TGA hits back on codeine controversy


tug of war vector

The TGA has responded to RMIT ABC’s Fact Check article, reaffirming its stance that OTC codeine sales have been responsible for more than 100 deaths per year

Last week, RMIT ABC Fact Check investigated the evidence behind Health Minister Greg Hunt’s claim that making codeine prescription-only would save 100 lives a year.

“Mr Hunt’s claim doesn’t stack up,” the Fact Check team concluded.

“There has not been any recent data to suggest that 100 Australians are dying every year from over-the-counter codeine products.”

See ABC Fact Check’s full breakdown of the figures here.

While the Fact Check team suggested the figures were overestimated, the TGA says it actually regards its numbers as an “underestimate” of the annual number of deaths related to OTC codeine.

And despite calls from some leaders in the pharmacy sector that Minister Hunt and the TGA should “publicly admit that they were using outdated data”, the TGA is not backing down.

In a statement released over the weekend, the TGA and the Department of Health “reaffirm” their advice that OTC codeine sales have been responsible for more than 100 deaths per year.

“This has been previously calculated through reference to coronial advice and statistics as well as research into the levels of abuse and harms associated with OTC codeine,” the TGA said in its statement.

“Indeed, the TGA and the Department regard this as an underestimate of the annual number of deaths.

“While an exact number of those who may have died from over the counter codeine is difficult to determine, the TGA has used the best available evidence to estimate this number.”

The TGA says it estimated that OTC codeine factored in at least 100 deaths per year in the following way:

  1. The TGA took into consideration the Roxburgh research (Roxburgh, A. et al, Trends and characteristics of accidental and intentional codeine overdose deaths in Australia, October 5, 2015) as well as noting other articles that highlight that OTC codeine misuse has increased:
    1. The rate of all codeine related deaths increased during the period 2000 -2009 by 0.5 deaths per million persons per year, from 3.5 deaths per million in 2000 to 8.7 per million in 2009.
    2. In 59.9% of cases (861), there was no information about whether the codeine consumed before death was prescribed or obtained over the counter. Where the name or specific details of the codeine product were available, a prescription codeine product (most commonly Panadeine forte) was recorded in 59.9% of cases (343 of 572), and OTC codeine products were recorded in the remaining 229 cases [40%].
  2. In noting the increased rate of deaths of 0.5 per million persons per year we calculated that in 2017 (eight years later) this rate would be 12.7 per million persons a year. Taking the Australian population at 24.45 million people in 2017 an estimate of 310.5 deaths due to codeine (both prescription and OTC) was calculated.
  3. The research also stated that where the name or specific details of the codeine product was available 40% were recorded as OTC. Given this we have calculated 310.5 x 40% = 124.2 deaths per year where OTC codeine was consumed. The TGA took a conservative approach and revised this figure down to 100 deaths that could be attributed to OTC codeine containing products.

Professor Peter Carroll from the University of Sydney stated that he has serious concerns regarding the TGA’s calculations.

He says the TGA noted that Roxburgh et al (2015) reported that the rate of all codeine-related deaths increased during the period 2000-2009 by 0.5 deaths per million persons per year, and then used this figure to calculate the figure for 2017 (eight years later).

“I believe that for an extrapolation like that to be valid, it is imperative that one compares apples with apples and like with like, and I do not believe this is the case with the TGA’s calculations,” Professor Carroll tells AJP.

For example, he says the codeine products were rescheduled to Schedule 3 in May 2010, and MedsASSIST was introduced in March 2016.

“The TGA’s calculations do not take into account these significant changes to the availability of the products which were not operational for the period 2000-2009,” he says.

“One could equally make a similar calculation for 2018, even though codeine products are no longer available OTC.

“To me the TGA’s calculations are just not valid. I believe it is clearly wrong to claim that OTC codeine-containing products were responsible for the deaths of 100 Australians in 2017 when the data used to calculate this figure was collected a decade or more ago, and under different circumstances”.

Professor Carroll also said it was important to note that the vast majority of deaths reported by Roxburgh et al (2015) involved multiple drug use, not just codeine.

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