Final decision on re-scheduling of codeine: frequently asked questions

Medicines containing codeine will be available by prescription only from 1 February 2018.

Specifically, the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) will be amended to delete the codeine entries from Schedule 2 (Pharmacy Medicines) and Schedule 3 (Pharmacist Only Medicines), leaving only the codeine entries in Schedule 4 (Prescription Only Medicine) and Schedule 8 (Controlled Drug) on 1 February 2018.

This decision has been made by the TGA, based on the evidence and advice provided through a lengthy consultation period.

Codeine is a commonly used medicine of abuse. Low-dose codeine (less than 30 mg) is currently available in a number of formulations in pharmacies over the counter (OTC) for consumers to self-administer. These include cough and cold preparations, and analgesic preparations combined with other pain relief medicines such as aspirin, paracetamol or ibuprofen. There is substantial evidence of harm from the abuse and misuse of low dose codeine-containing medicines.

For most individuals, there is little evidence that low-dose codeine medicines are more effective than alternative medicines without codeine.

The presence of low-dose codeine in widely accessible OTC combination medicines, and the development of tolerance and subsequent dependence on codeine, contributes to severe adverse health outcomes, including liver damage and death.

Low-dose codeine-containing medicines are not intended to treat long term conditions; however, public consultation has indicated that this is how most consumers use these medicines.

Additionally, some individuals, especially children, experience serious adverse reactions when given codeine, such as difficulty breathing and death.

Given these issues, it is clear that alternative regulatory controls are required to drive public health benefits that outweigh the known risks of codeine use.

Dependence:

In 2013, the National Opioid Pharmacotherapy Statistics showed that codeine was the opioid drug of dependence for 1,038 clients receiving opioid substitution pharmacotherapy.

At a single drug dependence unit in South Australia, the annual incidence of codeine as the drug of dependence leading to a need for intervention increased from 31 people in 2003 to 174 by 2014.

Morbidity and death:

The presence of codeine in OTC combination analgesics contributes to severe adverse outcomes associated with overdosage of the paracetamol31 or ibuprofen^[1] component.

A study by Roxburgh et al (2015)^[2] provides evidence of increasing rates of fatal codeine-related overdoses in Australia using data from the National Coronial Information System from between 2000 and 2013:

• Codeine toxicity was a contributory factor in 1437 deaths.
• The underlying cause of death was determined to be codeine toxicity in 7.8% of cases (113 deaths), and multiple drug toxicity (including codeine) in 83.7% of cases (1201 deaths).
• Approximately 24% (343 cases) of the deaths were related to a prescription codeine product (usually Panadeine forte), 16% (229 cases) included an OTC codeine product, and in the remaining 60% of deaths, there was no information about whether the codeine consumed before death was prescribed or OTC.
• Codeine-related deaths (with and without other drug toxicity) increased from 3.5 to 8.7 deaths per million persons between 2000 and 2009.
• Just under half of the deaths were attributed to accidental overdose.
• The rate of accidental deaths increased significantly by 9.3% each year, from 1.8 to 5.1 deaths per million persons between 2000 and 2009.

The scheduling changes take effect on 1 February 2018, when an updated Poisons Standard (a legislative instrument) is published with the amended Schedule 4 and Schedule 8 entries for codeine. The changes in the Poisons Standard are then adopted through state and territory government legislation.

Implementation of the decision in individual states and territories will depend on when and how the decision is adopted into state and territory legislation, but is likely to align with the implementation date specified in the decision.

No change in the availability of over-the-counter codeine medicines will occur until 1 February 2018.

As the decision comes into effect in February 2018, consumers should speak to their pharmacist or medical practitioner about why they take codeine, so that they are prepared for the change to accessing codeine containing medicines.

All codeine-containing products that are available over-the-counter (OTC), including combination analgesics (Schedule 3) and cough and cold preparations (Schedule 2), will be affected by this scheduling decision. The scheduling decision will be implemented from February 2018. Codeine containing medicines will then be available to consumers only by prescription.

Links to scheduling legislation are available on the TGA website.

Part 6-3 of the Therapeutic Goods Act 1989 - external site (the TG Act) provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their public access and supply, in the interests of public health and safety. Substance scheduling aims to minimise the health risks associated with poisoning from, misuse or abuse of, scheduled substances.

The Poisons Standard (known as the Standard for Uniform Scheduling of Medicines and Poisons) consists of decisions of the Secretary of the Department of Health, under Subsection 52D(2), Part 6-3 of the TG Act, regarding the classification of substances into the different Schedules, signifying the degree of control recommended to be exercised over the substance's availability to the public.

Often, the delegate will seek advice from the Advisory Committee on Medicines Scheduling (the ACMS), in accordance with the Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 before amending the Poisons Standard.

The ACMS is made up of experts, including state and territory representatives, who provide advice on how medicines will be made available to the public. More information on the ACMS is available on the TGA website.

The Poisons Standard aims to deliver a consistent approach that all state and territory governments can adopt to allow the supply of substances. However, it is up to the individual state and territory governments as to how they adopt and implement the Poisons Standard. This will depend on the respective state and territory legislation. For information on how each state and territory controls access to substances, refer to the state and territory drugs and poisons units.

USA

In the USA, under Food and Drug Administration (FDA) regulations, all codeine products are available by prescription only. However some states follow an exemption (21 CFR 290.2) from prescription requirements for certain low-dose codeine cough syrups.

Europe and Asia

Medicines containing codeine are available only with a prescription in Hong Kong, Iceland, India, Japan, the Maldives, Romania, Russia, and the United Arab Emirates.

Of the 28 European Union member states (including the United Kingdom), 15 countries require a prescription for products containing codeine: Austria, Belgium, Croatia, the Czech Republic, Finland, Germany, Greece, Hungary, Italy, Luxembourg, the Netherlands, Portugal, Slovakia, Spain and Sweden.

Canada

In February 2016, all non-prescription codeine was banned in the province of Manitoba.

Growing evidence suggests that countries with less strict regulations around codeine availability generally see more abuse and misuse of the low-dose OTC codeine medicines.^[3,4,5,6,7]

Codeine is an opioid drug closely related to morphine and, like morphine, is also derived from opium poppies. Codeine is a commonly used analgesic for the management of mild to moderate pain. It is currently present in both prescription and over-the-counter (OTC) medicines.

In the prescription medicine context, high dose codeine content (30 mg to 120 mg/dose), either alone or in combination with other medicines such as paracetamol, provides a good level of pain relief for some people with cancer pain, post-operative pain and other acute pain conditions.^[8,9]

In comparison, low-dose combination codeine OTC products (10-12 mg/unit dose) are used by many consumers to manage mild painful conditions such as migraine, headache, dental pain,^[10] or for the management of cold and flu symptoms (including cough). There is no clinical evidence that low-dose codeine is more effective than the combination product without codeine i.e. paracetamol, ibuprofen. There is a lot of evidence of harm from use of low-dose combination codeine products.

Alternative products that are considered to be safe and effective for the management of pain are available without a prescription. Speak to your healthcare professional for advice on a suitable alternative product. Post 1 February 2018, access to medicines containing codeine will require a prescription from your doctor. In the interim, you may like to begin discussions with your medical practitioner to explore treatment options relevant to your condition.

From 1 February 2018, consumers who wish to access medicines that contain codeine will need a prescription from their medical practitioner. Consumers may wish to discuss codeine availability with their doctor when they attend an appointment for any other medical issue prior to 1 February 2018.

Medicines must be considered and recommended for listing by the independent Pharmaceutical Benefits Advisory Committee (PBAC) before they are made available on the PBS. It is up to the relevant pharmaceutical companies to decide whether to apply to list newly scheduled codeine-containing medicines on the PBS, the Government cannot compel companies to do so.

Information on the PBS listing requirements for a medicine is available at www.pbs.gov.au - external site.

If these medicines are listed on the PBS in the future, patients will not be required to pay more than the PBS co-payment. If you are a general patient you will pay up to the general co-payment for a medicine listed on the PBS. If you are a concessional patient, you will pay no more than the concessional co-payment for your PBS medicine. In 2016, the general co-payment is $38.30 and the concessional co-payment is $6.20.

These co-payment amounts are indexed on 1 January every year in line with the Consumer Price Index (CPI). Patients who take large numbers of PBS medicine are protected from the high total cost by the PBS Safety Net. More information on the PBS Safety Net scheme is available at www.pbs.gov.au - external site.

If your medicine is not listed on the PBS, you can still have to fill the prescription as a private prescription. It will not be subsidised by the Australian Government.

Alternatively, there are several codeine-containing medicines currently available on the PBS. You should consult with your health practitioner on the most suitable treatment options.

Please note that the cost of private prescriptions do not count towards the Safety Net threshold.

A final decision on the scheduling of codeine has been published along with an implementation date of 1 February 2018. However, implementation of the decision in individual states and territories will depend on when and how the decision is adopted into each state and territory legislation.

Contact details for the Drugs and Poisons Units within each state and territory are available at: Contacts for State/Territory drugs & poisons units.

Noting that the decision comes into effect on 1 February 2018, you may wish to speak to your medical practitioner about your condition so that you are prepared for the change in access to codeine-containing medicines.

The delegate's decision is primarily based on the protection of public health as set out under section 52(E) of the Therapeutic Goods Act 1989 - external site (TG Act). These matters include the risks and benefits of the use of a substance, the purposes for which a substance is to be used, the substance's toxicity, dosage, formulation, labeling, packaging, presentation and any potential for abuse.

The delegate must also comply with the Scheduling Policy Framework.

Where the delegate seeks advice from the ACMS or the ACCS the delegate must have regard to any advice of the committee.

The delegate also considers advice from the public submissions made in response to a public notice.

The TGA received several pre-meeting submissions from the public prior to the August 2015 Advisory Committee on Medicines Scheduling (ACMS) meeting. After the medicines delegate released the interim decision in October 2015, the public was invited to provide further comments, and these de-identified submissions are available on the TGA website.

On 10 December 2015, a notice was published on the TGA website calling for further submissions from interested parties in relation to new scheduling proposals. This resulted in further public submissions received prior to 29 January 2016, which were included in the overall information considered at the March 2016 ACMS meeting. These submissions will be available on the Public submissions on scheduling matters web page in due course.

Yes. The medicines scheduling delegate received hundreds of submissions during the consultation rounds, in addition to ministerial correspondence during the scheduling process. Submissions received were both for, and against, the changes to codeine scheduling. All public submissions were considered by the Delegate and the Advisory Committee on Medicines Scheduling.

From 1 February 2018 with the rescheduling of codeine to Schedule 4 and availability on prescription only, Nurse Practitioners will be able to prescribe in most jurisdictions (the formulary is set on a jurisdictional basis). For remote areas, Remote Area Nurses in most jurisdictions follow ‘protocol prescribing' (again assuming that codeine products were part of the formulary).

1. Codeine safety reviews

   On 1 October 2015, the TGA published a safety review on the use of codeine in children and ultra-rapid metabolisers. The review was undertaken following actions by overseas regulators (US FDA and European Union) to prevent the use of codeine in children younger than 12 years of age for any indication, and in children 12-18 years undergoing surgery to remove the tonsils and adenoids. The Advisory Committee on the Safety of Medicines (ACSOM) also provided advice on codeine, which was published on the TGA website on 1 October 2015.

   The TGA also commissioned an external review into the efficacy and safety of OTC codeine combination analgesics for pain and codeine based antitussives. This review highlighted the uncertainty regarding whether codeine provides incremental pain relief when used in combination medicines.

2. Codeine Regulation Impact Statement (RIS)

   The Department of Health, through the TGA, has completed a Regulation Impact Statement (RIS) that reviews the significant public health concerns with use of codeine, the scheduling options available and the regulatory impacts associated with the scheduling options. The RIS was supported by an independent report prepared by KPMG that modelled the economic, social and regulatory impacts, and net benefit to society of all the scheduling options. The conclusion from the modelling was that a net benefit to society could be achieved only when codeine is up-scheduled to Schedule 4.

In making a decision to amend the Poisons Standard to protect public health, the delegate does not need to consider financial impacts to industry or the government. Often however, these considerations play a role in determining the implementation date for the scheduling decision.

While the delegate noted the regulatory or government costs estimated by the KPMG economic modelling report for the scheduling options, the significant public health benefits associated with the up-scheduling of codeine to Schedule 4 was the primary consideration by the delegate. Hence all elements in the RIS were noted by the delegate in making their decision.

Up-scheduling of a medicine occurs when there is a reclassification of that medicine from a lower control schedule to a more strict control schedule, e.g. from Schedule 2 (Pharmacy medicine) to Schedule 4 (Prescription-only medicine).

This happens when there is an application made to the TGA reconsidered the availability of a medicine. Such applications are usually due to increasing evidence that the use of a medicine in a lower-control schedule is causing harmful effects to consumers. Accordingly, a more restrictive availability is required in order to reduce the public health risk to an acceptable level. The medicine is then moved up into a higher schedule that has greater restrictions over its availability.

As a medical practitioner, the change in codeine scheduling will affect how you advise your patients regarding the use of codeine and what this means for them and their condition. For some patients, you may like to explore other treatment options and seek an alternative to prescribing codeine containing products as appropriate.

It is important to be aware of the timeline for the proposed rescheduling of codeine containing products, and provide early notification to your patients and have discussions with them regarding appropriate treatment options for them.

Schedule 4 codeine medicines are already available in the Australian marketplace. The scheduling decision will not affect the current pack size for these prescription medicines.

You may see an increase in the number of patients seeking advice on alternatives to low-dose codeine products. If you are not able to suggest an alternative product, you may need to advise the patient to see a medical practitioner.

Yes. From 1 February 2018, all low-dose codeine containing medicines will become prescription only medicines and will no longer to be able to be supplied as over the counter medicines.

The current stock of codeine-containing OTC medicines can continue to be sold as OTC medicines until 31 January 2018. Assuming that the State and Territory Governments adopt the implementation date of 1 February 2018, codeine-containing medicines will not be able to be sold as OTC medicines from 1 February 2018.

You will need to submit a variation application to the Prescription Medicines Authorisation Branch of the TGA along with the revised labels, Consumer Medicine Information and Product Information documents.

You will need to ensure you allow sufficient time for any variation application to be approved. You will also need to allow enough lead time to implement the changes before 1 February 2018.

You should consider how you will treat existing stock should your supply of OTC stock be of sufficient quantity to carry over the 1 February 2018 implementation date.

More information on the scheduling process is available on the TGA website.

More information on the scheduling process for codeine is available in the RIS.

Any further information on codeine availability will be circulated via the Scheduling Medicines and Poisons (SMP) email List Server Notice. You can subscribe to this list at: SMP email list. This will ensure timely access to information about scheduling via these alerts.

The current media release can be found on the TGA website.

Other information is available through the Related Information links above.