Codeine scheduling information

As of 1 February 2018, all medications containing codeine have been up-scheduled to S4 (Prescription Only Medicine). This includes all pain, cough and cold medicines containing codeine which were previously available as S2 or S3 medicines.

As a General Practitioner or pharmacist you may be seeking additional information regarding these changes. Please find a list of FAQs below:

Q: Why is codeine no longer available over the counter?
Over the counter (OTC) codeine containing medications have historically been provided for patients dealing with pain problems, and available in many cough and cold formulations. A decision was made in December 2016 by the Therapeutic Goods Administration (TGA) to address what they saw as inappropriate use of medicines containing codeine resulting in abuse and addiction issues in some patients.

Other reasons for the decision include that:

  • low dose codeine medicines have low benefits and high risks of dependency
  • codeine shares the properties of other opioid analgesics and all other opioids are at least S4
  • misuse can lead to death resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression
  • an appropriately qualified practitioner needs to assess the risk before making the decision that codeine will be used
  • ultra-rapid metabolisers are at risk of morphine overdose, with potentially fatal consequences, following “usual” doses of codeine.

The change was supported by RACGP, Consumers Health Forum, Pain Australia and all major medical groups. It brings Australia into line with many other countries in the world, such as USA, Japan, India and much of Europe, where codeine is only available with a prescription.

Q: What medicines have been affected?
The following codeine-containing medicines are no longer available without a prescription:

  • codeine-containing combination analgesics (painkillers) (available under brand names such as Panadeine, Nurofen Plus, Mersyndol and pharmacy generic pain relief products)
  • codeine-containing cough, cold and flu products (available under brand ranges such as Codral, Demazin and pharmacy generic cough, cold and flu medicines).

For a full list of codeine-containing medicines, visit the NPS Medicine Finder. The TGA has also compiled a current list of up-scheduled codeine containing products here.

Q: What services are available to support primary health practitioners in treating patients with chronic pain or opioid withdrawal?
Chronic pain management is complex. A multidimensional approach needs to be taken that encompasses a range of pain management strategies. NPS Medicine Wise offers advice on a number of pain management strategies that aren’t reliant on medication such as physiotherapy, massage, occupational therapy and lifestyle changes.

NPS Medicine Wise are also emphasising that medicines (including codeine) have a limited role for osteoarthritis. Information regarding pain management strategies for osteoarthritis can be found here.

Opioid withdrawal:

Service providers and clients can contact the Alcohol and Drug Information Service 24 hours a day to access free anonymous telephone counselling, information and referral regarding drug dependency. Call 1800 177 833 to access their consultancy service for health and related professionals.

Queensland Health has commenced a 12 month pilot of the Alcohol and Drug Clinical Advisory Service (ADCAS). ADCAS, which launched on 15 January 2018, is a specialist telephone support service for medical practitioners in Queensland, providing clinical advice by on-call addiction medical specialists regarding the management of patients with codeine dependency and other alcohol and drug concerns. The free service is available 8am to 11pm, seven days a week, and can be accessed by telephoning 1800 290 928.

Guidance is available for GPs from RACGP on how to prescribe opioids appropriately in the general practice context with a specific focus on the up scheduling of codeine.

Q: How can primary health practitioners assess whether a patient has a dependency and is shopping for codeine or opioid prescription?

The Prescription Shopping Programme (PSP) will continue to help registered prescribers identify and reduce the number of patients who get more Pharmaceutical Benefits Scheme accessed codeine than they need. If you are not already registered for the PSIS, call them on 1800 631 181, or complete and sign the PSIS Registration form and fax it to 07 3004 5218.

The Queensland Drugs of Dependence Enquiry Service is also available for clinicians and medical practitioners. This confidential service provides information regarding regulatory requirements, whether a patient is known to have a history of drug dependence, and treatment involving drugs of dependence. To access this service call 13 78 46.

To register to be a private prescriber for drugs of dependence consider contacting the Queensland Opioid Treatment Program, which is also found by calling 13 78 46.

Q: What resources are available for pharmacists regarding the changes?
The Pharmaceutical Society of Australia (PSA) has developed a codeine resource hub which provides pharmacists with a suite of resources to support the changes through the transition of codeine to a prescription only medicine. They include:

There are also pharmacist learning modules on the PSA website available for educational purposes.

Q: What support is available for patients affected by codeine up-scheduling?
Patients can contact the Alcohol and Drug Information Service to access support and information if struggling with codeine withdrawal. Visit the Queensland Government page Drug use: help and treatment to access a wide range of resources for patients.

There are also a number of fact sheets available on the Pain Australia website:

The Australian Pain Management Association (APMA) provides information and practical support for patients. This includes a PainLink helpline staffed by volunteers available 7am-7pm weekdays that is contactable on 1300 340 357.

The TGA website has a codeine information hub with an array of resources.

Patients may be registered on the Opioid Treatment Program provided through Queensland Health, which promotes harm minimisation in relation to opioid dependence. The program is offered through public clinics and registered prescribers. Patients may consider asking GPs to tell them more about the program.

Q: How has codeine up-scheduling influenced community pharmacy supplies of codeine?
Out of stock frustrations have become apparent since the change. Patients may have stockpiled prior to the implementation of up-scheduling. Since codeine containing producing moved to S4 not all previously available products are now suitable for supply to market. A listing of products now approved for supply is available here.

Pharmacists are encouraged to provide updates on their stock levels to GPs. Patients will also need to be advised that the price of codeine containing products may have increased to compensate for a new dispensing fee and the increased cost of newly packed product equivalents from wholesalers.

Prescribing patterns may also change over time further influencing stock levels required for codeine products. “Pharmacist medicine only” branded codeine products can still be dispensed with a valid prescription until 31 October 2018. More information regarding codeine stock management for wholesalers, sponsors and retail pharmacies can be found on the TGA website.

The NPS Medicine Wise step by step guide on supporting patients with codeine dependence is also available, which may assist with guidance on future prescribing patterns. This guide suggests preparing for patient presentation before consultation in line with RACGP clinical guidelines.