Response to article published in the AJP – OTC codeine death claims must stop

pillsThe Australian Journal of Pharmacy article with Pharmacy Guild NSW Branch president David Heffernan includes a number of disappointing claims about over-the-counter codeine medicines. It also attempts to discredit the data supporting the Therapeutic Goods Administration decision to make codeine medicines prescription only from 1 February 2018.

There is a broad body of evidence that documents the misuse, addiction, and secondary harm due to high dose exposure to combined codeine and non-opioid analgesic medicines.

  • The National Coronial Information Service (NCIS) fact sheet Opioid related deaths in Australia (2007-2011)1
  • Australia’s Annual Overdose Report 2017 (Penington Institute)2
  • Trends and characteristics of accidental and intentional codeine overdose deaths in Australia Roxburgh et al (2015)3
  • AIHW Report (2017)4
  • NDS household survey 2016 (AIHW, 2017)5.  

According to the AJP article, Mr Heffernan says data used in support of upscheduling codeine medicines, predates MedsASSIST- a voluntary monitoring system which was in fact developed by the Guild.

A nationally coordinated and implemented real-time reporting and monitoring system in the form of the Electronic Recording and Reporting of Controlled Drugs is a good idea. However, this means developing a system that is used national and consistently.

A monitoring system on its own is also not a solution to the problem.

Any suggestion that real-time reporting on its own will prevent deaths suggests a very limited understanding of the drivers of prescription and over-the-counter drug related risk and harm.

Mr Heffernan says that the Pharmacy Guild is not denying the harms caused by codeine and ‘one death is too many.’ Attempts to justify the continued use of over-the-counter codeine medicines or to discredit the data relating to mortality rates, are not helpful.

Upscheduling codeine is all about protecting patients.

As doctors, we see the consequences of these products being so freely available.

There are a number of clinical risks posed by polypharmacy. Drug-related death is the most serious adverse event arising from a pharmaceutical or illicit drug, but it is not our only concern in terms of adverse outcomes when it comes to codeine use.

Addiction and drug-related physical, social, economic, legal and psychological harms arise and need to be considered in terms of benefit, risk and harm to a patient.

Self-medicating for pain with OTC codeine can also mean that patients’ underlying health conditions go undiagnosed and untreated.

Key evidence, as cited above and outlined in the TGA consultation paper: Prescriptions strong (Schedule 8) opioid use and misuse in Australia–options for a regulatory response (January, 2018)6 highlights the need for the regulatory environment to change.

Pharmacists have an essential role in improving clinical practice and driving policy reforms when it comes to codeine use, based on their expertise in pharmacology, therapeutics and toxicology.

Doctors and pharmacists will continue to work together to ensure these changes are implemented by February 2018 and ensure that treatment optimisation and patient safety are prioritised.

Associate Professor Adrian Reynolds 
President of the Chapter of Addiction Medicine 
Royal Australasian College of Physicians


  1.  National Coronial Information System (Australia). (2014). Opioid deaths 2007–2011. NCIS Fact Sheet August 2014. Retrieved from
  2. Penington Institute. (2017). Australia’s annual overdose report 2017. Carlton : Penington Institute. Retrieved from 
  3. Roxburgh, A., Hall, W. D., Burns, L., Pilgrim, J., Saar, E., Nielsen, S., & Degenhardt, L. (2015). Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. The Medical journal of Australia, 203(7), 299.
  4. AIHW. National Opioid Pharmacotherapy Statistical Annual Data (NOPSAD) Collection. Australian Institute of Health and Welfare: Canberra; 2017. Retrieved from
  5. AIHW. National Drug Strategy Household Survey 2016. Australian Institute of Health and Welfare: Canberra; 2017. Retrieved from
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