Why Australia decided to make all codeine products prescription only

The recent decision in Australia to make codeine-containing medications prescription only from 2018 (
The Pharmaceutical Journal online, 23 December 2016
) was reported to have been met with disappointment from the Pharmaceutical Society of Australia.

As part of a pattern of increases in pharmaceutical opioid consumption and dependence reported in the western world, addiction services in Australasia are reporting increasing numbers of people presenting whose opioid dependence has developed with over-the-counter (OTC) opioids alone.

People who are dependent upon OTC opioids are not necessarily readily identified as people who might have a substance misuse problem, may describe their development of addiction as ‘accidental’, and often do not see addiction treatment as appropriate for them. There is limited data available on the prevalence of OTC opioid dependence. However, a recent, small study in France reported that in a sample of people purchasing OTC codeine (n=118), around 20% met diagnostic criteria for opioid dependence[1]

The harms experienced by people with OTC opioid dependence are related to the need over time for increased doses of opioid to avoid withdrawal, inevitably resulting in the consumption of excessive doses of both codeine and the co-formulated agent (paracetamol or ibuprofen). Significant increases in presentations to hospital for acute severe liver failure associated with paracetamol and codeine products in the United States have been linked to opioid misuse and dependence[2]
, and in Australasia admissions to hospital for gastric haemorrhage, renal tubular acidosis and opioid overdose were reported in a case series of people presenting to addiction treatment[3]

In the Australasian study, the average daily dose of ibuprofen/codeine product consumed by those who had developed dependence ranged from 49 to 65 tablets per day. A report prepared for the Therapeutic Goods Administration (the authority in Australia responsible for regulating medicines, medical devices, blood, and tissues) stated that over 100 deaths related to the misuse of combination codeine preparations had been recorded in Australia by 2016[4]

If one were to view the rescheduling of codeine products through the same harm reduction lens with which illicit opioid dependence is approached and managed, then the decision in Australia might seem entirely rational. Any decision to change the availability of OTC codeine should ensure in parallel that access to adequate pain relief is possible in a timely, affordable and appropriate manner through prescription or proven non-pharmacological interventions for the community.

Carina Walters

PhD candidate

School of Pharmacy

University of Auckland

New Zealand


Susanna Galea

Consultant psychiatrist

Addiction specialist

Clinical director

Community alcohol and drug services

Auckland, New Zealand


[1] Roussin A, Bouyssi A, Pouche L et al. Misuse and dependence on non-prescription codeine analgesics or sedative H1 antihistamines by adults: a cross-sectional investigation in France. PloS one. 2013;8(10):e76499. doi: 10.1371/journal.pone.0076499

[2] Bond GR, Ho M & Woodward RW. Trends in hepatic injury associated with unintentional overdose of paracetamol (Acetaminophen) in products with and without opioid: an analysis using the National Poison Data System of the American Association of Poison Control Centers, 2000-7. Drug safety. 2012;35(2):149-57. doi: 10.2165/11595890-000000000-00000

[3] McAvoy BR, Dobbin MD & Tobin CL. Over-the-counter codeine analgesic misuse and harm: characteristics of cases in Australia and New Zealand. The New Zealand medical journal. 2011;124(1346):29-33. Available at: https://www.nzma.org.nz/journal/read-the-journal/all-issues/2010-2019/2011/vol-124-no-1346/article-mcavoy (accessed 11 January 2017)

[4] Shaheed C, Maher C & McLachlan A. Investigating the efficacy and safety of over-the-counter codeine containing combination analgesics for pain and codeine based antitussives. Australia: Therapeutic Goods Administration; 2016. Available at: https://www.tga.gov.au/sites/default/files/review-efficacy-and-safety-over-counter-codeine-combination-medicines.pdf (accessed 11 January 2017)

Last updated
Clinical Pharmacist, CP, February 2017, Vol 9, No 2;9(2):DOI:10.1211/PJ.2017.20202178

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