THE Therapeutic Goods Administration has strongly affirmed its advice to Health Minister Greg Hunt about the number of deaths attributed to OTC codeine, rebutting claims to the contrary in an ABC 'Fact Check' article last week (PD yesterday).
The claim of 100 deaths annually has been the subject of significant criticism from PSA NSW president Peter Carroll and NSW Guild president David Heffernan, but the TGA insists it has used the "best available evidence to estimate this number" - and in fact regards it as an underestimate.
The agency took into consideration research by Roxburgh et al published in Oct 2015, as well as "noting other articles that clearly highlight that everywhere OTC codeine is available worldwide, harm and misuse have steadily increased".
The rate of all codeine related deaths between 2000 and 2009 increased by 0.5 deaths per million persons per year, to 8.7 per milllion in 2009.
In 59.9% of cases there was no information about whether the codeine consumed before death was prescribed or obtained over the counter, but where the name or specific details were available the most common item was Panadeine forte, recorded in 60% of cases, while OTC codeine products were recorded in the remaining.
"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 in 2017 an estimate of 310.5 deaths due to codeine (both prescription and OTC) was calculated," the TGA said.
Based on the research findings the TGA then took 40% of that figure to conclude that OTC codeine contributed to 124.2 deaths annually - taking a conservative approach by then revising this figure down to 100 deaths that could be attributed to codeine containing products.
The TGA defended the decision to reschedule OTC products, saying access to the medicines will now be based on the medical assessment of a prescriber.
"Rescheduling codeine to prescription only will save lives," the TGA concluded - tga.gov.au.
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