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.
