Data shows ‘pharmacy lobby’ were wrong: AMA


packs of OTC codeine
Low-dose codeine preparations featuring obsolete S3 packaging.

The AMA says that recent TGA data has “vindicated” the decision to upschedule low-dose codeine

Several days ago, the TGA issued a report which analysed pharmaceutical industry sales data and found that the total number of codeine-containing products supplied in Australia was around 50% lower than the average total supplied in the previous four years.

This data meant that in 2018, 17.1 million packs of codeine-containing products were sold, compared to a total yearly average of 34.7 million packs.

This 2018 total included January 2018, during which time OTC sales of low-dose codeine were still permitted.

“The evidence shows that low-dose codeine provides little benefit beyond placebo for short-term pain, and it is not a safe treatment for long-term or chronic pain,” Dr Bartone said.

“Studies showed that thousands of Australians were using codeine inappropriately and putting themselves at risk of addiction, organ damage, and other health problems,” he said.

“The AMA strongly supported the decision by the TGA, as the independent regulator, to act in the interests of patient safety, and up-schedule codeine products.

“The TGA and the Federal Government held firm in the face of great pressure from the pharmacy lobby groups, particularly the Pharmacy Guild of Australia, which launched a prolonged and very strong multi-State offensive against this change.

“The pharmacy lobby also claimed that up-scheduling would lead to doctor-shopping, and patients switching from low-dose to high-dose codeine medicines.

“However, the TGA analysis shows that the increase in the supply of high-strength 30mg codeine between February and December 2018 was not statistically significant.”

Dr Bartone said the reforms were aimed at reducing the amount of codeine in the community, not switching the sources of its supply.

In commenting on the TGA report last week, Pharmacy Guild Victorian branch president Anthony Tassone told the AJP that it was “still early” to determine whether the upschedule had achieved its aim of reducing codeine-related overdose deaths.

“The motivating reasons behind the recommendation by the TGA to upschedule codeine was to reduce harm. Reducing overall consumption of codeine in itself alone is not necessarily a marker for success unless there is a corresponding reduction in opioid related overdose deaths and better pain management,” he said at the time.

Both Mr Tassone and Dr Bartone called for the introduction of a comprehensive, national real time prescription management system for drugs of concern.

Meanwhile a Guild spokesperson responded to Dr Bartone’s comments stating that “The TGA statement makes clear it is relying on pharmaceutical manufacturer sales, not PBS dispense data, and that it will be doing further analysis”.

“It was never the Guild’s contention that the upscheduling would not lead to a reduction in aggregate codeine sales – that was obvious given the removal of all over-the-counter sales.

“The fact remains there was an increase in high dose codeine prescribing following upscheduling, as asserted by the Guild and confirmed by the PBS data the TGA is yet to consider.”

The spokesperson cited PBS Date of Supply codeine 30mg from January 2017 – in which 276,262 PBS scripts for this product were dispensed – to November 2018, which saw 351,419 scripts dispensed.

The month of January 2017 saw the lowest number of these script dispensed over this time, and May 2018, with 369,926 scripts dispensed, the highest.

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7 Comments

  1. Andrew Topp
    02/05/2019

    I have to wonder if the data set TGA used to “vindicate” the codeine up-scheduling was purposefully chosen to show no major changes.
    Our internal data analysis of hundreds of thousands of prescriptions shows a clear increase in 30mg codeine scripts (>7% in volume) while other pain modalities are flat (NSAIDs, S8s, pregabalin etc). 7% is well above “regular” script volume growth; I can only surmise that codeine patients have been forced into a doctor’s care and the response is, in many circumstances, a higher dose of codeine.
    While I am very happy for a pain patient to be cared for by a doctor I don’t believe that a higher dose of codeine is necessarily a better outcome.

    • M M
      02/05/2019

      Re: your internal data analysis…
      The main questions are

      1- Is the increase in higher dose codeine scripts significant? ((Yes or No)).

      2- Has the total amount of codeine Consumed by Australians increased or dropped significantly?

      The TGA analysis reveals the that pharmacy lobby group opinions could cause more harm and damage to our patients.

    • Sheshtyn Paola
      02/05/2019

      Hi Andrew,
      Thank you for your comment. Are you please able to provide further information of your internal data analysis to the AJP? You can email spaola@appco.com.au
      Kind regards,
      Sheshtyn Paola (Journalist, AJP)

    • Andrew
      02/05/2019

      >>> I don’t believe that a higher dose of codeine is necessarily a better outcome.

      According to EBM it is. Isn’t that what we do?

    • Not just codeine, what about other opioids? Just shifting the problem here.

  2. Ex-Pharmacist
    02/05/2019

    Mr Tassone: “The motivating reasons behind the recommendation by the TGA to upschedule codeine was to reduce harm. Reducing overall consumption of codeine in itself alone is not necessarily a marker for success unless there is a corresponding reduction in opioid related overdose deaths and better pain management”

    Um…. Anthony, I think you need to read this…
    https://www.mja.com.au/journal/2010/193/5/serious-morbidity-associated-misuse-over-counter-codeine-ibuprofen-analgesics

    • Anthony Tassone
      03/05/2019

      Ex-Pharmacist

      Yes I am aware of this study.

      It should be noted that it occurred between 2005 and 2008.

      This was prior to low-dose codeine products being made Pharmacist Only (Schedule 3) in pharmacies circa 2010 and also pre-dates the implementation of the MedsAssist real time monitoring system for codeine based products in 2016/17.

      My comment around ‘markers for success’ is simply to not judge the consumption of codeine alone, but quality of pain management and level of harm associated with opioid analgesics broadly,.

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

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