Fact check: Will the move to make codeine prescription-only save 100 lives a year?
Australians now need to visit a doctor to obtain codeine after the drug was taken off pharmacy shelves and made available only with a prescription.
Federal Health Minister Greg Hunt has been a vocal supporter of the move.
Speaking to ABC Radio in January, Mr Hunt said advice from the Therapeutic Goods Administration was that “up to 100 lives a year could be saved” by making over-the-counter codeine products prescription-only.
NSW Pharmacy Guild President, David Heffernan, strongly criticised the claim, saying he was not aware of any evidence to support it.
“If there is any data to back up such an overblown claim, those making the claims should produce it — but I doubt that they can because I do not believe it exists,” Mr Heffernan said.
Responding to Mr Heffernan, Adrian Reynolds, an associate professor from the Royal Australian College of Physicians, said there was a broad body of evidence that documents misuse, addiction and secondary harm caused by codeine and criticised Mr Heffernan for attempting to “discredit the data relating to mortality rates”.
So, will the move to make codeine prescription-only save 100 lives a year?
RMIT ABC Fact Check investigates.
Mr Hunt’s claim doesn’t stack up.
There has not been any recent data to suggest that 100 Australians are dying every year from over-the-counter codeine products.
The latest available data was published in a 2015 study covering 2000 to 2013, which showed that on average about 100 Australians were dying a year from all codeine products, both over-the-counter and prescription.
Mr Hunt’s claim comes from a Therapeutic Goods Administration estimate, which is based on an assumption that an increasing death rate seen in the early years of that research would have continued in the time since then.
This is not accepted by experts consulted by Fact Check.
In any case the study was unable to determine the source of the codeine involved in 60 per cent of the deaths.
In the 40 per cent where the source could be determined, over-the-counter products were involved in 40 per cent of cases.
That means over-the-counter codeine was only conclusively found in 16 per cent of all the deaths reported in the study, or 16 per year on average.
It appears that Mr Hunt and the Therapeutic Goods Administration have used the study’s findings to assume that over-the-counter products were involved in 40 per cent of all codeine-related deaths.
However, the authors of the study cautioned against that, saying that an absence of data “limits inferences about the source of codeine”.
In the lead-up to the decision to make codeine prescription-only, the Therapeutic Goods Administration commissioned an economic model from KPMG.
KPMG used the data from the 2015 study to arrive at an assumption that there could currently be 30 deaths per year from over-the-counter codeine.
The 2015 study also pointed out that making codeine available only on prescription would not prevent all the deaths attributable to over-the-counter codeine.
Using the reasons given in the study, KPMG’s model assumed that five lives a year would be saved by the move, which it described as a conservative number suitable for assessing the costs and benefits of banning over-the-counter sales.
While there is evidence of an overall increase in misuse and harm relating to codeine products, the available research does not support Mr Hunt’s claim that 100 lives a year could be saved by making codeine available only on prescription.
What’s going on with codeine?
Codeine, a pharmaceutical opioid developed from poppies and a close relative of morphine, is commonly used to treat moderate pain and relieve dry coughs, according to the Government’s Health Direct website.
Before February 2018, codeine was available over the counter — that is, it could be bought at pharmacies without a prescription.
The Therapeutic Goods Administration, which is responsible for regulating the sale of medicines in Australia, has a national classification program for pharmaceutical products made up of ten levels of control, known as schedules.
Cold and flu medicines containing codeine were previously categorised as Schedule 2 — they were available from pharmacies in packs of no more than six days’ supply.
Painkiller products containing codeine, including combination medicines such as codeine and ibuprofen, were Schedule 3 medicines — they were available on the advice of a pharmacist.
Changes in access to codeine were most recently made in 2010, when products previously categorised as Schedule 2 were “up-scheduled” to Schedule 3.
Since February 1, all these products have been moved to Schedule 4 — available with a prescription.
In total, 47 products have been put behind pharmacy counters as a result of the change.
The road to the decision
Mr Hunt has been unwavering in his support for changing the scheduling of codeine, regularly repeating the claim that 100 lives would be saved as result of the move.
In an October 2017 press release the minister said the change would “save lives and protect lives”.
“Over-the-counter codeine products have been estimated to be a factor in nearly 100 deaths each year,” the press release said.
And speaking to 2GB radio in November Mr Hunt said over-the-counter codeine products were “addictive and killing people to the tune of 100 people per year”.
Changing the scheduling of codeine has had the support of the Australian Medical Association, the Royal Australian College of General Practitioners and the Royal Australasian College of Physicians among others.
The Pharmacy Guild of Australia on the other hand, spoke strongly in opposition of the move, claiming it would do “little to address the issues of addiction and harm arising from medicines containing codeine”.
State and territory health ministers also voiced concern in the lead up to the rescheduling, with all but one signing a letter to Mr Hunt asking the Commonwealth to address “unintended consequences”.
“In particular, given codeine products are used widely across the community by people to manage a range of health issues, including pain, stakeholders are concerned about the impact a large increase in the number of people requiring access to General Practitioners for prescriptions will mean for the primary care system,” the letter stated.
A spokeswoman for Victorian State Health Minister Jill Hennessy told Fact Check “nothing happened to alleviate those concerns” raised in the letter, and the decision was implemented nationwide on February 1.
Codeine deaths in Australia
While there is research available about the risks of taking codeine, there is little focusing on deaths related to over-the-counter purchasing.
Experts contacted by Fact Check pointed to a 2015 study, Trends and characteristics of accidental and intentional codeine overdose deaths in Australia, which found there were 1437 deaths linked to codeine, both prescription and over-the-counter products, between 2000 and 2013.
This amounts to an average of around 103 deaths per year.
While this data is now half a decade old, experts said the study was the most comprehensive look at codeine-related deaths in Australia.
Newer data fails to focus on codeine on its own, and doesn’t attempt to identify the source of the codeine involved in the death.
The study found the rate of all codeine-related deaths in Australia increased by 0.5 deaths per million people per year — from 3.5 deaths per million in 2000 to 8.7 in 2009.
Records from 2010 to 2013 were incomplete and so while the study reports raw numbers for those years, no death rate was calculated.
Amanda Roxburgh, a senior research officer with the National Drug and Alcohol Research Centre and lead researcher of the 2015 study, told Fact Check many codeine-related deaths involved multiple drug toxicity.
“Most of the opioid deaths in this country are multiple drug deaths — there’s only a small proportion that have only one substance on board,” Ms Roxburgh said.
Whether the deaths reported in the study were the result of over-the-counter or prescription products was unclear in the majority of cases.
Ms Roxburgh said her research utilised National Coronial Information System reports to attempt to determine the source of codeine involved in a death.
“The online database is fantastic but what isn’t routinely recorded is whether the drugs were prescribed or whether they were over-the-counter,” Ms Roxburgh said.
The study was unable to determine the source of the codeine involved in 60 per cent of deaths. In the 40 per cent where the source could be determined, over-the-counter products were involved in 40 per cent of cases.
That means over-the-counter codeine was only conclusively found in 16 per cent of all the deaths reported in the study, or about 16 per year.
A 2018 study, Unintentional mortality associated with paracetamol and codeine preparations, with and without doxylamine, in Australia, found there were 441 unintentional deaths attributed to paracetamol/codeine combinations in Queensland, NSW and Victoria from 2002 to 2012.
Researchers were able to find the source of codeine in 39 per cent of cases (173). Over-the-counter products were a factor, whether on their own or with prescription products — in 50 per cent of deaths (86) where the source could be determined.
While not a nationwide study, the researchers found the rate of accidental paracetamol/codeine deaths rose from 0.9 per million people in 2002 to 3.6 per million people in 2009, but that the rate had fallen to 1.9 per million people by 2012.
“While this coincides with the rescheduling of over-the-counter codeine containing products in Australia in 2010, from ‘Schedule 2-Pharmacy Only’ to ‘Schedule 3-Pharmacist Only’ medicines, removing direct public access, and restricting quantities, further research is necessary to explore potential explanations for this phenomenon,” the study said.
The source of the claim
A request to Mr Hunt’s office for the source of the claim was met with a response from a spokesman for the Therapeutic Goods Administration.
“The estimate that over-the-counter codeine products have been a factor in nearly 100 deaths each year is a Therapeutic Goods Administration estimate based on the best available data,” he said in a statement to Fact Check.
He referred to the 2015 study described above.
He said the estimate was based on an assumption that the rate for all codeine-related deaths would have continued to rise at the same rate identified by the study between 2000 to 2009.
“If we assume that death rates have continued to increase in Australia between 2009 and 2018 at a constant rate (which is reasonable given all other data confirming continued increase in misuse/abuse) then current death rates would be of the order of 20 per million population (or 495 in absolute numbers),” the spokesman said.
Angela Higginson, a senior lecturer at the Queensland University of Technology consulted by Fact Check for statistical analysis, said this method of estimation would only be accurate if the death rate had risen perfectly steadily over time.
“At first glance [the Therapeutic Goods Administration] figures seem fine if the assumptions about the trend hold,” Dr Higginson said.
“But I don’t necessarily agree with those underlying assumptions, because the graphs do not look like a steady linear trend.”
Dr Higginson pointed out the death rate jumped in 2001 and 2005, with steady growth in other years.
“Indeed, if you look at the last five years [to 2009] there’s basically no increase at all.”
Dr Higginson’s analysis was backed by Jason Ferris, an associate professor at the Institute of Social Science Research at the University of Queensland.
When it came to estimating the number of the assumed 495 codeine-related deaths that could be attributed to over-the-counter products, the administration spokesman told Fact Check that the administration had assumed that 40 per cent of all codeine-related deaths involved over-the-counter products.
“As 40 per cent of these deaths are due to [over-the-counter] codeine this equates to 198 deaths annually. The figure of 100 deaths per year from [over-the-counter] codeine is therefore conservative.”
However, Ms Roxburgh told Fact Check the 2015 study warned against making this assumption.
“Missing data on the origin of codeine products consumed prior to death limits inferences about the source of codeine in these deaths, and hence inferences about the extent to which the diversion of prescribed codeine contributed to these deaths,” the study said.
“It also limits inferences that can be drawn about the likely impact of reducing over-the-counter codeine availability on the prevalence of codeine-related mortality.”
A different approach
In the lead up to the change, the administration commissioned consulting firm KPMG to produce an economic model of the costs and benefits of the scheduling change.
The report, which is published with the formal Regulation Impact Statement on the administration’s website, came up with a vastly different assumption about the current over-the-counter codeine death number from the one sent to Fact Check by the administration’s spokesman.
KPMG also referred to the 2015 study and noted that the 1437 deaths from all codeine products recorded in the 14 years from 2000 to 2013 was an average of 100 a year, and that “on average 16 codeine-related deaths per year had over-the-counter codeine products recorded”.
KPMG said this number could be “possibly up to 20 to take into account the deaths for which this information was missing (conservatively assuming that 10 per cent of all the unidentified sources were [over-the-counter] codeine)”.
The report then noted that the rate of deaths had increased from 3.5 million deaths per million in 2000 to 8.7 per million in 2009.
“Given the underreporting of type of codeine product and the ongoing increase in codeine related deaths, then, for the purpose of this model, it was assumed that up to 30 codeine deaths in 2017 could occur and also have had [over-the-counter] codeine as the codeine product,” it said.
In its final decision to reschedule codeine the Therapeutic Goods Administration does not make mention of numbers of deaths from the drug.
It does refer to misuse of over-the-counter codeine potentially leading to death, as well as an increase in the codeine-related death rate from 2000 to 2009.
There is no mention of 100 deaths per year from over-the-counter products.
Increasing misuse and harm from over-the-counter codeine
In justifying the estimate of 100 deaths per year, the Therapeutic Goods Administration spokesman told Fact Check the estimate took into account evidence of increasing rates of misuse and harm from over-the-counter codeine products.
“Recent UK data confirm that misuse and harm rates are increasing everywhere codeine is available [over-the-counter],” he said.
The UK study he provided, Misuse of non-prescription codeine containing products: Recommendations for detection and reduction of risk in community pharmacies, assessed other research to offer commentary on misuse and harm of over-the-counter codeine products.
“The misuse of combination products containing non-opioid analgesics (ibuprofen, paracetamol, aspirin) and codeine is increasing in countries where over-the-counter sales are available,” the study said, referring to a 2011 research paper.
That paper, Over-the-counter codeine analgesic misuse and harm: characteristics of cases in Australia and New Zealand, found misuse and harm from combination codeine products may be increasing in countries where such products were available over the counter.
The impact of codeine re-scheduling on misuse: a retrospective review of calls to Australia’s largest poisons centre is a 2016 study that found misuse of codeine combination products appeared to be increasing in Australia.
By reviewing phone calls to the NSW Poisons Information Centre, the study was able to conclude that the change to scheduling of codeine products in 2010 to pharmacist only had failed to curb an increase in misuse.
“Between 2010 and 2015, paracetamol/codeine cases increased threefold, while ibuprofen/codeine cases increased 1.7-fold,” the study said, adding that the majority of cases involved over-the-counter codeine formulations.
Dr Rose Cairns, a staff specialist in the NSW Poisons Information Centre, confirmed the increase in calls to the centre.
“Between 2004 and 2015, the centre recorded an annual average increase of 19.5 per cent in the number of calls relating to paracetamol/codeine overdose and misuse and a 17.9 per cent in ibuprofen/codeine overdose and misuse,” Dr Cairns said.
There is evidence of an overall increase in misuse and harm relating to codeine products, but the available research does not support Mr Hunt’s claim that 100 lives a year could be saved by making codeine available only on prescription.
Will 100 deaths be prevented?
Even if there were evidence that 100 lives a year were being lost to abuse of over-the-counter codeine, that would not necessarily mean making codeine prescription-only would save all those lives, as Mr Hunt suggests.
The Therapeutic Goods Administration’s Regulation Impact Statement noted there were concerns about using the 2015 paper, Trends and characteristics of accidental and intentional codeine overdose deaths in Australia, to predict how many deaths would be prevented.
“It was not possible to develop an accurate estimate of deaths that could be prevented as a consequence of [making codeine prescription-only],” the statement said.
“A published study provided an estimate of the annual deaths attributable specifically to over-the-counter codeine medicines, however, the authors indicated that when deaths involving over-the-counter codeine medicine abuse occurred, it was likely that there were multiple influencing factors and changed access to over-the-counter codeine medicines would not necessarily prevent these deaths.”
The statement also pointed to a “paucity of data that could inform the estimate of the key benefit of the proposed regulatory change; that being the proportion of current users of [over-the-counter] low-dose codeine will experience a health gain, including preventing deaths, as a consequence of this change”.
The KPMG economic model included an assumption of how many lives might be saved by the move.
The KPMG report noted that the 2015 study had identified four relevant factors:
- 83.7 per cent of all of the codeine-related deaths were attributed to multiple drug toxicity;
- The combination of mental health and chronic pain issues were found in 25.7 per cent of cases;
- 53.6 per cent of cases had a history of mental health issues;
- 36.1 per cent had a history of substance use problems.
Due to these factors, it was only reasonable to assume that the scheduling change would save some, and not all, of the lives being lost.
A “conservative” assumption was that 5 deaths a year would be prevented, the report said.
The Regulation Impact Statement repeated KPMG’s assumption, which appears to be the only published estimate of prevented deaths within the resources used by the administration in making its final decision.
What do the experts say?
Experts consulted by Fact Check were reluctant to confirm the number quoted by Mr Hunt.
Ms Roxburgh said making codeine prescription-only was one option to reduce harm, but having a wider array of other measures for codeine-dependent people would also be useful.
“We also need to think about how we identify people who are having a problem with their codeine use, how to engage with them, and how to get them into treatment.”
Ms Roxburgh said more work needs to be done in Australia in terms of identifying people with codeine problems and providing accessible treatment for those struggling with drugs such as codeine.
Michael Farrell, director of the National Drug and Alcohol Research Centre, told Fact Check codeine was one of a wider group of opioids becoming an increasing issue in Australia.
“Over the period of 2002-2011 there have been linear increases in the number of treatment episodes where pharmaceutical opioids have been specified as the drug of concern,” Professor Farrell said.
He added there had been increases in treatment episodes where codeine was the principal drug of concern in Queensland, NSW, Tasmania and South Australia.
“However, whether this is a result of over-the-counter or prescription codeine cannot be determined,” Professor Farrell said.
“The impact of the rescheduling of over-the-counter codeine products from February 1 remains to be seen.”
Dr Cairns told Fact Check the recent rescheduling of codeine would bring Australia in line with most other countries, where codeine is available only with a prescription.
“Over-the-counter codeine is only intended to be used for the management of acute pain,” Dr Cairns said.
“Up-scheduling will assist people with chronic injuries and illnesses in receiving appropriate and more effective treatment, based on advice from their GP.”
Consumers would still be able to buy effective painkillers over-the-counter, Dr Cairns said, including some which had be shown to be as effective as codeine products without the potential for misuse and dependence.
Dr Cairns said the NSW Poisons Information Centre would continue to track the number of calls relating to codeine use over coming years to determine the effectiveness of the move.
Lead researcher: Ellen McCutchan, Researcher, RMIT ABC Fact Check