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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