The TGA statement in relation to ABC’s Fact Check article on deaths from OTC codeine

25 March 2018

In reference to the ABC’s Fact Check article “Will the move to make codeine prescription-only save a 100 lives a year” the Therapeutic Goods Administration (TGA) would like to clarify:

  1. The TGA and the Department reaffirm our advice that over-the-counter (OTC) codeine sales have been responsible for more than 100 deaths per year. Rescheduling codeine to prescription only will save lives.
  2. 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. Indeed, the TGA and the Department regard this as an underestimate of the annual number of deaths.
  3. The decision to up-schedule codeine is supported by professional bodies including the Royal Australian College of General Practitioners, the Royal Australian College of Physicians, the Australian Medical Association, Faculty of Pain Management, Australian and New Zealand College of Anaesthetists, the Australian College of Rural and Remote and the Rural Doctors Association of Australia.
  4. 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.
  5. TGA estimated that OTC codeine factored in at least 100 deaths per year. In terms of how this was calculated:
    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 clearly highlight that everywhere OTC codeine is available worldwide harm and misuse have steadily 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.
  6. In moving OTC codeine containing products to Prescription Only, access to these medicines will now be based on the medical assessment of a doctor or other prescribing health care professional. This move will eliminate any future deaths from codeine containing OTC products.
  7. Many countries across the world, have similarly removed over the counter codeine, given the significant medical issues associated with addiction and misuse.