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

10 April 2017

This TGA behind-the-news article was published on 10 April 2017. 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.

What's changing?

From 1 February 2018, medicines that contain low-dose codeine will no longer be available without prescription in pharmacies.

Your pharmacist will be able to help you choose from a range of effective products that do not require a prescription. If you have strong or chronic (long-lasting) pain you will need to consult your doctor, and if medicines are part of your treatment, a prescription may be needed.

Why is access to low-dose codeine-containing medicines changing?

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

Codeine is an opioid drug closely related to morphine and, like morphine, is derived from opium poppies. Codeine can cause opioid tolerance, dependence, addiction, poisoning and in high doses, death. Regular use of medicines containing codeine, for example for chronic pain, has led to some consumers becoming addicted to codeine without realising it. The risks associated with codeine use are too high without oversight from a doctor.

Codeine use can be harmful

Most Australians are unaware that over-the-counter medicines containing codeine for pain relief offer very little additional benefit when compared with ­medicines without codeine. The use of such medicines however, is associated with high health risks, such as developing tolerance or physical dependence on codeine.

Tolerance occurs when codeine becomes less effective and so the body needs higher and higher doses to feel the same relief from your symptoms. Severe withdrawal symptoms can result when the medicine is stopped; these include head and muscle aches, mood swings, insomnia, nausea and diarrhoea. Some of these withdrawal symptoms, such as head or muscle aches mimic the symptoms that low-dose codeine products are often used to treat, leading to people incorrectly continuing to take the medicine longer or in higher doses.

Codeine poisoning contributes to both accidental and intentional deaths in Australia. The codeine-containing medicines that are currently available over-the-counter are usually combined with either paracetamol or ibuprofen. Long term use of high doses of paracetamol can also result in liver damage and the most severe adverse effects of long term ibuprofen use include serious internal bleeding, kidney failure and heart attack.

Codeine is also sometimes used in medicines to relieve the symptoms of cough and cold, however there are safer and more effective medicines available that may provide relief from these conditions. Talk to your pharmacist or doctor for advice on what may be best for you.

How and where to get advice

Pharmacists have an important role to play in minimising harm from codeine

The current range of codeine-containing over-the-counter medicines will continue to be available without a prescription in pharmacies until 31 January 2018. Pharmacists will continue to be an important source of information and advice for consumers both before and after this date.

Most people should be able to manage acute pain or cough and cold symptoms with safer alternative medicines. For acute pain, this may include products containing paracetamol or ibuprofen, or the two products in combination. Your pharmacist will be able to provide advice on the most appropriate medicines for you. Speaking with your pharmacist is particularly important if you have any other medical conditions, such as stomach, kidney, liver or heart problems.

Talk to your doctor

People with ongoing pain should talk to their doctor or healthcare provider to determine better alternative treatment options. These may include: alternative over-the-counter or prescription medicines; non-medicine therapies from an allied health professional such as a physiotherapist; 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 (CDM) Plan and a Team Care Arrangement (TCA). For more information see Chronic Disease Management Patient Information: Planning your health care, Patient Information Sheet.

If you think that you are unable to manage without codeine and experience some of the side effects of withdrawal talk to your doctor about getting help.

Next steps

A Nationally Coordinated Codeine Implementation Working Group (NCCIWG) has been established with representatives from state and territory health departments and peak professional bodies representing consumers, pharmacists and medical professionals. The purpose of this working group is to assist with the implementation of a communication strategy to help inform the community of the upcoming changes to the availability of low-dose codeine containing medicines from 1 February 2018.

Advice for pharmacists and medical professionals regarding the changes to codeine access and to help them provide the best advice to their patients will be made available on the Department's website.

For more information and support:

National support

Contact information for state and territory drugs & poisons units