This news story was first published in print and online by The Medical Republic on the 21st October 2015.


“When I heard that they were potentially rescheduling codeine I thought, I actually quite like Panadeine if I’ve got a bad headache,” says Amanda Roxburgh, of the National Drug and Alcohol Research Centre.

Roxburgh is lead author of a recent Medical Journal of Australia (MJA) study that showed rates of codeine-related death doubled between 2000 and 2009 to a rate of 188 per year.

This is comparable to the death rate associated with methamphetamine and about half that of all other opioid drugs. The coronial reports analysed in that study also showed just as much misuse of schedule 4 products such as Panadeine Forte as there was of over-the-counter (OTC) preparations.

Roxburgh isn’t sure whether the findings on their own warrant abolishing OTC formulations of codeine. “It’s much more complicated than that,” she says. “You’re often still going to have diversion [from recommended use]. There’s never just one strategy or quick fix.”


One of the key points of the Therapeutic Goods Administration (TGA) review is that the doses of codeine in OTC combinations are ineffective in treating moderate pain in many people.

“Combinations of ibuprofen plus paracetamol provide superior analgesic efficacy to the OTC codeine combination analgesics,” says Dr Evan Ackerman of the Royal Australian College of General Practitioners (RACGP) Expert Committee for Quality Care.

But Pharmacy Guild president George Tambassis points out that the ‘safe’ alternatives have complications of their own, which prevent some patients from using them.

“Some people can’t use ibuprofen and other non-steroidal anti-inflammatories when they have tummy problems, when they have heart or kidney conditions, when they have high blood pressure,” he says.

“Ibuprofen can in some people trigger underlying asthma [and it] interacts with warfarin whereas codeine doesn’t.”

The efficacy of codeine is unpredictable in part due to individual genotypes. Some people are deficient in the enzyme that converts it to the analgesic morphine while others are fast metabolisers and more susceptible to overdosing.

On the other hand, Dr Paul Grinzi, who sits on the Victorian Faculty of the RACGP Drug and Alcohol Committee, says he’s always been surprised that codeince hasnt been a Schedule 8 drug.

“That’s an anomaly compared to most other countries. It’s an interesting situation where patients vulnerable to addiction have a drug of dependence available rather easily.”


Dependence is a potential consequence of long-term codeine use in chronic pain.

In the MJA report, 40% of accidental deaths were associated with a history of chronic pain and 47% with a history of substance abuse.

Chronic misusers of combinations with ibuprofen are at risk of hypokalaemia and renal failure while combinations with paracetamol can lead to hepatotoxicity.

And mixing codeine with benzodiazepines greatly increases the risk of overdose. Roxburgh says: “In a lot of the accidental deaths you got the sense that people were topping up on their other pain meds which is why they were mixing. Because whatever they were being prescribed wasn’t hitting their pain.”

Dr Paul Grinzi says that thorough monitoring of patients suffering from chronic pain is best carried out in general practice, “so that a medical professional can continue to make a pain management plan and monitor these medications and their effects in a confidential and medically appropriate setting.”

He adds that codeine is appropriate for acute and post-surgical pain but should not be used for long-term management. GPs and pharmacists need to be explicit with their patients about the risks of multiple drug toxicity and dependence, and to be tuned in to comorbid mental health issues or a history of substance abuse.

Tambassis says the Pharmacy Guild would welcome more training for pharmacists on this pastoral responsibility. He thinks mandatory addiction warning labels on packages would also stimulate education and responsibility among consumers since it isn’t easy to challenge a patient on their history and drug use patterns.

“The honest patients that are using the drug properly can actually get offended if you discuss addiction and misuse.”


As recently as 2010 codeine-phosphate preparations of 15mg or less were restricted to schedule 3 and in packages for five-day use only.

The MJA study doesn’t reveal what impact the move has had on codeine-related deaths since complete coronial records are not complete after this date .

Tambassis says the Pharmacy Guild would support further reductions in OTC pack size. “Going really hard and saying that three or four days worth might be appropriate, because that’s enough for an acute minor ailment. There might be some push back from the drug companies but that’s life.”

According to Dr Paul Grinzi, “The packaging restrictions in 2010 helped minimise some of the harm but those that are vulnerable to addiction quickly found out ways and the right things to say to obtain the drug.”

Doctors and pharmacists are both agreed that electronic monitoring of sales and scripts is necessary to track overuse of codeine products, but Tambassis believes this is the real clincher.

“Real-time monitoring will be the solution rather than being a blunt instrument that prescriptiononly would be.”


According to a 2014 survey by Macquarie University and the Australian Self Medication Industry, if OTC analgesics were up-scheduled most consumers would see their doctor to get a script for them.

Tambassis is concerned that patients presenting to a GP would be more likely to receive stronger doses that come with a higher risk of dependence and misuse.

And given that codeine preparations make up 22% of analgesics sold in pharmacies, “it is estimated the direct cost to Medicare for additional doctor’s visits would be $170 million per annum,” says Australian Self Medication Industry chief executive officer, Deon Schoombi.

However Dr Evan Ackerman doesn’t believe patients with moderate pain will bother seeing their GP. “Rescheduling will not automatically lead to increased 30mg codeine and I am not sure it would add to health system costs,” he says.

“The alternatives for patient self management are there so I don’t believe this would automatically put pressure on GP appointments.” Dr Ackerman thinks the resistance from the Pharmacy Guild and the self-medication industry is driven by approximately $145 million that will be lost in sales of over-thecounter codeine.

But Tambassis’s response is firm. “It might be something that you don’t want to hear from the Guild President but we’re looking at patient outcomes rather than dollars and cents.

“At the end of the day we’ve got to look at those addicted patients or prospective addicts and we think our [script monitoring] solution would do that. And we still have to look after that cohort that’s actually doing the right thing.

“I got a massive text message from my next door neighbour and she’s not happy with this decision. She uses these medicines properly and she gets really good relief from her symptoms.”