Following the up-scheduling of over-the-counter codeine products on 1 February 2018, GPs may see an increase in patients presenting for codeine prescriptions. These resources have been gathered to help you handle these requests.
What medicines have been affected?
The TGA website provides a list of previously available over-the-counter codeine-containing medicines that have been up-scheduled to prescription medicine. Inclusion on this list is not a guarantee that the sponsor will continue to market the brand in Australia.
Why has codeine been made prescription-only?
NPS MedicineWise has provided an overview of the evidence behind the decision.
NPS MedicineWise clinical news articles on the harms of codeine-containing medicines such as deaths and the cost of hospitalisations associated with misuse are also available online.
The TGA has prepared detailed information on the history and rationale behind the decision.
The Royal Australian College of General Practitioners (RACGP) has established an up-scheduling of codeine clinical guidelines web page with links to other resources and offers a webinar covering the implications of the change.
The Australian College of Rural and Remote Medicine (ACCRM) offers a 1-hour accredited online education module.
The Australian Medical Association website includes a number of codeine resources.
Resources that may help with communicating the change
The NPS MedicineWise Action Plan Managing pain without over-the-counter codeine outlines the changes and medicines affected in consumer-friendly language and includes an interactive section on medicinal and non-medicinal pain management strategies that can be completed in partnership with your patient.
NPS MedicineWise consumer web resources also explain the changes. Printable patient fact sheets in a number of different languages are also available to download or order.
- Medicines with codeine – what you need to know
- Codeine rescheduling FAQs
- Codeine facts sheets in community languages
The TGA publication Tips for talking about codeine may assist when talking to patients about the change, including those patients with possible codeine dependency.
If a patient requests codeine for acute pain
Codeine, especially low-dose codeine, has a limited place in the management of acute pain.1,2 Guidelines recommend non-pharmacological measures (eg, hot or cold packs, rest), paracetamol and NSAIDs, when not contraindicated, for mild-to-moderate acute pain.3
The short-term addition of an oral opioid, such as codeine, should only be considered if these measures fail to adequately manage the pain.3
Find more information on the management of acute pain and recurrent acute pain:
There are now several paracetamol/ibuprofen combination products on the Australian market. These combinations offer similar pain relief to low-dose codeine-based analgesics in moderate acute pain, with generally improved tolerability.4-7 Review the evidence behind these combinations.
If patients request codeine for tension-type headache or migraine, advise that opioids are best avoided because of side effects and the risk of medication overuse headache.8
NPS MedicineWise consumer web resources can help explain to consumers why codeine is not the best option for headache or migraine.
If a patient requests codeine for chronic pain
Patients with poorly managed chronic pain are at high risk of codeine misuse and overdose, with chronic pain implicated in over a third of codeine-related deaths in one study.9
Chronic pain is a complex condition that requires holistic management, aimed at improving function and quality of life.3,10 NPS MedicineWise News has information on chronic pain management, including why opioids, in general, are best avoided in chronic pain.
- NPS MedicineWise News After over-the-counter codeine: opportunities for better care
- NPS MedicineWise Chronic pain resources for health professionals
- NPS MedicineWise consumer information Chronic pain explained
- Australian Prescriber article Principles of prescribing for persistent non-cancer pain
- Watch Dr Malcolm Hogg talk about chronic non-cancer pain and its management in a 2-part video series
- Complete the RACGP and ACCRM accredited online case study Chronic pain: opioids and beyond
RACGP provides guidance and recommendations for prescribing opioids for acute and chronic non-cancer pain.
Painaustralia outlines the particular risks of codeine in chronic pain and presents a case for an overhaul of chronic pain management in Australia.
If a patient requests codeine for neuropathic pain
For neuropathic pain, guidelines recommend antidepressants (amitriptyline and duloxetine) and anti-epileptics (pregabalin and gabapentin) first-line.8,11 Because of the risk of adverse effects and misuse, opioids are considered third-line agents.11 Specialist advice is recommended before prescribing.
- NPS MedicineWise News Neuropathic pain: Diagnosis and treatment today
- NPS MedicineWise information for health professionals on neuropathic pain
- NPS Medicinewise consumer information on neuropathic (nerve) pain
- NPS MedicineWise educational visiting program: Neuropathic pain: touchpoints for effective diagnosis and management commencing in March 2018
If a patient with suspected dependency requests codeine
Misuse of codeine-containing combination medicines not only puts a patient at risk of codeine toxicity, but can also lead to life-threatening toxicity from the non-opioid analgesic, including acute renal failure and gastrointestinal haemorrhage with ibuprofen or paracetamol-induced liver toxicity.1,12,13
Be aware that some patients presenting with NSAID or paracetamol toxicity may not disclose their use of codeine-containing medicines, as this recent letter in the Medical Journal of Australia explains.
If a patient aggressively requests a particular codeine-based medicine, this may also suggest a possible dependency and requires further exploration.14,15 These resources may help.
- Australian Prescriber article Dealing with drug-seeking behaviour
- NPS MedicineWise News After over-the-counter codeine: opportunities for better care
- NPS MedicineWise Supporting patients with codeine dependence
NPS MedicineWise podcasts feature Dr Malcolm Dobbin and Dr Jill Thistlethwaite in conversation,
When assessing drug dependency, the following tools may assist:
- Drug Abuse Screening Test (DAST‐10) a 10-item brief screening tool to assess drug use in the past 12 months
- 24-hour Alcohol and Drug Information Service (details listed below)
- RACGP Prescribing drugs of dependence in general practice Parts A, B and C
- National Guidelines for Medication Assisted Treatment of Opioid Dependence
Opioid replacement therapy
Australian Prescriber articles provide summaries of opioid replacement therapy (ORT) and the regulatory requirements for prescribing.
24-hour Clinical Advisory Services for GPs and other health professionals
|State or Territory||Service name||Telephone|
|ACT||Drug and Alcohol Clinical Advisory Service – ACT||03 9418 1082|
|New South Wales||Drug and Alcohol Specialist Advisory Service||02 9361 8006 (Sydney)
1800 023 687 (Rural)
|Northern Territory||Drug and Alcohol Clinical Advisory Service – NT||1800 111 092|
|Queensland||Medicines Regulation and Quality||137 846 (8am-8pm 7 days)|
|South Australia||Drug and Alcohol Clinical Advisory Service – SA||08 7087 1742|
|Tasmania||Drug and Alcohol Clinical Advisory Service – Tas||1800 630 093|
|Victoria||Drug and Alcohol Clinical Advisory Service – Vic||1800 812 804|
|Western Australia||Clinical Advisory Service||08 9442 5042|
- Australian Medicines Handbook. Adelaide: AMH Pty Ltd, 2016 (accessed 20 December 2016).
- Schug SA PG, Scott DA, Halliwell R, Trinca J, APM:SE Working Group of the Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine. Acute pain management: Scientific evidence. Melbourne: ANZCA & FPM, 2015 (accessed 6 January 2018).
- Analgesics Expert Group. Therapeutic Guidelines: Analgesic. Melbourne: Therapeutic Guidelines Ltd, 2012 (accessed 23 December 2016).
- Mitchell A, McCrea P, Inglis K, et al. A randomized, controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine (Tylenol 3) after outpatient breast surgery. Ann Surg Oncol 2012;19:3792-800.
- Sniezek PJ, Brodland DG, Zitelli JA. A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. Dermatol Surg 2011;37:1007-13.
- Daniels SE, Goulder MA, Aspley S, et al. A randomised, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain. Pain 2011;152:632-42.
- Chang AK, Bijur PE, Esses D, et al. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: A randomized clinical trial. JAMA 2017;318:1661-7.
- Neurology Expert Group. Therapeutic Guidelines: Neurology. Melbourne: Therapeutic Guidelines Ltd, 2017 (accessed 9 January 2018).
- Roxburgh A, Hall WD, Burns L, et al. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust 2015;203:299.
- Painaustralia. Painaustralia codeine fact sheet - October 2017. Canberra: Painaustralia Ltd, 2017 (accessed 6 January 2018).
- Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015;14:162-73.
- Frei MY, Nielsen S, Dobbin MD, et al. Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases. Med J Aust 2010;193:294-6.
- Mill D, Johnson JL, Cock V, et al. Counting the cost of over-the-counter codeine containing analgesic misuse: A retrospective review of hospital admissions over a 5 year period. Drug Alcohol Rev. 2018;37:247-256.
- Royal Australian College of General Practitioners. Prescribing drugs of dependence in general practice, Parts A, B, C. East Melbourne: RACGP, 2015 (accessed 5 January 2018).
- Royal College of Anaesthetists Faculty of Pain Medicine. Identification and treatment of prescription opioid dependent patients. London, UK: RCoA (UK), 2018. (accessed 5 January 2018).