Codeine information: Frequently asked questions

10 April 2017
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Frequently asked questions - consumers

From 1 February 2018 all medicines containing codeine will require a prescription.

The following codeine-containing medicines will no longer be 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); and
  • Codeine-containing cough, cold and flu products (available under brand ranges such as Codral, Demazin and pharmacy generic cough, cold and flu medicines).

Talk to your doctor or healthcare provider about alternative treatment options that may be available for you.

Most individuals will be able to manage acute pain with safer, non-codeine based medicines.

Your pharmacist will be able to provide advice on the most appropriate options for you.

Talk to your doctor or healthcare provider about the alternative treatment options that may be available for you.

Most individuals will be able to manage the symptoms of cough, cold or flu with safer, non-codeine based medicines. Your pharmacist will be able to provide advice on the most appropriate options for you.

People with chronic pain should talk to their doctor or healthcare provider to determine better treatment options. This may include: alternative over-the-counter (OTC) or prescription medicines; non-drug therapies from an allied health professional such as a physiotherapist or psychologist; self-management tools such as exercise or relaxation; or referral to a pain specialist or pain management clinic.

Ask your doctor about a Medicare-funded care plan, which will allow you access to a rebate for treatment from an allied health professional. Medicare provides a rebate for the preparation of a Chronic Disease Management Plan and a Team Care Arrangement For more information see: Chronic Disease Management Patient Information: Planning your health care, Patient Information Sheet

If your doctor does not bulk bill these services there may be a gap payment you will be required to pay.

Many Australians don't realise how much harm codeine can cause.

Codeine is an opioid drug closely related to morphine and, like morphine, is also derived from opium poppies. Codeine, like morphine and other opioids, can cause opioid tolerance, dependence, toxicity and in higher doses, death. A particular problem with codeine is that because different people's bodies break it down at quite different rates, it is hard to predict what doses may be suitable. These risks are too high for codeine to be used without oversight from a doctor.

Codeine is sometimes used to relieve symptoms of cough, cold or flu, however there are safer and more effective medicines targeted for these conditions. Codeine is sometimes used to relieve severe acute pain or cancer pain. Codeine is generally not effective at reducing chronic pain that is not caused by cancer, particularly in the long term.

People who take medicines containing codeine for long periods of time can develop tolerance and physical dependence to codeine. Codeine also has addictive properties.

Nurse practitioners will be able to prescribe codeine containing medicines in most states and territories for patients in remote or regional areas that require such medicines. For remote areas, Remote Area Nurses in most jurisdictions follow “protocol prescribing” when codeine medicines are part of the formulary.

Tolerance occurs when codeine becomes less effective and your body needs higher and higher doses to feel the same symptomatic relief. This may lead to codeine dependence.

Dependence on codeine using takes the form of physical dependence and can happen when the body develops a need for the drug. Severe withdrawal symptoms can result when the medicine is stopped; these include headaches and muscle aches, mood swings, insomnia, nausea and diarrhoea.

Codeine is potentially capable of producing dependence and in overdose, problems with breathing and oxygen startvation (respiratory depression) and reduced level of consciousness.

Codeine toxicity contributes to both accidental and intentional deaths in Australia. Over-the-counter codeine medicines are combined with other painkillers such as either or ibuprofen. Long term use of paracetamol can result in liver damage and the most severe adverse effects of high dose long term ibuprofen use include serious internal bleeding, kidney failure and heart attack.

The risks associated with codeine use in children under the age of 12 are of great concern.

Further information and support can be accessed at the following websites:

Consumer fact sheet: Codeine harms, access and advice

Frequently asked questions - medical professionals

All medicines containing codeine require a prescription from 1 February 2018. This includes:

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

Codeine is an opioid drug closely related to morphine and, like morphine, is also derived from opium poppies. Actually, codeine functions as an analgesic by conversion to morphine in the body. A particular problem with codeine is that because there are large differences in its metabolism rate between individuals, it is hard to predict suitable analgesic doses in individual patients. Codeine, like morphine and other opioids, has been linked to opioid tolerance, dependence, toxicity and death. These risks are too high for codeine to be used without oversight from a doctor.

Codeine is sometimes used to relieve symptoms of cough, cold or flu, however there are safer and more effective medicines targeted for these conditions. Although many individuals use codeine to relieve severe acute pain or cancer pain, more effective opiate and non-opiate analgesics are available, and doses of these products can be more readily titrated to suit individual requirements. Codeine is generally not effective at reducing chronic pain that is not caused by cancer, particularly in the long term.

Discuss this change with your patients, as well as any alternative treatment options. Your patients may have questions about long term pain management options which do not include codeine. Your patients may also have questions about cough and cold treatment options which do not include codeine.

This decision will not affect the current availability or prescribing controls or current pack size for codeine-containing prescription medicines.

Will codeine prescription medicines be available through the Pharmaceutical Benefits Scheme (PBS)?

Some codeine-containing medicines are currently listed on the PBS for severe pain conditions; however these medicines contain high doses of codeine. The currently available over the counter analgesics have low doses of codeine and are not currently on the PBS. Over the next few months the commercial sponsors (companies marketing the low-dose codeine products) will decide whether to apply to the TGA for registration of their low-dose products as prescription medicines.

All codeine-containing prescription medicines fall under the general PBS co-payment (currently $ 38.80)but are above the concessional co-payment of $6.30.

If low-dose codeine products are listed on the PBS in the future, patients will not be required to pay more than the PBS co-payment. In 2017, the general co-payment is $38.80 and the concessional co-payment is $6.30.

Frequently asked questions - pharmacists and pharmacy assistants

All medicines containing codeine require a prescription from 1 February 2018. This includes:

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

The current stock for codeine-containing over the counter medicines can continue to be sold over the counter until 31 January 2018.

You may want to suggest the use of alternative products that are available over the counter, or advise the patient to discuss their pain and cough, cold and flu management options with their GP.

Some consumers may seek to 'stockpile' codeine-containing medicines prior to the scheduling change. As these medicines should not be used for chronic pain and can cause dependence you need to ensure supply is consistent with quality use of medicines principles.

You may need to review low-dose codeine products for inclusion in your hospital formulary.

From 1 February 2018 you may no longer supply codeine-containing products labelled Pharmacist Only or Pharmacy Medicine.

Prior to 1 February 2018 let your pharmacist know if there attempts to purchase more frequent than normal supplies of codeine-containing products.

You may want to advise customers that due to the risk profile of the codeine-containing medicine the regulations have changed and a prescription is now required. Some customers may not understand why codeine-containing products are no longer available without a prescription. Refer these customers to the pharmacist as alternative products available over-the-counter may be appropriate.

Frequently asked questions - industry sponsors of codeine-containing products

All medicines containing codeine require a prescription from 1 February 2018. This includes:

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

The current stock of codeine-containing OTC medicines can continue to be sold as OTC medicines until 31 January 2018.

Changing the Schedule only

  • Sponsors of registered Schedule 3 OTC medicines containing codeine may submit an application to the Prescription Medicines Authorisation Branch to request that their registered product be converted into a prescription medicine. Such an application is made in accordance with 9D(3) of the Therapeutic Goods Act ('the Act') and is known as a 'minor variation'.
  • Further information is available on the TGA website and sponsors may refer to the M1 change type in Minor variations to registered prescription medicines: chemical entities.
  • The application must be accompanied by relevant labels and a clean and marked up copy of the proposed, amended Product Information (PI) document. The PI document must comply with subsection 7D(1) of the Act.
  • Such applications are processed within a 45 working day period. Sponsors planning to convert their registered products into prescription medicines by 1 February 2018 are advised to lodge an application with the TGA by November 2017, to allow sufficient time for assessment and decision making processes to be completed.

Other changes

  • If sponsors wish to make any additional changes to their registered products, then the relevant application must be submitted to the TGA for approval.
  • For example, if formulation, trade name or indication changes are requested then the registered entry must be varied through relevant prescription medicines pathway once the product has been successfully converted to a prescription medicine.
  • Further information is available on the TGA website or by contacting the Application Entry Team (AET.Application.Entry.Team@health.gov.au).

Until 31 January 2018, applications to register new products containing codeine may be lodged via the OTC registration pathway, noting that all registered products supplied in Australia from 1 February 2018 must meet requirements for prescription medicines.

Applications to register new products containing codeine in their formulation should be lodged with the Prescription Medicines Authorisation Branch from 1 February 2018. Most products would be classified as new generic medicines (Type D applications).

  • Further information is available on the TGA website or by contacting the Application Entry Team (AET.Application.Entry.Team@health.gov.au).
  • Sponsors should allow about 12 months for the pre market registration process for new prescription medicines. Online Evaluation Plan Estimators are available to assist sponsors with planning their application. Sponsors are strongly encouraged to submit their dossier in eCTD format.
  • The TGA will shortly publish an updated edition of the RASML No. 3 (effective 1 July 2017) which includes an additional warning/caution 'If [coughing/symptoms] persist(s), consult your doctor or pharmacist' for codeine. Given that these products are to be re-scheduled to Schedule 4 on 1 February 2018, the requirements for codeine will remain the same as the requirements currently in force in RASML No. 2.

    This should eliminate the need to include the statement 'If [coughing/symptoms] persist(s), consult your doctor or pharmacist' or to change RASML 2 compliant labels.