The ANZSPM is pushing for a longer notification period for the withdrawal of essential drugs and PBS listing for substitutes. A little help from Big Pharma would be good too.
Within one year, at least six pain-relieving medications have been withdrawn from the Australian market, says the Australia New Zealand Society of Palliative Medicine.
While some overseas-registered substitutes have been made available by the TGA, cost is massively prohibitive.
The effects are being acutely felt within the palliative care sector.
Speaking to The Medical Republic, president of ANZSPM Dr Michelle Gold said GPs and doctors within palliative care, who have carefully curated pain medication regimens, are being forced to start from scratch.
“A really common part of [regimens] is oral liquid morphine, which is now not available in many, many parts of the country,” she said.
“GPs are having to find out what local pharmacies have available, that’s time consuming.
“If there isn’t any reasonably locally available morphine mixture, then they are having to convert to another form of medication for a lot of their patients and there’s always a risk that the second drug doesn’t suit them.”
Substitutes can cause unwanted side effects or be less effective, said Dr Gold, and with the rapid pace of change of what’s available, doctors and patients are left in the lurch.
A number of variations of slow and immediate release oral liquid morphine – which is particularly helpful in paediatrics and for other patients unable to swallow pills – have been withdrawn over the past year.
But it’s not the only pain medication that has been withdrawn from the Australian market.
“There’s another one called Jurnista, which is a long-acting hydromorphone, a cousin of morphine if you like,” Dr Gold told TMR.
“[It’s] particularly useful for a group of patients that may have kidney or liver impairment or who don’t tolerate morphine for another reason.”
According to Dr Gold, the circumstances are particularly dire in rural and remote communities.
“[GPs] might have to try a little bit of trial and error to find out the right dose [for a new regimen],” she said.
“All of it takes extra visits, extra effort on the part of the patients and the doctors, and that’s even more magnified if you happen to be practicing somewhere regionally or rurally where there may not be many pharmacies.
“So, there’s an inequality there as well.”
The S19 process for accessing substitutes drugs can also be complex and costly, she said in a release.
“If a medicine is listed under S19A as being a substitute for the PBS listed medicine, this alternative may very well not have PBS listing, so that medicine is very expensive,” she said.
“For example, morphine liquid can be up to 10 times more expensive.
“Even worse is hydromorphone slow release. Previously, a pack of 100 x 32mg tablets of the Australian product would be $182. This has been removed from the market and the overseas alternative is $4209 for 100 tablets, which is 23 times more expensive.
“I am sure anyone can see the problem here.”
ANZSPM called for PBS listing for all substitute medicines, as the inequity in end-of-life care caused by the cost disparity was “unacceptable”.
Dr Gold told TMR that, as far as she’s aware, there was no legislative measure for the government or doctors to compel companies to apply for PBS sponsorship, meaning it is entirely at the behest of Big Pharma.
“One might think that with Big Pharma able to make profits in all sorts of areas, it wouldn’t be unreasonable for them to have some expectation of providing an essential medication.”
According to Dr Gold, despite flagging the issues with the government early on, it seems little has been done.
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Dr Gold told TMR that fixes were “complicated”, but one of the easiest first steps would be increasing the minimum notification period for withdrawal of essential medications from six to 12 months.
She called on the government to take more notice.
“I’ve been in palliative medicine for 25 or so years and I feel like we’re in a more difficult position now than we were when I started in terms of having flexibility to really tailor good pain management for individual patients,” she said.
“That just seems unbelievable.
“I think part of it will be simply the size of the Australian market, then there has obviously been the opioid crisis, people have been particularly aware of that in America and there may be some reticence of companies to take on extra risk in that regard.
“Patients receiving end-of-life care deserve better than what we can offer today.”
