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12 Oct 2017

The AMA fully supports the independence of the TGA in making decisions about medicines scheduling.

It is essential for public safety that the TGA makes evidence-based decisions about medicines, free from political interference and sectional interests.

Doctors rely on the independence and expertise of the TGA to ensure Australians have access to safe, effective and high quality medicines.

There is compelling evidence to support the decision to make codeine prescription only:

  • Deaths and illness from codeine use have increased in Australia;
  • This is despite a rescheduling decision in 2010 shifting many over-the-counter codeine medicines to Schedule 3 (pharmacist only); and
  • There is no evidence that low-dose codeine (8mg-15mg/unit) provides any benefit beyond placebo.

To put this change in perspective:

  • all other opioid medicines sold in Australia are available only on  prescription (S4 or S8); and
  • codeine is not available over-the-counter in 13 European countries nor in the US.

Patients who have short-term pain will still have access to alternative over-the-counter painkillers which are more effective than low-dose codeine (i.e. ibuprofen plus paracetamol), without codeine-associated risks.

It is better for patients with chronic pain to manage it with doctors’ advice on appropriate medicines and non-medicine treatments, rather than self-treating long-term with codeine.

It is unlikely doctors will see a large increase in patients. Most people who use codeine take it to relieve short-term pain; they can still buy effective painkillers (ibuprofen plus paracetamol) over the counter.

Doctors may see an increase in visits from patients who have long-term chronic pain. These patients should be helped by doctors to manage their pain with a combination of non-medicine and medicine treatments, rather than self-treating with codeine.

It may be years before State Governments have real time monitoring systems up and running. We can’t allow more unnecessary deaths while governments argue about funding. 

The AMA’s Position Statement on Medicines 2014 states that:

(a)    The AMA supports the role of the Therapeutic Goods Administration as the regulator of medicines in Australia to ensure that medicines meet appropriate standards for quality, safety and efficacy.

(b)    The AMA recommends medicines should only be up or down scheduled where there is strong evidence it is safe to do so, where there is demonstrated patient benefit and safety in dispensing the medication by this method, and where it would not adversely affect appropriate access to medicines.

Published: 12 Oct 2017