It Really Is A Bit Silly That We Are Having So Many Medicine Shortages

This appeared last week:

Why can’t I pick up my prescription? Australia’s medicine chaos explained

ADHD drug shortages wreak havoc on patients returning to work and school. It is just one symptom of Australia’s ailing medicine access systems, explained here.

James Dowling

9 February, 2025

Just in time for the return of children to school last week, federal health authorities advised of yet another shortage of a medication for those with ADHD.

This time the drug Concerta – a brand of methylphenidate – has “limited availability” across eight dosages, with half of the dosage shortages set to resolved by the end of May, while the other dosages will remain scarce until at least the end of the year.

Adults with ADHD and parents of children with the condition will now need to go pharmacy-hopping in search of supplies, or get a new prescription from their doctor.

It’s a familiar scenario: there were shortages of Vyvanse from August 30 to October 21 last year, and Ritalin was scarce until just a few weeks ago, until more became available on January 24.

Of course drug shortages are not unique to ADHD medications.

Australia is in the midst of drug shortages for a range of conditions, coupled with a subsidy system that is almost unanimously deemed flawed.

Delving into the details of why the supply of ADHD medication is so disrupted shows why so many other Australians cannot get the treatment they need at the time and the price they should.

In the case of Concerta, the Therapeutic Goods Administration cited “manufacturing errors” for causing the shortage.

But ADHD drugs are one of the most chronically inaccessible categories of medicine, with worldwide shortages attributed to spikes in demand.

Until 2021, there were no government-subsidised ADHD medications available in Australia for adults, which meant patients could be paying anywhere from tens to hundreds of dollars for near-identical drugs.

Australasian ADHD Professionals Association president David Coghill said between past subsidy delays and the present rolling shortages, affordable and accessible ADHD prescriptions had never been a reality for Australian adults.

“It’s not just about access to medication, because there are workarounds for these shortages of medication, but for many people, it’s really hard to access their healthcare providers because healthcare providers are (in) short (supply) and waiting times are long,” Professor Coghill said.

“If people’s ADHD medication is not optimal, then they struggle. Kids struggle at school, they struggle in out-of-school activities, so sport or music, and they struggle at home and then out with their peers. There are really big issues for kids, and for adults it’s the same. They don’t just struggle at work.”

Australian supply is reliant on foreign drug companies, which also work under mandates from the US Drug Enforcement Agency, which sets production caps on controlled substances, namely the active ingredients in stimulant-based ADHD drugs.

It means many companies cannot scale up production to meet demand even if they wish to, leaving access “patchy”.

“ADHD medication shortages are disruptive at any time, but they can be particularly stressful when people rely on them for school or work,” said Royal Australian and New Zealand College of Psychiatrists president Elizabeth Moore.

“When there are shortages, we see people feeling they need to ration or save up their medication to avoid running out. They might have exams coming up and are worried they won’t be able to get their prescription filled.

“It’s possible for people to switch to an alternative medication, and for some people this may be necessary. But this means additional appointments with their prescriber and possibly facing long wait lists and out-of-pocket costs due to a shortage of psychiatrists. With many people facing cost-of-living pressures, this is another source of stress for them.”

The systemic flaws that have caused the supply disruption for ADHD apply equally to other medications.

Medicine in Australia

Medicine access infrastructure in Australia is divided among a web of agencies independent of government, each with a siloed assessment process. To enter the country however, all drugs must go through the TGA, which is tasked with determining the safety, quality and viability of a drug.

Any number of stakeholders may have a role in supplying a drug or treatment once it has TGA approval, namely pharmacist wholesalers, hospitals, state health authorities and the Health Department if it is providing a federal access program. Despite the TGA having no direct role in supplying medicines to these stakeholders, it is the appointed body for managing access during a supply shortage.

While a drug will technically be available nationally after TGA approval, it will retail at the price set by its producer, often costing hundreds or thousands of dollars per dose, and is often geographically constrained. In order for the federal government to consider subsidising a drug, it must be rubber-stamped by the Pharmaceutical Benefits Scheme.

The PBS is also an independent evaluator, though its task is to find the cost-effectiveness and public necessity of certain drugs. For vaccines and immunisations, after TGA approval they go to the Australian Technical Advisory Group on Immunisation before potential listing on the National Immunisation Program

The NIP and PBS sit along with the Medicare Benefits Schedule, which lists all the treatments and medical services covered by the government. Collectively they make up the government’s Health Technology Assessments

Compared to the TGA, the approval process of the PBS – managed by another assessment body called the Pharmaceutical Benefits Advisory Committee – faces far harsher criticism. It has fewer mechanisms to scale up in line with demand, meets less frequently and faces longer delays on its decisions.

It is a system that even the government concedes is unfit for purpose, having commissioned three different assessments in recent years. The most recent was the Health Technology Assessment review, which provided 50 possible reforms, including a potential bridging fund to drive affordability during protracted evaluation periods.

Subsidy delays

From November last year, an investigative series by The Australian found PBAC was teetering on the brink of an administrative meltdown. A series of private communications between the PBS, the Health Department and drug companies whose products were affected showed 45 drug decisions had been pushed from the agenda of a thrice-yearly PBS meeting. Of those delayed, 24 were deemed “major” submissions.

The moment this was made public knowledge, Health Minister Mark Butler intervened to organise a special meeting to take on extra submissions and mitigate delays.

In the months since, stakeholders have been left fearing a future policy that caps the number of submissions considered each year. While plans for such a policy are stringently denied by the Health Department and PBS, both agencies have acknowledged the practical limitations of their assessors in private documents, and the PBS advised it would institute a “maximum total number” of drugs considered at each meeting since its mass deferral in late October.

While some subsidy decision delays may only hold back access to drugs with plentiful alternatives, or impact alterations to existing subsidies, it has previously affected cancer treatments, chronic-disease medications and drugs for conditions with no readily available alternative.

The Health Department estimates the PBAC will require years of work to reform, all the while being battered by a rising rate of submissions routinely beyond capacity.

Medicine shortages

Independent to the struggles of the PBS and PBAC, major medical groups have lobbied for reform to the TGA’s medicine shortages strategies, hoping to get one step ahead of an increasingly unpredictable international market.

Australia has a very limited local drug production industry, leaving it reliant on global supply chains that the Covid pandemic proved to be fraught.

There are currently more than 400 ongoing drug shortages, according to the TGA’s shortage database, while the Royal Australasian College of Physicians estimates 27 per cent of Australians are experiencing a shortage in a prescription drug they rely on.

With a consultation process under way to seek remedies to the chronic shortage, a slew of criticisms generally relegated to discussion within the medical community have made their way into public view.

Ongoing medicine delays

417 ongoing shortages (38 critical) with 68 more projected (8 critical)

Ozempic		April 15, 2022	December 31, 2025	1356 days
Morphine Juno (painkiller)		March 22, 2024	April 1, 2025	375 days
Saline IV fluid		July 26, 2024	Indefinite	N/A
Methylphenidate/Ritalin (ADHD)		November 28, 2024	31 December, 2025	398 days
Naxolone (overdose)		December 10, 2024	31 December, 2025	386 days
Insulin		December 20, 2024	January 31, 2025	42 days

 

Source: Therapeutic Goods Administration medicine shortage reports database (non-exhaustive)

The Australian Medical Association, Pharmacy Guild and RACP all called for more transparent information sharing and a dedicated authority for pre-empting and mitigating access droughts.

Currently ad hoc working groups are formed to respond to specific shortages as they arise, though a dedicated Medicine Shortage Work Party was formed during the pandemic and disbanded in 2021.

The AMA made its pitch for a single regulator, which the Guild echoed, having seen its prior appeals for the return of the Medicine Shortage Work Party denied.

Beyond shortages of ADHD medicine, drugs also regularly affected include hormone replacement therapies, weight loss drugs and opioid painkillers. In the recent past, federal access schemes, like the Take Home Naloxone program, have been undermined by rocky access.

Here is the link:

https://www.theaustralian.com.au/health/why-cant-i-pick-up-my-prescription-australias-medicine-chaos-explained/news-story/4482896fd4a957cf71664ceea7154dac

As an outsider it seems to me we are faced with a political and bureaucratic ‘stuff up’ where no one feels responsible to fix what are obviously long lasting, dangerous and annoying problems.

Maybe we could see the bureaucrats earn their pay and actually get on top of these issues or is that too much to ask?

Knowing there is a major issue and just abandoning a working party tasked with fixing the problems is just typical….

As some are often prompted to say – “God give us strength”

Worrying about vapes etc. when life saving drugs are hard to obtain talks to some distorted priorities I believe!!!

David.

Clearly The Systems That Approve Individuals To Be Employed In NSW Health Are Failing!

This report appeared today:

This appeared this morning

NSW Health nurses suspended over antisemitic video

Paul Karp NSW political correspondent

Feb 12, 2025 – 11.48am

Two nurses at Sydney’s Bankstown hospital have been stood down by NSW Health after an antisemitic video emerged online of them claiming they would refuse to treat and would kill Israeli patients.

State Health Minister Ryan Park said the video was the most “vile, shocking and appalling video” he had ever seen, and would be investigated by both NSW Health and the NSW Police, including for potential breach of hate speech laws. Police confirmed that Strike Force Pearl was investigating.

The NSW Health Department has called in police after footage surfaced appearing to show Bankstown Hospital workers bragging about killing Israeli patients.

In the video, a woman in a NSW Health uniform claims that she “won’t treat” Israeli patients and would “kill them”, while a man who falsely identified himself as a doctor said he had “literally sent” Israel patients to “jahannam” (hell).

Mr Park said the two had been identified and stood down just hours after the video – believed to have been taken during a night shift on Tuesday evening or Wednesday morning – was shown to the government.

At a media conference at NSW parliament, Mr Park addressed the Jewish community, saying he was “very sorry” and promising the two nurses “will not ever be working for NSW Health again”.

“There is no place in our hospitals or health system for this sort of view to ever take place.”

The investigation includes a referral to the Health Care Complaints Commission, to include the standard of care the hospital and nurses have given patients.

But Mr Park said that after an initial rapid review of patient incidents, the hospital appeared to be operating with the proper level of safety and care of patients.

NSW Health Minister Ryan Park says two hospital workers filmed making antisemitic comments and bragging about killing Israeli patients have been stood down, with a police investigation now under way.

The video was published by a Jewish influencer who encouraged followers to share it to ensure the nurses he interviewed were fired. “There’s no way such people should work in medicine,” he said in the video.

In the video the woman tells the influencer, “It’s Palestine’s country, not your country you piece of shit.” The man says: “I’m a doctor, my man, in a hospital. You’re going to get killed and you’re going to go to jahannam, inshallah [God willing].”

Premier Chris Minns said the video was “hugely distressing” and would be met with a full response from NSW Health and NSW Police.

He told 2GB Radio the pair “will not be back in the NSW Health system” but a full investigation was required to make sure “there’s not a glimmer of hope of some kind of administrative turnback”.

NSW Health secretary Susan Pearce condemned “in the strongest possible terms” the behaviour of the two nurses. “Never in my wildest dreams did I think I would be standing here with two staff members of NSW Health system having said such horrendous things about our community, particularly our Jewish community.”

Federal Health Minister Mark Butler, said the video “makes me sick to my stomach”.

“The idea that you would single out a particular group in our community and indicate you wouldn’t care for them runs against every single principle in our healthcare system,” Mr Butler said in a statement.

“At a time of unprecedented antisemitism in our country, this is a particularly sickening video.”

– with Tom McIlroy

 Here is the link:

https://www.afr.com/policy/foreign-affairs/nsw-health-nurses-suspended-over-antisemitic-video-20250212-p5lbh1

What a lovely pair! I am amazed to see such hate-filled material from health professionals in Australia. Pretty sad to say the least!

This pair really should go back to where they came from! They are not worthy of living here IMVHO!

David.

It Makes Good Sense To Help Individuals Lose Weight If The Are Significantly Overweight

This appeared last week:

Big pharma steps up push for taxpayer-funded weight-loss drugs

Michael Smith Health editor

Feb 9, 2025 – 1.00pm

Novo Nordisk and Eli Lilly have asked the federal government to list their blockbuster weight-loss drugs on the Pharmaceutical Benefits Scheme, arguing funding the treatment will reduce a costly obesity crisis.

Novo Nordisk, the Danish pharmaceutical giant that makes Ozempic and Wegovy, used a submission to the government’s budget process to push for the inclusion of so-called GLP-1 drugs on the PBS for chronic weight management. It said not doing so would be more expensive in the long term.

“Novo Nordisk recommends decisive action, including increased investment in health promotion, integrated disease prevention and care, and expanded access to pharmacotherapy. The cost of inaction is far greater than the cost of intervention,” the company said in its submission.

Eli Lilly, the American company that makes a rival weight-loss drug called Mounjaro, has also called for the obesity drugs to be listed on the PBS in its pre-budget submission. The Eli Lilly submission has not been made public, but people briefed on its contents confirmed the inclusion.

A PBS listing means the government subsidises most of the cost of a drug. Ozempic is listed on the PBS but only to treat people with diabetes rather than obesity. Novo Nordisk plans to resubmit an application to have Wegovy listed with the Pharmaceutical Benefits Advisory Committee, this year.

Pharmaceutical companies argued there were economic benefits to improving access to the drugs, which sell for between $345 and $645 per month, because a reduction in the number of obese people would take the pressure off the health system in the future.

Novo Nordisk last week reported a 29 per cent increase in fourth-quarter earnings to 28.23 billion Danish kroner ($6.3 billion) as sales of Wegovy jumped 107 per cent year-on-year. Eli Lilly on Friday said fourth-quarter sales surged 45 per cent to $US13.53 billion ($21.5 billion). The companies do not break down sales data for specific countries, including Australia.

Novo Nordisk’s pre-budget submission said chronic disease was the leading health challenge in Australia, affecting 61 per cent of the population and accounting for 91 per cent of preventable deaths. Its submission said obesity was a major contributor and 6.3 million Australians were obese, with the number expected to rise to 47 per cent of adults by 2035.

Doctors say while the drugs are proven to help people lose weight there is still a lot they do not know about the long-term effects of managing fat chemically and that it is important to lead a healthy and active lifestyle. The drugs are taken once a week by an injection.

The latest move by the drug companies reopens the debate about whether taxpayers should subsidise the new class of medicines. Last year, Mounjaro was made available on Britain’s public healthcare system to some patients.

Jonathan Karnon, a health economist at Flinders University, said it would be more difficult to convince the Australian government because of the way that subsidising those drugs would affect the federal budget.

“It will be interesting to see what happens in England because it affects local budgets, whereas in Australia, it affects the Commonwealth government’s budget and so the effect on the budget is of greater concern to those making decisions about whether the GLP-1s should be funded,” he said.

‘Unaffordable for many Australians’

Patients groups said GLP-1s were unaffordable for most Australians and some funding should be provided.

“Given that GLP1-s remain unaffordable for many Australians who could benefit from them, some form of government-funded access needs to be on the horizon. That said, government funding must remain contingent on the usual processes assessing value for money against benefit to patients,” Lisa Robins, chief executive of the Australian Patients Association said.

Woolworths-backed telehealth business Eucalyptus, which has earned more than $100 million from weight-loss services over the past 18 months from its operations in Australia, Japan, the United Kingdom and Germany, said a PBS listing was needed to tackle obesity in Australia.

“As we have seen recently, the Australian Institute of Health and Welfare has released figures showing that for the first time obesity has surpassed smoking as the leading risk factor contributing to death. This underlines the importance of ensuring patients have access to care,” Matt Vickers, the clinical director of Eucalyptus subsidiary Juniper said.

While a PBS listing could be restricted to a defined group of obese people with related health risks or the number of subscriptions capped, the popularity of the drugs and their wide use means government bureaucrats will be wary of approving a listing that could potentially bankrupt public healthcare systems if too many people wanted them.

Academics studying the take-up of GLP-1s said the lack of hard data on how many Australians were taking them was alarming, but they estimated the numbers were in the hundreds of thousands. Studies in the US suggest that between 8 per cent and 12 per cent of Americans are taking them.

Michael Smith is the health editor for The Australian Financial Review. He is based in Sydney. Connect with Michael on Twitter. Email Michael at michael.smith@afr.com

Here is the link:

https://www.afr.com/companies/healthcare-and-fitness/big-pharma-steps-up-push-for-taxpayer-funded-weight-loss-drugs-20250206-p5la1a

All this raises a lot of issues in my mind about the mass medication of a large number of people and just how both the costs and the side-effects would be managed.

There is certainly a strong case for use in the significantly obese as this will save lives etc. but how the costs (which will be significant) and the allocation of these meds will be managed will be a real challenge I suspect. Many clever bureaucrats will have to work out how all this will work given the large scale need, and the costs involved.

A real watch this space moment!

David.

I Have The Sense That The US System Of Government Is In For A Pretty Major Stress Test!

This appeared a day or so ago….

Judge extends brake on Musk’s Treasury raid, summons Trump to court

Hurubie Meko and Qasim Nauman

Feb 9, 2025 – 10.41am

A US federal judge in New York has temporarily restricted access by Elon Musk’s government efficiency program to the Treasury Department’s payment and data systems, saying there was a risk of “irreparable harm”.

The Trump administration’s new policy of allowing political appointees and “special government employees” access to these systems, which contain highly sensitive information such as bank details, heightens the risk of leaks and of the systems becoming more vulnerable than before to hacking, US District Judge Paul Engelmayer said in an emergency order late on Saturday (Sunday AEDT).

Judge Engelmayer ordered any such official who had been granted access to the systems since January 20 to “destroy any and all copies of material downloaded from the Treasury Department’s records and systems”. He also restricted the Trump administration from granting access to those categories of officials.

The defendants – President Donald Trump, Treasury Secretary Scott Bessent and the Treasury Department – must appear in February before Judge Jeannette Vargas, who is handling the case on a permanent basis, Judge Engelmayer said.

The White House called the ruling “absurd and judicial overreach” and attacked the judge as an “activist”.

“Grandstanding government efficiency speaks volumes about those who’d rather delay much-needed change with legal shenanigans than work with the Trump administration,” Harrison Fields, a spokesman, said in a statement.

Fundamental test

The situation could pose a fundamental test of America’s rule of law. If the administration fails to comply with the emergency order, it is unclear how it might be enforced. The Constitution says that a president “shall take Care that the Laws be faithfully executed”, but courts have rarely been tested by a chief executive who has ignored their orders.

Federal officials have sometimes responded to adverse decisions with dawdling or grudging compliance. Outright disobedience is exceedingly rare. There has been no clear example of “open presidential defiance of court orders in the years since 1865”, according to a Harvard Law Review article published in 2018.

Saturday’s order came in response to a lawsuit filed on Friday by New York Attorney-General Letitia James along with 18 other Democratic state attorneys-general, charging that when Mr Trump had given Mr Musk the run of government computer systems, he had breached protections enshrined in the Constitution and “failed to faithfully execute the laws enacted by Congress”.

The lawsuit was joined by the attorneys-general of Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, North Carolina, Oregon, Rhode Island, Vermont and Wisconsin.

They said the president had given “virtually unfettered access” to the federal government’s most sensitive information to young aides who worked for Mr Musk, who runs a program the administration calls the Department of Government Efficiency, or DOGE.

While the group was supposedly assigned to cut costs, members are “attempting to access government data to support initiatives to block federal funds from reaching certain disfavoured beneficiaries”, according to the suit. Musk has publicly stated his intention to “recklessly freeze streams of federal funding without warning”, the suit said, pointing to his social media posts in recent days.

In her own social media post on Saturday, Ms James reiterated that members of the cost-cutting team “must destroy all records they’ve obtained” and added, “I’ve said before, and I’ll say it again: no one is above the law,” she wrote.

New Jersey’s attorney-general, Matthew J. Platkin, said in a post on Saturday that the injunction meant “the world’s richest man has been stopped from stealing your data”.

Efforts to reach press officers at the White House were not immediately successful.

In a statement on Thursday, after the attorneys-general said they would sue, a spokesperson for the president said that Mr Musk’s team was acting legally. “Slashing waste, fraud and abuse, and becoming better stewards of the American taxpayer’s hard-earned dollars might be a crime to Democrats, but it’s not a crime in a court of law,” said the spokesperson, Harrison Fields.

Although the court order mandates an immediate halt to Mr Musk’s employees’ access to the Treasury Department’s payment system, it was not immediately clear when or if they would fully comply. Nor was it clear how the attorneys-general would monitor the administration’s actions.

In a previous action, 23 attorneys-general sued Mr Trump’s freeze of federal grants and won a temporary pause on January 31, with a judge ordering the administration to stop withholding funds. However, on Friday, the coalition appealed to the judge again, saying that the money was still being withheld from states, grantees and programs.

Musk unconstrained

Mr Trump has had scant success in the courts in years past. His first administration succeeded in only about 23 per cent of the legal challenges against the actions of his agencies, a review found, while prior administrations won about 70 per cent of the time.

But Mr Trump’s new term is already a thing apart.

The administration’s “shock and awe” approach since he was inaugurated last month has seen new policies and actions arrive at breakneck speed. On his first day in office, Mr Trump pardoned members of the mob that attacked the Capitol on January 6, 2021. He has signed dozens of executive orders, withdrawn the country from international agreements and even tried to install himself as chair of the John F. Kennedy Centre for the Performing Arts in Washington.

The aggressive approach is beginning to be tested by scores of lawsuits on a host of issues, but the legal system’s ability to restrain the administration remains uncertain.

If federal officials fail to comply with the Saturday order limiting DOGE, the judge may hold them in contempt, said Daniel Richman, a Columbia Law School professor and a former federal prosecutor in New York City. Courts have done that in the past, he said, “albeit rarely.”

“A contempt citation can come with fines, more likely imposed on the officials rather than the government itself, and even possible imprisonment,” Mr Richman said.

In 2002, then-interior secretary Gale Norton was held in contempt for failing to fix the department’s management of billions of dollars in royalties earned on American Indian land. The following year, a federal appeals court found that she could not be held in criminal contempt for problems that existed before her tenure.

Although contempt findings can be “devoid of sanction, they nonetheless have a shaming effect”, which is often enough to spur officials to compliance, Nicholas Parrillo, a professor at Yale Law School, wrote in the 2018 Harvard Law Review article.

However, he wrote, the “rise of partisan polarisation could potentially fracture the pro-compliance community so badly that members of one party would refuse to acknowledge the shame of a contempt finding against a member of their own camp”.

Since Mr Trump entered office last month, Musk has so far been unconstrained. When DOGE first turned its attention to the Treasury Department, a top official refused to give members access, leading to a standoff. The official, David Lebryk, was put on leave before suddenly retiring.

Almost immediately, Mr Musk’s team was given access to the government’s most fundamental computer data, including the US Treasury Department’s payment system, which is used to disburse funds including Social Security benefits, veterans’ benefits and federal employee wages.

The system – which channels about 90 per cent of the payments for the US government, which spent about $US6.75 trillion last fiscal year – pays funds directly to people in the states as well as to state governments, the suit says.

Before Mr Trump took office last month, access was granted only to a limited number of career civil servants with security clearances, the suit said. But Mr Musk’s efforts had interrupted federal funding for health clinics, preschools and climate initiatives, according to the filing.

The money had already been allocated by Congress. The Constitution assigns to legislators the job of deciding government spending.

“President Trump does not have the power to give away Americans’ private information to anyone he chooses, and he cannot cut federal payments approved by Congress,” Ms James said in a statement. “Musk and DOGE have no authority to access Americans’ private information and some of our country’s most sensitive data.”

Here is the link:

https://www.afr.com/world/north-america/judge-extends-brake-on-elon-musk-s-treasury-raid-summons-trump-to-court-20250209-p5lanh

It will be interesting to see if the centre holds here and that if Mt Musk is contained in what he can actually do without due and proper process! The next month or two will be very interesting I believe!

My view is that Mr Musk should stick to making cars and rocket-ships which he seems pretty good at and let the system get on with what is has done for the last few hundred years!

Will be fun to see how it all plays out!

David.