Codeine information: Frequently asked questions

This TGA behind-the-news article was published on 12 April 2018. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

On this page: Consumers | Medical professionals | Pharmacists and pharmacy assistants | Industry sponsors of codeine-containing products | Wholesale

Frequently asked questions - consumers

What's changed?

All codeine-containing medicines are now Prescription Only Medicines.

A list of codeine-containing medicines previously available over the counter that are now available with a prescription can be reviewed on the Current list of up-scheduled codeine containing products page.

Medicines containing the codeine derivatives pholcodine, dextromethorphan, or dihydrocodeine are unaffected by the decision to up-schedule codeine.

What medicines are affected?

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).
• Cough, cold and flu medicines (available under brand ranges such as Codral, Demazin and pharmacy generic cough, cold and flu medicines) have been reformulated without codeine and are still available at your local pharmacy.

I sometimes use codeine-containing medicines to treat acute or intermittent pain, what should I do?

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 alternative treatment options that may be available for you.

I sometimes use codeine-containing medicines to treat the symptoms of cough, cold or flu, what should I do?

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.

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

I suffer from chronic pain, what should I do?

You should talk to your doctor or healthcare provider to determine the best treatment options to manage you chronic condition. This may include:

• alternative over-the-counter 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; and/or
• or referral to a pain specialist or pain management clinic.

Speaking with your doctor or healthcare professional also allows you the opportunity to discuss any other health problems, side-effects, potentially dangerous medicine interactions or the risk of codeine dependence.

Ask your pharmacist about Pain MedsCheck, a trial funded by the Government to assist patients who are taking medication to manage ongoing chronic pain for three months or more. Your pharmacist will conduct a face to face consultation with you and develop a written action plan incorporating education, self-management and referral to doctors or other experts where additional support is required. Speak to your pharmacist for more information.

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

What if my pharmacy does not stock the codeine medicine my doctor has prescribed?

Many codeine-containing products previously available over-the-counter are still available with a prescription. See the Current list of up-scheduled codeine containing products.

If you don't already have a prescription, talk to your doctor during your consultation about the medicines on this list to see if any of them are suitable for you.

If you do already have a prescription, and your pharmacy does not currently stock the medicine that has been prescribed for you, talk to your pharmacist about generics available, ordering in stock from the list, communication with other pharmacies regarding their stock availability, or assisting you with getting your prescription changed by your doctor.

Can I travel to Australia with codeine products?

You must have a prescription or letter from your doctor to bring any medication containing codeine into Australia.

See the Office of Drug Control website Travelling to Australia with medicines and medical devices for more information and requirements around travelling with codeine.

What if I still have codeine purchases prior to 1 February 2018?

The laws regarding access, supply and possession of codeine and other medicines differs in each State and Territory. If you are in possession of a medicine that contains codeine that you purchased prior to 1 February 2018, and you are concerned because you do not currently have a prescription for it, you should contact your State or Territory government for advice.

Why has access to codeine-containing medicines changed?

The Australian Government is committed to delivering the best health outcomes for Australians through the appropriate regulation of medicines that are deemed by medical experts to have particular risks. This includes low dose codeine-containing medicines as these have been estimated to be a factor in over 100 deaths each year in Australia.

The evidence shows that medicines containing low-dose codeine combined with paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin, are generally no more effective than other non-codeine medicines.

The use of low-dose codeine-containing medicines is associated with high health risks. 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 acute pain and symptoms of cough, cold or flu, however there are safer and more effective medicines targeted for these conditions.

National and international guidelines are clear that opioids such as codeine are not to be used in the treatment of chronic pain. As a result, people who use OTC codeine-containing medicines to self-treat chronic or recurrent pain should seek advice from their doctor to ensure that the best treatment options (including non-medicinal) are used to manage their condition and discuss any other health problems, side-effects, potentially dangerous medicine interactions or the risk of codeine dependence.

People who take codeine-containing medicines for long periods of time can develop tolerance and physical dependence to codeine. About half a million Australians have misused over-the-counter codeine-containing medicines. Codeine also has addictive properties.

These changes are in-line with international best practice. At least 22 countries only allow prescription access to codeine-containing medicines, including the United States and most of Europe.

Who made the decision to make codeine a Prescription Only Medicine?

The decision to make codeine a Prescription-Only Medicine was not a decision of Government, but of a senior medical officer at the Therapeutic Goods Administration (TGA) acting on behalf of the Secretary of the Department of Health.

The TGA is a part of the Australian Department of Health and helps safeguard and enhance the health of the Australian community through effective and timely regulation of medicines. As part of this, the TGA determines how medicines should be accessed by the public through a process referred to as 'Scheduling'.

Scheduling is a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into Schedules in the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) according to the level of regulatory control over their availability to protect public health and safety.

What was taken into consideration when making the decision to reschedule codeine?

In making the decision to reschedule codeine, the delegate took into consideration:

• the expert advice provided on two occasions by the Advisory Committee on Medicines Scheduling (ACMS) and also the expert advice provided by the Advisory Committee on the Safety of Medicines (ACSOM). Both these committees are independent advisory committees that include medical and pharmacist experts from across Australia. Additionally, the ACMS has representatives from the all state and territory governments. The advice from both these committees on all three occasions was to up-schedule all codeine-containing medicines to Prescription Only Medicines;
• the presence of low-dose codeine in widely accessible over-the-counter (OTC) combination medicines and the development of tolerance and subsequent dependence on codeine contributed to severe health outcomes, including liver damage and death;
• the compelling evidence of harm caused by misuse, overuse and abuse of OTC codeine-containing medicines;
• that there is little evidence that these medicines are any more effective for pain relief or cough than similar medicines without codeine;
• some individuals, especially children, experience serious adverse reactions when given codeine, such as difficulty breathing and death; and
• low dose codeine-containing medicines are not intended to treat long term conditions. However, public consultation indicated that many consumers used these medicines to self-treat chronic pain potentially leading to codeine addiction.

Further information on the reasons for the change to codeine access can be found on the TGA website: Scheduling delegate's final decision: codeine, December 2016.

I live rurally or in a remote area, how do I gain access to codeine-containing medicines now that they are Prescription Only Medicines?

Visit your local healthcare professional, or community care centre and talk to the Remote Area Nurse or Aboriginal Health Practitioner.

Nurse practitioners will be able determine if you need a codeine-containing medicine or if alternative treatments should be considered. If required, nurse practitioners can prescribe codeine containing medicines in most states and territories for patients in remote or regional areas. Codeine containing medicines may be provided by Remote Area Nurses in most jurisdictions if it is part of their usual prescribed list of medicines.

For more information refer to the Community fact sheet: Codeine access for rural and remote Australians.

What is codeine tolerance?

Codeine 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.

What is codeine dependence?

Dependence on codeine use 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.

What are the symptoms of codeine-related toxicity?

Codeine shares the properties of other opioid analgesics and is capable of producing dependence, respiratory depression, reduced levels of consciousness, and in overdose, respiratory failure and death.

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

Where can I access further information and support?

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

• Agency for Clinical Innovation (ACI) Pain Management Network
• Alcohol and Drug Information Service (ADIS)
• Ask Your Pharmacist
• Australian Pain Management Association
• Australian Pain Society Facility Directory
• Chronic Pain Australia
• Healthdirect Australia - 24 Hour Health Advice Line 1800 022 222
• NPS MedicineWise
• Painaustralia
• Pain Link Helpline 1300 340 357
• Pain Management Network
• painHEALTH
• RealRelief
• ScriptWise
• WA PainHealth

Community factsheets:

Community fact sheet: Codeine-containing medicines: Harms and changes to patient access

Community fact sheet: Codeine access for rural and remote Australians

Frequently asked questions - medical professionals

What's changed?

All codeine-containing medicines are now Prescription Only Medicines.

A list of codeine-containing medicines previously available over the counter that are now available with a prescription can be reviewed on the Current list of up-scheduled codeine containing products page.

Medicines containing the codeine derivatives pholcodine, dextromethorphan or dihydrocodeine are unaffected by the decision to up-schedule codeine.

Why has access to codeine-containing medicines changed?

The Australian Government is committed to delivering the best health outcomes for Australians through the appropriate regulation of medicines based on the best advice by the medical experts.

Codeine is an opioid drug closely related to morphine and, like morphine, is also derived from opium poppies. 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.

The evidence shows that medicines containing low-dose codeine combined with paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin, are generally no more effective than other non-codeine medicines.

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 medicines 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. National and international guidelines are clear that opioids such as codeine are not to be used in the treatment of chronic pain.

I am a general practitioner. What does this mean for me?

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.

In partnership with the Nationally Coordinated Codeine Implementation Working Group (NCCIWG), the TGA has developed guidance documents that can assist you in talking to your patients about codeine - Tips for talking about codeine: Guidance for health professionals with prescribing authority

See the Codeine Information Hub for more education and training resources.

Are there any changes to prescription codeine-containing medicines?

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

Will codeine-containing 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. Low dose codeine-containing medicines are not currently on the PBS. Over the next few months the commercial sponsors (companies marketing the low-dose codeine-containing products) will decide whether to apply to the TGA for registration of their low-dose medicines as prescription medicines. See PBS website for prescribers for information on PBS listed medicines.

Frequently asked questions - pharmacists and pharmacy assistants

What's changed?

All codeine-containing medicines are now Prescription Only Medicines.

A list of codeine-containing medicines previously available over the counter that are now available with a prescription can be reviewed on the Current list of up-scheduled codeine containing products page.

What does the codeine up-scheduling mean for the over-the-counter medicines pholcodine, dextromethorphan and dihydrocodeine?

Medicines containing the codeine derivatives pholcodine, dextromethorphan, or dihydrocodeine are unaffected by the decision to up-schedule codeine.

Refer to the current Poisons Standard for information on the scheduling of pholcodine, dextromethorphan, and dihydrocodeine.

What does this mean for community pharmacists?

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

In partnership with the Nationally Coordinated Codeine Implementation Working Group (NCCIWG), the TGA has developed guidance documents that can assist you in talking to your patients about codeine - Tips for talking about codeine: Guidance for pharmacists

See the Codeine Information Hub for more education and training resources.

What support can community pharmacists provide to patients with chronic pain?

Further, the federal health minister, the Hon Greg Hunt, announced in January 2018 a new program to be funded by $20 million under the Sixth Community Pharmacy Agreement.

The Pain MedsCheck trial will see community pharmacists assist patients taking medication to deal with chronic pain that has been ongoing three months or longer. Through a Pain MedsCheck, a pharmacist will evaluate and review a patient's medicine and the pain management program that is being undertaken, ensuring it is supporting their clinical need.

Pharmacists will conduct a face to face consultation with the patient and develop a written action plan incorporating education, self-management and referral to doctors or other experts where additional support is required.

The Pharmacy Guild of Australia and the Pharmaceutical Society of Australia will jointly manage the Pain MedsCheck trial, which will be in place for the remainder of the Sixth Community Pharmacy Agreement which runs until June 2020. Training modules will be developed, and pharmacists will be encouraged to participate to ensure they are able to deliver counselling support to assist patients with the management of chronic pain. See the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia websites for more information.

What does this mean for pharmacy assistants?

All codeine-containing medicines are now Prescription Only Medicines. You may want to advise customers that due to the risk profile of the codeine-containing medicines, the regulations have changed and a prescription is now required.

Some customers may not understand why codeine-containing medicines are no longer available without a prescription. Refer customers to the pharmacist as alternative medicines available over- the- counter may be appropriate.

In partnership with the Nationally Coordinated Codeine Implementation Working Group (NCCIWG), the TGA has developed guidance documents that can assist you in talking to your patients about codeine - Tips for talking about codeine: Guidance for pharmacy assistants

See the Codeine Information Hub for more education and training resources.

Can codeine-containing medicines labelled as Schedule 3 Pharmacist Only Medicines continue to be supplied?

The following information has been extracted from the Fact sheet: Codeine stock management for wholesalers, sponsors and retail pharmacies:

1. Supply of codeine-containing medicines after 1 February 2018 when the product is not cancelled in the Australian Register of Therapeutic Goods
2. All States and Territories have agreed that Schedule 2 and 3 codeine-containing medicines that have been rescheduled to Schedule 4 prescription medicines and are in a retail pharmacy after 1 February 2018 can be dispensed after 1 February 2018 on prescription for a maximum period of 9 months (i.e. until 31 October 2018) or until the end of the shelf life, whichever is earlier, provided:
   • the stock is stored in the dispensary;
   • there is a valid prescription;
   • the stock is labelled with a dispensing label; and
   • any specific state or territory requirements are adhered to.
3. Contact your relevant State or Territory medicines and poisons regulation unit for more information regarding the requirements in your State or Territory.
4. Supply of codeine-containing medicines after 1 February 2018 when the product is cancelled in the Australian Register of Therapeutic Goods
5. Under the Therapeutic Goods Act 1989 (the Act), if an Australian Register of Therapeutic Goods (ARTG) entry for a product is cancelled, that product may continue to be supplied by a retailer (assuming the retailer is not a sponsor or selling wholesaler), if the goods were already available for retail sale at the date of cancellation of those products from the ARTG.
6. All States and Territories have agreed that any stock remaining on retail pharmacy shelves of OTC codeine-containing medicines (Schedules 2 and 3) that have been cancelled from the ARTG before 1 February 2018 can be dispensed after 1 February 2018 on prescription as a Schedule 4 prescription medicine in a retail pharmacy for a maximum period of 9 months (i.e. until 31 October 2018) or until the end of the shelf life, whichever is earlier, provided:
   • the stock is stored in the dispensary;
   • there is a valid prescription;
   • the stock is labelled with a dispensing label; and
   • any specific state or territory requirements are adhered to.
7. However, please note that the regulation of therapeutic goods is a co-regulatory scheme with the States and Territories. A person dealing with therapeutic goods must comply with all Commonwealth and state and territory laws. You should review the relevant state and territory laws carefully as in some states and territories; it is a criminal offence to supply therapeutic goods by retail unless the goods are included in the ARTG.
8. It is also the responsibility of the pharmacist to ensure that all of the legislative requirements are met.

Contact your relevant State or Territory medicines á poisons regulation unit for more information regarding the requirements in your state or territory.

Frequently asked questions - industry sponsors of codeine-containing medicines

What's changed?

All codeine-containing medicines are now Prescription Only Medicines.

How do I apply to the TGA to convert my registered Schedule 3 over-the-counter (OTC) medicine into a Schedule 4 Prescription Only Medicine?

Changing the Schedule only:

• Sponsors of registered Schedule 3 OTC codeine-containing medicines may submit an application to the Prescription Medicines Authorisation Branch to request that their registered medicine be converted into a prescription medicine. Such an application is made in accordance with 9D (3) of the Therapeutic Goods Act 1989 ('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.

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 Only 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).

How do I apply to register a new codeine-containing prescription medicine?

Applications to register new codeine-containing codeine in their formulation should be lodged with the Prescription Medicines Authorisation Branch. 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.

Frequently asked questions - wholesalers

Can codeine-containing medicines labelled as Schedule 3 Pharmacist-Only Medicines continue to be supplied now that codeine-containing medicines are Prescription Only Medicines?

The following information has been extracted from the Fact sheet: Codeine stock management for wholesalers, sponsors and retail pharmacies:

1. Supply of codeine-containing medicines after 1 February 2018 when the product is not cancelled in the Australian Register of Therapeutic Goods
2. All States and Territories have agreed that Schedule 2 and 3 codeine-containing medicines that have been rescheduled to Schedule 4 Prescription Only Medicines on the ARTG from 1 February 2018 can be supplied by wholesalers (providing they are not a sponsor) to retail pharmacies in their original Schedule 2 or 3 packaging for a maximum period of 9 months (i.e. until 31 October 2018).
3. However, please note that the regulation of therapeutic goods is a co-regulatory scheme with the States and Territories. A person dealing with therapeutic goods must comply with all Commonwealth and state and territory laws. You should review the relevant state and territory laws carefully as in some states and territories; it is a criminal offence to supply therapeutic goods unless the goods are included in the ARTG.
4. Contact your relevant State or Territory medicines á poisons regulation unit for more information regarding the requirements in your state or territory.
5. Supply of codeine-containing medicines after 1 February 2018 when the product is cancelled in the Australian Register of Therapeutic Goods
6. It is an offence under the Act for a person to supply therapeutic goods by wholesale if the goods are not included on the ARTG (unless they are exempt goods or otherwise the subject of an approval or authority under the Act).
7. Therefore once an ARTG entry is cancelled, any future supply by that product's wholesaler may amount to an offence under the Act.

For more information visit Selling and advertising of cancelled listed medicines: Questions and answers.