In the week before Christmas, a decision was made by the Therapeutic Goods Administration (TGA) that will have far-reaching effects for many thousands of Australians dealing with pain.

Summary of the changes

On 20 December 2016, the TGA released its final decision regarding the rescheduling of low-dose codeine medicines from over-the-counter (OTC) to prescription only1. This decision follows several years of consultation with a wide range of consumer and industry organisations.

This change means that all medicinal preparations that contain any amount of codeine will now only be available via prescription. This includes many popular pain-relieving products like Nurofen Plus, Mersyndol and Panadeine Extra. These analgesics are currently listed under Schedule 3 of the Poisons Standard – the legal name for the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)2. They contain codeine in combination with another active ingredient such as paracetamol.

The change also includes some cold and flu preparations currently listed under Schedule 2 of the Poisons Standard.

From 1 February 2018, all codeine preparations currently listed under Schedules 2 and 3 will be upgraded to Schedule 4. This means that anyone wanting access to any of these medications will now need to see a doctor for a prescription.

Why the change?

Right now, you are probably thinking, “Why does the Government want to restrict access to products that many people use for relieving pain or cold and flu symptoms?” It’s a simple question with a not-so-simple answer.

Codeine can be addictive
Codeine comes from the opiate family of drugs and has a high incidence of addiction, even in lower doses. Misuse of codeine products that contain other analgesic substances (including paracetamol and ibuprofen) has been proven to contribute to many severe adverse outcomes following an overdose of these substances.

A study by Roxburgh et al (2015)3 and referenced by the TGA, showed that codeine toxicity contributed to 1437 deaths in Australia between 2000 and 2013. It also showed that:

  • 343 deaths (around 24%) were related to a prescription codeine product.
  • 229 deaths (16%) included an OTC codeine product.
  • In around 60% of cases, it was not known if the codeine used was bought OTC or prescribed.
  • The rate of accidental deaths linked to codeine increased by 9.3% each year.

Codeine can lead to accidental overdose
Around half of these deaths noted in the above study were due to accidental overdose. This can happen when people misunderstand or don’t read the packet directions. However, it can also occur even when the directions have been followed correctly by people aiming to use the analgesic responsibly.

“How?” I hear you ask.

We all metabolise the substances we consume at different rates. Children and those adults with fast metabolisms absorb substances very quickly. When potentially harmful substances are rapidly absorbed, they can quickly create extremely toxic levels in the body and lead to respiratory failure, loss of consciousness or sometimes death.

The problem is that most people don’t know exactly how fast their metabolism works. Some drug information sources (including the Panadeine product information sheet) suggest that people should know their metaboliser status before taking any codeine products. The TGA argues that this makes it dangerous for any codeine products to be available without prescription.

Other factors
The TGA’s Scheduling delegate’s final decision: codeine, 2016 document on the rescheduling of codeine substances includes a number of other detailed arguements in favour of the change, including:

  • There is little evidence to prove that codeine doses of 30 mg or less in combined analgesic tablets are any more effective than the accompanying ingredient. The TGA also noted that new combination products containing both paracetamol and ibuprofen are more effective than low-dose codeine combination products.
  • The lack of efficacy of these low-dose products along with the high risks they carry make them unsuitable for listing under Schedules 2 or 3.
  • Codeine products listed under Schedules 2 and 3 are only intended for acute, short-term pain. However, evidence shows that many Australians use these products for long-term pain relief.
  • Previous up-scheduling of these products to Schedules 2 and 3 (in 2010) did not result in a reduction of rates of codeine abuse or accidental overdose.
  • Australia currently does not have a complete real-time monitoring system in use across the country and is unlikely to have one available in the foreseeable future.
  • The widespread availability of codeine-based medications in the past has created a (false) public perception that they are safe.
  • There are many, more effective and less dangerous treatment options to manage both acute and chronic pain. These options are best discussed with doctors and assessed on an individual basis.

What do the critics say?

The TGA received more than a hundred submissions on the rescheduling issue from o and individuals across Australia during the consultation process. Many of these were not in favour of the changes and their convictions remain unchanged after the handing-down on the TGA’s final decision.

Organisations such as Pain Australia, the Consumer Health Forum and the Pharmaceutical Guild of Australia – while agreeing with the need to address the underlying issues – have publicly stated their concerns following the final decision. Consumers have also voiced their concerns about the changes on multiple online forums and social media sites.

Some of the arguements against the changes include:

  • Changing the scheduling to solve the issues caused by the few who misuse codeine medications will penalise the majority of people who use them responsibly.
  • Making codeine medications prescription-only will increase pressure on GP’s, emergency departments and the Pharmaceutical Benefits Scheme (PBS).
  • Those who cannot easily get to a GP due to location or mobility issues will be unfairly penalised.
  • Decreasing the availability of these medications will force current users to either turn to less-appropriate products (legal and illegal) or to persevere through inadequately-controlled pain.
  • The cost of using these products will increase from a few dollars to now include the cost of a GP visit plus the cost of the medication. Also, the products to be up-scheduled will not automatically be covered under the PBS. Drug companies will need to apply for PBS listing for each of the products. If a product is available through the PBS, consumers will pay $38.30 per script or $6.20 for those on a Health Care Card. Products that are not listed could potentially cost much more than that.
  • Restricting access to codeine-based medications will not change the rate of abuse. It may even encourage people to go ‘doctor-shopping’ in order to get a regular supply of codeine.
  • Some people cannot use similar products such as paracetamol, aspirin or ibuprofen, so they need codeine products for effective pain relief.
  • Many GP’s do not discuss alternative options or potential contraindications when prescribing pain medications and there is a lack of public awareness as to what these may include.

Where to from here?

While there is no doubt that there is a big problem with codeine misuse in this country, one of the biggest concerns raised is that the changes do little to provide any alternatives for those using low-dose codeine products responsibly. The final decision document does suggest that other, more effective pain management treatments are available but it does not address how this information will be shared with consumers and medical professionals, let alone at what cost.

Many organisations have been pushing for pain-management therapies (including physiotherapy and psychotherapy) to be publicly available through Medicare; along with better support for those with addiction issues. There should also be public awareness campaigns to educate consumers about proven alternative, non-opioid medication options. There is currently insufficient support available for those with codeine abuse issues so services in these areas should be given more resources and funding.

Increased pressure is now on the Federal Government to adopt the National Pain Strategy 4 – a framework for the treatment and management of pain – developed in 2010 by Pain Australia and other peak industry bodies.

The changes will not come into effect until February 2018. This will allow time for pharmaceutical companies to adjust their supply and stock of these products. It will also give consumers, doctors and pharmacists time to become more educated about alternative pain-management options.

What can you do now?

If you have concerns about the changes to codeine access or about how to manage your own pain, there are many things you can do.

  • Ask your doctor or pharmacist about alternative products that could help you. It may be helpful to make an appointment to see your doctor for in-depth advice.
  • Consider non-drug approaches to pain-management, especially for chronic pain. There is extensive research to show that taking a proactive approach and changing how you think about your pain can make a big difference to how much your pain affects your daily life. Practices such as cognitive behavioural therapy, hydrotherapy, yoga and body scan meditation are all proven to be highly effective treatments for pain management.
  • Ask your doctor if it is appropriate for you to have a multi-repeat script for your codeine product to save you making lots of appointments with them. If you take Panadeine Forte, which contains 30mg of codeine, you could ask your doctor if it is suitable for you to take 1 x Panadeine Forte tablet plus 1 x paracetamol tablet instead. This often works out much cheaper than buying multiple packets of low-dose codeine products, especially if you are on a Health Care Card.

Pain affects everyone differently so you may find some treatments work better than others. It may also be worth considering treatments you have tried in the past, as they may be more appropriate for you now. Keep an open mind and do your homework on various treatments so you can make informed decisions about trying them. If you are unsure, speak to your health professional first.

If you have a strong opinion that you’d like to voice, contact your local member of parliament5 and tell them about your experiences and concerns.

What do you think about these changes?
Let us know in this short poll and we’ll publish the results in the near future.


Other references:

This information should never replace the information and advice from your treating physician. It is meant to inform the discussion that you have with healthcare professionals, as well as others who play a role in your care and well-being.