medications (that for many of us mean we can go to work, be a parent, a community member, and a little closer to happy and healthy) ignores the elephant in the room – chronic pain sufferers don’t get effective treatment from their GPs and Specialists. Invest in health care, don’t restrict management regimes.

  3. Toby
    16/11/2016

    No, the MedsAssist will be proven to be a waste of time in terms of preventing OTC Codeine going to script-only. Why? Because the decision was made initially by the TGA on the basis of ‘studies’ ie lobbying, by the doctors and supermarkets, to undermine pharmacy viability. The TGA only delayed the decision, so it could wait until the heat was off; and also of course so it could get more ‘evidence’ about the evils of pharmacist’-OTC-Codeine. All this will be shown to be correct, when the TGA decision is released as close as possible to Christmas Eve. This will have the intentional effect, of the media (let alone the pharmacy bodies) not even noticing the decision until the New Year. The decision to make OTC-Codeine script only will not even be reported until almost the end of January. The TGA will not be around to answer questions about until the holidays are over, even one lone reporter wants to challenge the TBA about it. If the decision is noticed when the holidays are over, the TGA will have as part of its response, ‘It is an old decision now; no-one said anything when it was published.’ Game over. Remember this prediction. It will show how inept pharmacy is at pharmacy politics. Are you reading this, Guild and PSA? Will you be on holidays when this very anti-pharmacy decision is announced?

    • Ronky
      23/11/2016

      Please explain to us why the TGA would have such an overpowering (yet secret) motivation to undermine pharmacy viability.

    • Anthony Tassone
      23/11/2016

      Toby

      Rather than comment on some points you have speculated on, I think it is important to draw our attention to an independent review commissioned by the TGA to inform discussion on the consultation following the interim decision to upschedule codeine; “Investigating the efficacy and safety of over-the-counter codeine containing combination analgesics for pain and codeine based antitussives”

      Full paper accessible from:

      https://www.tga.gov.au/sites/default/files/review-efficacy-and-safety-over-counter-codeine-combination-medicines.pdf

      An excerpt from the executive summary reads;

      “There is high quality evidence that combination codeine medicines provide clinically important pain relief in the immediate term (3 hours post ingestion) mean difference (MD).”

      The fact that there was a deferral of implementing the interim decision to up-schedule codeine demonstrates some interest in evaluating the potential utility of things such as real time monitoring through MedsAssist.

      Whilst the Guild has advocated from the beginning that recording should be mandated by the respective State and Territory Departments of Health, a voluntary system has still resulted in almost 70% of pharmacies using it (almost 4000 pharmacies), 4 million transactions being recorded (as at 21/11/2016) since its National roll out in March 2016.

      To your question whether the Guild is reading this? Yes we are.

      It was the Guild through its subsiduary GuildLink who scoped, built and implemented the MedsAssist real time monitoring platform in a matter of months (work commenced October 2015, piloted February 2016 and implemented for a national roll out March 2016).

      This is in addition to collaborative work undertaken with the Western Victoria PHN to develop resources to assist pharmacy staff in identifying potential codeine dependence, and advice and guidance on appropriate referral pathways.

      This is compared to the respective State and Territory governments still working their way through implementing the Electronic Recording and Reporting of Controlled Drugs (ERRCD) real time monitoring system of S8’s which has taken some years to only have Tasmania with a currently functional system.

      Will we be on holidays? Our work is never done on behalf of community pharmacy.

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

      • Ronky
        24/11/2016

        A very amusing effort to pluck out one sentence from the paper to make it appear to contradict the paper’s conclusions. The summary goes on to say,

        “the effect declines in the short term (4-6 hours post ingestion) MD -2.8 [95% CI -7.9, 2.18]. Codeine-based medicines have been shown to reduce cough severity, but not frequency, however the evidence for this is very low quality.

        It was difficult to evaluate the incremental effectiveness of codeine as some of the studies comparing combination codeine medicines with single ingredient medicines did not use same-drug comparisons e.g. NSAID + codeine vs paracetamol, making it difficult to attribute the findings to codeine alone. Three trials compared combination codeine medicines with appropriate single ingredient comparisons, two of which report no statistically significant difference in analgesia and one reported a marked difference in analgesia attributable to codeine.

        Documented harms associated with codeine combination misuse include death, gastric haemorrhage, renal impairment and life-threatening biochemical imbalances. The experience from RCTs shows less serious side effects such as irritated stomach and tiredness are common with these medicines. There were no data on long term outcomes from RCTs making it difficult to extrapolate findings beyond the short term.”
        Nobody questions whether OTC codeine-plus paracetamol/NSAID products relive pain. The relevant question is whether the ADDITION of codeine provides any ADDITIONAL benefit over paracetamol/NSAID alone. The paper concludes that there is little or no evidence of any additional benefit and strong evidence of increased risks.

        • Anthony Tassone
          25/11/2016

          Ronky

          There has been public commentary including from some doctors as to the clinical benefit of OTC doses of codeine even for acute pain.

          Consumer and community groups including the Australian Pain Management Association oppose the upscheduling of codeine to prescription only (their position is summarised via the below);

          https://www.painmanagement.org.au/using-joomla/extensions/components/content-component/article-category-list/276-apma-opposes-inappropriate-restrictions-on-codeine-medications-2.html

          The Guild’s position in its submissions and ongoing advocacy regarding scheduling of codeine has included;

          – final decision on codeine be deferred for at least 12 months so that a
          real-time monitoring system can be implemented and deployed and its impact on
          detecting abuse/misuse analysed and evaluated. (the findings you have quoted from the independent review commissioned by the TGA cannot take into account the affects of a real time monitoring system being in place);
          – State and Territory Governments as a matter of urgency amend their medicines and poisons regulations where applicable to mandate the online real-time recording of codeine in their respective jurisdictions.

          The Guild continues to advocate that the mandatory use of a real-time monitoring system should be complemented with additional measures such as:

          – Mandatory warning labels advising consumers of the potential for dependence from prolonged use of these products (greater than 3 days);
          – Consideration to reduce pack sizes for these products to a maximum of 3 days’ supply;
          – Ongoing education for pharmacists, and a consumer awareness campaign.

          If the evidence indicates that the risk/benefit profile of a product is not
          favourable, then the matter should be referred to the relevant section of the
          TGA who can assess whether these products should remain on the register of
          therapeutic goods.

          Given the widespread implications and cost of the rescheduling proposal, it is
          imperative that a formal regulatory impact statement (RIS) must be conducted
          prior to any final decision on rescheduling. This RIS should also examine the
          comparative risk/benefits of implementing a national real-time monitoring
          system as an alternative strategy.

          There has been ongoing discussion regarding the potential and actual rate of misuse/abuse of codeine. OTC codeine medicine abuse is a recognised problem internationally but is not completely understood.

          Studies have indicated research is needed to quantify the scale of abuse, evaluate interventions and capture individual experiences, to inform policy, regulation and interventions.

          The Guild believes it is often difficult to draw meaningful conclusions from reports due to factors such as:
          – in some cases the dates that are covered as part of a referenced study. Many studies assess abuse/misuse of codeine prior to 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.

          – Lack of specificity of misuse/abuse for OTC codeine compared to prescription codeine products. Several studies suggest that abuse/misuse of prescription codeine products is similar or worse than OTC codeine. Therefore the effectiveness of rescheduling codeine to prescription to address abuse/misuse must be questioned.

          Additional factors involved in abuse/misuse such as multiple drug toxicity and high rates of comorbid health problems such as mental illness illicit substance use and
          chronic pain.

          Accurately estimating the associated risk for the general population is difficult, which the NDPSC noted when it considered the scheduling of codeine in 2009. As noted in the interim decision, while the NDPSC stated it was not possible to accurately estimate the associated risk of harm, it was reasonably assumed:

          – The proportion of all users abuse OTC CCA is low
          – The risk of harm among all users of OTC CCA is low
          – The risk of harm among abusers of OTC CCA is high

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

          • Ronky
            25/11/2016

            Public commentary /= evidence.

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