Codeine drop ‘not necessarily a marker for success’


A new TGA report says the upschedule meant a “significant” drop in the amount of codeine supplied to Australians – but a Guild spokesperson says it’s early days yet

A TGA analysis of pharmaceutical industry sales data provided by IQVIA—a company specialising in collating and analysing data sets in the health sector— has showed that the total number of codeine-containing products supplied in Australia during 2018 was around 50% lower than the average total supplied in the previous four years (17.1 million packs in 2018 compared to an average of 34.7 million per year from 2014-2017).

The 2018 total included one month of sales data (January 2018) before the 1 February 2018 upscheduling of low-dose codeine products such as Nurofen Plus and Panadeine took effect; thus this data still includes some sales of over-the counter codeine-containing products.

For the first 11 months after upschedule, more than 15.3 million packs of codeine-containing products were supplied in Australia, totalling 8254kg of codeine, the report found.

A projection of the quantities of codeine that would have been sold if there had been no upscheduling and past supply trends had continued arrived at a figure of 15,213kg.

The actual amount supplied was 46% less than this, which the TGA says indicates that upscheduling low-dose codeine resulted in a decrease of 6959kg of codeine supplied to patients.

The TGA says the researchers also looked in detail at the supply of high-strength (30mg) Schedule 4 codeine-containing medicines.

“Our analysis does not support the assertion that many patients were switched from low- to high-strength codeine medicines after up-scheduling,” it says.

“Between February and December 2018, the supply of high-strength 30mg Schedule 4 codeine was 7274kg, as compared with the projected 6816kg without upscheduling. The difference was not statistically significant.”

These supply estimates were based on a trend analysis of monthly per capita data between 2014 and 2018, using the IQVIA sales and ABS population data, the TGA says.

The analysis was conducted for all codeine products combined, as well as separately for long-standing Schedule 4 and 8 high-strength (30mg) codeine-containing products, and for the lower-strength codeine products that were upscheduled.

The analysis excluded the data between November 2016 and January 2018 due to “considerable fluctuations in codeine product sales data that surrounded the public consultation and announcement of the upscheduling”.

“Our modelling showed that the decreases in total codeine sales were not due to long-term trends in the monthly per capita supply, which we found to be stable,” says the TGA.

It points out that the IQVIA data are aggregates and so do not allow the TGA to draw conclusions about codeine usage among population subgroups (for example by age and sex) or trace individual patients’ medicine supply over time.

Anthony Tassone, president of the Pharmacy Guild’s Victorian branch, told the AJP that the TGA release provides an “interesting update” following the upscheduling of low-dose codeine.

“However it is still early to determine whether it has been a success given we’re not fully aware whether there has been a reduction in codeine related overdose deaths,” he cautioned.

“What we do know is that there’s a reduction in codeine consumed by the community—what we don’t know is the overall impact on opioid 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.

“Upscheduling of codeine alone is not going to be successful in significantly reducing overdose deaths as we already know that more people die from prescription medicine overdose than the road toll. 

“What we clearly and urgently need is a comprehensive real time prescription monitoring system in every state and territory operating supported by appropriate treatment and support services for pain management and medicine dependence.”

The TGA says it is undertaking further analysis of the data and will also include comparisons with other data sets (for example, PBS data) to further understand the impact of upscheduling on the amounts of codeine dispensed.

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