Letter to the editor: Upschedule is about protecting patients

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

by A/Prof Adrian Reynolds

The 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.

For clarification, below are some key references that demonstrate the harms caused by over-the-counter codeine combination 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 (See references below)


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 http://www.ncis.org.au/wp-content/uploads/2014/08/NCIS-Fact-sheet_Opioid-Related-Deaths-in-Australia-2007-2011.pdf

2 Penington Institute. (2017). Australia’s annual overdose report 2017. Carlton : Penington Institute. Retrieved from http://www.penington.org.au/australias-annual-overdose-report-2017/

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 https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/national-opioid-pharmacotherapy-statistics-nopsad-2016/contents/introduction

5 AIHW. National Drug Strategy Household Survey 2016. Australian Institute of Health and Welfare: Canberra; 2017. Retrieved from https://www.aihw.gov.au/reports/illicit-use-of-drugs/ndshs-2016-detailed/contents/table-of-contents

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  1. Nicholas Logan

    The data has never been questioned. The inaccurate sound bites attributing all opiate misadventure to OTC sales is what’s wrong. Surely real time monitoring would prevent more deaths than no monitoring? Is A/Prof Reynolds congratulating or criticising the Pharmacy Guild for developing and funding MedsASSIST?

    • Amandarose

      I read the entire paper and looked at the graphs of data and have several questions:
      In 60 percent of codeine deaths it could not be differentiated between otc and prescription.
      Of the 40% left 60% of those where prescription related.
      The number of codeine deaths dropped since peaking in 2005.
      The data before 2000 was not shown so one wonders if this data was chosen for Impact.
      The vast majority of drug deaths are benzos.

      I actually think this is complex and addiction can only be treated when people are ready. I do worry about the many obvious addicts I honestly didn’t notice in my early career and I do wonder if the biggest issue is not infact availability but price. Those products once $20 a packet are suddenly 5 bucks at discounters making them an affordable high. I also think price effects prescription meds aswell.

      I would love to see if the death rates correlate with the rise of the discounters and also what the prescriptions rates were. I might have a little project right there to investigate in quiet time at work this week.

  2. Judy Plunkett

    A few quick questions for A/Prof Reynolds.
    1. Where in all those references does it say that 100 deaths/year are caused by Over-The-Counter codeine products? (As quoted by Minister Hunt and various members of the Department of Health.)
    2. Who wrote the thousands of prescriptions for Panadeine Forte and Endone dispensed in my pharmacy last year (not to mention Oxycontin, Targin, Durogesic etc.)?
    3. Has he actually taken the trouble to go to a pharmacy and see how MedsAssist works to capture people over-using OTC codeine products?
    4. Does he understand the meaning of the word “acute” versus “chronic”?
    5. Does he know the differences between mild, moderate and severe pain?
    6. Can he do maths? 2 x Panadeine Forte + 2 x Nurofen = 60mg Codeine + 1G Paracetamol + 400mg Ibuprofen. (This combination is regularly ordered by doctors and dentists in my area.) versus 2 x Panadeine Extra + 2 x Nurofen Plus= 55.6mg Codeine + 1G Paracetamol + 400mg Ibuprofen. There is hardly any difference in total dose so how can they keep claiming that the OTC products don’t work but then magically work when they are written on a prescription. This is a high combination I know, but I have used it occasionally when someone has severe pain and cannot access a doctor until the next day. Many migraine sufferers especially women who get migraines with their periods use Mersyndol to manage their lives very well – maybe they should be interviewed by the TGA to explain that this product does work and is far superior to Nurofen and Panadol. It is a myth that these products don’t work.
    7. Has he spoken to the GP’s on the ground as I have, who are very happy with the way pharmacists manage these products for short term pain and do not want their surgeries full of patients needing relief from short-term acute pain easily treated with Nurofen Plus or Panadeine?
    8. Can he tell me what to say to the following patients when I work on any evening or weekend and there are 29 people lined up at the medical centre at 5pm and so no hope of seeing a doctor, and an 6-8 hour wait at the hospital – a 15 yo girl with severe period pain who has already taken Panadol and Nurofen?
    – a man who has been kicked in the jaw at jujitsu and has four broken teeth?
    – a woman who has broken a toe and is in severe pain?
    – an 18 yo man with a huge tooth abcess that he has ignored until the pain is unbearable and is not being covered by Nurofen and Panadol?
    I have nothing to give these people other than Panadol and Nurofen which most of them have already tried. They will be distressed because of their pain and the TGA are telling me to offer accupuncture, meditation and tumeric.
    I really want the professor to tell me what to say and do when I work this weekend. And I am sure there are many pharmacists especially those in rural and regional areas, who would be also be very interested in his answers. He should especially provide guidance to someone like Peter Crothers in Bourke where a dentist only visits once every three weeks and the nearest one is 200kms away.

    Pharmacists just want a common-sense solution to the situation. We understand and are concerned about opioid abuse in our communities and are already involved in Drug and Alcohol management. We are more than happy to be involved in the management of chronic pain, but we need the OTC codeine products to be available in exceptional circumstances so we can look after patients when they have acute pain and no access to doctors or dentists. With mandatory real-time recording we will capture codeine over-use and yet there will no unnecessary suffering.
    I ask A/Prof Reynolds and his colleagues to listen to what we are saying and consider our solution seriously.
    Without real-time monitoring codeine abuse will only get worse not better. The re-scheduling of OTC codeine is not the answer.

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