The public health bureaucracy planning to put regular over-the-counter pain relief out of reach for millions of Australians admits its intervention will cost taxpayers hundreds of millions of dollars.
In a pre-Christmas sneak release reminiscent of the Australian Bureau of Statistics’ controversial 2015 census announcement, yesterday the Therapeutic Goods Administration announced it would ignore public opinion and cut access to all pain relief products containing codeine except via prescription. A public outcry forced the health bureaucrats to pause a planned ban in 2015. But from 2018, Australians wanting access to codeine, which is a more effective form of pain relief than supermarket-sold paracetamol products, will have to go to a GP to obtain a script.
The public health lobbyist body the Advisory Committee on Medicines Scheduling, run by government-appointed health bureaucrats and academics, made the decision based on a report commissioned by the TGA by consultants KPMG. The male-dominated committee decision has already been criticised for ignoring the needs of women with endometriosis. Given the TGA originally proposed the ban, it remains the case that no independently commissioned study has been done of the proposal.
[The unaccountable pencil-pushers who want you to suffer more pain]
Doctors’ groups were originally highly supportive of the ban, which would mean Australians would be forced to visit GPs more in order to access any pain relief products beyond the low-impact headache tablets available from supermarkets. However, that necessarily means a big additional call on taxpayers via the Medical Benefits Scheme, as well as some additional Pharmaceutical Benefits Scheme costs. A report commissioned by the Pharmacy Guild — which opposed the change — claimed that, after removing the variety of circumstances in which no additional GP visit would be necessary for someone who had previously purchased codeine over the counter from pharmacists, the proposal would require 8.7 million additional GP visits per year at an annual cost of $316 million, or more than $4 billion over a decade, adjusted for inflation.
While this industry costing is clearly self-interested and probably overstated, the KPMG offers a figure every bit as problematic: it claims the number of additional GP visits would be less than 10% of the number proposed by the Pharmacy Guild report — just 540,000 a year — and the whole cost would substantially fall after the first year because (for reasons not explained) costs “would taper off over time”. KPMG’s cost of the impact of the ban on the MBS and PBS is just $268 million over a decade.
But some of the assumptions underpinning the report appear, to the layperson, at least eccentric. Most bizarrely, the report assumes that non-codeine pain relief — for example, paracetamol from the local shops — can be readily swapped with codeine without any diminution of benefit for users: “for most of these consumers, as the evidence indicates, there is no incremental health effect of the use of low dose codeine combination products compared to using these analgesics without codeine”. Those who rely on codeine to manage intermittent but serious pain might take a different view from the consultants employed by the public health lobbyists.
[Sorry, nanny statists, alcohol is good for you]
The report arbitrarily assumes that five deaths will be prevented each year by the ban, and also assumes that most consumers will have ready to hand a valid repeat script for codeine-based pain relief from their GP when needed, rather than needing to undertake an additional visit to a GP to obtain a new script. The report also assumes that the government will fund an education campaign relating to the ban and ways for consumers to access pain relief. However, “the question of how an education campaign for consumers would be funded, and what form it might take is still to be determined and is dependent on the regulatory process changes, if any. The cost of this campaign was not included in these costings.”
Remarkably, the modelling and regulatory impact statement for the decision include no assessment of the tighter restrictions on availability introduced after the TGA’s first, abortive effort to ban access to codeine in 2015. The Pharmacy Guild rolled out MedsASSIST nationally after a New South Wales and Queensland trial in April this year, to track people’s purchase of codeine products — the reason why you’re now asked to produce a driver’s licence or other ID when you purchase Panadeine Extra at the chemist. Indeed, KPMG explicitly rejected using data from MedsASSIST in its work. The TGA has decided to ignore MedsASSIST entirely in its decision.
Averaging the cost estimates of the PGA and KPMG reports suggests that the total cost to taxpayers of the ban via higher MBS and PBS costs would be over $2 billion over the coming decade. But assuming the PGA report significantly overstates those costs would still mean a substantial impact on taxpayers in a health system where funding is already under serious pressure and the government is looking to curtail, not increase, cost pressures within the MBS and PBS budgets.
And that’s separate from the core problem of the TGA’s ban: that its committee of public health lobbyists knows better than individual Australians how to sensibly manage their pain without calling on governments to regulate and fund them.
Thanks Bernard. A painfully lousy decision. How many of us who use Panadeine etc occasionally and yes, ‘for pain’ will start stockpiling soon? More work for already harassed GPs and more expense for patients.
This decision is such a stinker, I suspect (and hope) it will end up being quietly dropped before it’s actually imposed on the poor suffering masses.
There’s still a whole year of outrage to go.
Bernard, in health care we use this thing called evidence. E-V-I-D-E-N-C-E. Same creature you’ve been calling for in other areas of public policy.
The evidence for codeine is not pretty. In double blind trials (the gold standard) codeine/paracetamol combinations are no more effective than paracetamol alone. Similalry in double blind trials codeine/ibuprofen combinations are no more effective than ibuprofen alone. In addition codeine is actually an inactive compound. It relies on conversion in the body to morphine to work. Except anywhere between 10 and 20 % of the population don’t actually have this enzyme, so for them codeine does precisely nothing. Zip. Zilch. Nada. Not a thing. No effect at all. Not even a smidgen of effect. A smaller subset of the population are rapid or hyper metabolisers. They get pronounced nausea, chest pains, and stomach cramps when they take codeine. Any other drug that was inneffective or not tolerated by 25% of the population wouldn’t be available at all, not even on prescription, and you’d probably be one of the first in the commentariat to be saying so.
Then we have the problems with addiction and overdose. So the evidence for codeine is pretty bleak.
This is actually what you so often bewail as missing in our public life – good public policy.
And yet it works great for me and my osteoarthritis. Apart from that, I saw precious little real evidence used in the KPMG report. KPMG should work exclusively for either Donald Trump or Peter Dutton, both well known for not requiring facts to help them to a conclusion.
For those for whom it doesn’t work, they can be trusted not to use it (I know this because I know such people).
For those whom it makes sick, well I suspect they can also be trusted not to use it. I also know people who have been prescribed oxycodone etc who don’t fill their prescriptions because it make them sick.
The problems with addiction and overdose have been far from adequately documented. For instance, how bad can the addiction problem be if such large proportions of the population get either nothing or sick from using it? The problem with overdose (and here I’m probably using at least as many facts as you have) is more likely to be from liver failure from overuse of paracetamol or ibuprofen (you know … say 8 tablets per day over a shortish period will achieve that). With the current tablets, barring a really stupid attempt to commit suicide, you won’t overdose on codeine.
So, Jackson, your comment, just like the self-serving pronouncements I’ve been hearing on TV, simply don’t add up. It isn’t even close to good public policy. It’s a stitch-up to benefit someone financially, I suspect, at a huge cost to the community. They’ve been trying for a couple of years now, whoever they are, and now they’ve finally found a bureaucracy and a government stupid enough to fall for it.
It’s still a poor drug. The dose in the over the counter form is homeopathic. Those who say they get benefit from it (such as yourself) show the same increased efficacy as those given a placebo. Perception bias is at play here.
In larger doses (paracetamol 500 mg/ codeine 30mg) it does have extra benefit. That’s known as panadeine forte and has always required a prescription. This decision doesn’t change the availability of that combination, it’s still prescription only. It’s also where most of the addiction and overdose issues arise.
And oxycodone causes side effects because it is an effective opioid. The side effects and the pain relief go hand in hand.
This decision was killed off last time by big pharma and the retail pharmacy mafia. When those two say they want to keep something then that’s when it’s time to get suspicious.
And you may say what you like. Many studies have shown that different people respond in different ways. Aspirin and ibuprofen type drugs worked well for me, but I cannot take them as I have to take warfarin. Paracetamol unaided is a bloody waste of time, as a good many studies have also shown where joint pain is involved. If it is pain enough to bother me panadol is useless. Panadeine works. My mother was the same. I do not live where there is a doctor on tap at a moment’s notice and I probably use panadeine a few days a month. I already had to show my photo ID at my pharmacist so the whole thing is bullshit.
Well said. This is the important evidence that codeine is not a very good medicine. Since codeine exerts any effect at all only by being metabolised to morphine, but only some people, some experts in pain management want to see codeine taken off the market altogether and replaced by appropriate (usually low) doses of morphine if and when any opiod is needed.
A black market in scripts and codeine is coming.
We already have that, my friend.
Plainly silly, and like many others, I – having regular severe toothache spreading through the jaw – will suffer if it goes through. Just a niggle about the term ‘nanny state’ though. The nanny state, to me, is one which intervenes to foster the safety and wellbeing of all its charges – just like old fashioned nannies used to. This, seatbelt legislation, anti smoking/assistance for quitting smoking campaigns, import controls on flammable nightwear and so on. There’s barely one of those that I don’t accept and heartily endorse. The sort of ‘policy’ sneaking through now is that of a bullying state. The overall safety and wellbeing of the mass of Australians is clearly not its driver.